In Vitro Diagnostic (IVD) Reagents, Research Biochemicals ... · monitoring of anticoagulant...

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Dear Valued Customers,

In the 14 years since its foundation in 1999 Hyphen Biomed has established itself as a key player in all areas of the Thrombosis and Heamostasis marketplace including routine and research biomedical laboratories, the biotech and pharmaceutical industries whether they are involved in drug discovery, marketing of extracted or recombinant blood derived products or anticoagulant anti-thrombotic treatments.

We continue in our commitment to offer highly innovative products, backed up by high quality and service that we bring to the scientific and medical fields. Hyphen is dedicated to use the best expertise and experience we have acquired to achieve these goals.

This catalogue contains not only unique products but also a comprehensive line of standardised and optimised diagnostic kits for diagnosis of Thrombosis and Hemostasis. These areas are complemented by custom manufacture to the specific needs of industry.

Please note in this catalogue special focus is given to the testing of the new anticoagulants with kits, calibrators and controls developed by us.

Discover all our innovations on our website at www.hyphen-biomed.com or contact us at +33 1 34 40 65 10.

3

*Kits and biochemicals presentation in this catalogue are subjected to minor changes when required; this catalogue content presents our offer but is not contractual.

IntroductionTable of ContentsExplanation of symbols used

134

36373839

PART 5 : LUPUS ANTICOAGULANTS ANDANTI-PHOSPHOLIPID ANTIBODIES (ACA/APA) 35

43PART 6 : CALIBRATORS AND CONTROLS

PART 8 : EXPLORATION OF FIBRINOLYSIS 61

Assays for fibrinolysis proteinsCardiovascular (liquid technology)

6265

PART 7 : AUXILIARY REAGENTS 55

Plasma factors and cofactorsHeparin and analoguesFactor V-LDirect Thrombin InhibitorsDirect FXa inhibitorsNon titrated human plasmas (normal)Enzyme immuno-assaysELITEST line of cardiovascular assays

4445484950515154

Reference materialELISA SubstratesBuffers for chromogenic assaysBuffers and solutions for clotting assaysBuffers and solutions for ElisaSolutions for microparticles

565656575960

PART 1 : ROUTINE ASSAYS 5

PART 2 :MEASUREMENT OF PLASMA FACTORSand their activated forms 9

PART 3 : THROMBOPHILIA 20

Antithrombin III activity and antigen Protein C activity and antigen Protein S activity and Protein S Free and Total antigens Protein Z antigen Factor V-L (involved in APC resistance) Heparin CoFactor II activity D-Dimer Thrombin generation (release of FPA) Lupus anticoagulants Microparticles

2122

2324252526262626

PART 4 : ANTICOAGULANT DRUGS 28

Heparin and heparin like substancesHeparin Induced Thrombocytopenia (HIT)Monostrip HIT

293133

Prothrombin Time (PT) reagents Activated Partial Thrombin Time (aPTT) reagents Thrombin Time Fibrinogen

66, 7

78

Prothrombin activity Factor V activity and antigen Factor VII activity and antigen Factor VIIa activity Factor VII+X activity Factor VIII:C activity Auto-antibodies to Factor VIII:C Factor IX activity and antigen Factor IXa activity Factor X activity and antigen Factor XIa activity Factor XIII antigen Von Willebrand Factor antigen and activity Deficient plasmas, immuno depleted

1010111212121313141414151516

29Heparin

34New Oral anticoagulants (NOACs: dtiS, DiXAIs)

3434

Direct thrombin inhibitorsDirect FXa inhibitors

Table of Contents*Diagnostic and research reagents for Thrombosis, Hemostasis and Autoimmunity

Lupus anticoagulantsAnti-Cardiolipin/Anti-phopholipid antibodies (ACA/APA)Anti-β2GP1 auto-antibodies Auto-antibodies to Phospholipid cofactor proteins

Pricing and orderingTerms and conditions of saleIndex

959697

PART 9 : AGGREGOMETRY 66

Recombinant human proteins

IMMUNOCHEMICALS

ANIMAL MODELS

83

89

92

Human enzymes 84

Human enzymes 78

Bovine proteins

Polyclonal antibodies

Bovine enzymes

Monoclonal antibodies

Other proteins and enzymes

Miscellaneous

86

89

87

91

88

88

Cross-reactivities with homologous animalproteins for the various ZYMUTEST kits 93

Hemostasis and Fibrinolysis human proteinsMiscellaneous Vitamin K dependent proteinsPlatelet proteins

78818182

Rat �brinolysisRat biochemicalsRat immunochemicals

929293

ADPEpinephrineArachidonic AcidRistocetinCollagenLyophilized platelets

676767686868

94GENERAL INFORMATION

Substrates for ThrombinSubstrates for Factor XaSubstrate for Activated Protein CSubstrate for KallikreinSubstrate for Plasmin and Plasminogen – SKSubstrate for Factor IXaSubstrate for UrokinaseBroad spectrum substrate for tPA

7474757575767676

Chromogenic substrates 74

Other Hemostasis proteins 72

Thrombosis and vascular diseases 70

Table of proteins involved in Hemostasis and Fibrinolysis 77

Fluorogenic substrate for Factor Xa 76

Fluorogenic substrates 76

74BIOCHEMICALS

READY TO USE ASSAYS

BIOLOGICALS

EXPLANATION OF SYMBOLS

*Kits and biochemicals presentation in this catalogue are subjected to minor changes when required; this catalogue content presents our o�er but is not contractual.

The symbols below indicate the intended use and regulatory status of the products in various countries.

These kits are intended for In Vitro Diagnostic Use in countries where they are appropriately marked, cleared, approved, or licensed.

These kits are intended for Research Use Only in all countries and are not intended to be used for diagnostic procedures.

These kits are manufactured in compliance with the 98/79 CE Directive for In-Vitro Diagnostic devices. Only CE marked products can be used for diagnostic applications in Europe.

These kits are cleared by the US FDA for in vitro diagnostic use in the United States.

HYPHEN BioMed,An ISO 9001 and ISO 13485Certi�ed company

IVD

RUO

CE

510(k)

4

PART 10 : RESEARCH KITS 69

High sensitivity C-Reactive Protein (CRP)Tissue FactorPlatelet markers

707071

Plasma factors(Annexin V, B2GPI, Fibrinogen, Fibronectin)

72

78

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PART 1 :

ROUTINE ASSAYS

Complete line of routine assays for hemostasis testing

PART

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PART 1: ROUTINE ASSAYS

Prothrombin Time (PT)

THROMBOPHENCalcium Thromboplastin CE

#CK550K / CK550M / #CK550L #CK551K / CK551M / #CK551L

Thromboplastin reagents (containing recombinant rabbit tissue factor) for the determination of Prothrombin Time (PT) on citrated human plasma, using a manual, semi-automated or automated clotting method. Two different ISI are proposed: Low ISI (THROMBOPHEN HS) or High ISI (THROMBOPHEN LS).

Pres

enta

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Ready to use reagents

THROMBOPHEN HS (Low ISI)6x2.5 mL (CK550K)6x5 mL (CK550M)6x10 mL (CK550L)

THROMBOPHEN LS (High ISI)6x2.5 mL (CK551K)12x5 mL (CK551M)6x10 mL (CK551L) A

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Total Assay Time: < 5 min.Intra-Assay CV: < 3 %Inter-Assay CV: < 5%

Number of tests: 150 tests (CK550K) 300 tests (CK550M)

600 tests (CK550L)150 tests (CK551K)

600 tests (CK551M)600 tests (CK551L)

Established against the International Standard thromboplastin (rabbit).

Intended use : This test is used to explore a congenital or acquired bleeding tendency (in one of the factors associated with the coagulation extrinsic pathway: Factor II, V, VII, X), liver diseases, vitamin K deficiencies, fibrinolysis, DIC. PT test is the most commonly used coagulation assay for laboratory monitoring of anticoagulant therapy with vitamin K antagonists (VKA) such as dicumarol.

PT does not explore factor deficiencies of the intrinsic coagulation pathway (Factors VIII, IX, XI, and XII), platelets, Factor XIII or natural inhibitors of coagulation (antithrombin, Protein C and Protein S).

CEPHENLupus Anticoagulant ResistantAPTT (intrinsic pathway)

CE #CK511K / #CK512K#CK515K / #CK515L

Reagent, for the determination of Activated Partial Thromboplastin Time (APTT) on citrated human plasma, using a manual, semi-automated or automated clotting method. Low sensitivity to Lupus Anticoagulant.

Pres

enta

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Ready to use reagents

CEPHEN 16x1 mL (CK511K)

CEPHEN 2.56x2.5 mL (CK512K)

CEPHEN 58x5 mL (CK515K)12x5 mL (CK515L)

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Total Assay Time: < 5 min.Intra-Assay CV: < 0.6 %Inter-Assay CV: < 2.5 %Number of tests: 6x10 tests (CK511K) 6x25 tests (CK512K) 8x50 tests (CK515K) 12x50 tests (CK515L)

Intended use : Measurement of the plasma recalcification time, in presence of the standardized APTT (Activated Partial Thromboplastin Time) reagent (cephalin and activator), on human citrated plasma, to explore the activity of the intrinsic pathway coagulation factors (II, V, VIII:C, IX, X, XI, XII) and “anticoagulant” activities.

Activated Partial Clotting Time (APTT)

IVD

IVD

HEMOCLOT Thrombin Time (T.T.)Thrombin Time (Conventional/Bovine Thrombin) CE #CK011K / #CK011L

Reagent for the determination of Thrombin Time (TT) on human citrated plasma, using a clotting method, which can be manual, semi-automatic or automatic. Measurement of the clotting time induced by bovine thrombin, in presence of calcium, on plasma, and exploration of the anti-thrombin activities. Excellent sensitivity to low concentrations of heparin in plasma (from 0.05 to 0.10 IU/mL Unfractionated Heparin (UFH), or from > 0.20 IU/mL Low Molecular Weight Heparin (LMWH) in plasma).

Pres

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Highly purified bovine thrombin (a form)

6x2 mL (CK011K)

6x8 mL (CK011L)

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Total Assay Time: < 2 min.Intra-Assay CV: < 4%Inter-Assay CV: < 6%Number of tests: 6x20 tests (CK011K) 6x80 tests (CK011L)

Intended use : Conventional Thrombin Time, highly sensitive to heparins and thrombin inhibitors.

Thrombin Time (TT)

IVD

HEMOCLOT Thrombin (Human)Thrombin Time with Human ThrombinLow DTI concentrations

CE in progress #CK001K / #CK001L

Optimized Thrombin Time in presence of calcium, designed with highly purified human thrombin, mainly in the a-form, which is very stable (> 7 days at room temperature or > 3 weeks at 2-8°C). This thrombin is obtained by activation of purified human Prothrombin, in presence of factor Xa, Phospholipids, factor V and calcium, followed by the specific purification of thrombin and its stabilization. It is a «True Thrombin Time» using highly purified, fully active, human Thrombin.

Pres

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Highly purifiedhuman thrombin (a-form)

6x2 mL (CK001K)

6x8 mL (CK001L)

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Total Assay Time: < 2 min.Intra-Assay CV: < 4%Inter-Assay CV: < 6%Number of tests: 6x20 tests (CK001K) 6x80 tests (CK001L)

Intended use : Assay proposed for the measurement of Thrombin Time in research applications.

RUO

CEPHEN LSLupus Anticoagulant SensitiveAPTT (intrinsic pathway)

CE #CK521K / #CK522K

Reagent, for the determination of Activated Partial Thromboplastin Time (APTT) on citrated human plasma, using a manual, semi-automated or automated clotting method. This reagent offers a good sensitivity to the presence of Lupus Anticoagulant.

Pres

enta

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Liquid reagent. Ready to use

CEPHEN 1 LS6x1 mL (CK521K)

CEPHEN 2.5 LS6x2.5 mL (CK522K)

Ass

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cs Total Assay Time: < 5 min.Intra-Assay CV: < 0.6%Inter-Assay CV: < 2.5%Number of tests: 6x10 tests (CK521K)

6x25 tests (CK522K)

Intended use : Measurement of the plasma recalcification time, in presence of the standardized APTT (Activated Partial Throm-boplastin Time) reagent (cephalin and activator), on human citrated plasma, to explore the activity of the intrinsic pathway coagulation factors (II, V, VIII:C, IX, X, XI, XII) and “anticoagulant” activities.

IVD

7

8

CALIBRATORS AND CONTROLSRefer to page 43

FIBRIPHENFibrinogen Measurement in Plasma withthe Von Clauss Method

CE#CK571K

#CK572K / #CK575K

Thrombin reagent proposed for the quantitative determination of Fibrinogen in human citrated plasma using a clotting method (Clauss method).

Pres

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Reagent containing calciumthrombin from bovine origin:about 100 NIH/ml.

FIBRIPHEN 16x1 mL (CK571K)



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Total Assay Time: < 3 min.Intra-Assay CV: < 3%Inter-Assay CV: < 4%Dynamic range: 1–12 g/LNumber of tests: 6x10 tests (CK571K)

6x20 tests (CK572K)8x50 tests (CK575K)

Intended use : Measurement of fibrinogen in plasma.Detection of low fibrinogen concentrations.Detection of elevated fibrinogen concentrations (> 4g/L) : In clinical situations associated with inflammation ; Risk factor for cardiovascular disease and thrombosis ; Hypofibrinogenemia, mainly associated with severe liver disease, and excessive consumption of fibrinogen (DIC, hyperfibrinolysis).Numerous variants of fibrinogen described, associated to asymptomatic cases, or to cases with bleeding and/or thrombosis.

Fibrinogen (Von Claus method)

IVD

LIAPHEN Fibrinogen Fibrinogen Latex Immunoassay CE #120102

Latex immunoassay for measuring Fibrinogen in human citrated plasma or in purified milieu (cell culture supernatant), using a manual or automated method, in vitro exclusively.

Pres

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4x5 mL Latex reagent4x25 tests

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Total Assay Time: 20 min.Detection Threshold: 1 µg/mLDynamic Range: 0-10 µg/mLIntra-Assay CV: < 4%Inter-Assay CV: < 8%No hook effect is observed for Fibrinogen concentra-tions < 100µg/mL

No interference is observed for Unfractionated Heparin concentrations < 2 IU/ml in plasma.

The presence of rheumatoid factor may result in an overestimation of the Fibrinogen concentration.

Intended use : Assay of Fibrinogen in human citrated plasma or in cell culture supernatants.

IVD

ZYMUTEST Fibrinogen Fibrinogen Immunoassay #RK024A

Two-site ELISA method for the measurement of Fibrinogen. Assay designed with affinity purified rabbit polyclonal antibodies for coating the ELISA plate and preparation of Horse Radish Peroxidase (HRP) marker.

Useful for testing low fibrinogen concentrations in culture media or cell exsudates, and for various research applications.

Pres

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12x8 test kit2x B2F Sample Diluent3x Fibrinogen Standard1x high & low Fibrinogen controls3x Anti-h-Fibrinogen-HRP IC1x B2F Conjugate Diluent1x Wash Solution1x TMB1x 0.45M Sulfuric Acid A

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Total Assay Time: 2h15Detection Threshold: 1 ng/mLDynamic Range: 0 to 100 ng/mLIntra-Assay CV: 4 – 6%Inter-Assay CV: 5 – 8%

Specimen dilution must be adjusted to the expected concentration.Reactive with rat and mouse Fibrinogen.

Intended use : Assay proposed for the measurement of Fibrinogen in research applications.

RUO

9

PART 2 :

MEASUREMENT OF PLASMA FACTORS

and their activated forms

Measurement of plasma factors and some of their activated formsinvolved in coagulation and thrombosis using clotting,

chromogenic or immunological methods.

PART

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PLAS

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FACT

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10

PART 2 : PLASMA FACTORS

Biophen® ProthrombinProthrombin Chromogenic Assay #221605

Chromogenic assay for the quantitative determination of Prothrombin in human citrated plasma or in concentrates, using a manual or automated protocol.

Very useful assay for elevated Prothrombin concentrations.

Pres

enta

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R1: 4x2.5 mL Ecarin®, which specifically activates Prothrombin into meizothrombin

R2: 4x5 mg Chromogenicsubstrate, specific forThrombin (SIIa-01)

R3: 4x5 mL x10 concen-tratedTris-BSA buffer

Ass

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Total Assay Time: 5 min.Detection Threshold: ≤ 5%Dynamic Range: 5-200%Intra-Assay CV: 2 - 5%Inter-Assay CV: 3 - 6%

Not sensitive to the presence of heparin in plasma up to a concentration of at least 2 IU/mL.

Intended use : Assay proposed for the measurement of Prothrombin in research applications.

Prothrombin Activity

RUO

HEMOCLOT Factor V ReagentFactor V Clotting Test CE #CK071K

Assay designed with a Factor V deficient clotting mixture, containing highly purified Fibrinogen and a Prothrombin complex concentrate.

Must be used in combination with a commercially available Calcium Thromboplastin. Pr

esen

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FV deficient clotting mixture (Fibrinogen and Prothrombin complex concentrate)

6x1 mL

Ass

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cs Total Assay Time: < 3 min.Detection Threshold: < 1%Dynamic Range: 0 to 100%Intra-Assay CV: < 4%Inter-Assay CV: < 7%Number of tests: 6x10 tests

Intended use : FV deficiency, congenital or acquired.Hepatic disorders.DIC.

Factor V Activity and Antigen

IVD

ZYMUTEST Factor VFactor V immunoassay

#RK009A

Two-site ELISA method for the measurement of human factor V antigen. Assay designed with a monoclonal antibody specific for the factor V heavy chain, for coating the microplate (immunocapture), and a horse anti-factor V polyclonal antibody, coupled to peroxidase, for revelation. This assay preferentially measures native factor V, and is also reactive with factor Va, but with a decreased reactivity.

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12x8 test kit2x FV Sample Diluent3x Plasma FV Calibrator1x high & low FV controls3x Anti-h-FV-HRP IC1x FV Conjugate Diluent1x Wash Solution1x TMB1x 0.45M Sulfuric Acid

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Total Assay Time: 4h05Detection Threshold: 2 ng/mLDynamic Range: 0 to 200 ng/mLIntra-Assay CV: 3-8%Inter-Assay CV: 5-10%

Intended use : Assay proposed for the measurement of Factor V antigen in research applications.

RUO

11

HEMOCLOT Factor VII ReagentFactor VII Clotting Test CE #CK081K

Assay designed with a Factor VII deficient clotting mixture, containing highly purified bovine Fibrinogen and Factor V, human Prothrombin and Factor X complex concentrate.

Must be used in combination with a commercially available Calcium Thromboplastin.

Pres

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FVII deficient clotting mixture (bovine Fibri-nogen and FV, human Prothrombin and FX complex concentrate)

6x1 mL

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Total Assay Time: < 3 min.Detection Threshold: < 1%Dynamic Range: 0 to 100%Intra-Assay CV: < 4%Inter-Assay CV: < 7%Number of tests: 6x10 tests

Intended use : FVII deficiency, congenital or acquired. Vitamin K deficiency (hepatic diseases, primary biliary cirrhosis, deficiency in newborns, antibiotherapy) Vitamin K antagonists (dicoumarol therapy) Isolated deficiencies of factor VII. Accelerated clotting factor consumption (DIC)

Factor VII Activity and Antigen

IVD

ZYMUTEST Factor VIIFactor VII Immunoassay #RK036A

Two-site immuno-assay for measuring human Factor VII (FVII) Antigen in plasma, or in any fluid where FVII can be present.

Assay designed with a rabbit polyclonal antibody specific for FVII for coating the ELISA plate and preparation of horse radish peroxidase (HRP). Pr

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12x8 test kit2x Sample Diluent3x Plasma FVII Calibrator1x high & low Plasma controls3x Anti-h-FVII-HRP IC 1x Conjugate Diluent1x Wash Solution1x TMB1x 0.45M Sulfuric Acid A

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Total Assay Time: 1h30 (one step method)Detection Threshold: ≤ 5%Dynamic Range: 0 to 25 ng/mLIntra-Assay CV: 3-5%Inter-Assay CV: 3-8%

No Significant interference of Heparin up to 2 IU/mL

Reference Material: NIBSC International Standard

Intended use : Assay proposed for the measurement of Factor VII antigen in research applications.

RUO

Biophen® FVIIFactor VII Chromogenic Assay #221304

Chromogenic assay for the measurement of Factor VII activity in human plasma, Factor VII in concentrates or in biological fluids. Automatic or Manual method.

Pres

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R1: 2 vials containing H FX

R2: 2 vials of rabbit brainThromboplastin, containingcalcium

R3: 2x8 mg Chromogenic substrate, specific for FXa (SXa-11)

R4 : 4x25 mL of Tris-BSA Buffer, at pH 7.40

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Total Assay Time: 12 min.Detection Threshold: 5%Dynamic Range: 5 to 200%Intra-Assay CV: 3 - 5%Inter-Assay CV: 4 – 7% Reference Material NIBSC International Standard

Intended use : Assay proposed for the measurement of Factor VII activity in research applications.

RUO

12

Biophen® Factor VIIa (Activated FVII) Factor VIIa Chromogenic Assay #221312

Chromogenic assay for the quantitative determination of Factor VIIa (Activated FVII, FVIIa) activity, in purified milieu (or biological fluids), using manual or automated method.

Pres

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R1: 2 vials containing H FX

R2: 2 vials of FVIIa cofactor(rTTF) and syntheticphospholipids

R3: 2x Chromogenic substrate, specific for FXa (SXa-11)

R4 : 4x25 mL of Tris-BSA Buffer, at pH 7.50 A

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Total Assay Time: 12 min.Detection Threshold: 1 ng/mLDynamic Range: 0 to 50 ng/mLIntra-Assay CV: < 6%Inter-Assay CV: < 10%

Intended use : Assay proposed for the measurement of Factor VIIa activity in research applications.

HEMOCLOT VII-XClotting Test for Combined Factor VII and X Activities CE #CK051K / #CK051L

Assay designed for the specific measurement of combined Factors VII+X in human citrated plasma. The assay measures Factors VII+X in human citrated plasma using a clotting method, triggered with calcium thromboplastin. It is proposed as screening for Factor VII or Factor X deficiency with a single test. Highly stable and fully reproducible assay from lot to lot.The ideal screening assay for the combined diagnosis of Factor VII and X clotting activity deficiencies.

Pres

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Deficient FVII and FXclotting mixture (highlypurified bovine Prothrom-bin, Fibrinogen and FV)

6x1 mL (CK051K)20x1 mL (CK051L)

Ass

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csTotal Assay Time: < 4 min.Detection Threshold: < 5%Dynamic Range: 0 to 100%Intra-Assay CV: < 5%Inter-Assay CV: < 8%Number of tests: 6x10 tests (CK051K)

20x10 tests (CK051L)

Intended use : Vitamin K deficiency. Vitamin K antagonists.Isolated factor VII or X deficiency.Accelerated clotting factor consumption (DIC).

Factor VIIa Activity

Factors VII+X Activity

RUO

IVD

Biophen® FVIII:CFactor VIII:C Chromogenic Assay CE #221402 / #221406

Chromogenic assay for the measurement of Factor VIII:C activity in human plasma, factor VIII:C concentrates, or Factor VIII:C in biological fluids. Automatic or Manual method. Calibrator plasma and controls (at two levels) are available (see p XX). This assay offers two working ranges for factor VIII:C (Low: 0 to 25% and High: 0 to 200%).

It is indicated for measuring low (hemophilia A) or high (increased thrombotic risk) factor VIII:C concentrations in human citrated plasma, and in factor VIII:C concentrates.

Pres

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R1: Human FX

R2: Activation Reagent

R3: FXa (SXa-11) Chro-mogenic substrate

R4: Tris-BSA Buffer

#221402 (2.5 mL) 2x2.5 mL: R1,R2,R34x25 mL: R4

#221406 (6 mL)2x6 mL: R1,R2,R34x25 mL: R4

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Total Assay Time: ≤ 10 min.Detection Threshold: 10% (high range) 0.2% (low range)Dynamic Range: 5 to 200% (high range) < 1 to 25% (low range)Intra-Assay CV: 3 – 5%Inter-Assay CV: 4 – 7%

Reference Material : FVIII:C International Standard

Intended use : Diagnosis of congenital or acquired FVIII:C deficiencies (hemophilia A).Follow-up of FVIII:C recovery in treated patients.Measurement of high FVIII:C concentrations

IVD

FVIII:C activity

13

ZYMUTEST Anti-VIII Mono-strip, IgGFactor VIII Antibody Immunoassay #RK039A

The ZYMUTEST anti-VIII, IgG, a qualitative or quantitative Monostrip ELISA kit, is a standardised and optimised enzyme immuno-assay designed for measuring auto and allo-antibodies to Factor VIII, of the IgG isotype, in human plasma or serum or in any biological fluid where auto-antibodies to FVIII can be present.

IgM or IgA isotypes are not measured.

Pres

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4 individual 8 well strips2x Sample Diluent4x Anti-FVIII, IgG, Positive control4x Negative control4x Anti-IgG (Fc)-HRP IC1x Conjugate Diluent2x Wash Solution1x TMB1x 0.45M Sulfuric Acid A

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Total Assay Time: 2h15Intra-Assay CV: < 8%Inter-Assay CV: < 10%Semi quantitative Possibility of quantitation

Intended use : Assay proposed for the measurement of anti-VIII antibodies in research applications.

Auto-Antibodies to Factor VIII:C

RUO

Biophen® Factor IXFactor IX Chromogenic Assay #221802 / #221805

Chromogenic assay (high and low range) for measuring Factor IX activity in human citrated plasma (or in Factor IX concentrates), using a chromogenic method, manual or automated.

For purified Factor IX or concentrates, a pre-dilution in Factor IX deficient plasma is recommended.

Pres

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R1: FX, and FVIII:CR2: FXIa (h), h Thrombin, calcium and syntheticPhospholipidsR3: Chromogenic substratespecific for FXa (SXa-11)R4: Tris-BSA Buffer

#221802 (2.5 mL)2x2.5 mL: R1, R2, R32x25 mL: R4#221805 (5 mL)2x5 mL: R1, R2, R34x25 mL: R4

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Total Assay Time: 10 min.Detection Threshold: 10%Dynamic Range: 10 – 100 ng/mLHigh Dynamic Range 20-200%Low Dynamic Range: 0.5-20%Intra-Assay CV: 3 - 5%Inter-Assay CV: 4 – 6%Reference Material: NIBSC International standard

Intended use : Assay proposed for the measurement of Factor IX activity in research applications.

ZYMUTEST Factor IXFactor IX Immunoassay #RK032A

Two-site ELISA method for the measurement of coagulation Factor IX, in human citrated plasma. Assay designed with affinity purified rabbit polyclonal antibodies for coating the ELISA plate and preparation of Horse Radish Peroxidase (HRP) marker.

Pres

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12x8 test kit2x Sample Diluent3x FIX Calibrator1x high & low FIX controls3x Anti-h-FIX-HRP IC1x Conjugate Diluent1x Wash Solution1x TMB1x 0.45M Sulfuric Acid

Ass

ay c

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cs Total Assay Time: 1h05 (one step method)Detection Threshold: ≤ 5%Dynamic Range: 0 to 100 ng/mLIntra-Assay CV: 3-8%Inter-Assay CV: 5-10%No Significant interference of Heparin up to 2 IU/mL

Reference Material : NIBSC International Standard

Intended use : Assay proposed for the measurement of Factor IX antigen in research applications.

Factor IX Activity and Antigen

RUO

RUO

14

Biophen® Factor IXa (Act FIX) Activated Factor IX (FIXa) Chromogenic Assay #221812

Chromogenic assay for measuring Factor IXa (Activated Factor IX) activity in human citrated plasma (or in Factor IX concentrates), using a chromogenic method, manual or automated.

For testing Factor IXa in purified Factor IX or concentrates, a pre-dilution in Factor IX deficient plasma or in R4 buffer can be performed.

Pres

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R1: 2x2.5 mL FX and FVIII:CR2: 2x2.5 mL h Thrombin,calcium and synthetic PhospholipidsR3: 2x2.5 mL Chromogenicsubstrate specific for FXa (SXa-11)R4: 2x25 mL of Tris-BSA BufferCal: 2x1 mL FIXa Calibrator

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Total Assay Time: 10 min.Detection Threshold: 0.1 mIU/mL (0.1 ng/mL)Dynamic Range: 3-30 mIU/mLIntra-Assay CV: 3 - 5%Inter-Assay CV: 4 – 6%

Reference Material: NIBSC International Standard for FIXa

Intended use : Assay proposed for the measurement of Factor IXa activity in research applications.

Factor IXa Activity

RUO

Biophen® Factor XFactor X Chromogenic Assay #221705

Chromogenic assay for the quantitative determination of Factor X in human citrated plasma, or in concentrates, using a manual or automated protocol.

