Substrates P400 En

8/10/2019 Substrates P400 En

1/111


2/111

Albumin CP

ABX Pentra

S.A.S. au capital de 41.700.000 - RCS Montpellier 328 031 042 - SIRET 328 031 042 000 42 - APE 332 B Latest version documents on www.horiba.com

Waste ManagementPlease refer to local legal requirements.

General Precautions1. Reagent, for professional in-vitrodiagnostic use only.

2. The reagent cassettes are disposable and should be disposed of in

accordance with the local legal requirements.

3. Please refer to the MSDS associated with the reagent.

Performance on ABX Pentra 400The performance data listed below have been obtained on the ABX

Pentra 400 analyser.

Number of tests: 327 tests.

On board Reagent Stability:

Once opened, the reagent cassette placed in the refrigerated ABX

Pentra 400 compartment is stable for 83 days.

Sample volume: 2 l/test

Detection limit:

The detection limit is determined according to the Valtec protocol (6)

and equals 2.9 mol/l.

Accuracy and Precision:

Repeatability (within-run precision)

3 specimens of low, medium and high concentration and 2 controls aretested 20 times according to the recommendations found in the Valtec

protocol (6).

Reproducibility (run-to-run precision)

2 specimens of low and high levels and 2 controls are tested in

duplicate for 20 days (2 series per day) according to therecommendations found in the NCCLS, EP5-A protocol (7).

Linearity and Measuring Range:

The reagent linearity is determined according to the recommendations

found in the NCCLS, EP6-P protocol (8).

Low linearity: 2.9 mol/l

High linearity: 909 mol/l, with automatic post-dilution: 1818 mol/l.

Correlation:

59 patient samples are correlated with a commercial reagent taken as

reference according to the recommendations found in the NCCLS, EP9-

A2 protocol (9).

The equation for the allometric line obtained is:

Y = 0.95 x + 22 with a correlation coefficient r = 0.992.

Interferences:

Conversion factora:

mol/l x 0.066 = g/l

mol/l x 0.0066 = g/dl

Calibration stabilityb:

The reagent is calibrated on Day 0. The calibration stability is checked

by testing 2 control specimens.

The calibration stability is at least 14 days.

Note: A recalibration is recommended when reagent lots change, and

when quality control results fall outside the range established.

Application release: 4.xx

WarningIt is the user's responsibility to verify that this document is applicable

to the reagent used.

Reference1. Doumas B. et al., Watson. W, Ard and Biggs H.G. Albumin

standards and the measurement of serum albmin with bromocresol

green, Clin. Chim. Acta, 31, (1971), 87.

2. Doumas B. T. and Biggs H.G., Determination of serum albumin

Standard Methods of Clinical Chemistry, Acad. Press N.Y., 7,

(1972), 175.

3. Drupt F., Dosage de lalbumine srique par le vert de bromocrsol

Pharm. Biol., 9, (1974), 777.4. Metais P. Biochimie Clinique. Tome 3: Biochimie fonctionnelle:

Srum Albumine. Paris: Simep; 1988:107.

5. Doumas BT., PETERS T Jr. - Serum and urine albumin albumin: a

progress report on their measurement and clinical significance.

Clin. Chim. Acta., 258(1), (1997), 3-20.

6. Vassault A., Grafmeyer D. Naudin C. et al., Protocole de validation

de techniques (document B), Ann. Biol. Clin., 1986, 44, 686-745.

7. Evaluation of Precision Performance of Clinical Chemistry Devices,

Approved Guideline, NCCLS document EP5-A, Vol. 19, No. 2,

february 1999.

Mean value mol/l CV %

Normal control 514 0.6

Pathological control 506 0.8

Specimen 1 349 0.4

Specimen 2 629 0.5

Specimen 3 848 0.8




Specimen 1 357 1.66

Specimen 2 643 1.85

Haemoglobin: No significant influence is observed up to 232 mol/l

Triglycerides: No significant influence is observed up to 7 mmol/l

Total Bilirubin: No significant influence is observed up to 616 mol/l

Direct Bilirubin: No significant influence is observed up to 616 mol/l

a. Modification from index I to J: correction of conversion factor.b. Modification from index I to J: modification of calibration stability.


3/111

Albumin CP

ABX Pentra


8. Evaluation of the Linearity of Quantitative Analytical Methods,

Proposed Guideline, NCCLS document EP6-P, Vol. 6, No. 18,

september 1986.

9. Method Comparison and Bias Estimation Using Patient Samples,

Approved Guideline, 2nded., NCCLS document EP9-A2, Vol. 22, No.

19, 2002.

10. Johnson, A.M., Rohlfs, E.M., Silverman, L.M., Proteins, Tietz

Fundamentals of Clinical Chemistry, 5thEd., Burtis, C.A., Ashwood,

E.R., (W.B. Saunders eds. Philadelphia USA), (2001), 325.


4/111

Albumin CP

ABX Pentra



5/111

Bilirubin, Direct CP

ABX Pentra

2007/08/27A93A00122H EN

A11A01635

24 ml

7 ml

HORIBA ABX

BP 729034184 Montpellier- cedex 4 - France

S.A.S. au capital de 41.700.000- RCS Montpellier 328 031 042 - SIRET 328 031 042 000 42 - APE 332 B Latest version documents on www.horiba-abx.com

ABX Pentra Bilirubin, Direct CPRef.: A11A01635Volume R1: 24 mlVolume R2: 7 ml

Diagnostic reagent for quantitative in-vitrodetermination of direct Bilirubin in serumand plasma.

Clinical Interest (1,2)Bilirubin is a breakdown product of hemoglobin. Free, unconjugated

bilirubin is extremely apolar and nearly insoluble in water, thus

forming a complex with albumin for the transport in the blood from

the spleen to the liver. In the liver, bilirubin is conjugated with

glucoronic acid and the resulting water soluble bilirubin glucoronicacid is excreted via the bile ducts.

Hyperbilirubinemia can be caused by increased bilirubin production due

to hemolysis (pre-hepatic jaundice), by parenchymal damages of the

liver (intra-hepatic jaundice) or by occlusion of bile ducts (post-hepatic

jaundice). A chronic congenital (predominantly unconjugated)

hyperbilirubinemia called Gilberts syndrome is quite frequent in the

population. High levels of total bilirubin are observed in 60-70% of

neonates due to an increased postpartal breakdown of erythrocytes and

because of delayed function of enzymes for bilirubin degradation.

Common bilirubin methods detect either total bilirubin or direct

bilirubin. Determinations of direct bilirubin measure mainly conjugated,

water soluble bilirubin. Unconjugated bilirubin can therefore be

estimated as the difference between total bilirubin and direct bilirubin.

MethodPhotometric test using 2,4-dichloroaniline (DCA).

Direct bilirubin in presence of diazotized 2,4-dichloroaniline forms a

red colored azocompound in acidic solution.

