Stago Canada Ltd. Product Catalog 2016

STA® Family of Hemostasis Analyzers

The STA® Family of Hemostasis Analyzers provides automation of coagulation testing for a variety of laboratory situations.Each system performs clotting, chromogenic and immunoassay methodologies in random access mode. Because allSTA® analyzers use the same analysis methods and the same reagent formulations, they offer standardization in the laboratory.

MODELS: AUTOMATED STA R Max®: Automation capable, high throughputSTA Compact Max®: Moderate throughputSTA Satellite®: Low throughput

MODELS: SEMI-AUTOMATED STart®

FEATURES Host-query bi-directional interfacePrimary tube samplingContinuous sample accessOpen reagent systemReagent and disposable managementReagent level detectionQC management with Levy-JenningsReagent and sample bar code readerAuto re-run and auto re-dilute optionsProgrammable and pre-programmed optionsUp to 70 on-board reagent capacityCapacity of up to 1,000 disposable cuvettesMulti-constituent controls and calibrator

METHODOLOGIES Clotting - VDS™ Mechanical Clot DetectionChromogenic - Optical densityImmunological - Optical density

STA® ASSAY MENUPTAPTTFibrinogen (Clauss)D-dimer (Quantitative)Thrombin TimeReptilase TimeExtrinsic FactorsIntrinsic FactorsAnti-Xa Activity

Unfractionated Heparin (UFH)Low Molecular Weight Heparin (LMWH)Rivaroxaban*Apixaban*Edoxaban*

Ecarin Chromogenic Assay (ECA-II)*Dabigatran*

Antithrombin (AT) ActivityAntithrombin (AT) AntigenProtein C Activity (clot-based and chromogenic)Protein S ActivityFree Protein S AntigenTotal Protein S AntigenVWF AntigenPlasminogen ActivityAntiplasmin ActivityFibrin Monomer*Lupus Anticoagulants

DRVVT (Screen and Confirm)PTT-LAStaclot LA

2 Product Catalog 2016

*(research use only; not for use in diagnostic procedures)

For the most up-to-date information on all our products, contact the Diagnostica Stago, Inc. Marketing Dept. at 800-222-COAG or visit our website at www.stago-ca.com.

PRODUCT AVAILABILITY: Most clinical reagents are available within 5 days after receipt of order. However if a sequestered lot of reagent is required, please contact Sales Administration for availability.

For availability of research products, please contact Sales Administration at 800-222-COAG, option 3. Research products not in stock may require a 60-day notice prior to availability.

Tabl

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Con

tent

s Section 1 Instruments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Section 2 Disposables & Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Section 3 Screening Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

Section 4 Factor Assays . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11

Section 5 Anticoagulants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Section 6 Thrombophilia . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Section 7 Fibrin Formation & Degradation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Section 8 Fibrinolysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

Section 9 Primary Hemostasis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

Section 10 Control Plasmas. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17

Section 11 Calibrators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

Section 12 Auxiliary Reagents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

Section 13 Quality & Compliance Solutions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

Section 14 Stago Added Value on Request (SAVOR™) . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

Section 15 Thrombin Generation Research Products . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

Section 16 Ecarin Chromogenic Assay (ECA) Products . . . . . . . . . . . . . . . . . . . . . . . . . 25

Section 17 Flow Cytometry Research Products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

Section 18 Research Kits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

Section 19 Research Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33 Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34 Terms & Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36 Main Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37-38

1

Instruments (continued)

CAT. NO. PRODUCT/ DESCRIPTION

59010 STA R Max® Hemostasis System with Cap PiercingFully Automated, High-Throughput Hemostasis Analyzer (Automation-Capable)

59013 STA R Max® Hemostasis SystemFully Automated, High-Throughput Hemostasis Analyzer (Automation-Capable)

The newest member of the Max Generation family of hemostasis analyzers, the STA R Max® is a high-volume, high-effi ciency analyzer that embodies Stago’s standardization of methodology, software, reagents, and consumables. Built on the most reliable platform in the industry with an expansive test menu, the STA R Max® is the perfect hemostasis partner for high-volume and reference laboratories performing routine and specialty assays.Interference free Viscosity-based Detection System (VDS), exclusive to Stago, is at the heart of the STA R Max® providing maximum sensitivity for weak clot detection and insensitivity to interferences ensuring reliability of results.The STA R Max® enhances effi ciency with features including the largest sample capacity in the industry and true STATsample priority. Optimized random access test management provides maximum throughput for routine and specialtycoagulation testing. With the most TLA connections worldwide, the STA-R® family of analyzers is the industry leaderfor total laboratory automation (TLA) connectivity and throughput.STA Coag Expert® software integrates over fi fty years of Stago coagulation expertise into every STA R Max® system.The STA Coag Expert® automates laboratory processes such as multi-dilution factor assays, automatic refl ex testing, automatic repeats and delta checks to ensure standardization and effi ciency for routine tests as well as complex specialty assays. Integrated accreditation tools, automated maintenance logs, integrated video tutorials and fi ve years of patient and QC archives stored onboard ensure industry leading tools for regulatory compliance. The STA R Max® with STA Coag Expert® equips laboratories with an easy to use system that ensures effi cient, reliable results the fi rst time, every time.

Analyzer is provided with:22 inch LCD touch screen fl at panel monitorUSB handheld barcode reader STA R Max® Computer Table STA Coag Expert® PackRJ45 straight Ethernet cable 10M Max Generation mouse pad

Uninterruptible power supplyOperator’s reference manualAccessory kit1-year warrantyBrother printer (optional)

Dimensions• Height: 126.5 cm (49.8 inches)• Width: 122 cm (48.0 inches)

• Depth: 80.5 cm (31.6 inches)• Weight: 238 kg (524.7 lb)

Test Selections200 user defi nable tests

Samples• 215 sample tubes onboard• 15 sample racks/75 samples• Continuous loading and unloading of sample racks• True STAT capability• Primary tube sizes accepted including pediatrics & microcontainers• Barcode identifi cation/Positive patient ID• Automatic pre-dilution and dilution of samples

LIS InterfaceBi-directional host-query

AutomationCompatible with all major automation line solutions

Reagent Menu• 70 reagent positions capable of performing a complete range

of routine and specialty tests. Contact your Stago Representativefor the most current listing.

• Random loading of reagents• Positive barcode identifi cation• Temperature controlled• Precalibration for many reagents• Automatic pre-dilution of calibrators• Automatic Quality Control STA R Max®

Section 1

3



58990 STA Compact Max® Coagulation SystemFully Automated, Moderate-Throughput Hemostasis Analyzer

58989 STA Compact Max® Coagulation System Cap Piercing ModelFully Automated, Moderate-Throughput Hemostasis Analyzer

The STA Compact Max® is a fully automated, bench top hemostasis workstation capable of performing clotting, chromogenic and immunological assays simultaneously in random access mode. The system’s unique method of sample management offers moderate throughput and rapid processing of STAT samples with no impact on the instrument’s performance. All sample and calibrator dilutions are performed automatically, increasing staff productivity for laboratories performing moderate-volume routine and specialty coagulation testing. The STA Compact Max® takes innovation to the next level by adding the state of the art STA Coag Expert® software. The STA Coag Expert® automates laboratory processes such as multi-dilution factor assays, automatic refl ex testing, automatic repeats and delta checks to ensure standardization and effi ciency for the complete analyzer testing profi le. Integrated accreditation tools, automated maintenance logs, integrated video tutorials and fi ve years of patient and QC archives stored onboard ensure industry leading tools for regulatory compliance. The combination of VDS methodology and the STA Coag Expert® on theSTA Compact Max® give you complete confi dence in your results - the most important part of any analyzer.

Analyzer is provided with:• STA Coag Expert® Pack • 22-inch LCD touch screen fl at panel monitor • Uninterruptible power supply• Max Generation mouse pad • Operator’s reference manual• Accessory kit• 1-year warranty• Brother printer (optional)

Dimensions• Height: 70.5 cm (27.75 inches)• Width: 97.0 cm (38.1 inches)• Depth: 73.0 cm (28.73 inches)• Weight: 140 kg (309 lb)

Test Selections80 user-defi nable tests

Samples• 96 sample tubes onboard (84 primary tube positions;

12 pediatric tube positions)• All common tube sizes accepted including

pediatrics & microcontainers • Random loading of samples• True STAT management• New 4th generation cap piercing option• Barcode identifi cation/Positive patient ID• Automatic pre-dilution and dilution of samples

LIS InterfaceBi-directional host-query or dynamic download

Reagent Menu• 45 reagent positions, supporting multiple vial sizes,

capable of performing most routine and specialty tests.Contact your Stago Representative for the most current listing.

• Random loading of reagents• Positive barcode identifi cation• Temperature controlled• Pre-calibration for all routine tests• Automatic pre-dilution of calibrators• Automatic Quality Control

STA Compact Max®

Section 1




58104 STA Satellite® Hemostasis SystemFully Automated, Low-Throughput Hemostasis Analyzer

The STA Satellite® is a fully automated benchtop hemostasis analyzer capable of performing clotting, chromogenic and immunological assays simultaneously in random access mode. The system enables lntegrated Health Networks to standardize patient testing results including D-dimer and Anti-Xa. Thanks to its technological innovations, STA Satellite® ensures a high reliability level as well as ease of use, fl exibility and complete security, all within a reduced footprint.

Analyzer is provided with:• Accessory Kit• Operator’s reference manual• 1-year warranty

Dimensions• Height: 70.0 cm (27.4 inches)• Width: 53.5 cm (21.1 inches)• Depth: 64.5 cm (25.5 inches)• Weight: 32.7 kg (72 pounds)

Test Selections80 user Test Selections

Samples• 20 onboard sample capacity• Primary tube sampling• Removable sample carousel• Continous sample loading• Positive sample identifi cation

LIS InterfaceBi-directional host-query

Other Features• LED for chromogenic assays• Internal barcode reader for samples and reagents• Stago’s exclusive method of VDSTM Mechanical Clot Detection (Viscosity-based Detection System) technology

Reagent Menu• PT• APTT• Fibrinogen• AT• Liquid Anti-Xa (UFH and LMWH)• D-dimer

STA Satellite®

Section 1

5



58121 STart® Hemostasis AnalyzerBenchtop Hemostasis Analyzer for Batch Testing

The STart® is a benchtop hemostasis analyzer featuring Stago’s exclusive method of VDS™ Mechanical Clot Detection (Viscosity-based Detection System). This method eliminates interference from lipemic, icteric or other optically dense samples or reagents. The analyzer offers programmable and pre-programmed assays with curve storage, 4 independently-timed incubation stations, electronically-linked multiple pipettor, 40-character liquid crystal display and an internal thermal printer. Its lightweight, compact size makes it ideal for low to medium volume batch testing or as a back-up to an optical clot detection system.

