enzymes p400 en

8/10/2019 Enzymes p400 En

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2/45

ALP 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

Materials required but not provided Automated clinical chemistry analyser Standard laboratory equipment.

Specimen Serum. heparin plasma.

Loss of activity within 2 - 3 days at 15 - 25 C < 10 %.

Reference range (4,5)Adults:

Children:

Storage and StabilityReagents, in unopened cassettes, are stable up to the expiry date onthe label if stored at 2-8 C protected from light and contamination isavoided.Stability after opening : refer to the paragraph Performance on ABXPentra 400.

Do not freeze the reagents.

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

Waste Management1. Please refer to local legal requirements.2. This reagent contains sodium azide (0.95 g/l) as a preservative. As

sodium azide may react with lead or copper to form explosive metal azides, this reagent should be disposed of by flushing with copiousamounts of water.

General Precautions1. This reagent is for professional in-vitro diagnostic use only.2. Do not swallow! Avoid contact with skin and mucous membranes.3. During reaction p-nitrophenol is produced which is poisonous

when inhaled, swallowed or absorbed through skin. If the reactionmixture comes in contact with skin or mucous membranes washcopiously with water.

4. Take the necessary precautions for the use of laboratory reagents.5. The reagent cassettes are disposable and should be disposed of in

accordance with the local legal requirements.6. Please refer to the MSDS associated with the reagent.

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

Number of tests: 125 tests

Reagent Stability:Use fresh reagent each day. Discard the remaining reagent in containerafter use. Once open, the cassette is stable for 29 days.

Sample volume: 4 l/test

Detection limit:The detection limit is determined according to the Valtec protocol (6)and equals 8 U/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 Valtecprotocol (6) .

Reproducibility (run-to-run precision)2 specimens of medium and high levels and 2 controls are tested induplicate for 20 days (2 series per day) according to therecommendations found in the NCCLS, EP5-A protocol (7) .

Stability : 7 days at 4 - 8 C2 months at - 20 C

37 CWomen [U/l] 35 - 104Men [U/l] 40 - 129

37 C1 day [U/l] < 2502 to 5 days [U/l] < 2316 days to 6 months [U/l] < 4497 months to 1 year [U/l] < 4621 to 3 years [U/l] < 2814 to 6 years [U/l] < 2697 to 12 years [U/l] < 30013 to 17 years (female) [U/l] < 18713 to 17 years (male) [U/l] < 390

Mean value U/l CV %Normal control 98 1,26Pathological control 278 0,80Specimen 1 36 4,01Specimen 2 63 2,11Specimen 3 467 0,60

Mean value U/l CV %Normal control 96 2,75Pathological control 270 2,52Specimen 1 32 6,00Specimen 2 474 2,15


3/45

ALP CP

ABX Pentra


Linearity and Measuring Range:The reagent linearity is determined according to the recommendationsfound in the NCCLS, EP6-P protocol (8) .Low linearity: 8 U/l High linearity: 1825 U/l, with automatic post-dilution: 7300 U/l.

Correlation:95 patient samples are correlated with a commercial reagent taken asreference according to the recommendations found in the NCCLS, EP9-A2 protocol (9) .The equation for the allometric line obtained is:y = x with a correlation coefficient r 2 = 0.9936.

Interferences:

Calibration stability:The calibration stability is 6 hours.

Note: A recalibration is recommended when reagent lots change, and when quality control results fall outside the range established.

Application release a: 9.xx

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

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

Books Verlagsgesellschaft; 1998. p. 36-46.2. Moss DW, Henderson AR. Clinical enzymology. In: Burtis CA,

Ashwood ER, editors. Tietz Textbook of Clinical Chemistry. 3 rd ed.Philadelphia: W.B Saunders Company; 1999. p. 617-721.

3. Tietz NW, Rinker D, Shaw LM. IFCC method for alkalinephosphatase. J. Clin. Chem. Clin. Biochem. 1983; 21:731-748.

4. Abitch K, El-Samalouti V, Junge W, Kroll M, Luthe H, Treskes M etal.. Multicenter evaluation of new GGT and ALP reagents with newreference standardization and determination of 37C referenceintervals. Clin Chem Lab Med 2001; 39, Special Supplement pp S346.

5. Tietz NW, Shuey DF. Reference intervals for Alkaline PhosphataseActivity Determined by IFCC and AACC Reference Methods. ClinChem 1986; 32: 1593-1594.

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

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, 2nd ed., NCCLS document EP9-A2, Vol. 22, No.19, 2002.

Haemoglobin: No significant influence is observed up to 59 mol/l Triglycerides: No significant influence is observed up to 7 mmol/l Total Bilirubin: No significant influence is observed up to 502 mol/l Direct Bilirubin: No significant influence is observed up to 371 mol/l

a. Modification from index P to Q: new application release.


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5/45

ALP CP

ABX Pentra

Form-0846R

ev.2

Use in reagent rack

2007/06/08 A93A00012N EN

A11A01626

26 ml

6.5 ml

HORIBA ABXBP 729034184 Montpellier- cedex 4 - France


ABX Pentra ALP CP (Use in reagent rack)Ref.: A11A01626Volume R1: 26 mlVolume R2: 6.5 ml

Diagnostic reagent for quantitative in-vitro determination of Alkaline Phosphatase (ALP)in serum or plasma.

Clinical Interest (1,2)Alkaline phosphatase (ALP), an hydrolytic enzyme acting optimally atalkaline pH, exists in blood in numerous distinct forms which originatemainly from bone and liver, but also from other tissues as kidney,placenta, intestine, testes, thymus, lung and tumors. Physiological

increases are found during bone growth in childhood and inpregnancy, while pathological increases are largely associated withhepatobiliary and bone diseases. In hepatobiliary disease theyindicate obstruction of the bile ducts as in cholestasis caused by gall stones, tumors or inflammation. Elevated activities are also observedin infectious hepatitis. In bone diseases elevated ALP activitiesoriginate from increased osteoblastic activity as in Pagets disease,osteomalacia (rickets), bone metastases and hyperparathyroidism.

MethodKinetic photometric test, according to the International Federation of Clinical Chemistry (IFCC).

(ALP = Alkaline Phosphatase)

ReagentsABX Pentra ALP CP is ready-to-use.

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

HandlingTransfer the required volume of Reagent 1 in a container 15, 10 or 4ml.Transfer the required volume of Reagent 2 in a container 10 or 4 ml.

Reagent 1 and Reagent 2 should be placed on the same reagent racksector A, B or C (see diagram below, sector A is taken as an example).