Pres

enta

tion

R1: 4x5mg Chromogenic substrate, specific for FXa (SXa-11)R2: 4 vials of highly purifiedFX activating enzyme (RVVextracted from snake venom)R3: 4x5 mL x10 concen-tratedTris-NaCl buffer. Contains sodium azide

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Total Assay Time: 3 min.Detection Threshold: ≤ 5%Dynamic Range: 5-200%Intra-Assay CV: 3 - 5%Inter-Assay CV: 4 – 7%

Not sensitive to the presence of heparin in plasma up to a concentration of at least 1 IU/mL.

Intended use : Assay proposed for the measurement of Factor X in research applications.

Factor X Activity and AntigenRUO

ZYMUTEST Factor XFactor X Immunoassay #RK033A

Two-site ELISA method for the measurement of coagulation Factor X, in human citrated plasma.

Assay designed with affinity purified rabbit polyclonal antibodies for coating the ELISA plate and preparation of Horse Radish Peroxidase (HRP) marker. Pr

esen

tati

on

12x8 test kit2x Sample Diluent3x FX Calibrator1x high & low FX controls3x Anti-h-FX-HRP IC1x Conjugate Diluent1x Wash Solution1x TMB1x 0.45M Sulfuric Acid A

ssay

cha

ract

eris

tics Total Assay Time: 1h05 (One Step Method)

Detection Threshold: ≤ 5%Dynamic Range: 0 to 200 ng/mLIntra-Assay CV: 3-8%Inter-Assay CV: 5-10%

No Significant interference of Heparin up to 2 IU/mL

Reference Material : NIBSC International Standard

Intended use : Assay proposed for the measurement of Factor X antigen in research applications.

RUO

Biophen® FXIaFactor XIa Chromogenic Assay #220412

Chromogenic assay for measuring activated Factor XI (FXIa) activity through Factor IX activation and Factor Xa generation, using a manual or automated protocol.

Pres

enta

tion

R1A: 2x3 mL h FX and FVIII:CR1B: 2x3 mL h FIX(without FIXa)R2: 2x3 mL ActivationreagentR3: 2x3 mL FXa Chro-mogenic substrateR4: 2x25 mL Tris-BSA buffer(Contains sodium azide)R5 2x2 mL FXIa calibrator

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Total Assay Time: 10 min.Detection Threshold: < 0.25 ng/mLDynamic Range: 0.1 to 5 ng/mLIntra-Assay CV: < 4%Inter-Assay CV: < 6%

Intended use : Assay proposed for the measurement of Factor XIa activity in research applications.

Factor XIa Activity

RUO

15

ZYMUTEST Factor XIIIFactor XIII Immunoassay #RK034A

Two-site ELISA method for the measurement of coagulation human Factor XIII (subunit A) (FXIII-A) in plasma, or in any fluid where FXIII can be present.

Assay designed with affinity purified rabbit polyclonal antibodies for coating the ELISA plate and preparation of Horse Radish Peroxidase (HRP) marker.

Pres

enta

tion

12x8 test kit2x Sample Diluent3x FXIII Calibrator1x high & low FXIII controls3x Anti-h-FXIII-HRP IC1x Conjugate Diluent1x Wash Solution1x TMB1x 0.45M Sulfuric Acid A

ssay

cha

ract

eris


Detection Threshold: ≤ 10%Dynamic Range: 0 to 200 ng/mLIntra-Assay CV: 3-8%Inter-Assay CV: 5-10%

Intended use : Assay proposed for the measurement of Factor XIII-A in research applications.

ZYMUTEST vWFVon Willebrand Factor Immunoassay CE #RK030A

Two-site ELISA method for the measurement of vWF. Assay designed with specific rabbit polyclonal antibodies for coating the ELISA plate and preparation of Horse Radish Peroxidase (HRP) marker; contains calibrators, established against the NIBSC International Standard, and controls at 2 levels. This assay is indicated for measuring low (von Willebrand disease) or high (increased thrombotic risk) vWF concentrations in human citrated plasma.

Pres

enta

tion

12x8 test kit2x Sample Diluent3x vWF Calibrator1x high & low vWF plasma controls3x Anti-h-vWF-HRP IC1x Conjugate Diluent1x Wash Solution1x TMB1x 0.45M Sulfuric Acid

Ass

ay c

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Total Assay Time: 3h05Detection Threshold: ≤ 5%Dynamic Range: 0 to About 150%Intra-Assay CV: 3-8%Inter-Assay CV: 5-10%

No Significant interference of Heparin up to 2 IU/mL, Bilirubin up to 0.05 mg/mL, Hemoglobin up to 10 mg/mL

Intended use : Diagnosis of von Willebrand disease (vWD).Assay of vWF in clinical samples, as a disease marker or as an indicator for cardiovascular diseases.

vWF deficiency associated with auto-antibodies to vWF (malignancy).

High vWF concentrations in cardiovascular diseases.

ZYMUTEST CBA (Collagen Binding Assay)Immunoassay for Von Willebrand FactorCollagen Binding Activity

CE #RK038A

The ZYMUTEST vWF:CBA kit is an enzyme-immuno-assay for measuring Collagen Binding Activity (CBA) of human von Willebrand Factor (vWF) in plasma, or in any fluid where this activity needs to be measured.

Pres

enta

tion

12x8 test kit2x Sample Diluent3x vWF Calibrator1x high & low vWF plasma controls3x Anti-h-vWF-HRP IC1x Conjugate Diluent1x Wash Solution1x TMB1x 0.45M Sulfuric Acid A

ssay

cha

ract

eris

tics

Total Assay Time: 3h25Detection Threshold: ≤ 5%Dynamic Range: 0 to About 150%Intra-Assay CV: < 10%Inter-Assay CV: < 10%

Intended use : Diagnosis of von Willebrand disease (vWD).

Assay of vWF:CBA in clinical samples, as a disease marker or as an indicator for cardiovascular diseases.

Factor XIII Antigen

Von Willebrand Factor Antigen and Activity

RUO

IVD

IVD

16

Prothrombin Deficient Plasma CE #DP010A / #DP010K

Deficient plasma for the assay of Prothrombin. All the clotting factors are present (constant and in the normal range, brought by the deficient plasma), excepted for FII, which is brought by the diluted tested plasma. Clotting is triggered with calcium thromboplastin. FII is the limiting factor and clotting time is inversely proportional to the concentration of FII.

Pres

enta

tion

Citrated h plasma,deficient for Prothrombin,immuno-depleted, lyophilized in the presence of glycine and stabilizers

1x 1 mL (DP010A)6x 1 mL (DP010K)

Ass

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s

Plasma deficient for Prothrombin <1%Other coagulation factors > 50%

Intended use : Measurement of Factor II (FII or Prothrombin) activity in human citrated plasma using a clotting method, triggered with calcium thromboplastin.For any in vitro protocol or research study where a source of human Prothrombin deficient plasma is required

Deficient Plasmas, Immuno Depleted

IVD

Human citrated, immunodepleted, freeze dried plasmas for clotting assays or research applications where a source of deficient plasma is required. When used for testing coagulation factor activities these deficient plasmas must be used along with a commercially available Prothrombin Time (PT) reagent, for factors II, V, VII, X or with an Activated Partial Thromboplastin Time (APTT) reagent, for factors VIII:C, IX, XI, XII, Prekallikrein and HMW Kininogen.

Factor V Deficient Plasma CE #DP020A / #DP020K

Deficient plasma for the assay of Factor V. All the clotting factors are present (constant and in the normal range, brought by the deficient plasma), excepted for FV, which is brought by the diluted tested plasma. Clotting is triggered with calcium thromboplastin. FV is the limiting factor and clotting time is inversely proportional to the concentration of FV.

Pres

enta

tion

Citrated h plasma, deficient for FV,immuno-depleted, lyophilized in the presence of glycine and stabilizers

1x 1 mL (DP020A)6x 1 mL (DP020K)

Ass

ay

char

acte

rist

ics

Plasma deficient for Factor V <1%Other coagulation factors > 50%

Intended use : Measurement of Factor V (FV or Proaccelerin) activity in human citrated plasma using a clotting method, triggered with calcium thromboplastin.For any in vitro protocol or research study where a source of human FV deficient plasma is required

IVD

Factor VII Deficient Plasma CE #DP030A / #DP030K

Deficient plasma for the assay of Factor VII. All the clotting factors are present (constant and in the normal range, brought by the deficient plasma), excepted for FVII, which is brought by the diluted tested plasma, and clotting is triggered with calcium thromboplastin. FVII is the limiting factor and clotting time is inversely proportional to the concentration of FVII.

Pres

enta

tion

Citrated human plasma, deficient for Factor VII, immuno-depleted, lyophilized in the presence of glycine and stabilizers.

1x 1 mL (DP030A)6x 1 mL (DP030K)

Ass

ay

char

acte

rist

ics

Plasma deficient for FVII <1%Other coagulation factors > 50%

Intended use : Measurement of Factor VII (FVII or Proconvertin) activity in human citrated plasma using a clotting method, triggered with calcium thromboplastin.For any in vitro protocol or research study where a source of human FVII deficient plasma is required.

IVD

Factor VIII:C Deficient Plasma CE #DP040A / #DP040K

Deficient plasma for the assay of Factor VIII:C. All the clotting factors are present (constant and in the normal range, brought by the deficient plasma), excepted for FVIII:C, which is brought by the diluted tested plasma, and clotting is triggered with cephalin, activator and calcium (APTT). FVIII:C is the limiting factor and clotting time is inversely proportional to the concentration of FVIII:C.

Pres

enta

tion

Citrated human plasma, deficient for Factor VIII:C, immuno-depleted, lyo-philized in the presence of glycine and stabilizers.

1x 1 mL (DP040A)6x 1 mL (DP040K)

Ass

ay

char

acte

rist

ics

Plasma deficient for FVIII:C <1%Other coagulation factors > 50%

Intended use : Measurement of Factor VIII:C (FVIII:C) activity in human citrated plasma using a clotting method, in the presence of cephalin, activator and calcium (APTT reagent).For any in vitro protocol or research study where a source of human FVIII:C deficient plasma is required.

Factor IX Deficient Plasma CE #DP050A / #DP050K

Deficient plasma for the assay of Factor IX. All the clotting factors are present (constant and in the normal range, brought by the deficient plasma), excepted for FIX, which is brought by the diluted tested plasma, and clotting is triggered with cephalin, activator and calcium (APTT). Pr

esen

tati

on

Citrated human plasma, deficient for Factor IX, immuno-depleted, lyo-philized in the presence of glycine and stabilizers.

1x 1 mL (DP050A)6x 1 mL (DP050K)

Ass

ay c

hara

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Plasma deficient for FIX <1%Other coagulation factors >50%

Intended use : Measurement of Factor IX (FIX) activity in human citrated plasma using a clotting method, in the presence of cephalin, activator and calcium (APTT reagent).For any in vitro protocol or research study where a source of human FIX deficient plasma is required.

Factor X Deficient Plasma CE #DP060A / #DP060K

Deficient plasma for the assay of Factor X. All the clotting factors are present (constant and in the normal range, brought by the deficient plasma), excepted for FX, which is brought by the diluted tested plasma, and clotting is triggered with calcium thromboplastin. FX is the limiting factor and clotting time is inversely proportional to the concentration of FX.

Pres

enta

tion

Citrated human plasma, deficient for Factor X, immuno-depleted, lyo-philized in the presence of glycine and stabilizers.

1x 1 mL (DP060A)6x 1 mL (DP060K)

Ass

ay

char

acte

rist

ics

Plasma deficient for FX <1%Other coagulation factors >50%

Intended use : Measurement of Factor X (FX or Stuart Factor) activity in human citrated plasma using a clotting method, triggered with calcium thromboplastin.For any in vitro protocol or research study where a source of human FX deficient plasma is required

Factor XI Deficient Plasma CE #DP070A / #DP070K

Deficient plasma for the assay of Factor XI. All the clotting factors are present (constant and in the normal range, brought by the deficient plasma), excepted for FXI, which is brought by the diluted tested plasma, and clotting is triggered with cephalin, activator and calcium (APTT). FXI is the limiting factor and clotting time is inversely proportional to the concentration of FXI.

Pres

enta

tion

Citrated human plasma, deficient for Factor XI, immuno-depleted, lyo-philized in the presence of glycine and stabilizers.

1x 1 mL (DP070A)6x 1 mL (DP070K)

Ass

ay

char

acte

rist

ics

Plasma deficient for FXI <1%Other coagulation factors >50%

Intended use : Measurement of Factor XI (FXI or factor Rosenthal) activity in human citrated plasma using a clotting method, in the presence of cephalin, activator and calcium (APTT reagent).For any in vitro protocol or research study where a source of human FXI deficient plasma is required

IVD

IVD

IVD

IVD

17

18

Factor XII Deficient Plasma CE #DP080A / #DP080K

Deficient plasma for the assay of Factor XII. All the clotting factors are present (constant and in the normal range, brought by the deficient plasma), excepted for FXII, which is brought by the diluted tested plasma, and clotting is triggered with cephalin, activator and calcium (APTT). FXII is the limiting factor and clotting time is inversely proportional to the concentration of FXII.

Pres

enta

tion

Citrated human plasma,deficient for Factor XII,immuno-depleted, lyo-philized in the presence of glycine and stabilizers.

1x 1 mL (DP080A)6x 1 mL (DP080K)

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ay c

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Plasma deficient for FXII <1%Other coagulation factors > 50%

Intended use : Measurement of Factor XII (FXII or factor Hageman) activity in human citrated plasma using a clotting method, in the presence of cephalin, activator and calcium (APTT reagent).For any in vitro protocol or research study where a source of human FXII deficient plasma is required.

Factor XIII Deficient Plasma #DP200A / #DP200K

Deficient plasma for Factor XIII.

Pres

enta

tion

Citrated human plasma,deficient for FXIII,immuno-depleted, lyo-philized in the presence of glycine and stabilizers.

1x 1 mL (DP200A)6x 1 mL (DP200K)

Ass

aych

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teri

stic

sPlasma deficient for FXIII <1%Other coagulation factors > 50%

Intended use : For any in vitro protocol or research study where a source of human FXIII deficient plasma is required.

Kininogen Deficient Plasma #DP300A / #DP300K

Deficient plasma for Kininogen.

Pres

enta

tion

Citrated human plasma, deficient for Kininogen, immuno-depleted, lyo-philized in the presence of glycine and stabilizers.

1x 1 mL (DP300A)6x 1 mL (DP300K)

Ass

aych

arac

teri

stic

s

Plasma deficient for Kininogen <1%Other coagulation factors > 50%

Intended use : For any in vitro protocol or research study where a source of human Kininogen deficient plasma is required.

IVD

RUO

RUO

Prekallikrein Deficient Plasma #DP310A / #DP310K

Deficient plasma for Prekallikrein.

Pres

enta

tion

Citrated human plasma, deficient for Prekallikrein, immuno-depleted, lyo-philized in the presence of glycine and stabilizers.

1x 1 mL (DP310A)6x 1 mL (DP310K)

Ass

aych

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stic

s

Plasma deficient for Prekallikrein <1%Other coagulation factors > 50%

Intended use : For any in vitro protocol or research study where a source of human Prekallikrein deficient plasma is required.

RUO

19

Protein S Deficient Plasma #DP110A / #DP110K

Deficient plasma for Protein S.

Pres

enta

tion

Citrated human plasma, deficient for Protein S, im-muno-depleted, lyophilized in the presence of glycine and stabilizers.

1x 1 mL (DP110A)6x 1 mL (DP110K)

Ass

aych

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teri

stic

s Plasma deficient for Protein S <1%Other coagulation factors > 50%

Intended use : For any in vitro protocol or research study where a source of human Protein S deficient plasma is required.

RUO

Protein Z Deficient Plasma #DP120A / #DP120K

Deficient plasma for Protein Z.

Pres

enta

tion

Citrated human plasma, deficient for Protein Z, immu-no-depleted, lyophilized in the presence of glycine and stabilizers.

1x 1 mL (DP120A)6x 1 mL (DP120K)

Ass

aych

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stic

s Plasma deficient for Protein Z <1%Other coagulation factors > 50%

Intended use : For any in vitro protocol or research study where a source of human Protein Z deficient plasma is required.

RUO

tPA/PAI-1 Deficient Plasma #DP210A / #DP210K

Deficient plasma for tPA and PAI-1.

Pres

enta

tion

Citrated human plasma, deficient for tPA/PAI-1, immu-no-depleted, lyophilized in the presence of glycine and stabilizers.

1x 1 mL (DP210A)6x 1 mL (DP210K)

Ass

aych

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stic

s Plasma deficient for tPA and PAI-1 Ag <1ng/mLPlasma deficient for PAI-1 activity <1ng/mLOther coagulation factors > 50%

Intended use : For any in vitro protocol or research study where a source of human tPA/PAI-1 deficient plasma is required.

RUO

vWF Deficient Plasma #DP150A / #DP150K

Deficient plasma for vWF.

Pres

enta

tion

Citrated human plasma, deficient for vWF, immuno-depleted, lyophilized in the presence of glycine and stabilizers.

1x 1 mL (DP150A)6x 1 mL (DP150K)

Ass

ay

char

acte

rist

ics Plasma deficient for vWF <1%

Other coagulation factors >50%

Intended use : For any in vitro protocol or research study where a source of vWF deficient plasma is required.

RUO

Calibrators and ControlsRefer to page 43

Protein C Deficient Plasma #DP100A / #DP100K

Deficient plasma for Protein C.

Pres

enta

tion

Citrated human plasma,deficient for Protein C,immuno-depleted, lyo-philized in the presence of glycine and stabilizers.

1x 1 mL (DP100A)6x 1 mL (DP100K)

Ass

aych

arac

teri

stic

s Plasma deficient for Protein C <1%Other coagulation factors > 50%

Intended use : For any in vitro protocol or research study where a source of human Protein C deficient plasma is required.

RUO

PART 3 :THROMBOPHILIA

Measurement of plasma proteins controlling thrombosis and exhibiting antithrombotic properties (PC, PS, AT, etc...).

20

21

Biophen® AntithrombinAntithrombin (Anti-Xa) Chromogenic Assay CE 510(k) #221102 / #221105

Chromogenic assay for the measurement of antithrombin (AT) activity in human plasma, with an anti-Xa method. Automatic or manual method.

Pres

enta

tion

R1: Bovine Factor XaR2: Chromogenic substrate,specific for Factor Xa (SXa-11)R3 : Tris-Heparin Buffer

#2211022x2.5 mL: R1, R22x5 mL: R3

#2211054x5 mL: R1, R24x10 mL: R3

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Total Assay Time: < 3 min.Detection Threshold: ≤ 5%Dynamic Range: 0 to 100%Intra-Assay CV: < 3%Inter-Assay CV: < 5%No known drug interference in the assay.No interference of Heparin Cofactor II, a2-acroglo-bulin or a1-Antitrypsin.No interference for hemoglobin concentrations up to 5 mg/mL, for Bilirubin concentrations up to0.1 mg/mL, and for plasma from hyperlipaemic patients.

Intended use : Diagnosis of congenital or acquired Antithrombin deficiencies.Measurement of ATIII activity in biological milieu or purified fractions.

Biophen® AT (LRT)Antithrombin Chromogenic Assay (anti-Xa)(Liquid technonogy)

CE #221111

Chromogenic assay for the measurement of antithrombin (AT) activity in human plasma, with an anti-Xa method. Liquid Reagent Technology(LRT).

Pres

enta

tion

All reagents are in the liquid presentation and ready to use

R1: 4x11 mL Bovine Factor Xa

Liquid ReagentTechnology (LRT).

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Total Assay Time: < 3 min.Detection Threshold: ≤ 15%Dynamic Range: 0 to 100%Intra-Assay CV: < 3%Inter-Assay CV: ≤ 5%

No interference of Heparin Cofactor II, a2-macroglo-bulin or a1-Antitrypsin.


Biophen® AT (Anti-IIa)Antithrombin (Anti-IIa) Chromogenic Assay CE #221122

Chromogenic assay for the measurement of antithrombin (AT) activity in human plasma, with an anti-IIa method, in presence of an excess of heparin. All the reagents are optimized and ready to use, and are reconstituted with distilled water.

The assay of choice for measuring AT III based anti-IIa activity in plasma or concentrates.

Pres

enta

tion

R1: 2x2.5 mL Bovine Thrombin

R2: 2x2.5 mL Chromogenic substrate specific for Thrombin

R3: 2x25 mL Sample Diluent with heparin A

ssay

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tics

Total Assay Time: < 3 min.Detection Threshold: ≤ 15%Dynamic Range: 0 to 100%Intra-Assay CV: < 3%Inter-Assay CV: ≤ 5%

No interference of Heparin Cofactor II, a2-macroglo-bulin or a1-Antitrypsin.


Antithrombin III Activity and Antigen

IVD

IVD

IVD

PART 3 : THROMBOPHILIA

PART

3 :

THRO

MBO

PHIL

IA

22

Biophen® Protein CProtein C Chromogenic Assay CE 510(k) #221202 / #221205

Chromogenic assay for the measurement of Protein C (PC) activity in human plasma, following activation with Protac®, a specific enzymatic activator extracted from snake venom (Agkistrodon C. Contortrix). Automatic or Manual method.

Pres

enta

tion

R1: Protac®

R2: Chromogenic subs-trate, specific for Activated protein C (SaPC-21)

#2212023x2.5 mL: R13x4 mg: R2

#2212054x5 mL: R14x8 mg: R2

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Total Assay Time: ≤ 10 min.Detection Threshold: ≤ 5%Dynamic Range: 0 to 100 %Intra-Assay CV: < 3%Inter-Assay CV: < 5%

No significant interference observed for heparin concentrations < 1 IU/mL, Bilirubin concentrations < 0.1 mg/mL, hemoglobin concentrations <1 mg/mL and triglycerides concentrations <1.25 mg/mL.

Intended use : Diagnosis of congenital or acquired Protein C deficiencies.Protein C concentrates.

Biophen® Protein C (LRT) Protein C Chromogenic Assay(Liquid Technology)

CE #221211

Chromogenic assay for the measurement of Protein C (PC) activity in human plasma, following activation with Protac®, a specific enzymatic activator extracted from snake venom (Agkistrodon C. Contortrix). Automatic or Manual method.

Liquid Reagent Technology (LRT): all the reagents are in the liquid presentation. Ready to use.

Pres

enta

tion

R1: Protac®

R2: Chromogenic subs-trate, specific for Activa-ted protein C (SaPC-21)

3x3 mL

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Total Assay Time: ≤ 10 min.Detection Threshold: ≤ 5%Dynamic Range: 0 to 100 %Intra-Assay CV: < 3%Inter-Assay CV: < 5%

No significant interference observed for heparin concentrations < 1 IU/mL, Bilirubin concentrations < 0.1 mg/mL, hemoglobin concentrations <1 mg/mL and triglycerides concentrations<1.25 mg/mL.


Protein C Activity and Antigen

IVD

IVD

LIAPHEN AT Antithrombin Latex Immunoassay CE #120002

Latex immunoassay for measuring Antithrombin (AT) in human citrated plasma or in purified milieu, using a manual or automated method, in vitro exclusively.

Pres

enta

tion

R1: 2x2 mL Latex reagent

R2: 2x10 mL Reaction Buffer

Ass

ay c

hara

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Total Assay Time: <10 min.Detection Threshold: ≤ 5%Dynamic Range: 0 to 150 %Intra-Assay CV: < 4%Inter-Assay CV: < 6%No hook effect is observed for ATIII concentrations ≤ 200% (7.5µg/ml of purified ATIII).

No interference is observed for Unfractionated and Low Molecular Weight Heparin concentrations ≤ 2 IU/ml added in plasma.

The presence of rheumatoid factor may result in an overestimation of the ATIII concentration.

Intended use : Assay of ATIII in human citrated plasma.AT concentrates

IVD

23

HEMOCLOT Protein CProtein C Clotting Assay CE # CK031K

Protein C is measured with a clotting method, following activation with Protac®, a specific activating enzyme extracted from snake venom (Agkistrodon C. Contortrix), in Protein C deficient plasma.

Pres

enta

tion

R1: 3x1 mL Protein C deficient plasma

R2: 3x1 mL Protein CActIvator (Protac®)

Ass

ay c

hara

cter

isti

cs Total Assay Time: 8 min.Detection Threshold: 10%Dynamic Range: 0 to 200%Intra-Assay CV: < 7%Inter-Assay CV: 5-8 %

No interference of heparin up to 1 IU/mL


ZYMUTEST Protein CProtein C Immunoassay CE #RK027A

Two-site ELISA method for the measurement of coagulation Protein C, in human citrated plasma.

Assay designed with affinity purified rabbit polyclonal antibodies for coating the ELISA plate and preparation of Horse Radish Peroxidase (HRP) marker.

Pres

enta

tion

12x8 test kit2x Sample Diluent3x Plasma PC Calibrator1x high & low PC controls3x Anti-h-PC-HRP IC1x Conjugate Diluent1x Wash Solution1x TMB1x 0.45M Sulfuric Acid

Ass

ay c

hara

cter

isti

csTotal Assay Time: 2h15 (Two Step Method)Detection Threshold: ≤ 5%Dynamic Range: 0 to About 130%Intra-Assay CV: 3-8%Inter-Assay CV: 5-10%

No Significant interference of Heparin up to 2 IU/mL, Bilirubin up to 0.05 mg/mL, hemoglobin up to 5 mg/mL

No interference of rheumatoid factorNo prozone effect observed for PC concentration up to 100 µg/mL Assay calibrated against the NIBSC International Standard for PC


Protein S Activity and Protein S Free and Total Antigens

HEMOCLOT Protein S Protein S Clotting Assay CE

# CK041K

Clotting assay for Protein S anticoagulant activity : Protein S is measured with a clotting method using a Protein S deficient plasma, and coagulation is initiated with FIXa in presence of Activated Protein C (APC) in excess and calcium.

Pres

enta

tion

R1: 3x1 mL Protein S deficient plasma

R2: 3x1 mL Activator reagent

Ass

ay c

hara

cter

isti

cs Total Assay Time: 5 min.Detection Threshold: 10%Dynamic Range: 0 to 100%Intra-Assay CV: < 7%Inter-Assay CV: < 10%

No interference of heparin up to 1 IU/mL

Intended use : Diagnosis of congenital or acquired Protein S deficiencies, associated with an increase risk of thrombosis.

IVD

IVD

IVD

24

ZYMUTEST Free Protein S Free Protein S Immunoassay CE #RK015A

Two-site ELISA method for the measurement of free Protein S (form which supports the anticoagulant activity), in human citrated plasma.

Assay designed with two conformational Murine monoclonal antibodies, calcium dependent, the first one for coating the microplate (immunocapture) and the second one, labelled with a Horse Radish Peroxidase (HRP) marker.

Pres

enta

tion

12x8 test kit2x PS Sample Diluent3x Plasma PS Calibrator1x high & low PS controls3x Anti-h-Free PS-HRP IC1x PrS Conjugate Diluent1x PS Wash Solution1x TMB1x 0.45M Sulfuric Acid

Ass

ay c

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Total Assay Time: 1h15 (One Step Method)Detection Threshold: ≤ 5%Dynamic Range: 0 to about 100%Intra-Assay CV: 3-8%Inter-Assay CV: 5-10%

No Significant interference of Heparin up to 2 IU/mL, Bilirubin up to 0.1 mg/mL, Hemoglobin up to 10 mg/mL

Reference Material : International Standard for PS (93/950) and normal plasma pools

Intended use : Diagnosis of Protein S deficiencies (congenital, acquired or transitory).• Type I deficiency: Partial deficiency of total and Free Protein S antigen.• Type II deficiency: Normal total and Free Protein S antigen, reduced activity.• Type III deficiency: Normal total antigen, decreased activity and free antigen.

Assay of Protein S in clinical studies.

ZYMUTEST Total Protein S Total Protein S Immunoassay CE #RK021A

Two-site ELISA method for the measurement of total Protein S (free or complexed with C4b-BP), in human citrated plasma.

Assay designed with two conformational Murine monoclonal antibodies, calcium dependent, the first one for coating the microplate (immunocapture) and the second one, labelled with a Horse Radish Peroxidase (HRP) marker.

Pres

enta

tion

12x8 test kit2x PS Sample Diluent3x Plasma PS Calibrator1x high & low PS controls3x Anti-h-Total PS-HRP IC1x PS Conjugate Diluent1x PS Wash Solution1x TMB1x 0.45M Sulfuric Acid

Ass

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Total Assay Time: 1h15 (One Step Method)Detection Threshold: ≤ 5%Dynamic Range: 0 to about 100%Intra-Assay CV: 3-8%Inter-Assay CV: 5-10%

No Significant interference of Heparin up to 2 IU/mL Bilirubin up to 0.1 mg/mL Hemoglobin up to 10 mg/mLReference Material : International Standard for PS (93/950) and normal plasma pools

Intended use : Diagnosis of Protein S deficiencies (congenital, acquired or transitory).• Type I deficiency: Partial deficiency of total and Free Protein S antigen.• Type II deficiency: Normal total and Free Protein S antigen, reduced activity.• Type III deficiency: Normal total antigen, decreased activity and free antigen.

