Albumin in Urine/CSF FS* (Microalbumin) - Asterisco...Albumin in Urine/CSF FS* (Microalbumin) Diagnostic reagent for quantitative in vitro determination of albumin in urine, CSF, serum

Reagent information * fluid stable

Albumin in Urine/CSF FS* (Microalbumin) Diagnostic reagent for quantitative in vitro determination of albumin in urine, CSF, serum or plasma on BioMajesty JCA-BM6010/C

Order information Cat. No. 1 0242 99 10 964 R1: 6 x 100 tests R2: 6 x 100 tests

Method Immunoturbidimetric test

Principle Determination of the albumin concentration via photometric measurement of antigen-antibody-reaction among antibodies against albumin and albumin present in the sample

Reagents

Components and Concentrations R1: TRIS pH 7.5 100 mmol/L NaCl 50 mmol/L Polyethylenglycol (PEG) Detergents, stabilizers R2: TRIS pH 8.0 83 mmol/L NaCl 165 mmol/L Antibodies (goat) against human albumin with stabilizers

Storage Instructions and Reagent Stability The reagents are stable up to the end of the indicated month of expiry, if stored at 2 – 8 °C and contamination is avoided. Do not freeze reagents! R1 and R2 must be protected from light.

Warnings and Precautions 1. The reagents contain sodium azide (0.95 g/L) as

preservative. Do not swallow! Avoid contact with skin and mucous membranes.

2. Please refer to the safety data sheets and take the necessary precautions for the use of laboratory reagents.

3. The albumin concentration in serum samples is much higher than in urine/CSF samples. In order to avoid contaminations and carry over from serum samples into urine/CSF samples, cuvettes and other material must be cleaned thoroughly after being used for tests with serum.

Waste Management Please refer to local legal requirements.

Reagent Preparation The reagents are ready to use. The bottles are placed directly into the reagent trays.

Specimen Urine, CSF, serum and heparin plasma If contaminations are avoided the stability is [1]: in urine: 7 days at 20 – 25 °C 1 month at 4 – 8 °C

6 months at -20 °C in CSF: 1 day at 20 – 25 °C 2 months at 4 – 8 °C

1 year at -20 °C in serum/plasma: 2.5 months at 20 – 25 °C 5 months at 4 – 8 °C

3 months at -20 °C

Discard contaminated specimens.

Calibrators and Controls For calibration of the urine/CSF determination, the DiaSys Albumin U/CSF calibrator set is recommended, whereas the DiaSys Calibrator set TruCal Protein is recommended for determination in serum. For internal quality control of the urine/CSF determination, DiaSys TruLab Albumin U/CSF control should be assayed. For internal quality control of the serum determination, DiaSys TruLab Protein control should be assayed. Each laboratory should establish corrective action in case of deviations in control recovery.

Cat. No. Kit size TruCal Albumin U/CSF (5 Level) 1 9300 99 10 059 5 x 1 mL TruCal Protein (5 Levels) 5 9200 99 10 039 5 x 1 mL TruLab Albumin U/CSF Level 1 5 9710 99 10 046 3 x 1 mL TruLab Albumin U/CSF Level 2 5 9720 99 10 046 3 x 1 mL TruLab Protein Level 1 5 9500 99 10 046 3 x 1 mL TruLab Protein Level 2 5 9510 99 10 046 3 x 1 mL TruLab Urine Level 1 5 9170 99 10 061 6 x 5 mL TruLab Urine Level 1 5 9170 99 10 062 20 x 5 mL TruLab Urine Level 2 5 9180 99 10 061 6 x 5 mL TruLab Urine Level 2 5 9180 99 10 062 20 x 5 mL

Performance Characteristics (Urine) Measuring range up to 350 mg/L (5.32 µmol/L) albumin (in case of higher concentrations re-measure samples after manual dilution or use rerun function) Limit of detection** 1 mg/L (0.0152 µmol/L) albumin No prozone effect up to 60000 mg/L (912 µmol/L) albumin On-board stability 6 weeks Calibration stability 6 weeks

Interferences < 10% by Hemoglobin up to 200 mg/dL Bilirubin (conjugated and unconjugated) up to 25 mg/dL

Precision

Within run (n=20) Sample 1 Sample 2 Sample 3 Mean [mg/L] 22.0 91.9 239 Mean [µmol/L] 0.34 1.40 3.63 Coefficient of variance [%] 2.21 1.11 0.86

Between run (n=20) Sample 1 Sample 2 Sample 3 Mean [mg/L] 23.8 93.7 241 Mean [µmol/L] 0.36 1.42 3.67 Coefficient of variance [%] 2.08 0.96 1.26

Method comparison (n=81) Test x Competitor Microalbumin Test y DiaSys Albumin in Urine/CSF FS Slope 1.06 Intercept 0.921 mg/L (0.014 µmol/L) Coefficient of correlation 0.997

** lowest measurable concentration which can be distinguished from zero mean + 3 SD (n=20) of an analyte free specimen

Conversion factor Urine/CSF: Albumin [mg/L] x 0.0152 = Albumin [µmol/L]

Urine: Albumin [mg/g crea] x 0.113 = Albumin [g/mol crea]

Reagent information

Performance Characteristics (Serum) Measuring range up to 110 g/L (1672 µmol/L) albumin (in case of higher concentrations re-measure samples after manual dilution or use rerun function) Limit of detection** 1.0 g/L (15.2 µmol/L) albumin No prozone effect up to 200 g/L (3040 µmol/L) albumin On-board stability 6 weeks Calibration stability 6 weeks

Interferences < 10% by Hemoglobin up to 1000 mg/dL Bilirubin (conjugated and unconjugated) up to 60 mg/dL Lipemia (triglycerides) up to 2000 mg/dL

Precision

Within run (n=20) Sample 1 Sample 2 Sample 3 Mean [g/L] 26.0 34.0 41.0 Mean [µmol/L] 396 517 622 Coefficient of variance [%] 1.11 1.87 1.44

Between run (n=20) Sample 1 Sample 2 Sample 3 Mean [g/L] 25.8 34.6 41.5 Mean [µmol/L] 393 526 631 Coefficient of variance [%] 2.13 2.25 1.73

Method comparison (n=100) Test x Competitor Microalbumin Test y DiaSys Albumin in Urine/CSF FS Slope 1.0 Intercept 0.45 g/L (6.84 µmol/L) Coefficient of correlation 0.9998


Conversion factor Serum/plasma: Albumin [g/L] x 15.2 = Albumin [µmol/L] Albumin [g/dL] x 152 = Albumin [µmol/L]

Reference Range Urine [3,4]: Albumin excretion rate in urine: < 30 mg/24 h (< 0.456 µmol/24 h) Albumin concentration (early morning urine): < 30 mg/L (< 0.456 µmol/L) Albumin/creatinine ratio (first morning urine): < 30 mg/g Creatinine (< 3.39 g/mol Creatinine)

CSF/Serum albumin ratio (RAlb) adults [5]: < 7 x 10 -3

Serum/plasma [6]: 35 – 53 g/L (3.5 – 5.3 g/dL)

Each laboratory should check if the reference ranges are transferable to its own patient population and determine own reference ranges if necessary.

Literature

1. Guder WG, Zawta B et al. The Quality of Diagnostic Samples. 1st ed. Darmstadt: GIT Verlag; 2001; p. 14-5, 50-1, 54-5.

2. Dati F, Schumann G, Thomas L, Aguzzi F, Baudner S, Bienvenu J et al. Consensus of a group of professional societies and diagnostic companies on guidelines for interim reference ranges for 14 proteins in serum based on the standardization against the IFCC/BCR/CAP reference material (CRM 470). Eur J Clin Chem Clin Biochem 1996; 34: 517-20.

3. Dati F, Metzmann E. Proteins-Laboratory testing and clinical use. 1st ed. Holzheim: DiaSys Diagnostic Systems; 2005: p. 93.

4. Sacks DB, Bruns DE, Goldstein DE, Mac Laren NK, Mc Donald JM, Parrott M. Guidelines and recommendations for laboratory analysis in the diagnosis and management of diabetes mellitus. Clin Chem 2002; 48: 459-62.

5. Thomas L. Clinical Laboratory Diagnostics. 1st ed. Frankfurt: TH-Books Verlagsgesellschaft; 1998. p. 1312.

6. Thomas L. Clinical Laboratory Diagnostics. 1st ed. Frankfurt: TH-Books Verlagsgesellschaft; 1998. p. 652-3.

7. Johnson AM, Rohlfs EM, Silverman LM. Proteins. In: Burtis CA, Ashwood ER. editors. Tietz textbook of clinical chemistry. 3rd ed. Philadelphia: W. B. Saunders Company; 1999. p. 477-540.

Manufacturer DiaSys Diagnostic Systems GmbH Alte Strasse 9 65558 Holzheim Germany IVD

Application BioMajesty JCA-BM6010/C February 2011/1

Albumin in Urine/CSF FS

Chemistry code 10 024

Application for serum and plasma samples

This application was set up and evaluated by DiaSys. It is based on the standard equipment at that timeand does not apply to any equipment modifications undertaken by unqualified personnel.

# entered by user

Analytical ConditionsR1 volume 125R2e volume 0R2 volume 25R1 diluent vol 0R2e diluent vol 0R2 diluent vol 0Sample vol (S) 1Sample vol (U) 1Reagent 1 mix weakReagent 2e mix weakReagent 2 mix weakReaction time 10

Sub-analy. ConditionsName MALBSDigits 1M-wave L. 571S-wave.L 805Analy.mthd. EPACalc.mthd. MSTDQualit. judge No

Analysis Test Condition Setting (M)Sample Type Serum UrineReac. sample vol. 1 1Diluent method With dil No dilUndil. sample vol. 5 0Diluent volume 95 0Diluent position # 0

Endpoint MethodRe.absorb (u) 9.999Re.absorb (d) -9.999

Calculation Method SettingM-DET.P.I 2M-DET.P.m 41M-DET.P.n 42S-DET.P.p 17S-DET.P.r 18Check D.P.I. 0Limit value 0.003Variance 10Reac.type Inc

Reaction Rate MethodCycle 2Factor 2E2 corre Not doBlank (u) 9.999Blank (d) -9.999Sample (u) 9.999Sample (d) -9.999

ProzoneProzone form NoProzone limit 9.999Prozone judge Upper limitJudge limit 9.999M-DET.P.m 0M-DET.P.n 0S-DET.P.p 0S-DET.P.r 0

MULTI-STD SettingFormula Spline Axis Conv No convBlank Not passes Points 6

FV Reac.smp. vol.

Dil.method

Dil. smp.vol.

Diluentvol.

Diluentpos.

STD H STD L

BLK # 1 With dil 5 95 # 9.999 -9.9991 # 1 With dil 5 95 # 9.999 -9.9992 # 1 With dil 5 95 # 9.999 -9.9993 # 1 With dil 5 95 # 9.999 -9.9994 # 1 With dil 5 95 # 9.999 -9.9995 # 1 With dil 5 95 # 9.999 -9.999


Albumin in Urine/CSF FS


Application for CSF and urine samples


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Sub-analy. ConditionsName MALBUDigits 1M-wave L. 410S-wave.L 805Analy.mthd. EPACalc.mthd. MSTDQualit. judge No

Analysis Test Condition Setting (M)Sample Type Serum UrineReac. sample vol. 4 4Diluent method No dil No dilUndil. sample vol. 0 0Diluent volume 0 0Diluent position 0 0






FV Reac.smp. vol.

Dil.method

Dil. smp.vol.

Diluentvol.

Diluentpos.

STD H STD L

BLK # 4 No dil 0 0 0 9.999 -9.9991 # 4 No dil 0 0 0 9.999 -9.9992 # 4 No dil 0 0 0 9.999 -9.9993 # 4 No dil 0 0 0 9.999 -9.9994 # 4 No dil 0 0 0 9.999 -9.9995 # 4 No dil 0 0 0 9.999 -9.999


Albumin FS*

Diagnostic reagent for quantitative in vitro determination of albumin in serum or plasma on BioMajesty JCA-BM6010/C

Order Information Cat. No. Tests 1 0220 99 10 960 R 4 x 245 tests

1 0220 99 10 967 R 6 x 250 tests

Method Photometric test using bromocresol green

Principle In the presence of bromocresol green at a slightly acid pH, serum albumin produces a color change of the indicator from yellow-green to green-blue.

Reagents

Components and Concentrations Citrate buffer pH 4.2 30 mmol/L Bromocresol green 0.26 mmol/L

Storage Instructions and Reagent Stability The reagent is stable up to the end of the indicated month of expiry, if stored at 2 – 25 °C, protected from ligh t and contamination is avoided. Do not freeze the reagent!

Warnings and Precautions Please refer to the safety data sheets and take the necessary precautions for the use of laboratory reagents.


Reagent Preparation The reagent is ready to use. The bottles are placed directly into the reagent trays.

Specimen Serum, heparin plasma or EDTA plasma Stability [1]: 2.5 months at 20 - 25 °C 5 months at 4 - 8 °C 3 months at -20 °C Discard contaminated specimens.

Calibrators and Controls

For calibration, DiaSys TruCal U calibrator is recommended. For internal quality control DiaSys TruLab N and P controls should be assayed. Each laboratory should establish corrective action in case of deviations in control recovery.

Performance Characteristics Measuring range up to 6 g/dL (60 g/L) albumin (in case of higher concentrations re-measure samples after manual dilution or use rerun function) Limit of detection** 0.1 g/dL (1 g/L) albumin On-board stability 6 weeks Calibration stability 6 weeks

Interferences < 10% by Ascorbate up to 30 mg/dL Bilirubin (conjugated and unconjugated) up to 60 mg/dL Hemoglobin up to 300 mg/dL Lipemia (triglycerides) up to 1200 mg/dL

Precision

Within run (n=20) Sample 1 Sample 2 Sample 3 Mean [g/dL] 3.26 4.03 4.48 Mean [g/L] 32.6 40.3 44.8 Coefficient of variation [%] 1.00 0.63 1.02

Between run (n=20) Sample 1 Sample 2 Sample 3 Mean [g/dL] 3.96 4.53 2.46 Mean [g/L] 39.6 45.3 24.6 Coefficient of variation [%] 0.73 0.98 1.42

Method comparison (n=100) Test x Competitor Albumin (ALB) Test y DiaSys Albumin FS Slope 0.987 Intercept 0.168 g/dL (1.68 g/L) Coefficient of correlation 0.997

** lowest measurable concentration which can be distinguished from zero mean + 3 SD (n = 20) of an analyte free specimen

Conversion factor Albumin [g/dL] x 144.9 = Albumin [µmol/L] Albumin [g/L] x 14.49 = Albumin [µmol/L]

Reference Range [2] Adults: 3.5 – 5.2 g/dL (35 – 52 g/L) Each laboratory should check if the reference ranges are transferable to its own patient population and determine own reference ranges if necessary.

Literature 1. Guder WG, Zawta B et al. The Quality of Diagnostic Samples. 1st ed.

Darmstadt: GIT Verlag; 2001; p. 14-5. 2. Dati F, Schumann G, Thomas L, Aguzzi F, Baudner S, Bienvenu J et

al. Consensus of a group of professional societies and diagnostic companies on guidelines for interim reference ranges for 14 proteins in serum based on the standardization against the IFCC/BCR/CAP reference material (CRM 470). Eur J Clin Chem Clin Biochem 1996; 34: 517-20.



Manufacturer DiaSys Diagnostic Systems GmbH Alte Strasse 9 65558 Holzheim Germany

Cat. No. Kit size TruCal U 5 9100 99 10 063 20 x 3 mL 5 9100 99 10 064 6 x 3 mL TruLab N 5 9000 99 10 062 20 x 5 mL 5 9000 99 10 061 6 x 5 mL TruLab P 5 9050 99 10 062 20 x 5 mL 5 9050 99 10 061 6 x 5 mL

IVD

Application BioMajesty JCA-BM6010/C June 2011/2

Albumin FS



This application was set up and evaluated by DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by unqualified personnel.