Reagent 1 : 2-Amino-2-methyl-1-propanol pH 10.4 440 mmol/l Magnesium sulphate 2.0 mmol/l Zinc sulphate 1.25 mmol/l HEDTA 2.5 mmol/l Sodium azide < 1 g/l

Reagent 2 : p-Nitrophenylphosphate 80 mmol/l Sodium azide < 1 g/l

p-Nitrophenylphosphate + H 2O Phosphate + p-Nitrophenol

ALP

Place Reagent 1 in position 1 of one available sector using either: Reagent container 15 ml Reagent container 10 ml + its specific adaptor Reagent container 4 ml + its specific adaptor

Place Reagent 2 in position 2 of same selected sector using either: Reagent container 10 ml Reagent container 4 ml + its specific adaptor

Place the reagent rack in the refrigerated ABX Pentra 400 reagentcompartment.

Calibrator For calibration, use: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)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.

ABX Pentra ALP CP

Reagent 2

ABX Pentra ALP CP Reagent 1


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ALP CP

ABX Pentra


The frequency of controls and the confidence intervals shouldcorrespond 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 resultsexceed these confidence limits.


Specimen Serum.

heparin plasma.Loss of activity within 2 - 3 days at 15 - 25 C < 10 %.

Reference range (4,5)

Adults:

Children:

Storage and StabilityReagents, in unopened cassettes, are stable up to the expiry date onthe label if stored at 2-8 C protected from light and contamination isavoided.Stability after opening : refer to the paragraph Performance on ABXPentra 400.Do not freeze the reagents.




General Precautions1. This reagent is for professional in-vitro diagnostic use only.2. Do not swallow! Avoid contact with skin and mucous membranes.3. During reaction p-nitrophenol is produced which is poisonous

when inhaled, swallowed or absorbed through skin. If the reaction

mixture comes in contact with skin or mucous membranes washcopiously with water.4. Take the necessary precautions for the use of laboratory reagents.5. The reagent cassettes are disposable and should be disposed of in




Reagent Stability:

Use fresh reagent each day. Discard the remaining reagent in containerafter use. Once open, the cassette is stable for 29 days.




Stability : 7 days at 4 - 8 C2 months at - 20 C

37 CWomen [U/l] 35 - 104Men [U/l] 40 - 129

37 C1 day [U/l] < 2502 to 5 days [U/l] < 2316 days to 6 months [U/l] < 4497 months to 1 year [U/l] < 4621 to 3 years [U/l] < 2814 to 6 years [U/l] < 2697 to 12 years [U/l] < 30013 to 17 years (female) [U/l] < 18713 to 17 years (male) [U/l] < 390

Mean value U/l CV %Normal control 90.79 1.27Pathological control 252.68 0.62Specimen 1 28.05 3.98Specimen 2 54.88 2.42Specimen 3 430.87 0.84


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ALP CP

ABX Pentra


Reproducibility (run-to-run precision)2 specimens of medium and high levels and 2 controls are tested induplicate for 20 days (2 series per day) according to therecommendations found in the NCCLS, EP5-A protocol (7) .


Correlation:100 patient samples are correlated with a commercial reagent taken asreference according to the recommendations found in the NCCLS, EP9-A2 protocol (9) .The equation for the allometric line obtained is:Y = 0.99 x - 1.22 with a correlation coefficient r 2 = 0.99.

Interferences:

Calibration stability:The calibration stability is 7 hours.



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

to the reagent used.

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

Books Verlagsgesellschaft; 1998. p. 36-46.2. Moss DW, Henderson AR. Clinical enzymology. In: Burtis CA,

Ashwood ER, editors. Tietz Textbook of Clinical Chemistry. 3 rd ed.Philadelphia: W.B Saunders Company; 1999. p. 617-721.

3. Tietz NW, Rinker D, Shaw LM. IFCC method for alkalinephosphatase. J. Clin. Chem. Clin. Biochem. 1983; 21:731-748.

4. Abitch K, El-Samalouti V, Junge W, Kroll M, Luthe H, Treskes M et al..Multicenter evaluation of new GGT and ALP reagents with newreference standardization and determination of 37C referenceintervals. Clin Chem Lab Med 2001; 39, Special Supplement pp S 346.

5. Tietz NW, Shuey DF. Reference intervals for Alkaline PhosphataseActivity Determined by IFCC and AACC Reference Methods. ClinChem 1986; 32: 1593-1594.





Mean value U/l CV %Normal control 90.79 3.62Pathological control 254.38 2.39Specimen 1 64.11 4.36Specimen 2 190.44 2.66

Haemoglobin: No significant influence is observed up to 195 mol/l

Triglycerides: No significant influence is observed up to 7 mmol/l Total Bilirubin: No significant influence is observed up to 470 mol/l Direct Bilirubin: No significant influence is observed up to 250 mol/l

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


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9/45

ALT CP

ABX Pentra

Form-0846R

ev.2

2007/06/08 A93A00022I EN

A11A01627

56 ml

14 ml



ABX Pentra ALT CPRef.: A11A01627Volume R1: 56 mlVolume R2: 14 ml

Diagnostic reagent for quantitative in-vitro determination of Alanine AminoTransferase (ALT) inserum or plasma.

Clinical Interest (1,2)Alanine Aminotransferase (ALAT/ALT), formerly called GlutamicPyruvic Transaminase (GPT) and Aspartate Aminotransferase (ASAT/ AST), formerly called Glutamic Oxalacetic Transaminase (GOT) are themost important representatives of a group of enzymes, the

aminotransferases or transaminases, which catalyze the conversion of -keto acids into amino acids by transfer of amino groups.As a liver specific enzyme ALT is only significantly elevated inhepatobiliary diseases. Increased AST levels, however, can occur inconnection with damages of heart or skeletal muscle as well as of liverparenchyma. Parallel measurement of ALT and AST is therefore appliedto distinguish liver from heart or skeletal muscle damages. The AST/ ALT ratio is used for differential diagnosis in liver diseases. Whileratios < 1 indicate mild liver damage, ratios > 1 are associated withsevere, often chronic liver diseases.

MethodOptimized UV-test according to IFCC (International Federation of

Clinical Chemistry) modified method without pyridoxal phosphate.

(ALT = Alanine Aminotransferase, LDH = Lactate Dehydrogenase)

ReagentsABX Pentra ALT CP is ready-to-use.

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

HandlingRemove both caps of the cassette, place in the refrigerated ABX Pentra400 reagent compartment.If present, remove foam by using a plastic pipette.

Reagent 1: TRIS pH 7.5 140 mmol/l L-Alanine 709 mmol/l

LDH (lactate dehydrogenase) 1700 U/l Sodium azide < 1 g/l

Reagent 2: 2-Oxoglutarate 85 mmol/l NADH 1.09 mmol/l Sodium azide < 1 g/l

L-Alanine + 2-Oxoglutarate L-Glutamate + Pyruvate ALT

Pyruvate + NADH + H + D-Lactate + NAD +LDH



Each control should be assayed daily and/or after each calibration.The frequency of controls and the confidence intervals shouldcorrespond 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 resultsexceed these confidence limits.