Analyzer is provided with:• Accessory kit• Cabled pipette• Operator’s reference manual• 1-year warranty

Dimensions• Height: 12.0 cm (4.7 inches)• Width: 41.0 cm (16.1 inches)• Depth: 42.0 cm (16.5 inches)• Weight: 5.7 kg (12.5 pounds)

MethodologyClotting - Standard VDSTM Mechanical Clot Detection

Test Selections• 17 test selections• Preprogrammed and programmable options

Other Features• Electronically-linked multiple pipettor for convenience and accuracy• Integrated printer• Four independently-timed incubation stations with audible signal• Lightweight and compact

Reagent Menu• PT• APTT• Fibrinogen• Thrombin Time• Reptilase Time• Extrinsic Factors• Intrinsic Factors• Protein C Activity• Protein S Activity• PTT-LA• Staclot® LA (Lupus Anticoagulants)• DRVV

STart®

Section 1


Disposables & AccessoriesCAT. NO. PRODUCT/ DESCRIPTION CONTENTS

STA-R® Family, STA Compact® and STA Satellite® Disposables & Accessories

00741 STA®-Microtainers (for samples) 500 each

00797 STA®-Mini Reducer (5 mL vials) 100 each

00801 STA®-Maxi Reducer (10 and 15 mL vials) 100 each

00802 STA®-Microcups (for reagents) 100 each

26538 STA®-Colorimetry Box Filter (metal frame) 1 each

26555 Magnetic Ball Extractor 1 each

26674 Magnetic Red Stir Bar (C.K. Prest Only) 1 each

26699 Halogen Lamp 1 each

27307 Needle # 3 1 each

27354 Needle # 2 1 each (STA Compact®)

27420 Rear Panel Air Filters 2 each (STA Compact®)

27423 Sample Microtainer Adapter (tall) 2 each (STA Compact®)

27425 Magnetic White Stir Bar 1 each

27457 Rinsing Plate Assay Air Filter (paper fi lter) 1 each (STA Compact®)

27458 Liquid Filter 1 each

27530 Tefl on Syringe Tip and O-Ring Kit Pack 6 each

27538 Hamilton Syringe 1 each

27543 Reduction Ring for Microcups 2 each

38125 Optical Module Fan Filter 1 each

38517 Air Filter 1 each (STA-R®)

38581 Tubing, Cap Piercing Electrovalve 1 each (STA Compact®)

38640 Liquid Cooling Glycol (Peltier System) 1 liter

38646 Needle #1 1 each (STA Compact®)

38669 STA®-Cuvettes 6 x 1000 (STA Compact® & STA-R®)

38960 STA-R® Shuttle 1 each

39002 Aluminum Microtainer Adapters 10 each (STA-R®)

39010 Tray for 15 Racks 2 each

39011 Mapping Adjustment Cuvette 1 each

39022 Needle # 1 Cap Piercing 1 each (STA Compact®)

39134 Wheel Tube Rotation 1 each

39164 Needle # 1 Cap Piercing 1 each (STA-R®)

39249 Needle # 1 1 each (STA-R®)

39250 Needle # 2 1 each (STA-R®)

88349 V2 (Pediatric Racks) Set of 2 (STA-R®)

Section 2

7

Disposables & Accessories (continued)

CAT. NO. PRODUCT/ DESCRIPTION CONTENTS

STA-R® Family, STA Compact® and STA Satellite® Disposables & Accessories (continued)

39356 Sample Needle 1 each (STA Satellite®)

39430 STA Satellite® Cuvettes 6 x 220 (STA Satellite®)

39968 Microcup Adapter 2 each (STA Satellite®)

80057 Microtainer Reducer 2 each (STA Satellite®)

80132 Air Filters 3 each (STA Satellite®)

80203 Microtainer Rack 2 each (STA-R®)

80343 Soft Stylet Pack of 10

87063 Suction Tip 2 each (STA-R®)

88828 Reducer DIN 14 2 each (STA Satellite®)

STart® Disposables & Accessories

26405 Magnetic Stir Bars (white triangular) 1 each

26441 Ball Vial (1850 / vial) 1 each

26555 Ball Extractor 1 each

26649 Thermal Paper 1 each

26729 5 mL Reduction Ring 1 each

38876 STart® Cuvettes (4 x 150) 600 / box

39476 Ball Dispenser 1 each

80109 Finnpipette 1 each

80600 Finntips® 1.25 mL (position 1 = 25 µL) (Finnpipette Only) 1 box of 100 Finntips®

80601 Finntips® 2.5 mL (Finnpipette Only) 100 / box

80602 Combitips® 1.25 mL (Eppendorf Only) 100 / box

80603 Combitips® 2.5 mL (Eppendorf Only) 100 / box

Miscellaneous Parts

26605 Reduction Ring DIN 14 (1.0 to 10 mL) 2 each

26610 Reagent Vial Reduction Ring DIN 18 (5.0 to 10 mL) 2 each

26681 Fuse 6.3 Amp Pack of 10 (STA Satellite®)

26694 Fuse 15 Amp Pack of 10

27037 Fuse 4.0 Amp Pack of 10






Section 2


* ISI values for PT reagents are approximations. Actual ISI values are assigned for each lot of PT reagent.

Screening TestsCAT. NO. PRODUCT/ DESCRIPTION CONTENTS

00238 STA®-Fib 2Quantitative determination of fi brinogen by Clauss method.

6 x 2 mL vials of STA®-Fib 2

00595 STA®-PTT Automate 5Determination of Activated Partial Thromboplastin Time (APTT) by STA® analyzers. Cephalin reagent with particulate (silica) activator.

12 x 5 mL vials

00597 STA®-C.K. Prest® 5Determination of Activated Partial Thromboplastin Time (APTT) by STA® analyzers. Cephalin reagent with kaolin activator.

6 x 5 mL vials of STA® C.K. Prest® 56 x 5 mL vials of Activator

00605* STA®-Neoplastine® CI 5Determination of Prothrombin Time (PT) by STA® analyzers (ISI~1.8). Freeze-dried rabbit brain thromboplastin with heparin inhibitor.

6 x 5 mL vials of STA® Neoplastine® CI 56 x 5 mL vials of Solvent

00606* STA®-Neoplastine® CI Plus 5Determination of Prothrombin Time (PT) by STA® analyzers (ISI~1.3). Freeze-dried rabbit brain thromboplastin with heparin inhibitor.

6 x 5 mL vials of STA® Neoplastine® CI Plus 56 x 5 mL vials of Solvent

00611 STA®-Thrombin 2Determination of Thrombin Time by STA® analyzers. Freeze-dried human thrombin (1.5 NIH units/mL) with calcium.

12 x 2 mL vials

00613 Fibri-Prest® Automate 2Quantitative determination of fi brinogen by Clauss method.

12 x 2 mL vials of Fibri-Prest® Automate 2

00614 STA®-Reptilase®

Determination of Reptilase® Time. Extracted venomof Bothrops atrox, ~20 BU (Batroxobin unit) per vial.

6 x 2 mL vials

00667* STA®-Neoplastine® CI Plus 10Determination of Prothrombin Time (PT) by STA® analyzers (ISI~1.3). Freeze-dried rabbit brain thromboplastin with heparin inhibitor.

12 x 10 mL vials of STA® Neoplastine® CI Plus 1012 x 10 mL vials of Solvent

00674 STA®-Fibrinogen 5Quantitative determination of Fibrinogen by STA® analyzers (Clauss Method). Freeze-dried human thrombin (~80 NIH units/mL) with heparin inhibitor and calcium.

12 x 5 mL vials

00669 STA®-Thrombin 10Determination of Thrombin Time by STA® analyzers. Freeze-dried human thrombin (1.5 NIH units/mL) with calcium.

12 x 10 mL vials

Section 3


Factor AssaysCAT. NO. PRODUCT/ DESCRIPTION CONTENTS

00722 STA®-Defi cient XIISubstrate plasma for Factor XII assay by STA® analyzers.Freeze-dried human plasma lacking Factor XII.

6 x 1 mL vials

00723 STA®-Defi cient XISubstrate plasma for Factor XI assay by STA® analyzers.Freeze-dried human plasma lacking Factor XI.

6 x 1 mL vials

00724 STA®-Defi cient IXSubstrate plasma for Factor IX assay by STA® analyzers.Freeze-dried human plasma from which Factor IX has been removed by selective immuno-adsorption.

6 x 1 mL vials

00725 STA®-Defi cient VIIISubstrate plasma for Factor VIII assay by STA® analyzers.Freeze-dried human plasma from which Factor VIII has been removed by selective immuno-adsorption.

6 x 1 mL vials

00738 STA®-Defi cient XSubstrate plasma for Factor X assay by STA® analyzers.Freeze-dried human plasma from which Factor X has been removed by selective immuno-adsorption.

6 x 1 mL vials

00743 STA®-Defi cient VIISubstrate plasma for Factor VII assay by STA® analyzers.Freeze-dried human plasma from which Factor VII has been removed by selective immuno-adsorption.

6 x 1 mL vials

00744 STA®-Defi cient VSubstrate plasma for Factor V assay by STA® analyzers.Freeze-dried human plasma, artifi cially depleted of Factor V.

6 x 1 mL vials

00745 STA®-Defi cient IISubstrate plasma for Factor II assay by STA® analyzers.Freeze-dried human serum and absorbed bovine plasma,the latter providing Factor V and fi brinogen to the test system.

6 x 1 mL vials

00943 Asserachrom® IX:AgEnzyme immunoassay of Factor IX Antigen by ELISA method, 96 tests.

3 x 2 Coated Strips3 x 8 mL vials of Anti-IX:Ag-Peroxidase3 x 8 mL vials of TMB3 x 50 mL bottles of Dilution Buffer1 x 50 mL bottle of Washing Solution3 x 0.5 mL vials of F. IX:Ag Calibrator3 x 0.5 mL vials of F. IX:Ag Control1 Plate Frame; 1 Plate Cover

Section 4

11

AnticoagulantsCAT. NO. PRODUCT/ DESCRIPTION CONTENTS

Heparin Anti-Xa Chromogenic Assays

00311US STA®-Liquid Anti-Xa 4 Chromogenic assay for the quantitative determination of unfractionated (UFH) and low molecular weight heparins (LMWH) in plasma by measuring anti-Xa activity on antithrombin in a competitive assayby STA® analyzers.

6 x 4 mL vials of Reagent 1 (Substrate)6 x 4 mL vials of Reagent 2 (F.Xa)

00322US STA®-Liquid Anti-Xa 8Chromogenic assay for the quantitative determination of unfractionated (UFH) and low molecular weight heparins (LMWH) in plasma by measuring anti-Xa activity on antithrombin in a competitive assayby STA® analyzers.

6 x 8 mL vials of Reagent 1 (Substrate)6 x 8 mL vials of Reagent 2 (F.Xa)

00906 Stachrom® HeparinChromogenic assay of unfractionated and low molecular weight heparins. Lyophilized chromogenic substrate CBS 31.39, purifi ed bovine AT III, purifi ed bovine Factor Xa, Tris buffer.