# entered by user

Endpoint method Re.absorb (u) 9.999 Re. Absorb (d) -9.999 Calculation Method Setting M-DET.P.I 0 M-DET.P.m 7 M-DET.P.n 9 S-DET.P.p 0 S-DET.P.r 0 Check D.P.I. 0 Limit value 0.003 Variance 10 Reac.type Inc Reaction Rate Method Cycle 3 Factor 3 E2 corre Not do Blank (u) 9.999 Blank (d) -9.999 Sample (u) 9.999 Sample (d) -9.999 Standards Setting FV # BLK H 9.999 BLK L -9.999 STD H 9.999 STD L -9.999

Analytical Conditions R1 volume 90 R2e volume 0 R2 volume 0 R1 diluent vol 0 R2e diluent vol 0 R2 diluent vol 0 Sample vol (S) 1 Sample vol (U) 1 Reagent 1 mix weak Reagent 2e mix weak Reagent 2 mix weak Reaction time 3

Sub-analy. Conditions Name ALB Digits 1 M-wave L. 596 S-wave.L 694 Analy.mthd. EPA Calc.mthd. STD Qualit. judge No

Analysis Test Condition Setting (M) Sample Type Serum Urine Reac. sample vol. 1 1 Diluent method No dil No dil Undil. sample vol. 0 0 Diluent volume 0 0 Diluent position 0 0

Reagent Information * fluid stable

ALAT (GPT) FS* (IFCC mod.)

with/without pyridoxal-5-phosphate

Diagnostic reagent for quantitative in vitro determination of ALAT (GPT) in serum or plasma onBioMajesty JCA-BM6010/C

Order InformationCat. No. 1 2701 99 10 962R1: 6 x 230 testsR2: 6 x 230 tests

Pyridoxal-5-Phosphate FSCat. No. 2 5010 99 10 0306 x 3 mL

MethodOptimized UV-test according to IFCC (International Federation ofClinical Chemistry and Laboratory Medicine) [modified]

Principle

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

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

+

Addition of pyridoxal-5-phosphate (P-5-P) stabilizes the activity oftransaminases and avoids falsely low values in samples containinginsufficient endogenous P-5-P, e.g. from patients with myocardialinfarction, liver disease and intensive care patients [1].

Reagents

Components and Concentrations

R1: TRIS pH 7.15 140 mmol/LL-Alanine 700 mmol/LLDH (lactate dehydrogenase) 2300 U/L

R2: 2-Oxoglutarate 85 mmol/LNADH 1 mmol/L

Pyridoxal-5-Phosphate FSGood’s buffer pH 9.6 100 mmol/LPyridoxal-5-phosphate 13 mmol/L

Storage Instructions and Reagent Stability

The reagents are stable up to the end of the indicated month ofexpiry, if stored at 2 – 8 °C, protected from light and contaminationis avoided. Do not freeze the reagents!

Warnings and Precautions

1. The reagents contain sodium azide (0.95 g/L) aspreservative. Do not swallow! Avoid contact with skin andmucous membranes.

2. Please refer to the safety data sheets and take the necessaryprecautions for the use of laboratory reagents.

Waste Management

Please refer to local legal requirements.

Reagent Preparation

The reagents are ready to use. The bottles are placed directly intothe reagent trays.For the determination with P-5-P add 250 µL of P-5-P to reagent 1and mix gently.

Stability after mixing: 6 days at 2 - 8 °C24 hours at 15 - 25 °C

SpecimenSerum, heparin plasma or EDTA plasma

Stability [2]:3 days at 20 - 25 °C7 days at 4 - 8 °C7 days at -20 °C


Calibrators and ControlsFor calibration the DiaSys TruCal U calibrator is recommended.For internal quality control DiaSys TruLab N and P controls shouldbe assayed. Each laboratory should establish corrective actions incase of deviations in control recovery.

Performance Characteristics(with P-5-P activation)

Measuring range up to 600 U/L (10 µkat/L) ALAT(in case of higher activities re-measure samples after manual dilution oruse rerun function)Limit of detection** 0.6 U/L (0.01 µkat/L) ALATOn-board stability 6 daysCalibration stability 6 days

Interferences < 10% byAscorbate up to 30 mg/dLHemoglobin up to 500 mg/dLConjugated bilirubin up to 54 mg/dLUnconjugated bilirubin up to 54 mg/dLLipemia (triglycerides) up to 400 mg/dL

Precision

Within run (n=20) Sample 1 Sample 2 Sample 3

Mean [U/L] 33.7 80.2 192Mean [µkat/L] 0.562 1.34 3.20Coefficient of variation [%] 1.37 0.89 0.80

Between run (n=20) Sample 1 Sample 2 Sample 3


Method comparison (n=100)Test x Competitor ALAT (GPT)Test y DiaSys ALAT (GPT) FSSlope 1.020Intercept 1.74 U/L (0.029 µkat/L)Coefficient of correlation 1.000

** lowest measurable activity which can be distinguished from zeromean + 3 SD (n=20) of an analyte free specimen

Conversion factor

ALAT [U/L] x 0.0167 = ALAT [µkat/L]

Cat. No. Kit sizeTruCal U 5 9100 99 10 063 20 x 3 mL

5 9100 99 10 064 6 x 3 mLTruLab N 5 9000 99 10 062 20 x 5 mL

5 9000 99 10 061 6 x 5 mLTruLab P 5 9050 99 10 062 20 x 5 mL

5 9050 99 10 061 6 x 5 mL

Reagent Information

(without P-5-P activation)

Measuring range up to 600 U/L (10 µkat/L) ALAT(in case of higher activities re-measure samples after manual dilution oruse the rerun function)Limit of detection*** 0.6 U/L (0.01 µkat/L) ALATOn-board stability 6 weeksCalibration stability 6 weeks


Precision

Within run (n=20) Sample 1 Sample 2 Sample 3Mean [U/L] 34.5 82.0 190Mean [µkat/L] 0.576 1.37 3.18Coefficient of variation [%] 1.54 1.23 0.85



Method comparison (n=100)Test (x) Competitor ALAT (GPT)Test (y) DiaSys ALAT (GPT) FSSlope 1.000Intercept -0.60 U/L (-0.01 µkat/L)Coefficient of correlation 1.000

*** lowest measurable activity which can be distinguished from zeromean + 3 SD (n=20) of an analyte free specimen

Conversion factor

ALAT [U/L] x 0.0167 = ALAT [µkat/L]

Reference Range

With pyridoxal-5-phosphate activation

Women [3] < 34 U/L < 0.57 µkat/LMen [3] < 45 U/L < 0.75 µkat/LChildren [1] 1 – 30 day(s) < 25 U/L < 0.42 µkat/L

2 – 12 months < 35 U/L < 0.58 µkat/L1 – 3 year(s) < 30 U/L < 0.50 µkat/L

4 – 6 years < 25 U/L < 0.42 µkat/L7 – 9 years < 25 U/L < 0.42 µkat/L

10 – 18 years < 30 U/L < 0.50 µkat/L

Without pyridoxal-5-phosphate activation

Women < 31 U/L < 0.52 µkat/LMen < 41 U/L < 0.68 µkat/L

Each laboratory should check if the reference ranges aretransferable to its own patient population and determine ownreference ranges if necessary.

Literature1. Thomas L. Alanine aminotransferase (ALT), Aspartate

aminotransferase (AST). In: Thomas L, editor. Clinical LaboratoryDiagnostics. 1

sted. Frankfurt: TH-Books Verlagsgesellschaft; 1998.

p. 55-65.2. Guder WG, Zawta B et al. The Quality of Diagnostic Samples. 1

sted.

Darmstadt: GIT Verlag; 2001; p. 14-5.3. Schumann G, Bonora R, Ceriotti F, Férard G et al. IFCC primary

reference procedure for the measurement of catalytic activityconcentrations of enzymes at 37 °C. Part 5: Reference procedure forthe measurement of catalytic concentration of alanineaminotransferase. Clin Chem Lab Med 2002; 40: 718-24.

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

ManufacturerDiaSys Diagnostic Systems GmbHAlte Strasse 9 65558 Holzheim GermanyIVD

Application BioMajesty JCA-BM6010/C December 2010/2

ALAT (GPT) FS (IFCC mod.)



This application was set up and evaluated by DiaSys. It is based on the standard equipment at that time anddoes not apply to any equipment modifications undertaken by unqualified personnel.

# entered by user

Endpoint methodRe.absorb (u) 9.999Re. Absorb (d) -9.999

Calculation Method SettingM-DET.P.I 21M-DET.P.m 25M-DET.P.n 42S-DET.P.p 0S-DET.P.r 0Check D.P.I. 21Limit value 0.003Variance 10Reac.type Dec

Reaction Rate MethodCycle 2Factor 2E2 corre DoBlank (u) 9.999Blank (d) -9.999Sample (u) 9.999Sample (d) -9.999

Standards SettingFV #BLK H 9.999BLK L -9.999STD H 9.999STD L -9.999

Analytical ConditionsR1 volume 80R2e volume 0R2 volume 20R1 diluent vol 0R2e diluent vol 0R2 diluent vol 0Sample vol (S) 6Sample vol (U) 6Reagent 1 mix weakReagent 2e mix strongReagent 2 mix strongReaction time 10

Sub-analy. ConditionsName ALTDigits 2M-wave L. 340S-wave.L 410Analy.mthd. RRACalc.mthd. STDQualit. judge No


Reagent Information * complete color** fluid stable

α-Amylase CC* FS**

Diagnostic reagent for quantitative in vitro determination of α-amylase in serum, plasma or urine onBioMajesty JCA-BM6010/C


MethodEnzymatic photometric test, in which the substrate 4,6-ethylidene-(G7)-p-nitrophenyl-(G1)-α-D-maltoheptaoside (EPS-G7) is cleavedby α-amylases into various fragments. These are furtherhydrolyzed in a second step by α-glucosidase producing glucoseand p-nitrophenol. The increase in absorbance represents the total(pancreatic and salivary) amylase activity in the sample [1,2].

Principle

5 EPS-G7 + 5 HO α-Amylase 2 Ethylidene-G5 + 2 G2PNP+ 2 Ethylidene-G4 + 2 G3PNP+ Ethylidene-G3 + G4PNP

2 G2PNP + 2 G3PNP + G4PNP + 14 H2O α-Glucosidase 5 PNP + 14 G

(PNP = p-Nitrophenol, G =Glucose)

Reagents


R1: Good's buffer pH 7.15 0.1 mol/LNaCl 62.5 mmol/LMgCl2 12.5 mmol/Lα-Glucosidase 2 kU/L

R2: Good's buffer pH 7.15 0.1 mol/LEPS-G7 8.5 mmol/L




1. Saliva and skin contain α-Amylase, therefore, avoid contactwith the reagents.



Waste Management


Reagent Preparation

The reagents are ready to use. The bottles are placed directly intothe reagent trays.

SpecimenSerum, heparin plasma or EDTA plasma, urine

Stability in serum or plasma [3]:7 days at 20 – 25 °C7 days at 4 – 8 °C1 year at -20 °CStability in urine [3]:2 days at 20 – 25 °C10 days at 4 – 8 °C3 weeks at -20 °C


Calibrators and ControlsFor calibration the DiaSys TruCal U calibrator is recommended.For internal quality control DiaSys TruLab N, TruLab P and TruLabUrine controls should be assayed. Each laboratory shouldestablish corrective actions in case of deviations in controlrecovery.


5 9100 99 10 064 6 x 3 mLTruLab N 5 9000 99 10 062 20 x 5 mL

5 9000 99 10 061 6 x 5 mLTruLab P 5 9050 99 10 062 20 x 5 mL

5 9050 99 10 061 6 x 5 mLTruLab Urine Level 1 5 9170 99 10 062 20 x 5 mL


5 9180 99 10 061 6 x 5 mL

Performance CharacteristicsMeasuring range up to 1920 U/L (32 µkat/L) α-amylase(in case of higher activities re-measure samples after manual dilution oruse rerun function)Limit of detection*** 0.6 U/L (0.01 µkat/L) α-amylaseOn-board stability 6 weeksCalibration stability 6 weeks

Interferences < 10% byAscorbate up to 30 mg/dLConjugated bilirubin up to 60 mg/dLUnconjugated bilirubin up to 60 mg/dLLipemia (triglycerides) up to 1200 mg/dLHemolysis interferes

Precision (Serum/plasma)

Within run (n=20) Sample 1 Sample 2 Sample 3Mean [U/L] 36.9 74.9 238Mean [µkat/L] 0.616 1.25 3.97Coefficient of variation [%] 1.86 1.11 0.78


Mean [U/L] 37.2 119 242Mean [µkat/L] 0.622 1.98 4.04Coefficient of variation [%] 1.83 1.59 1.90

Method comparison (Serum/plasma; n=100)

Test x Competitor α-AmylaseTest y DiaSys α-Amylase CC FSSlope 0.973Intercept -3.17 U/L (-0.053 µkat/L)Coefficient of correlation 0.999

Precision (Urine)



Between run (n=20) Sample 1 Sample 2 Sample 3Mean [U/L] 16.7 44.7 126Mean [µkat/L] 0.279 0.747 2.10Coefficient of variation [%] 2.30 0.79 0.76

Method comparison (Urine; n=100)Test x Competitor α-AmylaseTest y DiaSys α-Amylase CC FSSlope 0.986Intercept -1.50 U/L (-0.025 µkat/L)Coefficient of correlation 0.999


Reagent Information

Conversion factor

α-Amylase [U/L] x 0.0167 = α-Amylase [µkat/L]

Reference Range [4]

Women MenSerum/plasma

< 100 U/L (< 1.67 µkat/L) < 100 U/L (< 1.67 µkat/L)

Urine < 447 U/L (< 7.45 µkat/L) < 491 U/L (< 8.18 µkat/L)


Literature1. Kruse-Jarres JD, Kaiser C, Hafkenscheid JC, Hohenwallner W, Stein

W., Bohner J et al. Evaluation of a new alpha-amylase assay using

4,6-ethylidene-(G7)-1-4-nitrophenyl-(G1)-alpha-D-maltoheptaoside as

substrate. J Clin Chem Biochem 1989; 27: 103-13.

2. Schumann G, Aoki R, Ferrero CA et al. IFCC primary reference

procedures for the measurement of catalytic activity concentrations of

enzymes at 37 °C. Clin Chem Lab Med 2006; 44(9): 1146-1155.3. Guder WG, Zawta B et al. The Quality of Diagnostic Samples. 1st ed.

Darmstadt: GIT Verlag; 2001; p. 16-7, 50-1.

4. Junge W, Wortmann W, Wilke B, Waldenstroem J et al. Development

and evaluation of assays for determination of total and pancreatic

amylase at 37 °C according to the principle recommended by the

IFCC. Clin Biochem 2001; 34: 607-15.

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

diagnostics. 1st ed. Frankfurt: TH-Books Verlagsgesellschaft; 1998.

p. 192-202.

6. Moss DW, Henderson AR. Digestive enzymes of pancreatic origin. In:

Burtis CA, Ashwood ER, editors. Tietz Textbook of Clinical Chemistry.

3rd ed. Philadelphia: W.B Saunders Company; 1999. p.689-98.

ManufacturerDiaSys Diagnostic Systems GmbHAlte Strasse 9 65558 Holzheim Germany

IVD

Application BioMajesty JCA-BM6010/C July 2010/1

α-Amylase CC FS


Application for serum, plasma and urine samples


# entered by user





Analytical ConditionsR1 volume 80R2e volume 0R2 volume 20R1 diluent vol 0R2e diluent vol 0R2 diluent vol 0Sample vol (S) 1.5Sample vol (U) 1.5Reagent 1 mix weakReagent 2e mix weakReagent 2 mix weakReaction time 10

Sub-analy. ConditionsName AMYDigits 2M-wave L. 410S-wave.L 694Analy.mthd. RRACalc.mthd. STDQualit. judge No

Analysis Test Condition Setting (M)Sample Type Serum UrineReac. sample vol. 1.5 1.5Diluent method No dil With dilUndil. sample vol. 0 25Diluent volume 0 25Diluent position 0 0


Alkaline phosphatase FS* (IFCC mod. 37 °C) Diagnostic reagent for quantitative in vitro determ ination of alkaline phosphatase (AP) in serum or pl asma on BioMajesty JCA-BM6010/C

Order Information Cat. No. 1 0441 99 10 962 R1: 6 x 220 tests R2: 6 x 220 tests

Method Kinetic photometric test according to IFCC (International Federation of Clinical Chemistry and Laboratory Medicine) [modif.]

Principle p-Nitrophenylphosphate + H2O AP Phosphate + p-Nitrophenol

Reagents

Components and Concentrations R1: 2-Amino-2-methyl-1-propanol pH 10.4 1.1 mol/L Magnesium acetate 2 mmol/L Zinc sulphate 0.5 mmol/L HEDTA 2.5 mmol/L R2: p-Nitrophenylphosphate 80 mmol/L

Storage Instructions and Reagent Stability The reagents are stable up to the end of the indicated month of expiry, if stored at 2 – 8 °C, protected from light and contamination is avoided. Do not freeze the reagents!



2. 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 wash copiously with water!