Assay of Protein S in clinical studies.

IVD

IVD

Protein Z Antigen

ZYMUTEST Protein Z Protein Z Immunoassay #RK031A

Two-site ELISA method for the measurement of coagulation Protein Z, in human citrated plasma.

Assay designed with affinity purified rabbit polyclonal antibodies for coating the ELISA plate and preparation of Horse Radish Peroxidase (HRP) marker. Pr

esen

tati

on

12x8 test kit2x Sample Diluent3x PZ Calibrator1x high & low PS controls3x Anti-h-PZ-HRP IC1x Conjugate Diluent1x Wash Solution1x TMB1x 0.45M Sulfuric Acid A

ssay

cha

ract

eris


Detection Threshold: ≤ 0.25 µg/mLDynamic Range: 0 to 5 µg/mLIntra-Assay CV: 3-8%Inter-Assay CV: 5-10%

No Significant interference of Heparin up to 2 IU/mL Assay calibrated using a well characterized and highly purified human Protein Z preparation.

Intended use : Assay proposed for the measurement of Protein Z in research applications.

RUO

25

HEMOCLOT Factor V-LFactor V-L Clotting Assay (Qualitative) CE #CK061K /# CK061L

Variant assay for measuring the Resistance of Factor V (Factor V-Leiden is resistant) to its inactivation by Activated Protein C (APC), in human plasma, using a clotting method. Assay fully designed with purified proteins and enzymes. It offers a well defined identification of heterozygous or homozygous patients carrying the factor V-Leiden mutation. The clotting time of diluted plasma is assayed with or without APC, and the ratio is calculated. Normal plasmas have a ratio > 2.00.

Pres

enta

tion

R1: Clotting mixture R2A: Purified h FXR2B: Purified h FX, contai-ning h APCR3: Purified h FIXa

#CK061K2x4 mL: R1,R32x1 mL: R2A, R2B

#CK061L4x4 mL: R1,R34x1 mL: R2A, R2B

Ass

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Total Assay Time: < 10 min.Detection Threshold: ratio= 2Dynamic Range: ratio= 1 to >2.5Intra-Assay CV: < 3%Inter-Assay CV: < 5%Number of tests: 2x20 tests (CK061L)

4x20 tests (CK061K)

Intended use : Measurement of FV-L by its resistance to the action of Activated Protein C (APC).Clotting time is measured without or with APC.

IVD

HEMOCLOT Quanti. V-LFactor V Clotting Assay (Quantitative) CE 510(k) #CK065K

Clotting method for the quantitative measurement of Factor V-L (Factor V Leiden) concentration in citrated plasma, by its resistance to the action of Activated Protein C (APC). The assay is performed in the presence of Activated Protein C and Protein S (one single test for each patient). In the presence of APC, the prolongation of clotting time is an inverse relationship of the concentration of Factor V-Leiden (mutation R506Q). Normal Factor V is not measured.

Pres

enta

tion

R1: 3x2 mL Clotting mixture (h-Fibrinogen, h-Prothrombin and Protein S)

R2: 3x1 mL FXa andPhospholipids

Ass

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Total Assay Time: < 5 min.Detection Threshold: < 1%Dynamic Range: 0 to 100%Intra-Assay CV: < 3%Inter-Assay CV: < 5%Number of tests: 3x20 tests

No Significant interference of Heparin, Bilirubin, Hemoglobin

Intended use : Quantitative measurement of FV-L, resistant to the action of Activated Protein C, for diagnosing patients carrying the R506Q FV mutation (Factor V-Leiden), or any FV mutant resistant to APC.

IVD

Biophen® H-CoIIHeparin CoFactor II Chromogenic Assay #221902

Chromogenic assay for measuring the Heparin Cofactor II inhibitory activity to Thrombin in presence of Dermatan Sulfate. Highly specific and insensitive to AT III presence.

Pres

enta

tion

R1: 2x2.5 mL humanThrombin

R2: 2x2.5 mL specificThrombin Chromogenicsubstrate

R3: 2x25 mL reaction buf-fer containing Dermatan Sulfate A

ssay

cha

ract

eris

tics Total Assay Time: < 5 min.

Detection Threshold: 0.05 IU/mLDynamic Range: 0 to 1 IU/mLIntra-Assay CV: < 3%Inter-Assay CV: < 5%

Intended use : Assay proposed for the measurement of Heparin Cofactor II in research applications.

RUO

Heparin Cofactor II Activity

Factor V-L (involved in APC-Resistance)

26

HEMOCLOT LA SCREENdRVVT Based Clotting assay for Lupus Anticoagulant(Screening)

CE #CK090K

DRVVT based assay for Lupus anticoagulant: Diluted Russell’s Viper Venom clotting Test (DRVVT) performed in presence of low (screening) phospholipid concentrations for the measurement of Lupus Anticoagulant activity in citrated plasma.

Pres

enta

tion

6x1 mL

Ass

ay c

hara

cter

isti

cs Total Assay Time: < 3 min.Intra-Assay CV: < 4%Inter-Assay CV: < 6%Number of tests: ≥ 60

Intended use : Diagnosis of Lupus Anticoagulant using the dRVVT clotting assay.

IVD

Lupus anticoagulant

ZYMUTEST FPA (Fibrino-Peptide A) Fibrino-Peptide A Immunoassay #RK016A

Competitive Enzyme Linked Immuno Assay (CELIA) of Fibrino-Peptide A (FPA), for measuring FPA on Bentonite adsorbed human plasma or any biological sample where FPA must be measured. If tested sample contains fibrinogen, it must be removed (i.e. Bentonite adsorption), in order to avoid any cross-reactivity. The kit contains all the necessary reagents for the assay, and particularly the Bentonite suspension and the anticoagulant solution. All the reagents are ready to use and the MicroELISA plate is already precoated with synthetic human FPA and stabilized.

Pres

enta

tion

12x8 test kit1x Sample Diluent1x Bentonite suspension, ready to use1x 2% Tween 20 , ready to use3x FPA Calibrator3x Rabbit antibodies specific for h-FPA.3x Anti-rabbit-IgG-HRP IC1x Anticoagulant solution1x Conjugate Diluent1x Wash Solution1xTMB1x0.45M Sulfuric Acid

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Total Assay Time: 3h00Detection Threshold: 0.5 ng/mLDynamic Range: 0.5 to 50 ng/mLIntra-Assay CV: 4-7%Inter-Assay CV: 5-10%

Intended use : Assay proposed for the measurement of FPA in research applications.

RUO

Thrombin Generation (release of FPA)

ZYMUTEST DDimer DDimer Immunoassay # RK023A

Two-site ELISA method for the measurement of DDimer in human plasma. Assay designed with two Murine monoclonal antibodies, the first one highly specific for human DDimer, is used for coating the ELISA plate and the second one, conjugated with a Horse Radish Peroxidase (HRP) marker. The assay includes a calibrator and two controls (normal or pathological). Normal ranges are < 400 µg/mL. DDimer concentrations are expressed as “Fibrinogen Equivalent Unit” (FEU).

Pres

enta

tion

12x8 test kit2x Sample Diluent3x DDimer Calibrator1x high & low Plasma DDimer controls3x Anti-h-DDimer-HRP IC1x Conjugate Diluent1x Wash Solution1x TMB1x 0.45M Sulfuric Acid

Ass

ay c

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Total Assay Time: 2h15Detection Threshold: 2 ng/mLDynamic Range: 0 to 200 ng/mLIntra-Assay CV: < 5%Inter-Assay CV: < 8%

Intended use : Assay proposed for the measurement of D-Dimer in research applications.

RUO

Pathological markers

D-Dimer

HEMOCLOT LA CONFIRMdRVVT Based Clotting assay for Lupus Anticoagulant(Confirmation)

CE#CK091K

DRVVT based assay for Lupus anticoagulant: Diluted Russell’s Viper Venom clotting Test (DRVVT) performed in presence of high (confirmation) phospholipid concentrations for the measurement of Lupus Anticoagulant activity in citrated plasma. Pr

esen

tati

on

6x1 mL

Ass

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Intended use : Confirmation of Lupus Anticoagulant using the dRVVT clotting assay in presence of an excess of phospholipids.

IVD

27

ZYMUPHEN MP-TF Bio-Immunoassay for ProcoagulantMicroparticles exposing Tissue Factor

#521196

Functional assay for the measurement of procoagulant activity of microparticles exposing Tissue Factor (TF) in human plasma, in vitro, using automated or manual method.

Pres

enta

tion

All the necessary relipida-ted (h) TF for measuring TF-exposing microparticles on a micro Elisa plate coated with anti-(h) TF monoclonal antibodies.

Ass

ay c

hara

cter

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cs Total Assay Time: < 3hDetection Threshold: < 50 pg/mLDynamic Range: 0-1000 pg/mLIntra-Assay CV: < 8%Inter-Assay CV: < 10%

Intended use : Assay proposed for the measurement of procoagulant activity of microparticles exposing Tissue Factor in research applications.

RUO

ZYMUPHEN MP-Activity Bio-Immunoassay for ProcoagulantMicroparticles in Plasma

#521096

Functional assay for the measurement of microparticles’ procoagulant activity in human plasma (through thrombin generation) using automated or manual method.

Pres

enta

tion

12x8 test kit (coated with Annexin V)2x Sample DiluentR1: 2x Bovine FXa-FVa mixtureR2: 2x purified h FIIR3: 2x Thrombin specific Chromogenic substrate2x Calibrator1x Control (CI & CII)1x Wash Solution1x 2% Citric Acid

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Total Assay Time: < 1h25Detection Threshold: ≤ 0.05 nMDynamic Range: 0 to 50 nMIntra-Assay CV: 3-8%Inter-Assay CV: 5-10%

Intended use : Assay proposed for the measurement of microparticles’ procoagulant activity in research applications.

RUO

Microparticles

28

PART 4 : ANTICOAGULANT DRUGS

. Measurement of Heparins in plasma or in purifi ed milieus, using Anti-Xa or Anti-Ila assays, one or two stages.

. Heparin Induced Thrombocytopenia Measurement.

. New Oral Anticoagulants (NOACs) in plasma (DTIs, DiXals).

29

PART

4 :

AN

TICO

AG

ULA

NT

DRU

GS

HEPARIN

Biophen® HeparinHeparin Chromogenic Assay, Anti-Xa, Kinetics CE 510(k)* #221003 / #221006

Chromogenic anti-Xa method for measuring homogeneously heparin (UFH) and Low Molecular Weight Heparin (LMWH), using the same calibration curve (kinetics method, one stage).

The assay can also be used for testing heparin analogues, such as Sodium Danaparoid (Orgaran®), or Pentasaccharide (Fondaparinux). Automatic or Manual method.

Pres

enta

tion

R1: Chromogenic substratespecific for FXa (SXa-11)

R2: Bovine FXa

#2210033x3.75 mL: R13x3.75 mL: R2

#2210064x7.5 mL: R14x7.5 mL: R2

Ass

ay c

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Total Assay Time: < 3 min.Detection Threshold: 0.05 IU/mLDynamic Range: 0 to 2 IU/mLIntra-Assay CV: < 3%Inter-Assay CV: < 5%

No significant interference observed for Bilirubin concentrations <0.1 mg/mL, hemoglobin concen-trations <2 mg/mL and triglycerides concentrations <1.25 mg/mL added to plasma.

Intended use : Measuring the heparin concentration in patients’ plasma for monitoring the therapy and adjusting drug dosage.* In US, BIOPHEN Heparin is cleared only for UFH

Biophen® Heparin (AT+)Heparin Chromogenic Assay, Anti-Xa, Kinetics #221007

Chromogenic anti-Xa method for measuring homogeneously heparin and heparin-like anticoagulants, using the same calibration curve (kinetics method, one stage) with addition of exogenous AT III.


Pres

enta

tion

R1: 2x7.5 mL FXasubstrate (SXa-11)

R2: 2x7.5 mL Bovine FXa

R3: 2x2.5 mL AT III

Ass

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Intended use : Assay proposed for the measurement of heparin in research applications.

Biophen® Heparin (LRT)Heparin Chromogenic Assay, Anti-Xa, Kinetics(Liquid Technology)

CE #221011 / #221013

Chromogenic anti-Xa method for measuring homogeneously heparin (UFH) and Low Molecular Weight Heparin (LMWH), using the same calibration curve (kinetics method, one stage).


Pres

enta

tion

Liquid reagents, ready to use.

R1: FXa substrate (SXa-11)

R2: Bovine FXa

#2210114x7.5 mL: R14x7.5 mL: R2

#2210133x3mL: R13x3mL: R2

Ass

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Intended use : Measuring the heparin concentration in patients’ plasma for monitoring the therapy and adjusting drug dosage.

Heparin and Heparin Like Substances

IVD

RUO

IVD

PART 4 : ANTICOAGULANT DRUGS

Biophen® Anti-Xa (2 stages)Heparin Chromogenic Assay, Anti-Xa, 2 stages

#221010

Chromogenic anti-Xa method for measuring homogeneously heparin in purified systems or in plasma (tested diluted 1:10) using a two stage method. First, Factor Xa, in excess, is inhibited by heparin in presence of AT III, also in excess (and provided in the assay), then the residual Xa activity is measured by its activity on the specific substrate SXa-11.

This assay meets USP/EP requirements.

Pres

enta

tion

R1: 2x1 mL AT III

R2: 2x1 mL FXa

R3: 2x5 mL FXasubstrate (SXa-11)

R4: 4x25 mL Reaction buffer

Ass

ay c

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cs

Total Assay Time: < 5 min.Detection Threshold: 0.1 IU/mLDynamic Range: 0 to 2 IU/mL

(0 to 0.2 IU/mL when diluted)Intra-Assay CV: < 3%Inter-Assay CV: < 5%

Intended use : Assay proposed for the measurement of anti-Xa Heparin activity in research applications.

Biophen® Heparin Anti-IIa (Kinetics)Heparin Chromogenic Assay, Anti-IIa, Kinetics

#221020

Chromogenic anti-IIa method for measuring homogeneously heparin in purified systems, using a kinetics/competitive method.

Offers a wide measurement range from 0 to 6 IU/mL and is appropriate for testing heparins for their anti-thrombin activity.

Pres

enta

tion

R1: 2x5 mL AT III

R2: 2x10 mL Thrombin substrate

R3: 2x10 mL Thrombin


Ass

ay c

hara

cter

isti

cs Total Assay Time: < 10 min.Detection Threshold: 0.2 IU/mLDynamic Range: 0 to 6 IU/mLIntra-Assay CV: < 3%Inter-Assay CV: < 5%

Intended use : Assay proposed for the measurement of heparin in research applications.

Biophen® Heparin Anti-IIa (2 stages)Heparin Chromogenic Assay, Anti-IIa, 2 stages

#221025

Chromogenic anti-IIa method for measuring homogeneously heparin in plasma (tested diluted 1:25) or in purified systems, using a two-stage method.

Offers a wide measurement range from 0 to 1 IU/mL for plasma, or from 0.002 to 0.04 IU/mL for purified systems and is appropriate for testing heparins for their anti-thrombin activity.This assay meets USP/EP requirements.

Pres

enta

tion

R1: 2x1 mL AT III

R2: 2x1 mL Thrombin

R3: 2x5 mL Thrombin substrate


Ass

ay c

hara

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cs

Total Assay Time: < 3 min.Detection Threshold: < 0.1 IU/mLDynamic Range: 0 to 1 IU/mL (0 to 0.04 IU/mL when diluted)Intra-Assay CV: < 3%Inter-Assay CV: < 5%

Intended use : Assay proposed for the measurement of heparin anti-thrombin activity in research applications.

RUO

RUO

RUO

Calibrators and ControlsRefer to page 43

30

ZYMUTEST HIA, IgGELISA for Heparin Induced Antibodies (HIT) CE 510(k) #RK040A

Enzyme Immuno-assay designed for measuring heparin-dependent antibodies of the IgG isotype, in human plasma or serum, or in any biological fluid where these antibodies must be measured. This assay measures only the IgG isotype, reported as the most associated with the clinical complications of heparin dependent antibodies (HIT/HITT), allowing confirmation of the diagnosis of HIT/HITT or its clinical suspicion. However, some cases associated with only IgM and/or IgA isotypes can be missed.

Pres

enta

tion

12x8 test kit2x HIA Sample Diluent3x HIA IgG positive Control3x Negative control3x Platelet lysate3x Anti-IgG (Fc)-HRP IC1x Conjugate Diluent1x Wash Solution1x TMB1x 0.45M Sulfuric Acid A

ssay

cha

ract

eris

tics

Total Assay Time: 2h15Cut-off: A450 > 0.30Dynamic Range: A450 up to 3.0Intra-Assay CV: 4 - 6%Inter-Assay CV: 5 – 8%

Intended use : Clinical suspicion of HIT during heparin therapy.

Heparin-dependent antibodies of the IgG isotype are those strongly associated with the clinical diagnosis of HIT. The ZYMUTEST HIA IgG assay offers then a better specificity for the clinical complication of HIT, but it has less sensitivity as cases associated with only IgM and/or IgA isotypes are missed.

Heparin Induced Thrombocytopenia (HIT)

IVD

ZYMUTEST HIA, IgMELISA for Heparin Induced Antibodies (HIT) CE #RK040B

Enzyme immuno-assay designed for measuring heparin-dependent antibodies of the IgM isotype, in human plasma or serum, or in any biological fluid where these antibodies must be measured.

Pres

enta

tion

12x8 test kit2x HIA Sample Diluent3x HIA IgM positive Control3x Negative control3x Platelet lysate3x Anti-IgM (µ)-HRP IC1x Conjugate Diluent1x Wash Solution1x TMB1x 0.45M Sulfuric Acid

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Intended use : Measurement of human heparin-dependent antibodies of the IgM isotype, in research or prospective studies on the risk of HIT development during heparin therapy.

ZYMUTEST HIA, IgAELISA for Heparin Induced Antibodies (HIT) CE #RK040C

Enzyme immuno-assay designed for measuring heparin-dependent antibodies of the IgA isotype, in human plasma or serum, or in any biological fluid where these antibodies must be measured.

Pres

enta

tion

12x8 test kit2x HIA Sample Diluent3x HIA IgA positive Control3x Negative control3x Platelet lysate3x Anti- IgA (a)-HRP IC1x Conjugate Diluent1x Wash Solution1x TMB1x 0.45M Sulfuric Acid

Ass

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Intended use : Measurement of human heparin-dependent antibodies of the IgA isotype, in research or prospective studies on development of HIT during heparin therapy.

IVD

IVD

31

32

ZYMUTEST HIA IgGAMELISA for Heparin Induced Antibodies (HIT),Screening Assay

CE 510(k) #RK040D

Enzyme immuno-assay designed for measuring globally all heparin-dependent antibodies, whether the isotype is: IgG, IgM and IgA, in human plasma or serum, or in any biological fluid where these antibodies must be measured. This assay is proposed as screening, as an early identification of heparin treated patients presenting a risk to develop HIT or HITT. This assay measures the whole of antibodies. It offers the highest sensitivity as all isotypes are detected. It is the preferred assay when an early detection of heparin dependent antibodies is required for assessing the development risk of HIT/HITT.

Pres

enta

tion

12x8 test kit2x HIA Sample Diluent3x HIA IgGAM positive Control3x Negative control3x Platelet lysate3x Anti-IgG (Fc)- IgM (m)-IgA(a)-HRP IC1x Conjugate Diluent1x Wash Solution1x TMB1x 0.45M Sulfuric Acid A

ssay

cha

ract

eris

tics

Total Assay Time: 2h15Cut-off: A450 ≥ 0.50Dynamic Range: A450 up to 3.0Intra-Assay CV: 4 - 6%Inter-Assay CV: 5 – 8%

Intended use : Assessment of the risk to develop HIT/HITT, in patients treated with heparins (Unfractionated or LMWH): presence of antibodies is a risk indicator for development of HIT/HITT.

Clinical suspicion of HIT during heparin therapy.

IVD

IVDZYMUTEST HIA IgG, IgA, IgMELISA for Heparin Induced Antibodies (HIT), Full isotyping

CE #RK040E

Enzyme immuno-assay designed for specifically measuring heparin-dependent antibodies of IgG, or IgM, or IgA isotype, in human plasma or serum, or in any biological fluid where these antibodies must be measured. Specific isotyping assay. Assay designed for the full isotyping of heparin dependent antibodies, applications to characterization of isotype distribution in patients with a risk or a suspicion of HIT/HITT, or for research investigations.

Pres

enta

tion

12x8 test kit2x HIA Sample DiluentPositive Controls (IgG,IgA and IgM)3x Negative control3x Platelet lysateAnti-IgG (Fc)/IgM (µ)/IgA(a)-HRP IC (1 each)1x Conjugate Diluent1x Wash Solution1x TMB1x 0.45M Sulfuric Acid

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Note: The kit allows running 32 tests foreach specific isotype.

Intended use : Complete isotyping of Heparin dependent antibodies, as a primary approach in research applications or as a second intention assay for characterizing patients measured positive with the ZYMUTEST HIA IgGAM, screening assay (# RK040D).

ZYMUTEST HIA Mono Strip, IgGELISA for Heparin Induced Antibodies (HIT), IgG isotype, Mono-strip

CE 510(k) #RK041A

Enzyme Immuno-assay designed for measuring heparin-dependent antibodies of the IgG isotype, in human plasma or serum, or in any biological fluid where these antibodies must be measured. This assay measures only the IgG isotype, reported as the most associated with the clinical complications of heparin dependent antibodies (HIT/HITT), allowing confirmation of the diagnosis of HIT/HITT or its clinical suspicion. However, some cases associated with only IgM and/or IgA isotypes can be missed.

This kit allows individual test as it offers a packaging for 4 individual 8 well strips along with controls.

Pres

enta

tion

4 individual 8 well strips2x HIA Sample Diluent4x HIA IgG positive Control4x Negative control4x Platelet lysate4x Anti-IgG (Fc)-HRP IC1x Conjugate Diluent2x Wash Solution1x TMB1x 0.45M Sulfuric Acid

Ass

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Intended use : Individual test.

Clinical suspicion of HIT during heparin therapy.Heparin-dependent antibodies of the IgG isotype are those strongly associated with the clinical diagnosis of HIT.

The ZYMUTEST HIA Mono Strip IgG assay offers then a better specificity for the clinical complication of HIT, but it has less sensitivity as cases associated with only IgM and/or IgA isotypes are missed.

IVD

Mono Strip HIT (4x8 tests)

33

ZYMUTEST HIA Mono strip, IgGAMELISA for Heparin Induced Antibodies (HIT),Screening Assay, Mono-strip

CE 510(k) #RK041D

Enzyme immuno-assay designed for measuring globally all heparin-dependent antibodies, whether the isotype is: IgG, IgM and IgA, in human plasma or serum, or in any biological fluid where these antibodies must be measured. This assay is proposed as screening, as an early identification of heparin treated patients presenting a risk to develop HIT or HITT. This assay measures the whole of antibodies. It offers the highest sensitivity as all isotypes are detected. It is the preferred assay when an early detection of heparin dependent antibodies is required for assessing the development risk of HIT/HITT.

This kit allows individual test as it offers a packaging for 4 individual 8 well strips along with controls.

Pres

enta

tion

4 individual 8 well strips2x HIA Sample Diluent4x HIA IgGAM positive Control4x Negative control4x Platelet lysate4x Anti-IgG (Fc)- IgM (m)-IgA(a)-HRP IC1x Conjugate Diluent4x Wash Solution1x TMB1x 0.45M Sulfuric Acid

Ass

ay c

hara

cter

isti

cs

Total Assay Time: 2h15Cut-off: A450 ≥ 0.50Dynamic Range: A450 up to 3.0Intra-Assay CV: 4 - 6%Inter-Assay CV: 5 – 8%

Intended use : Individual test.

Assessment of the risk to develop HIT/HITT, in patients treated with heparins (Unfractionated or LMWH): presence of antibodies is a risk indicator for development of HIT/HITT.

Clinical suspicion of HIT during heparin therapy.

IVD

34

Biophen® DTIDirect Thrombin Inhibitors (DTI) Chromogenic Assay #220202

Quantitative assay for measuring the anti-IIa activity of Dabigatran and other Direct Thrombin Inhibitors (DTIs) in human citrated plasma, using a chromogenic method, manual or automated.

Pres

enta

tion

R1: 2x2.5 mL ThrombinChromogenic substrate

R2: 2x2.5 mL h Thrombin

R3: 2x25 mL of Tris-BSA Buffer

Ass

ay c

hara

cter

isti

cs Total Assay Time: ≤ 10 min.Detection Threshold: 0.30 µg/ml (high range) 0.15 µg/ml (low range)Dynamic Range: 0 to 5 µg/mL (high range) 0 to 2 µg/mL (low range)Intra-Assay CV: < 5%Inter-Assay CV: < 5%

Intended use : Assay proposed for the measurement of anti-IIa activity in research applications.

Biophen® DiXaI Direct Factor Xa Inhibitor Chromogenic Assay CE #221030

Quantitative assay for measuring the Factor Xa Direct Inhibitor, such as Rivaroxaban in human citrated plasma, using a chromogenic method, manual or automated.

Pres

enta

tion

R1: 3x2.5 mL human FXa

R2: 3x2.5 mL FXaChromogenic substrate

R3: 4x25 mL of Tris-NaCl-EDTA Buffer

Ass

ay c

hara

cter

isti

cs Total Assay Time: ≤ 10 min.Detection Threshold: 0.02 µg/mLDynamic Range: 0 to 0.50 µg/mL Intra-Assay CV: < 5%Inter-Assay CV: <10-15%

Intended use : Measurement of Rivaroxaban and other Factor Xa inhibitors in citrated plasma or other biological fluids.Nota : Biophen® Heparin (3 or 6) or Biophen Heparin LRT can also be used for testing Direct Factor Xa Inhibitors(DiXaIs), such as Rivaroxaban or Apixaban. Adjusted protocols are available on demand.

RUO

IVD

Direct Factor Xa Inhibitors

NEW ORAL ANTICOAGULANTS (NOACs : DTIs ; DiXals)

HEMOCLOT Thrombin InhibitorsDirect Thrombin Inhibitors (DTI) Clotting Assay CE #CK002K / #CK002L

Assay designed for the quantitative measurement of direct thrombin inhibitors (DTI), such as Dabigatran and Argatroban®, in human citrated plasma, with a clotting method based on the inhibition of a constant and defined concentration of thrombin. It is intended for prescription use. Measuring DTI concentrations in patient’s plasma may be used as an aid in the management of patients receiving DTIs who are suspected of having excess anticoagulant activity.

Pres

enta

tion

3x1 mL (CK002K) 3x2.5 mL (CK002L)

R1: normal pooled citra-ted plasma

R2: highly purified humancalcium thrombin (a form)

Ass

ay c

hara

cter

isti

cs

Total Assay Time: < 3 min.Detection Threshold: < 0.1 µg/mLDynamic Range: 0 - 5 µg/mLIntra-Assay CV: < 4%Inter-Assay CV: < 6%

Intended use : Quantitative measurement of Dabigatran, and anti-Thrombin activities in plasma (e.g. Dabigatran Plasma Calibrator (#222801), Dabigatran Control Plasma (#224701), Argatroban® Plasma Calibrator (#SC030K), Argatroban® Control Plasma (#SC035K)).

IVD

Direct Thrombin Inhibitors

35

PART 5 : LUPUS ANTICOAGULANTS AND

ANTI-ANTIPHOSPOLIPID ANTIBODIES (ACA/APA)

PART

5 :

LA, A

CA/A

PA

36

PART 5 : LUPUS ANTICOAGULANTS AND ANTI-ANTIPHOSPOLIPID ANTIBODIES (ACA/APA)

Lupus anticoagulant

HEMOCLOT LA SCREENdRVVT Based Clotting assay forLupus Anticoagulant (Screening)

CE #CK090K

DRVVT based assay for Lupus anticoagulant: Diluted Russell’s Viper Venom clotting Test (DRVVT) performed in presence of low (screening) phospholipid concentrations for the measurement of Lupus Anticoagulant activity in citrated plasma. Pr

esen

tati

on

6x1 mL

Ass

ay c

hara

cter

isti


Intended use : Diagnosis of Lupus Anticoagulant using the dRVVT clotting assay.

HEMOCLOT LA CONFIRMdRVVT Based Clotting assay forLupus Anticoagulant (Confirmation)

CE#CK091K

DRVVT based assay for Lupus anticoagulant: Diluted Russell’s Viper Venom clotting Test (DRVVT) performed in presence of high (confirmation) phospholipid concentrations for the measurement of Lupus Anticoagulant activity in citrated plasma. Pr

esen

tati

on

6x1 mLA

ssay

cha

ract

eris

tics Total Assay Time: < 3 min.