4 x 2 mL vials of AT III2 x 15 mL vials of Buffer4 x 4 mL vials of F. Xa4 x 4 mL vials of Substrate

Heparin Induced Thrombocytopenia (HIT)

00615 Asserachrom® HPIA (ELISA)Determination of anti-heparin - PF4 antibodies by ELISA method, 48 tests.

3 x 2 Coated Strips6 x 2 mL vials of Anti-lgG,A,M-Peroxidase6 x 8 mL vials of TMB3 x 30 mL bottles of Dilution Buffer1 x 50 mL bottle of Washing Solution3 x 1 mL vials of HPIA Reference3 x 1 mL vials of Control 13 x 1 mL vials of Control 21 Plate Frame; 1 Plate Cover

ThrombophiliaCAT. NO. PRODUCT/ DESCRIPTION CONTENTS

lnhibitors

00516 STA®-Liatest® Free Protein Slmmuno-turbidimetric assay for Free Protein S Antigen bySTA® analyzers. Suspension of microparticles coated with monoclonal antibodies to Free Protein S.

6 x 6 mL vials of Latex6 x 5 mL vials of Buffer

00527 STA®-Liatest® Free Protein S 2Quantitative determination of Free Protein S byimmuno-turbidimetric method.


Section 5

Section 6


Thrombophilia (continued)


00568 Liatest® AT IIIlmmuno-turbidimetric assay for Antithrombin Antigen. Suspension of microlatex particles coated with rabbit anti-human AT antibodies.


00596 STA®-Stachrom® AT IIIChromogenic assay of Antithrombin activity by STA® analyzers. Bovine thrombin ~ 11.3 nKat/mL, freeze-dried.

4 x 3 mL vials of Thrombin4 x 3 mL vials of Substrate4 x 3 mL vials of Thrombin Solvent

00671 STA®-Stachrom® Protein CChromogenic assay for the quantitative determination of functional Protein C by STA® analyzers. Highly purifi ed extract of Agkistrodon c. contortrix venom for specifi c activation of Protein C with chromogenic substrate CBS 42.46 of ~15 μmoles/vial.

6 x 3 mL vials of PC-Actlvator6 x 3 mL vials of Substrate

00672 STA®-Stachrom® AT III 6Chromogenic assay of Antithrombin.

4 x 6 mL vials of Thrombin4 x 6 mL vials of Substrate4 x 6 mL vials of Thrombin Solvent

00746 STA®-Staclot® Protein SClotting assay for the quantitative measurement of the functional Protein S level based on the principal of Factor Va inhibition by STA® analyzers. Lyophilized human plasma, human activated Protein C; bovine Va; free of Protein S.

2 x 1 mL vials of Protein S Defi cient Plasma2 x 1 mL vials of PCa2 x 1 mL vials of F.Va

00747 STA®-Staclot® Protein CClotting assay of Protein C activity of STA® analyzers. Lyophilized human plasma free of Protein C; highly purifi ed extract of Agkistrodon c. contortrix venom for specifi c activation of Protein C. Freeze-dried with an activator selected specially for Protein C assay.

3 x 1 mL vials of Protein C Defi cient Plasma3 x 1 mL vials of PC-Activator

00944 Asserachrom® Protein CEnzyme lmmunoassay for Protein C Antigen by ELISA method, 96 tests.

3 x 2 Coated Strips3 x 8 mL vials of Anti-Protein C-Peroxidase3 x 8 mL vials of TMB3 x 50 mL bottles of Dilution Buffer1 x 50 mL bottles of Washing Solution3 x 0.5 mL bottles of Protein C Calibrator3 x 0.5 mL bottles of Protein C Control1 Plate Frame; 1 Plate Cover

00945 Asserachrom® Total Protein SEnzyme immunoassay for Total Protein S Antigen by ELISA Method, 96 tests.

3 x 2 Coated Strips3 x 2 mL vials of Anti-Total PS-Peroxidase3 x 8 mL vials of TMB3 x 50 mL bottles of Dilution Buffer1 x 50 mL bottles of Washing Solution3 x 0.5 mL bottles of Total Protein S Calibrator3 x 0.5 mL bottles of Total Protein S Control1 Plate Frame; 1 Plate Cover

00946 Asserachrom® Free Protein SEnzyme immunoassay for Free Protein S Antigen by ELISA Method, 96 tests.

3 x 2 Coated Strips3 x 2 mL vials of Anti-Free PS-Peroxidase3 x 8 mL vials of TMB3 x 50 mL bottles of Dilution Buffer1 x 50 mL bottles of Washing Solution3 x 0.5 mL bottles of Free Protein S Calibrator3 x 0.5 mL bottles of Free Protein S Control1 Plate Frame; 1 Plate Cover

Section 6

13

Thrombophilia (continued)


Lupus Anticoagulants

00266 Asserachrom® APA ScreenQualitative determination of IgG, IgA, IgM anti-phospholipid antibodies by ELISA method, 96 tests.

3 x 2 Coated Strips3 vials of Anti-IgG, A, M-peroxidase3 vials of APA Screen reference3 vials of dilution buffer1 vial of washing solution3 vials of TMB3 vials of Control 13 vials of Control 2

00267 Asserachrom® APA IgG, MQualitative determination of anti-phospholipid antibodies (IgG and/or IgM)by ELISA method, 96 tests.

3 x 2 Coated Strips3 vials of Anti-IgG-peroxidase3 vials of Anti-IgM-peroxidase3 vials of APA IgG, M Calibrator3 vials of dilution buffer1 vial of washing solution3 vials of TMB3 vials of Control 13 vials of Control 2

00339 STA®-Staclot® DRVV Screen 2Detection of Lupus Anticoagulants by the diluted Russell’s viper venom test by STA® analyzers.Russell’s viper venom, phospholipids (low concentration), calcium and heparin inhibitor, freeze-dried.

12 x 2 mL vials

00333 STA®-Staclot® DRVV Screen 5Detection of Lupus Anticoagulants by the diluted Russell’s viper venom test by STA® analyzers.Russell’s viper venom, phospholipids (low concentration), calcium and heparin inhibitor, freeze-dried.

12 x 5 mL vials

00334 STA®-Staclot® DRVV Confi rmDetection of Lupus Anticoagulants by the diluted Russell’s viper venom test by STA® analyzers.Russell’s viper venom, phospholipids (high concentration), calcium and heparin inhibitor, freeze-dried.

12 x 2 mL vials

00600 Staclot® LADetection of Lupus Anticoagulants.Freeze-dried hexagonal phase phosphatidylethanolamine, normal human plasma with heparin inhibitor, PTT-LS reagent of cephalin and particulate activator (silica), 10 tests.

2 x 1 mL vials of Buffer2 x 0.25 mL vials of Phospholipids4 x 0.5 mL vials of Normal Plasma2 x 1 mL vials of PTT-LS2 x 1.5 mL vials of Solvent

00599 PTT-LA (LA Screen)Lupus Anticoagulant sensitive APTT reagent.Cephalin reagent with particulate activator (silica), freeze-dried.

6 x 2 mL vials

01139 Pool Norm For use as a normal control for the activated partial thromboplastintime (APTT) and dilute Russell’s viper venom time (dRVVT) assays.A lyophilized pool, consisting of at least 20 citrated normal human plasmas.

12 x 1 mL vials

Section 6


Fibrin Formation & DegradationCAT. NO. PRODUCT/ DESCRIPTION CONTENTS

00515 STA®-Liatest® D-DiImmuno-turbidimetric assay of D-dimer by STA® analyzers. Microlatex particles coated with two different mouse monoclonal anti-human D-dimer antibodies.

6 x 5 mL vials of Buffer6 x 6 mL vials of Latex

00947 Asserachrom® D-DiEnzyme immunoassay of D-dimer by ELISA method, 96 tests.

3 x 2 Coated Strips3 x 8 mL vials of Anti-D-Peroxidase3 x 8 mL vials of TMB3 x 50 mL bottles of Dilution Buffer1 x 50 mL bottle of Washing Solution3 x 0.5 mL vials of D-Di Calibrator3 x 0.5 mL vials of D-Di Control1 Plate Frame; 1 Plate Cover

00454 D-Di Test®

Latex agglutination slide test for the qualitative and semi-quantitative determination of D-dimer in plasma, 60 tests.

1 x 1.3 mL vial of Latex1 x 20 mL bottle of Buffer1 x 1 mL vial of Negative Control1 x 1 mL vial of Positive Control10 - Test Cards; Mixing Rods

00550 Test cards for D-Di Test kit 10 test cards

00540 FDP PlasmaQualitative and semi-quantitative determination of fi brinogen degradation products (FDP) in plasma by latex agglutination.

1 x 1.3 mL vial of latex1 x 1.3 mLvial of negative control1 x 1.3 mL vial of positive control1 x 1.3 mL vial of buffer10 test cards mixing rods

00541 FDP Plasma (Latex) 12 x 1.3 mL vials of x 20 latex

00543 STA®-Liatest® FMQuantitative determination of fi brin monomers by immuno-turbidimetric method (Liquid reagent).


00544 STA®-FM CalibratorCalibration plasmas for assay of fi brin monomers by immuno-turbidimetric method (STA®-Liatest® FM).

2 x 1 mL vials of STA®-FM Calibrator 12 x 1 mL vials of STA®-FM Calibrator 22 x 1 mL vials of STA®-FM Calibrator 32 x 1 mL vials of STA®-FM Calibrator 42 x 1 mL vials of STA®-FM Calibrator 5

00545 STA®-FM ControlControl plasmas for assay of fi brin monomers by immuno-turbidimetric method (STA®-Liatest® FM).

6 x 1 mL vials of STA®-FM Control 16 x 1 mL vials of STA®-FM Control 2

00551 FDP Plasma (Buffer) 12 vials of buffer

00548 F.S./FDP Plasma Test CardsFor use with catalog #00540 and #00887.

10 test cards

00887 F.S. Test UnitStat detection of soluble fi brin monomer complexes by hemagglutination, 32 tests.

8 x 0.2 mL vials of F.S. Test Unit Reagent8 x 0.2 mL vials of Positive Control8 x 0.2 mL vials of Negative Control10 - Test Cards

00857 F.S. TestBatch detection of soluble fi brin monomer complexes by hemagglutination, 40 tests.

4 x 0.5 mL vials of F.S. Test Reagent4 x 0.5 mL vials of Positive Control4 x 0.5 mL vials of Negative Control

Section 7

15

FibrinolysisCAT. NO. PRODUCT/ DESCRIPTION CONTENTS

00658 STA®-Stachrom® PlasminogenChromogenic assay of plasminogen activity by STA® analyzers.

6 x 3 mL vials of Streptokinase6 x 3 mL vials of Substrate

00659 STA®-Stachrom® AntiplasminChromogenic assay of antiplasmin activity by STA® analyzers.

4 x 2 mL vials of Plasmin4 x 6 mL vials of Substrate4 x 2 mL vials of Plasmin Solvent

00807 Stachrom® PAIChromogenic assay of plasminogen activator inhibitor-1 (PAI-1).

2 x 2 mL vials of Urokinase2 x 2 mL vials of Plasminogen2 x 2 mL vials of Substrate2 x 2 mL vials of PAI Calibrator 12 x 2 mL vials of PAI Calibrator 2

00948 Asserachrom® tPAEnzyme immunoassay of tissue plasminogen activator antigen by ELISA method, 96 tests.

3 x 2 Coated Strips3 x 8 mL vials of Anti-tPA-Peroxidase3 x 8 mL vials of TMB3 x 50 mL bottle of Dilution Buffer1 x 50 mL bottle of Washing Solution3 x 0.5 mL vials of tPA Calibrator3 x 0.5 mL vials of tPA Control1 Plate Frame; 3 Plate Covers

00949 Asserachrom® PAI-1Quantitative determination of Plasminogen Activator Inhibitor-1Antigen (PAI-1) by ELISA method, 96 tests.