Specimen Serum or heparin plasma Don’t use hemolytic samples! Stability [1]: 7 days at 20 – 25 °C 7 days at 4 – 8 °C 2 months at -20 °C Discard contaminated specimens.

Calibrators and Controls For calibration the DiaSys TruCal U calibrator is recommended. For internal quality control DiaSys TruLab N and P controls should be assayed. Each laboratory should establish corrective actions in case of deviations in control recovery.

Performance Characteristics

Measuring range up to 1400 U/L (24 µkat/L) AP (in case of higher activities re-measure samples after manual dilution or use rerun function) Limit of detection** 0.6 U/L (0.01 µkat/L) AP On-board stability 11 days Calibration stability 11 days

Interferences < 10% by Ascorbate up to 30 mg/dL Hemoglobin up to 150 mg/dL Conjugated Bilirubin up to 60 mg/dL Unconjugated Bilirubin up to 36 mg/dL Lipemia (triglycerides) up to 2000 mg/dL

Precision Within run (n=20) Sample 1 Sample 2 Sample 3 Mean [U/L] 86.4 197 277 Mean [µkat/L] 1.44 3.29 4.62 Coefficient of variation [%] 0.66 0.72 0.53 Between run (n=20) Sample 1 Sample 2 Sample 3 Mean [U/L] 29.7 139 305 Mean [µkat/L] 0.496 2.32 5.08 Coefficient of variation [%] 3.10 1.49 1.70

Method comparison (n=100) Test x Competitor Alkaline phosphatase Test y DiaSys Alkaline phosphatase FS Slope 1.031 Intercept 3.96 U/L (0.066 µkat/L) Coefficient of correlation 1.000

** lowest measurable activity which can be distinguished from zero mean + 3 SD (n=20) of an analyte free specimen

Conversion factor AP [U/L] x 0.0167 = AP [µkat/L]

Reference Range

Adults [2] Women 20 - 50 years [U/L] 42 – 98 [µkat/L] 0.70 – 1.63 Men 20 - 50 years [U/L] 53 – 128 [µkat/L] 0.89 – 2.13 Women > 60 years [U/L] 53 – 141 [µkat/L] 0.88 – 2.35 Men > 60 years [U/L] 56 – 119 [µkat/L] 0.93 – 1.98

Children [3] Female Male 1 - 30 day(s) [U/L] 48 - 406 75 - 316 1 month - 1 year [U/L] 124 - 341 82 - 383 1 - 3 year(s) [U/L] 108 - 317 104 - 345 4 - 6 years [U/L] 96 - 297 93 - 309 7 - 9 years [U/L] 69 - 325 86 - 315 10 - 12 years [U/L] 51 - 332 42 - 362 13 - 15 years [U/L] 50 - 162 74 - 390 16 - 18 years [U/L] 47 - 119 52 - 171 Female Male 1 - 30 day(s) [µkat/L] 0.80 – 6.77 1.25 – 5.27 1 month - 1 year [µkat/L] 2.07 – 5.68 1.37 – 6.38 1 - 3 year(s) [µkat/L] 1.80 – 5.28 1.73 – 5.75 4 - 6 years [µkat/L] 1.60 – 4.95 1.55 – 5.15 7 - 9 years [µkat/L] 1.15 – 5.42 1.43 – 5.25 10 - 12 years [µkat/L] 0.85 – 5.53 0.70 – 6.03 13 - 15 years [µkat/L] 0.83 – 2.70 1.23 – 6.51 16 - 18 years [µkat/L] 0.78 – 1.98 0.87 – 2.85



Reagent Information


Darmstadt: GIT Verlag; 2001; p. 14-5. 2. Burtis CA, Ashwood ER. Eds. Tietz textbook of clinical chemistry. 3rd

ed. Philadelphia: W. B. Saunders Company, 1999. p. 1829. 3. Soldin JS, Brugnara C., Wong CE. In: MJ Hicks, editor. Pediatric

reference intervals. 6th ed. Washington: AACC Press, 2007. p. 11. 4. Thomas L. Clinical Laboratory Diagnostics. 1st ed. Frankfurt: TH-Books

Verlagsgesellschaft; 1998. p. 36-46. 5. Tietz NW, Rinker D, Shaw LM. IFCC method for alkaline phosphatase.

J Clin Chem Clin Biochem 1983; 21: p. 731-48. 6. Moss DW, Henderson AR. Clinical enzymology. In: Burtis CA,

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


IVD

Application BioMajesty JCA-BM6010/C April 2011/3

Alkaline phosphatase FS IFCC 37 °C




# entered by user






Sub-analy. ConditionsName APDigits 2M-wave L. 410S-wave.L 694Analy.mthd. RRACalc.mthd. STDQualit. judge No

Analysis Test Condition Setting (M)Sample Type Serum UrineReac. sample vol. 1.5 1.5Diluent method No dil No dilUndil. sample vol. 0 0Diluent volume 0 0Diluent position 0 0


Apolipoprotein A1 FS*

Diagnostic reagent for quantitative in vitro determination of apolipoprotein A1 (Apo A1) in serum or plasma on BioMajesty JCA-BM6010/C



Principle Determination of the concentration of Apo A1 via photometric measurement of antigen-antibody-reaction between antibodies to human Apo A1 and Apo A1 present in the sample.

Reagents Components and Concentrations R1: TRIS pH 7.5 100 mmol/L Polyethylenglycol (PEG), detergents, stabilizers R2: TRIS pH 7.5 100 mmol/L Anti-human apolipoprotein A1antibody (goat) with stabilizers

Storage Instructions and Reagent Stability The reagents are stable up to the end of the indicated month of expiry, if stored at 2 – 8 °C, protected from light and contam ination is avoided. Do not freeze the reagents!

Warnings and Precautions 1. The reagents contain sodium azide (0.95 g/L) as preservative. Do not

swallow! Avoid contact with skin and mucous membranes! 2. Please refer to the safety data sheets and take the necessary

precautions for the use of laboratory reagents.



Specimen Serum, heparin plasma or EDTA plasma

Stability [1]: 1 day at 20 - 25 °C 3 days at 4 - 8 °C 2 months at -20 °C Freeze only once! Discard contaminated specimens.

Calibrators and Controls For calibration the DiaSys TruCal HDL/LDL calibrator set is recommended. Please refer to the red insert sheet of TruCal HDL/LDL for procedure. For internal quality control a DiaSys TruLab L control should be assayed. Each laboratory should establish corrective action in case of deviations in control recovery.

Performance Characteristics Measuring range up to 250 mg/dL (89.3 µmol/L) Apo A1, at least up to the concentration of the highest calibrator (in case of higher concentrations re-measure samples after manual dilution or use the rerun function). Limit of detection** 0.5 mg/dL (0.178 µmol/L) Apo A1 No prozone effect up to 500 mg/dL (179 µmol/L) Apo A1 On-board stability 6 weeks Calibration stability 6 weeks


Precision

Within run (n=20) Sample 1 Sample 2 Sample 3 Mean [mg/dL] 107 133 165 Mean [µmol/L] 38.3 47.6 58.9 Coefficient of variance [%] 1.18 1.20 1.50

Between run (n=20) Sample 1 Sample 2 Sample 3 Mean [mg/dL] 130 286 468 Mean [µmol/L] 46.4 102 167 Coefficient of variance [%] 2.13 1.51 2.04

Method comparison (n=94) Test x Competitor Apolipoprotein A1 Test y DiaSys Apolipoprotein A1 FS Slope 0.967 Intercept -3.11 mg/dL (-1.11 µmol/L) Coefficient of correlation 0.996


Conversion factor Apo A1 [mg/dL] x 0.357 = Apo A1 [µmol/L]

Reference Range

Mean values according to data reported in [2]


Clinical Interpretation Several studies indicate that increased concentrations of Apo B (> 150 mg/dL (> 2.73 µmol/L) in women and > 155 mg/dL (> 2.82 µmol/L) in men) and decreased concentrations of Apo A1 (< 120 mg/dL (< 42.8 µmol/L) in women and < 110 mg/dL (< 39.3 µmol/L) in men) may be good predictors of risk of CHD. [3]


Darmstadt: GIT Verlag; 2001; p. 18-9. 2. Jungner I, Marcovina SM, Walldius G, Holme I, Kolar W, Steiner E.

Apolipoprotein B and A-I values in 147576 Swedish males and females, standardized according to the World Health Organization-International Federation of Clinical Chemistry First International Reference Materials. Clin Chem 1998; 44: 1641-9.

3. Rifai N, Bachorik PS, Albers JJ. Lipids, lipoproteins and apolipoproteins. In: Burtis CA, Ashwood ER, editors. Tietz Textbook of Clinical Chemistry. 3rd ed. Philadelphia: W.B Saunders Company; 1999. p. 809-61.

4. Bhatnagar D, Durrington PN. Measurement and clinical significance of apolipoproteins A-I and B. In: Rifai N, Warnick GR, Dominiczak MH, eds. Handbook of lipoprotein testing. Washington: AACC Press, 1997: p. 177-98.


Cat. No. Kit size TruLab L Level 1 5 9020 99 10 065 3 x 3 mL TruLab L Level 2 5 9030 99 10 065 3 x 3 mL

mg/dL g/L µmol/L Women 120 – 190 1.20 – 1.90 42.8 – 67.8 Men 110 – 170 1.10 – 1.70 39.3 – 60.7

IVD

Application BioMajesty JCA-BM6010/C October 2011/1

Apolipoprotein A1 FS

Chemistry code 10 710 Application for serum and plasma samples This application was set up and evaluated by DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by unqualified personnel.

# entered by user

Analytical Conditions R1 volume 100 R2e volume 0 R2 volume 20 R1 diluent vol 0 R2e diluent vol 0 R2 diluent vol 0 Sample vol (S) 1.0 Sample vol (U) 1.0 Reagent 1 mix weak Reagent 2e mix weak Reagent 2 mix weak Reaction time 10

Sub-analy. Conditions Name APOA1 Digits 2 M-wave L. 571 S-wave.L 694 Analy.mthd. EPA Calc.mthd. MSTD Qualit. judge No

Analysis Test Condition Setting (M) Sample Type Serum Urine Reac. sample vol. 1.0 1.0 Diluent method No dil No dil Undil. sample vol. 0 0 Diluent volume 0 0 Diluent position 0 0

Endpoint Method Re.absorb (u) 9.999 Re.absorb (d) -9.999 Calculation Method Setting M-DET.P.I 0 M-DET.P.m 41 M-DET.P.n 42 S-DET.P.p 17 S-DET.P.r 18 Check D.P.I. 0 Limit value 0.003 Variance 10 Reac.type Inc

Reaction Rate Method Cycle 2 Factor 2 E2 corre Not do Blank (u) 9.999 Blank (d) -9.999 Sample (u) 9.999 Sample (d) -9.999 Prozone Prozone form No Prozone limit 9.999 Prozone judge Upper limit Judge limit 9.999 M-DET.P.m 0 M-DET.P.n 0 S-DET.P.p 0 S-DET.P.r 0

MULTI-STD Setting Formula Logit Log 1 Axis Conv No conv Blank passes Points 4

FV Reac.

smp. vol. Dil.

method Dil. smp.

vol. Diluent

vol. Diluent

pos. STD H STD L

BLK # 1.0 No dil 0 0 0 9.999 -9.999 1 # 1.0 No dil 0 0 0 9.999 -9.999 2 # 1.0 No dil 0 0 0 9.999 -9.999 3 # 1.0 No dil 0 0 0 9.999 -9.999 4 # 1.0 No dil 0 0 0 9.999 -9.999 5 # 1.0 No dil 0 0 0 9.999 -9.999


Apolipoprotein B FS*

Diagnostic reagent for quantitative in vitro determination of apolipoprotein B (Apo B) in serum or plasma on BioMajesty JCA-BM6010/C



Principle Determination of the concentration of Apo B via photometric measurement of antigen-antibody-reaction between antibodies to human Apo B and Apo B present in the sample.

Reagents

Components and Concentrations R1: TRIS pH 7.5 100 mmol/L Polyethylenglycol (PEG), detergents, stabilizers R2: TRIS pH 7.5 65 mmol/L Anti-human apolipoprotein B antibody (goat) with stabilizers


Warnings and Precautions 1. The reagents contain sodium azide (0.95 g/L) as preservative.

Do not swallow! Avoid contact with skin and mucous membranes!




Specimen Serum, heparin plasma or EDTA plasma Stability [1]: 1 day at 20 - 25 °C 3 days at 4 - 8 °C 2 months at -20 °C Freeze only once! Discard contaminated specimens.


For calibration the DiaSys TruCal Apo B calibrator set is recommended. For internal quality control a DiaSys TruLab L control should be assayed. Each laboratory should establish corrective action in case of deviations in control recovery.

Performance Characteristics Measuring range up to 250 mg/dL (4.55 µmol/L) Apo B, at least up to the concentration of the highest calibrator (in case of higher concentrations re-measure samples after manual dilution or use rerun function). Limit of detection** 0.5 mg/dL (0.01 µmol/L) Apo B No prozone effect up to 1000 mg/dL (18.2 µmol/L) Apo B On-board stability 6 weeks Calibration stability 6 weeks


Precision

Within run (n=20) Sample 1 Sample 2 Sample 3 Mean [mg/dL] 60.7 80.8 98.6 Mean [µmol/L] 1.10 1.47 1.79 Coefficient of variation [%] 1.36 1.27 1.23

Between run (n=20) Sample 1 Sample 2 Sample 3 Mean [mg/dL] 67.7 141 201 Mean [µmol/L] 1.23 2.57 3.66 Coefficient of variation [%] 0.92 1.31 1.55

Method comparison (n=100) Test x Competitor Apolipoprotein B Test y DiaSys Apolipoprotein B FS Slope 0.992 Intercept -15.3 mg/dL (-0.28 µmol/L) Coefficient of correlation 0.999


Conversion factor Apo B [mg/dL] x 0.0182 = Apo B [µmol/L]

Reference Range

Mean values according to data reported in [2] Each laboratory should check if the reference ranges are transferable to its own patient population and determine own reference ranges if necessary.

Clinical Interpretation Several studies indicate that increased concentrations of Apo B (> 150 mg/dL/> 2.73 µmol/L) in women and > 155 mg/dL/ > 2.82 µmol/L) in men and decreased concentrations of Apo A1 (< 120 mg/dL/< 42.8 µmol/L) in women and < 110 mg/dL/ < 39.3 µmol/L) in men may be good predictors of risk of CHD. [3]


Darmstadt: GIT Verlag; 2001; p. 18-9. 2. Jungner I, Marcovina SM, Walldius G, Holme I, Kolar W, Steiner E.

Apolipoprotein B and A-I values in 147576 Swedish males and females, standardized according to the World Health Organization-International Federation of Clinical Chemistry First International Reference Materials. Clin Chem 1998; 44: 1641-9.


4. Bhatnagar D, Durrington PN. Measurement and clinical significance of apolipoproteins A-I and B. In: Rifai N, Warnick GR, Dominiczak MH, eds. Handbook of lipoprotein testing. Washington: AACC Press, 1997: p. 177-98.


Cat. No. Kit size TruCal Apo B (3 levels) 1 7110 99 10 041 3 x 1 mL TruLab L Level 1 5 9020 99 10 065 3 x 3 mL TruLab L Level 2 5 9030 99 10 065 3 x 3 mL

mg/dL g/L µmol/L Women 75 – 150 0.75 – 1.50 1.37 – 2.73 Men 80 – 155 0.80 – 1.55 1.46 – 2.82

IVD

Application BioMajesty JCA-BM6010/C October 2011/1

Apolipoprotein B FS




# entered by user


Sub-analy. ConditionsName APOBDigits 2M-wave L. 340S-wave.L 694Analy.mthd. EPACalc.mthd. MSTDQualit. judge No






MULTI-STD SettingFormula Logit Log 1 Axis Conv No convBlank passes Points 4

FV Reac.smp. vol.

Dil.method

Dil. smp.vol.

Diluentvol.

Diluentpos.

STD H STD L

BLK # 1.0 No dil 0 0 0 9.999 -9.9991 # 1.0 No dil 0 0 0 9.999 -9.9992 # 1.0 No dil 0 0 0 9.999 -9.9993 # 1.0 No dil 0 0 0 9.999 -9.9994 # 1.0 No dil 0 0 0 9.999 -9.9995 # 1.0 No dil 0 0 0 9.999 -9.999


Antistreptolysin O FS*

Diagnostic reagent for quantitative in vitro determination of antistreptolysin O (ASO) in serum onBioMajesty JCA-BM6010/C


MethodParticle enhanced immunoturbidimetric test

PrincipleDetermination of the concentration of ASO via photometricmeasurement of the antigen-antibody-reaction of latex particlescoated with streptolysin O and antibodies to streptolysin O presentin the sample.