Intra-Assay CV: < 4%Inter-Assay CV: < 6%Number of tests: ≥ 60

Intended use : Confirmation of Lupus Anticoagulant using the dRVVT clotting assay in presence of an excess of phospholipids.

IVD

IVD

LA-Negative PlasmaNegative Control set for Lupus Anticoagulant CE in progress #SC080K

Negative lyophilized plasmas for LA activity, as measured with the HEMOCLOT LA Screen (ref CK090K) and HEMOCLOT LA Confirm (ref CK091K) kits, for the quality control of Lupus Anticoagulant clotting assays.

Pres

enta

tion

6x1mL

Ass

ay c

hara

cter

isti

cs Negative for LA

High stability following reconstitution.

Intended use : Quality control for Lupus Anticoagulant clotting assays.

LA-Positive PlasmaPositive Control set for Lupus Anticoagulant CE in progress #SC081K

Positive lyophilized plasmas for LA activity, as measured with the HEMOCLOT LA Screen (ref CK090K) and HEMOCLOT LA Confirm (ref CK091K) kits, for the quality control of Lupus Anticoagulant clotting assays.

Pres

enta

tion

6x0.5 mL

Ass

ay c

hara

cter

isti

cs Positive for LA


Intended use : Quality control for Lupus Anticoagulant clotting assays.

RUO

RUO

37

ZYMUTEST ACA-APA, IgGImmunoassay for ACA/APA, IgG CE #RK029A

Two-site Enzyme ImmunoAssay (ELISA), designed with Murine monoclonal antibodies, for the quantitative determination of ELISA method for the measurement of IgG isotype auto antibodies targeted to ACA-APA (Anti-Cardiolipin/Anti-Phospholipid-Antibodies). Assay designed with highly characterized and stabilized anionic Phospholipids, saturated with an optimal concentration of a fully active human β2GP1 preparation, for auto antibody immunocapture. These are then revealed with a goat antibody specific for IgG Fcg fragments, and labelled with peroxidase. Sample Diluent is adjusted for offering the highest sensitivity and specificity.

Pres

enta

tion

12x8 test kit2x Sample Diluent3x Anti-Cardiolipin, IgG Calibrator3x Negative Control3x Anti-IgG (Fc)-HRP IC1x Conjugate Diluent1x Wash Solution1x TMB1x 0.45M Sulfuric Acid

Ass

ay c

hara

cter

isti

cs

Total Assay Time: 1h15 Detection Threshold: ≤ 2 GPLNormal Range: ≤ 5 GPLIntra-Assay CV: 3-6%Inter-Assay CV: 4-8%

Optimized specificity and sensitivity (only the “true” antibodies are measured).

Intended use : Anti-Phospholipid Syndrome (APS).Pregnancies with recurrent miscarriage.Unexplained thrombosis.Any clinical situation where the assay of anti-Cardiolipin/Anti-Phospholipid Antibodies is required.

ZYMUTEST ACA-APA, IgMImmunoassay for ACA/APA, IgM CE #RK029B

ELISA method for the measurement of IgM isotype auto antibodies targeted to ACA-APA (Anti-Cardiolipin/Anti-Phospholipid-Antibodies). Assay designed with highly characterized and stabilized anionic Phospholipids, saturated with an optimal concentration of a fully active human β2GP1 preparation, for auto antibody immunocapture. These are then revealed with a goat antibody specific for IgM µ fragments, and labelled with peroxidase. Sample Diluent is adjusted for offering the highest sensitivity and specificity.

Pres

enta

tion

12x8 test kit2x Sample Diluent3x Anti-Cardiolipin, IgM Calibrator3x Negative Control3x Anti-IgM-HRP IC1x Conjugate Diluent1x Wash Solution1x TMB1x 0.45M Sulfuric Acid

Ass

ay c

hara

cter

isti

cs

Total Assay Time: 1h15 Detection Threshold: ≤ 1 MPLNormal Range: ≤ 3 MPLIntra-Assay CV: 3-6%Inter-Assay CV: 4-8%

Optimized specificity and sensitivity (only the “true” antibodies are measured)

Intended use : Anti-Phospholipid syndrome (APS).Pregnancies with recurrent miscarriage.Unexplained thrombosis.Any clinical situation where the assay of anti-Cardiolipin/anti-Phospholipid antibodies is required.

IVD

IVD

ZYMUTEST ACA-APA, IgAImmunoassay for ACA/APA, IgA #RK029C

ELISA method for the measurement of IgA isotype auto antibodies targeted to ACA-APA (Anti-Cardiolipin / Anti-Phosphol ipid-Ant ibodies) .Assay designed with highly characterized and stabilized anionic Phospholipids, saturated with an optimal concentration of a fully active human β2GP1 preparation, for auto antibody immunocapture. These are then revealed with a goat antibody specific for IgA, a fragments, and labelled with peroxidase. Sample Diluent is adjusted for offering the highest sensitivity and specificity.

Pres

enta

tion

12x8 test kit2x Sample Diluent3x Anti-Cardiolipin, IgA Calibrator3x Negative Control3x Anti-IgA-HRP IC1x Conjugate Diluent1x Wash Solution1x TMB1x 0.45M Sulfuric Acid

Ass

ay c

hara

cter

isti

cs

Total Assay Time: 1h15 Detection Threshold: ≤ 2 APLNormal Range: ≤ 5 APLIntra-Assay CV: 3-6%Inter-Assay CV: 4-8%


Intended use : Assay proposed for the measurement of IgA isotype auto antibodies targeted to ACA/APA in research applications.

RUO

Anti-Cardiolipin / Anti-Phospholipid Antibodies (ACA/APA)

38

ZYMUTEST anti-β2GP1, IgGImmunoassay for Anti Beta2 Glycoprotein I, IgG CE #RK014A

ELISA method for the measurement of IgG isotype auto antibodies targeted to β2GP1. Assay designed with highly purified human β2GP1, obtained with non-denaturing methods, for auto antibody immunocapture. These are then revealed with a goat antibody specific for IgG Fc fragments and labelled with peroxidase.

Pres

enta

tion

12x8 test kit2x Sample Diluent3x Anti-β2GP1, IgG Cali-brator3x Negative Control3x Anti- IgG (Fc)-HRP IC1x Conjugate Diluent1x Wash Solution1x TMB1x 0.45M Sulfuric Acid A

ssay

cha

ract

eris

tics Total Assay Time: 1h15

Detection Threshold: ≤ 5 AUNormal Range: ≤ 10 AU*Intra-Assay CV: 3-6%Inter-Assay CV: 4-8%


*AU: Arbitrary Unit (Mean + 2SD = 10AU)

Intended use : Recurrent unexplained miscarriages.Unexplained lupus anticoagulant, without or with thrombosis.Anti-Phospholipid syndrome.Any clinical situation where the assay of anti-b2GP1 auto antibodies is required.

ZYMUTEST anti-β2GP1 IgM Immunoassay for Anti Beta2 Glycoprotein I, IgM CE #RK014B

ELISA method for the measurement of IgM isotype auto antibodies targeted to β2GP1. Assay designed with highly purified human β2GP1, obtained with non-denaturing methods, for auto antibody immunocapture. These are then revealed with a goat antibody specific for IgM µ fragments, and labelled with peroxidase.

Pres

enta

tion

12x8 test kit2x Sample Diluent3x Anti-β2GP1, IgM Cali-brator3x Negative Control3x Anti- IgM (µ)-HRP IC1x Conjugate Diluent1x Wash Solution1x TMB1x 0.45M Sulfuric Acid A

ssay

cha

ract

eris




Intended use : Recurrent unexplained miscarriages.Unexplained lupus anticoagulant, without or with thrombosis.Anti-Phospholipid syndrome.Any clinical situation where the assay of anti-b2GP1 auto antibodies is required.

ZYMUTEST anti-β2GP1, IgA Immunoassay for Anti Beta2 Glycoprotein I, IgA #RK014C

ELISA method for the measurement of IgA isotype auto antibodies targeted to β2GP1. Assay designed with highly purified human β2GP1, obtained with non-denaturing methods, for auto antibody immunocapture. These are then revealed with a goat antibody specific for IgA, a fragments, and labelled with peroxidase.

Pres

enta

tion

12x8 test kit2x Sample Diluent3x Anti-β2GP1, IgA Cali-brator3x Negative Control3x Anti- IgA (a)-HRP IC1x Conjugate Diluent1x Wash Solution1x TMB1x 0.45M Sulfuric Acid A

ssay

cha

ract

eris




Intended use : Assay proposed for the measurement of IgA isotype auto antibodies targeted to β2GP1 in research applications.

IVD

IVD

RUO

Anti-β2GP1 Auto-Antibodies

39

ZYMUTEST anti-Annexin V, IgGImmunoassay for Anti-Annexin V, IgG #RK005A

ELISA method for the measurement of IgG isotype auto antibodies targeted to annexin V. Assay designed with highly purified human recombinant annexin V, obtained with non-denaturing methods, for auto antibody immunocapture. These are then revealed with a goat antibody specific for IgG, Fc fragments, and labelled with peroxidase.

Pres

enta

tion

12x8 test kit2x Sample Diluent3x Anti-Annexin V, IgG Calibrator3x Negative Control3x Anti- IgG (Fc)-HRP IC1x Conjugate Diluent1x Wash Solution1x TMB1x 0.45M Sulfuric Acid A

ssay

cha

ract

eris




Intended use : Assay proposed for the measurement of IgG isotype auto antibodies targeted to Annexin V in research applications.

ZYMUTEST anti-Annexin V, IgMImmunoassay for Anti-Annexin V, IgM #RK005B

ELISA method for the measurement of IgM isotype auto antibodies targeted to annexin V. Assay designed with highly purified human recombinant annexin V, obtained with non-denaturing methods, for auto antibody immunocapture. These are then revealed with a goat antibody specific for IgM, µ fragments, and labelled with peroxidase.

Pres

enta

tion

12x8 test kit2x Sample Diluent3x Anti-Annexin V, IgM Calibrator3x Negative Control3x Anti- IgM (µ)-HRP IC1x Conjugate Diluent1x Wash Solution1x TMB1x 0.45M Sulfuric Acid A

ssay

cha

ract

eris




Intended use : Assay proposed for the measurement of IgM isotype auto antibodies targeted to Annexin V in research applications.

ZYMUTEST anti-Protein C, IgGImmunoassay for Anti-Protein C, IgG #RK026A

ELISA method for the measurement of IgG isotype auto antibodies targeted to protein C. Assay designed with highly purified human protein C, obtained with non-denaturing methods, for auto antibody immunocapture. These are then revealed with a goat antibody specific for IgG, Fc fragments, and labelled with peroxidase.

Pres

enta

tion

12x8 test kit2x Sample Diluent3x Anti-PC, IgG Calibrator3x Negative Control3x Anti- IgG (Fc)-HRP IC1x Conjugate Diluent1x Wash Solution1x TMB1x 0.45M Sulfuric Acid

Ass

ay c

hara

cter

isti

cs Total Assay Time: 1h15 Detection Threshold: ≤ 5 AUNormal Range: ≤ 10 AU*Intra-Assay CV: 3-6%Inter-Assay CV: 4-8%


Intended use : Assay proposed for the measurement of IgG isotype auto antibodies targeted to Protein C in research applications.

RUO

RUO

RUO

Auto-Antibodies to Phospholipid Cofactor Proteins

40

ZYMUTEST anti-Protein C, IgMImmunoassay for Anti-Protein C, IgM #RK026B

ELISA method for the measurement of IgM isotype auto antibodies targeted to protein C. Assay designed with highly purified human protein C, obtained with non-denaturing methods, for auto antibody immunocapture. These are then revealed with a goat antibody specific for IgM, µ fragments, and labelled with peroxidase.

Pres

enta

tion

12x8 test kit2x Sample Diluent3x Anti- PC, IgM Calibrator3x Negative Control3x Anti- IgM (µ)-HRP IC1x Conjugate Diluent1x Wash Solution1x TMB1x 0.45M Sulfuric Acid A

ssay

cha

ract

eris




Intended use : Assay proposed for the measurement of IgM isotype auto antibodies targeted to Protein C in research applications.

ZYMUTEST anti-Protein S, IgGImmunoassay for Anti-Protein S, IgG #RK020A

ELISA method for the measurement of IgG isotype auto antibodies targeted to protein S. Assay designed with highly purified human protein S, obtained with non-denaturing methods, for auto antibody immunocapture. These are then revealed with a goat antibody specific for IgG, Fc fragments, and labelled with peroxidase.

Pres

enta

tion

12x8 test kit2x Sample Diluent3x Anti-PS, IgG Calibrator3x Negative Control3x Anti- IgG (Fc)-HRP IC1x Conjugate Diluent1x Wash Solution1x TMB1x 0.45M Sulfuric Acid

Ass

ay c

hara

cter

isti



Intended use : Assay proposed for the measurement of IgG isotype auto antibodies targeted to Protein S in research applications.

ZYMUTEST anti-Protein S, IgMImmunoassay for Anti-Protein S, IgM #RK020B

ELISA method for the measurement of IgM isotype auto antibodies targeted to protein S. Assay designed with highly purified human protein S, obtained with non-denaturing methods, for auto antibody immunocapture. These are then revealed with a goat antibody specific for IgM, µ fragments, and labelled with peroxidase.

Pres

enta

tion

12x8 test kit2x Sample Diluent3x Anti- PS, IgM Calibrator3x Negative Control3x Anti- IgM (µ)-HRP IC1x Conjugate Diluent1x Wash Solution1x TMB1x 0.45M Sulfuric Acid

Ass

ay c

hara

cter

isti



Intended use : Assay proposed for the measurement of IgM isotype auto antibodies targeted to Protein S in research applications.

RUO

RUO

RUO

ZYMUTEST anti-Protein Z, IgGImmunoassay for Anti-Protein Z, IgG #RK025A

ELISA method for the measurement of IgG isotype auto antibodies targeted to protein Z. Assay designed with highly purified human protein Z, obtained with non-denaturing methods, for auto antibody immunocapture. These are then revealed with a goat antibody specific for IgG, Fc fragments, and labelled with peroxidase.

Pres

enta

tion

12x8 test kit2x Sample Diluent3x Anti-PZ, IgG Calibrator3x Negative Control3x Anti- IgG (Fc)-HRP IC1x Conjugate Diluent1x Wash Solution1x TMB1x 0.45M Sulfuric Acid

Ass

ay c

hara

cter

isti

cs

Total Assay Time: 1h15 Detection Threshold: ≤ 5 AUNormal Range: ≤ 10 AU*Intra-Assay CV: 3-6%Inter-Assay CV: 4-8%


Intended use : Assay proposed for the measurement of IgG isotype auto antibodies targeted to Protein Z in research applications.

RUO

41

ZYMUTEST anti-Protein Z, IgMImmunoassay for Anti-Protein Z, IgM #RK025B

ELISA method for the measurement of IgM isotype auto antibodies targeted to protein C. Assay designed with highly purified human protein C, obtained with non-denaturing methods, for auto antibody immunocapture. These are then revealed with a goat antibody specific for IgM, µ fragments, and labelled with peroxidase.

Pres

enta

tion

12x8 test kit2x Sample Diluent3x Anti- PC, IgM Calibrator3x Negative Control3x Anti- IgM (µ)-HRP IC1x Conjugate Diluent1x Wash Solution1x TMB1x 0.45M Sulfuric Acid

Ass

ay c

hara

cter

isti



Intended use : Assay proposed for the measurement of IgM isotype auto antibodies targeted to Protein Z in research applications.

RUO

ZYMUTEST anti-Prothrombin, IgGImmunoassay for Anti-Prothrombin, IgG #RK007A

ELISA method for the measurement of IgG isotype auto antibodies targeted to Prothrombin. Assay designed with highly purified human Prothrombin, obtained with non-denaturing methods, for auto antibody immunocapture. These are then revealed with a goat antibody specific for IgG, Fc fragments, and labelled with peroxidase.

Pres

enta

tion

12x8 test kit2x Sample Diluent3x Anti-FII, IgG Calibrator3x Negative Control3x Anti- IgG (Fc)-HRP IC1x Conjugate Diluent1x Wash Solution1x TMB1x 0.45M Sulfuric Acid A

ssay

cha

ract

eris


Detection Threshold : ≤ 5 AUNormal Range: ≤ 10 AU*Intra-Assay CV: 3-6%Inter-Assay CV: 4-8%


Intended use : Assay proposed for the measurement of IgG isotype auto antibodies targeted to Prothrombin in research applications.

RUO

ZYMUTEST anti-Prothrombin, IgMImmunoassay for Anti-Prothrombin, IgM #RK007B

ELISA method for the measurement of IgM isotype auto antibodies targeted to Prothrombin. Assay designed with highly purified human Prothrombin, obtained with non-denaturing methods, for auto antibody immunocapture. These are then revealed with a goat antibody specific for IgM, µ fragments, and labelled with peroxidase.

Pres

enta

tion

12x8 test kit2x Sample Diluent3x Anti- FII, IgM Calibrator3x Negative Control3x Anti- IgM (µ)-HRP IC1x Conjugate Diluent1x Wash Solution1x TMB1x 0.45M Sulfuric Acid

Ass

ay c

hara

cter

isti



Intended use : Assay proposed for the measurement of IgM isotype auto antibodies targeted to Prothrombin in research applications.

RUO

42

PART 6 : CALIBRATORS & CONTROLS

Complete line of calibrators and controls, established against WHO International Standards, when available, for the

measurement of the various proteins involved in regulation of blood hemostasis and thrombosis, and for anticoagulant drugs.

43

PAR

T 6

: C

ALI

BR

ATO

RS

AN

D C

ON

TRO

LS

Biophen® Plasma Calibrator Multifactor Plasma Calibrator CE 510(k)* #222101

Calibration plasma for the assay of Protein C, Protein S, Antithrombin, PT, aPTT, Fibrinogen, Factor VIII:C, Factors VII+X, Factors II, V, VII, IX, X, XI, XII and Plasminogen.The exact concentration for each factor is indicated on the flyer provided in each kit. Pr

esen

tati

on

12x1 mL of normal citratedhuman pooled plasma

Ass

ay c

hara

cter

isti

cs Normal human citrated plasmas, freeze dried and stabilized, titrated for various factor activities.

Concentrations are established against the NIBSCInternational Standard.


Intended use : Calibration plasma for the corresponding clotting or chromogenic assays.

Biophen® Normal Control PlasmaMultifactor Plasma Control, Normal CE 510(k)* #223201

Normal plasma for the quality control of assays for Protein C, Protein S, Antithrombin, PT, aPTT, Fibrinogen, Factor VIII:C, Prothrombin, Factors VII+X, Factors II, V, VII, IX, X, XI, XII and Plasminogen. The exact concentration and the acceptance ranges for each factor are indicated on the flyer provided with each kit.

Pres

enta

tion

12x1 mL of normal citrated human pooled plasma

Ass

ay c

hara

cter

isti




Intended use : Quality control plasma for the corresponding clotting or chromogenic assays, and for non mutated FV (not resistant to APC).

IVD

IVD

Calibrators and Controls for Plasma Factors and Cofactors

* In US, BIOPHEN Plasma Calibrator is cleared only for calibration of Antithrombin and Protein C assays.

* In US, BIOPHEN Normal Control Plasma is cleared only for calibration of Antithrombin, Protein C, and Factor V-Leiden quantitative assays.

Biophen® FIXa Control SetControl set for FIXa in plasma #224601

Factor IXa Controls are intended for the quality control of activated Factor IX (FIXa) chromogenic measurements, using Biophen® Factor IXa assay(Ref 221812).

Pres

enta

tion

C1: 6x1 mLC2: 6x1 mL

Lyophilized preparation, withstabilizers, supplemented with FIXa

Ass

ay c

hara

cter

isti

cs Normal human plasmas supplemented with FIXa at various levels (level 1 at about 10 mIU/mL / level 2 at about 20 mIU/mL).

Biophen® FIXa Controls are calibrated against an Internal Reference Standard, initially validated by reference to the 1st International Standard for acti-vated Factor IX (FIXa), human (NIBSC) (code 97/562).


Intended use : FIXa controls are proposed for the quality control of FIXa measurements, in FIXa therapeutic concentrates or in purified milieus, using Biophen® Factor IXa (#221812).The Ultra Low FIXa control can be used in association with Biophen® FIXa kit (#221812) for testing FIXa in therapeutic concentrates or in purified milieus.

RUO

Biophen® Abnormal Control PlasmaMultifactor Plasma Control, Abnormal CE 510(k)* #223301

Abnormal plasma for the quality control of assays for Protein C, Protein S, Antithrombin, PT, aPTT, Fibrinogen, Factor VIII:C, Factors VII+X, Factors II, V, VII, IX, X, XI, XII and Plasminogen. The exact concentration and the acceptance ranges for each factor are indicated on the flyer provided with each kit.

Pres

enta

tion

12x1 mL of abnormal citrated human pooled plasma

Ass

ay c

hara

cter

isti

cs Abnormal human citrated plasmas, freeze dried and stabilized, titrated for various factor activities.



Intended use : Quality control plasma for the corresponding clotting or chromogenic assay.

IVD

* In US, BIOPHEN Abnormal Control Plasma is cleared only for calibration of Antithrombin and Protein C assays.

44

PART 6 : CALIBRATORS & CONTROLS

45

Biophen® FXIa Control SetControl set for FXIa in plasma #224801

Factor XIa Controls are intended for the quality control of activated Factor XI (FXIa) chromogenic measurements, using Biophen® FXIa colorimetric assay (Ref 220412).

Pres

enta

tion

C1: 3x 1 mL

C2: 3x 1 mL

Lyophilized preparation, with stabilizers, supplemented with FXIa

Ass

ay c

hara

cter

isti

cs

Normal human plasmas supplemented with FXIa at various levels (level 1 at about 1ng/mL / level 2 at about 4 ng/mL).

Biophen® FXIa Controls are calibrated against inter-nal reference standard, initially validated against NIBSC standard reference material, Non WHO 11/236.


Intended use : FXIa Controls are proposed for the quality control of FXIa measurements, in therapeutic concentrates or in purified milieus, using Biophen® FXIa kit (#220412)

RUO

Biophen® UFH CalibratorCalibrator set for Unfractionated Heparin in Plasma CE 510(k) #222301

Range of calibration plasmas supplemented with Unfractionated Heparin(UFH) (4 sets at 5 different UFH levels from 0 to 1.40 IU/mL) for the assay of Unfractionated Heparin.

Pres

enta

tion

Human plasma

20 vials (4 sets of 5 vials) of 1 ml human plasma supplemented with different concentrations of Unfractionated Heparin (UFH).

Ass

ay c

hara

cter

isti

cs Normal human plasmas supplemented with UFH at various levels.



Intended use : Calibration set for chromogenic heparin assays (Biophen® Heparin).Specific for UFH.

IVD

Biophen® Heparin CalibratorCalibrator set for Kinetics anti-Xa Assay CE 510(k) #222001

Range of calibration plasmas supplemented with Low Molecular Weight Heparin (LMWH) (4 sets at 5 different heparin levels from 0 to 1.60 IU/ml) for the assay of heparin (UFH or LMWH) using the Biophen® Heparin kit.

Pres

enta

tion

Human plasma

20 vials (4 sets of 5 vials) of 1 ml human plasma supplemented with different concentrations of Low Molecular Weight Heparin (LWMH).

Ass

ay c

hara

cter

isti

cs Normal human plasmas supplemented with LMWH at various levels.



Intended use : Calibration of heparin assays (Biophen® Heparin):LMWH or UFH when Biophen® Heparin is used with a “hybrid calibration curve”.

IVD

Heparin and Analogues

46

Biophen® LMWH Control PlasmaControl set for Low Molecular Weight Heparinin Plasma, High range

CE 510(k) #223001 / #223801 / #224201

Quality control plasmas (2 different levels: about 0.80 and 1.20 IU/mL) for the quality control of LMWH testing (Low Molecular Weight Heparin) in the high concentration range.

Pres

enta

tion

Human plasma

#223001C3: 6x1 mLC4: 6x1 mL

#223801C3: 12x1 mL

#224201C4: 12x1 mL A

ssay

cha

ract

eris

tics Normal human plasmas supplemented with LMWH

at various levels.

Concentrations are established against the NIBSC International Standard.


Intended use : Quality control of heparin (LMWH) testing (Biophen® Heparin).High therapeutic range.

IVD

Biophen® LMWH Control LowControl set for Low Molecular Weight Heparinin Plasma, Low range

CE 510(k) #223701 / #224301 / #224401

Quality control plasmas (2 different levels: about 0.25 and 0.50 IU/mL) for the quality control of LMWH testing, in the low concentration range.

Pres

enta

tion

Human plasma

#223701CI: 6x1 mLCII: 6x1 mL

#224301CI: 12x1 mL

#224401CII: 12x1 mL A

ssay

cha

ract

eris

tics Normal human plasmas supplemented with LMWH

at various levels.



Intended use : Quality control of heparin (LMWH) testing (Biophen® Heparin).Low therapeutic range.

IVD

Biophen® UFH Control PlasmaControl set for Unfrationated Heparin in Plasma CE 510(k) #223101 / #224101 / #223901

Quality control plasmas (2 different levels: about 0.20 and 0.50 IU/mL) for the quality control of UFH testing (Unfractionated Heparin).

Pres

enta

tion

Human plasma

#223101C1: 6x1mLC2: 6x1mL

#224101C1: 12x1 mL

#223901C2: 12x1 mL A

ssay

cha

ract

eris

tics

Normal human plasmas supplemented with UFH at various levels.



Intended use : Quality control of heparin (UFH) testing (Biophen® Heparin).

IVD

Biophen® Purified UFH Cal.Calibrator set for Unfractionated Heparin inPurified Solution

#222601

Range of calibration solution supplemented with Unfractionated Heparin (UFH) (3 sets at 4 different UFH levels from 0 to 2IU/mL).

Pres

enta

tion

12 vials (3 sets of 4 vials) of 1 ml solution supple-mented with different concentrations of Unfrac-tionated Heparin (UFH).

Ass

ay c

hara

cter

isti

cs Purified solution supplemented with UFH at various levels.



Intended use : Calibration set for chromogenic heparin assays in purified systems.Specific for UFH.

RUO

47

Biophen® Arixtra® Control Plasma Control set for Arixtra® in plasma CE #224001

Quality control plasmas (2 different levels at about 0.40 and 1.20 µg/mL) for the quality control of Arixtra® (Fondaparinux) testing using anti-Xa colorimetric assays.

Pres

enta

tion

12 vials of 1 mL of human plasma supplemented at 2 different concentrations of Arixtra® (6 vials for each concentration).

Ass

ay c

hara

cter

isti

cs Normal human plasmas supplemented with Arixtra® at various levels.

Concentrations are established against a reference preparation for Arixtra®.


Intended use : Quality control of Arixtra® testing (Biophen® Heparin).Specific for Arixtra®.

Biophen® Orgaran® ControlControl set for Orgaran® in plasma CE #223501

Quality control plasmas (2 different levels at about 0.50 and 1.00 U/mL) for the quality control of Sodium Danaparoid testing.

Pres

enta

tion

12 vials of 1 ml human plasma supplemented with 2 different concen-trations of Sodium Dana-paroïd (Orgaran®).

Ass

ay c

hara

cter

isti

cs Normal human plasmas supplemented with Orga-ran® at various levels.

Concentrations are established against a reference preparation for Orgaran®.


Intended use : Quality control of heparin testing (Biophen® Heparin).Specific for Sodium Danaparoid (Orgaran®).

IVD

IVD

Biophen® Orgaran® CalibratorCalibrator set for Orgaran® in plasma CE #222201

Range of calibration plasmas (4 sets at 5 different Orgaran® levels from 0 to 1.60 U/mL) for the assay of Sodium Danaparoid (Orgaran®).

Pres

enta

tion

20 vials (4 sets of 5 vials) of 1 ml human plasma supplemented with different concentrations of Sodium Danaparoïd (Orgaran®).

Ass

ay c

hara

cter

isti

cs Normal human plasmas at various levels.

Concentrations are established against a reference preparation for Orgaran®.


Intended use : Calibration of heparin assays (Biophen® Heparin).Specific for Sodium Danaparoid (Orgaran®).

IVD

Biophen® Arixtra® CalibratorCalibrator set for Arixtra® in plasma CE #222501

Range of calibration plasmas (3 sets at 4 different Arixtra® levels from 0 to 1.50 µg/mL) for the assay of Fondaparinux (Arixtra®).

Pres

enta

tion

12 vials (3 sets of 4 vials) of 1 ml human plasma supplemented with different concentrations of Arixtra®.

Ass

ay c

hara

cter

isti

cs Normal human plasmas at various levels.

Concentrations are established against a reference preparation for Arixtra®.