ReagentsABX Pentra Bilirubin, Direct CPis ready-to-use.

ABX Pentra Bilirubin, Direct CP should be used according to thisreagent notice. HORIBA ABX cannot guarantee its performance if used

otherwise.

Handlinga

Remove both caps of the cassette. If present, remove foam by using a

plastic pipette.

Position the respective protective cap, ref. GBM0969 on R1 and Ref.

GBM0970 on R2 and place in the refrigerated ABX Pentra 400 reagent

compartment.

Reagent 1: EDTA-Na2 0.1 mmol/l

NaCl 9 g/l

Sulfamic acid 100 mmol/l

Reagent 2: 2,4-Dichlorophenyl-diazonium salt 0.5 mmol/l

HCl 700 mmol/l

EDTA-Na2 0.13 mmol/l

a. Modification from index G to H: new handling.

CalibratorFor calibration, use:

ABX Pentra MultiCal, Ref. A11A01652 (not included)10 x 3 ml (lyophilisate)

Control

For internal quality control, use:ABX Pentra N Control, Ref. A11A01653 (not included)10 x 5 ml (lyophilisate)

ABX Pentra P Control, Ref. A11A01654 (not included)10 x 5 ml (lyophilisate)

Each control should be assayed daily and/or after each calibration.

The frequency of controls and the confidence intervals should

correspond to laboratory guidelines and country-specific directives.

The results must be within the range of the defined confidence limits.

Each laboratory should establish a procedure to follow if the results

exceed these confidence limits.

Materials required but not provided

Automated clinical chemistry analyser NaCl solution: 9 g/l

Standard laboratory equipment.

Specimen Serum.

Heparin Plasma.

It is very important to store the sample protected from light.

Freeze only once.

Stability: 2 days at 15 - 25 C

7 days at 2 - 8 C

3 months at - 20 C in case of immediate freezing.


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ABX Pentra


Reference range (1)Adults and children:0 - 0.2 mg/dl (0 - 3.4 mol/l).

Storage and StabilityReagents, in unopened cassettes, are stable up to the expiry date on

the label if stored at 2 - 8 C protected from light and contamination

is avoided.

Stability after opening : refer to the paragraph Performance on ABX

Pentra 400.

Do not freeze the reagents.

Assay Procedure

Test instructions for other automated systems than ABX Pentra 400 areavailable on request.


General Precautions1. This reagent is for professional in-vitrodiagnostic use only.

2. Take the necessary precautions for the use of laboratory reagents.






Number of tests: 100 tests

On board Reagent Stabilitya:Once opened, the reagent cassette placed in the refrigerated ABX



Detection limit:The detection limit is determined according to the Valtec protocol (4)

and equals 0.69 mol/l.

Accuracy and Precision: Repeatability (within-run precision)

3 specimens of low, medium and high concentration and 2 controls are

tested 20 times according to the recommendations found in the Valtec

protocol (4).



duplicate for 20 days (2 series per day) according to the

recommendations found in the NCCLS, EP5-A protocol (5).

Linearity and Measuring Range:The reagent linearity is determined according to the recommendations

found in the NCCLS, EP6-P protocol (6).Low linearity: 0.69 mol/l


Correlation:100 patient samples are correlated with a commercial reagent taken as


A2 protocol (7).


Y = 0.92 x + 0.58 with a correlation coefficient r2= 0.9899.

Interferences:

Conversion factor:mol/l x 0.584 = mg/l

mol/l x 0.0584 = mg/dl

Calibration stabilityb:The reagent is calibrated on Day 0. The calibration stability is checked





Application release

c

: 3.xx

WarningIt is the users responsibility to verify that this document is applicable


Reference1. Thomas L. ed. Clinical Laboratory Diagnostics. 1sted. Frankfurt:

TH-Books Verlagsgesellschaft, 1998; 192-202.

2. Tolman K.G., Rej R. Liver function. In: Burtis C.A., Ashwood E.R.,

editors. Tietz Textbook of Clinical Chemistry. 3rded. Philadelphia:

W.B Saunders Company; 1999. p. 1125-1177.

a. Modification from index G to H: new on board reagent stability.


Normal control 15.3 0.67

Pathological control 31.6 0.44

Specimen 1 4.0 3.23

Specimen 2 25.9 0.59

Specimen 3 134.6 2.69






Haemoglobin: Do not use haemolysed samples.

Triglycerides: No significant influence is observed up to 7 mmol/l.

b. Modification from index G to H: modification of calibration stability.c. Modification from index F to G: suppression of minor index.


7/111


ABX Pentra


3. Rand R.N., di Pasqua A. A new diazo method for the determination

of bilirubin. Clin. Chem. 1962; 6:570-8.4. Vassault A., Grafmeyer D. Naudin C. et al., Protocole de validation

de techniques (document B), Ann. Biol. Clin., 1986, 44, 686-745.5. Evaluation of Precision Performance of Clinical Chemistry Devices,


february 1999.



september 1986.



19, 2002.


8/111


ABX Pentra



9/111

Bilirubin, Total CP

ABX Pentra

2009/10/21A93A00112O EN

A11A01639

44 ml

14 ml

HORIBA ABX SAS



ABX Pentra Bilirubin, Total CPRef.: A11A01639Volume R1: 44 mlVolume R2: 14 ml

Intended Use

Diagnostic reagent for quantitative in-vitrodetermination of total Bilirubin in serum and plasmaof adults and neonates.

Clinical Interest (1,2)Bilirubin is a breakdown product of hemoglobin. Free, unconjugated

bilirubin is extremely apolar and nearly insoluble in water, thus

forming a complex with albumin for the transport in the blood from

the spleen to the liver. In the liver, bilirubin is conjugated with

glucoronic acid and the resulting water soluble bilirubin glucoronidesare excreted via the bile ducts.

Hyperbilirubinemia can be caused by increased bilirubin production

due to hemolysis (pre-hepatic jaundice), by parenchymal damages of

the liver (intra-hepatic jaundice) or by occlusion of bile ducts (post-

hepatic jaundice). A chronic congenital (predominantly unconjugated)

hyperbilirubinemia called Gilberts syndrome is quite frequent in the

population. High levels of total bilirubin are observed in 60-70% of

neonates due to an increased postpartal breakdown of erythrocytes

and because of delayed function of enzymes for bilirubin degradation.

Common bilirubin methods detect either total bilirubin or direct

bilirubin. Determinations of direct bilirubin measure mainly

conjugated, water soluble bilirubin. Unconjugated bilirubin can

therefore be estimated as the difference between total bilirubin and

direct bilirubin.

Method (3)Photometric test using 2,4-dichloroaniline (DCA).

Direct bilirubin in presence of diazotized 2,4-dichloroaniline forms a

red colored azocompound in acidic solution. A specific mixture of

detergents enables a safe determination of the total bilirubin.