Reagents


R1: Phosphate buffer pH 7.4 100 mmol/LNaCl 150 mmol/L

R2: Latex particles coated with streptolysin OGlycine buffer pH 8.2 100 mmol/LNaCl 150 mmol/L


The reagents are stable up to the end of the indicated month ofexpiry, if stored at 2 – 8 °C and contamination is avoided. Do notfreeze the reagents!


1. The reagents contain sodium azide (0.95 g/L) as preservative.Do not swallow! Avoid contact with skin and mucousmembranes.


Waste Management


Reagent Preparation

The reagents are ready to use. Reagent 2 must be carefully mixedbefore use. The bottles are placed directly into the reagent trays.

SpecimenSerum

Stability [1]:2 days at 20 - 25 °C2 days at 4 - 8 °C6 months at -20 °C


Calibrators and ControlsFor calibration, the DiaSys TruCal ASO calibrator set isrecommended. For internal quality control a DiaSys TruLab Proteincontrol should be assayed. Each laboratory should establishcorrective action in case of deviations in control recovery.

Performance CharacteristicsMeasuring range up to 800 IU/mL ASO, at least up to the concentrationof the highest calibrator (in case of higher concentrations re-measuresamples after manual dilution or use rerun function).Limit of detection** 4.5 IU/mL ASONo prozone effect up to 1500 IU/mL ASOOn-board stability 12 weeksCalibration stability 12 weeks

Interferences < 10% byConjugated Bilirubin up to 60 mg/dLUnconjugated Bilirubin up to 54 mg/dLHemoglobin up to 500 mg/dLLipemia (triglycerides) up to 2000 mg/dL

Precision

Within run (n=20) Sample 1 Sample 2 Sample 3Mean [IU/mL] 44.4 93.2 229Coefficient of variation [%] 1.92 1.50 1.72

Between run (n=20) Sample 1 Sample 2 Sample 3Mean [IU/mL] 91.6 197 280Coefficient of variation [%] 2.93 2.09 1.66

Method comparison (n=80)

Test x DiaSys ASO FS (Hitachi 917)Test y DiaSys ASO FS (JCA-BM6010/C)Slope 1.04Intercept -1.55 IU/mLCoefficient of correlation 0.997

** lowest measurable concentration which can be distinguished from zeromean + 3 SD (n=20) of an analyte free specimen

Reference Range [2]

Adults 200 IU/mLChildren 150 IU/mL


Literature1. Guder WG, Zawta B et al. The Quality of Diagnostic Samples. 1st ed.

Darmstadt: GIT Verlag; 2001; p. 16-7.2. Thomas L. Clinical Laboratory Diagnostics. Frankfurt: TH-Books

Verlagsgesellschaft, 1998: p. 1201-3.3. Bisno AL. Group A infections and acute rheumatic fever. N Engl J Med

1991; 325: 783-93.4. Curtis GD, Kraak WA, Mitchell RG. Comparison of latex and

haemolysin tests for determination of anti-streptolysin O (ASO)antibodies. J Clin Pathol 1988; 41: 1331-3.

5. Stevens DL. Invasive Group A streptococcus infections. Clin Infect Dis1992; 14: 2-11.


Cat. No. Kit sizeTruCal ASO (5 levels) 1 7010 99 10 059 5 x 1 mLTruLab Protein Level 1 5 9500 99 10 046 3 x 1 mLTruLab Protein Level 2 5 9510 99 10 046 3 x 1 mL

IVD

Application BioMajesty JCA-BM6010/C August 2011/2

Antistreptolysin O FS


Application for serum samples


# entered by user


Sub-analy. ConditionsName ASODigits 1M-wave L. 596S-wave.L ****Analy.mthd. EPACalc.mthd. MSTDQualit. judge No







FV Reac.smp. vol.

Dil.method

Dil. smp.vol.

Diluentvol.

Diluentpos.

STD H STD L



ASAT (GOT) FS* (IFCC mod.)

with/without pyridoxal-5-phosphate

Diagnostic reagent for quantitative in vitro determination of ASAT (GOT) in serum or plasma onBioMajesty JCA-BM6010/C


Pyridoxal-5-Phosphate FSCat. No. 2 5010 99 10 0306 x 3 mL

MethodOptimized UV-test according to IFCC (International Federation ofClinical Chemistry and Laboratory Medicine) [modified]

Principle

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

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

Addition of pyridoxal-5-phosphate (P-5-P) stabilizes the activity oftransaminases and avoids falsely low values in samples containinginsufficient endogenous P-5-P, e.g. from patients with myocardialinfarction, liver disease and intensive care patients [1].

Reagents


R1: TRIS pH 7.65 110 mmol/LL-Aspartate 320 mmol/LMDH (malate dehydrogenase) 800 U/LLDH (lactate dehydrogenase) 1200 U/L

R2: 2-Oxoglutarate 65 mmol/LNADH 1 mmol/L

Pyridoxal-5-Phosphate FSGood’s buffer pH 9.6 100 mmol/LPyridoxal-5-phosphate 13 mmol/L






Waste Management


Reagent Preparation

The reagents are ready to use. The bottles are placed directly intothe reagent trays.For the determination with P-5-P add 250 µL of P-5-P to reagent 1and mix gently.

Stability after mixing: 6 days at 2 - 8 °C24 hours at 15 - 25 °C


Stability [2]:4 days at 20 - 25 °C7 days at 4 - 8 °C3 months at -20 °C


Calibrators and ControlsFor calibration the DiaSys TruCal U calibrator is recommended.For internal quality control DiaSys TruLab N and P controls shouldbe assayed. Each laboratory should establish corrective action incase of deviations in control recovery.

Performance Characteristics(with P-5-P activation)

Measuring range up to 700 U/L (12 µkat/L) ASAT(in case of higher activities re-measure samples after manual dilution oruse the rerun function)Limit of detection** 1.2 U/L (0.02 µkat/L) ASATOn-board stability 6 daysCalibration stability 6 days

Interferences < 10% byAscorbate up to 30 mg/dLConjugated bilirubin up to 60 mg/dLUnconjugated bilirubin up to 60 mg/dLLipemia (triglycerides) up to 200 mg/dLHemoglobin up to 100 mg/dL

Precision

Within run (n=20) Sample 1 Sample 2 Sample 3Mean [U/L] 37.6 164 231Mean [µkat/L] 0.628 2.74 3.86Coefficient of variation [%] 1.68 0.89 0.90



Method comparison (n=100)Test x Competitor ASAT (GOT)Test y DiaSys ASAT (GOT) FSSlope 1.018Intercept 3.78 U/L (0.063 µkat/L)Coefficient of correlation 1.000


Conversion factor

ASAT [U/L] x 0.0167 = ASAT [µkat/L]


5 9100 99 10 064 6 x 3 mLTruLab N 5 9000 99 10 062 20 x 5 mL

5 9000 99 10 061 6 x 5 mLTruLab P 5 9050 99 10 062 20 x 5 mL

5 9050 99 10 061 6 x 5 mL

Reagent Information

(without P-5-P activation)

Measuring range up to 600 U/L (10 µkat/L) ASAT(in case of higher activities re-measure samples after manual dilution oruse rerun function)Limit of detection*** 1.2 U/L (0.02 µkat/L) ASATOnboard stability 6 weeksCalibration stability 6 weeks

Interferences < 10% byAscorbate up to 30 mg/dLConjugated bilirubin up to 60 mg/dLUnconjugated bilirubin up to 60 mg/dLLipemia (triglycerides) up to 200 mg/dLHemoglobin up to 100 mg/dL

Precision


Mean [U/L] 39.2 106 157Mean [µkal/L] 0.655 1.77 2.62Coefficient of variation [%] 1.16 0.93 0.99

Between run (n=20) Sample 1 Sample 2 Sample 3Mean [U/L] 35.0 86.2 213Mean [µkal/L] 0.584 1.44 3.55Coefficient of variation [%] 1.51 0.91 0.83

Method comparison (n=100)Test x Competitor ASAT (GOT)Test y DiaSys ASAT (GOT) FSSlope 0.997Intercept - 2.34 U/L (-0.039 µkat/L)Coefficient of correlation 1.000


Conversion factor

ASAT [U/L] x 0.0167 = ASAT [µkat/L]

Reference Range

With pyridoxal-5-phosphate activation

Women [3] < 31 U/L < 0.52 µkat/LMen [3] < 35 U/L < 0.58 µkat/LChildren [1] 1 – 3 year(s) < 50 U/L < 0.83 µkat/L

4 – 6 years < 45 U/L < 0.75 µkat/L7 – 9 years < 40 U/L < 0.67 µkat/L

10 – 12 years < 40 U/L < 0.67 µkat/L13 – 15 years < 35 U/L < 0.58 µkat/L16 – 18 years < 35 U/L < 0.58 µkat/L

Without pyridoxal-5-phosphate activation

Women < 31 U/L < 0.52 µkat/LMen < 35 U/L < 0.58 µkat/L


Literature1. Thomas L. Alanine aminotransferase (ALT), Aspartate

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

2. Guder WG, Zawta B et al. The Quality of Diagnostic Samples. 1st

ed.Darmstadt: GIT Verlag; 2001; p. 18-9.

3. Schumann G, Bonora R, Ceriotti F, Férard G et al. IFCC primaryreference procedure for the measurement of catalytic activityconcentrations of enzymes at 37 °C. Part 5: Reference procedure forthe measurement of catalytic concentration of aspartateaminotransferase. Clin Chem Lab Med 2002; 40: 725-33.



Application BioMajesty JCA-BM6010/C December 2010/2

ASAT (GOT) FS (IFCC mod.)




# entered by user





Analytical ConditionsR1 volume 80R2e volume 0R2 volume 20R1 diluent vol 0R2e diluent vol 0R2 diluent vol 0Sample vol (S) 6Sample vol (U) 6Reagent 1 mix weakReagent 2e mix strongReagent 2 mix strongReaction time 10

Sub-analy. ConditionsName ASTDigits 2M-wave L. 340S-wave.L 410Analy.mthd. RRACalc.mthd. STDQualit. judge No



Bicarbonate FS*

Diagnostic reagent for quantitative in vitro determination of bicarbonate/total CO2 in serum or plasma on BioMajesty JCA-BM6010/C

Order Information Cat. No. 1 0950 99 10 961 6 x 160 tests

Method Enzymatic test using phosphoenolpyruvate carboxylase (PEPC) and a stable NADH analog.

Principle Phosphoenolpyruvate + HCO3

- PEPC+Mg2+ Oxaloacetate + H2PO4

-

Oxaloacetate + Cofactor red. MDH Malate + Cofactor

The reaction disturbs the following equilibrium.

CO2 + H2O H2CO3 H+ + HCO3-

This results in a conversion of CO2 to bicarbonate (HCO3-) which

then is included in the reaction. Therefore, the total CO2 concentration is measured. The decrease of reduced cofactor concentration is measured at 410 nm and is proportional to the concentration of total carbon dioxide in the sample.

Reagents Components and Concentrations Buffer pH 7.5 Phosphoenolpyruvate (PEP) 12.5 mmol/LPhosphoenolpyruvate carboxylase (PEPC) > 400 U/LMalate dehydrogenase (MDH) > 4100 U/LNADH analog 0.6 mmol/LActivators, stabilizers, surfactant, preservative Standard: 30 mmol/LStorage Instructions and Reagent Stability The reagent is stable up to the end of the indicated month of expiry, if stored at 2 – 8 °C, protected from light and contamination is avoided. Do not freeze the reagent! The standard is stable up to the end of the indicated month of expiry, if stored at 2 – 25 °C. Once opened, the standard is stable for 3 months, if recapped immediately after use. Warnings and Precautions 1. The reagent contains sodium azide (0.8 g/L) as preservative.



Waste Management Please refer to local legal requirements. Reagent Preparation The reagent is ready to use. The bottles are placed directly into the reagent trays.

Specimen Serum or heparin plasma Serum or plasma should be separated from cells immediately and stored at 2 – 8 °C. Exposure of samples to air should be minimized. Samples should be stored tightly sealed to prevent loss of carbon dioxide and assayed as soon as possible after collection. Stability [1]: 1 day at 20 - 25 °C 7 days at 4 - 8 °C 2 weeks at -20 °C Discard contaminated specimens.

Calibrators and Controls For calibration DiaSys Bicarbonate Standard FS is recommended. For internal quality control DiaSys TruLab Bicarbonate control should be assayed. Each laboratory should establish corrective action in case of deviations in control recovery.

Cat. No. Kit size Bicarbonate Standard FS 1 0950 99 10 030 6 x 3 mLTruLab Bicarbonate 5 9700 99 10 065 3 x 3 mL

Performance Characteristics Measuring range up to 46 mmol/L CO2 (in case of higher concentrations re-measure samples after manual dilution or use the rerun function) Limit of detection** 1.1 mmol/L CO2 On-board stability 3 weeks Calibration stability 3 weeks

Interferences < 10% by Ascorbate up to 30 mg/dL Conjugated bilirubin up to 60 mg/dL Unconjugated bilirubin up to 42 mg/dL Hemoglobin up to 500 mg/dL Lipemia (triglycerides) up to 1600 mg/dL

Precision

Within run (n=20) Sample 1 Sample 2 Sample 3 Mean [mmol/L] 12.9 21.6 25.1 Coefficient of variation [%] 1.61 1.74 1.36

Between run (n=20) Sample 1 Sample 2 Sample 3 Mean [mmol/L] 13.8 20.6 26.2 Coefficient of variation [%] 2.66 1.84 2.03

Method comparison (n=100) Test x DiaSys Bicarbonate FS (Hitachi 917) Test y DiaSys Bicarbonate FS (BioMajesty JCA-

BM6010/C) Slope 0.994 Intercept 0.849 mmol/L Coefficient of correlation 0.999


Conversion factor Bicarbonate [mmol/L] = Bicarbonate [mEq/L]

Reference Range [2] Adults: 22 – 29 mmol/L (mEq/L)



Darmstadt: GIT Verlag; 2001; p. 18-9. 2. Müller-Plathe O. Acid base balance and blood gases. In: Thomas L,

editor. Clinical laboratory diagnostics. 1st ed. Frankfurt: TH-Books Verlagsgesellschaft; 1998. p. 318-329.

3. Norris KA, Atkinson AR, Smith WG. Colorimetric enzymatic determination of serum total carbon dioxide as applied to the Vickers multichannel 300 discrete analyser. Clin Chem 1975; 21: 1093-1101.

4. US patent #5,801,006


IVD

Application BioMajesty JCA-BM6010/C May 2012/2

Bicarbonate FS




# entered by user

Endpoint method Re.absorb (u) 9.999 Re. Absorb (d) -9.999 Calculation Method Setting M-DET.P.I 0 M-DET.P.m 32 M-DET.P.n 33 S-DET.P.p 3 S-DET.P.r 4 Check D.P.I. 0 Limit value 0.003 Variance 10 Reac.type Dec. Reaction Rate Method Cycle 2 Factor 2 E2 corre Not do Blank (u) 9.999 Blank (d) -9.999 Sample (u) 9.999 Sample (d) -9.999 Standards Setting FV # BLK H 9.999 BLK L -9.999 STD H 9.999 STD L -9.999


Sub-analy. Conditions Name HCO3 Digits 1 M-wave L. 410 S-wave.L 505 Analy.mthd. EPA Calc.mthd. STD Qualit. judge No



Bilirubin Auto Direct FS*

Diagnostic reagent for quantitative in vitro determination of direct bilirubin in serum or plasma on BioMajesty JCA-BM6010/C


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

Principle Direct bilirubin in presence of diazotized 2,4-dichloroaniline forms a red colored azocompound in acidic solution.

Reagents Components and Concentrations R1: EDTA-Na2 0.1 mmol/L NaCl 150 mmol/L Sulfamic acid 100 mmol/L

R2: 2,4-Dichlorophenyl-diazonium salt 0.5 mmol/L HCl 900 mmol/L EDTA-Na2 0.13 mmol/L


Warnings and Precautions 1. Reagents S24/25: Avoid contact with skin and eyes. 2. Please refer to the safety data sheets and take the necessary




Specimen Serum or heparin plasma It is very important to store the samples protected from light! Stability [1]: 2 days at 20 - 25 °C 7 days at 4 - 8 °C 6 months at -20 °C in case of immediate freezing. Freeze only once! Discard contaminated specimens.