Intended use : Calibration of Arixtra® assays (Biophen® Heparin).Specific for Arixtra®.

IVD

48

Biophen® V-L CAL (Undiluted)Calibrator set for Quantitative Factor V-LClotting Assay (undiluted)

CE 510(k) #222401

Lyophilized, undiluted human plasmas, at defined Factor V-Leiden (FV-L) concentrations, for the calibration of Factor V-L activity quantitative clotting assay on human citrated plasma, using the HEMOCLOT Quanti. V-L kit (ref CK065K).

Pres

enta

tion

9 vials (3 sets of 3 vials) of 0.5 mL of undiluted human plasma at different concentrations of FV-L, to cover the assay range, from about 10% to 100% (4 points for the calibra-tion curve).

Ass

ay c

hara

cter

isti

cs Undiluted, freeze dried plasma set at defined concentrations of Factor V-L (10 to 50%).

Intended use : Calibration of HEMOCLOT Quanti-V-L kit (CK065K).

IVD

Biophen® Act. PC-r Control PlasmaControl Plasma Heterozygous for Factor V-L CE 510(k) #223405

Quality control plasma presenting an Activated Protein C Resistance (heterozygous), tested for Factor V-L concentration.

Pres

enta

tion

12x0.5 mL of human plasma, presenting an APC-R, citrated andlyophilized

Ass

ay c

hara

cter

isti


Concentrations are established against a reference preparation from normal donors and patients pres-enting APC resistance (FVL).


Intended use : Quality control plasma for the qualitative or quantitative assay of FV-Leiden (resistant to APC), with clotting assays (e.g. HEMOCLOT Factor V-L, HEMOCLOT Quanti V-L).

IVD

Factor V-L CalibratorCalibrator set for Quantitative Factor V-LClotting Assay (diluted)

CE 510(k) #SC065K

Lyophilized, prediluted (1:20) human plasmas, at defined Factor V-Leiden (FV-L) concentrations, for the calibration of Factor V-L activity quantitative clotting assay on human citrated plasma, using the HEMOCLOT Quanti. V-L kit (ref CK065K).

Pres

enta

tion

12 vials (3 sets of 4 vials) of 1 ml of prediluted human plasma (1:20) at different concentrations of FV-L, ranging from about 10% to 100% (3 vials for each concentra-tion).

Ass

ay c

hara

cter

isti

cs Prediluted, freeze dried plasma set at defined concentrations of Factor V-Ln (10 to 100%).

Intended use : Calibration of HEMOCLOT Quanti-V-L kit (CK065K).

IVD

Calibrators and Controls for Factor V-L

Argatroban® Plasma CalibratorCalibrator set for Argatroban® in plasma CE #SC030K

Set of calibration plasmas for Argatroban® (also called Argatra®, Arganova®, or Novastan®), measurements, titrated and optimised using the anti-IIa clotting assay HEMOCLOT Thrombin Inhibitors (#CK002K/CK002L). Pr

esen

tati

on

20 vials (4 sets of 5 vials from 0 to 2.00 µg/ml) of 1 ml human plasma supplemented with dif-ferent concentrations of Argatroban®.

Ass

ay c

hara

cter

isti

cs Normal human plasma, freeze dried, without or with Argatroban®, at a defined level.


Intended use : Calibrating the assays of Argatroban® using clotting anti-IIa methods, especially when the HEMOCLOT Thrombin Inhibitors kit (#CK002K, CK002L) is used, with the low range protocol.

IVD

Direct Thrombin Inhibitors

49

Argatroban® Control PlasmaControl set for Argatroban® in plasma CE #SC035K

Set of control plasmas for the quality control of Argatroban® (also called Argatra®, Arganova® or Novastan®) measurements, using anti-IIa clotting assays. This kit is optimised for being used with the HEMOCLOT Thrombin Inhibitors assay (low range protocol) (#CK002K/CK002L).

Pres

enta

tion

12 vials of 1 mL of human plasma supplemented at 2 different concentrations of Argatroban®(6 vials for each concentration of about 0.65 and 1.25µg/ml)

Ass

ay c

hara

cter

isti

cs Normal human plasma, freeze dried, with Argatroban®, at a defined level.


Concentrations are established against a reference preparation for Argatroban®.

Intended use : Quality control of clotting assays proposed for measuring Argatroban® concentrations in plasma (especially #CK002K, CK002L).

IVD

Plasma Hirudin StandardCalibrator set for Hirudin in plasma(Low range/High range)

CE #SC020K / #SC020L

Human plasma supplemented with Hirudin, for the calibration of HEMOCLOT Thrombin Inhibitors assay (CK002K/CK002L), low range (SC020K) or high range (SC020L).

Pres

enta

tion

#SC020K (Low range)Std 0: 3x1 mL (0 μg/mL)Std 2: 3x1 mL (2 μg/mL)

#SC020L (High range)Std 0: 3x1 mL (0 μg/mL)Std 5: 3x1 mL (5 μg/mL)

Ass

ay c

hara

cter

isti

cs Normal human plasma, freeze dried, without or with Hirudin, at a defined level.


Intended use : Quality control of Hirudin assays (HEMOCLOT Thrombin Inhibitors: CK002K/CK002L).

IVD

50

Biophen® Rivaroxaban Plasma CalibratorCalibrator set for Rivaroxaban® in plasma CE #222701

Lyophilized plasmas, at a defined Rivaroxaban concentration (3 levels of about 0 to 500 ng/ml), as measured with the Biophen® DiXaI (ref 221030), for the calibration of Rivaroxaban measurements using the chromogenic assays and especially Biophen® DiXaI (Ref 221030).

Pres

enta

tion

12 vials of 1 ml human plasma supplemented with different concen-trations of Rivaroxaban® (3 levels, 4 vials for each concentration).

Ass

ay c

hara

cter

isti

cs Normal human plasma, freeze dried, with Rivaroxa-ban, at three different concentrations.


These calibrators have Rivaroxaban® concentrations accurately established against an Internal Standard for Rivaroxaban®, with concentrations exactly deter-mined using the reference HPLC method.

Intended use : Quality control titrated and optimized for anti-Xa colorimetric assays (Biophen® DiXaI: 221030).

IVD

Direct Factor Xa Inhibitors

Dabigatran Control PlasmaControl set for Dabigatran in plasma CE #224701

Lyophilized plasmas, at a defined Dabigatran concentration (2 levels of about 100 and 300 ng/ml), as measured with the HEMOCLOT Thrombin Inhibitors kit (ref CK002K/CK002L), for the quality control of Dabigatran measurement with clotting or chromogenic assays. Pr

esen

tati

on

12 vials (6 sets of 2 vials) of of 1 mL of human plasma supplemented at 2 different concentrations of dabigatran.

Ass

ay c

hara

cter

isti

cs

Normal human plasma, freeze dried, with Dabiga-tran, at two different concentrations (high and low).


Dabigatran Controls are accurately determined against an Internal Reference Standard, initially validated against fresh reference preparations of dabigatran, and confirmed with a physico-chemical method (HPLC).

Intended use : Quality control titrated and optimized for anti-IIa colorimetric assays (HEMOCLOT Thrombin Inhibitors:CK002K/CK002L).

IVD

Dabigatran Plasma Calibrator Calibrator set for Dabigatran in plasma CE #222801

Lyophilized plasmas, at a defined Dabigatran concentration (3 levels from about 50 to 500 ng/ml), as measured with the HEMOCLOT Thrombin Inhibitors kit (ref CK002K/CK002L), for the calibration of Direct Thrombin Inhibitor assays (clotting or chromogenic) for Dabigatran. Pr

esen

tati

on

12 vials (4 sets of 3 vials) of 1 ml human plasma supplemented with dif-ferent concentrations of Dabigatran.

Ass

ay c

hara

cter

isti

cs

Normal human plasma, freeze dried, with Dabiga-tran, at three different concentrations.


Concentrations are accurately determined against an Internal Reference Standard, initially validated against fresh reference preparations of Dabigatran, spiked into a normal human citrated plasma pool, and confirmed with a physico-chemical method (HPLC).

Intended use : Quality control titrated and optimized for anti-IIa colorimetric assays (HEMOCLOT Thrombin Inhibitors #CK002K/CK002L)

IVD

Plasma Hirudin controlControl set for Hirudin in plasma CE #SC025K

Lyophilized plasmas, at a defined Hirudin concentration (2 levels), as measured with the HEMOCLOT Thrombin Inhibitors kit (ref CK002K/CK002L), for the quality control of Hirudin clotting assays.

Pres

enta

tion

6 vials of 1 mL of human plasma supplemented at 2 different concentrations of Hirudin (3 vials of each concentration of about 1 and 2 µg/ml).

Ass

ay c

hara

cter

isti

cs Normal human plasma, freeze dried, with Hirudin, at two different concentrations (high and low).


Hirudin Controls are calibrated against an Internal Standard for Hirudin, initially validated against a fresh reference preparation of Lepirudin (Refludan®).

Intended use : Quality control of Hirudin assays (HEMOCLOT Thrombin Inhibitors #CK002K/CK002L)

IVD

Biophen® Rivaroxaban Control PlasmaControl set for Rivaroxaban® in plasma CE #224501

Lyophilized plasmas, at a defined Rivaroxaban concentration (2 levels of about 100 and 300 ng/ml), as measured with the Biophen® DiXaI (ref 221030), for the quality control of Rivaroxaban measurements using the chromogenic assays.

Pres

enta

tion

12 vials of 1 mL of human plasma supplemented at 2 different concentrations of Rivaroxaban® (6 vials for each concentration).

Ass

ay c

hara

cter

isti

cs

Normal human plasma, freeze dried, with Rivaroxa-ban, at two different concentrations.


These controls are calibrated against an Internal Standard for Rivaroxaban®, which concentrations have been accurately determined using the refe-rence HPLC method.

Intended use : Quality control titrated and optimized for anti-Xa colorimetric assays (Biophen® DiXaI: 221030).

IVD

51

Biophen® NormalplasmaNon Titrated Human Plasmas (Normal) CE #223602 / #223605

Non-titrated normal citrated human plasma, lyophilized. This plasma is useful at any time when a source of normal citrated human plasma is required. Coagulation factors and clotting assays are within the normal range. Pr

esen

tati

on

Normal citrated human plasma

#22360210x2 mL

#2236058x5 mL

Ass

ay c

hara

cter

isti

cs Freeze dried citrated human plasma.


Intended use : Non-titrated quality control human citrated plasma for coagulation assays.Dilution plasma for the assay of Lupus Anticoagulant (LA) with usual laboratory methods.

IVD

Non Titrated Human Plasmas (Normal)

Plasma PAI-1 controlControl plasma for PAI-1 #SC011K

Human plasmas, at two different and defined levels of PAI-1, for the quality control of PAI-1 ELISA.

Pres

enta

tion

CI: 3x1 mL normal plasma,(high)

CII: 3x1 mL normal plasma, (low)

Ass

ay c

hara

cter

isti

cs Normal human plasma, freeze dried, with PAI-1, at two different concentrations (high and low).

Concentrations established against the NIBSC International Standard

Intended use : Quality control of PAI-1 assay (RK012A).

RUO

Controls for Enzyme Immuno-Assays

52

FPA controlControls for FPA #SC015K

Preparations at two different and defined levels of FPA, for the quality control of FPA ELISA.

Pres

enta

tion

CI: 3x1 mL Control high

CII: 3x1 mL Control low

Ass

ay c

hara

cter

isti

cs Freeze dried preparations containing FPA at two different concentrations (high and low).

Intended use : Quality control of FPA assay (RK016A).

RUO

UTA controlsControl Plasma for uPA, tPA and Annexin V #SC017K

Lyophilized plasmas, at defined uPA: Ag, Annexin V, and tPA (UTA) concentrations for the quality control of the Annexin V assay (RK004A), the tPA assay (RK011A) and the uPA antigenic (RK013A) assay.

Pres

enta

tion

CI: 3x1 mL normal plasma (high)

CII: 3x1 mL normal plasma(low)

Ass

ay c

hara

cter

isti

cs Normal human plasma, freeze dried, with Annexin V, tPA and uPA, at two different concen-trations (high and low).


Intended use : Quality control of Annexin V assay (RK004A), tPA assay (RK011A), uPA assay (RK013A).

RUO

Plasma PF4 controlControl plasma for PF4 #SC013K

Human plasmas, at two different and defined levels of PF4, for the quality control of PF4 ELISA.

Pres

enta

tion

CI: 3x0.5 mL normal plasma (high)

CII: 3x0.5 mL normal plasma (low)

Ass

ay c

hara

cter

isti

cs Normal human plasma, freeze dried, with PF4, at two different concentrations (high and low).


Intended use : Quality control of PF4 assay (RK006A).

RUO

Plasma TAFI controlControl plasma for TAFI #SC014K

Human plasmas, at two different and defined levels of TAFI, for the quality control of TAFI ELISA.

Pres

enta

tion



Ass

ay c

hara

cter

isti

cs Normal human plasma, freeze dried, with TAFI, at two different concentrations (high and low).


Intended use : Quality control of TAFI assay (RK008A).

RUO

Plasma Protein S controlControl Plasma for Protein S #SC050K

Human plasmas, at two different and defined levels of Protein S (free and total), for the quality control of Protein S ELISA (free or total).

Pres

enta

tion



Ass

ay h

arac

teri

stic

s Normal human plasma, freeze dried, with Protein S, at two different concentrations (high and low).

Concentrations established against the NIBSC Internatio-nal Standard

Intended use : Quality control of Protein S assays (RK015A or RK021A).

RUO

Positive DDimer Control PlasmaControl Plasma for DDimer, High Positive #SC101K

Human plasmas, at a defined DDimer concentration (about 2 µg/mL), as measured with commercially available methods and especially the VIDAS-DDimer (Biomérieux) and the ZYMUTEST DDimer assays, for the quality control of DDimer ELISA assay. Reactive with most of the DDimer assays.

Pres

enta

tion

6x1 mL Human PlasmaA

ssay

cha

ract

eris

tics Normal human plasma, freeze dried, with

DDimer, at a positive concentration

Intended use : Quality control of DDimer assays (RK023A).

RUO

RUOLow Positive DDimer Control PlasmaControl Plasma for DDimer, Low Positive #SC103K

Human plasmas, at a defined DDimer concentration (about 0.6 µg/mL), as measured with commercially available methods and especially the VIDAS-DDimer (Biomérieux) and the ZYMUTEST DDimer assays, for the quality control of DDimer ELISA assay. Reactive with most of the DDimer assays.

Pres

enta

tion

6x1 mL Human Plasma

Ass

ay c

hara

cter

isti

cs

Normal human plasma, freeze dried, with DDimer, at a positive concentration


Negative DDimer Control PlasmaControl plasma for DDimer,Negative (normal range)

#SC102K

Human plasmas, at a defined DDimer concentration (< 0.4 µg/mL), as measured with commercially available methods and especially the VIDAS-DDimer assay, for the quality control of DDimer ELISA assay.

Pres

enta

tion

6x1 mL Human Plasma

Ass

ay c

hara

cter

isti

cs Normal human plasma, freeze dried, with DDi-mer, at a negative concentration


RUO

53

Plasma PAI-1 ControlControl Plasma for PAI-1 #SC011K/E

Lyophilized plasmas, at two defined PAI-1:Ag concentrations, as measured with the ELITEST-PAI-1 : Ag kit (ref CK102A), for the quality control of ELITEST PAI-1 antigenic assays.

Pres

enta

tion

CI: 3x1 mL normal plasma, (high)


Ass

ay c

hara

cter

isti

cs Normal human plasma, freeze dried, with PAI-1, at two different concentrations (high and low).

Concentrations established against the NIBSC Inter-national Standard

Intended use : Quality control of PAI-1 assay (CK102A).

UTA controlsControl Plasma for uPA, tPA and Annexin V #SC017K/E

Lyophilized plasmas, at defined uPA: Ag, Annexin V, and tPA (UTA) concentrations for the quality control of the ELITEST tPA antigenic assay (CK101A).

Pres

enta

tion

CI: 3x1 mL normal plasma, (high)


Ass

ay c

hara

cter

isti

cs Normal human plasma, freeze dried, with Annexin V, tPA and uPA, at two different concentrations (high and low).

Concentrations established against the NIBSC Inter-national Standard

Intended use : Quality control of tPA assay (CK101A).

RUO

RUO

Controls for the ELITEST Line of Cardiovascular Assays

54

55

PART 7 : AUXILIARY REAGENTS

PAR

T 7

: A

UX

ILIA

RY

REA

GEN

TS

56

PART 7 : AUXILIARY REAGENTS

Para-Nitro-Aniline (pNA) #AR014A

Size 1x5 mL Standard pNA solution at 0.10 mmol/L

Molecular weight: 138.1 Da

Intended use : For quality control of spectrophotometers or photometers at 405 nm.

RUO

TMB substrate #AR012A

Size 1x25 mL Ready to use

Peroxidase substrate containing TMB and hydrogen peroxide, stabilized

Intended use : Colour development in ELISA techniques using peroxidase.

TMB-HS #AR027A

Size

1x25 mL High sensitivity TMB substrate.Ready to usePeroxidase substrate containing TMB and hydrogen peroxide, stabilized

Intended use : Colour development in ELISA techniques using peroxidase.

RUO

RUO

Reference Material

ELISA Substrate

Buffers for Chromogenic Assays

Tris buffer #AR008A/AR008K

Size

1x50 mL (AR008A)3x50 mL (AR008K)

Ready to usepH 8.40

Intended use : For chromogenic assays.

RUO

Tris-NaCl buffer #AR009A/AR009K

Size

1x50 mL (AR009A)3x50 mL (AR009K)

Ready to usepH 8.40

Intended use : For chromogenic assays (anti-IIa).

RUO

Tris-EDTA buffer #AR015A/AR015B

Size

1x10 mL (AR015A)1x20 mL (AR015B)

pH 8.40 ± 0.110 fold concentrated

Intended use : For chromogenic assays (anti-Xa).

RUO

57

Buffers and Solutions for Clotting Assays

Tris-BSA buffer #AR020A

Size

1x20 mL pH 7.30 ± 0.1010 fold concentrated

Intended use : Diluent for proteins.

RUO

Prothrombin Activator Diluent #AR022A

Size

1x20 mL Ready to usepH 7.90 ± 0.10Contains a fibrin polymerization inhibitor

Intended use : Specific Diluent for the chromogenic assay of Prothrombin.

RUO

Progressive AT - Tris buffer – Anti Xa #AR103A

Size

1x10 mL Ready to usepH 7.85

Intended use : Dilution buffer for Progressive Antithrombin activity assay, using a variant protocol for Biophen® Antithrombin kit (#221102/221105).

RUO

Progressive AT - Tris buffer – Anti IIa #AR104A

Size

1x10 mL Ready to usepH 8.40

Intended use : Dilution buffer for Progressive Antithrombin activity using an Anti IIa method, and a variant protocol of Biophen® AT (Anti IIa) kit (#221122), performed in the absence of Heparin.

RUO

Special Tris-BSA buffer CE #AR026A/AR026K

Size

3x25 mL(AR026A)12x25 mL(AR026K)

Ready to use pH 7.90 ± 0.10Contains 1% BSA and FVIII:C stabilizers.

Intended use : Special dilution buffer for FVIII:C or FIX(a) chromogenic assays, especially using Biophen® FVIII:C (ref 221402) or Biophen® FIX (ref 221802) or Biophen® FIXa (act FIX) (ref 221812) kit.

IVD

Calcium Chloride CE #AR001A/AR001K

Size

3x25 mL (AR001A)12x25 mL (AR001K)

Ready to useCalcium Chloride solution 0.025 M (M/40)

Intended use : Coagulation assays, such as the Activated Partial Thromboplastin Time (APTT) or for the assays of factors of the intrinsic coagulation pathway.

IVD

58

Tris-NaCl buffer (TBS) #AR004A/AR004K

Size

1x50 mL (AR004A) 3x50 mL (AR004K)

Ready to usepH 7.50 (I=0.15)

Intended use : For clotting tests.Diluent for plasma samples.

RUO

Tris-NaCl buffer (TBSA) #AR005A/AR005K

Size

1x50 mL (AR005A) 3x50 mL (AR005K)

Ready to usepH 7.40Contains 1% BSA

Intended use : Diluent for purified proteins and enzymes.

RUO

Phosphate-NaCl buffer (PBS) #AR006A/AR006K

Size

1x50 mL (AR006A) 3x50 mL (AR006K)

Ready to usepH 7.50Usual physiological Diluent

Intended use : Biological dilution buffer.Cannot be used for tests performed in presence of calcium.

RUO

Calcium Chloride CE #AR002A/AR002K

Size

1x25 mL (AR002A) 3x25 mL (AR002K)

10 fold ConcentratedCalcium Chloride solution 0.25 M (M/4)

Intended use : Coagulation assays, such as the Activated Partial Thromboplastin Time (APTT) or for the assays of factors of the intrinsic coagulation pathway.

IVD

Phosphate-NaCl buffer (PBSA) #AR007A/AR007K

Size

1x50 mL (AR007A) 3x50 mL (AR007K)

Ready to usepH 7.50Contains 1% BSA

Intended use : Cannot be used for tests performed in presence of calcium.Diluent for purified proteins and enzymes

RUO

Imidazole buffer CE #AR021A/AR021K/AR021L

Size

1x25 mL (AR021A) 3x25 mL (AR021K)12x25 mL (AR021L)

Ready to usepH 7.30

Intended use : Buffer for clotting assays (plasma samples).Diluent for plasma

IVD

59

TMB substrate Refer to page 56RUO

Buffers and solutions for ELISA

Fibrinolysis Sample Diluent #AR016A

Size

1x50 mL Ready to usepH 7.50Phosphate buffer with EDTA, BSA and Tween 20

Intended use : For fibrinolysis investigation.

RUO

Conjugate Diluent #AR017A

Size

1x25 mL Ready to usepH 7.50Phosphate buffer with Sodium Chloride, BSA and Tween 20

Intended use : For ELISA methods.

RUO

Autoimmunity Sample Diluent #AR018A

Size

1x50 mL Ready to usepH 7.50PBS with goat serum

Intended use : For testing autoantibodies by ELISA.

RUO

ELISA Dilution buffer, with albumin #AR010A


Contains sodium phosphate, Sodium Chloride, Tween 20 (0.1%) and BSA (1%)

Intended use : For immuno-enzymatic assays.

RUO

FPA anticoagulant solution #AR013A


Contains TriSodium citrate, Heparin, Aprotinin and Hirudin

Intended use : Blood collection for FPA testing.

RUO

Wash solution for ELISA #AR011A/AR011K

Size 1x50 mL (AR011A)

3x50 mL(AR011K)20 fold concentratedContains sodium phosphate, Sodium Chloride and Tween 20 (0.1% after dilution)

Intended use : For immuno-enzymatic assays.

60

Stop solution #AR019A

Size 1x6 mL 0.45 M sulfuric acid

Ready to use

Intended use : For ELISA methods.

RUO

Bentonite suspension #AR024A


Bentonite slurry

Intended use : Removal of Fibrinogen in plasma for the assay of FPA.

RUO

B2F Sample Diluent #AR023A

Size

1x60 mL Ready to usepH 7.50Buffer containing phosphate, Sodium Chloride, Prionex® and Tween 20

Intended use : Dilution buffer for Fibrinogen, Fibronectin and β2GP1 ELISA method

RUO

Solutions for Microparticles

Wash solution for Microparticles #AR025A

Size 1x50 mL 10 fold concentrated

pH 7.50 (after 1: 10 dilution)

Intended use : For microparticle kit (ZYMUPHEN MP-Activity #521096).

RUO

PART 8 : EXPLORATION OF FIBRINOLYSIS

61

PART

8 :

FIBR

INOL

YSIS

62

PART 8EXPLORATION OF FIBRINOLYSIS

Assays for Fibrinolysis Proteins

ZYMUTEST PAI-1 ActivityPlasminogen Activator Inhibitor-1Bio-Immunoassay

#RK019A

Bio-immuno assay for the measurement of PAI-1 activity.

Assay designed with an ELISA plate coated with active tPA, then stabilized, which binds active PAI-1 present in plasma or in tested sample. This is then revealed with a specific Murine monoclonal antibody, specific for PAI-1, and labelled with Horse Radish Peroxidase (HRP).

Pres

enta

tion

12x8 test kit2x Sample Diluent3x PAI-1 activity Calibrator1x high & low Plasma PAI-1 Controls3x Anti-h-PAI-1-HRP IC1x Conjugate Diluent1x Wash Solution1x TMB1x 0.45M Sulfuric Acid A

ssay

cha

ract

eris

tics

Total Assay Time: 2h15Detection Threshold: ≤ 0.1 ng/mLDynamic Range: 0 to 20 ng/mLIntra-Assay CV: 3-8%Inter-Assay CV: 5–10%

Specific for PAI-1 active forms, this can bind to tPA.

Intended use : Assay proposed for the measurement of PAI-1 activity in research applications.

ZYMUTEST PAI-1 AgPlasminogen Activator Inhibitor-1 Immunoassay CE #RK012A

Two-site ELISA method for the measurement of PAI-1 antigen (Plasminogen-Activator-Inhibitor 1).

Assay designed with two complementary Murine monoclonal antibodies specific for PAI-1. The assay measures homogeneously PAI-1 whether its presentation is: free, active, latent, inactive, complexed with tPA, uPA or vitronectin. Controls are included.

Pres

enta

tion

12x8 test kit2x Sample Diluent3x PAI-1 standard1x high & low Plasma PAI-1 Controls3x Anti-h-PAI-1-HRP IC1x Conjugate Diluent1x Wash Solution1x TMB1x 0.45M Sulfuric Acid A

ssay

cha

ract

eris

tics

Total Assay Time: 2h15Detection Threshold: ≤ 0.5 ng/mLDynamic Range: 0 to 100 ng/mLIntra-Assay CV: 3-8%Inter-Assay CV: 5-10%

No Significant interference of: Heparin up to 2 IU/mL

Intended use : Assay of PAI-1: Ag in clinical samples.

Measurement of PAI-1 as a cardiovascular risk factor.

Assay of PAI-1 in diabetes or in metabolic disorders.

Biophen® PlasminogenPlasminogen Chromogenic Assay CE #221502

Chromogenic assay of Plasminogen tested as a Plasminogen streptokinase complex, by its specific activity on a chromogenic substrate. Insensitive to the fibrinogen concentration.

Pres

enta

tion

R1: 2x2.5 mL Activationreagent containingstreptokinase (about25,000 IU) andPlasminogen-free fibri-nogen

R2: 2x6.25 mg ofChromogenic substrate,specific for Plasmin and“Plasminogen-streptoki-nase” complexes (SPm41). A

ssay

cha

ract

eris

tics

Total Assay Time: 6 min.Detection Threshold: ≤ 10%Dynamic Range: 10-150%Intra-Assay CV: < 4%Inter-Assay CV: < 6%

No significant interference observed for heparin concentrations <2 IU/mL, Bilirubin concentrations <0.2 mg/mL, and hemoglobin concentrations <2 mg/mL in plasma.

No significant interference of plasma fibrinogen concentration in the assay.

Intended use : Assay of Plasminogen in human plasma for the diagnosis of hereditary or acquired Plasminogen deficiencies.Assay of Plasminogen in any biological fluid where it must be measured.

RUO

IVD

IVD

63

Biophen® Plasminogen (LRT)Plasminogen Chromogenic AssayLiquid technology

CE #221511

Chromogenic assay for the quantitative determination of Plasminogen Activity in human plasma, using a manual or an automated method.

Liquid Reagent Technology (LRT)

Pres

enta

tion

Ready to use reagent. R1: 3x3 mL streptokinase (10,000 IU/ml) and plasmi-nogen-free fibrinogen.

R2: 3x3 mL substrate, specific for plasmin and “plasminogen-streptoki-nase” complexes (SPm41) A

ssay

cha

ract

eris

tics

Total Assay Time: 6 min.Detection Threshold: ≤ 10%Dynamic Range: 10-150%Intra-Assay CV: < 4%Inter-Assay CV: < 6%

No significant interference observed for heparin concentrations <2 IU/mL, Bilirubin concentrations <0.2 mg/mL, and hemoglobin concentrations <2 mg/mL in plasma.

No significant interference of plasma fibrinogen concentration in the assay.

Intended use : Assay of Plasminogen in human plasma for the diagnosis of congenital or acquired Plasminogen deficiencies. An abnormal Plasminogen activity is an indicator for fibrinolytic troubles.

Biophen® a-2-APa2-Anti-Plasmin Chromogenic Assay

#220502

Quantitative assay for measuring plasmin inhibitor (a2-antiplasmin) activity in human citrated plasma.

Pres

enta

tion

R1: 3x3 mL Purified plasmin

R2: 3X3 mL Plasmin substrate

Ass

ay c

hara

cter

isti

cs Total Assay Time: 8 min. Detection Threshold: < 5%Dynamic Range: 0 to 150%Intra-Assay CV: < 4%Inter-Assay CV: < 5%

Intended use : Assay proposed for the measurement of plasmin inhibitor (a2-antiplasmin) activity in research applications.