3 x 2 Coated Strips3 vials of Anti-PAI-1-Peroxidase3 vials of PAI-1 Calibrator 3 vials of PAI-1 Control 3 vials of TMB3 vials of dilution buffer1 vial of washing solution

Primary HemostasisCAT. NO. PRODUCT/ DESCRIPTION CONTENTS

00518 STA®-Liatest® VWF:Aglmmuno-turbidimetric assay of Von Willebrand Factor (VWF:Ag) Antigen by STA ® analyzers.Microlatex particles coated with rabbit anti-human VWF antibodies.

4 x 2 mL vials of Latex4 x 4 mL vials of Latex Diluent4 x 5 mL vials of Buffer

00239 Asserachrom® VWF:CBQuantitative determination of the capacity of Von Willbrand Factor to bind to Collagen by ELISA method, 96 tests.

3 x 2 Coated Strips3 vials of Anti-VWF-Peroxidase3 vials of VWF:CB Calibrator3 vials of VWF:CB Control3 vials of TMB3 vials of Dilution Buffer1 vial of Washing Solution

00919 Asserachrom® VWF:FVIIIBQuantitative determination of the capacity of Von Willbrand Factor to bind to FVIII by ELISA method, 96 tests.

3 x 2 Coated Strips3 vials of Anti-FVIII-Peroxidase3 vials of VWF:FVIII Calibrator3 vials of VWF:FVIII Control3 vials of Anti-FVIII-Peroxidase Buffer3 vials of TMB3 vials of sample diluent1 vial of Washing Solution3 vials of recomb. FVIII

Section 8

Section 9


Primary HemostasisCAT. NO. PRODUCT/ DESCRIPTION CONTENTS

00950 Asserachrom® β-TGEnzyme immunoassay for β-Thromboglobulin Antigenby ELISA method, 96 tests.

3 x 2 Coated Strips3 x 8 mL vials of Anti- β-TG-Peroxidase3 x 8 mL vials of TMB3 x 50 mL bottles of Dilution Buffer1 x 50 mL bottle of Washing Solution3 x 0.5 mL vials of β-TG Calibrator3 x 0.5 mL vials of β-TG Control1 Plate Frame; 1 Plate Cover

00951 Asserachrom® PF4Enzyme immunoassay for Platelet Factor 4by ELISA method, 96 tests.

3 x 2 Coated Strips3 x 8-mL vials of Anti-PF4-Peroxidase3 x 8 mL vials of TMB3 x 50 mL bottles of Dilution Buffer1 x 50 mL bottle of Washing Solution3 x 0.5 mL vials of PF4 Calibrator3 x 0.5 mL vials of PF4 Control1 Plate Frame; 1 Plate Cover

01076 Cy-Quant VASP/P2Y12For the monitoring of P2Y12 ADP receptor antagonists by ELISA method, 96 tests.

96 divisible Anti-VASP coated wells3 vials of PGE13 vials of PGE1 + ADP1 vial of Anti-VASP-P Peroxidase1 vial of Lysis Buffer1 vial of Washing Solution1 vial of Dilution Buffer 1 vial of TMB1 vial of Stop Solution

Control PlasmasCAT. NO. PRODUCT/ DESCRIPTION CONTENTS

00381 STA®-Quality HNF/UFH Control plasma for assay of unfractionated heparin (UFH) usingthe STA ® Liquid Anti-Xa method on STA® analyzers.

6 x 1 mL vials of STA® Quality HNF/UFH 26 x 1 mL vials of STA® Quality HNF/UFH 5

00678 STA®-System Control N + PMulti-constituent normal and abnormal plasma controls for routine and specialty assays performed on the STA® analyzers.

12 x 1 mL vials of STA® System Control N12 x 1 mL vials of STA® System Control P

00679 STA®-Coag Control N + PNormal and abnormal control plasmas for PT, APTT, fi brinogen,thrombin time (N) and AT (activity).

12 x 1 mL vials of STA® -Coag Control N12 x 1 mL vials of STA® -Coag Control P

00677NEW

STA®-Coag Control N + ABN PlusNormal and abnormal control plasmas for PT INR, APTT, fi brinogen, thrombin time, and AT (activity) (24-hour stability).

12 x 2 mL vials of STA® -Coag Control N Plus12 x 2 mL vials of STA® -Coag Control ABN Plus

00522 Coag-Norm®

Unassayed normal control plasma for PT, APTT and fi brinogen.100 x 1 mL vials of Coag-Norm®

00523 Coag-Path®

Unassayed abnormal control plasma for PT, APTT and fi brinogen.100 x 1 mL vials of Coag-Path®

00526 STA®-Liatest® Control N + PNormal and abnormal control plasmas for immuno-turbidimetric assays of VWF, D-dimer and Free Protein S on STA® analyzers.For use with STA® Liatest® VWF:Ag (#00518), STA® Liatest® D-DI (#00515) and STA® Liatest® Free Protein S (#00516).

12 x 1 mL vials of STA® Liatest® Control N12 x 1 mL vials of STA® Liatest® Control P

NEW

Section 9

Section 10

17

Auxiliary ReagentsCAT. NO. PRODUCT/ DESCRIPTION CONTENTS00279 Polyethylene Glycol (PEG 25%) 6 x 2.5 mL

00360 STA®-Owren-Koller Buffer 24 x 15 mL

00367 STA®-CaCl2 0.025M 24 x 15 mL

00555 Asserachrom® Washing Solution 2 x 50 mL

00973 STA®-Cleaner Solution 6 x 2.5 L

00975 STA®-Desorb U 24 x 15 mL

CalibratorsCAT. NO. PRODUCT/ DESCRIPTION CONTENTS

00348 STA®-Multi Hep Calibrator Calibration plasmas for both UFH and LMWH using the STA® Liquid Anti-Xa method on the STA® analyzers.

4 X 1 mL vials of STA® Multi Hep Calibrator 04 X 1 mL vials of STA® Multi Hep Calibrator 44 X 1 mL vials of STA® Multi Hep Calibrator 74 X 1 mL vials of STA® Multi Hep Calibrator 104 X 1 mL vials of STA® Multi Hep Calibrator 18

00496 Etaloquick®

Calibration plasmas for the determination of Prothrombin Time (%, INR).4 x 0.5 mL vials of Etaloquick® 14 x 0.5 mL vials of Etaloquick® 2 4 x 0.5 mL vials of Etaloquick® 3

00681 STA®-Hepanorm® HBPM/LMWH Calibration plasma for LMWH assay using anti-Xa method(Stachrom® Heparin).

4 x 1 mLvials of STA® - Hepanorm® HBPM/LMWH 04 x 1 mL vials of STA® - Hepanorm® HBPM/LMWH 44 x 1 mL vials of STA® - Hepanorm® HBPM/LMWH 9

00684 STA®-Hepanorm® HCalibration plasmas for assays of unfractionated heparin (UFH) using the Anti-Xa method (Stachrom® Heparin).

4 x 1 mL vials of STA® Hepanorm® H 04 x 1 mL vials of STA® Hepanorm® H 34 x 1 mL vials of STA® Hepanorm® H 6

00520 STA®-VWF:Ag CalibratorCitrated human plasma for the calibration of VWF assays by the immuno-turbidimetric method on STA® analyzers. For use with STA® Liatest® VWF:Ag (#00518).

6 x 1 mL vials

00675 STA®-UnicalibratorMulti-constituent calibration plasma for functional assays of coagulation parameters on STA® analyzers.

6 x 1 mL vials

Control PlasmasCAT. NO. PRODUCT/ DESCRIPTION CONTENTS

00682 STA®-HBPM/LMWH ControlControl plasma for assays of low molecular weight heparin (LMWH)using the Anti-Xa method (Stachrom® Heparin).

6 x 1 mL vials of STA®- Quality HBPM/LMWH Control 36 x 1 mL vials of STA®- Quality HBPM/LMWH Control 8

00683 STA®-Heparin ControlControl plasma for assays of unfractionated heparins (UFH) using the Anti-Xa method (Stachrom® Heparin).

6 x 1 mL vials of STA® Heparin Control 26 x 1 mL vials of STA® Heparin Control 5

00686 STA®-Quality HBPM/LMWHControl plasma for assays of low molecular weight heparins (LMWH) using the Anti-Xa method on STA® analyzers.

6 x 1mL vials of STA® Quality HBPM/LMWH Control 86 x 1mL vials of STA® Quality HBPM/LMWH Control14

00201 STA®-Control LA 1 + 2Control plasmas for lupus anticoagulant (LA) detection.

3 x 1 mL vials of STA® Control LA 1 3 x 1 mL vials of STA® Control LA 2

Control PlasmasSection 10

CalibratorsSection 11

Auxiliary ReagentsSection 12


Quality & Compliance SolutionsCAT. NO. PRODUCT/ DESCRIPTION CONTENTS

EQA (External Quality Assessment)

Qualiris by Stago is a dedicated hemostasis profi ciency testing program. Qualiris programs include routine (PT, APTT, Fibrinogen, and Thrombin Time) hemostasis tests and a wide variety of specialty tests including D-dimer, unfractionated heparin, low molecular weight heparin, factor assays and thrombophilia assays. Qualiris also offers a diagnostic challenge module for use as competency testing to satisfy continuing education requirements.Qualiris is an easy to use, web-based system which provides monthly, biannual, and annual reports with quantitative and qualitative statistics. Contact your sales representative for more information and to set up a custom comparison group.

IQC (Internal Quality Control)

Clarity Check Peer Program by Stago is a comprehensive quality control management program that offers peer comparison with the ability to create custom peer groups, pre-loaded reagent and QC lot information, 24/7 secure web based program with no need for additional hardware or software, and fl exible report types to review monthly and cumulative data to monitor assay accuracy and precision.

Core Programs

85145 Clarity Check Peer ProgramClarity Check is a comprehensive quality control management program that offers:• peer comparison with the ability use create custom peer groups• pre-loaded reagent and QC lot information• 24/7 secure web based program with no need for additional hardware or software• fl exible report types to review monthly and cumulative data

01044 Qualiris QC Premium Semester 1Monthly external quality assessment of PT, APTT, Fibrinogen, Thrombin Time.

12 x 1 mL

01045 Qualiris QC Premium Semester 2Monthly external quality assessment of PT, APTT, Fibrinogen, Thrombin Time.

12 x 1 mL

Optional Add-On Programs

85093 Qualiris QC Premium FactorsMonthly external quality assessment of Factors II, V, VII, VIII, IX, X, XI, XII, & VWF.

85094 Qualiris QC Premium ThrombophiliaMonthly external quality assessment of Antithrombin, Protein C,Protein S, Plasminogen, Antiplasmin.