For calibration the DiaSys TruCal U calibrator is recommended. For internal quality control DiaSys TruLab N and P controls should be assayed. Each laboratory should establish corrective action in case of deviations in control recovery.

Performance Characteristics Measuring range up to 10 mg/dL (171 µmol/L) bilirubin (in case of higher concentrations re-measure samples after manual dilution or use rerun function) Limit of detection** 0.01 mg/dL (0.171 µmol/L) bilirubin On-board stability 4 weeks Calibration stability 9 days

Interferences < 10% by Ascorbate up to 30 mg/dL Hemoglobin up to 100 mg/dL Lipemia (triglycerides) up to 600 mg/dL

Precision

Within run (n=20) Sample 1 Sample 2 Sample 3 Mean [mg/dL] 0.25 1.52 2.90 Mean [µmol/L] 4.28 25.9 49.5 Coefficient of variation [%] 2.79 1.55 1.96

Between run (n=20) Sample 1 Sample 2 Sample 3 Mean [mg/dL] 0.85 2.20 2.35 Mean [µmol/L] 14.5 37.6 40.2 Coefficient of variation [%] 2.49 1.86 1.63

Method comparison (n=109) Test x DiaSys Bilirubin Auto Direct FS

(Hitachi 917) Test y DiaSys Bilirubin Auto Direct FS

(BioMajesty JCA-BM6010C) Slope 1.02 Intercept -0.004 mg/dL (-0.061 µmol/L) Coefficient of correlation 0.9999


Conversion factor Bilirubin [mg/dL] x 17.1 = Bilirubin [µmol/L]

Reference Range [2]

Adults and children ≤ 0.2 mg/dL (≤ 3.4 µmol/L)



Darmstadt: GIT Verlag; 2001; p. 18-9. 2. Thomas L ed. Clinical Laboratory Diagnostics. 1st ed. Frankfurt: TH-

Books Verlagsgesellschaft, 1998: p. 192-202. 3. Tolman KG, Rej R. Liver function. In: Burtis CA, Ashwood ER, editors.

Tietz Textbook of Clinical Chemistry. 3rd ed. Philadelphia: W.B Saunders Company; 1999. p. 1125-77.

4. Rand RN, di Pasqua A. A new diazo method for the determination of bilirubin. Clin Chem 1962; 6: 570-8.



IVD


Bilirubin Auto Direct FS




# entered by user






Sub-analy. ConditionsName DBILDigits 2M-wave L. 545S-wave.L 658Analy.mthd. EPACalc.mthd. STDQualit. judge No



Bilirubin Auto Total FS*

Diagnostic reagent for quantitative in vitro determination of total bilirubin in serum or plasma onBioMajesty JCA-BM6010/C


MethodPhotometric test using 2,4-dichloroaniline (DCA)

PrincipleDirect bilirubin in presence of diazotized 2,4-dichloroaniline formsa red colored azocompound in acidic solution. A specific mixture ofdetergents enables a safe determination of the total bilirubin.

Reagents


R1: Phosphate buffer 50 mmol/LNaCl 150 mmol/LDetergent, stabilizers

R2: 2,4-Dichlorophenyl-diazonium salt 5 mmol/LHCl 130 mmol/LDetergent




1. Reagents: S24/25: Avoid contact with skin and eyes.2. Reagent 1 R52/53: Harmful to aquatic organisms, may cause

long-term adverse effects in the aquatic environment.S61: Avoid release to the environment. Refer to specialinstructions/safety data sheets.


Waste Management


Reagent Preparation


SpecimenSerum or heparin plasmaIt is very important to store the samples protected from light!

Stability [1]:1 day at 20 - 25 °C7 days at 4 - 8 °C6 months at -20 °Cin case of immediate freezing.Freeze only once!


Calibrators and ControlsFor calibration, DiaSys TruCal U calibrator is recommended. Forinternal quality control DiaSys TruLab N and P controls should beassayed. Each laboratory should establish corrective action incase of deviations in control recovery.

Performance CharacteristicsMeasuring range up to 30 mg/dL (513 µmol/L) bilirubin(in case of higher concentrations re-measure samples after manualdilution or use rerun function)Limit of detection** 0.03 mg/dL (0.5 µmol/L) bilirubinOn-board stability 6 weeksCalibration stability 4 weeks

Interferences < 10% byAscorbate up to 30 mg/dLHemoglobin up to 500 mg/dLLipemia (triglycerides) up to 1000 mg/dL

Precision


Mean [mg/dL] 0.42 3.21 7.22Mean [µmol/L] 7.25 54.9 123Coefficient of variation [%] 1.78 1.66 1.09

Between run (n=20) Sample 1 Sample 2 Sample 3Mean [mg/dL] 1.37 5.34 7.17Mean [µmol/L] 23.4 91.3 123Coefficient of variation [%] 2.25 1.81 1.19

Method comparison (n=100)Test x Competitor Bilirubin TotalTest y DiaSys Bilirubin Auto Total FSSlope 1.04Intercept 0.045 mg/dL (0.777 µmol/L)Coefficient of correlation 0.9998


Conversion factor

Bilirubin [mg/dL] x 17.1 = Bilirubin [µmol/L]

Reference Range [2]

[mg/dL] [µmol/L]Neonates 24 h < 8.8 < 150

2nd day 1.3 - 11.3 22 - 1933rd day 0.7 - 12.7 12 - 2174th - 6th day 0.1 - 12.6 1.7 - 216

Children > 1 month 0.2 - 1.0 3.4 - 17Adults 0.1 - 1.2 1.7 - 21



Darmstadt: GIT Verlag; 2001; p. 18-9.2. Thomas L ed. Clinical Laboratory Diagnostics. 1st ed. Frankfurt: TH-

Books Verlagsgesellschaft, 1998: p. 192-202.3. Tolman KG, Rej R. Liver function. In: Burtis CA, Ashwood ER, editors.

Tietz Textbook of Clinical Chemistry. 3rd ed. Philadelphia: W.BSaunders Company; 1999. p. 1125-77.

4. Rand RN, di Pasqua A. A new diazo method for the determination ofbilirubin. Clin Chem 1962; 6: 570-8.



5 9100 99 10 064 6 x 3 mLTruLab N 5 9000 99 10 062 20 x 5 mL

5 9000 99 10 061 6 x 5 mLTruLab P 5 9050 99 10 062 20 x 5 mL

5 9050 99 10 061 6 x 5 mL

IVD

Application BioMajesty JCA-BM6010/C January 2011/1

Bilirubin Auto Total FS




# entered by user






Sub-analy. ConditionsName TBILDigits 1M-wave L. 545S-wave.L 658Analy.mthd. EPACalc.mthd. STDQualit. judge No



Complement C3c FS*

Diagnostic reagent for quantitative in vitro determination of complement component C3c in serum or plasma on BioMajesty JCA-BM6010/C



Principle Determination of the concentration of C3c by photometric measurement of antigen-antibody-reaction of antibodies to human C3c with C3c present in the sample.

Reagents Components and Concentrations R1: TRIS pH 7.5 100 mmol/L NaCl 320 mmol/L Polyethylenglycol (PEG) detergents, stabilizers R2: TRIS pH 8.0 100 mmol/L NaCl 300 mmol/L Anti-human C3c antibody (goat) with stabilizers







Specimen [1]

Serum, heparin plasma or EDTA plasma During storage, C3 and C4 proteins slowly degrade into C3c resp. C4 fragments (fragmentation is inhibited by EDTA). These fragments still contain the reactive epitopes and may even display higher signals than the intact protein. Depending on the conditions of this aging process, fresh serum samples may show up to 30 % lower C3 values than samples stored at 2 - 8 °C for 8 days. The fragmentation of C4 is much slower than for C3 and only 15 % lower values can be observed under similar storage conditions. Discard contaminated specimens.

Calibrators and Controls For calibration DiaSys TruCal Protein calibrator set is recommended. For internal quality control a DiaSys TruLab Protein control should be assayed. Each laboratory should establish corrective action in case of deviations in control recovery.

Cat. No. Kit size TruCal Protein Set 5 9200 99 10 039 5 x 1 mL TruLab Protein Level 1 5 9500 99 10 046 3 x 1 mL TruLab Protein Level 2 5 9510 99 10 046 3 x 1 mL

Performance Characteristics Measuring range up to 480 mg/dL (4.8 g/L) complement component C3c, at least up to the concentration of the highest calibrator (in case of higher concentrations re measure samples after manual dilution or use rerun function). Limit of detection** 0.1 mg/dL C3c (0.001 g/L) No prozone effect up to 1000 mg/dL (10 g/L) C3c On-board stability 5 weeks Calibration stability 5 weeks

Interferences < 10% by Conjugated bilirubin up to 60 mg/dL Unconjugated bilirubin up to 60 mg/dL Hemoglobin up to 800 mg/dL Lipemia (triglycerides) up to 2000 mg/dL

Precision

Within run (n=20) Sample 1 Sample 2 Sample 3 Mean [mg/dL] 92.3 161 228 Mean [g/L] 0.92 1.61 2.28 Coefficient of variance [%] 1.36 1.59 1.84

Between run (n=20) Sample 1 Sample 2 Sample 3 Mean [mg/dL] 92.7 157 217 Mean [g/L] 0.93 1.57 2.17 Coefficient of variance [%] 2.60 2.73 2.37

Method comparison (n=100) Test x Competitor Complement C3c test Test y DiaSys Complement C3c FS Slope 0.993 Intercept 0.241 mg/dL (0.002 g/L) Coefficient of correlation 0.9998

** lowest measurable concentration which can be distinguished from zero; mean + 3 SD (n=20) of an analyte free specimen

Reference Range [2]

90 – 180 mg/dL (0.9 – 1.8 g/L)

In case of fresh samples lower reference ranges are expected for C3c.


Literature 1. Okumura N, Nomura M, Tada T et al. Effects of sample storage on

serum C3c assay by nephelometry. Clin Lab Sci 1990; 3(1): 54-57. 2. Dati F, Schumann G, Thomas L, Aguzzi F, Baudner S, Bienvenu J et al.

Consensus of a group of professional societies and diagnostic companies on guidelines for interim reference ranges for 14 proteins in serum based on the standardization against the IFCC/BCR/CAP reference material (CRM 470). Eur J Clin Chem Clin Biochem 1996; 34: p. 517-20.




IVD


Complement C3c FS




# entered by user


Sub-analy. ConditionsName C3cDigits 2M-wave L. 340S-wave.L ****Analy.mthd. EPACalc.mthd. MSTDQualit. judge No







FV Reac.smp. vol.

Dil.method

Dil. smp.vol.

Diluentvol.

Diluentpos.

STD H STD L



Complement C4 FS*

Diagnostic reagent for quantitative in vitro determination of complement component C4 in serum or plasma on BioMajesty JCA-BM6010/C



Principle Determination of the concentration of C4 by photometric measurement of antigen-antibody-reaction of antibodies to human C4 with C4 present in the sample.

Reagents Components and Concentrations R1: TRIS pH 7.5 100 mmol/L NaCl 320 mmol/L Polyethylenglycol (PEG) detergents, stabilizers R2: TRIS pH 8.0 100 mmol/L NaCl 300 mmol/L Anti-human C4 antibody (goat) with stabilizers







Specimen [1]

Serum, heparin plasma or EDTA plasma During storage, C3 and C4 proteins slowly degrade into C3c resp. C4 fragments (fragmentation is inhibited by EDTA). These fragments still contain the reactive epitopes and may even display higher signals than the intact protein. Depending on the conditions of this aging process, fresh serum samples may show up to 30 % lower C3 values than samples stored at 2 – 8 °C for 8 days. The fragmentation of C4 is much slower than for C3 and only 15 % lower values can be observed under similar storage conditions. Discard contaminated specimens.

Calibrators and Controls For calibration DiaSys TruCal Protein calibrator set is recommended. For internal quality control a DiaSys TruLab Protein control should be assayed. Each laboratory should establish corrective action in case of deviations in control recovery.

Cat. No. Kit size TruCal Protein Set 5 9200 99 10 039 5 x 1 mL TruLab Protein Level 1 5 9500 99 10 046 3 x 1 mL TruLab Protein Level 2 5 9510 99 10 046 3 x 1 mL

Performance Characteristics Measuring range up 90 mg/dL (0.90 g/L) complement component C4, at least up to the concentration of the highest calibrator (in case of higher concentrations re-measure samples after manual dilution or use rerun function). Limit of detection** 1 mg/dL (0.01 g/L) C4 No prozone effect up to 180 mg/dL (1.8 g/L) C4 On-board stability 6 weeks Calibration stability 6 weeks

Interferences < 10% by Bilirubin (conjugated and unconjugated) up to 60 mg/dL Hemoglobin up to 900 mg/dL Lipemia (triglycerides) up to 2000 mg/dL RF up to1200 IU/mL IgA up to 6400 mg/dL IgM up to 4100 mg/dL IgG up to 6400 mg/dL

Precision

Within run (n=20) Sample 1 Sample 2 Sample 3 Mean [mg/dL] 15.8 27.0 43.6 Mean [g/L] 0.158 0.270 0.436 Coefficient of variance [%] 3.04 2.41 1.94

Between run (n=20) Sample 1 Sample 2 Sample 3 Mean [mg/dL] 15.6 30.8 41.7 Mean [g/L] 0.156 0.308 0.417 Coefficient of variance [%] 3.17 2.57 2.23

Method comparison (n=100) Test x Competitor Complement C4 Test y DiaSys Complement C4 FS Slope 1.003 Intercept 0.38 mg/dL (0.0038 g/L) Coefficient of correlation 0.9997

** lowest measurable concentration which can be distinguished from zero; mean + 3 SD (n=20) of an analyte free specimen

Reference Range [2] 10 - 40 mg/dL (0.1 – 0.4 g/L)


Literature 1. Okumura N, Nomura M, Tada T et al. Effects of sample storage on

serum C3c assay by nephelometry. Clin Lab Sci 1990; 3(1): 54-57. 2. Dati F, Schumann G, Thomas L, Aguzzi F, Baudner S, Bienvenu J et al.

Consensus of a group of professional societies and diagnostic companies on guidelines for interim reference ranges for 14 proteins in serum based on the standardization against the IFCC/BCR/CAP reference material (CRM 470). Eur J Clin Chem Clin Biochem 1996; 34: p. 517-20.




IVD


Complement C4 FS


# entered by user


Sub-analy. Conditions Name C4 Digits 2 M-wave L. 340 S-wave.L **** Analy.mthd. EPA Calc.mthd. MSTD Qualit. judge No




MULTI-STD Setting Formula Spline Axis Conv No conv Blank Not passes Points 6

FV Reac.

smp. vol. Dil.

method Dil. smp.

vol. Diluent

vol. Diluent

pos. STD H STD L



Calcium P FS*

Diagnostic reagent for quantitative in vitro determination of calcium in serum, plasma or urine onBioMajesty JCA-BM6010/C


MethodPhotometric endpoint determination with Phosphonazo III

PrincipleAt acidic pH calcium forms a purple-blue colored complex withphosphonazo III. In a second step calcium is bound to a chelatingagent whereby the specific signal is eliminated. The resultingdifference in absorbance is directly proportional to the calciumconcentration in the sample. This guarantees a specificmeasurement of calcium.

Reagents


R1: Malonic acid buffer pH 5.0 150 mmol/LPhosphonazo III 150 µmol/LDetergents, preservatives

R2: Malonic acid 150 mmol/LChelating agentPreservatives


Reagents are stable up to the end of the indicated month of expiry,if stored at 2 – 8 °C and contamination is avoided. Do not freezethe reagents!


1. Samples of patients with myeloma or suspected of myelomamight give false values due to unspecific turbidity byparaprotein precipitation. In case of implausible calciumresults in samples of myeloma patients, the sample should beretested after dilution or using a different method.

2. As calcium is an ubiquitous ion, special precaution must betaken against accidental contamination. Only use disposablematerials.

3. Traces of chelating agent, such as EDTA can prevent theformation of the colored complex.


Waste Management


Reagent Preparation

The reagents are ready to use. The bottles are placed directly intothe reagent rotor.

SpecimenSerum, heparin plasma or urineDo not use EDTA plasma.

Stability [1]:

in Serum/Plasma 7 days at 20 – 25 °C3 weeks at 4 – 8 °C8 months at -20 °C

in Urine 2 days at 20 – 25 °C4 days at 4 – 8 °C3 weeks at -20 °C

Add 10 mL of concentrated HCl to 24 h urine and heat thespecimen to dissolve calcium oxalate.