ZYMUTEST TAFI AgThrombin Activatable FibrinolysisInhibitor Immunoassay

#RK008A

Two-site ELISA method for the measurement of TAFI antigen (Thrombin Activatable Fibrinolysis Inhibitor). Assay designed with a Murine monoclonal antibody specific for TAFI, for coating, and a goat polyclonal antibody labelled with a Horse Radish Peroxidase (HRP) marker. Assay calibrator has a defined concentration of TAFI Ag, expressed as % of normal pooled human plasma, and exactly determined with three selected human plasma pools. TAFI and TAFIa are identically measured.

Pres

enta

tion

12x8 test kit2x Sample Diluent3x Plasma TAFI Calibrator1x high & low Plasma Controls3x Anti-h-TAFI-HRP IC1x Conjugate Diluent1x Wash Solution1x TMB1x 0.45M Sulfuric Acid

Ass

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Total Assay Time: 3h15 Detection Threshold: ≤ 5%Dynamic Range: 5 to 100%Intra-Assay CV: 3-8%Inter-Assay CV: 5-10%

Intended use : High TAFI Ag concentrations involve a hypofibrinolytic status, which can induce an elevated risk of thrombosis.Measurement of TAFI Ag on plasma in order to diagnose a risk of a hypofibrinolysis resulting from an excess of TAFI.

IVD

RUO

RUO

ZYMUTEST proTAFI proTAFI Immunoassay #RK037A

Two-site ELISA method, designed with a pair of specific and complementary monoclonal antibodies, for measuring human TAFI zymogen (Thrombin Activatable Fibrinolysis Inhibitor), i.e. proTAFI, in plasma, or in any fluid where proTAFI can be present.

Pres

enta

tion

12x8 test kit2x Sample Diluent3x Plasma proTAFI Cali-brator1x high & low Plasma Controls3x Anti-h-proTAFI-HRP IC1x Conjugate Diluent1x Wash Solution1x TMB1x 0.45M Sulfuric Acid

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Total Assay Time: 3h15Detection Threshold: ≤ 10%Dynamic Range: 10-140%Intra-Assay CV: 2-5%Inter-Assay CV: 1-6%

Intended use : Assay proposed for the measurement of proTAFI in research applications.

RUO

64

ZYMUTEST tPA Ag Immunoassay for Tissue PlasminogenActivator, Antigen

CE #RK011A

Two-site ELISA method for the measurement of tPA antigen (tissue-type Plasminogen activator). Assay designed with two complementary Murine monoclonal antibodies.

The assay measures homogeneously tPA whether its presentation is: free or complexed with its inhibitors. Controls are included.

Pres

enta

tion

12x8 test kit2x Sample Diluent4x tPA standard1x high & low Plasma Controls3x Anti-h-tPA-HRP IC1x Conjugate Diluent1x Wash Solution1x TMB1x 0.45M Sulfuric Acid

Ass

ay c

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Total Assay Time: 2h15Detection Threshold: ≤ 0.5 ng/mLDynamic Range: 0 to 20 ng/mLIntra-Assay CV: 3-8%Inter-Assay CV: 5-10%

No Significant interference of Heparin up to 2 IU/mL, endogenous PAI-1 up to 100 ng/mL.

The kit measures homogeneously tPA, whether its presentation is, free and active or complexed with its inhibitors.

Intended use : Assay of tPA:Ag in clinical samples, as a disease marker.Assay of tPA:Ag in thrombolysis with recombinant tPA drugs.Assay of tPA:Ag as a cardiovascular disease marker.

ZYMUPHEN tPA Activity Bio-Immunoassay for Tissue PlasminogenActivator, Activity

#521296

Bio-immuno assay for the measurement of tPA activity. Assay designed with an ELISA plate coated with murine monoclonal antibody specific for tPA, then stabilized, which binds tPA present in plasma or in tested sample. tPA activity is then revealed through activation of plasminogen, in presence of tPA stimulator, and consequent cleavage of a substrate specific for Plasmin.

Pres

enta

tion

All the necessary for performing a 96 well microElisa plate.

tPA is measured in acidi-fied plasma for blocking tPA inhibitors.

Ass

ay c

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csTotal Assay Time: about 2hDetection Threshold: 0.1 IU/mLDynamic Range: 0 to 2 IU/mLIntra-Assay CV: ≤ 8%Inter-Assay CV: ≤ 10%

Intended use : Assay proposed for the measurement of tPA activity in research applications.

IVD

RUO

ZYMUTEST tPA-PAI-1 complexes tPA-PAI-1 Complexes Immunoassay #RK017A

Two-site ELISA method for the measurement of tPA-PAI-1 complexes. Assay designed with a Murine monoclonal antibody specific for tPA for coating, and capturing tPA-PAI-1 complexes, and a Murine monoclonal antibody, specific for PAI-1 and labelled with a Horse Radish Peroxidase (HRP) marker. The assay only measures tPA-complexed with PAI-1.

Pres

enta

tion

12x8 test kit2x Sample Diluent3x tPA-PAI-1 Calibrator1x high & low Plasma Controls3x Anti-h-PAI-1-HRP IC1x Conjugate Diluent1x Wash Solution1x TMB1x 0.45M Sulfuric Acid A

ssay

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eris


Detection Threshold: ≤ 0.5 ng/mLDynamic Range: 0 to 20 ng/mLIntra-Assay CV: 3-8%Inter-Assay CV: 5–10%

Intended use : Assay proposed for the measurement of tPA-PAI-1 complexes in research applications.

ZYMUTEST uPAUrokinase-TypePlasminogen Activator Immunoassay

#RK013A

Two-site ELISA method for the measurement of uPA (Urokinase-type Plasminogen activator). Assay designed with three complementary Murine monoclonal antibodies specific for uPA, are being used for coating the microplate (immunocapture), and the two others labelled with a Horse Radish Peroxidase (HRP) marker. This assay measures similarly High Molecular Weight Urokinase (HMW-PA or u-PA) or Low Molecular Weight Urokinase (UK) in plasma, whether free of complexed with its inhibitors.

Pres

enta

tion

12x8 test kit2x Sample Diluent3x uPA standard1x high & low Plasma Controls3x Anti-h-uPA-HRP IC1x Conjugate Diluent1x Wash Solution1x TMB1x 0.45M Sulfuric Acid

Ass

ay c

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Total Assay Time: 1h15 Detection Threshold: ≤ 0.5 ng/mLDynamic Range: 0 to 20 ng/mLIntra-Assay CV: 3-8%Inter-Assay CV: 5–10%

Measures HMW and LMW Urokinase forms in plasma.

Intended use : Assay proposed for the measurement of uPA in research applications.

RUO

RUO

65

ZYMUTEST uPA-PAI-1 complexesuPA-PAI-1 Complexes Immunoassay #RK018A

Two-site ELISA method for the measurement of uPA-PAI-1 complexes. Assay designed with a Murine monoclonal antibody specific for uPA for coating, and capturing uPA-PAI-1 complexes, and a Murine monoclonal antibody, specific for PAI-1 and labelled with a Horse Radish Peroxidase (HRP) marker. The assay only measures uPA complexed with PAI-1.

Pres

enta

tion

12x8 test kit2x Sample Diluent3x uPA-PAI-1 Calibrator1x high & low Plasma Controls3x Anti-h-PAI-1-HRP IC1x Conjugate Diluent1x Wash Solution1x TMB1x 0.45M Sulfuric Acid A

ssay

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eris


Detection Threshold: ≤ 0.5 ng/mLDynamic Range: 0 to 20 ng/mLIntra-Assay CV: 3-8%Inter-Assay CV: 5–10%

Intended use : Assay proposed for the measurement of uPA-PAI-1 complexes in research applications.

RUO

ELITEST tPATissue Plasminogen Activator Immunoassay #CK101A

Two-site Enzyme ImmunoAssay (ELISA), designed with Murine monoclonal antibodies, for the quantitative determination of tissue-type Plasminogen Activator (t-PA) in human plasma or cell culture supernatant.

Pres

enta

tion

12x8 test kit2x Sample Diluent6x rec. t-PA standard solution1x Conjugate (mouse monocl. anti-tPA-HRP)1x Substrate Buffer (phos-phate citrate buff.)1x Conjugate Diluent2x Wash Solution1x TMB1x 0.45M Sulfuric Acid A

ssay

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Total Assay Time: 2h30Detection Threshold: 0.5 ng/mLDynamic Range: 0 to 100 ng/mLIntra-Assay CV: 4 - 6%Inter-Assay CV: 5 – 8%No interference of Urokinase solutions up to10 µg/mLAssay highly specific for t-PA (one-chain and two-chain forms).Presence of PAI does not interfere with the t-PA quantization.Heparin in the plasma (<10 UI/mL) does not influence the determination.Reference Material: t-PA standard solutions carefully calibrated against the W.H.O. reference preparation (2nd International Standard 86/670).

Intended use : Assay proposed for the measurement of tPA antigen in research applications.

RUO

ELITEST PAI-1Plasminogen ActivatorInhibitor-1 Immunoassay

#CK102A

Two-site Enzyme ImmunoAssay (ELISA), designed with Murine monoclonal antibodies, for the quantitative determination of Plasminogen Activator Inhibitor-1 (PAI-1) in human plasma or cell culture supernatant.

Pres

enta

tion

12x8 test kit2x Sample Diluent6x rec. PAI-1 standard solution1x Conjugate (mouse monocl. anti-PAI-1-HRP)1x Substrate Buffer (phos-phate citrate buff.)1x Conjugate Diluent2x Wash Solution1x TMB1x 0.45M Sulfuric Acid

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Total Assay Time: 2h30Detection Threshold: ≤ 2.5 ng/mLDynamic Range: 0 to 100 ng/mLIntra-Assay CV: 4 - 6%Inter-Assay CV: 5 – 8%

Intended use : Assay proposed for the measurement of PAI-1 antigen in research applications.

RUO

ELITEST Lp(a)Lipoprotein (a) Immunoassay #CK103A

Enzyme Immunoassay (ELISA) for the quantitative determination of lipoprotein (a) Lp(a) concentrations in human plasma or serum.

A Murine monoclonal antibody is used for coating (specific for Apo (a)), and a goat anti-Lp(a) polyclonal antibody (specific for Apo (b)) for Horse Radish Peroxidase (HRP) marker. The kit contains controls at two different Lp(a) levels.

Pres

enta

tion

12x8 test kit2x Sample Diluent1x Lp(a) standard1x Control serum (Level I and II)1x Substrate Buffer (phos-phate citrate buff.)1x Conjugate Diluent2x Wash Solution1x TMB A

ssay

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Total Assay Time: 3h30Detection Threshold: 1 mg/dlDynamic Range: 0 to 100 mg/dLIntra-Assay CV: 4 – 6%Inter-Assay CV: 5 – 8%Measures all the forms

Intended use : Assay proposed for the measurement of Lp(a) in research applications.

RUO

Cardiovascular (Liquid Technology)

66

PART 9 : AGGREGOMETRY REAGENTS

PART 9 : AGGREGOMETRY REAGENTS

PART

9 :

AGGR

EGOM

ETRY

RE

AGEN

TS

ADPAssay for Platelet Aggregation CE #AG001K

Investigation of platelet aggregation induced by ADP.

Pres

enta

tion

3x0.5 mLAdenosine-5’-diphos-phate (200 μM)

Ass

aych

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teri

stic

s Total Assay Time: 50 min.Final Test Concentration: 1-10 μM

Intended use : Investigation of congenital (e.g., Glanzmann’s thrombasthenia, Bernard-Soulier, gray platelet syndrome) or acquired thrombopathy (e.g., myelodisplasic or myeloproliferative syndrome, Waldenström’s disease, multiple myeloma, hepatic or renal failure).

Follow-up of patients treated with antiplatelet drugs such as aspirin, thienopyridines, abciximab and other NSAIDs and GPIIb/IIIa inhibitors.

EpinephrineAssay for Platelet Aggregation CE #AG002K

Investigation of platelet aggregation induced by Epinephrine.

Pres

enta

tion

3x0.5 mL L-Epinephrine (1 mM)

Ass

aych

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teri

stic

s Total Assay Time: 50 min.Final Test Concentration: 1-10 μM

Intended use : Investigation of congenital (e.g., Glanzmann’s thrombasthenia, storage pool disease, gray platelet syndrom) or acquired thrombopathy (e.g., myelodisplasic or myeloproliferative syndrome, Waldenström’s disease, multiple myeloma).


Arachidonic Acid Assay for Platelet Aggregation CE #AG003K

Investigation of platelet aggregation induced by Arachidonic Acid.

Pres

enta

tion

3x0.5 mL Arachidonic Acid (15 mM)

Ass

aych

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teri

stic

s Total Assay Time: 50 min.Final Test Concentration: 1.5 mM

Intended use : Investigation of congenital (e.g., Glanzmann’s thrombasthenia, gray platelet syndrome) or acquired thrombopathy (e.g., myelodisplasic or myeloproliferative syndrome, Waldenström’s disease, multiple myeloma).


IVD

IVD

IVD

67

68

Ristocetin Assay for Platelet Aggregation CE #AG004K

Measurement of the von Willebrand Factor Ristocetin cofactor by platelet aggregation.

Pres

enta

tion

3x0.5 mL Ristocetin (15 mg/mL)

Ass

aych

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teri

stic

s Total Assay Time: 50 min.Final Test Concentration: 0.5 - 1.5 mg/mL

Intended use : The Ristocetin reagent is proposed for platelet aggregation tests, as an aid for the detection of von Willebrand disease, von Willebrand factor (vWF) determination, and identification of Bernard-Soulier Syndrome.

Collagen Assay for Platelet Aggregation CE #AG005K

Investigation of platelet aggregation induced by Collagen.

Pres

enta

tion

R1: 3x0.5 mL Collagen (1 mg/mL)

R2: 9x4 mL diluent Ass

aych

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stic

s Total Assay Time: 50 min.Final Test Concentration: 2 - 10 µg/mL

Intended use : Investigation of congenital (e.g., Glanzmann’s thrombasthenia, gray platelet syndrome, storage pool disease) or acquired thrombopathy (e.g., myelodisplasic or myeloproliferative syndrome, Waldenström’s disease, multiple myeloma).


Lyophilized platelets Assay For Platelet Aggregation CE #AG006A / #AG006K

Quantitative determination of von Willebrand Factor (vWF) in human plasma, through its Ristocetin cofactor activity, by using lyophilized platelets and ristocetin.

Pres

enta

tion

R1: Formalin-fixed pla-telets, lyophilized in the presence of stabilizersR2: Tris Buffer Saline (TBS) for Lyophilized platelet reconstitution (Contains BND as stabilizer).

#AG006A1x5 mL: R1

#AG006K3x5 mL: R13x5 mL: R2

Ass

aych

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Total Assay Time: <10 min.To be used along with Ristocetin

Intended use : Measurement of Ristocetin cofactor activity of vWF.

IVD

IVD

IVD

69

PART 10 : RESEARCH KITS

PART

10 :

RESE

ARCH

KIT

S

PART

9: R

ESEA

RCH

70

ZYMUTEST HS-CRP (High Sensitivity) Immunoassay for C-Reactive Protein, with High Sensitivity #RK010A

Two-site ELISA method for the measurement of C-Reactive Protein (low concentrations) with a high sensitivity assay designed with goat polyclonal antibodies for coating the MicroELISA plate (immunocapture), as well as preparing the Horse Radish Peroxidase (HRP) immunoconjugate. Pr

esen

tati

on

12x8 test kit2x Sample Diluent3x Plasma CRP Calibrator1x high & low CRP controls3x Anti-h-CRP-HRP IC1x Conjugate Diluent1x Wash Solution1x TMB1x 0.45M Sulfuric Acid A

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tics

Total Assay Time: 1h15Detection Threshold: 1 ng/mLDynamic Range: 0 to 10 µg/mL

(0 to 100 ng/mL in the tested dilution)Intra-Assay CV: < 5%Inter-Assay CV: < 7%

Referenced to the NIBSC International StandardNo interference of Rheumatoid Factor.

No Prozone effect observed for CRP concentrations up to 100µg/mL.

Intended use : Assay proposed for the measurement of C-Reactive Protein in research applications.

RUO

High Sensitivity CRP (C-Reactive Protein)

PART 10 : RESEARCH KITS

ZYMUTEST Tissue Factor (full length) Tissue Factor Immunoassay #RK035A

Two-site ELISA method for the measurement of full length Tissue Factor (TF, full length) in human plasma or purified milieu.

The kit uses a biotin-streptavidin-HRP system to enhance greatly the sensitivity, thus permitting to detect TF concentration as low as 50 pg/mL. Pr

esen

tati

on

12x8 test kit2x Sample Diluent3x TF Calibrator1x high & low TF Controls1x Anti-h-TF biotinylated MoAb3x Streptavidin-HRP Conjugate1x Conjugate Diluent1x Wash Solution1x TMB-HS1x 0.45M Sulfuric Acid A

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Total Assay Time: 4h35Detection Threshold: < 20 pg/mLDynamic Range: 0 to 500 pg/mLIntra-Assay CV: < 8%Inter-Assay CV: < 10%

Intended use : Assay proposed for the measurement of full length Tissue Factor in research application

RUO

Tissue Factor

Thrombosis and Vascular Diseases

71

ZYMUTEST TOTAL TISSUE FACTOR Total Tissue Factor Immunoassay #RK042A

Two-site, enhanced, immuno-assay for measuring human total Tissue Factor (TF), in plasma and purified milieu, or in any biological fluid where TF can be present.

Pres

enta

tion

12x8 test kit2x TF Sample Diluent3x TF Calibrator1x high & low TF Controls1x Anti-h-TF biotinylated PoAb3x Streptavidin-HRP Conjugate1x TF Conjugate Diluent1x Wash Solution1x TMB-HS1x 0.45M Sulfuric Acid

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Total Assay Time: 5h00Detection Threshold: < 10 pg/mLDynamic Range: 10 to 600 pg/mLIntra-Assay CV: < 6%Inter-Assay CV: < 10%

Intended use : Assay proposed for the measurement of Total Tissue Factor in research application

RUO

ZYMUTEST PF4 (Platelet Factor 4) Platelet Factor 4 Immunoassay #RK006A

Two-site ELISA method for the measurement of human PF4 (platelet factor 4), on platelet poor human plasma, or any biological sample where PF4 must be measured. Assay designed with affinity purified rabbit polyclonal antibodies for coating the MicroELISA plate (immunocapture) as well as preparing the Horse Radish Peroxidase (HRP) immunoconjugate marker. This assay measures native or recombinant PF4. It is insensitive to the presence of heparin in the tested sample, and PF4 is measured homogeneously whether its presentation is. The assay calibrator is standardized with the NIBSC International Standard.

Pres

enta

tion

12x8 test kit2x PF4 Sample Diluent3x PF4 Standard1x high & low PF4 Controls3x Anti-h-PF4-HRP IC1x Conjugate Diluent1x Wash Solution1x TMB1x 0.45M Sulfuric Acid

Ass

ay c

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Total Assay Time: 2h15Detection Threshold: < 0.1 ng/mLDynamic Range: 0.1 to 10 ng/mLIntra-Assay CV: 1-5%Inter-Assay CV: 2-7%

Reference Material established against NIBSC International Standard

Intended use : Assay proposed for the measurement of Platelet Factor 4 in research application

RUO

Platelet Markers

72

Other Hemostasis Proteins

ZYMUTEST Annexin V Annexin V Immunoassay #RK004A

Two-site ELISA method for the measurement of human annexin V. Assay designed with affinity purified rabbit polyclonal antibodies for coating the MicroELISA plate (immunocapture), as well as preparing the Horse Radish Peroxidase (HRP) immunoconjugate marker. This assay measures native or recombinant annexin V.

In addition to annexin V measurements in plasma, this assay is very useful for the quality control of platelet and blood cell concentrates (annexin V released correlates with platelet and blood cell surface lesion).

Pres

enta

tion

12x8 test kit2x Sample Diluent3x h Annexin V (rec) standard1x high & low Plasma Controls3x Anti-h-Annexin V-HRP IC1x Conjugate Diluent1x Wash Solution1x TMB1x 0.45M Sulfuric Acid A

ssay

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tics

Total Assay Time: 2h15Detection Threshold: 0.1 ng/mLDynamic Range: 0.1 to 120 ng/mLIntra-Assay CV: 1-5%Inter-Assay CV: 2.5-8%No interference of rheumatoid factor.

Intended use : Assay proposed for the measurement of Annexin V in research applications.

ZYMUTEST β2GP1 Beta2 GlycoProtein I Immunoassay #RK022A

Two site ELISA method for the measurement of b2GP1 on plasma or any biological sample where it must be measured. Assay designed with polyclonal antibodies specific for b2GP1, for coating the microplate (immunocapture) and also labelled with a Horse Radish Peroxidase (HRP) marker. This assay measures homogeneously b2GP1 in plasma.

Pres

enta

tion

12x8 test kit2x B2F Sample Diluent3x b2GPCalibrator1x high & low (h) β2GP1 Controls3x Anti-h-b2GP1-HRP IC1x B2F Conjugate Diluent1x Wash Solution1x TMB1x 0.45M Sulfuric Acid A

ssay

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eris

tics

Total Assay Time: 2h15Detection Threshold: ≤ 5 ng/mlDynamic Range: 0 to 100 ng/mLIntra-Assay CV: 3 - 8%Inter-Assay CV: 5 - 10%

Reference material : Calibrator established againsta normal citrated plasma pool, and against highly purified human b2GP1, which protein concentration has been precisely determined by Lowry method.

Intended use : Assay proposed for the measurement of b2GP1 antigen in research applications.

RUO

RUO

Assays for the Other Plasma Factors

LIAPHEN Fibrinogen Fibrinogen Latex Immunoassay CE #120102

Latex immunoassay for measuring Fibrinogen in human citrated plasma or in purified milieu (cell culture supernatant), using a manual or automated method, in vitro exclusively.

Pres

enta

tion

4x5 mL Latex reagent4x25 tests

Ass

ay c

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Total Assay Time: 20 min.Detection Threshold: 1 µg/mLDynamic Range: 0-10 µg/mLIntra-Assay CV: < 4%Inter-Assay CV: < 8%

No hook effect is observed for Fibrinogen concentra-tions < 100µg/mL

No interference is observed for Unfractionated Heparin concentrations < 2 IU/ml in plasma.

The presence of rheumatoid factor may result in an overestimation of the Fibrinogen concentration.

Intended use : Assay of Fibrinogen in human citrated plasma or in cell culture supernatants.

IVD

73

ZYMUTEST Fibrinogen Fibrinogen Immunoassay #RK024A

Two-site ELISA method for the measurement of Fibrinogen. Assay designed with affinity purified rabbit polyclonal antibodies for coating the ELISA plate and preparation of Horse Radish Peroxidase (HRP) marker.

Useful for testing low fibrinogen concentrations in culture media or cell exsudates, and for various research applications.

Pres

enta

tion

12x8 test kit2x B2F Sample Diluent3x Fibrinogen Standard1x high & low Fibrinogen Controls3x Anti-h-Fibrinogen-HRP IC1x B2F Conjugate Diluent1x Wash Solution1x TMB1x 0.45M Sulfuric Acid A

ssay

cha

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eris

tics

Total Assay Time: 2h15Detection Threshold: 1 ng/mLDynamic Range: 0 to 100 ng/mLIntra-Assay CV: 4 – 6%Inter-Assay CV: 5 – 8%

Specimen dilution must be adjusted to the expected concentration.

Reactive with rat and mouse Fibrinogen.

Intended use : Assay proposed for the measurement of Fibrinogen in research applications.

ZYMUTEST Fibronectin Fibronectin Immunoassay #RK028A

Two-site ELISA method for the measurement of Fibronectin. Assay designed with affinity purified rabbit polyclonal antibodies for coating the ELISA plate and preparation of Horse Radish Peroxidase (HRP) marker.

Useful for testing low Fibronectin concentrations in culture media or cell exsudates, and for various research applications.

Pres

enta

tion

12x8 test kit2x B2F Sample Diluent3x Fibronectin Calibrator1x high & low Fibronectin Controls3x Anti-h-Fibronectin-HRP IC1x B2F Conjugate Diluent1x Wash Solution1x TMB1x 0.45M Sulfuric Acid

Ass

ay c

hara

cter

isti

csTotal Assay Time: 1h15Detection Threshold: 1 ng/mLDynamic Range: 0 to 100 ng/mLIntra-Assay CV: 4 – 6%Inter-Assay CV: 5 – 8%

Specimen dilution must be adjusted to the expected concentration.

Intended use : Assay proposed for the measurement of Fibronectin in research applications.

RUO

RUO

74

BIOCHEMICALS

Substrates for Thrombin

Biophen® CS-01(38) Thrombin Chromogenic Substrate #229001 / #229001C

Size

1x25 mg (229001)12x25 mg (229001C)

Peptide sequence: H-D-Phe-Pip-Arg-pNa, 2HClChemical structure: C27H36N8O5, 2HClMolarity: 45 µMolesPurity grade: > 95%.Molecular weight (-2HCl): 552.6 DaMolecular weight (+2HCl): 625.6 DaFree pNA content (measured on substrate at 2.5g/L): OD405nm ≤ 0.30

Intended use : Chromogenic substrate for Thrombin.

RUO

Biophen® CS-01(81) Thrombin Chromogenic Substrate #229005

Size

1x25 mg Peptide sequence: Tos-Gly-Pro-Arg-pNa. AcOHChemical structure: C26H34N8O5, AcOHMolarity: about 37.75 µMolesPurity grade: > 95%.Molecular weight: 662.6 DaFree pNA content (measured on substrate at 2.5g/L): OD405nm ≤ 0.30

Intended use : Chromogenic substrate for Thrombin.

RUO

Substrates for Factor Xa

Biophen® CS-11(32) FXa Chromogenic Substrate #229011

Size

1x25 mg Peptide sequence: Suc-Ile-Glu (g Pip)Gly-Arg-pNa, HClChemical structure: C34H52N10O10, HClMolarity: about 33 µMolesPurity grade: > 95%Molecular weight: 760.9 DaFree pNA content (measured on substrate at 2.5g/L): OD405nm ≤ 0.30

Intended use : Chromogenic substrate for Factor Xa.

RUO

Biophen® CS-11(65) FXa Chromogenic Substrate #229014 / #229014C

Size

1x25 mg (#229014)12x25 mg (#229014C)

Peptide sequence: -D-Arg-Gly-Arg-pNA, 2HClChemical structure: C28H39N11O7, 2HClMolarity: about 39.0 µmol/vialPurity grade: > 95%Molecular weight (-2 HCl): 641.7 DaMolecular weight (+2 HCl): 714.7 DaFree pNA content (measured on substrate at 2.5g/L): OD405nm ≤ 0.30


RUO

Chromogenic Substrates

75

Substrate for Activated Protein C

Biophen® CS-21(66) Activated Protein C Chromogenic Substrate #229021

Size

1x25 mg Peptide sequence: p-Glu-Pro-Arg-pNa. HClChemical structure: C22H30N6O6, HClMolarity: about 50 µmol/vialPurity grade: > 95%.Molecular weight: 502.5 DaFree pNA content (measured on substrate at 2.5g/L): OD405nm ≤ 0.30

Intended use : Chromogenic substrate for Activated Protein C.

RUO

Biophen® CS-11(22) FXa Chromogenic Substrate #229015

Size

1x25 mg Peptide sequence: Mixture (50%-50%) of Bz-Ile-Glu (gOCH3)-Gly-Arg-pNa (form 1) and Bz-Ile- Glu (gOH)Gly-Arg-pNa (form 2)Chemical Structure: C33H45N9O9, HClMolecular weight: 711.8 Da (form 1) and 697.7 Da (form 2)Molarity: about 35 µmol/vialPurity grade: > 95%.Free pNA content (measured on substrate at 2.5g/L): OD405nm ≤ 0.30


RUO

Substrate for Kallikrein

Substrate for Plasmin and Plasminogen–SK

Biophen® CS-31(02)Kallikrein Chromogenic Substrate #229031

Size

1x25 mg Peptide sequence: D-Pro-Phe-Arg-pNa, 2HClChemical structure: C26H34N8O5, 2HClMolarity: about 46 µmol/vialPurity grade: > 95%Molecular weight: 538.6 DaFree pNA content (measured on substrate at 2.5g/L): OD405nm ≤ 0.30

Intended use : Chromogenic substrate for Kallikrein.

RUO

Biophen® CS-41(03)Plasmin and Plasminogen-SK Chromogenic Substrate #229041

Size

1x25 mg Peptide sequence: PyroGlu-Phe-Lys-pNa, HClChemical structure: C26H32N6O6, HClMolarity: about 48 µmol/vialPurity grade: > 95%Molecular weight: 524.6 DaFree pNA content (measured on substrate at 2.5g/L): OD405nm ≤ 0.30.