01047 Qualiris QC Heparin HBPM / LMWHExternal quality assessment of low molecular weight heparins. (6 times per year)

6 x 1 mL

01048 Qualiris QC Heparin HNF / UFHExternal quality assessment of unfractionated heparin.(6 times per year)

6 x 1 mL

01049 Qualiris QC D-dimerExternal quality assessment of D-dimer. (6 times per year)

6 x 1 mL

01063 Qualiris QC Lupus AnticoagulantExternal quality assessment of lupus anticoagulant.(3 times per year)

3 x 1 mL

01050 Qualiris Diagnostic ChallengeCompetency assessment with unassayed sample and a Clinical Case History for CE credit.(3 cases per year)

6 x 1 mL

Section 13

19

Stago Added Value on Request (SAVOR™)

SAVO™ (Stago Added Value on Request) offers tailored solutions for training, inventory management and other services to enhance productivity and effi ciency. For additional details related to logistics and pricing contact your Stago Account Manager.

Basic Operator TrainingTraining at our Parsippany, New Jersey facility is included with each new instrument purchased. Price includes transportation, hotel, meals and training materials for in-house train-the-trainer implementation.

Following the completion of this course, participants will be able to:• Recognize analyzer hardware• Prepare and load consumables/reagents• Complete practice runs included in the training materials• Understand the software• Perform user maintenance functions on the analyzer

CAT. NO. INSTRUMENTS

08416 STA Compact Max® & STA Compact®

08417 STA R Max® & STA-R Evolution®

Stago Added Value on Request (SAVORSection 14


Stago Added Value on Request (SAVOR™) cont.

Reagent Application Technical Support

08427 On-Site Technical Assistance

The Stago Technical Support Specialist will assist with adding a test parameter to a Stago instrument. Assistance could include test set-up, method validation, running test samples, and data collection and analysis.

Stago Inventory Management

08431 Inventory Management and Shipping

Stago often receives requests for customized inventory management solutions, including sequestering of products that typically would not be sequestered. A nominal fee is to charged for this customized solution.

Requirements include:• Hard copy purchase order with specifi ed quantity• Shipping schedule including beginning and end dates

Lab AutomationThe STA R Max® and STA-R Evolution® can be integrated into a lab automation line. To accomplish the connection, a connection kit and/or additional accessory items may be required. A Stago automation consultant is available to answer questions and assure a smooth transition.

CAT. NO. ACCESSORIES

80182 Kit TLA Type 2 Roche (STA-R Evolution®)

80950 Kit TLA Ortho Engen (STA-R Evolution®)

88517 Kit TLA Type 1 Universal (STA-R Evolution®)

88541 Ramp and Adjustment (STA R Max® and STA-R Evolution®)

89031 Kit TLA Type 1 Universal (STA R Max®)

89032 Kit TLA Type 1 Ortho Engen (STA R Max®)

89033 Kit TLA Type 2 Roche (STA R Max®)

Section 14

21


Method Validation

Standard Service: Accurate method validation is key to maintaining standardization and quality of results. In depth training and tools are provided during the new instrument training program. Standard method validation services include telephone support by your Stago Technical Support Specialist for review of protocols,to answer questions, and to provide fi nal data review.

SAVOR Method Validation Service: For customers who would prefer to have a Stago Technical Support Specialist on-site to coordinate and perform method validation, the Technical Support Specialist will run the tests, collect data, perform data analysis and provide an electronic data presentation.

CAT. NO. DAYS OF ON-SITE SUPPORT SERVICE DESCRIPTION

08428 3 Routine Assays: PT, APTT, Fib, TT, D-dimer

08429 4 Routine + Specialty Assays

CAT. NO. DESCRIPTION

85080 Method Validation Binder: For customers without access to a network enabled computer, Stago provides the convenience of a paper report.

Lot Conversion

Lot Conversion/Simple Method Validation (eg. a single test parameter)

Lot Conversion: For customers who would prefer to have a Stago Technical Support Specialist on-site to perform a lot conversion, the Technical Support Specialist will run the tests, collect data, perform data analysis and provide an electronic data presentation.

Method Validation: A Stago Technical Support Specialist will be on-site for one full day to perform method validation studies. Prior to arrival, the Technical Support Specialist will work with the lead coagulation technologist/key operator to develop the plan for sample requirements and time management. The Technical Support Specialist will schedule a time to be present to run samples, generate data and complete the process.

CAT. NO. DAYS OF ON-SITE SUPPORT SERVICE DESCRIPTION

08430 1 Routine Assay Lot Conversion

Lot Conversion Analysis

A Stago Technical Support Specialist will receive data generated by the lab via email, fax or other locally acceptable means of sharing data. The Technical Support Specialist will load the data into the appropriate template, review data for outliers, and provide a report back to the customer.

CAT. NO. SERVICE DESCRIPTION

08434 TSS Assistance: Lot Conversion Analysis

Stago Added Value on Request (SAVORSection 14



Preventive Maintenance on DemandPreventive Maintenance on Demand is designed for customers who have a backup instrument that does not include a service contract. The Stago Field Service Group will perform a preventative maintenance program which includes decontamination of the instrument, general cleaning, instrument calibration, replacement of fi lters, and a biological test for precision. Price includes travel, parts and labor.

CAT. NO. INSTRUMENT SERVICE DESCRIPTION

85075 STA Compact Max® & STA Compact® Preventative Maintenance

85076 STA R MAX® & STA-R Evolution® Preventative Maintenance

Instrument DecommissionA Stago Field Service Engineer will decontaminate your retired coagulation instrument and remove the hard drive in compliance with local regulatory and HIPAA requirements.

CAT. NO. SERVICE DESCRIPTION

85077 Decommission

85078 Decommission and return instrument to Stago for disposal

85079 Special visit to perform decommission procedure

Section 14

23

Thrombin Generation Research Products(Research Use only, not for use in diagnostic procedures)


Instrument

86186 Calibrated Automated Thrombogram®

The Calibrated Automated Thrombogram® (CAT) measuresthe concentration of thrombin generated over time in clotting plasma using either platelet poor or platelet rich plasma. The CAT corrects for substrate consumption, the inner fi lter effect and color differences between plasmas by running a calibrator with every patient sample. The CAT provides a description of hyper- as well as hypo-activity of the clotting system.

Thermo Electron Fluoroskan Ascent AnalyzerComputerThrombinoscope SoftwareOperator’s reference manualDongleFilters: 1 - 390 nm, 1- 460 nm

Reagents

86192 Thrombin CalibratorCorrects for substrate consumption, the inner fi lter effect and color differences between plasmas, which is necessary for use in parallel with each sample.

20 x 16 tests

86193 PPP ReagentUsed with platelet poor plasma for general applications using the CAT System.

20 x 16 tests

86194 PPP Reagent LOWUsed with platelet poor plasma and has a high sensitivity to Factors VIII, IX and XI. This reagent increases sensitivity in hemophiliac plasma.

20 x 16 tests

86195 PPP Reagent HIGHUsed with platelet poor plasma when thrombin generation is strongly inhibited. This reagent increases sensitivity in plasmas containing anticoagulants such as heparin.

20 x 16 tests

86196 PRP ReagentUsed with platelet-rich plasma for thrombin generation measurements. PRP-Reagent can also be used in platelet-poor plasma to determine the presence of phospholipids and to examine the activity of phospholipid microparticles.

20 x 16 tests

86197 FluCa KitSpecifi c fl uorogenic substrate and buffer suitable for thrombin generation.

10 x 16 tests

86222 MP ReagentUsed with platelet-free plasma and is specifi cally sensitive to circulating Tissue Factor present on the surface of procoagulant microparticles.

20 x 16 tests

Disposables & Accessories

86175 Immulon Round Bottom plate, 2HB 50/box

86176 Dispensing Tip1 replacement tip for use with dispenser tip assembly of Calibrated Automated Thrombogram (CAT) instrument.

1 tip

86191 Thrombinoscope PackageTrombinoscope Software and dongle for running thrombin generation experiments via the Calibrated Thrombogram (CAT) platform. The Thrombinoscope Package can be purchased separately if the user already has a Fluoroskan Ascent® FL or Ascent® instrument along with a desktop computer with a RS232 serial port connection available.

1 Thrombinoscope software and 1 dongle

Thrombin Generation Research Products(Research Use only, not for use in diagnostic procedures)

Section 15


Ecarin Chromogenic Assay (ECA) Products(Research Use only, not for use in diagnostic procedures)


01108 STA®-ECA IIQuantitative determination of dabigatran in plasma samples by the Ecarin Chromogenic Assay (ECA) method.

2 x 3.5 mL Prothrombin Reagent2 x 2 mL Substrate2 x 2 mL Ecarin Reagent

01109 STA®-Dabigatran CalibratorCalibration plasmas for dabigatran measurement using Ecarin Chromogenic Assay method.

2 x 1 mL vials of Calibrator 02 x 1 mL vials of Calibrator 12 x 1 mL vials of Calibrator 22 x 1 mL vials of Calibrator 32 x 1 mL vials of Calibrator 4

01110 STA®-Dabigatran ControlControl plasmas for dabigatran measurement using Ecarin Chromogenic Assay method.

3 x 1 mL Vials of Control 13 x 1 mL Vials of Control 2

Section 16

25

Flow Cytometry Research Products(Research Use only, not for use in diagnostic procedures)


Flow Cytometry research kits from BioCytex

00111 Platelet Gp Receptors 5 tests

The PLT Gp/Receptors kit allows precise quantitation of GpIIb, GpIb and GMP140 glycoproteins on platelet surfaces in the resting state and after TRAP (Thrombin Receptor Agonist Peptide) activation for detection of constitutive thrombopathies, including Glanzmann Thrombasthenia, Bernard Soulier syndrome, Fechtner syndrome, X-linked thrombocytopenia, and Gray platelet syndrome.

00112 Platelet Gpllb/llla Occupancy 10 tests

Single color fl ow cytometric analysis of the GpIIb/IIIa glycoprotein receptor for testing of occupancy by various anti-GpIIb/IIIa drugs including abciximab (Reopro®), eptifi batide (Integrilin®), or tirofi ban (Aggrastat®).

00418 Platelet Gp Screen 10 tests

Single color fl ow cytometric analysis of the platelet glycoproteins GpIIIa, GpIb and GpIa.

00420 Megamix 50 tests

For standardizing microparticle setup within a given analysis region (0.5-1 μm) and providing setting stability.

00452 Platelet PAlg Kit 10 tests

For dual color fl ow cytometric analysis of Platelet Associated Immunoglobulins (PAIg).

00457 Platelet Calibrator 5 curves

Calibration kit for the measurement of platelet glycoprotein expression level or any other human platelet surface molecules.

01000 Cellquant PNH 12 tests

For analysis of defi ciencies of CD55 and CD59 on the granulocyte surface for the purpose of analyzing samples from patients suspected of Paroxysmal Nocturnal Haemoglobinuria (PNH).

01001 Cellquant Calibrator 5 curves

Calibration kit for the measurement of human leukocyte surface antigen expression level by multiple color analysis.