Materials required but not provided

Automated clinical chemistry analyser Standard laboratory equipment.

Specimen Serum. heparin Plasma or EDTA Plasma.

Loss of activity within 3 days:at 2 - 8 C: < 10 %at 15 - 25 C : < 17 %

Stability at -20 C: at least 3 months


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ALT CP

ABX Pentra


Reference range (4)

Storage and StabilityReagents, in unopened cassettes, are stable up to the expiry date onthe label if stored at 2-8 C protected from light and contamination isavoided.Stability after opening : refer to the paragraph Performance on ABXPentra 400.Do not freeze the reagents.




General Precautions1. This reagent is for professional in-vitro diagnostic use only.2. Do not swallow. Avoid contact with skin and mucous membranes.3. Take the necessary precautions for the use of laboratory reagents.4. The reagent cassettes are disposable and should be disposed of in




On board Reagent Stability:Once opened, the reagent cassette placed in the refrigerated ABXPentra 400 compartment is stable for 42 days.




Reproducibility (run-to-run precision)2 specimens of low and high levels and 2 controls are tested induplicate for 20 days (2 series per day) according to therecommendations found in the NCCLS, EP5-A protocol (6) .


Correlation:100 patient samples are correlated with a commercial reagent taken asreference according to the recommendations found in the NCCLS, EP9-A2 protocol (8) .The equation for the allometric line obtained is:Y = x + 5 with a correlation coefficient r 2 = 0.9964.

Interferences:

Calibration stability:The reagent is calibrated on Day 0. The calibration stability is checkedby testing 2 control specimens.

The calibration stability is at least 8 days.




37 CWomen: 34 U/l Men: 45 U/l

Mean value U/l CV %Normal control 39.73 1Pathological control 126.09 1.19Specimen 1 17.43 3.07Specimen 2 28.44 2.28Specimen 3 127.88 0.59

Mean value U/l CV %Normal control 39.79 2.53Pathological control 124.91 1.77Specimen 1 31.49 6Specimen 2 87.6 2.48

Haemoglobin: No significant influence is observed up to 195 mol/l.Triglycerides: No significant influence is observed up to 5 mmol/l.Total Bilirubin: No significant influence is observed up to 450 mol/l.

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


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ALT CP

ABX Pentra


Reference1. Thomas L. Alanine aminotransferase (ALT), Aspartate

aminotransferase (AST). In: Thomas L, editor. Clinical LaboratoryDiagnostics. 1 st ed. Frankfurt: TH-Books Verlagsgesellschaft; 1998.p. 55-65.

2. Moss DW, Henderson AR. Clinical enzymology. In: Burtis CA,Ashwood ER, editors. Tietz Textbook of Clinical Chemistry. 3 rd ed.Philadelphia: W.B Saunders Company; 1999. p. 617-721.

3. Bergmeyer HU, Horder M, Rej R. International Federation of Clinical Chemistry (IFCC) Scientific Committee, Analytical section:approved recommendation (1985) on IFCC methods for themeasurement of catalytic concentration of enzymes. Part 3. IFCCmethod for alanine aminotransferase (L-alanine:2-oxoglutarateaminotransferase, EC 2.6.1.2). J. Clin. Chem. Clin. Biochem. 1986;24:481-495.

4. IFCC Primary Reference Procedures for the Measurement of Catalytic Activity Concentrations of Enzymes at 37C; Part 4 ; ClinChem Lab Med 2002; 40(7) : 718-724.






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ALT CP

ABX Pentra



13/45

Amylase CP

ABX Pentra

Form-0846R

ev.2

2008/10/10 A93A00042M EN

A11A01628

26 ml

6.5 ml



ABX Pentra Amylase CPRef.: A11A01628Volume R1: 26 mlVolume R2: 6.5 ml

Diagnostic reagent for quantitative in-vitro determination of -Amylase in serum,plasma and urine.

Clinical Interest (1,2) -Amylases are hydrolytic enzymes which break down starch intomaltose. In the human body -amylases originate from various organs:the pancreatic amylase is produced by the pancreas and released into theintestinal tract, the salivary amylase is synthesized in the salivary glands

and secreted into saliva. The amylase present in the blood is eliminatedthrough the kidney and excreted into the urine. Therefore, elevation of serum activity is reflected in a rise of urinary amylase activity.Measurement of -amylase in serum and urine is mainly used for thediagnosis of pancreatic disorders as well as for detecting thedevelopment of complications. In acute pancreatitis the blood amylaseactivity increases within few hours after onset of abdominal pain,peaks after approx. 12 hours and returns to values within the referencerange at the latest after 5 days. The specificity of -amylase forpancreatic disorders is not very high as elevated levels are measuredalso in various non-pancreatic diseases, e.g. parotitis and renal insufficiency. Therefore, for confirmation of an acute pancreatitismeasurement of lipase should be additionally performed.

MethodEnzymatic photometric test, in which the substrate 4,6-ethylidene-(G7)-p-nitrophenyl-(G1)- -D-maltoheptaoside (EPS-G7) is cleaved by-amylases into various fragments. These are further hydrolyzed in asecond step by -glucosidase producing glucose and p-nitrophenol.The increase in absorbance represents the total (pancreatic andsalivary) amylase activity in the sample (3,4) .

(PNP = p-Nitrophenol, G =Glucose)

ReagentsABX Pentra Amylase CP is ready-to-use.

Reagent 1 : Goods buffer pH 7.1 0.1 mol/l NaCl 62.5 mmol/l MgCl 2 12.5 mmol/l -Glucosidase 2.5 kU/l Sodium azide < 1 g/l

Reagent 2 : Goods buffer pH 7.1 0.1 mol/l EPS-G7 8.5 mmol/l Sodium azide < 1 g/l

5 EPS-G7+5 H 2O2 EthylideneG5 + 2G2PNP + 2 Ethylidene-G4 +2G3PNP + Ethylidene-G3 + G4PNP

-Amylase

5 PNP + 14 G2 G2PNP + 2 G3PNP + G4PNP + 14 H 2O-Glucosidase

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

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 reagentcompartment.


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



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Amylase CP

ABX Pentra


Materials required but not provided Automated clinical chemistry analyser ABX Pentra Clean-Chem CP, Ref. A11A01755, 30 ml Standard laboratory equipment.

Specimen Serum. heparin Plasma. Urine.

Reference range (4)

Storage and Stability

Reagents, in unopened cassettes, are stable up to the expiry date onthe label if stored at 2 - 8 C, protected from light and contaminationis avoided.Stability after opening : refer to the paragraph Performance on ABXPentra 400.Do not freeze the reagents.


Waste Management1. Please refer to local legal requirements.

2. This reagent contains sodium azide (0.95 g/l) as a preservative. Assodium azide may react with lead or copper to form explosive metal azides, this reagent should be disposed of by flushing with copiousamounts of water.