Intended use : Chromogenic substrate for Plasmin and Plasminogen – SK.

RUO

76

Substrate for Factor IXa

Biophen® CS-51(09)FIXa Chromogenic Substrate #229051

Size

1x25 mg Peptide sequence: CH3SO2-(D-)CHG-Gly-Arg-pNa, AcOHChemical structure: C23H36N8O7S, AcOHMolarity: about 40 µmol/vialPurity grade: > 95%Molecular weight: 628.7 DaFree pNA content (measured on substrate at 2.5g/L): OD405nm ≤ 0.30

Intended use : Chromogenic substrate for Factor IXa.

RUO

Substrate for UrokinaseBiophen® CS-61(44)Urokinase Chromogenic Substrate #229061

Size

1x25 mg Peptide sequence: pyro-Glu-Gly-Arg-pNa.HClChemical structure: C19H26N8O6, HClMolarity: about 54 µmol/vialPurity grade: > 95%Molecular weight: 462.5 DaFree pNA content (measured on substrate at 2.5g/L) : OD405nm ≤ 0.30.

Intended use : Chromogenic substrate for Urokinase.

RUO

Biophen® CS-05(88) tPA and Broad Spectrum Chromogenic Substrate #229091

Size

Chromogenic substrate for tPA.

Peptide sequence: H-D-Ile-Pro-Arg-pNa-2HClMolarity: about 49.5 µmol/vialPurity grade: > 95%Molecular weight: 504.6 DaFree pNA content (measured on substrate at 2.5g/L) OD405nm ≤ 0.30

Intended use : Chromogenic substrate for tPA.

RUO

Fluorogenic Substrates

Fluorogenic Substrate for Factor Xa

FLUOPHEN® FXaFXa Fluorogenic Substrate #329011

Size

1x25 mg Peptide sequence: Suc-Ile-Gly (g Pip)Gly-Arg-AMCPurity grade: > 95%Molecular weight: 798 DaFree pNA content: < 0.05%.

Intended use : Synthetic Fluorogenic substrate for testing Factor Xa.

RUO

Broad Spectrum Substrate for tPA

77

TABLE OF PROTEINS INVOLVED IN HEMOSTASIS AND FIBRINOLYSIS

Factor MWkDa

PlasmaConcentration Synthesis Half-Life

in vivo

Factor XII 80 30 µg/mL Liver 2-3 day(s)

Factor XI 160Homodimer 3-7 µg/mL Liver 2-3 day(s)

HMW Kininogen 85 30-50 µg/mL Liver 5-6 day(s)

Prekallikrein 120 60-80 µg/mL Liver 1-2 day(s)

Factor II or Prothrombin 72 100 µg/mL Liver 1-2 day(s)

Factor VII 50 0.3-0.5 µg/mL Liver 4-6 Hours(s)

Factor IX 55 4-5 µg/mL Liver 24 Hours(s)

Factor X 58 8-12 µg/mL Liver 1-2 day(s)

Protein C 62 4-5 µg/mL Liver 4-6 Hours(s)

Protein S 69 10 µg/mL (free)25 µg/mL (total) Liver 1-2 day(s)

Protein Z 62 2-4 µg/mL Liver 2-3 day(s)

AT III 58 150 µg/mL Liver 2-3 day(s)

a2- Macroglobuline 725 2-5 mg/mL LiverEndothelial cells 2-3 day(s)

Heparin Co-II 66 90 µg/mL Liver 2-3 day(s)

Protein C inhib. (PAI-3) 57 5 µg/mL Liver 1 day

TFPI 33 8-15 ng/mL (free)60-100 ng/mL (total) Endothelial cells -

(short)

Protein Z inhib. (ZPI) 72 3-7 µg/mL Liver 2-3 day(s)

Factor V 330 10 µg/mL LiverMegacaryocytes 12 Hours(s)

Factor VIII:C 265 0.1 µg/mL Liver 12 Hours(s)

Thrombomodulin 60 Expressed on Endothelial cells Endothelial cells -

C1-INH 106 180 µg/mL Liver 1-2 day(s)

Plasminogen 90 200 µg/mL Liver 2-3 day(s)

HRGP 67 100 µg/mL Liver 3 day(s)

a2-AP 70 70 µg/mL Hepatocytes 60 Hours(s)

tPA 68 < 10 ng/mL Endothelial cells 5 min

uPA 55 < 5 ng/mL Kidney 8 min

PAI-1 50 < 30 ng/mL Endothelial cells, Liver, Megacaryocytes 5 min

PAI-2 47 < 10 ng/mL Placenta, Leukocytes, Macrophages 120 min

TAFI 60 2.5 µg/mL Liver -

C4b-BP 590 250 µg/mL - 2-3 day(s)

vWF 500-2000(sub-units of 260) 8-12 µg/mL Endothelial cells,

Megacaryocytes 12 Hours(s)

Tissue Factor 45 Extra vascular Many non vascular cellsMonocytes, Endothelial cells

-(short)

Fibrinogen 340 2-4 mg/mL Liver 2-3 day(s)

b2GP1 50 200 µg/mL Liver -

Factor XIII 320 (A2B2 Complex) 10-15 µg/mL Liver 3-4 day(s)

Cont

act P

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Inhi

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78

Hemostasis and Fibrinolysis Human Proteins

Antithrombin III Molecular Weight: 58,000 Da

Intended use : Recommended for any study on heparin and glyco-amino-glycans. Useful for designing heparin assays (clotting or chromogenic) where a source of ATIII is required.

Specifications :

Preserved structure and activity of the native protein

Stability of reconstituted product > 15 days

Specific activity > 6 U/mg

Plasma Equivalent Unit (amount in 1 mL of human normal plasma) noted PEU or U, corresponds to about 150 µg of AT III Grade 1 > 60 PEU

150 µg (1mL-1 PEU) #PP004A6x150 µg (6x1 mL) #PP004K

1.5 mg (1mL-10 PEU) #PP004B10x1.5 mg (10x1 mL) #PP004L

3.75 mg (1mL-25 PEU) #PP004D10x3.75 mg (10x1 mL) #PP004M10 mg (2 mL > 60 PEU) #PP004C

Presence of sodium phosphate and sodium chloride (can be used for covalent coupling)

RUO

β2GP1 Molecular Weight: 50,000 Da

Intended use : Recommended for use as a protein cofactor for the binding of anti-b2GP1 auto antibodies in the presence or the absence of anionic Phospholipids.

Specifications :

High purity grade protein, purified with non-denaturing procedures, which keep the structure and the Phospholipid binding capacity of the native protein

100 µg (1 mL) ≈20 PEU #PP010A

For testing Phospholipid dependent antibodies, see also Prothrombin (PP006B), Protein S (PP012A), Annexin V (RP004A), Protein C (PP009A) and Protein Z (PP011A).

RUO

C4b-BP Molecular Weight: 590,000 Da

Intended use : Research studies and protocols where a source of highly purified C4b-BP is required.

Specifications :

Highly purified human protein, fully active for the binding to Protein S

100 µg (1 mL ≈ 0.5 PEU) #PP015A

RUO

Fibrinogen Molecular Weight: 340,000 Da

Intended use : Source of highly purified human fibrinogen for laboratory studies.

Specifications :

Full preservation of the native protein structure and activity.

Coagulability > 98%.

Stability of reconstituted product > 48 hrs.

Contains TriSodium citrate, sodium chloride and barbital.

5 mg (1 mL) #PP001A6x5 mg (6x1 mL) #PP001K100 mg (10 mL) #PP001B

1 g (50 mL) #PP001C100 mg #PP001R

Presence of sodium phosphate and sodium chloride (can be used for covalent coupling)

RUO

BIOLOGICALSHuman Proteins

79

Fibrinogen fragment DMolecular Weight:

80,000 – 100, 000 Da

Intended use : Research studies.

Specifications :

Plasmin cleaved Fragment D during fibrinogen degradation 200 µg (1 mL) #PP016A

RUO

Fibrinogen fragment E Molecular Weight: 50,000 Da


Specifications :

Plasmin cleaved fragment E from fibrinogen 200 µg (1 mL) #PP018A

RUO

Fibrinogen fragment E3t Molecular Weight: 45,000 Da


Specifications :

Terminal fragment E generated upon extensive degradation of fibrinogen by Plasmin 200 µg (1 mL) #PP019A

RUO

Fibrinogen fragment DDMolecular Weight:

160,000 – 200, 000 Da


Specifications :

Fragment DD is the latest degradation product from the fibrin degradation by fibrinolysis 200 µg (1 mL) #PP017A

RUO

Fibrinogen, Plasminogen free Molecular Weight: 340,000 Da

Intended use : Source of highly purified human fibrinogen for laboratory studies.

Specifications :

Full preservation of the native protein structure and activity.Plasminogen is specifically depleted by affinity chromatographyCoagulability > 98%.Stability of reconstituted product > 48 hrs.Contains TriSodium citrate, sodium chloride and barbital.

5 mg (1 mL) #PP002A6x5 mg (6x1 mL) #PP002K100 mg (10 mL) #PP002B

1 g (50 mL) #PP002C

RUO

80

Fibrin fragment E Molecular Weight: 50,000 Da


Specifications :

Fibrin fragment E is released during fibrin degradation by fibrinolysis. FPA and FPB are missing 200 µg (1 mL) #PP020A

RUO

Prekallikrein pool

Intended use : Substrate for Prekallikrein activation. Generates Kallikrein activity when activated.

Specifications :

Semi purified source of plasma Prekallikrein for the assay of Prekallikrein activators

2 mL #PP501B6x2 mL #PP501K

RUO

tPA Stimulator

Intended use : Protocols or research studies where a source of tPA stimulator is required.

Specifications :

Tissue Plasminogen Activator (tPA) stimulator, obtained from oxidized Fibrin(ogen) fragments.

1 mg (2 mL) #PP021B6x1 mg #PP021K

RUO

Heparin Cofactor II Molecular Weight: 66,000 Da

Intended use : Heparin studies.

Specifications :

Highly purified human protein, fully activeThe unit PEU or (U) represents the biological activity in 1 mL of normal plasma.

100 µg (1 mL = 1 PEU) #PP014A

1 mg (1 mL = 10 PEU) #PP014C

RUO

Plasminogen Molecular Weight: 88,000 Da

Intended use : Recommended for any study on fibrinolysis.

Specifications :

Homogeneous and non-activatedSpecific activity > 4 U/mg

Lyophilized in presence of sodium phosphate and sodium chloride (can be used for covalent coupling)

200 µg (1 mL) #PP005A

1.5 mg (2 mL) #PP005B

5 mg (0.5 mL) #PP005C

RUO

81

Alpha 1 Acid GlycoProtein (AGP) Molecular Weight: ≈ 40,000 Da

Intended use : For laboratory studies.

Specifications :

Highly purified AGP preparation 100 µg (1mL) #PP201A

RUO

Prothrombin Molecular Weight: 72,000 Da

Intended use : Research and Laboratory technology applications.

Specifications :

Specific activity ≥ 8 U/mgThe unit PEU or (U) represents the biological activity in 1 mL of normal plasma.

1 mg (1 mL) ≈10 PEU #PP006B

6x1 mg (6x1 mL) ≈10 PEU #PP006K

RUO

Factor VII Molecular Weight: 55,000 Da


Specifications :

Specific activity ≥ 2,000 U/mg 100 µg (1 mL) #PP013A

RUO

Miscellaneous

Factor IX Molecular Weight: 55,000 Da


Specifications :

Specific activity ≥ 160 U/mg

The unit PEU or (U) represents the biological activity in 1 mL of normal plasma.

100 µg (1 mL) ≈ 20 PEU #PP007A

RUO

Factor X Molecular Weight: 59,000 Da


Specifications :

Specific activity ≥ 80 U/mg

The unit PEU or (U) represents the biological activity in 1 mL of normal plasma.

100 µg (1 mL) ≈ 10 PEU #PP008A

RUO

Vitamin K Dependent Proteins

82

Platelet factor 4 (PF4) Molecular Weight: 30,000 Da

Intended use : High purity preparation, in the tetrameric form, tested for its anti-heparin activity. In presence of heparin, this product offers an optimized binding capacity for heparin dependent antibodies developed in HIT (Heparin Induced Thrombocytopenia).

Specifications :

Specific activity ≥ 250 U/mg 100 µg (1 mL) #PP003A

RUO

Protein C Molecular Weight: 62,000 Da


Specifications :


100 µg (1 mL) ≈ 20 PEU #PP009A

RUO

Protein S Molecular Weight: 75,000 Da


Specifications :


100 µg (1 mL) ≈ 10 PEU #PP012A

RUO

Protein Z Molecular Weight: 62,000 Da


Specifications :

Specific activity ≥250 U/mgThe unit PEU or (U) represents the biological activity in 1 mL of normal plasma.

100 µg (1 mL) ≈ 25 PEU #PP011A

RUO

Platelet Proteins

83

Recombinant Human Proteins

Annexin V (recombinant, human) Molecular Weight: 36,000 Da


Specifications :

Expressed in E. Coli 100 µg (1 mL) #RP004A

RUO

PAI-1 (recombinant, human) Molecular Weight: 52,000 Da


Specifications :

Stable mutant (slightly mutated structure in order to offer increased stability) 10 µg (1 mL) #RP005A

RUO

PAI-1 (recombinant, human) Molecular Weight: 52,000 Da


Specifications :

Native form 10 µg (1 mL) #RP006A

RUO

tPA (recombinant, human) Molecular Weight: 72,000 Da


Specifications :

Recombinant human tPA (wild type) 10 µg (1 mL) #RP007A1 mg (1 mL) #RP007C

RUO

84

Human Enzymes

Human Factor IXa Molecular Weight: 45,000 Da

Intended use : Source of Factor IXa (activated Factor IX) for research studies.

Specifications :

Activated Factor IX prepared from the highly purified Fac-tor IX through solid phase activation with Factor XIa. 100 IU #EZ010B

RUO

Human Factor XIIa Molecular Weight: 80,000 Da

Intended use : Research studies or protocols where a source of highly purified human Factor XIIa is required.

Specifications :

Factor XIIa (prekallikrein activator) highly purified from human plasma (human FactorXII activated using dextran sulphate,removed after activation). 100 ng is about 0.80 IU.

100 ng (1 mL) #EZ012A

6x100 ng (6x1 mL) #EZ012K

RUO

Human Factor Xa Molecular Weight: 46,000 Da

Intended use : Recommended for studies on heparin, glyco-amino-glycans and related products, using anti-Xa assays.

Specifications :

Prepared by activation of highly purified (h)-FX with RVV coupled to agarose beads

Stability after reconstitution > 3 months

10 µg (1 mL) #EZ007A 6x10 µg (6x1 mL) #EZ007K

100 µg (1 mL) #EZ007B6x100 µg (6x1 mL) #EZ007L

500 µg (5 mL) #EZ007C

RUO

Activated Protein C Molecular Weight: 60,500 Da

Intended use : Recommended for studies concerning the Protein C-Protein S-Thrombomodulin pathway, and for the Activated Protein C Resistance assay, or any research protocols on factors Va and VIIIa.

Specifications :

Activated with (h)-thrombin (in the a form) covalently coupled to agarose beadsStability after reconstitution > 48hrs

2.5 µg (1 mL) #EZ004A10 µg (1 mL) #EZ004B

100 µg (1 mL) #EZ004C

RUO

Human Thrombin Molecular Weight: 35,000 Da

Intended use : Recommended for all the research protocols where a source of highly purified and characterized (h)-thrombin is necessary, and for studies on anti-thrombin activities.

Specifications :

Mainly in the a formPrepared by activation of highly purified Prothrombin, in presence of factor Xa, V and calcium, then specifically purified and stabilizedStability after reconstitution > 7 days

10 NIH (1 mL) #EZ006O6x10 NIH (6x1 mL) #EZ006K

100 NIH (1 mL) #EZ006A10x100 NIH (10x1 mL) #EZ006L

1000 NIH (2 mL) #EZ006B

RUO

85

Human Plasmin Molecular Weight: 83,000 Da

Intended use : Recommended for all research protocols where a source of human plasmin is required.

Specifications :

Obtained through solid phase activation with urokinase. 0.2 mg (1 mL) #EZ013A2.0 mg (1 mL) #EZ013B

RUO

uPA (Urokinase-type Plasminogen Activator) Molecular Weight: 50,000 Da

Intended use : Recommended for all the research protocols where a source of purified urokinase is required.Can be used for the assay of human plasminogen.Activates plasminogen to generate plasmin.

Specifications :

High molecular weight Urokinase 1,000 units (1 mL) #EZ005A10,000 units (1 mL) #EZ005B

100,000 units (2 mL) #EZ005C

RUO

86

Plasminogen, Bovine Molecular Weight: 88,000 Da

Intended use : Research and laboratory technology application.

Specifications :

Specific activity > 4 U/mgPresence of sodium phosphate and sodium chloride (can be used for covalent coupling)

5 mg (5 mL) #BP105C

RUO

Fibrinogen, Bovine Molecular Weight: 330,000 Da

Intended use : Research and laboratory technology application.

Specifications :

Coagulability > 98%.Very stable following reconstitution (>48 hrs)

10 mg (1 mL) #BP101O6x10 mg (6x1mL) #BP101K

100 mg (5 mL) #BP101A1 g (50 mL) #BP101B

RUO

Bovine Proteins

Antithrombin III, Bovine (grade 1) Molecular Weight: 60,000 Da

Intended use : Heparin binding studies. Research protocols

Specifications :

Specific activity ≥ 6 U/mgPresence of sodium phosphate and sodium chloride (can be used for covalent coupling)

10 mg (2 mL) #BP104C

RUO

Prothrombin, Bovine Molecular Weight: 72,000 Da

Intended use : Research and laboratory technology application

Specifications :

Specific activity ≥ 8 U/mg 1 mg (1 mL) #BP103A6x1 mg (6x1mL) #BP103K

RUO

Factor X, Bovine Molecular Weight: 56,000 Da

Intended use : Heparin binding studies. Research protocols

Specifications :

Specific activity ≥ 80 U/mg 100 µg (1 mL) #BP102A6x100 µg (6x1mL) #BP102K

RUO

87

Bovine Enzymes

Factor Xa, Bovine Molecular Weight: 45,300 Da

Intended use : Recommended for studies on heparin, glyco-amino-glycans and related products, using anti-Xa assays

Specifications :

Prepared by activation of highly purified bovine factor X with RVV coupled to agarose beads

Stability after reconstitution > 3 months

1 µg corresponds to about 2.25 nkats using the Factor Xa chromogenic substrate BIOPHEN® CS-11(32)

15 µg (1 mL) #BE101C30 µg (2 mL) #BE101D

10x30 µg (10x2 mL) #BE101L50 µg (1 mL) #BE101O

6x50 µg (6x1 mL) #BE101K500 µg (2 mL) #BE101B

RUO

Thrombin, Bovine Molecular Weight: 35,000 Da

Intended use : Recommended for all the research protocols where a source of highly purified and characterized thrombin is ne-cessary, and studies on anti-thrombin activities.

Specifications :

Mainly in the a formPrepared by activation of highly purified Prothrombin, in presence of factor Xa, V and calcium, then specifically purified and stabilized.Stability after reconstitution > 7 days1 NIH corresponds to about 2.5 nkats using the thrombin chromogenic substrate BIOPHEN® CS-01(38)

21 NIH (1 mL) #BE102A

6x21 NIH (6x1 mL) #BE102K

100 NIH (1 mL) #BE102B

1000 NIH (2 mL) #BE102C

RUO

Thrombin, Bovine Molecular Weight: 35,000 Da

Intended use : Useful for measuring Fibrinogen with the clotting method. Fibriphen reagent (CK571K/CK572K/CK575K) is also available.

Specifications :

Optimized thrombin concentration for the classic Clauss

method

500 NIH (5 mL) #BE501C10x500 NIH (10x5 mL) #BE501K

RUO

88

Other Proteins & Enzymes

Protac® Molecular Weight: 40,000 Da

Intended use : Activates Protein C.

Specifications :

Protein C Activating Enzyme extracted from Akgistrodon Contortrix snake venom. 1 unit is the amount which activates totally Protein C present in 1 mL normal human plasma

1 unit #EZ011A

5 units #EZ011B

RUO

Rabbit recombinant Tissue Factor Molecular Weight: 46,000 Da

Intended use : Research Studies

Specifications :

About 50 µg of rabbit (rec) Tissue Factor lyophilized with additives and stabilizers. 50 µg (1 mL) #RE030A

RUO

Recombinant Hirudin

Intended use : Thrombin inhibitor which can be used in any in vitro laboratory research application where an efficient inhibition of Thrombin is required.

Specifications :

Activity 16,000 ATU/mg(ATU=Anti Thrombin Unit) 1 mg (1 mL) #RE020A

RUO

Relipidated Rabbit recombinant Tissue Factor Molecular Weight: 46,000 Da

Intended use : Research Studies

Specifications :

About 25 µg of relipidated rabbit (rec) Tissue Factor using a phospholipids mixture close to the activated platelet membrane for full expression of its clotting activity.

25 µg (1 mL) #RE031A

RUO

Streptokinase Molecular Weight: 47,000 Da

Intended use : Fibrinolysis studies. Activates Plasminogen.

Specifications :

Highly purified streptokinase, for Plasminogen assays, stabilized with albumin, freeze dried

1,000 U (1 mL) #EZ008A10,000 U (1 mL) #EZ008B

100,000 U (2 mL) #EZ008C

RUO

Miscellaneous

89

IMMUNOCHEMICALS

Polyclonal Antibodies

Anti-Annexin V

Intended use : Research reagent for all studies where a source of anti-Annexin V antibody is required.

Specifications :

Reacts with recombinant or native Annexin V 100 µg #PA120A

RUO

Anti-β2GP1

Intended use : Research reagent for all studies where a source of anti-β2GP1 antibody is required.

Specifications :

Reacts with the various forms of human β2GP1 100 µg #PA200A

RUO

Anti-Cytochrome C

Intended use : Research reagent for all studies where a source of anti-cytochrome C antibody is required.

Specifications :

Specific for Cytochrome C 100 µg #PA110A

RUO

Anti-Fibrinogen

Intended use : Research reagent for all studies where a source of anti-Fibrinogen antibody is required.

Specifications :

Reacts with the various forms of human Fibrinogen, Fibrin and degradation products 100 µg #PA140A

RUO

Anti-FPA

Intended use : Research reagent for all studies where a source of anti-FPA antibody is required.

Specifications :

Purified by immunoaffinity on immobilized human FPA Presents a cross-reactivity with fibrinogen 100 µg #PA100A

RUO

Anti-Prothrombin

Intended use : Research reagent for all studies where a source of anti-Prothrombin antibody is required.

Specifications :

Reacts with the various forms of human Prothrombin 100 µg #PA150A

RUO

90

Anti-human Factor IX

Intended use : Research reagent for all studies where a source of anti-Factor IX antibody is required.

Specifications :

Reacts with the various forms of human Factor IX 100 µg #PA160A

RUO

Anti-Factor X

Intended use : Research reagent for all studies where a source of anti-Factor X antibody is required.

Specifications :

Reacts with the various forms of human Factor X 100 µg #PA190A

RUO

Anti-PF4

Intended use : Research reagent for all studies where a source of anti-PF4 antibody is required.

Specifications :

Reacts with the various forms of human PF4 100 µg #PA130A

RUO

Anti-human Protein C

Intended use : Research reagent for all studies where a source of anti-Protein C antibody is required.

Specifications :

Reacts with the various forms of human Protein C 100 µg #PA170A

RUO

Anti-human Protein S

Intended use : Research reagent for all studies where a source of anti-Protein S antibody is required.

Specifications :

Reacts with the various forms of human Protein S 100 µg #PA180A

RUO

Anti-human Protein Z

Intended use : Research reagent for all studies where a source of anti-Protein Z antibody is required.

Specifications :

Reacts with the various forms of human Protein Z 100 µg #PA185A

RUO

91

Monoclonal Antibodies

Anti-h-PAI-1 Clone 1

Intended use : Immuno-chemistry. Research studies.

Specifications :

Murine monoclonal antibody specific for human PAI-1 100 µg (1 mL) #MA011A

RUO

Anti-h-PAI-1 Clone 2


Specifications :


RUO

Anti-h-PAI-1 substrate


Specifications :


RUO

ZYMUTEST Rat PAI-1 AgRat PAI-1 Immunoassay #RK001A

A two-site ELISA method for the measurement of rat PAI-1 antigen (Plasminogen-activator-inhibitor 1), on rat plasma or any other biological fluid where rat PAI-1 antigen must be measured. This assay is designed with two Murine monoclonal antibodies, specific for rat PAI-1, the first one for coating the microplate (immunocapture) and the second one, labelled with a Horse Radish Peroxidase (HRP) marker. Measures all PAI-1 forms, as well as the PAI-1 complexed with tPA.

Pres

enta

tion

12x8 test kit2x F-Sample Diluent3x rat PAI-1 Standard (rec.)1x high & low Rat PAI-1 Controls3x Anti-rat-PAI-1-HRP IC1x Conjugate Diluent1x Wash Solution1x TMB1x 0.45M Sulfuric Acid

Ass

ay c

hara

cter

isti

cs

Total Assay Time: 2h15Detection Threshold : 0.1 ng/mLDynamic Range: 0-10 ng/mLIntra-Assay CV: 3-6%Inter-Assay CV: 4-8%

Intended use : Assay proposed for the measurement of rat PAI-1 antigen in research applications.

ZYMUTEST Rat PAI-1 ActivityRat PAI-1 Activity Immunoassay #RK003A

A two-site ELISA method for the measurement of rat PAI-1 activity (Plasminogen-activator-inhibitor 1), on rat plasma or any other biological fluid where rat PAI-1 activity must be measured. Uses active and stabilized tPA, bound onto the MicroELISA plate, for active PAI-1 capture. It is then revealed with a Murine monoclonal antibody, specific for rat PAI-1, and coupled with peroxidase (HRP).

Pres

enta

tion

12x8 test kit2x F-Sample Diluent3x Active rat PAI-1 Stan-dard (rec.)1x high & low Rat PAI-1 Controls3x Anti-rat-PAI-1-HRP IC1x Conjugate Diluent1x Wash Solution1x TMB1x 0.45M Sulfuric Acid

Ass

ay c

hara

cter

isti

cs

Total Assay Time: 2h15Detection Threshold: 0.1 ng/mLDynamic Range: 0-10 ng/mLIntra-Assay CV: < 6%Inter-Assay CV: < 8%

Intended use : Assay proposed for the measurement of rat PAI-1 avtivity in research applications.

RUO

RUO

Rat Fibrinolysis

ANIMAL MODELS

92

93

Species/Factor Human Monkey

CynomolgusMonkeyRhesus Pig Goat Sheep Horse Dog Rabbit Guinea

Pig Rat Mouse

Annexin V + + + + ND ND + + + + + + + + + + + + + + + + + - + + + + + + + +

PF4 + + + + + + + + + + + + +/- + + + + + - - - + + + + + + + +

CRP + + + + + + + + + + + + - - - - - + + + + - - -

tPA Antigen + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + +/- +/- +/-

PAI-1 Antigen + + + + + + + + + + - +/- +/- - - - - - -

Protein S, Free + + + + + + + + + + + + - - - - - - - - -

Protein S, Total + + + + + + + + - - - - - - - - -

B2GPI + + + + + + + + + + + + + + + +/- + + + + + - + + + + + + + +

Fibrinogen + + + + + + + + + + + + + + + + + + + + - - + +

Protein C + + + + + + + + + + + + +/- + + + + + + - - - +/- - -

Fibronectin + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + - + + + + + + + + + + + +

vWF + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + - + + + + + + +

Protein Z + + + + + + + + + + + + +/- + + + + + + + +/- + + + + +

Factor IX + + + + + + + + + + + + + + + + + + + + + + + + + + + + + +/- + + + + + + + + + + + +

Factor X + + + + + + + + + + + + + + + + + + + + + - + + + + + + +

Factor XIII-A + + + + + + + + + + + + + + + + +/- + + - - -

ESTIMATION OF RESPECTIVE CROSS REACTIVITY

> 60 % 40 to 60 % 20 to 40 % 10 to 20 % 2 to 10 % < 2 %

+ + + + + + + + + + +/- -

Cross-reactivities with homologous animal proteins for the various ZYMUTEST Kits

Rat Biochemicals

Rat PAI-1 Standard

Intended use : Source of calibrated rat-PAI-1 protein

Specifications :

Lyophilized in presence of BSA 1 µg (1 mL) #RE001A

RUO

Rat PAI-1

Intended use : Research applications

Specifications :

Lyophilized in presence of BSA 10 µg (1 mL) #RE005O

RUO

94

GENERAL INFORMATION

GENE

RAL

INFO

RMAT

ION

PRICING AND ORDERING

Exclusive distributors available in most of the countries.