01003 Redquant PNH 12 tests

For analysis of defi ciencies of CD55 and CD59 on the red blood cell surface for the purpose of analyzing samples from patients suspected of Paroxysmal Nocturnal Haemoglobinuria (PNH).

01077 Megamix-Plus FSC 50 tests

For standardizing microparticle setup within a given analysis region (0.3-1 µm) and providing setting stability. Designed for use with newer generation forward scatter (FSC)-optimized fl ow cytometer models such as the Gallios® or Navios® from Beckman Coulter.

01078 Megamix-Plus SSC 50 tests

For standardizing microparticle setup within a given analysis region (0.3-1 µm) and providing setting stability. Designed for use with newer generation forward scatter (SSC)-optimized fl ow cytometer models from Becton Dickinson.

Section 17

27

Flow Cytometry Research Products (continued)(Research Use only, not for use in diagnostic procedures)


Monoclonal antibodies for fl ow cytometry from BioCytex

01005 Fibrinogen, clone 9F9, FITC 100 tests

01006 CD146, clone COM3D9, purifi ed 100 tests

01007 CD146, clone COM2F6, purifi ed 100 tests

01008 CD146, clone COM5G6, purifi ed 100 tests

01009 CD146, clone COM7A4, Biotin 100 tests

01010 CD146, clone COM7A4, FITC 100 tests

01012 CD146, clone S-Endo 1, Biotin 100 tests

01013 CD146, clone S-Endo 1, FITC 100 tests

01015 CD146, clone S-Endo 1, PE 100 tests

01016 CD61, clone 4F8, FITC 100 tests

01017 CD61, clone 4F8, purifi ed 100 µg

01018 Ctl. neg. lgG1 - FITC (2DNP2H11) 100 tests

01019 Ctl. neg. lgG1 purifi ed (2DNP2H11) 100 µg

01020 Ctl. neg. lgG1 - PE (2DNP2H11) 100 tests

01021 CD62P, clone LYP20, FITC 100 tests

01022 CD62P, clone LYP20, purifi ed 100 µg

01023 CD62P, clone LYP20, PE 100 tests

01024 CD41, clone PL2-49, FITC 100 tests

01025 CD41, clone PL2-49, purifi ed 100 µg

01026 CD41, clone PL2-49, PE 100 tests

01027 CD42b, clone ALMA 19, FITC 100 tests

01028 CD42b, clone ALMA 19, purifi ed 100 µg

01029 CD42b, clone ALMA 19, PE 100 tests

01030 CD36, clone 10.5, FITC 100 tests

01031 CD36, clone 10.5, purifi ed 100 µg

Flow Cytometry Research Products (Research Use only, not for use in diagnostic procedures)

Section 17


Flow Cytometry Research Products (continued)(Research Use only, not for use in diagnostic procedures)


Monoclonal antibodies for fl ow cytometry from BioCytex

01032 CD36, clone 10.5, PE 100 tests

01033 CD32, clone 2B2, purifi ed 100 µg

01034 Ctl. neg. lgG2b-FITC (2DNP14G5) 100 tests

01035 Ctl. neg. lgG2b purifi ed (2DNP14G5) 100 µg

01036 Ctl. neg. lgG2b PE (2DNP14G5) 100 tests

01037 Ctl. neg. lgG2a-FITC (2DNP16C12) 100 tests

01038 Ctl. neg. lgG2a purifi ed (2DNP16C12) 100 µg

01039 Ctl. neg. lgG2a - PE (2DNP16C12) 100 tests

01040 CD61, clone LYP18, FITC 100 tests

01041 CD61, clone LYP18, purifi ed 100 µg

01042 CD61, clone LYP18, PE 100 tests 100 µg

01083 Anti-human GPVI, purifi ed 100 µg

01084 Anti-human GPVI, PE 100 tests

01148 CD146, clone COM7A4, purifi ed 100 µg

01149 CD146, clone S-Endo 1, purifi ed 100 µg

Section 17

29

Research Kits(Research Use only, not for use in diagnostic procedures)


00261 Asserachrom® Total TFPIQuantitative determination of total Tissue Factor Pathway Inhibitor (TFPI) by ELISA method, 96 tests.

3 x 2 Coated Strips3 x 2 mL vials of Anti-Total TFPI-Peroxidase6 tablets of Ortho-Phenylenediamine2 x 50 mL bottles of Dilution Buffer1 x 50 mL bottle of Washing Solution3 x 0.5 mL vials of Total TFPI Calibrator3 x 0.5 mL vials of Total TFPI Control1 Plate Frame; 1 Plate Cover6 tablets of Urea Peroxide

00262 Asserachrom® Free TFPIQuantitative determination of free Tissue Factor Pathway Inhibitor (TFPI) by ELISA method, 96 tests.

3 x 2 Coated Strips3 x 2 mL vials of Anti-Free TFPI-Peroxidase6 tablets of Ortho-Phenylenediamine6 tablets of Urea Peroxide2 x 50 mL bottles Dilution Buffer1 x 50 mL bottle of Washing Solution3 x 0.5 mL vials of Free TFPI Calibrator3 x 0.5 mL vials of Free TFPI Control1 Plate Frame; 1 Plate Cover

00264 Asserachrom® sEPCRQuantitative determination of soluble Endothelial Protein C Receptor by ELISA method, 96 tests.

3 x 2 Coated Strips3 x 8 mL vials of Anti-sEPCR-Peroxidase3 x 8 mL vials of TMB3 x 50 mL bottles of Dilution Buffer1 x 50 mL bottle of Washing Solution3 x 0.5 mL vials of sEPCR Calibrator3 x 0.5 mL vials of sEPCR Control1 Plate Frame; 1 Plate Cover

00265 Asserachrom® Anti-Prothrombin IgG,MSemi-quantitative determination of anti-prothrombin antibodies of IgG and/or IgM class by ELISA method, 96 tests.

3 x 2 Coated Strips3 x 4 mL vials of Anti-IgG-Peroxidase3 x 4 mL vials of Anti-IgM-Peroxidase3 x 8 mL vials of TMB3 x 50 mL bottles of Dilution Buffer1 x 50 mL bottle of Washing Solution3 x 2 mL vials of Anti-Prothrombin IgG,M Calibrator3 x 2 mL vials of Control 13 x 2 mL vials of Control 21 Plate Frame; 1 Plate Cover

00276 Asserachrom® Soluble GPVQuantitative determination of soluble Glycoprotein V by ELISA method, 96 tests.

3 x 2 Coated Strips3 x 8 mL vials of Anti-sGPV-Peroxidase3 x 8 mL vials of TMB3 x 50mL bottles of Dilution Buffer1 x 50 mL bottle of Washing Solution3 x 0.5 mL vials of sGPV Calibrator3 x 0.5 mL vials of sGPV Control1 Plate Frame; 1 Plate Cover

00280 Asserachrom® VIII:AgQuantitative determination of Factor VIII Antigen by ELISA method, 96 tests.

3 x 2 Coated Strips3 x 8 mL vials of Anti- F.VIII:Ag-Peroxidase3 x 8 mL vials of TMB3 x 50mL bottles of Dilution Buffer1 x 50 mL bottle of Washing Solution3 x 0.5 mL vials of F. VIII:Ag Calibrator3 x 0.5 mL vials of F. VIII:Ag Control1 Plate Frame; 3 Adhesive Films

00281 Staclot® VIIa-rTFClotting assay of activated Factor VII, 20 tests.

2 x 2 mL vials of Buffer2 x 1 mL vials of F. VII Defi cient Plasma2 x 1 mL vials of rsTF-Phospholipids2 x 0.5 mL vials of F. VIIa Calibrator2 x 0.5 mL vials of F. VIIa Control 12 x 0.5 mL vials of F. VIIa Control 2

Research Kits(Research Use only, not for use in diagnostic procedures)

Section 18


Research Kits (continued)


00346 STA®-Stachrom® TAFIQuantitative determination of thrombin activable fi brinolysisinhibitor activity, Chromogenic Assay, 60 tests.

2 x 2 mL vials of TAFI Activator2 x 2 mL vials of Substrate4 x 4 mL vials of Carboxypeptidase A2 x 1 mL vials of TAFI Calibator2 x 1 mL vials of TAFI Control

00429 STA®-Procoag-PPLClot-based assay for the detection of procoagulant phospholipids by STA® analyzer, 60 tests.

3 x 1 mL vials of P-PPL Depleted plasma3 x 4 mL vials of F.Xa, ~0.040 IU/vial3 x 1 mL vials of P-PPL Control N3 x 1 mL vials of P-PPL Control P

00491 Asserachrom® Vlla-ATQuantitative determination of the FVlla-AT complex by ELISA method, 96 tests.

3 x 2 Coated Strips3 x 8 mL vials of Anti-AT-Peroxidase3 x 8 mL vials of TMB3 x 50 mL Bottles of Sample Buffer3 x 15 mL vials of Dilution Buffer3 x 0.5 mL vials of Vlla-AT Calibrator3 x 0.5 mL vials of Vlla-AT Control1 Plate Frame; 1 Adhesive Film1 x 50 mL bottle of Washing Solution

00581 Liatest® C4b-BPQuantitative determination of C4b-BP by Immuno-turbidimetric measurement, 60 tests.


00616 Asserachrom® TAFIa/TAFIaiQuantitative determination of TAFIa/TAFIai by ELISA method, 96 tests.

3 x 2 Coated Strips3 x 8 mL vials of Anti-TAFIa/TAFIai-Peroxidase3 x 8 mL vials of TMB3 x 50 mL Bottles of Dilution Buffer1 x 50 mL Bottle of Washing Solution3 x 0.5 mL vials of TAFIa/TAFIai Calibrator3 x 0.5 mL vials of TAFIa/TAFIai Control1 Plate Frame; 1 Plate Cover

00704US STA®-Rivaroxaban CalibratorCalibration plasmas for rivaroxaban measurement using chromogenic anti-Xa Method.

3 x 1 mL vials of Calibrator 13 x 1 mL vials of Calibrator 23 x 1 mL vials of Calibrator 33 x 1 mL vials of Calibrator 4

00706US STA®-Rivaroxaban ControlControl plasmas for rivaroxaban measurement using chromogenic anti-Xa Method.

3 x 1 mL vials of Control 13 x 1 mL vials of Control 2

00851 Stachrom® Heparin Cofactor IIChromogenic assay of heparin cofactor II activity, 60 tests.

6 x 2 mL vials of Thrombin6 x 2 mL vials of Substrate1 x 15 mL bottle of Buffer

Section 18

31

Research Kits (continued)(Research Use only, not for use in diagnostic procedures)


00955 Asserachrom® VII:AgQuantitative determination of Factor VII:Ag by ELISA method, 96 tests.

3 x 2 Coated Strips3 x 8 mL vials of Anti-VII:Ag Peroxidase3 x 8 mL vials of TMB3 x 50 mL vials Dilution Buffer1 x 50 mL vial Washing Solution3 x 0.5 mL vials of F. VII:Ag Calibrator3 x 0.5 mL vials of F. VII:Ag Control1 Plate Frame1 Plate Cover

00956 Asserachrom® X:AgQuantitative determination of Factor X:Ag by ELISA method, 96 tests.

3 x 2 Coated Strips3 x 8 mL vials of Anti-X:Ag Peroxidase3 x 8 mL vials of TMB3 x 50 mL vials Dilution Buffer1 x 50 mL vial Washing Solution3 x 0.5 mL vials of F. X:Ag Calibrator3 x 0.5 mL vials of F. X:Ag Control1 Plate Frame1 Plate Cover

01004 Cy-Quant CD146For the determination of soluble CD146 (sCD146, S-ENDO 1, MUC 18, melanoma cell adhesion molecule) in plasma and serum, by ELISA method, 96 tests.