General Precautions1. This reagent is for professional in-vitro diagnostic use only.2. Saliva and skin contain -amylase therefore never pipette reagents

by mouth and avoid skin contact with the reagents.3. Do not swallow. Avoid contact with skin and mucous membranes.4. Take the necessary precautions for the use of laboratory reagents.5. The reagent cassettes are disposable and should be disposed of in



Serum, Plasma



Sample volume: 4.0 l/test



Reproducibility (run-to-run precision)3 specimens of low, medium and high levels and 2 controls are testedin duplicate for 20 days (2 series per day) according to therecommendations found in the NCCLS, EP5-A protocol (6) .


Correlation:100 patient samples are correlated with a commercial reagent taken asreference according to the recommendations found in the NCCLS, EP9-A2 protocol (8) .The equation for the allometric line obtained is:Y = 0.96 x + 2.46 with a correlation coefficient r 2 = 0.9955.

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

7 days at 4 - 8 C1 year at - 20 C

Urine: 2 days at 20 - 25 C10 days at 4 - 8 C3 weeks at - 20 C

Women MenSerum/plasma < 100 U/l < 100 U/l Urine < 447 U/l < 491 U/l Mean value U/l CV %

Normal control 81.7 1.47Pathological control 206.2 0.91Specimen 1 69.0 1.18Specimen 2 151.8 1.23Specimen 3 383.6 1.32


Specimen 3 389.60 2.50


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Amylase CP

ABX Pentra


Interferences:





Urine


On board Reagent Stability:Once opened, the reagent cassette placed in the refregerated ABXPentra 400 compartment is stable for 60 days.


Detection limit:The detection limit is determined according to the Valtec protocol (5)and equals 4.92 U/l.


Reproducibility (run-to-run precision)2 controls are tested in duplicate for 20 days (2 series per day)according to the recommendations found in the NCCLS, EP5-A protocol (6) .

Linearity and Measuring Range:The reagent linearity is determined according to the recommendationsfound in the NCCLS, EP6-P protocol (7) .Low linearity: 4.92 U/l High linearity: 2000 U/l, with automatic post-dilution: 6000 U/l.

Correlation:109 patient samples are correlated with a commercial reagent taken asreference according to the recommendations found in the NCCLS, EP9-A2 protocol (8) .The equation for the allometric line obtained is:Y = 0.94 x + 0.21 with a correlation coefficient r 2 = 0.99.

Interferences:




Application release: 7.xx


Reference1. Lorentz K. -Amylase. In : Thomas L, editor. Clinical laboratory

diagnostics. 1 st ed. Frankfurt: TH-Book Verlagsgesellschaft ; 1998.p.192-202.

2. Moss DW, Henderson AR. Digestive enzymes of pancreatic origin.In: Burtis CA, Ashwood ER, editors. Tietz Textbook of Clinical Chemistry. 3 rd ed. Philadelphia: W.B Saunders Company; 1999.p.689-698.

3. Kruse-JarresJD,KaiserC,Hafkenscheid JC, Hohenwallner W, SteinW.,Bohner J et al. Evaluation of a new alpha-amylase assay using 4,6-ethylidene-(G7)-1-4-nitrophenyl-(G1)-alpha,D-maltoheptaoside assubstrate. J. Clin. Chem. Biochem. 1989; 27:103 - 113.

4. Junge W, Wortmann W, Wilke B, Waldenstroem J et al.Development and evaluation of assays for determination of total and pancreatic amylase at 37C according to the principlerecommended by the IFCC. Clin Biochem 2001; 34:607-15.


6. Evaluation of Precision Performance of Clinical Chemistry Devices,Approved Guideline, NCCLS document EP5-sA, Vol. 19, No. 2,february 1999.

Haemoglobin: No significant influence is observed up to 209 mol/l Triglycerides: No significant influence is observed up to 7 mmol/l Total Bilirubin: No significant influence is observed up to 375 mol/l Direct Bilirubin: No significant influence is observed up to 300 mol/l

a.Modification from index L to M: New application release.

Mean value U/l CV %Normal control 44.72 3.16Pathological control 169.38 1.14

Specimen 1 86.35 1.65Specimen 2 157.73 0.63Specimen 3 286.80 0.63

Mean value U/l CV %Normal control 46.26 5.24Pathological control 163.00 2.94

Haemoglobin: No significant influence is observed up to 278 mol/l


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Amylase CP

ABX Pentra





17/45

AST CP

ABX Pentra

Form-0846R

ev.2

2007/06/08 A93A00032I EN

A11A01629

56 ml

14 ml



ABX Pentra AST CPRef.: A11A01629Volume R1: 56 mlVolume R2: 14 ml

Diagnostic reagent for quantitative in-vitro determination of Aspartate AminoTransferase (AST)in serum or plasma.

Clinical Interest (1,2)Aspartate Aminotransferase (ASAT/AST), formerly called GlutamicOxalacetic Transaminase (GOT) and Alanine Aminotransferase (ALAT/ ALT), formerly called Glutamic Pyruvic Transaminase (GPT) are themost important representatives of a group of enzymes, the

aminotransferases or transaminases, which catalyze the conversion of -keto acids into amino acids by transfer of amino groups.As a liver specific enzyme ALT is only significantly elevated inhepatobiliary diseases. Increased AST levels, however, can occur inconnection with damages of heart or skeletal muscle as well as of liverparenchyma. Parallel measurement of ALT and AST is therefore appliedto distinguish liver from heart or skeletal muscle damages. The AST/ ALT ratio is used for differential diagnosis in liver diseases. Whileratios < 1 indicate mild liver damage, ratios > 1 are associated withsevere, often chronic liver diseases.

MethodOptimized UV-test according to IFCC (International Federation of

Clinical Chemistry) modified method without pyridoxal phosphate.

(AST = Aspartate Aminotransferase, MDH = Malate Dehydrogenase)

ReagentsABX Pentra AST CP is ready-to-use.

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


Reagent 1: TRIS pH 7.8 110 mmol/l L-Aspartate 340 mmol/l MDH (malate dehydrogenase) 900 U/l LDH (lactate dehydrogenase) 900 U/l Sodium azide < 1 g/l

Reagent 2: 2-Oxoglutarate 85 mmol/l NADH 1.09 mmol/l Sodium azide < 1 g/l

L-Aspartate + 2-Oxoglutarate L-Glutamate + 2-Oxalacetate AST

Oxalacetate + NADH + H + L-Malate + NAD +MDH




Materials required but not provided

Automated clinical chemistry analyser Standard laboratory equipment.

Specimen Serum. Heparin Plasma or EDTA Plasma.