ReagentsABX Pentra Bilirubin, Total CPis ready-to-use.

ABX Pentra Bilirubin, Total CP should be used according to thisreagent notice. The manufacturer cannot guarantee its performance if

used otherwise.

HandlingRemove both caps of the cassette, place in the refrigerated ABX Pentra

400 reagent compartment.

If present, remove foam by using a plastic pipette.

Reagent 1:Phosphate buffer 50 mmol/l

NaCl 9 g/l

Detergent, stabilizersReagent 2:2,4-Dichlorophenyl-diazonium salt 5 mmol/l

HCl 130 mmol/l

Detergent



Control

For internal quality control, use:ABX Pentra N Control, Ref. A11A01653 (not included)10 x 5 ml (lyophilisate)ABX Pentra P Control, Ref. A11A01654 (not included)10 x 5 ml (lyophilisate)







Materials required but not provided Automated clinical chemistry analyser: ABX PENTRA 400 Calibrator: ABX Pentra Multical, Ref. A11A01652 Controls: ABX Pentra N Control, Ref. A11A01653, and

ABX Pentra P Control, Ref. A11A01654 NaCl solution 9 g/l


Specimen Serum.

Plasma in lithium heparin.


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Bilirubin, Total CP

ABX Pentra


Stability (1,10):

1 day at 20-25C

7 days at 4-8C

6 months at -20C

It is very important to store the sample protected from light!

In the case of intensive sun irradiation: decrease in total bilirubin by

up to 30% after 1 hour.

Reference range (1)Each laboratory should establish its own reference ranges. The values

given here are used as guidelines only.


the label if stored at 2 - 8 C and contamination is avoided.


Pentra 400.Do not freeze the reagents.

Assay ProcedureTest instructions for other automated systems than ABX Pentra 400 are

available on request (not available in the USA).




3. The reagent cassettes are disposable and should be disposed of inaccordance with the local legal requirements.





On board Reagent Stability:Once opened, the reagent cassette placed in the refrigerated ABX



Limits:Limit of blank:

The limit of blank is determined according to CLSI (NCCLS), EP17-A

protocol (8) and equals 1.09 mol/l.

Limit of detection:

The detection limit is determined according to CLSI (NCCLS), EP17-A

protocol (8)and equals 1.49 mol/l.

Limit of quantitation:The limit of quantitation is determined according to CLSI (NCCLS),

EP17-A protocol (8) and equals 2.4 mol/l.


4 specimens of very low, low, medium and high concentration and 2

controls are tested 20 times according to the recommendations found

in the Valtec protocol (4).

Reproducibility (total precision)

3 specimens of low, medium and high levels and 2 controls are tested

in duplicate for 20 days (2 series per day) according to the

recommendations found in the CLSI (NCCLS), EP5-A protocol (5).

Measuring Range:The assay confirmed a measuring range in serum and plasma from 2.4

to 450.0 mol/l, providing an upper linearity of 450.0 mol/l, with an

automatic post-dilution up to 1350 mol/l.


found in the CLSI (NCCLS), EP6-A protocol (6)

Correlation (adult samples):101 patient samples (serum)are correlated with a commercial reagent

taken as reference according to the recommendations found in the

CLSI (NCCLS), EP9-A2 protocol (7). Values ranged from 5.6 to 441.8

mol/l.

mg/dl mol/l

Neonates:

24 hours: < 8.7 < 150

2nd day: 1.3 - 11.3 22 - 193

3rd day: 0.7 - 12.7 12 - 217

4th - 6th day: 0.1 - 12.6 2 - 216

Adults: 0.1 - 1.2 2 - 21


Control specimen 1 16.59 2.14


Specimen 1 10.34 3.09

Specimen 2 14.57 2.23Specimen 3 37.65 1.33

Specimen 4 142.82 0.83


Control specimen 1 17 4.04

Control specimen 2 94 1.70

Specimen 1 13.62 5.97

Specimen 2 48.96 2.78Specimen 3 156.13 2.20


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Bilirubin, Total CP

ABX Pentra


The equation for the allometric line obtained using Passing-Bablock

regression procedure (9)is:

Y = 1.03 x - 2.43 mol/l with a correlation coefficient r2= 0.9965.

Correlation (neonatal samples):112 patient samples (serum) are correlated with a commercial reagent



mol/l.


regression procedure (9) is:

Y = 0.95 X + 0.085 mol/l with a correlation coefficient r2= 0.993.

Interferences:

Other limitations are given by Young as a list of drugs and preanalytical

variables known to affect this methodology (11,12).

Calibration stability:The reagent is calibrated on Day 0. The calibration stability is checked







Software version: 4.4 - Application release: 7.xx

Software version: 5.0 - Application release: 8.xx

Warning

It is the users responsibility to verify that this document is applicableto the reagent used.

Reference1. Thomas L. ed. Clinical Laboratory Diagnostics. 1sted. Frankfurt:

TH-Books Verlagsgesellschaft, 1998. p 192-202.

2. Tolman K.G., Rej R. Liver function. In: Burtis C.A., Ashwood E.R.,

editors. Tietz Textbook of Clinical Chemistry. 3rded. Philadelphia:

W.B Saunders Company; 1999. p. 1125-77.

3. Rand R.N., di Pasqua A. A new diazo method for the determination

of bilirubin. Clin. Chem. 1962; 6:570-8.4. Vassault A., Grafmeyer D. Naudin C. et al., Protocole de validation



february 1999.


Approved Guideline, CLSI (NCCLS) document EP6-A, Vol. 23, No.

16, april 2003.


Approved Guideline, 2nded., CLSI (NCCLS) document EP9-A2, Vol.

22, No. 19, 2002.

8. Protocols for determination of limits of detection and limits of

quantitation, Approved Guideline, CLSI (NCCLS) document EP17-A,

Vol. 24, No. 34, 2004.

9. Passing H., Bablock W. A new biometrical procedure for testing the

equality of measurements from two different analytical methods.

J. Clin. Chem. Clin. Biochem. 1983; 21: 709-20.

10. Use of Anticoagulants in Diagnostics Laboratory Investigations.

WHO Publication WHO/DIL/LAB/99.1 rev.2, 2002.

11. Young D.S., Effects of Drugs on Clinical Laboratory Tests, 4th

Edition, Washington, DC, AACC Press, 1995, 3: 143-163.

12. Young D.S., Effects of Preanalytical Variables on Clinical

Laboratory Tests, 2ndEdition, Washington, DC, AACC Press, 1997,

3: 120-132.

Haemoglobin: No significant influence is observed up to 500 mg/dl

(290 mol/l).

Triglycerides: No significant influence is observed up to 612.5 mg/dl

(7 mmol/l).