Calibrators and ControlsFor calibration, DiaSys TruCal U calibrator is recommended. Forinternal quality control DiaSys TruLab N and P or TruLab Urinecontrols should be assayed. Each laboratory should establishcorrective action in case of deviations in control recovery.


5 9100 99 10 064 6 x 3 mLTruLab N 5 9000 99 10 062 20 x 5 mL

5 9000 99 10 061 6 x 5 mLTruLab P 5 9050 99 10 062 20 x 5 mL



5 9180 99 10 061 6 x 5 mL

Performance CharacteristicsMeasuring range up to 25 mg/dL (6.2 mmol/L) calcium(in case of higher concentrations re-measure samples after manualdilution or use rerun function)Limit of detection** 0.1 mg/dL (0.025 mmol/L) calciumOn-board stability 6 weeksCalibration stability 3 weeks

Interferences < 10% byAscorbate up to 30 mg/dLHemoglobin up to 700 mg/dLConjugated Bilirubin up to 60 mg/dLUnconjugated Bilirubin up to 60 mg/dLLipemia (triglycerides) up to 2000 mg/dLMagnesium up to 8 mmol/LStrontium salts in medicine may lead to strongly increased calciumvalues.



Mean [mg/dL] 5.91 10.5 13.2Mean [mmol/L] 1.47 2.62 3.28Coefficient of variation [%] 0.84 0.84 0.85

Between run (n=20) Sample 1 Sample 2 Sample 3Mean [mg/dL] 5.77 9.82 12.5Mean [mmol/L] 1.44 2.45 3.13Coefficient of variation [%] 1.58 1.13 0.97

Method comparison (Serum/plasma; n=100)Test x Competitor CalciumTest y DiaSys Calcium P FSSlope 1.00Intercept 0.120 mg/dL (0.030 mmol/L)Coefficient of correlation 0.9965

Precision (Urine)





Method comparison (Urine; n=93)

Test x Competitor CalciumTest y DiaSys Calcium P FSSlope 1.03Intercept 0.409 mg/dL (0.102 mmol/L)Coefficient of correlation 0.997


Reagent Information

Conversion factor

Calcium [mg/dL] x 0.2495 = Calcium [mmol/L]

Calcium/U [mg/24 h] x 0.025 = Calcium/U [mmol/24 h]

Reference Range

Serum/Plasma [2]:

8.6 - 10.3 mg/dL (2.15 - 2.57 mmol/L)

Urine [2]:

Women < 250 mg/24 h (< 6.24 mmol/24 h)

Men < 300 mg/24 h (< 7.49 mmol/24 h)

Literature1. Guder WG, Zawta B et al. The Quality of Diagnostic Samples. 1

sted.

Darmstadt: GIT Verlag; 2001. p. 20-1 and p. 50-12. Endres DB, Rude RK. Mineral and bone metabolism. In: Burtis CA,

Ashwood ER, editors. Tietz Textbook of Clinical Chemistry. 3rd

ed.Philadelphia: W.B Saunders Company; 1999. p. 1395-1406.

3. Thomas L. Clinical Laboratory Diagnostics. 1st

ed. Frankfurt: TH-BooksVerlagsgesellschaft; 1998. p. 231-241.



IVD


Calcium P FS




# entered by user






Sub-analy. ConditionsName CAPDigits 2M-wave L. 658S-wave.L 805Analy.mthd. EPACalc.mthd. STDQualit. judge No



Cholinesterase FS*

Diagnostic reagent for quantitative in vitro determination of cholinesterase (CHE) in serum or plasma onBioMajesty JCA-BM6010/C


MethodKinetic photometric test, optimized method according to therecommendation of the German Society of Clinical Chemistry(DGKC)

PrincipleCholinesterase hydrolyses butyrylthiocholine under release ofbutyric acid and thiocholine. Thiocholine reduces yellow potassiumhexacyanoferrate (III) to colorless potassium hexacyanoferrate (II).The decrease of absorbance is measured at 410 nm.

Butyrylthiocholine + H2O Cholinesterase Thiocholine + Butyrate

2 Thiocholine + 2[Fe(CN)6]3- + H2O

Dithiobis(choline) + 2[Fe(CN)6]4-

+ H2O

Reagents


R1: Pyrophosphate pH 7.6 95 mmol/LPotassium hexacyanoferrate(III) 2.5 mmol/L

R2: Butyrylthiocholine 75 mmol/L




Please refer to the safety data sheets and take the necessaryprecautions for the use of laboratory reagents.

Waste Management


Reagent Preparation


SpecimenSerum, heparin or EDTA plasma

Stability [1,2]:1 week at 15 - 25 °C2 weeks at 2 - 8 °C6 months at -20 °C


Calibrators and ControlsFor calibration DiaSys TruCal U calibrator is recommended. Forinternal quality control DiaSys TruLab N and P controls should beassayed. Each laboratory should establish corrective action incase of deviations in control recovery.

Performance CharacteristicsMeasuring range up to 19 kU/L (317 µkat/L) CHE(in case of higher activities re-measure samples after manual dilution oruse rerun function)Limit of detection** 0.04 kU/L (0.7 µkat/L) CHEOn-board stability 5 weeksCalibration stability 5 weeks

Interferences < 10% byAscorbate up to 30 mg/dLConjugated Bilirubin up to 54 mg/dLUnconjugated Bilirubin up to 42 mg/dLHemoglobin up to 500 mg/dLLipemia (triglycerides) up to 1000 mg/dL

Precision

Within run (n=20) Sample 1 Sample 2 Sample 3Mean [kU/L] 4.34 5.75 6.90Mean [µkat/L] 72.3 95.9 115Coefficient of variation [%] 1.13 1.08 0.97


Mean [kU/L] 4.22 4.88 6.90Mean [µkat/L] 70.3 81.4 115Coefficient of variation [%] 0.89 1.46 1.69


Test x Competitor CholinesteraseTest y DiaSys Cholinesterase FSSlope 1.000Intercept -0.240 kU/L (-4.00 µkat/L)Coefficient of correlation 0.9996


Conversion factor

Cholinesterase [kU/L] x 16,67 = Cholinesterase [µkat/L]

Reference Range [1]

Women 3.93 – 10.8 kU/L 65.5 – 180 µkat/LMen 4.62 – 11.5 kU/L 77.0 – 192 µkat/L


Literature1. Recommendations of the German Society for Clinical Chemistry.

Standardization of methods for the estimation of enzyme activities inbiological fluids: Standard method for the determination ofCholinesterase activity. J Clin Chem Clin Biochem 1992; 30: 163-70.

2. Hallbach J, Klinische Chemie für den Einstieg. 1st ed Stuttgart: Thieme;2001. p. 143-4.

3. Thomas L, Clinical laboratory diagnostics. 1st ed Frankfurt: TH-BooksVerlagsgesellschaft; 1998. p. 65-71.



5 9100 99 10 064 6 x 3 mLTruLab N 5 9000 99 10 062 20 x 5 mL

5 9000 99 10 061 6 x 5 mLTruLab P 5 9050 99 10 062 20 x 5 mL

5 9050 99 10 061 6 x 5 mL

IVD


Cholinesterase FS




# entered by user





Analytical ConditionsR1 volume 80R2e volume 0R2 volume 20R1 diluent vol 0R2e diluent vol 0R2 diluent vol 0Sample vol (S) 1,5Sample vol (U) 1,5Reagent 1 mix weakReagent 2e mix weakReagent 2 mix weakReaction time 10

Sub-analy. ConditionsName CHEDigits 1M-wave L. 410S-wave.L ****Analy.mthd. RRACalc.mthd. STDQualit. judge No

Analysis Test Condition Setting (M)Sample Type Serum UrineReac. sample vol. 1,5 1,5Diluent method No dil No dilUndil. sample vol. 0 0Diluent volume 0 0Diluent position 0 0


Cholesterol FS* Diagnostic reagent for quantitative in vitro determination of cholesterol in serum or plasma on BioMajesty JCA-BM6010/C

Order Information Cat. No. Tests 1 1300 99 10 960 R 4 x 530 tests

1 1300 99 10 967 R 6 x 350 tests

Method “CHOD-PAP”: enzymatic photometric test

Principle Determination of cholesterol after enzymatic hydrolysis and oxidation. The colorimetric indicator is quinoneimine which is generated from 4-aminoantipyrine and phenol by hydrogen peroxide under the catalytic action of peroxidase (Trinder’s reaction) [1,2].

Cholesterol ester + H2O CHE Cholesterol + Fatty acid

Cholesterol + O2 CHO Cholesterol-3-one + H2O2

2 H2O2 + 4-Aminoantipyrine + Phenol POD Quinoneimine + 4 H2O

Reagent

Components and Concentrations Good's buffer pH 6.7 50 mmol/L Phenol 5 mmol/L 4-Aminoantipyrine 0.3 mmol/L Cholesterol esterase (CHE) ≥ 200 U/L Cholesterol oxidase (CHO) ≥ 50 U/L Peroxidase (POD) ≥ 3 kU/L

Storage Instructions and Reagent Stability The reagent is stable up to the end of the indicated month of expiry, if stored at 2 – 8 °C, protected from light and contamination is avoided. Do not freeze the reagent!

Warnings and Precautions 1. The reagent contains sodium azide (0.95 g/L) as preservative. Do not

swallow! Avoid contact with skin and mucous membranes. 2. Please refer to the safety data sheet and take the necessary



Reagent Preparation The reagent is ready to use. The bottles are placed directly into the reagent tray.


Stability [3]: 7 days at 20 - 25 °C 7 days at 4 - 8 °C 3 months at -20 °C Discard contaminated specimens.

Calibrators and Controls For calibration the DiaSys TruCal U calibrator is recommended. For internal quality control DiaSys TruLab N and P or TruLab L controls should be assayed. Each laboratory should establish corrective actions in case of deviations in control recovery.

Cat. No. Kit size TruCal U 5 9100 99 10 063 20 x 3 mL 5 9100 99 10 064 6 x 3 mL TruLab N 5 9000 99 10 062 20 x 5 mL 5 9000 99 10 061 6 x 5 mL TruLab P 5 9050 99 10 062 20 x 5 mL 5 9050 99 10 061 6 x 5 mL TruLab L Level 1 5 9020 99 10 065 3 x 3 mL TruLab L Level 2 5 9030 99 10 065 3 x 3 mL

Performance Characteristics Measuring range up to 750 mg/dL (20 mmol/L) cholesterol (in case of higher concentrations re-measure samples after manual dilution or use rerun function) Limit of detection** 2 mg/dL (0.05 mmol/L) cholesterol On-board stability 6 weeks Calibration stability 6 weeks

Interferences < 10% by Ascorbate up to 6 mg/dL Hemoglobin up to 200 mg/dL Conjugated bilirubin up to 24 mg/dL Unconjugated bilirubin up to 24 mg/dL Lipemia (triglycerides) up to 2000 mg/dL

Precision

Within run (n=20) Sample 1 Sample 2 Sample 3 Mean [mg/dL] 139 201 284 Mean [mmol/L] 3.60 5.21 7.34 Coefficient of variation [%] 1.07 0.65 0.72

Between run (n=20) Sample 1 Sample 2 Sample 3 Mean [mg/dL] 104 171 242 Mean [mmol/L] 2.70 4.43 6.26 Coefficient of variation [%] 1.77 1.50 1.47

Method comparison (n=100) Test x Competitor Cholesterol Test y DiaSys Cholesterol FS Slope 1.000 Intercept 2.13 mg/dL (0.055 mmol/L) Coefficient of correlation 0.999


Conversion factor Cholesterol [mg/dL] x 0.02586 = Cholesterol [mmol/L]

Reference Range [4] Desirable ≤ 200 mg/dL (5.2 mmol/L) Borderline high risk 200 - 240 mg/dL (5.2 – 6.2 mmol/L) High risk > 240 mg/dL (> 6.2 mmol/L)


Clinical Interpretation 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) [5].

Literature 1. Artiss JD, Zak B. Measurement of cholesterol concentration. In:

Rifai N, Warnick GR, Dominiczak MH, eds. Handbook of lipoprotein testing. Washington: AACC Press, 1997: p. 99-114.

2. Deeg R, Ziegenhorn J. Kinetic enzymatic method for automated determination of total cholesterol in serum. Clin Chem 1983; 29: 1798-802.

3. Guder WG, Zawta B et al. The Quality of Diagnostic Samples. 1st ed. Darmstadt: GIT Verlag; 2001. p. 22-3.

4. Schaefer EJ, McNamara J. Overview of the diagnosis and treatment of lipid disorders. In: Rifai N, Warnick GR, Dominiczak MH, eds. Handbook of lipoprotein testing. Washington: AACC press, 1997: p. 25-48.

5. 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: 1434-503.



IVD


Cholesterol FS




# entered by user



Sub-analy. Conditions Name CHOL Digits 2 M-wave L. 505 S-wave.L 694 Analy.mthd. EPA Calc.mthd. STD Qualit. judge No



CK-NAC FS* IFCC

Diagnostic reagent for quantitative in vitro determination of creatinkinase (CK) in serum or plasma onBioMajesty JCA-BM6010/C


MethodOptimized UV-test according to IFCC (International Federation ofClinical Chemistry and Laboratory Medicine) and DGKC (GermanSociety of Clinical Chemistry)

PrincipleCreatine phosphate + ADP CK Creatine + ATP

Glucose + ATP HK Glucose-6-phosphate + ADP

Glucose-6-phosphate + NADP+ G6P-DH Gluconate-6-phosphate + NADPH + H+

Reagents


R1: Imidazole pH 6.5 60 mmol/LGlucose 27 mmol/LN-Acetylcysteine (NAC) 27 mmol/LMagnesium acetate 14 mmol/LEDTA-Na2 2 mmol/LNADP 2.7 mmol/LHexokinase (HK) 5 kU/L

R2: Imidazole 160 mmol/LADP 11 mmol/LAMP 28 mmol/LDiadenosine pentaphosphate 55 µmol/LGlucose-6-phosphate dehydrogenase (G6P-DH) 14 kU/LEDTA-Na2 2 mmol/LCreatine phosphate 160 mmol/L




1. Reagent R2 is toxic. R61: May cause harm to the unbornchild. S53: Avoid exposure – obtain special instructionsbefore use. S28: After contact with skin, wash immediatelywith plenty of water. S29: Do not empty into drains. S36/37:Wear suitable protective clothing and gloves. S45: In case ofaccident or if you feel unwell, seek medical adviceimmediately (show the lable where possible).



Waste Management


Reagent Preparation



Stability [1]:2 days at 20 - 25 °C7 days at 4 - 8 °C4 weeks (in the dark) at -20 °C


Calibrators and ControlsFor calibration, DiaSys TruCal U calibrator is recommended. Forinternal quality control, DiaSys TruLab N and P controls should beassayed. Each laboratory should establish corrective action incase of deviations in control recovery.


5 9100 99 10 064 6 x 3 mLTruLab N 5 9000 99 10 062 20 x 5 mL

5 9000 99 10 061 6 x 5 mLTruLab P 5 9050 99 10 062 20 x 5 mL

5 9050 99 10 061 6 x 5 mL

Performance CharacteristicsMeasuring range up to 1200 U/L (20 µkat/L) CK(in case of higher activities re-measure samples after manual dilution oruse rerun function)Limit of detection** 0.6 U/L (0.01 µkat/L) CKOn-board stability 12 weeksCalibration stability 12 weeks


Precision

Within run (n=20) Sample 1 Sample 2 Sample 3Mean [U/L] 106 327 727Mean [µkat/L] 1.77 5.46 12.1Coefficient of variation [%] 0.87 1.23 1.06


Mean [U/L] 112 409 728Mean [µkat/L] 1.87 6.82 12.1Coefficient of variation [%] 1.13 1.49 1.95


Test x Competitor CK-NACTest y DiaSys CK-NAC FSSlope 1.07Intercept -0.24 U/L (-0.004 µkat/L)Coefficient of correlation 1.00


Conversion factor

CK-NAC [U/L] x 0.0167 = CK-NAC [µkat/L]

Reagent Information

Reference Range

Adults [2]

Women < 145 U/L (< 2.42 µkat/L)Men < 171 U/L (< 2.85 µkat/L)

These reference ranges ensure high diagnostic sensitivity. Thediagnostic specificity is low; however, it can be improved byadditional measurement of CK-MB.Myocardial infarction: The risk of myocardial infarction is high iffollowing three conditions are fulfilled [3]:

1. CK (Men) > 190 U/L (3.17 µkat/L)***CK (Women) > 167 U/L (2.78 µkat/L)***

2. CK-MB > 24 U/L (0.40 µkat/L)***3. CK-MB activity is between 6 and 25 % of total CK activity.

*** calculated using temperature conversion factor 2.38 (25 °C 37 °C)

If myocardial infarction is suspected and the conditions are notfulfilled, the infarction may be fresh. In this case the measurementsshould be repeated after 4 hours with fresh samples. In healthyindividuals different values are found depending on race and age[3,4].