Loss of activity within 3 days:at 2 - 8 C : < 8 %at 15 - 25 C: < 10 %

Stability at -20 C: a t least 3 months


18/45

AST CP

ABX Pentra


Reference range (4)

Storage and StabilityReagents, in unopened cassettes, are stable up to the expiry date onthe label if stored at 2 - 8 C, protected from light and contaminationis avoided.Stability after opening : refer to the paragraph Performance on ABXPentra 400. Do not freeze the reagents.








On board Reagent Stability:

Once opened, the reagent cassette placed in the refrigerated ABXPentra 400 compartment is stable for 55 days.






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

reference according to the recommendations found in the NCCLS, EP9-A2 (8) .The equation for the allometric line obtained is:Y = 0.98 x + 2.43 with a correlation coefficient r 2 = 0.9977 .

Interferences:

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

by testing 2 control specimens.The calibration stability is at least 8 days.





Mean value U/l CV %Normal control 42.2 2.71Pathological control 123.4 1.43Specimen 1 21.7 2.32Specimen 2 38.3 2.01Specimen 3 145.4 1.08


Haemoglobin: No significant influence is observed up to 55 mol/l Triglycerides: No significant influence is observed up to 4.6 mmol/l Total Bilirubin: No significant influence is observed up to 100 mol/l Direct Bilirubin: No significant influence is observed up to 130 mol/l

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


19/45

AST CP

ABX Pentra


Reference1. Thomas L. Alanine aminotransferase (ALT), Aspartate

aminotransferase (AST). In: Thomas L, editor. Clinical LaboratoryDiagnostics. 1 st ed. Frankfurt: TH-Books Verlagsgesellschaft; 1998.p. 55-65.


3. Bergmeyer HU, Horder M, Rej R. International Federation of Clinical Chemistry (IFCC) Scientific Committee, Analytical section:approved recommendation (1985) on IFCC methods for themeasurement of catalytic concentration of enzymes. Part 2. IFCCmethod for aspartate aminotransferase (L-aspartate: 2-oxoglutarate aminotransferase, EC 2.6.1.1). J. Clin. Chem. Clin.Biochem. 1986; 24:497-510.







20/45


21/45

CK- MB RTU

ABX Pentra

Form-0846R

ev.2

2008/10/10 A93A00062L EN

A11A01643

1 x 20 ml

1 x 5 ml



ABX Pentra CK-MB RTURef. : A11A01643Volume R1: 1 x 20 mlVolume R2: 1 x 5 ml

Diagnostic reagent for quantitative in-vitro determination of CK-MB in serum.

Clinical Interest (1,2)Creatine kinase (CK) is an enzyme which consists of isoenzymes mainlyof the muscle (CK-M) and the brain (CK-B). CK exists in serum indimeric forms as CK-MM, CK-MB, CK-BB and as macro-enzymes.Measurement of CK-MB is a quite specific test for detection of cardiac

muscle damage and is therefore used for diagnosis and monitoring of myocardial infarction.

MethodOptimized UV test according to DGKC (German Society of Clinical Chemistry) and IFCC (International Federation of Clinical Chemistry)for CK with inhibition of CK-M isoenzymes by polyclonal antibodies.

CK-MB consists of the subunits CK-M and CK-B.Specific antibodies against CK-M inhibits the complete CK-MM activity(main part of the total CK activity) and the CK-M subunit of CK-MB.Only CK-B activity is measured, which is half of the CK-MB activity.

ReagentsABX Pentra CK-MB RTU is ready-to-use.

ABX Pentra CK-MB RTU should be used according to this reagent notice.HORIBA ABX cannot guarantee its performance if used otherwise.

Reagent 1:Imidazole pH 6.7 62.5 mmol/l Glucose 27.5 mmol/l N-Acetyl cysteine (NAC) 27.5 mmol/l Magnesium acetate 13.8 mmol/l EDTA-Na2 2.1 mmol/l NADP 2.75 mmol/l Hexokinase (HK) 3 kU/l Polyclonal antibodies (sheep) againsthuman CK-M; inhibiting capacity

2500 U/l

Sodium azide < 1 g/l Reagent 2:Imidazole 160 mmol/l Creatine phosphate 30 mmol/l EDTA-Na2 2.1 mmol/l ADP 11 mmol/l AMP 28 mmol/l Diadenosine pentaphosphate 56 mol/l Glucose-6-phosphate dehydrogenase (G6P-DH) 7.5 kU/l Sodium azide < 1 g/l

HandlingReagent 1 and Reagent 2 should be placed on the same reagent racksector A, B or C (see diagram below, sector A is taken as an example).

Place Reagent 1 in position 1 of one available sector using either: Reagent container 15 ml Reagent container 10 ml + its specific adaptorPlace Reagent 2 in position 2 of same selected sector using either: Reagent container 10 ml Reagent container 4 ml + its specific adaptor.

Place the reagent rack in the refrigerated ABX Pentra 400 reagentcompartment.

Calibrator N/A.

ControlFor internal quality control, use:ABX Pentra CK Control, Ref. A11A01786 (not included)4 x 3 ml (lyophilisate)

Each control should be assayed daily and/or after each calibration.The frequency of controls and the confidence intervals shouldcorrespond 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.

ABX Pentra CK-MB RTU Reagent 2

ABX Pentra CK-MB RTU Reagent 1


22/45

CK- MB RTU

ABX Pentra



SpecimenSerum.

Reference range (1)

Storage and StabilityReagents, in unopened vials, are stable up to the expiry date on thelabel if stored at 2 - 8 C, protected from light and contamination.Once opened, ABX Pentra CK-MB RTU is stable 28 days at 2-8C.Do not freeze the reagents.




General Precautions1. This reagent is for professional in-vitro diagnostic use only.2. Do not swallow. Avoid contact with skin and mucous membranes.3. Take the necessary precautions for the use of laboratory reagents.4. The reagent vials should be discarded after use.5. Please refer to the MSDS associated with the reagent.




Detection limit:The detection limit is determined according to the Valtec protocol (5)and equals 5.24 U/l.

Accuracy and Precision: Repeatability (within-run precision)3 specimens of low, medium and high concentration and 1 control aretested 20 times according to the recommendations found in the Valtecprotocol (5) .

Reproducibility (run-to-run precision)2 specimens of medium and high levels and 1 control are tested induplicate for 20 days (2 series per day) according to therecommendations found in the NCCLS, EP5-A protocol (6) .

Linearity and Measuring Range:The reagent linearity is determined according to the recommendationsfound in the NCCLS, EP6-P protocol (7) .Low linearity: 5.24 U/l High linearity: 300 U/l, with automatic post-dilution: 900 U/l.


Interferences:



Reference1. Stein W. Creatine kinase (total activity), creatine kinase

isoenzymes and variants. In: Thomas L, ed. Clinical laboratorydiagnostics.Frankfurt: TH-Books Verlagsgesellschaft;1998.p.71-80.