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13/111

Calcium AZ III CP

ABX Pentra

2008/09/09A93A01221A EN


A11A01894

79 ml

HORIBA ABX

BP 729034184 Montpellier - cedex 4 - France

ABX Pentra Calcium AZ III CPRef.: A11A01894Volume R1: 79 mlVolume R2: 1 x 5 ml

Intended use

Diagnostic reagent for quantitative in-vitrodetermination of Calcium in serum, plasma andurine.

Clinical Interest (1,2,3)Calcium plays an essential role in many cell functions: intracellularly

in muscle contraction and glycogen metabolism, extracellularly, in

bone mineralization, in blood coagulation and in transmission of nerve

impulses. Calcium is present in plasma in three forms: free, bound to

proteins or complexed with anions as phosphate, citrate andbicarbonate. Under physiological conditions, calcium balance is

determined by the relationship between calcium intake and calcium

absorption and excretion. Urinary excretion is an important

determinant of calcium retention in the body.

Decreased total calcium levels can be associated with diseases of the

bone apparatus (especially osteoporosis), kidney diseases (especially

under dialysis), defective intestinal absorption and

hypoparathyroidism.

Increased total calcium can be measured in hyperparathyroidism,

malignant diseases with metastases and sarcoidosis. Calcium

measurements also help in monitoring of calcium supplementation

mainly in the prevention of osteoporosis.

Method (4,5,6,7)Many colourimetric methods for determining calcium have been used

in the past. Connerty and Briggs described methods using alizarin 3-

sulphonate (4)and cresolphthalein complexone (5)whilst Gindler and

King have described a method using thymol blue (6).

There have been many subsequent modifications to these methods.

The method used here is based on the metallochromogen Arsenazo III.

Calcium ions (Ca2+) react with Arsenazo III (2,2-[1,8-Dihydroxy-3,6-

disulphonaphthylene-2,7-bisazo]- bisbenzenearsonic acid) at pH 6.75

to form an intense purple coloured chromophore. The absorbance of

the Ca-Arsenazo III complex is measured bichromaticcally at 660/700

nm. The resulting increase in absorbance of the reaction mixture is

directly proportional to the calcium concentration in the sample.

Arsenazo III has a high affinity (K = 1 x 10-7) for calcium ions (7) andshows no interference from other cations normally present in serum,

plasma or urine.

pH 6.75Ca+++ Arsenazo III Ca-Arsenazo III complex (purple)

ReagentsABX Pentra Calcium AZ III CPis ready-to-use.

ABX Pentra Calcium AZ III CP should be used according to this

reagent notice. HORIBA ABX cannot guarantee its performance if used

otherwise.

HandlingRemove the cap of the cassette. If present, remove foam by using a

plastic pipette. Position the protective cap, ref. GBM0969 and place

the cassette in the refrigerated ABX Pentra 400 reagent compartment.


ABX Pentra MultiCal, Ref. A11A01652 (not included)

10 x 3 ml (lyophilisate)

ControlFor internal quality control, use:

ABX Pentra N Control, Ref. A11A01653 (not included)


ABX Pentra P Control, Ref. A11A01654 (not included)


ABX Pentra Urine Control L/H, Ref. A11A01674 (not included)

1 x 10 ml + 1 x 10 ml

Reagent : Arsenazo III 0.2 mmol/l

Imidazole buffer 100 mmol/l

Sodium azide 0.05%

SurfactantStabilizers

pH 6.75 0.1


14/111


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Calcium AZ III CP

ABX Pentra






protocol (11).



tested 20 times according to the recommendations found in the CLSI

(NCCLS) EP05-A protocol (12).

Measuring Range:

The assay confirmed a measuring range from 0.1 mmol/l to 4.50 mmol/l, providing an upper linearity of 4.50 mmol/l, with an automatic post-

dilution up to 13.50 mmol/l.


found in the CLSI (NCCLS), EP6-A protocol (13).

Correlation:

134 patient samples (serum) are correlated with a commercial reagent



mmol/l.



Y = 0.98 x - 0.02 with a correlation coefficient r2= 0.9958.

Interferences:



Conversion factor:

mmol/l x 40.1 = mg/l

Calibration stability:



The calibration stability is 7 days.




Urine


On board Reagent Stability:

Once opened, the reagent cassette placed in the refrigerated ABX



Detection limit:The detection limit is determined according to CLSI (NCCLS), EP17-A

protocol (10)and equals 0.08 mmol/l.

Limit of quantitation:

The limit of quantitation is determined according to CLSI (NCCLS),

EP17-A protocol (10)and equals 0.25 mmol/l.





protocol (11).

Mean value mmol/l CV %













(500 mg/dl).


(612.5 mg/dl).

(as Intralipid, representative of lipemia)


(23.4 mg/dl).

Direct Bilirubin:No significant influence is observed up to 450 mol/l

(26.3 mg/dl).








16/111

Calcium AZ III CP

ABX Pentra



3 specimens of low, medium and high levels and 2 controls are tested

in duplicate for 20 days (2 series per day) according to the

recommendations found in the CLSI (NCCLS), EP5-A protocol (12).

Measuring Range:

The assay confirmed a measuring range from 0.25 mmol/l to 4.50mmol/l, with an automatic post-dilution up to 13.50 mmol/l.

The reagent linearity has been assessed up to 4.50 mmol/l, in

accordance with CLSI (NCCLS), EP6-A protocol (13).

Correlation:

83 patient samples (urine) are correlated with a commercial reagent



mmol/l.




Interferences:



Conversion factor:mmol/l x 40.1 = mg/l




The calibration stability is 7 days.






Reference1. Thomas L. Clinical Laboratory Diagnostics. 1sted. Frankfurt: TH-

Books Verlagsgesellschaft; 1998. p. 192-202.

2. Endres D.B., Rude R.K. Mineral and bone metabolism. In: Burtis

C.A., Ashwood E.R., editors. Tietz Textbook of Clinical Chemistry.

3rded. Philadelphia: W.B. Saunders Company; 1999. p. 1395-1457.

3. Matkovic V., Llich J.Z.; Andon M.B.; Hsieh L.C., Tzagournis M.A.,

Lagger B.J.; Goel PK., Am. J. Clin. Nutr., 1995, 62(2):417-25.

4. Connerty HV, Briggs AR.: Clin. Chem., 1965; 11: 716-28..5. Connerty HV, Briggs AR.: Am. J. Clin. Path., 1966; 45: 290-6.

6. Gindler EM, Kin JD, Am.: J. Clin. Path., 1972; 58: 376-82.

7. Bauer PJ Anal.: Biochem, 1981; 110: 61-72.

8. NCCLS. Urinalysis and collection, transportation and preservation

of urine specimen; Approved guideline - 2nd Edition, NCCLS

document GP16-A2, Vol.21, No 19.

9. Use of anticoagulants in diagnostic laboratory investigations. WHO

publication WHO/DIL/LAB/99.1 Rev.2, 2002.