Please contact them directly for any product information, offer or for placing an order. Refer to the actualized list of distributors on the website:

www.hyphen-biomed.com

If no distributor is available in your country or if you do not find it:

Contact us directly: HYPHEN BioMed, SAS 155 rue d’Eragny 95000 Neuville-sur-Oise (France) Tel : +33.1.34.40.65.10 – Fax : +33.1.34.48.72.36 or +33.1.34.48.71.84 website: www.hyphen-biomed.com

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TERMS AND CONDITIONS OF SALETERMS AND CONDITIONS OF SALE

1. Application of the General Terms & Conditions: These Terms & Conditions apply to all product sales entered into by Hyphen BioMed with its customers, irrespective of any other provisions appearing on any documents of the customer, in particular its terms & conditions of purchase, unless otherwise agreed to in writing by Hyphen BioMed. All orders placed with Hyphen BioMed entail acceptance of these Terms & Conditions. The contract of sale entered into between Hyphen BioMed and the customer will consist of the order, as accepted by Hyphen BioMed, and these Terms & Conditions (hereinafter the “Contract”).

2. Orders:Orders placed by telephone must be confirmed in writing, either by mail or by fax, and be marked “confirmation of telephone order of (date)”. Orders are only final following acceptance by Hyphen BioMed and will become firm and irrevocable as of acceptance.

3. Payment:The settlement of invoices related to the products must be made within 30 days following the date of the Hyphen BioMed invoice. Hyphen BioMed nevertheless reserves the right to request the payment of any order in cash after analysing the credit situation of the customer. In the event of any delay in payment, Hyphen BioMed may, without prejudice to its other rights and remedies, nor with any formal notice being necessary, (i) suspend all pending orders, (ii) invoice late payment penalties as of the day following the invoice due date by applying to the amount including taxes an annual interest equal to the closest reference rate applied by the ECB to its refinancing operations + 10 points, and (iii) apply a fixed compensation of €40 for recovery costs without prejudice to its right to claim any additional expenses incurred in recovery.

4. Price:The prices of Hyphen BioMed products are given excluding taxes. All taxes on turnover, value added, all registration fees, customs duties on imports or exports and, more generally, all taxes and duties charged by any governmental authority (including local or municipal authorities) are not included in the price of the products and will be payable by the customer in addition to the price.The prices appearing on the documents issued by Hyphen BioMed are not set for a determined duration and may vary between two orders. The price invoiced will be that of the applicable tariff on the day of the order. However, in the event of any increase in excess of 5% compared to the previous order, the customer’s prior consent will be requested to maintain the order.

5. Deliveries:5.1. Product deliveries will be made EXW from the laboratories of Hyphen BioMed, ZAC Neuville-sur-Oise, 155 rue d’Eragny, 95000 Neuville-sur-Oise, Incoterms 2010.5.2. The contract of carriage will nevertheless be concluded by Hyphen BioMed. Within metropolitan France, packaging and delivery/transport costs are borne by Hyphen BioMed for all orders higher than €230 excluding taxes; for all orders below €230 excluding taxes, a flat-rate charge for processing costs of €30 excluding taxes will be charged per order; for all urgent deliveries (less than 24 hours), an additional flat-rate charge of €23 excluding taxes will be charged per order, irrespective of the amount of the order. The cost of any special packaging (containers, insulators, dry ice or ice packs) necessary for certain deliveries will be borne by the customer, irrespective of the amount of the order. For all deliveries outside of metropolitan France, all packaging and delivery/transport costs shall be borne by the client.5.3. Irrespective of the delivery conditions, the goods travel at the risk and peril of the recipient, with no insurance subscribed by Hyphen BioMed, from the above-named place of delivery in accordance with the EXW rule of Incoterms 2010. In the event of loss or damage during transport, the customer must notify the carrier of any loss or damage noted within the deadlines set by law and inform Hyphen BioMed of such notification. 5.4. The delivery periods are indicative. No damages for delay may be claimed; the customer may however cancel the order one month following the issue of a formal notice to Hyphen BioMed remained without effect.5.5. Unless expressly agreed between Hyphen BioMed and the customer, no deliveries will be made on a Friday because of the weekend and the risk of inappropriate storage.

6. Non-conformity – Claims – Liability:6.1. Hyphen BioMed warrants that its products are in conformity with the specifications indicated in the order and the order acceptance as well as in the Hyphen BioMed catalogue. 6.2. Any claim for non-conformity concerning the order or defective product must be sent by means of registered letter with acknowledgment of receipt within a period of 7 days as from delivery of the products. Failing this, the products delivered will be deemed to be in conformity with the order as regards their quantity and quality.6.3. No products may be returned without the prior consent of Hyphen BioMed. Following the agreement of Hyphen BioMed and the allocation of a return number, return will be carried out at the expense and risk of the customer. The use of reagents in their entirety entails the waiving by the customer of any claim for non-conformity.6.4. The warranty provided by Hyphen BioMed is, at the choice of Hyphen BioMed, strictly limited to the free replacement of products recognised by Hyphen BioMed as non-conforming or defective or to their reimbursement by Hyphen BioMed, to the exclusion of any other damages for whatever cause or prejudice. This warranty will not apply in the event of any accident or negligence in the use of the products, nor of any usage, storage or handling of the products that does not comply with the instructions of Hyphen BioMed or industry standards, or in the event of any modification or intervention from the customer on the original products.6.5. To the full extent permitted by law, no other warranty than those mentioned in Article 7 and this Article 6 will be provided by Hyphen BioMed, in particular no warranty against hidden defects or warranty of title or non-infringement of third-party rights, of quality or conformity, or that the products are fit for any ordinary or particular purpose. To the full extent permitted by law, the liability of Hyphen BioMed is in any event limited to the amount of the sums received by Hyphen BioMed for the order in question; Hyphen BioMed may in no case be held liable for any commercial or intangible loss (including, but not limited to, any loss of profit, savings, business interruption or any loss arising from any third-party claim). The customer in this respect recognises that the prices set by Hyphen BioMed take account of the exclusions and limitations of liability and warranty provided under these Terms & Conditions and that, consequently, it must assume liability or insure itself for any damage or loss related to such exclusions and limitations. These exclusions and limitations are also applicable to any recourse by the customer’s insurers, either by direct action or subrogation.6.6. Hyphen BioMed will be released from its obligations under the Contract in cases of force majeure: in particular, war, riot, fire, floods, strikes, accidents, or the inability of Hyphen BioMed to receive supplies or ensure delivery of the products under reasonable conditions will all be deemed cases of force majeure.

7. Intellectual property: Hyphen BioMed warrants only that the products do not violate any intellectual property law in France. This warranty will not apply if the products are manufactured according to the specifications of the customer. In the event of any violation of intellectual property law, the warranty of Hyphen BioMed will be limited, at the choice of Hyphen BioMed, to the replacement of the products by non-infringing products, on acquisition at the expense of Hyphen BioMed of the right to use the products by the customer, or to the reimbursement of the sums received by Hyphen BioMed from the customer for the products in question.

8. Use: The Hyphen BioMed products are solely intended for in vitro use for the purposes of medical diagnosis. The use of the products by the customer shall in no way violate any law or regulation. For all pro-duct sales by Hyphen BioMed outside France, the customer will be liable, at its expense and risk, for ensuring the conformity of the products with any law or regulation applicable to the use or sale of the products in the country of destination of the products; in particular, the customer must ensure that any registration or other approval, any translation, labelling, instructions for use or other information or warning concerning the Contract or the products conform with the applicable laws or regulations of the country of destination of the products.

9. Retention of title:UNTIL SUCH TIME AS THE CUSTOMER MAKES FULL PAYMENT OF THE PRICE (INCLUDING ANY PENALTIES FOR LATE PAYMENT), HYPHEN BIOMED RESERVES THE RIGHT OF TITLE TO THE PRODUCTS SOLD, PERMITTING IT TO REPOSSESS SAID PRODUCTS. THE RISK OF LOSS OF OR DAMAGE TO THE PRODUCTS, AS WELL AS THE RISK OF ANY DAMAGE THEY MIGHT CAUSE, WILL NEVERTHELESS BE TRANSFERRED TO THE CUSTOMER AS OF DELIVERY OF THE PRODUCTS. THE CUSTOMER WILL CONSEQUENTLY, AT ITS EXPENSE, ARRANGE FOR THE INSURANCE OF THE PRODUCTS FOR THE BENEFIT OF HYPHEN BIOMED UNTIL THE FULL TRANSFER OF TITLE, WITH PROOF OF INSURANCE PROVIDED ON DELIVERY UPON REQUEST. THE CUSTOMER ALSO UNDER-TAKES TO STORE THE PRODUCTS SEPARATELY FROM ITS OTHER ASSETS AND CLEARLY IDENTIFY THEM AS BEING THE PROPERTY OF HYPHEN BIOMED UNTIL FULL PAYMENT OF THE PRICE. THE CUSTOMER WILL HAVE THE RIGHT TO USE OR RESELL THE PRODUCTS IN THE NORMAL COURSE OF BUSINESS, BUT THIS RIGHT WILL CEASE IMMEDIATELY IN THE EVENT OF NON-PAYMENT OF ANY SUM DUE TO HYPHEN BIOMED BY THE DUE DATE: HYPHEN BIOMED MAY IN THIS CASE REPOSSES THE PRODUCTS.

10. General: 10.1. If any provision of the Contract is declared invalid, ineffective or unenforceable, this will not affect the validity and enforceability of the other provisions and the parties will undertake to replace such provision with another valid provision which will have the closest possible economic effect. 10.2. The failure to exercise any right under this Contract will in no case entail the waiving of such right, which may subsequently be exercised by the party concerned.

11. Disputes:11.1. The Contract will be subject to and interpreted in accordance with French law. The 1980 United Nations Convention on Contracts for the International Sale of Goods will not apply to this Contract. 11.2. ANY DISPUTE ARISING FROM OR IN RELATION TO THIS CONTRACT WILL BE SUBJECT TO THE SOLE JURISDICTION OF THE COMMERCIAL COURT OF PONTOISE INCLUDING, BUT NOT LIMITED TO, ANY DISPUTE RELATING TO ITS INTERPRETATION, VALIDITY, PERFORMANCE OR TERMINATION, AND ANY SUMMARY PROCEEDINGS (PROCÉDURES EN RÉFÉRÉ) OR PROVISIONAL AND PROTECTIVE MEASURES (MESURES PROVISOIRES OU CONSERVATOIRES) NOTWITHSTANDING ANY NUMBER OF DEFENDANTS, ANY ACTION ON A WARRANTY OR GUARANTEE OR OTHER THIRD PARTY PROCEEDINGS AND ANY COUNTER-CLAIMS.

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AActivated Partial Clotting Time (APTT) ................11, 13

Activated Protein C Chromogenic substrate ........................................75 Human enzyme .......................................................84

Activators (Protac®/Streptokinase) ..............................88

Activator Diluent Buffers and solutions for ELISA .........................59 Solutions for Microparticles ................................60

Adenosine-5’-diphosphate (ADP) ................................67

Aggregometry .....................................................................67

Alpha 1 Acid GlycoProtein (AGP) ..................................81

Alpha 2 anti-plasmin (chromogenic assay) ...............63

Anti-IIa activity See Direct Thrombin Inhibitors ..........................34 See Heparin .............................................................. 30 See Thrombophilia ................................................ 21

Anti-VIII Elisa kit ........................................................................13

Anti-Xa activity See Heparin ........................................................29, 30

Annexin V Control .................................................................52, 54 Elisa kit ........................................................................72 Polyclonal antibody ...............................................89 Recombinant human protein .............................83

Anti-Annexin V auto antibodies ....................................39

Anti-β2GP1 auto-antibodies ..........................................38

Anti-cardiolipin/Anti-Phospholipidantibodies (ACA/APA) .......................................................37

Anti-Protein C auto-antibodies ..............................39, 40

Anti-Protein S auto-antibodies ......................................40

Anti-Protein Z auto-antibodies .....................................41

Anti-Prothrombin auto-antibodies ..............................42

Antithrombin III Bovine protein ..........................................................86 Buffers .........................................................................57 Chromogenic assay ................................................21 Latex Immuno-assay ..............................................22 Human protein .........................................................78

Argatroban® (Calibrator & Control) ..............................49

Arachidonic Acid ................................................................67

Arixtra® (Calibrator & Control) ........................................47

Autoimmunity sample diluent ......................................59

Bβ2GP1 Buffer and solutions for ELISA ............................60 Elisa kit ........................................................................72 Human protein .........................................................78 Polyclonal antibodies ............................................89

Bentonite ...............................................................................60

CC4b-BP (human protein) ..................................................78

Calcium chloride ..........................................................57, 58

Calcium Thromboplastin ....................................................6

Calibrators .............................................................................43

Collagen .................................................................................68

Collagen Binding Assay (CBA) .......................................15

Control plasmas ..................................................................43

Conjugate Diluent ..............................................................59

C-Reactive Protein (CRP) Elisa kit ........................................................................70

Cytochrome C (Polyclonal antibody) ...........................89

DDabigatran (Calibrator & Control).................................50

D-Dimer Control ........................................................................53 Elisa kit ........................................................................26

Deficient Plasmas ...............................................................16

Dilution buffers ...................................................................59

Direct Thrombin Inhibitors (DTI) ...................................34

EEpinephrine .........................................................................67

FFactor II ......................................................see Prothrombin

Factor V Clotting method ......................................................10 Deficient plasma .....................................................16 Elisa kit ........................................................................10

Factor V-Leiden Calibrator ...................................................................48 Clotting method ......................................................25 Control ........................................................................48

Factor VII Chromogenic assay ................................................11 Clotting method ......................................................11 Deficient plasma......................................................16 Elisa kit ........................................................................11 Human protein .........................................................81

Factor VIIa (Chromogenic assay) ...................................12

Factor VII-X (Clotting method) .......................................12

Factor VIII:C Chromogenic assay ................................................12 Deficient plasma .....................................................17

Factor IX Chromogenic assay ................................................13 Deficient plasma......................................................17 Elisa kit ........................................................................13 Human protein .........................................................81 Polyclonal antibody ...............................................90

Factor IXa Chromogenic assay ...............................................14 Chromogenic substrate ........................................76 Control ........................................................................44 Human enzyme .......................................................84

Factor X

Bovine protein ..........................................................86 Chromogenic assay ...............................................14 Deficient plasma......................................................17 Elisa kit ........................................................................14 Human protein .........................................................81 Polyclonal antibody ...............................................90

Factor Xa Bovine enzyme ........................................................87 Chromogenic assay ...............................................34 Chromogenic substrate .................................74, 75 Fluorogenic substrate ...........................................76 Human enzyme .......................................................84

Factor XI Deficient plasma......................................................17

Factor XIa Chromogenic assay ...............................................14

Factor XII Deficient plasma......................................................18

Factor XIIa Human Enzyme .......................................................84

Factor XIII Deficient plasma......................................................18 Elisa kit ........................................................................15

Fibrin (fragment) .................................................................80

Fibrinolysis sample diluent .............................................59

Fibrino Peptide A (FPA) Buffer and solutions for ELISA ............................59 Polyclonal antibodies ............................................89 Elisa kit ........................................................................26 Control ........................................................................52

Fibrinogen Bovine protein ..........................................................86 Buffer and solutions for ELISA ............................60 Elisa kit ....................................................................8, 73 Human protein ..................................................78, 79 Fragments D, DD, E, E3t ........................................79 Latex immuno-assay ..........................................8, 72 Polyclonal antibody ...............................................89 Von Clauss Method....................................................8

Fibronectin Elisa kit ........................................................................73 Buffer and solutions for ELISA ............................60

HHeparin Chromogenic assay .........................................29, 30 Calibrators..................................................................45 Controls ......................................................................46

Heparin CoFactor II Chromogenic assay ................................................25 Human protein .........................................................80

Heparin dependent antibodies (Elisa kit) ...... 31 to 33

Hirudin Calibrators & Control.......................................49, 50 Recombinant Hirudin ............................................88

IImidazole buffer ..................................................................58

ALPHABETICAL INDEX

98

KKallikrein (Chromogenic substrate) .............................75

Kininogen (Deficient plasma) ........................................18

LLipoProtein a (Lp(a)) (Elisa kit) .......................................65

Low Molecular Weight Heparin (Control) ..................45

Lupus Anticoagulant Clotting method ...............................................26, 36 Controls ......................................................................36

Lyophilized platelets .........................................................68

MMicroparticles’ coagulant activity .................................27

NNon titrated human plasmas (Chromogenic assay) ....51

OOrgaran® (Calibrator & Control) .....................................47

PPhosphate-NaCl buffers ...................................................58

Plasminogen Activator Inhibitor-1 (PAI-1) Control .................................................................51, 54 Elisa kit (activity & Antigen) ..........................62, 65 Elisa kit (animal model) .........................................92 Protein (Animal model) .........................................93 Recombinant human protein .............................83 Monoclonal antibody ............................................91 Deficient plasma (tPA/PAI-1) ...............................19

Platelet aggregation ...................................................67, 68

Para-Nitro-Aniline (PNA) ..................................................56

Plasma factors and cofactors (Chromogenic assay) ........................................................44

PlasminChromogenic substrate ...................................................75Human enzyme ...................................................................85

Plasminogen Bovine protein ..........................................................86 Chromogenic assay .........................................62, 63 Human protein .........................................................79

Platelet Factor 4 (PF4) Control ........................................................................52 Elisa kit ........................................................................71 Human protein .........................................................82 Polyclonal antibodies ............................................90

Prekallikrein Deficient plasma......................................................18 Human protein .........................................................80

Protac® ...................................................................................88

Pro TAFI...................................................................................63

Protein C Chromogenic assay ................................................22 Clotting method ......................................................23 Deficient plasma......................................................19 Elisa kit ........................................................................23 Human protein .........................................................82 Polyclonal antibody ...............................................90

Protein S Clotting method ......................................................23 Control ........................................................................53 Deficient plasma......................................................19 Elisa kit (Free & Total) .............................................24 Human protein .........................................................82 Polyclonal antibody ...............................................90

Protein Z Deficient plasma......................................................19 Elisa kit ........................................................................24 Human protein .........................................................82 Polyclonal antibody ...............................................90

Prothrombin Bovine protein ..........................................................86 Buffer and solutions ...............................................57 Chromogenic assay ...............................................10 Deficient plasma......................................................16 Human protein .........................................................81 Polyclonal antibody ...............................................89

Prothrombin Time (PT) Clotting method .........................................................6

RRistocetin ...............................................................................68

Rivaroxaban (Calibrator & Control) .......................50, 51

SSample Diluents ...........................................................59, 60

Stop Solution .......................................................................60

Streptokinase .......................................................................88

Substrates ...........................................................59, 74 to 76

TThrombin Activatable Fibrinolysis Inhibitor (TAFI) Elisa kit .......................................................................63, Control ........................................................................52

Thrombin Bovine enzyme ........................................................87 Chromogenic substrate ........................................74 Clotting method .........................................................7 Human enzyme .......................................................84

Thrombin Time (T.T.) .............................................................7

Tissue Factor Elisa kits ...............................................................70, 71 Recombinant, rabbit ..............................................88

Tissue Plasminogen Activator (tPA) Elisa kits (Antigen & Activity) .......................64, 65 Plasma control...................................................52, 54 Recombinant human protein .............................83 Deficient Plasma (tPA/PAI-1) ...............................19

tPA and broad spectrum (Chrom. Substrate) ...........76

tPA stimulator ......................................................................80

Tetra-Methyl Benidine (TMB) .........................................59

Tris buffers .............................................................................57

UUnfractionated heparin Calibrator ............................................................45, 46 Control ........................................................................46Urokinase (Chromogenic substrate)............................76

Urokinase-type Plasminogen Activator (uPA) Control .................................................................52, 54 Elisa kits ......................................................................64 Human enzyme .......................................................85VVon Willebrand Factor (vWF) Deficient plasma......................................................19 Elisa kit ........................................................................15

WWash solutions .............................................................58, 60

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INDEX BY REFERENCES

BIOPHEN® line220202 ............................................................... 34220412 ............................................................... 14220502 ............................................................... 63221003/221006 .............................................. 29221007 ............................................................... 29221010 ............................................................... 30221011/221013 .............................................. 29221020 ............................................................... 30221025 ............................................................... 30221030 ............................................................... 34221102/221105 .............................................. 21221111 ............................................................... 21221122 ............................................................... 21221202/221205 .............................................. 22221211 ............................................................... 22221304 ............................................................... 11221312 ............................................................... 12221402/221406 .............................................. 12221502 ............................................................... 62221511 ............................................................... 63221605 ............................................................... 10221705 ............................................................... 14221802/221805 .............................................. 13221812 ............................................................... 14221902 ............................................................... 25222001 ............................................................... 45222101 ............................................................... 44222201 ............................................................... 47222301 ............................................................... 45222401 ............................................................... 48222501 ............................................................... 47222601 ............................................................... 46222701 ............................................................... 50222801 ............................................................... 50223001/223801/224201 .............................. 46223101/223901/224101 .............................. 46223201 ............................................................... 44223301 ............................................................... 44223405 ............................................................... 48223501 ............................................................... 47223602/223605 .............................................. 51223701/224301/224401 .............................. 46224001 ............................................................... 47224501 ............................................................... 51224601 ............................................................... 44224701 ............................................................... 50224801 ............................................................... 45229001/C .......................................................... 74229005 ............................................................... 74229011 ............................................................... 74229014/C .......................................................... 74229015 ............................................................... 75229021 ............................................................... 75229031 ............................................................... 75229041 ............................................................... 75229051 ............................................................... 76229061 ............................................................... 76229091 ............................................................... 76

Aggregometry lineAG001K ............................................................. 67AG002K ............................................................. 67AG003K ............................................................. 67AG004K ............................................................. 68AG005K ............................................................. 68

AG006A/AG006K ........................................... 68

CEPHEN lineCK511K/ CK512K ...............................................6CK515K/L .............................................................6CK521K/ CK522K ...............................................7

ELITEST lineCK101A .............................................................. 65CK102A .............................................................. 65CK103A .............................................................. 65

FIBRIPHEN lineCK571K/ CK572K/ CK575K .............................8

FLUOPHEN line329011 ............................................................... 76

HEMOCLOT lineCK001K/L .............................................................7CK002K/L .......................................................... 34CK011K/L .............................................................7CK031K .............................................................. 23CK041K .............................................................. 23CK051K/L .......................................................... 12CK061K/L .......................................................... 25CK065K .............................................................. 25CK071K .............................................................. 10CK081K .............................................................. 11CK090K ....................................................... 26, 36CK091K ....................................................... 27, 36

LIAPHEN® line120002 ............................................................... 22120102 ............................................................... 72

THROMBOPHEN lineCK550K/M/L ........................................................6CK551K/M/L ........................................................6

ZYMUPHEN line521096 ............................................................... 27521196 ............................................................... 27521296 ............................................................... 64

ZYMUTEST lineRK001A .............................................................. 92RK003A .............................................................. 92RK004A .............................................................. 72RK005A/B .......................................................... 39RK006A .............................................................. 71RK007A/B .......................................................... 42RK008A .............................................................. 63RK009A .............................................................. 10RK010A .............................................................. 70RK011A .............................................................. 64RK012A .............................................................. 62RK013A .............................................................. 64RK014A/B/C ..................................................... 38RK015A .............................................................. 24RK016A .............................................................. 26RK017A .............................................................. 64RK018A .............................................................. 65RK019A .............................................................. 62RK020A/B .......................................................... 40

RK021A .............................................................. 24RK022A .............................................................. 72RK023A .............................................................. 26RK024A .............................................................. 73RK025A/B .......................................................... 41RK026A/B ................................................... 39, 40RK027A .............................................................. 23RK028A .............................................................. 73RK029A/B/C ..................................................... 37RK030A .............................................................. 15RK031A .............................................................. 24RK032A .............................................................. 13RK033A .............................................................. 14RK034A .............................................................. 15RK035A .............................................................. 70RK036A .............................................................. 11RK037A .............................................................. 63RK038A .............................................................. 15RK039A .............................................................. 13RK040A .............................................................. 31RK040B .............................................................. 31RK040C .............................................................. 31RK040D .............................................................. 32RK040E............................................................... 32RK041A .............................................................. 33RK041D .............................................................. 33RK042A .............................................................. 71

Auxiliary reagentsAR001A/K ......................................................... 57AR002A/K ......................................................... 58AR004A/K ......................................................... 58AR005A/K ......................................................... 58AR006A/K ......................................................... 58AR007A/K ......................................................... 58AR008A/K ......................................................... 56AR009A/K ......................................................... 56AR010A .............................................................. 59AR011A/K ......................................................... 59AR012A .............................................................. 56AR013A .............................................................. 59AR014A .............................................................. 56AR015A/B ......................................................... 56AR016A .............................................................. 59AR017A .............................................................. 59AR018A .............................................................. 59AR019A .............................................................. 60AR020A .............................................................. 57AR021A/K/L ..................................................... 58AR022A .............................................................. 57AR023A .............................................................. 60AR024A .............................................................. 60AR025A .............................................................. 60AR026A/K ......................................................... 57AR027A .............................................................. 56AR103A .............................................................. 57AR104A .............................................................. 57

Bovine EnzymesBE101C/D/L/O/K/B ........................................ 87BE102A/K/B/C/................................................ 87BE501C/K .......................................................... 87

Bovine ProteinsBP101O/K/A/B ................................................ 86BP102A/K .......................................................... 86

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BP103A/K .......................................................... 86BP104C .............................................................. 86BP105C .............................................................. 86

Deficient plasmasDP010A/K ......................................................... 16DP020A/K ......................................................... 16DP030A/K ......................................................... 16DP040A/K ......................................................... 17DP050A/K ......................................................... 17DP060A/K ......................................................... 17DP070A/K ......................................................... 17DP080A/K ......................................................... 18DP100A/K ......................................................... 19DP110A/K ......................................................... 19DP120A/K ......................................................... 19DP150A/K ......................................................... 19DP200A/K ......................................................... 18DP210A/K ......................................................... 19DP300A/K ......................................................... 18DP310A/K ......................................................... 18

Human EnzymesEZ004A/B/C ..................................................... 84EZ005A/B/C ..................................................... 85EZ006O/K/A/L/B ............................................. 84EZ007A/K/B/L/C ............................................. 84EZ008A/B/C ..................................................... 88EZ010B .............................................................. 84EZ011A/B .......................................................... 88EZ012A/K .......................................................... 84EZ013A/B .......................................................... 85

Monoclonal AntibodiesMA011A ............................................................ 91MA012A ............................................................ 91MA013A ............................................................ 91

Polyclonal AntibodiesPA100A .............................................................. 89PA110A .............................................................. 89PA120A .............................................................. 89PA130A .............................................................. 90

PA140A .............................................................. 89PA150A .............................................................. 89PA160A .............................................................. 90PA170A .............................................................. 90PA180A .............................................................. 90PA185A .............................................................. 90PA190A .............................................................. 90PA200A .............................................................. 89

Purified ProteinsPP001A/K/B/C/R ............................................. 78PP002A/K/B/C ................................................. 79PP003A .............................................................. 82PP004A/K/B/L/D/M/C ................................... 78PP005A/B/C ..................................................... 80PP006B/K .......................................................... 81PP007A .............................................................. 81PP008A .............................................................. 81PP009A .............................................................. 82PP010A .............................................................. 78PP011A .............................................................. 82PP012A .............................................................. 82PP013A .............................................................. 81PP014A/C .......................................................... 80PP015A .............................................................. 78PP016A .............................................................. 79PP017A .............................................................. 79PP018A .............................................................. 79PP019A .............................................................. 79PP020A .............................................................. 80PP021B/K .......................................................... 80PP201A .............................................................. 81PP501B/K .......................................................... 80

Recombinant Human ProteinsRP004A .............................................................. 83RP005A .............................................................. 83RP006A .............................................................. 83RP007A/C.......................................................... 83

Recombinant Proteins

RE001A .............................................................. 93

RE005O .............................................................. 93RE020A .............................................................. 88RE030A .............................................................. 88RE031A .............................................................. 88

Standard and ControlsSC011K .............................................................. 51SC011K/E .......................................................... 54SC013K .............................................................. 52SC014K .............................................................. 52SC015K .............................................................. 52SC017K .............................................................. 52SC017K/E .......................................................... 54SC020K/L .......................................................... 49SC025K .............................................................. 50SC030K .............................................................. 49SC035K .............................................................. 49SC050K .............................................................. 53SC065K .............................................................. 48SC080K .............................................................. 36SC081K .............................................................. 36SC101K .............................................................. 53SC102K .............................................................. 53SC103K .............................................................. 53

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In Vitro Diagnostic (IVD) Reagents, Research Biochemicals ... · monitoring of anticoagulant...

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