Loss of activity:after 24 h at 2 - 8 C < 10 %after 1 h at 15 - 25 C < 10 %Stability: at -20 C 4 weeks (in the dark)

37 C< 24 U/l

Mean value U/l CV %Pathological control 200.84 0.94Specimen 1 50.36 2.81Specimen 2 179.85 1.45Specimen 3 282.23 0.87

Mean value U/l CV %Pathological control 194.2 3.7Specimen 1 46.8 6.5Specimen 2 163.2 5.6

Haemoglobin: Positive interference starting from 56 mol/l Triglycerides: No significant influence is observed up to 7 mmol/l Total Bilirubin: No significant influence is observed up to 119 mol/l Direct Bilirubin: No significant influence is observed up to 600 mol/l

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


23/45

CK- MB RTU

ABX Pentra



3. Wrzburg U, Hennrich N, Orth HD, Lang H. Quantitativedetermination of creatine kinase isoenzyme catalyticconcentrations in serum using immunological methods. J. Clin.Chem. Clin. Biochem. 1977; 15:131-137.

4. Recommendations of the German Society for Clinical Chemistry.Standardization of methods for the estimation of enzyme activitiesin biological fluids: Standard method for the determination of creatine kinase activity. J. Clin. Chem. Clin. Biochem. 1977;15:255-260.






24/45

CK- MB RTU

ABX Pentra



25/45

CK NAC CP

ABX Pentra

Form-0846R

ev.2

2007/06/11 A93A00052K EN

A11A01632

26 ml

6.5 ml



ABX Pentra CK NAC CPRef.: A11A01632Volume R1: 26 mlVolume R2: 6.5 ml

Diagnostic reagent for quantitative in-vitro determination of Creatine Kinase (CK) inserum or plasma.

Clinical Interest (1,2)Creatine kinase (CK) is an enzyme which consists of isoenzymes mainlyof the muscle (CK-M) and the brain (CK-B). CK exists in serum indimeric form as CK-MM, CK-MB, CK-BB and as macroenzyme. ElevatedCK values are observed in cardiac muscle damages and in skeletal

muscle diseases. Measurement of CK is used especially in conjunctionwith CK-MB for diagnosis and monitoring of myocardial infarction.

MethodOptimized UV-test according to DGKC (German Society of Clinical Chemistry ) and IFCC (International Federation of Clinical Chemistry).

(CK = Creatine Kinase, HK = Hexokinase, G6P-DH = Glucose-6-phosphatedehydrogenase)

ReagentsABX Pentra CK NAC CP is ready-to-use.

Reagent 1:Imidazole pH 6.7 62.5 mmol/l Glucose 27.5 mmol/l N-Acetylcysteine (NAC) 27.5 mmol/l Magnesium acetate 13.8 mmol/l EDTA-Na2 2.1 mmol/l

NADP 2.75 mmol/l Hexokinase (HK) 3 kU/l Sodium azide < 1 g/l Reagent 2:Imidazole 160 mml/l Creatine phosphate 170 mmol/l EDTA-Na2 2.1 mmol/l ADP 11 mmol/l AMP 28 mmol/l Diadenosine pentaphosphate 56 mol/l Glucose-6-phosphate dehydrogenase(G6P-DH) 7.5 kU/l Sodium azide < 1 g/l

CKCreatine + ATPCreatine phosphate+ ADP

Glucose + ATPHK Glucose-6-phosphate+ADP

Glucose-6-phosphate+NADP +G6P-DH

Gluconate-6-phosphate+NADPH+H +

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

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

400 reagent compartment.If present, remove foam by using a plastic pipette.


ControlFor internal quality control, use:ABX Pentra CK Control, Ref. A11A01786 (not included)4 x 3 ml (lyophilisate)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)




26/45

CK NAC CP

ABX Pentra


Specimen Serum. Heparin Plasma or EDTA Plasma.

Reference range (1,3)

Storage and StabilityReagents, in unopened cassettes, are stable up to the expiry date onthe label if stored at 2 - 8 C, protected from light and contaminationis avoided.

Stability after opening : refer to the paragraph Performance on ABXPentra 400.Do not freeze the reagents.











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 Valtecprotocol (6) .



Correlation:100 patient samples are correlated with a commercial reagent taken asreference according to the recommendations found in the NCCLS, EP9-A2 protocol (9) .The equation for the allometric line obtained is:Y = 0.94 x - 9.53 with a correlation coefficient r 2 = 0.994 .

Interferences:

Stability: 1 week at 2 - 8 C1 day at 15 - 25 C

Stability at - 20 C: 4 weeks (in the dark)

in [U/l] 37 CAdults:Women 145Men 171Children:Umbilical cord blood 175 - 402Newborns 468 - 1200< 5 days 195 - 700< 6 months 41 - 330> 6 months 24 - 229

Mean value U/l CV %Normal control 165 1.20Pathological control 474 0.92Specimen 1 46.0 2.54Specimen 2 115 1.14Specimen 3 347 0.79

Mean value U/l CV %Normal control 161.8 2.56Pathological control 468.6 2.50Specimen 1 81.4 4.65Specimen 2 311 2.61

Haemoglobin: No significant influence is observed up to 55 mol/l.Direct Bilirubin: No significant influence is observed up to 100 mol/l.Total Bilirubin: No significant influence is observed up to 125 mol/l.


27/45

CK NAC CP

ABX Pentra






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

to the reagent used.

Reference1. Stein W. Creatine kinase (total activity), creatine kinase

isoenzymes and variants. In: Thomas L, ed. Clinical laboratorydiagnostics.Frankfurt: TH-Books Verlagsgesellschaft;1998.p.71-80.



4. Recommendations of the German Society for Clinical Chemistry.Standardization of methods for the estimation of enzyme activitiesin biological fluids: Standard method for the determination of creatine kinase activity. J Clin Chem Clin Biochem 1977;15:255-260.

5. Lorentz K, Rhle G, Siekmann L. Introduction of new standardmethods 1994 for the determination of catalytic enzymeconcentrations at 37 C. DG Klinische Chemie Mitteilungen1995;26:290-293.



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, 2nd ed., NCCLS document EP9-A2, Vol. 22, No.19, 2002.

a. Modification from index J to K: suppression of minor index.


28/45

CK NAC CP

ABX Pentra



29/45

GGT CP

ABX Pentra

Form-0846R

ev.2

2007/06/11 A93A00072H EN

A11A01630

56 ml

14 ml



ABX Pentra GGT CPRef.: A11A01630Volume R1: 56 mlVolume R2: 14 ml

Diagnostic reagent for quantitative in-vitro determination of Gamma-GlutamylTransferase(GGT) in serum or plasma.