10. Protocols for determination of limits of detection and limits of

quantitation, Approved Guideline, CLSI (NCCLS) document EP17-A,

Vol. 24, No. 34, 2004.



12. Evaluation of Precision Performance of Clinical Chemistry Devices,Approved Guideline, CLSI (NCCLS) document EP5-A, Vol. 19, No. 2,

february 1999.


Approved Guideline, CLSI (NCCLS) document EP6-A, Vol. 23, No.

16, april 2003.


Approved Guideline, 2nded., CLSI (NCCLS) document EP9-A2, Vol.

22, No. 19, 2002.

15. Passing H., Bablock W. A new biometrical procedure for testing the

equality of measurements from two different analytical methods.

J. Clin. Chem. Clin. Biochem. 1983; 21: 709-20.

16. Young D.S., Effects of Preanalytical Variables on Clinical

Laboratory Tests, 2nd

Edition, Washington, DC, AACC Press, 1997,3: 120-132.

17. Young D.S., Effects of Drugs on Clinical Laboratory Tests, 4th

Edition, Washington, DC, AACC Press, 1995, 3: 143-163.








(500 mg/dl).


(612.5 mg/dl).

(as Intralipid, representative of lipemia)

Direct Bilirubin:No significant influence is observed up to 438 mol/l

(25.6 mg/dl).

Acidification No significant influence is observed up to pH 2.


17/111

Calcium CP

ABX Pentra

2007/09/06A93A00132N EN

A11A01633

66 ml

16.5 ml

HORIBA ABX



ABX Pentra Calcium CPRef.: A11A01633Volume R1: 66 mlVolume R2: 16.5 ml

Diagnostic reagent for quantitative in-vitrodetermination of Calcium in serum, plasmaor urine.

Clinical Interest (1,2)Calcium plays an essential role in many cell functions: intracellularly




proteins or complexed with anions as phosphate, citrate andbicarbonate. Decreased total calcium levels can be associated with

diseases of the bone apparatus (especially osteoporosis), kidney

diseases (especially under dialysis), defective intestinal absorption

and hypoparathyroidism. Increased total calcium can be measured in

hyperparathyroidism, malignant diseases with metastases and

sarcoidosis. Calcium measurements also help in monitoring of calcium

supplementation mainly in the prevention of osteoporosis.

MethodPhotometric test using ortho-cresolphtalein complexone (OPC).

Cresolphthalein complexone reacts with calcium ions in alkaline

medium forming a red-violet color. Interference by magnesium is

eliminated by addition of 8-hydroxyquinoline.

ReagentsABX Pentra Calcium CPis ready-to-use.

ABX Pentra Calcium CP should be used according to this reagentnotice. HORIBA ABX cannot guarantee its performance if used

otherwise.

HandlingRemove both caps of the cassette. If present, remove foam by using a

plastic pipette. Position the respective protective cap, ref. GBM0969

on R1 and Ref. GBM0970 on R2 and place in the refrigerated ABX

Pentra 400 reagent compartment.



Reagent 1: Ethanolamine pH 10.7 0.75 mol/l

Detergents

Reagent 2: o-Cresolphthalein complexone 0.3 mmol/l

8-Hydroxyquinoline 34.5 mmol/l

Hydrochloric acid pH 1.1 100 mmol/l


ABX Pentra N Control, Ref. A11A01653 (not included)10 x 5 ml (lyophilisate)ABX Pentra P Control, Ref. A11A01654 (not included)10 x 5 ml (lyophilisate)

ABX Pentra Urine Control L/H, Ref. A11A01674 (not included)1 x 10 ml + 1 x 10 ml







Materials required but not provided Automated clinical chemistry analyser


Specimen Serum. heparin Plasma.

Urine.

Do not use EDTA plasma.

Add 10 ml of concentrated HCl to 24 h urine and heat the specimen to

dissolve calcium oxalate.

Stability in: Serum /Plasma: 7 days at 20 - 25 C

3 weeks at 4 - 8 C

8 months at - 20 C

Urine: 2 days at 20 - 25 C

4 days at 4 - 8 C

3 weeks at - 20 C


18/111

Calcium CP

ABX Pentra


Reference range (2)


the label if stored at 2-8C, protected from light, and contamination

is avoided.

Dont allow to stand open, otherwise the pH decreases because of CO2absorption from the air.

Stability after opening: refer to the paragraph Performance on ABX

Pentra 400.



available on request.



2. As calcium is an ubiquitous ion, essential precaution must be taken

against accidental contamination. Only use disposable materials.







Serum, Plasma






and equals 0.04 mmol/l.




protocol (5).


A variance analysis is carried out for 6 days out of 2 specimens of low

and high levels and 2 controls.



Low linearity: 0.04 mmol/l

High linearity: 5 mmol/l

Correlation:100 patient samples are correlated with another method taken as


A2 protocol (8).The equation for the allometric line obtained is:

Y = 0.97 x + 0.03 with a correlation coefficient r2= 0.9907 .

Interferences:

Conversion factor:mmol/l x 40 = mg/l

Calibration stabilitya

:The reagent is calibrated on Day 0. The calibration stability is checked


The calibration stability is 1 day.




Serum / Plasma: 8.6 - 10.3 mg/dl (2.15 - 2.57 mmol/l)

Urine: Women:


19/111

Calcium CP

ABX Pentra


Urine










protocol (5).

Reproducibility (run-to-run precision)2 specimens of low and high levels and 2 controls are tested in





Low linearity: 0.03 mmol/l.High linearity: 6 mmol/l.



A2 protocol (8).



Interferences:

Conversion factor:mmol/l x 40 = mg/l

Calibration stabilitya:The reagent is calibrated on Day 0. The calibration stability is checked


The calibration stability is 1 day.











3. Baginski E.S., Marie S.S., Clark W.L., Zak B. Direct

microdetermination of serum calcium. Clin. Chim. Acta 1973; 46:46-54.

4. Sarkar BCR., Chauhan UPS. A new method of determining microquantities of calcium in biological materials. Anal. Biochem. 1967;

20:155-166.




february 1999.



september 1986.



19, 2002.












Haemoglobin: No significant influence is observed up to 55 mol/l.

a.Modification from index M to N: Modification of calibration stability.


20/111

Calcium CP

ABX Pentra



21/111

Calcium CP

ABX Pentra

Use in reagent rack

2008/04/21A93A01182G EN

A11A01633

66 ml

16.5 ml

HORIBA ABX



ABX Pentra Calcium CP (Rack)Use in reagent rackRef. : A11A01633Volume R1: 66 mlVolume R2: 16.5 ml

Diagnostic reagent for quantitative in-vitrodetermination of Calcium in serum, plasmaor urine.