3 x 2 Coated Strips3 vials of Calibrator1 vial of Stop Solution1 vial of TMB1 vial of Washing solution1 vial of Dilution buffer1 vial of Anti CD146-peroxidase1 vial of Control plasma1 Plate Frame

01111 STA®-Apixaban ControlControl plasmas for apixaban measurement using chromogenic anti-Xa Method.

3 x 1 mL vials of Control 13 x 1 mL vials of Control 2

01112 STA®-Apixaban CalibratorCalibration plasmas for apixaban mesurement chromogenic anti-Xa Method.

3 x 1 mL vials of calibrator 13 x 1 mL vials of calibrator 23 x 1 mL vials of calibrator 33 x 1 mL vials of calibrator 4

Research Kits (Research Use only, not for use in diagnostic procedures)

Section 18


Research Components(Research Use only, not for use in diagnostic procedures)


Purifi ed Proteinsa

00461 Purifi ed VWF 100 µg

00462 Purifi ed Factor X 20 Plasma Equivalent Units (PEU), approx 200 μg

00463 Purifi ed Heparin Cofactor II 1 Plasma Equivalent Units (PEU), approx 100 μg

00519 Purifi ed Fibrinogen 8 mg

00557 Purifi ed Prothrombin 5 Plasma Equivalent Units (PEU), approx 500 μg

00828 Purifi ed APC 10 μg

00888 Purifi ed AT III 150 μg

00896 Purifi ed Thrombin 1000 NIH Units

00912 Purifi ed Factor Xa 10 μg

Chromogenic Substratesb

00811 CBS 31.39 (Substrate for Factor Xa) 1 vial, 7.5 μMoles

00873 CBS 34.47 (Substrate for Thrombin) 1 vial, 7.5 μMoles

Venoms and Inhibitorsb

00823 Ecarin 1 vial, 50 Ecarin Units (EU)

00830 r-Hirudin 1 vial, 2,000 r-Hirudin Antithrombin Units (ATU)

b All chromogenic substrates, venoms and inhibitors are freeze-dried.a Purifi ed proteins are freeze-dried and are from human sources.

Section 19

33

Abbreviations ABBREVIATION NAME ABBREVIATION NAME

α2-AP Alpha-2-Antiplasmin GPO Group Purchasing Organization

ACA Anticardiolipin Antibodies GPV Glycoprotein V

APA Antiphospholipid Antibody(ies) HBPM Héparines de bas poids moléculaire(French designation for LMWH)

APC Activated Protein C HPIA Heparin-PF4 Induced Antibodies

APTT Activated Partial Thromboplastin Time LA Lupus Anticoagulants

AT Antithrombin LMWH Low Molecular Weight Heparin

AT:Act Antithrombin Activity N+ABN Normal and Abnormal

AT:Ag Antithrombin Antigen N+P Normal and Pathologic

CaCl2 Calcium Chloride OPD Ortho-phenylenediamine

DIC Disseminated Intravascular Coagulation PAI 1 Plasminogen Activator Inhibitor 1

DSI Diagnostica Stago Inc PC Protein C

ELISA Enzyme-Linked Immunosorbent Assay PF4 Platelet Factor 4

Fib Fibrinogen PIVKA Protein Induced by Vitamin K Antagonists

FDP Fibrinogen Degradation Products PNP Pooled Normal Plasma

FII Factor II or Prothrombin PS Protein S

FOB Free On Board PT Prothrombin Time

FSE Field Service Engineer PTT-LA LA Sensitive APTT

FV Factor V TAFI Thrombin Activable Fibrinolysis Inhibitor

FVII Factor VII TFPI Tissue Factor Pathway Inhibitor

FVIII Factor VIII TMB Tetra Methyl Benzidine

FIX Factor IX TSS Technical Support Specialist

FX Factor X TT Thrombin Time

FXI Factor XI UFH Unfractionated Heparin

FXII Factor XII VWD Von Willebrand Disease

FM Fibrin Monomer VWF Von Willebrand Factor


Fibrinogen

Plasminogen Plasmin Fibrin

FDPD-Dimer

tPA

V

II

PSAPC

ATPAI-1

Activation pathways Inhibition pathways

Coagulation

Fibrinolysis

PSAPC

PAI-1

AT

AT

AT

TF

TFPITFPI

PSAPC

PSAPC

PC

ActivatedPlateletXaVa

IXa

AT

IIa

XaXa

IIa

TM

vWF

XI VIIIa VIII

IXXIa

X

VIIa AT

H E M O S T A S I S

AT THE HEART OF HEMOSTASIS

Terms & Conditions of Sale

FOR REAGENTS, DISPOSABLES & ACCESSORIES

Ordering information:Please reference your customer number when placing all orders. Orders are accepted by Stago Canada Ltd. Customer Care Line: • By fax: 1-973-426-9460 • By telephone: 1-888-283-0175 • By email: [email protected] through Friday: 8:30 a.m. to 5:00 p.m. (Eastern Time)

By mail, please refer all orders to: Stago Canada Ltd. Attn: Sales Department 251 Consumers Rd., Suite 1200 Toronto, Ontario M2J 4R3 Canada

Application:These Terms and Conditions of Sale supersede any terms specified in the purchase order placed by Customer or related correspondence. Any additions, modifications or deletions made to these Terms and Conditions of Sale shall be null and void unless approved in writing by Stago Canada. The failure or delay of Stago Canada to enforce any of these Terms and Conditions of Sale shall not be deemed to be a waiver by Stago Canada of any such terms.

Payment:The prices for the Products are those indicated in Stago Canada’s price lists in effect at the time the order is placed by Customer. A minimum purchase of $50 per order is required. Terms of payment are net 30 days from the date of Stago Canada’s invoice. Payments shall be made either by check mailed to Stago Canada Ltd. T46267, P.O. Box 46267, Postal Station A, Toronto, ON M5W 4K9 - Canada or by ACH (Automated Clearing House), at Customer’s option. Customer shall report any incorrect billing to Stago Canada’s Sales Administration Department within 15 days after the delivery of invoice.Customer shall pay all taxes, federal goods and services, provincial and local. In addition, Customer agrees to reimburse Stago Canada on demand for any taxes, fines, or penalties paid by Stago Canada on behalf of Customer. Stago Canada will not bill third party providers for such payments. Stago Canada reserves the right, in addition to all other remedies available, at its sole discretion and without prior notice (i) to suspend deliveries of Products and to reject any new orders made unless and until payment in full is made by Customer of all outstanding amounts due to Stago Canada and (ii) to charge interest on past due amounts at a rate of one and one half percent per month (eighteen percent per annum) from the due date until paid, compounded monthly, and the maximum amount permitted by law.

Delivery:All shipments are F.O.B. Origin, freight prepaid and added to the invoice. UPS is the carrier of Products for Stago Canada. Delivery of the Products shall be deemed to have occurred at the earlier of: (1) the date the Products are handed over to the first carrier, or (ii) in case of an unsuccessful attempt at shipment, 2 business days following the sending of notice to Customer stating that Products are at Customer’s disposal at Stago Canada’s shipping point.

Sequestering:Reagents to be sequestered (by storing a pre-established quantity of a single lot of Reagent) are determined by Stago Canada based on Customer’s sequestering request. Sequestering will require a hard copy Purchase Order indicating line item quantity and a specified delivery schedule including beginning and end dates. First delivery of sequestered Reagents cannot be less than 30 days from the date of the sequestering request.

Returns:Customer may not return Reagents ordered in error. Returns will not be accepted or a credit issued without prior approval and a Return Authorization Number assigned by a Sales Administration Representative. Please call 1-888-283-0175, Menu option 3. Two categories of returns will be accepted: 1) Products shipped in error by Stago Canada, and 2) Analyzer parts, disposables, or accessories, ordered in error by Customer may be returned provided a Return Authorization number is assigned by a Sales Administration Representative, the item is returned in the original unopened packaging, and received undamaged. However, in category 2), Customer will be charged a 35% restocking fee. In order to receive replacement Product or credit, the following criteria must be met: The problem must be reported within 30 working days from the date stated on the Product invoice; returned Product must be in the same condition as it was received; no returns will be accepted after 30 days from the date on the Product invoice. Please send all returns indicating the Return Authorization number on the outside of the package to:

Stago Canada Ltd / Stago Canada Ltée.Return’s Department

Distribution Warehouse330 Waterloo Valley Road

Mount Olive, NJ 07828 USA

Limited Warranty:

Each of the Products shall be free from defects in material and workmanship and shall conform to Stago Canada’s specifications as specified in the package insert when delivered by Stago Canada. Subject to Stago Canada’s acceptance of the non-conformity of the Products delivered, the warranty for defective Products is strictly limited to the replacement free of charge of the corresponding Products. EXCEPT TO THE EXTENT OF THE LIMITED WARRANTY SPECIFICALLY SET FORTH IN THIS ARTICLE, AND NOTWITHTANDING ANY PROVISION TO THE CONTRARY CONTRAINED HEREIN OR IN ANY OTHER DOCUMENT, NO WARRANTY OR GUARANTEE, EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FITNESS IS MADE FOR A PARTICULAR PURPOSE OR USE, IS MADE. In no event shall Stago Canada, its employees or its suppliers be liable for lost profits or any special, indirect, incidental, consequential, or exemplary damages, irrespective of whether attributable to contract, warranty, negligence, strict liability, or otherwise.

Choice of Law & Dispute Resolution:These Terms and Conditions of Sale shall be governed by and interpreted under the law of the Province of Ontario and the federal laws of Canada applicable therein, without reference to conflict of law provisions. For greater certainty, application of the Sales of Goods Act (Ontario) and the United Nations Convention on Contracts for the International Sale of Goods is excluded from this document. Any action at law or in equity of any kind arising directly, indirectly, or otherwise in connection with, out of, related to, or from these Terms and Conditions of Sale or the relationship between the parties shall be litigated only in the courts located in the City of Toronto, Province of Ontario, Canada and the parties waive any right they may have to challenge the jurisdiction of this court or seek to bring any action in any other forum, whether originally or by transfer, removal, or change of venue. The losing party in any lawsuit shall pay its own and the prevailing party’s attorney’s fees and expenses.