Clinical Interest (1)Gamma-glutamyltransferase (Gamma-GT or GGT), also called gamma-glutamyltranspeptidase, is an enzyme present in liver and bile ductwhich is the most sensitive indicator of hepatobiliary diseases.Because of a high negative predictive value for these diseases the

measurement of gamma-GT is widely used to rule out an hepatic orbiliary origin. Together with other enzymes such as alanineaminotransferase (ALAT), aspartate aminotransferase (ASAT) andcholinesterase gamma-GT is a valuable tool for the differential diagnosis in liver diseases.

Method (2)Kinetic photometric test according to Szasz modified (1974).Gamma-GT catalyzes the transfer of glutamic acid to acceptors likeglycylglycine in this case.This process releases 5-amino-2-nitrobenzoate, which can bemeasured at 405 nm. The increase in absorbance at this wavelength isdirectly related to the activity of gamma-GT.

ReagentsABX Pentra GGT CP is ready-to-use.

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



Reagent 1: TRIS pH 8.25 137 mmol/l Glycylglycine 137 mmol/l Sodium azide < 1 g/l

Reagent 2: L-Gamma-glutamyl-3-carboxy-4-nitroanilide 22 mmol/l Sodium azide < 1 g/l

Gamma-GT

L-Gamma-glutamyl-3-carboxy-4-nitranilide + Glycylglycine

Gamma-glutamyl-glycylglycine + 5-Amino-2-nitrobenzoate




Specimen Serum.

EDTA Plasma.Stability: at least 1 week between - 20 C and 25 C.

Reference range (3)

Storage and StabilityReagents, in unopened cassettes, are stable up to the expiry date on thelabel if stored at 2 - 8 C protected from light and contamination is avoided.Stability after opening : refer to the paragraph Performance on ABXPentra 400.Do not freeze the reagents.



30/45


31/45

GGT CP

ABX Pentra





32/45

GGT CP

ABX Pentra



33/45

LDH CP

ABX Pentra

Form-0846R

ev.2

2007/06/11 A93A01192D EN

A11A01824

26 ml

6.5 ml


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.comS.

ABX Pentra LDH CPRef.: A11A01824Volume R1: 26 mlVolume R2: 6.5 ml

Diagnostic reagent for quantitative in-vitro determination of Lactate Dehydrogenase (LDH)in serum or plasma.

Clinical Interest (1,2)Lactate dehydrogenase (LDH) is an enzyme, consisting of five differentisoenzymes that catalyze the interconversion of L-lactate andpyruvate. LDH is present in the cytoplasm of all human tissues withhigher concentrations in liver, heart and skeletal muscle, and lower in

erythrocytes, pancreas, kidney and stomach. Increased LDH activitiesare found in a variety of pathological conditions such as myocardial infarction, liver diseases, blood diseases, cancer or muscle diseases.However, because of the lack of organ specificity , determination of itsisoenzymes or other enzymes such as alkaline phosphatase or ALAT / ASAT is necessary for differential diagnosis.

Method (3)Optimized test according to German Society of Clinical Chemistry(DGKC) .

(LDH = Lactate Dehydrogenase)

ReagentsABX Pentra LDH CP is ready-to-use.

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



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

Reagent 1: Phosphate buffer, pH 7.5 64 mmol/l Pyruvate 0.81 mmol/l Sodium azide < 1 g/l

Reagent 2: Goods buffer, pH 9.6NADH 1.05 mmol/l Sodium azide < 1 g/l

LDHPyruvate + NADH + H + Lactate + NAD +

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 shouldcorrespond 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 resultsexceed these confidence limits.


Specimen Serum. Heparin plasma or EDTA plasma.

Reference range (4)

Storage and StabilityReagents, in unopened vials, are stable up to the expiry date on thelabel if stored at 2 - 8 C protected from light and contamination isavoided.Do not freeze the reagents.

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

available on request.

Loss of activity within 3 days at 2 - 8 C < 8 %and at 15 - 25 C < 2 %

Stability at -20C: 6 weeks

Adults [U/l] : < 480


34/45

LDH CP

ABX Pentra








On board Reagent Stability: 32 days







Interferences:






Reference1. Thomas L. Clinical laboratory diagnostics. 1 st ed. Frankfurt: TH-

Books Verlagsgesellschaft; 1998. 89-94.2. Moss DW, Henderson AR. Clinical enzymology In: Burtis CA,

Ashwood ER, editors. Tietz Textbook of Clinical Chemistry. 3 rd ed.Philadelphia: W.B Saunders Company; 1999. 617-721.

3. Deutsche Gesellschaft fr Klinische Chemie. Empfehlungen derdeutschen Gesellschaft fr Klinische Chemie (DGCK).Standardisierung von Methoden zur Bestimmung vonEnzymaktivitten in biologischen Flssigkeiten. (Recommendationof the German Society of Clinical Chemistry. Standardization of methods for measurement of enzymatic activities in biological fluids.) Z. Klin. Chem. Klin. Biochem. 1972; 10:182-192.

4. Fischbach F., Zawta B., Age-dependent reference limits of several enzymes in plasma at different measuring temperatures. Klin. Lab.1992; 38:555-561.


Mean value U/l CV %Normal control 323 1.05Pathological control 512 0.51Specimen 1 147 1.46Specimen 2 269 1.13Specimen 3 681 0.56

Mean value U/l CV %Normal control 333 2.59Pathological control 521 2.41Specimen 1 272 4.38Specimen 2 701 2.78

Haemoglobin: Do not use haemolysed samples.Triglycerides: No significant influence is observed up to 7 mmol/l.Total Bilirubin: No significant influence is observed up to 450 mol/l.Direct Bilirubin: No significant influence is observed up to 900 mol/l.

a. Modification from index C to D: suppression of minor index.


35/45

LDH CP

ABX Pentra






36/45

LDH CP

ABX Pentra



37/45

LDH IFCC CP

ABX Pentra

Form-0846R

ev.2

2008/10/09 A93A01218D EN

A11A01871

26 ml

6.5 ml



ABX Pentra LDH IFCC CPRef.: A11A01871Volume R1: 26 mlVolume R2: 6.5 ml

Intended use

Diagnostic reagent for quantitative in-vitro determination of Lactate Dehydrogenase (LDH)in serum or plasma.

Clinical Interest (1,2)Lactate dehydrogenase (LDH) is an enzyme, consisting of five differentisoenzymes that catalyze the interconversion of L-lactate andpyruvate. LDH is present in the cytoplasm of all human tissues withhigher concentrations in liver, heart and skeletal muscle, and lower in

erythrocytes, pancreas, kidney and stomach. Increased LDH activitiesare found in a variety of pathological conditions such as myocardial infarction, liver diseases, blood diseases, cancer or muscle diseases.However, because of the lack of organ specificity , determination of itsisoenzymes or other enzymes such as alkaline phosphatase or ALAT / ASAT is necessary for differential diagnosis.

Method (3)Optimized UV-test according to International Federation of Clinical Chemistry and Laboratory Medecine (IFCC) .