Clinical Interest (1,2)Calcium plays an essential role in many cell functions: intracellularly




proteins or complexed with anions as phosphate, citrate andbicarbonate. Decreased total calcium levels can be associated with

diseases of the bone apparatus (especially osteoporosis), kidney

diseases (especially under dialysis), defective intestinal absorption

and hypoparathyroidism. Increased total calcium can be measured in

hyperparathyroidism, malignant diseases with metastases and

sarcoidosis. Calcium measurements also help in monitoring of calcium

supplementation mainly in the prevention of osteoporosis.

MethodPhotometric test using ortho-cresolphtalein complexone (OPC).

Cresolphthalein complexone reacts with calcium ions in alkaline

medium forming a red-violet color. Interference by magnesium is

eliminated by addition of 8-hydroxyquinoline.

ReagentsABX Pentra Calcium CPis ready-to-use.

ABX Pentra Calcium CP should be used according to this reagent

notice. HORIBA ABX cannot guarantee its performance if used

otherwise.

HandlingTransfer the required volume of Reagent 1in a container 15, 10 or 4 ml.

Transfer the required volume of Reagent 2in a container 10 or 4 ml.

Reagent 1 and Reagent 2 should be placed on the same reagent rack

sector A, B or C (see diagram below, sector A is taken as an example).

Reagent 1: Ethanolamine pH 10.7 0.75 mol/l

Detergents

Reagent 2: o-Cresolphthalein complexone 0.3 mmol/l

8-Hydroxyquinoline 34.5 mmol/l

Hydrochloric acid pH 1.1 100 mmol/l

Place Reagent 1in position 1 of one available sector using either:

Reagent container 15 ml

Reagent container 10 ml + its specific adaptor


Place Reagent 2in position 2 of same selected sector using either:

Reagent container 10 ml


Place the reagent rack in the refrigerated ABX Pentra 400 reagent

compartment.

Important : Discard the remaining reagent at the end of the day.




ABX Pentra Calcium CPReagent 2

ABX Pentra Calcium CP

Reagent 1


22/111

Calcium CP

ABX Pentra







ABX Pentra Urine Control L/H, Ref. A11A01674 (not included)

1 x 10 ml + 1 x 10 ml









Specimen Serum.

heparin Plasma.

Urine.

Do not use EDTA plasma.

Add 10 ml of concentrated HCl to 24 h urine and heat the specimen to

dissolve calcium oxalate.

Reference range (2)


the label if stored at 2-8C, protected from light, and contamination

is avoided.

Dont allow to stand open, otherwise the pH decreases because of CO2absorption from the air.

Stability after opening: 28 days if the reagents are stored in a capped

cassette between 2 and 8C.






2. As calcium is an ubiquitous ion, essential precaution must be

taken against accidental contamination. Only use disposable

materials.

3. Take the necessary precautions for the use of laboratory reagents.4. The reagent cassettes are disposable and should be disposed of in





Serum, Plasma



Detection limit:

The detection limit is determined according to the Valtec protocol (5)






protocol (5).


A variance analysis is carried out for 6 days out of 2 specimens of low

and high levels and 2 controls.

Stability in: Serum /Plasma: 7 days at 20 - 25 C3 weeks at 4 - 8 C

8 months at - 20 C

Urine: 2 days at 20 - 25 C

4 days at 4 - 8 C

3 weeks at - 20 C

Serum / Plasma: 8.6 - 10.3 mg/dl (2.15 - 2.57 mmol/l)

Urine: Women:


23/111

Calcium CP

ABX Pentra






High linearity: 5 mmol/l

Correlation:

100 patient samples are correlated with another method taken as


A2 protocol (8).


Y = 0.97 x + 0.03 with a correlation coefficient r2= 0.9907 .

Interferences:

Conversion factor:

mmol/l x 40 = mg/l




The calibration stability is 4 hours.



Application releasea: 3.xx

Urine



Detection limit:

The detection limit is determined according to the Valtec protocol (5)and equals 0.03 mmol/l.





protocol (5).








Low linearity: 0.03 mmol/l.

High linearity: 6 mmol/l.

Correlation:


reference according to the recommendations found in the NCCLS, EP9-A2 protocol (8).



Interferences:

Conversion factor:

mmol/l x 40 = mg/l




The calibration stability is 4 hours.



Application releaseb: 3.xx




Triglycerides: No significant influence is observed up to 7 mmol/l.

Total Bilirubin: No significant influence is observed up to 101 mol/l.


a. Modification from index F to G: suppression of minor index.







Mean value mmol/l CV %Normal control 1.64 2.44





b. Modification from index F to G: suppression of minor index.


24/111

Calcium CP

ABX Pentra







3. Baginski E.S., Marie S.S., Clark W.L., Zak B. Direct

microdetermination of serum calcium. Clin. Chim. Acta 1973; 46:

46-54.

4. Sarkar BCR., Chauhan UPS. A new method of determining micro

quantities of calcium in biological materials. Anal. Biochem. 1967;

20:155-166.





february 1999.



september 1986.



19, 2002.


25/111

Cholesterol CP

ABX Pentra

2008/11/17A93A00142K EN


A11A01634

90 ml

HORIBA ABX


ABX Pentra Cholesterol CPRef.: A11A01634Volume: 90 ml

Diagnostic reagent for quantitative in-vitrodetermination of Cholesterol in serum or plasma.

Clinical InterestCholesterol is a component of cell membranes and a precursor for

steroid hormones and bile acids synthesized by body cells and

absorbed with food (1). Cholesterol is transported in plasma via

lipoproteins, namely complexes between lipids and apolipoproteins

(1). There are four classes of lipoproteins: high density lipoproteins(HDL), low density lipoproteins (LDL), very low density lipoproteins

(VLDL) and chylomicrons. While LDL is involved in the cholesterol

transport to the peripheral cells, HDL is responsible for the cholesterol

uptake from the cells. The four different lipoprotein classes show

distinct relationship to coronary atherosclerosis (1). LDL-cholesterol

(LDL-C) contributes to atherosclerotic plaque formation within the

arterial intima and is strongly associated with coronary heart disease

(CHD) and related mortality. Even with total cholesterol within the

normal range an increased concentration of LDL-C indicates high risk.

HDL-C has a protective effect impeding plaque formation and shows an

inverse relationship to CHD prevalence. In fact, low HDL-C values

constitute an independent risk factor. The determination of the

individual total cholesterol (TC) level is used for screening purposes

while for a better risk assessment it is necessary to measure

additionally HDL-C and LDL-C.

In the last few years several controlled clinical trials using diet, life

style changes and / or different drugs (especially HMG CoA reductase

inhibitors [statins]) have demonstrated that lowering total cholesterol

and LDL-C levels reduce drastically CHD risk (2).

MethodCHOD-PAP: enzymatic photometric test.

Determination of cholesterol after enzymatic hydrolysis and oxidation

(3,4). The colorimetric indicator is quinoneimine which is generated

from 4-aminoantipyrine and phenol by hydrogen peroxide under the

catalytic action of peroxidase (Trinders reaction) (3).