Children [5]

Umbilical cord blood 175 - 402 U/L 2.92 – 6.71 µkat/LNewborns 468 - 1200 U/L 7.82 – 20.0 µkat/L 5 days 195 - 700 U/L 3.26 – 11.7 µkat/L< 6 months 41 - 330 U/L 0.68 – 5.51 µkat/L> 6 months 24 - 229 U/L 0.40 – 3.82 µkat/L

Each laboratory should check if the reference ranges aretransferable to its own patient population and determine ownreference ranges if necessary. For diagnostic purposes CK valuesshould always be assessed in conjunction with the anamnesis, theclinical examination and other findings.


Darmstadt: GIT Verlag; 2001; p. 24-5.2. Schumann G, Bonora R, Ceriotti F, Férard G et al. IFCC primary

reference procedure for the measurement of catalytic activityconcentrations of enzymes at 37 °C. Part 5: Reference procedure forthe measurement of catalytic concentration of creatine kinase. ClinChem Lab Med 2002; 40: 635-42.

3. Stein W. Strategie der klinisch-chemischen Diagnostik des frischenMyokardinfarkts. Med Welt 1985; 36: 572-7.

4. Myocardial infarction redefined – a consensus document of the JointEuropean society of Cardiology/America College of CardiologyCommittee for the redefinition of myocardial Infarction. Eur Heart J2000; 21: 1502-13.

5. Stein W. Creatine kinase (total activity), creatine kinase isoenzymesand variants. In: Thomas L, ed. Clinical laboratory diagnostics.Frankfurt: TH-Books Verlagsgesellschaft; 1998. p.71-80.


7. Recommendations of the German Society for Clinical Chemistry.Standardization of methods for the estimation of enzyme activities inbiological fluids: Standard method for the determination of creatinekinase activity. J Clin Chem Clin Biochem 1977; 15: 255-60.



CK-NAC FS




# entered by user






Sub-analy. ConditionsName CKDigits 2M-wave L. 340S-wave.L 410Analy.mthd. RRACalc.mthd. STDQualit. judge No



CK-MB FS* Diagnostic reagent for quantitative in vitro determination of CK-MB in serum or plasma on BioMajesty JCA-BM6010/C


Method Optimized UV test according to DGKC (German Society of Clinical Chemistry) and IFCC (International Federation of Clinical Chemistry and Laboratory Medicine) for CK with inhibition of CK-M isoenzymes by monoclonal antibodies

Principle CK-MB consists of the subunits CK-M and CK-B. Specific antibodies against CK-M inhibit 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.

Reaction Principle

Creatine phosphate + ADP CK Creatine + ATP

Glucose + ATP HK Glucose-6-phosphate + ADP

Glucose-6-phosphate + NADP+ G6P-DH 6-Phosphogluconolactone + NADPH + H+

Reagents Components and Concentrations R1: Imidazole/Good`s buffer 120 mmol/L Glucose 25 mmol/L N-Acetylcysteine (NAC) 25 mmol/L Magnesium acetate 12.5 mmol/L EDTA-Na2 2 mmol/L NADP 2.5 mmol/L Hexokinase (HK) ≥ 5 kU/L Monoclonal antibodies against human

CK-M; inhibiting capacity

≥ 2500 U/L R2: Imidazole/Good`s buffer 90 mmol/L ADP 10 mmol/L AMP 28 mmol/L Glucose-6-phosphate dehydrogenase (G6P-DH) ≥ 15 kU/L Diadenosine pentaphosphate 50 µmol/L Creatine phosphate 150 mmol/L Stabilizers







Specimen Serum or plasma Stability [1]: 2 days at 20 - 25 °C 7 days at 4 - 8 °C 4 weeks at -20 °C Discard contaminated specimens.

Calibrators and Controls For calibration the DiaSys TruCal U calibrator is recommended. Control sera and calibrators containing non-human CK-MB fractions are not suitable to be applied with this test due to the monoclonal antibody used in the reagent. Please take care to use controls and calibrators containing exclusively human CK-MB. For internal quality control DiaSys TruLab N and P controls should be assayed. Each laboratory should establish corrective actions in case of deviations in control recovery.


Performance Characteristics Measuring range up to 1920 U/L (32 µkat/L) CK-MB (in case of higher activities re-measure samples after manual dilution or use rerun function) Limit of detection** 1.2 U/L (0.02 µkat/L) CK-MB On-board stability 5 weeks Calibration stability 5 weeks


Precision

Within run (n=20) Sample 1 Sample 2 Sample 3 Mean [U/L] 33.8 108 198 Mean [µkat/L] 0.564 1.80 3.30 Coefficient of variation [%] 3.47 1.64 2.36

Between run (n=20) Sample 1 Sample 2 Sample 3 Mean [U/L] 18.6 52.0 196 Mean [µkat/L] 0.310 0.868 3.27 Coefficient of variation [%] 4.86 2.80 1.89

Method comparison (n=109) Test x DiaSys CK-MB FS Hitachi 911 Test y DiaSys CK-MB FS BM6010/C Slope 0.954 Intercept 0.48 U/L (0.008 µkat/L) Coefficient of correlation 0.999


Conversion factor CK-MB [U/L] x 0.0167 = CK-MB [µkat/L]

Reagent Information

Reference Range Myocardial infarction: the risk of myocardial infarction is high if the following three conditions are fulfilled [2]: 1. CK (Men) > 190 U/L (3.12 µkat/L)***

CK (Women) > 167 U/L (2.87 µkat/L)*** 2. CK-MB > 24 U/L (0.40 µkat/L)*** 3. CK-MB activity is between 6 and 25 % of total CK activity ***calculated using temperature conversion factor 2.38 (25 °C � 37 °C)

If myocardial infarction is suspected and the conditions are not fulfilled, the infarction may be fresh. In this case the measurements should be repeated after 4 hours with fresh samples. In healthy individuals different values are found depending on race and age [2,3].

Each laboratory should check if the reference ranges are transferable to its own patient population and determine own reference ranges if necessary. For diagnostic purposes CK values should always be assessed in conjunction with the anamnesis, the clinical examination and other findings.


Darmstadt: GIT Verlag; 2001; p. 24-5. 2. Stein W. Strategie der klinisch-chemischen Diagnostik des frischen

Myokardinfarkts. Med Welt 1985; 36: 572-7. 3. Myocardial infarction redefined – a consensus document of the Joint

European society of Cardiology / America College of Cardiology Committee for the redefinition of myocardial Infarction. Eur Heart J 2000; 21: 1502-13.

4. Recommendations of the German Society for Clinical Chemistry. Standardization of methods for the estimation of enzyme activities in biological fluids: Standard method for the determination of creatine kinase activity. J Clin Chem Clin Biochem 1977; 15: 255-60.

5. Stein W. Creatine kinase (total activity), creatine kinase isoenzymes and variants. In: Thomas L, ed. Clinical laboratory diagnostics. Frankfurt: TH-Books Verlagsgesellschaft; 1998. p.71-80.

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

7. Würzburg U, Hennrich N, Orth HD, Lang H. Quantitative determination of creatine kinase isoenzyme catalytic concentrations in serum using immunological methods. J Clin Chem Clin Biochem 1977; 15: 131-7.

8. Schumann G, Bonora R, Ceriotti F, Férard G et al. IFCC primary reference procedure for the measurement of catalytic activity concentrations of enzymes at 37 °C. Part 5: Referen ce procedure for the measurement of catalytic concentration of creatine kinase. Clin Chem Lab Med 2002; 40: 635-42.


IVD


CK-MB FS




# entered by user






Sub-analy. ConditionsName CKMBDigits 2M-wave L. 340S-wave.L 410Analy.mthd. RRACalc.mthd. STDQualit. judge No



Creatinine FS* Diagnostic reagent for quantitative in vitro determ ination of creatinine in serum, plasma or urine on BioMajesty JCA-BM6010/C


Method Kinetic test without deproteinization according to the Jaffé method

Principle Creatinine forms a colored orange-red complex in an alkaline picrate solution. The difference in absorbance at fixed times during conversion is proportional to the concentration of creatinine in the sample.

Creatinine + Picric acid Creatinine picrate complex

Reagents

Components and Concentrations R1: Sodium hydroxide 0.2 mol/L R2: Picric acid 20 mmol/L

Storage Instructions and Reagent Stability The reagents are stable up to the end of the indicated month of expiry, if stored at 2 – 25 °C, protected from ligh t and contamination is avoided. Do not freeze the reagents!

Warnings and Precautions 1. Reagent 1 is irritating. R36/38: Irritating to eyes and skin. S2:

Keep out of the reach of children. S26: In case of contact with eyes rinse immediately with plenty of water and seek medical advice. S37/39: Wear suitable gloves and eye/face protection.

2. Reagents S24/25: Avoid contact with skin and eyes. 3. Please refer to the safety data sheets and take the necessary



Reagent Preparation The reagents are ready to use. The bottles are placed directly into the reagent rotors.

Specimen Serum, heparin plasma or urine Stability in serum and plasma [1]: 7 days at 4 - 25 °C 3 months at -20 °C Stability in urine [1]: 2 days at 20 – 25 °C 6 days at 4 – 8 °C 6 months at -20 °C


Calibrators and Controls For calibration DiaSys TruCal U calibrator is recommended. The calibrator values have been made traceable to NIST (National Institute for Standardization) Standard Reference Material SRM 967 using level 1 and 2 and therefore to GC-IDMS (gas chromatography-isotope dilution mass spectrometry). For internal quality control DiaSys TruLab N, TruLab P and TruLab Urine controls should be assayed. Each laboratory should establish corrective action in case of deviations in control recovery.

Cat. No. Kit size TruCal U 5 9100 99 10 063 20 x 3 mL 5 9100 99 10 064 6 x 3 mL TruLab N 5 9000 99 10 062 20 x 5 mL 5 9000 99 10 061 6 x 5 mL TruLab P 5 9050 99 10 062 20 x 5 mL 5 9050 99 10 061 6 x 5 mL TruLab Urine Level 1 5 9170 99 10 062 20 x 5 mL 5 9170 99 10 061 6 x 5 mL TruLab Urine Level 2 5 9180 99 10 062 20 x 5 mL 5 9180 99 10 061 6 x 5 mL

Compensated method [2-4] Picric acid which forms the coloured complex reacts unspecifically with interfering serum components, so-called pseudo-creatinines. This leads to falsely elevated creatinine values in serum and plasma samples especially in the low measuring range. To compensate these interferences the calibrator value for the compensated method indicated in the value sheet of TruCal U has to be used for calculation. Additionally 0.3 mg/dL (27 µmol/L) has to be subtracted from the calculated creatinine value. When using the compensated method, calibration with the calibrator TruCal U is strictly recommended. The method is applicable only for serum and plasma samples. The compensated method is traceable to GC-IDMS and can, therefore, be used for estimation of the glomerular filtration rate using the MDRD formula as mentioned below.

Performance Characteristics Measuring range up to 14 mg/dL (1270 µmol/L) creatinine (in case of higher concentrations re-measure samples after manual dilution or use the rerun function) Limit of detection** 0.1 mg/dL (9 µmol/L) creatinine On-board stability 8 days Calibration stability 1 day

Interferences < 10% by Ascorbate up to 30 mg/dL Hemoglobin up to 600 mg/dL Conjugated bilirubin up to 3 mg/dL Unconjugated bilirubin up to 1.5 mg/dL Lipemia (triglycerides) up to 1800 mg/dL


Within run (n=20) Sample 1 Sample 2 Sample 3 Mean [mg/dL] 0.66 1.52 4.70 Mean [µmol/L] 58.3 134 415 Coefficient of variation [%] 1.49 1.26 0.70

Between run (n=20) Sample 1 Sample 2 Sample 3 Mean [mg/dL] 0.64 1.50 4.65 Mean [µmol/L] 56.7 133 411 Coefficient of variation [%] 3.07 2.05 0.94

Method comparison (Serum/plasma; n=98) Test x DiaSys Creatinine FS Test y Competitor Creatinine Slope 1.03 Intercept 0.029 mg/dL (2.55 µmol/L) Coefficient of correlation 0.9998

Reagent Information

Precision (Urine)

Within run (n=20) Sample 1 Sample 2 Sample 3 Mean [mg/dL] 27.8 58.3 107 Mean [mmol/L] 2.46 5.15 9.50 Coefficient of variation [%] 1.03 0.63 0.67

Between run (n=20) Sample 1 Sample 2 Sample 3 Mean [mg/dL] 35.4 60.5 122 Mean [mmol/L] 3.13 5.35 10.8 Coefficient of variation [%] 2.74 2.13 1.81

Method comparison (Urine; n=99) Test x DiaSys Creatinine FS Test y Competitor Creatinine Slope 0.957 Intercept 0.113 mg/dL (0.010 mmol/L) Coefficient of correlation 1.00


Conversion factor Creatinine [mg/dL] x 88.4 = Creatinine [µmol/L] Creatinine [mg/dL] x 0.0884 = Creatinine [mmol/L]

Calculation of Creatinine Clearance [mL/min/1.73 m2] [5]

timecollectionUrineminSerummL100/CreatininemgUrinemLUrinemL100/Creatininemg

××=

The calculated creatinine clearance refers to the average body surface of an adult (1.73 m2).

Estimated Glomerular Filtration Rate [mL/min/1.73 m2] according to MDRD (modification of diet in renal disease) using creatinine values obtained by a standardized method [4].

For serum creatinine (sCr) (mg/dL):

GFR = 175 x sCr-1.154 x age-0.203 x 1.212 (if Afro-American) x 0.742 (if female)

For serum creatinine (sCr) (µmol/L):


Reference Range

Serum/plasma, Jaffé method not compensated

mg/dL µmol/L Adults [6] Women 0.6 – 1.1 53 – 97 Men 0.9 – 1.3 80 – 115 Children [7,8] Neonate 0.5 – 1.2 45 - 105 Infant 0.4 – 0.7 35 - 62 Child 0.5 – 1.2 45 - 105

Serum/plasma, Jaffé method compensated

mg/dL µmol/L Adults [2] Women 0.5 – 0.9 44 - 80 Men 0.7 – 1.2 62 - 106 Children [9] Neonate 0.24 – 1.04 21 – 92 Infant 0.17 – 0.42 15 – 37 Child 0.24 – 0.87 21 - 77

Urine [6] Women 11 – 20 mg/kg/24h 97 – 177 µmol/kg/24h Men 14 – 26 mg/kg/24h 124 – 230 µmol/kg/24h

Creatinine clearance [7] Women 95 - 160 mL/min/1.73 m2 Men 98 - 156 mL/min/1.73 m2


Literature 1. Guder WG, Zawta B. Recommendations of the Working group on

Preanalytical Quality of the German Society for Clinical Chemistry and the German Society for Laboratory Medicine: The Quality of Diagnostic Samples. 1st ed Darmstadt: GIT Verlag 2001; p. 24-5,50-1

2. Mazzachi BC, Peake MJ, Ehrhardt V. Reference Range and Method Comparison Studies for Enzymatic and Jaffé Creatine Assays in Plasma and Serum and Early Morning Urine. Clin. Lab. 2000; 46: 53-55.

3. Swanson AF, Swartzentruber M, Nolen PA et al. Multicenter Evaluation of the Boehringer Mannheim Compensated, Rate-Blanked Creatinine/Jaffe Application on BM/Hitachi Systems. Advances in Clinical Diagnostics. 1993. Boehringer Mannheim Corporation.

4. Levey AS, Coresh J, Greene T, Marsh J et al: Expressing the Modification of Diet in Renal Disease Study Equation for Estimating Glomerular Filtration Rate with Standardized Serum Creatinine Values. Clin Chem 2007; 53 (4): 766-72.

5. Junge W, Wilke B, Halabi A, Klein G. Determination of reference intervals for serum creatinine, creatinine excretion and creatinine clearance with an enzymatic and a modified Jaffé method. Clin Chim Acta 2004; 344: 137-148

6. Newman DJ, Price CP. Renal function and nitrogen metabolites. In: Burtis CA, Ashwood ER, editors. Tietz Textbook of Clinical Chemistry. 3rd ed. Philadelphia: W.B Saunders Company; 1999. p. 1204-1270.