(LDH = Lactate Dehydrogenase)

ReagentsABX Pentra LDH IFCC CP is ready-to-use. 1g/l

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

Handling

Remove both caps of the cassette, place in the refrigerated ABX Pentra400 reagent compartment.If present, remove foam by using a plastic pipette.


ControlFor 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)

Reagent 1: N-Methyl-D-Glucamine 420 mmol/l L-Lactate 65 mmol/l

Reagent 2: NAD+ 50 mmol/l Sodium azide < 1 g/l

LDHL-Lactate + NAD + Pyruvate + NADH + H +


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 Standard laboratory equipment.

Specimen (12) Serum. Heparin-lithium plasma.

Reference range (4)Each laboratory should establish its own reference ranges. The valuesgiven here are used as guidelines only.

Stability:7 days at 20 - 25 C4 days at 2 - 8C6 weeks at -20C

Women [U/l] at 37C: < 247Men [U/l] at 37C: < 248


38/45

LDH IFCC CP

ABX Pentra


Storage and StabilityReagents, in unopened cassettes, are stable up to the expiry date onthe label if stored at 2 - 8 C and contamination is avoided.Reagent 2 must be protected from light.Do not freeze the reagents!Stability after opening: refer to the paragraph "Performance on ABXPentra 400".

Assay ProcedureTest instructions for other automated systems than ABX Pentra 400 areavailable on request (not available in the USA).




accordance with the local legal requirements.

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



On board Reagent Stability (refrigerated area):If the ABX Pentra LDH IFCC CP cassette is left on board the instrumentat all times, the cassette is stable for 31 days.


Detection limit:The detection limit is determined according to CLSI (NCCLS), EP17-Aprotocol (13) and equals 11 U/l.


Reproducibility (total precision)3 specimens of low, medium and high levels and 2 controls are testedin duplicate for 20 days (2 series per day) according to therecommendations found in the CLSI (NCCLS), EP5-A protocol (6) .

Measuring Range:The assay confirmed a measuring range from 11 U/l to 800 U/l, withan automatic post-dilution up to 2400 U/l.The reagent linearity has been assessed up to 800 U/l according to therecommendations found in the CLSI (NCCLS), EP6-A protocol (7) .

Correlation:128 patient samples (serum) are correlated with a commercial reagenttaken as reference according to the recommendations found in theCLSI (NCCLS), EP9-A2 protocol(8) . Values ranged from 15 U/l to 791U/l.

The equation for the allometric line obtained using Passing-Bablockregression procedure (9) is:Y = 1.02 x - 9.09 with a correlation coefficient r 2 = 0.9959.

Interferences:

Other limitations are given by Young as a list of drugs and preanalyticalvariables known to affect this methodology (10,11).




Application release a: 5.xxMean value U/l CV %Control specimen 1 197.2 2.66Control specimen 2 274.4 1.27Specimen 1 113.4 2.58Specimen 2 256.5 1.67Specimen 3 519.5 1.05

Mean value U/l CV %Control specimen 1 189.46 2.78Control specimen 2 266.82 2.38Specimen 1 157.2 3.31Specimen 2 316.0 2.67Specimen 3 914.5 2.33

Haemoglobin: Do not use hemolysed samples.Triglycerides: No significant influence is observed up to 612.5 mg/dl

(7 mmol/l).(as Intralipid, representative of lipemia).

Total Bilirubin: No significant influence is observed up to 29.3 mg/dl(500 mol/l).

Direct Bilirubin: No significant influence is observed up to 29.3 mg/dl(500 mol/l).

a. Modification from index C to D: new application release.


39/45

LDH IFCC CP

ABX Pentra



Reference1. Thomas L. Clinical laboratory diagnostics. 1 st ed. Frankfurt: TH-

Books Verlagsgesellschaft; 1998. 89-94.2. Moss DW, Henderson AR. Clinical enzymology In: Burtis CA,

Ashwood ER, editors. Tietz Textbook of Clinical Chemistry. 3 rd ed.Philadelphia: W.B Saunders Company; 1999. 617-721.

3. Deutsche Gesellschaft fr Klinische Chemie. Empfehlungen derdeutschen Gesellschaft fr Klinische Chemie (DGCK).

Standardisierung von Methoden zur Bestimmung vonEnzymaktivitten in biologischen Flssigkeiten. (Recommendationof the German Society of Clinical Chemistry. Standardization of methods for measurement of enzymatic activities in biological fluids.) Z. Klin. Chem. Klin. Biochem. 1972; 10:182-192.

4. Schumann G., Bonora R., Ceriotti F., Frard G. et al., IFCC primaryreference procedure for the measurement of catalytic activityconcentrations of enzymes at 37C. Part 3: Reference procedure forthe measurement of catalytic concentration of lactatedehydrogenase. Clin. Chem. Lab. Med., 2002, 40: 643-648.





9. Passing H., Bablock W. A new biometrical procedure for testing theequality of measurements from two different analytical methods.J. Clin. Chem. Clin. Biochem. 1983; 21: 709-20.

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

Edition, Washington, DC, AACC Press, 1995, 3: 143-163.11. Young D.S., Effects of Preanalytical Variables on Clinical

Laboratory Tests, 2nd

Edition, Washington, DC, AACC Press, 1997,3: 120-132.12. Guder W.G., Zawta B., The Quality of Diagnostics Samples. Samples:

From the Patient to the Laboratory. 1 st ed. Guder W.G., NarayananS., Zawta B. (WHILEY -VCH, darmstadt, Germany), (2001), 24.

13. Protocols for determination of limits of detection and limits of quantitation, Approved Guideline, CLSI (NCCLS) document EP17-A,Vol. 24, No. 34, 2004.


40/45

LDH IFCC CP

ABX Pentra



41/45

Lipase CP

ABX Pentra

Form-0846R

ev.2

2007/08/27 A93A00092I EN

A11A01631

24 ml

7 ml



ABX Pentra Lipase CPRef.: A11A01631Volume R1: 24 mlVolume R2: 7 ml

Diagnostic reagent for quantitative in-vitro determination of Lipase in serum or plasma.

Clinical Interest (1,2)Lipases are enzymes which hydrolyze glycerol esters of long fattyacids. The enzyme and its cofactor colipase is produced in thepancreas, lipase being also secreted in small amounts by the salivaryglands as well as by gastric, pulmonary and intestinal mucosa. Bile

acids and colipase form micellar complexes with the lipids and bindlipase on the substrate / water interface. Determination of lipase isused for investigation of pancreatic disorders. In acute pancreatitisthe lipase concentrations rise to 2-50 fold the upper reference limitwithin 4-8 hours after begin of abdominal pain peaking at 24 hoursand decreasing within 8 to 14 days. Elevated lipase values can also beobserved in chronic pancreatitis and obstruction of the pa

enzymes p400 en

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