(CHE = Cholesterol Esterase, CHO = Cholesterol oxydase, POD = Peroxidase)

Cholesterol ester + H2O Cholesterol + Fatty acidCHE

Cholesterol + O2 Cholesterol-3-one + H2O2CHO

2H2O2+ 4-Aminoantipyrine + Phenol Quinoneime + 4H2OPOD

ReagentsABX Pentra Cholesterol CPis ready-to-use.

ABX Pentra Cholesterol CPshould be used according to this reagent

notice. HORIBA ABX cannot guarantee its performance if used

otherwise.

HandlingRemove the cap of the cassette, place in the refrigerated ABX Pentra

400 reagent compartment.

If present, remove foam by using a plastic pipette.




Reagent: Goods buffer pH 6.7 50 mmol/l

Phenol 5 mmol/l

4-Aminoantipyrine 0.3 mmol/l

Cholesterol esterase (CHE) 200 U/lCholesterol oxidase (CHO) 50 U/l

Peroxidase (POD) 3 kU/l

Sodium azide 0.95 g/l


26/111

Cholesterol CP

ABX Pentra

S.A.S. au capital de 41.700.000 - RCS Montpellier 328 031 042 - SIRET 328 031 042 000 42 - APE 332 B Latest version documents on www.horiba-abx.com














Specimen Serum.

Heparin Plasma or EDTA Plasma.

Reference range (5)

The European Task Force on Coronary Prevention recommends to lower

TC concentration to less than 190 mg/dl (5.0 mmol/l) and LDL-

cholesterol to less than 115 mg/dl (3.0 mmol/l) (2).


the label if stored at 2-8C, protected from light and contamination is

avoided.


Pentra 400.


Note: It has to be mentioned, that the measurement is not influenced

by occasionally occurring color changes, as long as the absorbance of

the reagent is 240 mg/dl (>6.2 mmol/l)






Specimen 3 10.04 0.62







27/111

Cholesterol CP

ABX Pentra





Low linearity: 0.09 mmol/l.

High linearity: 15 mmol/l.

Correlation:



A2 protocol (9).



Interferences:







Conversion factor:

mmol/l x 0.387 = g/l

mmol/l x 38.7 = mg/dl




Reference1. Rifai N., Bachorik P.S., Albers J.J. Lipids, lipoproteins and

apolipoproteins. In: Burtis C.A., Ashwood E.R., editors. Tietz

Textbook of Clinical Chemistry. 3rded. Philadelphia: W.B. Saunders

Company; 1999. p. 809-861.

2. Recommendation of the Second Joint Task Force of European and

other Societies on Coronary Prevention. Prevention of coronary

heart disease in clinical practice. Eur. Heart J. 1998; 19, 1434-

1503.

3. Artiss J.D., Zak B. Measurement of cholesterol concentration. In:

Rifai N., Warnick G.R., Dominiczak M.H., eds. Handbook of

lipoprotein testing. Washington: AACC Press, 1997, 99-114.

4. Deeg R., Ziegenhorn J. Kinetic enzymatic method for automated

determination of total cholesterol in serum. Clin. Chem. 1983; 29,

1798-1802.

5. Schaefer E.J., McNamara J. Overview of the diagnosis and

treatment of lipid disorders. In: Rifai N., Warnick G.R., Dominiczak

M.H., eds. Handbook of lipoprotein testing. Washington: AACC

press, 1997, 25-48.





february 1999.



september 1986.



19, 2002.Haemoglobin: No significant influence is observed up to 195 mol/l




a. Modification from index J to K: new application release.


28/111

Cholesterol CP

ABX Pentra



29/111

CO2RTU

ABX Pentra

2007/07/05A93A00172I EN


A11A01645

2 x 20 ml

HORIBA ABX


ABX Pentra CO2RTURef.: A11A01645Volume: 2 x 20 ml

Diagnostic reagent for quantitative in-vitrodetermination of Bicarbonate / total CO2in serum or plasma.

Clinical Interest (1)Plasmatic bicarbonates are one of the principle buffer of the organism.

Their measurement is used in the diagnosis of the acid-base-balance

in the blood. This balance is based on the Henderson-Hasselbach

equation (pH=pK+log[bicarbonates/apCO2]) which implies that all

compensation mechanisms are intended for maintening the relation(bicarbonates/apCO2) constant.

Elevated and decreased values indicate disorders associated with

disturbances of the metabolic and respiratory systems.

MethodEnzymatic test using phosphoenolpyruvate carboxylase (PEPC) and a

stable NADH analog.

The reaction disturbs following equilibrium:

(PEPC = Phosphoenolpyruvate carbolyxase, MDH = Malate Dehydrogenase)

This results in a conversion of CO2to bicarbonate (HCO3-) which then

is included in the reaction. Therefore the total CO2concentration is

measured.

The decrease of reduced cofactor concentration is measured at 405 nm

and is proportional to the concentration of total carbon dioxide in the

sample.

Reagents

ABX Pentra CO2RTUis ready-to-use.

ABX Pentra CO2RTUshould be used according to this reagent notice.HORIBA ABX cannot guarantee its performance if used otherwise.

Reagent: Buffer pH 7.5

Phosphoenolpyruvate (PEP) 12.5 mmol/l

Phosphoenolpyruvate carboxylase (PEPC) >400 U/l

Malate dehydrogenase (MDH) >4100 U/l

NADH analog 0.6 mmol/l

Activators, stabilizers, surfactant, preservative

Phosphoenolpyruvate + HCO3- Oxaloacetate + H2PO4

-PEPC + Mg2+

Oxaloacetate + Cofactor red. Malate + CofactorMDH

CO2+ H2O H+ + HCO3

-H2CO3

HandlingTransfer the necessary Reagent 1volume for one day of tests into areagent container 15, 10 or 4 ml.

Place Reagent 1in position 1 of one available sector using either: Reagent container 15 ml



Place the reagent rack in the refrigerated ABX Pentra 400 reagent

compartment. Wait for 3 hours to stabilize the reagent.

Important: Discard the remaining reagent at the end of the day.


ABX Pentra CO2Cal, Ref. A11A01648 (not included)3 x 3 ml

ABX Pentra CO2 RTUReagent 1


30/111

CO2RTU

ABX Pentra



ABX Pentra CO2Control, Ref. A11A01650 (not included)3 x 3 ml







Materials required but not provided

Automated clinical chemistry analyser Standard laboratory equipment.

Specimen Serum.

heparin Plasma.

1. Serum or plasma should be separated from cells immediately.

2. Exposure of samples to air should be minimized.

3. Samples should be stored tightly sealed to prevent loss of carbon

dioxide and assayed as soon as possible after collection.

4. Do not use icteric samples.

Reference range (1)Adults:22 - 29 mmol/l (mEq/l).