Anti-human GPVI, PE .....................................................29Anti-human GPVI purified ...............................................29Asserachrom® Anti-Prothrombin IgG, M ........................30Asserachrom® APA IgG, M .............................................14Asserachrom® APA Screen.............................................14Asserachrom® D-Di ........................................................15Asserachrom® Free Protein S .........................................13Asserachrom® Free TFPI.................................................30Asserachrom® PAl- 1 ......................................................16Asserachrom® Protein C .................................................13Asserachrom® sEPCR .....................................................30Asserachrom® Soluble GPV. ...........................................30Asserachrom® Total Protein S.........................................13Asserachrom® Total TFPI ................................................30Asserachrom® tPA ..........................................................16Asserachrom® VII:Ag ......................................................32Asserachrom® VIII:Ag .....................................................30Asserachrom® VWF:Ag ..................................................16Asserachrom® VWF:FVIIIB .............................................16Asserachrom® X:Ag ........................................................32Asserachrom® ß-TG .......................................................17Asserachrom® HPIA (ELISA) ..........................................12Asserachrom® IX:Ag .......................................................11Asserachrom® PF4 .........................................................17Calibrated Automated Thrombogram® ...........................24CBS 31.39 ......................................................................33CBS 34.47 ......................................................................33CD146, clone COM2F6, purified ...................................28CD146, clone COM3D9, purified ..................................28CD146, clone COM5G6, purified ..................................28CD146, clone COM7A4, Biotin ......................................28CD146, clone COM7A4, FITC ........................................28CD146, clone COM7A4, purified ...................................29CD146, clone S-Endo 1, Biotin ......................................28CD146, clone S-Endo 1, FITC ........................................28CD146, clone S-Endo 1, PE ...........................................28CD146, clone S-Endo 1, purified ...................................29CD32, clone 2B2, purified .............................................29CD36, clone 10.5, FITC ..................................................28CD36, clone 10.5, PE .....................................................29CD36, clone 10.5, purified .............................................28CD41, clone PL2-49, FITC..............................................28CD41, clone PL2-49, PE.................................................28CD41, clone PL2-49, purified ........................................28CD42b, clone ALMA 19, FITC ........................................28CD42b, clone ALMA 19, PE ...........................................28CD42b, clone ALMA 19, purified ...................................28CD61, clone 4F8, FITC ...................................................28CD61, clone LYP18, FITC ...............................................29CD61, clone LYP18, PE ..................................................29

CD61, clone LYP18, purified ..........................................29CD61, clone 4F8, purified ..............................................28CD62P, clone LYP20, FITC .............................................28CD62P, clone LYP20, PE ................................................28CD62P, clone LYP20, purified ........................................28Cellquant calibrator .........................................................27Cellquant PNH ................................................................27Coag Norm® ...................................................................17Coag Path®......................................................................17Ctl. Neg. lgG1 - FITC (2DNP2H11) .................................28Ctl. Neg. lgG1 - PE (2DNP2H11) ....................................28Ctl. Neg. lgG1 - purified (2DNP2H11) ............................28Ctl. Neg. lgG2a PE (2DNP16C12) ..................................29Ctl. Neg. lgG2a purified (2DNP16C12) ..........................29Ctl. Neg. lgG2a - FITC (2DNP16C12) .............................29Ctl. Neg. lgG2b - FITC (2DNP14G5) ..............................29Ctl. Neg. lgG2b PE (2DNP14G5) ...................................29Ctl. Neg. lgG2b purified (2DNP14G5) ...........................29Cy-Quant VASP/P2Y12 ..................................................17D-Di Test® .......................................................................15Dispensing Tip ................................................................24Ecarin Chromogenic Assay (ECA) ...................................25Etaloquick® .....................................................................18External Quality Assessment Program ............................19F.S. Test ...........................................................................15F.S. Test Unit....................................................................15FDP Plasma .....................................................................15FDP Plasma Buffer ..........................................................15FDP Plasma Latex ...........................................................15Fibrinogen, clone 9F9, FITC ............................................28FluCa Kit ..........................................................................24FS/FDP Plasma Test Cards .............................................15Halogen Lamp ..................................................................7Internal Quality Control Peer Program ...........................19 Immulon Round Bottom plate, 2HB................................24Liatest® AT III ..................................................................13Liatest® C4b-BP ..............................................................31Liatest® Protein S ............................................................12Megamix .........................................................................27Miscellaneous Parts .........................................................8MP Reagent ....................................................................24PAlg kit ............................................................................27Platelet Calibrator ............................................................27Platelet GP Receptors .....................................................27Platelet Gp Screen ..........................................................27Platelet gpllb/llla Occupancy ..........................................27Polyethylene Glycol ........................................................18Pool Norm ......................................................................14 PPP Reagent HIGH .........................................................24PPP Reagent LOW ..........................................................24

Main Index ITEM PAGE(S) ITEM PAGE(S)

37

PPP Reagent ...................................................................24PRP Reagent ...................................................................24PTT-LA ............................................................................14Purified ß2-GP1 ..............................................................33Purified APC ...................................................................33Purified AT III ..................................................................33Purified Factor X .............................................................33Purified Factor Xa ............................................................33Purified Fibrinogen .........................................................33Purified Heparin Cofactor II ............................................33Purified Thrombin ...........................................................33Purified VWF ...................................................................33r-Hirudin .........................................................................33Redquant PNH ................................................................27STA®-Apixaban Calibrator ...............................................32STA®-Apixaban Control ...................................................32STA®-Rivaroxaban Calibrator...........................................31STA®-Rivaroxaban Control ..............................................31STA®-C.K. Prest 5 ...........................................................10STA®-CaCl2 ......................................................................18STA®-Cleaner Solution ....................................................18STA® -Coag Control N + ABN Plus .................................17STA®-Coag Control N + P ...............................................17STA Compact Max® Coagulation System .........................4STA Compact Max® Coag System with Cap Piercing .......4STA®-Control LA 1 + 2 ....................................................18STA®-Deficient II .............................................................11STA®-Deficient IX ............................................................11STA®-Deficient V . ...........................................................11STA®-Deficient VII . .........................................................11STA®-Deficient VIII ..........................................................11STA®-Deficient X .............................................................11STA®-Deficient XI ............................................................11STA®-Deficient XII ...........................................................11STA®-Desorb U ...............................................................18STA®-Fibrinogen 5 ..........................................................10STA®-FM Calibrator & Control ........................................15Stago Added Value on Request (SAVOR). .......................20STA®-HBPM/LMWH Control ..........................................18STA®-Hepanorm H. .........................................................18STA®-Hepanorm® HBPM/LMWH ...................................18STA®-Heparin Control .....................................................18STA®-Liatest® Control N + P . .........................................17STA®-Liatest® D-Di .........................................................15STA®-Liatest®-FM ............................................................15STA®-Liatest® Free Protein S ...........................................12STA®-Liatest® VWF:Ag ....................................................16STA®-Multi Hep Calibrator ..............................................18 STA®-Neoplastine ® CI 5 .................................................10

STA®-Neoplastine ® CI Plus 10 .......................................10STA®-Neoplastine ® CI Plus 5 .........................................10STA®-Owren-Koller Buffer...............................................18STA®-Procoag - PPL ........................................................31STA®-PTT Automate 5.....................................................10STA®-Quality HBPM/LMWH...........................................18STA®-Reptilase ................................................................10STA®-Liquid Anti-Xa 4 .....................................................12STA®-Liquid Anti-Xa 8 .....................................................12STA® Satellite® Hemostasis System .................................5STA®-Stachrom® Antiplasmin .........................................16STA®-Stachrom® AT III ....................................................13STA®-Stachrom® AT III 6 .................................................13STA®-Stachrom® Plasminogen ........................................16STA®-Stachrom® Protein C .............................................13STA®-Stachrom® TAFI .....................................................31STA®-Staclot® DRVV Confirm .........................................14STA®-Staclot® DRVV Screen 2 ........................................14STA®-Staclot® DRVV Screen 5 ........................................14STA®-Staclot® Protein C ..................................................13STA®-Staclot® Protein S ..................................................13STA®-System Control N + P ............................................17STA®-Thrombin 10 ..........................................................10STA®-Thrombin 2 ............................................................10STA®-Unicalibrator ..........................................................18STA®-VWF:Ag Calibrator ................................................18STA-R Evolution® Expert Series ........................................3Hemostasis SystemSTA-R Evolution® Expert Series Hemostasis ....................3System with Cap PiercingSTA-R Evolution®, STA Compact Max® and ................... 7-8STA Satellite® Disposables and AccessoriesStachrom® Heparin .........................................................12Stachrom® Heparin Cofactor II .......................................31Stachrom® PAI ................................................................16Staclot® LA......................................................................14Staclot® VIIa-rTF .............................................................30STart® Disposables and Accessories................................8STart® Hemostasis Analyzer .............................................6Test cards for D-Di Test kit ..............................................15 Thrombin Calibrator ........................................................24

Main Index ITEM PAGE(S) ITEM PAGE(S)


Notes

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$60.00

$40.00

$20.00

$ 0.00

CASE POINTinPatient is admitted with deep vein thrombophlebitis.

USA

1From CMS FY2013 Geometric Mean LOS for DRG 295.2Costs taken from Vandiver JW, Vondracek TG. Antifactor Xa levels versus APTT for monitoring heparin. Pharmacother 2012; 32: 546-58.3Guervil DJ, Rosenberg AF, Winterstein AG, Harris NS, Johns TE, Zumberg MS. Activated partial thromboplastin time versus antifactor Xa

heparin assay in monitoring unfractionated heparin by continuous intravenous infusion. Ann Pharmacother 2011;45:861–8.4Assumes a nomogram with testing every 6 hours while dosing until therapeutic & 24 hours thereafter.

*Contingent on assumptions per reference 4. **Institutional costs include lab and nursing costs.

Total Hours to Reach Therapeutic Range3

In the same 84 hour hospital stay, the mean time spent getting patients into the therapeutic range using Anti-Xa is faster than aPTT.

Time is critical Fewer dosage changesPatients spend more time in the therapeutic range with fewer dosage changes when using the Anti-Xa assay.

aPTTAnti-Xa

Lab costs matter By using Anti-Xa, fewer lab tests4, and therefore fewer lab labor hours, are needed to reach the patient’s therapeutic range, thus saving time and money over each patient’s hospital stay.

Institutional Cost Breakdown

aPTTAnti-Xa$29.84$26.27

The bottom line: you can save up to 24.1 % when using Anti-Xa to get patients into the therapeutic range.

1 2

3

Overall Institutional** Impact 4

§ Length of Stay (LOS) = 3.5 days (84 hours)1

§ Anti-Xa reagent cost per test = $ 2.552

§ aPTT reagent cost per test = $ 0.652

§ Lab labor cost per either test = $ 3.082

§ Nursing labor cost per dosage change = $ 2.582

When considering ALL costs involved in anticoagulant monitoring, Anti-Xa may provide greater cost efficiency compared to aPTT methods*.

8.004.67Anti-Xa

aPTT28

48

Number of Dosage Changes

Total Lab Cost to Reach Therapeutic Range

aPTTAnti-Xa

$20.64$12.04

Lab Cost (Reagent & Labor) to Reach Therapeutic Range

Nursing Cost to Reach Therapeutic Range

$60.00

$40.00

$20.00

$ 0.00 $29.84$26.27

©2013 Diagnostica Stago, Inc. All rights reserved. DSI 29578 eff. 12/2013

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