Storage and StabilityReagents, in unopened vials, are stable up to the expiry date on the

label if stored at 2 - 8 C protected from light and contamination is

avoided.

Once opened, the ABX Pentra CO2RTU reagentis stable for 28 dayswhen stored at 2-8C.

Do not freeze the reagent.






3. The reagent vials should be discarded after use.






Detection limit:The detection limit is determined according to the Valtec protocol (4)and equals 1.8 mmol/l.


3 specimens of low, medium and high concentration and 1 control are


protocol (4).


2 specimens of low and high levels and 1 control are tested in






High linearity: 60.8 mmol/l, with automatic post-dilution: 121.6 mmol/l.

Correlation:

99 patient samples are correlated with a commercial reagent taken asreference according to the recommendations found in the NCCLS, EP9-

A2 protocol (7).



Interferences:








Specimen 1 9.5 7.7







31/111

CO2RTU

ABX Pentra


Calibration stability:The reagent is calibrated on H0. The calibration stability is checked by

testing 2 control specimens.

The calibration stability is 1 day by discarding the remaining reagent

at the end of the day.




Warning

It is the users responsibility to verify that this document is applicableto the reagent used.

Reference1. Mller-Plathe O. Acid base balance and blood gases. In: Thomas L.,

editor. Clinical laboratory diagnostics. 1sted. Frankfurt: T.H. Books

Verlagsgesellschaft; 1998. p.318-329.

2. Norris K.A., Atkinson A.R., Smith W.G. Colorimetric enzymatic

determination of serum total carbon dioxide as applied to the

Vickers multichannel 300 discrete analyser. Clin. Chem. 1975;21;1093-1101.

3. US patent #5,801,006.




february 1999.



september 1986.



19, 2002.

a. Modification from index H to I: suppression of minor index.


32/111

CO2RTU

ABX Pentra



33/111

Creatinine CP

ABX Pentra

2007/07/04A93A00182M EN

A11A01666

28 ml

28 ml

HORIBA ABX



ABX Pentra Creatinine CPRef.: A11A01666Volume R1: 28 mlVolume R2: 28 ml

Diagnostic reagent for quantitative in-vitrodetermination of creatinine in serum,plasma and urine by colorimetry.

Clinical InterestCreatinine is a product of the degradation of the creatine. It is a tiny

nitrogenised molecule eliminated primarily by the kidneys. Under

stable conditions of the muscular mass and proteic contribution,

creatininaemia is an excellent reflection of renal function. The

determination of urinary creatinine permits the calculation ofclarification, which is an independent parameter of diuresis and

proteic contribution.

MethodMeasurement of the formation of a colorimetric complex between the

creatinine and the alkaline picrate (Jaff). The speed of the formation

of this complex is proportional to the creatinine present in the sample.

This kinetic method reduces the effects of interfering substances.

ReagentsABX Pentra Creatinine CPis ready-to-use.

ABX Pentra Creatinine CPshould be used according to this reagentnotice. HORIBA ABX cannot guarantee its performances if used

otherwise.

HandlingRemove both caps of the cassette. If present, remove foam by using a

plastic pipette. Position the respective protective cap, ref. GBM0969

on R1 and Ref. GBM0970 on R2 and place it in the position 45of theABX Pentra 400 reagent compartment.

Important : for a new cassette, wait for 30 minutes to stabilize thetemperature of the reagent.




ABX Pentra N Control, Ref. A11A01653 (not included)10 x 5 ml (lyophilisate)

Reagent 1: Picric acid 8.73 mmol/l

Reagent 2: Sodium hydroxide 312.5 mmol/l

Disodium phosphate 12.5 mmol/l

ABX Pentra P Control, Ref. A11A01654 (not included)10 x 5 ml (lyophilisate)

ABX Pentra Urine Control L/H, Ref. A11A01674 (not included)1 x 10 ml + 1 x 10 ml


The frequency of controls and the confidence intervals shouldcorrespond to laboratory guidelines and country-specific directives.





Standard laboratory equipment

Specimen Serum

Plasma in heparin and EDTA

Fresh centrifuged urine

Reference range(7)

We recommended that each laboratory establishes its own reference

range.

Men Women

Serum/Plasma: 8 - 13 6 - 12 mg/l

0.8 - 1.3 0.6 - 1.2 mg/dl

71 - 115 53 - 106 mol/l

Urine: 0.8 - 2.0 0.6 - 1.8 g/24 h

7.1 - 17.7 5.3 - 15.9 mmol/24 h


34/111

Creatinine CP

ABX Pentra



the label if stored at 2-8 C and protected from light.

Stability opening: refer to the paragraph "Performance on ABX Pentra

400".




General Precautions1. Reagent, for professional in-vitrodiagnostic use only

2. The reagent 2 contains diluted sodium hydroxide and is

consequently irritating to the eyes and the skin. In case of contact

with eyes, rinse generously with water and consult a specialist.

Avoid all contact with the skin; use gloves when handling.






Serum, Plasma


On board Reagent Stability:If the ABX Pentra Creatinine CP cassette is left on board theinstrument at all times, the cassette is stable for 21 days.



and equals 10 mol/l.




protocol (4).


A variance analysis out of 2 specimens of medium and high levels is

carried out (n=30).



Low linearity: 10 mol/l




A2 protocol (6).



Interferences:



Calibration stability:The reagent is calibrated each day.




Urine


On board Reagent Stability:If the ABX Pentra Creatinine CP cassette is left on board theinstrument at all times, the cassette is stable for 21 days.



and equals 200 mol/l.




Specimen 1 53 2.09

Specimen 2 137 0.71

Specimen 3 676 0.39


Specimen 1 111 2.35

Specimen 2 601 1.36





Glucose: No significant influence is observed up to 22.5 mmol/l

a.Modification from index L to M: suppression of minor index.


35/111


36/111

Creatinine CP

ABX Pentra



37/111

Creatinine 120 CP

ABX Pentra

2007/06/28A93A01215C EN


A11A01868

1 x 27 ml

HORIBA ABX


ABX Pentra Creatinine 120 CPTest instructions for Mira instrumentsRef.: A11A01868Volume: 1 x 27 ml

Intended use

Diagnostic reagent for quantitative in-vitrodetermination of creatinine in serum, plasma andurine by colorimetry.

Clinical Interest (1,2)Creatinine, formed in the muscle, is a product of the degradation of

creatine phosphate, a high energy storage component. Creatininaemia

is quite constant (contrary to ureamia), it mainly depends of the

muscular mass. It is not very modified by food diet, age, sex or

exercise. Creatinine is extracted out of plasma by glomerular filtrationand then, eliminated in urine. The determination of urinary creatinine

permits the calculation of clarification, which is an independent

parameter of diuresis and proteic contribution.

Crea

Substrates P400 En

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