8. Soldin SJ, Brugnara C, Wong EC, eds. Pediatric Reference Intervals. 6th ed. AACC Press, 2007: p. 77-78

9. Schlebusch H, Liappis N, Klein G. Ultrasensitive CRP and Creatinine: Reference intervals from infancy to childhood. Clin Chem Lab Med. 2001; 39 Special supplement pp S1-S448; May 2001. PO-T042


IVD

Application BioMajesty JCA-BM6010/C September 2011/2

Creatinine FS




# entered by user

Endpoint method Re.absorb (u) 9.999 Re. Absorb (d) -9.999 Calculation Method Setting M-DET.P.I 21 M-DET.P.m 24 M-DET.P.n 32 S-DET.P.p 0 S-DET.P.r 0 Check D.P.I. 21 Limit value 0.003 Variance 10 Reac.type Inc Reaction Rate Method Cycle 2 Factor 2 E2 corre Do Blank (u) 9.999 Blank (d) -9.999 Sample (u) 9.999 Sample (d) -9.999 Standards Setting FV # BLK H 9.999 BLK L -9.999 STD H 9.999 STD L -9.999


Sub-analy. Conditions Name CREA Digits 2 M-wave L. 505 S-wave.L 571 Analy.mthd. RRA Calc.mthd. STD Qualit. judge No

Analysis Test Condition Setting (M) Sample Type Serum Urine Reac. sample vol. 5 5 Diluent method No dil With dil Undil. sample vol. 0 2 Diluent volume 0 98 Diluent position 0 0


Creatinine PAP FS* Diagnostic reagent for quantitative in vitro determination of creatinine in serum, plasma or urine on BioMajesty JCA-BM6010/C

Order information Cat. No. Tests 1 1759 99 10 963 R1 4 x 525 tests R2 3 x 700 tests 1 1759 99 10 962 R1 6 x 340 tests R2 6 x 340 tests

Method Enzymatic colorimetric test

Principle Creatinine is determined by the following reaction:

Creatinine + H2O Creatininase Creatine

Creatine + H2O Creatinase Sarcosine + Urea

Sarcosine + O2 + H2O Sarcosine oxidase Glycine + HCHO + H2O2

H2O2 + HTIB + 4-AA Peroxidase Quinone dye

The absorbance of the produced red dye at 545 nm is proportional to the creatinine concentration in the sample.

Reagents

Components and Concentrations R1: Goods buffer pH 8.1 25 mmol/L Creatinase ≥ 30 kU/L Sarcosine oxidase ≥ 10 kU/L Ascorbate oxidase ≥ 2.5 kU/L Catalase ≥ 350 kU/L HTIB (3-Hydroxy 2,4,6-triiodo benzoic acid) 2.3 mmol/L Detergents, stabilizers and preservatives R2: Goods buffer pH 8.1 25 mmol/L Creatininase ≥ 150 kU/L Peroxidase ≥ 50 kU/L 4-Aminoantipyrine (4-AA) 2 mmol/L Potassium hexacyanoferrate 0.18 mmol/L Stabilizers and preservatives


Warnings and Precautions 1. Reagent 2 contains sodium azide (0.95 g/L) as preservative.

Do not swallow! Avoid contact with skin and mucous membranes.




Specimen Serum, heparin plasma or urine Stability in serum and plasma [1]: 7 days at 4 - 25 °C 3 months at -20 °C Stability in urine [1]: 2 days at 20 – 25 °C 6 days at 4 – 8 °C 6 months at -20 °C


Calibrators and Controls For calibration the DiaSys TruCal U calibrator is recommended. The calibrator values have been made traceable to NIST (National Institute for Standardization) Standard Reference Material SRM 967 using level 1 and 2 and therefore to GC-IDMS (gas chromatography-isotope dilution mass spectrometry). For internal quality control DiaSys TruLab N, TruLab P and TruLab Urine controls should be assayed. Each laboratory should establish corrective action in case of deviations in control recovery.


Performance Characteristics Measuring range up to 30 mg/dL (2800 µmol/L) creatinine (in case of higher concentrations re-measure samples after manual dilution or use rerun function) Limit of detection** 0.02 mg/dL (1.59 µmol/L) creatinine On-board stability 6 weeks Calibration stability 6 weeks

Interferences < 10% by Ascorbate up to 27 mg/dL Conjugated Bilirubin up to 42 mg/dL Unconjugated Bilirubin up to 24 mg/dL Hemoglobin up to 500 mg/dL Creatine up to 40 mg/dL Lipemia (triglycerides) up to 1700 mg/dL Proline up to 12 mg/dL


Within run (n=20) Sample 1 Sample 2 Sample 3 Mean [mg/dL] 0.654 1.23 7.13 Mean [µmol/L] 57.8 109 630 Coefficient of variation [%] 0.94 1.32 0.93

Between run (n=20) Sample 1 Sample 2 Sample 3 Mean [mg/dL] 0.649 1.85 6.44 Mean [µmol/L] 57.4 164 569 Coefficient of variation [%] 1.67 1.51 1.77

Method comparison (Serum/plasma; n=100) Test x Competitor Creatinine Test y DiaSys Creatinine PAP FS Slope 0.993 Intercept 0.04 mg/dL (3.42 µmol/L) Coefficient of correlation 0.999

Reagent Information

Precision (Urine)



Method comparison (Urine; n=100) Test x Competitor Creatinine Test y DiaSys Creatinine PAP FS Slope 1.018 Intercept 0.69 mg/dL (0.061 mmol/L) Coefficient of correlation 0.998


Conversion factor Creatinine [mg/dL] x 88.4 = Creatinine [µmol/L] Creatinine [mg/dL] x 0.0884 = Creatinine [mmol/L]

Calculation

Creatinine-Clearance [mL/min/1.73 m2] [2]

timecollectionUrineminSerummL100/CreatininemgUrinemLUrinemL100/Creatininemg

××=

The calculated creatinine clearance refers to the average body surface of an adult (1.73 m2).

Estimated Glomerular Filtration Rate [mL/min/1.73 m2] according to MDRD (modification of diet in renal disease) using creatinine values obtained by a standardized method [3].

For serum creatinine (sCr) (mg/dL):


For serum creatinine (sCr) (µmol/L):


Reference Range

Serum/Plasma mg/dL µmol/L Adults [4] Women 0.5 – 1.0 45 – 84 Men 0.7 – 1.2 59 – 104 Children [4,5] Neonate 0.3 – 1.0 27 – 87 Infant 0.2 – 0.4 14 – 34 Child 0.2 – 0.8 23 – 68

Morning urine [4] Women 29 – 226 2.55 – 20.0 Men 40 – 278 3.54 – 24.6

Creatinine clearance [2] 66.3 - 143 mL/min/1.73 m2


Literature 1. Guder WG, Zawta B. Recommendations of the Working group on

Preanalytical Quality of the German Society for Clinical Chemistry and the German Society for Laboratory Medicine: The Quality of Diagnostic Samples. 1st ed Darmstadt: GIT Verlag 2001; p. 24-5,50-1.

2. Junge W, Wilke B, Halabi A, Klein G. Determination of reference intervals for serum creatinine, creatinine excretion and creatinine clearance with an enzymatic and a modified Jaffé method. Clin Chim Acta 2004; 344: 137-148

3. Levey AS, Coresh J, Greene T, Marsh J et al: Expressing the Modification of Diet in Renal Disease Study Equation for Estimating Glomerular Filtration Rate with Standardized Serum Creatinine Values. Clin Chem 2007; 53 (4): 766-72.

4. Mazzachi BC, Peake M, Erhardt V. Reference range and method comparison for enzymatic and Jaffé Creatinine assays in plasma and serum and early morning urine. Clin Lab 2000; 46: 53-5.

5. Schlebusch H, Liappis N, Klein G. Ultrasensitive CRP and Creatinine: Reference intervals from infancy to childhood. Clin Chem Lab Med. 2001; 39 Special supplement pp S1-S448; May 2001. PO-T042

6. Newman DJ, Price CP. Renal function and nitrogen metabolites. In: Burtis CA, Ashwood ER, editors. Tietz Textbook of Clinical Chemistry. 3rd ed. Philadelphia: W.B Saunders Company; 1999. p. 1204-1270.



IVD


Creatinine PAP FS




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Reaction Rate MethodCycle 2Factor 2E2 corre Not DoBlank (u) 9.999Blank (d) -9.999Sample (u) 9.999Sample (d) -9.999



Sub-analy. ConditionsName CREAPDigits 2M-wave L. 545S-wave.L 694Analy.mthd. EPACalc.mthd. STDQualit. judge No

Analysis Test Condition Setting (M)Sample Type Serum UrineReac. sample vol. 2 2Diluent method No dil With dilUndil. sample vol. 0 5Diluent volume 0 45Diluent position 0 0


CRP FS*

Diagnostic reagent for quantitative in vitro determination of C-reactive protein (CRP) in serum or plasma on BioMajesty JCA-BM6010/C



Principle Determination of the concentration of CRP by photometric measurement of antigen-antibody reaction between antibodies against human CRP and CRP present in the sample.

Reagents Components and Concentrations R1: TRIS pH 7.5 100 mmol/L Polyethylenglycol (PEG), detergents and stabilizers

R2: TRIS pH 8.0 100 mmol/L Anti-human CRP antibodies (goat) with stabilizers




2. Reagent 2 S24/25: Avoid contact with skin and eyes. 3. Please refer to the safety data sheets and take the necessary




Specimen Serum, heparin plasma or EDTA plasma Stability [1]: 15 days at 20 – 25 °C 2 months at 4 – 8 °C 3 years at -20 °C Only freeze once! Discard contaminated specimens.


For calibration the DiaSys TruCal CRP calibrator set is recommended. For internal quality control a DiaSys TruLab CRP or TruLab Protein control should be assayed. Each laboratory should establish corrective action in case of deviations in control recovery.

Cat. No. Kit size TruCal CRP 1 7000 99 10 039 5 x 2 mL TruLab CRP Level 1 5 9600 99 10 045 3 x 2 mL TruLab CRP Level 2 5 9610 99 10 045 3 x 2 mL TruLab Protein Level 1 5 9500 99 10 046 3 x 1 mL TruLab Protein Level 2 5 9510 99 10 046 3 x 1 mL

Performance Characteristics Measuring range up to 250 mg/L CRP, at least up to the concentration of the highest calibrator. (in case of higher concentrations re-measure samples after manual dilution or use rerun function) Limit of detection** 0.1 mg/L CRP No prozone effect up to 2000 mg/L CRP On-board stability 6 weeks Calibration stability 6 weeks


Precision

Within run (n=20) Sample 1 Sample 2 Sample 3 Mean [mg/L] 7.30 22.3 43.9 Coefficient of variation [%] 1.10 0.85 2.66

Between run (n=20) Sample 1 Sample 2 Sample 3 Mean [mg/L] 7.45 22.5 43.8 Coefficient of variation [%] 1.94 1.31 1.44

Method comparison (n=100) Test x Competitor CRP test Test y DiaSys CRP FS Slope 1.023 Intercept 0.156 mg/L Coefficient of correlation 1.000


Reference Range [2]

Adults < 5 mg/L



Darmstadt: GIT Verlag; 2001. p. 24 -5. 2. Dati F, Schumann G, Thomas L, Aguzzi F, Baudner S, Bienvenu J et


3. Thompson D, Milford-Ward A, Whicher JT. The value of acute phase protein measurements in clinical practice. Ann Clin Biochem 1992; 29: 123-31.

4. Gabay C, Kushner I. Acute-phase proteins and other systemic responses to inflammation. N Engl J Med 1999; 340: 448-54.

5. Hansson LO, Lindquist L. C-reactive protein: its role in the diagnosis and follow-up of infectious diseases. Curr Opin Infect Diseases 1997; 10: 196-201.

6. Sipe JD. Acute-phase proteins in osteoarthritis. Semin Arthritis Rheum 1995; 25: 75-86.


IVD


CRP FS


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Analytical Conditions R1 volume 80 R2e volume 0 R2 volume 16 R1 diluent vol 0 R2e diluent vol 0 R2 diluent vol 0 Sample vol (S) 4.8 Sample vol (U) 0 Reagent 1 mix weak Reagent 2e mix weak Reagent 2 mix weak Reaction time 10

Sub-analy. Conditions Name CRP Digits 2 M-wave L. 340 S-wave.L 694 Analy.mthd. EPA Calc.mthd. MSTD Qualit. judge No

Analysis Test Condition Setting (M) Sample Type Serum Urine Reac. sample vol. 4.8 0 Diluent method No dil No dil Undil. sample vol. 0 0 Diluent volume 0 0 Diluent position 0 0



MULTI-STD Setting Formula Logit Log 3 Axis Conv No conv Blank passes Points 6

FV Reac.

smp. vol. Dil.

method Dil. smp.

vol. Diluent

vol. Diluent

pos. STD H STD L



Iron FS* Ferene Diagnostic reagent for quantitative in vitro determination of iron in serum or plasma on BioMajesty JCA-BM6010/C


Method Photometric test using Ferene

Principle Iron bound to transferrin is released in an acidic medium as ferric iron and is then reduced to ferrous iron in the presence of ascorbic acid. Ferrous iron forms a blue complex with Ferene. The absorbance at 595 nm is directly proportional to the iron concentration. Transferrin (Fe3+)2 Ascorbic acid, Buffer 2 Fe2+ + Transferrin Fe2+ + 3 Ferene Ferrous Ferene (blue complex)

Reagents Components and Concentrations R1: Acetate buffer pH 4.5 1 mol/L Thiourea 120 mmol/L R2: Ascorbic acid 240 mmol/L Ferene 3 mmol/L Thiourea 120 mmol/L

Storage Instructions and Reagent Stability The reagents are stable up to the end of the indicated month of expiry, if stored at 2 - 8 °C, protected from light and contamination is avoided. Do not freeze the reagents!

Warnings and Precautions 1. Reagent 1 is irritating. R36: Irritating to eyes. S2: Keep out of

the reach of children. S25: Avoid contact with eyes. S26: In case of contact with eyes, rinse immediately with plenty of water and seek medical advice.

2. Reagent 2 S25: Avoid contact with eyes. 3. Use only disposable material to avoid iron contamination. 4. Please refer to the safety data sheets and take the necessary




Specimen Serum or heparin plasma Separate serum/plasma at the latest 2 h after blood collection to minimize hemolysis. Stability [1]: 7 days at 20 - 25 °C 3 weeks at 4 - 8 °C 1 year at -20 °C Discard contaminated specimens.

Calibrators and Controls For calibration, DiaSys TruCal U calibrator is recommended. For internal quality control DiaSys TruLab N and P controls should be assayed. Each laboratory should establish corrective actions in case of deviations in control recovery.

Performance Characteristics Measuring range up to 1000 µg/dL (179 µmol/L) iron (in case of higher concentrations re-measure samples after manual dilution or use rerun function) Limit of detection** 2.2 µg/dL (0.39 µmol/L) iron On-board stability 6 weeks Calibration stability 6 weeks

Interferences < 10% by Ascorbate up to 30 mg/dL Hemoglobin up to 100 mg/dL Bilirubin (conjugated and unconjugated) up to 60 mg/dL Lipemia (triglycerides) up to 2000 mg/dL Zinc up to 400 µg/dL

Precision

Within run (n=20) Sample 1 Sample 2 Sample 3 Mean [µg/dL] 78.2 169 261 Mean [µmol/L] 14.0 30.3 46.8 Coefficient of variation [%] 1.36 1.25 0.91

Between run (n=20) Sample 1 Sample 2 Sample 3 Mean [µg/dL] 78.6 254 330 Mean [µmol/L] 14.1 45.4 59.0 Coefficient of variation [%] 2.23 1.53 0.98

Method comparison (n=143) Test x Competitor Iron Test y DiaSys Iron FS Ferene Slope 1.04 Intercept -3.87 µg/dL (-0.694 µmol/L) Coefficient of correlation 0.9999


Conversion factor Iron [µg/dL] x 0.1791 = [µmol/L]


Reagent Information

Reference Range [2]

µg/dL µmol/L Children 2 weeks 63 - 201 11.3 – 36.0 6 months 28 - 135 5.0 – 24.2 12 months 35 - 155 6.3 – 27.8 2 - 12 years 22 - 135 3.9 – 24.2 Women 25 years 37 - 165 6.6 - 29.5 40 years 23 - 134 4.1 - 24.0 60 years 39 - 149 7.0 - 26.7 Pregnant women 12th gestational week 42 - 177 7.6 - 31.6 at term 25 - 137 4.5 - 24.5 6 weeks postpartum 16 - 150 2.9 - 26.9 Men 25 years 40 - 155 7.2 - 27.7 40 years 35 - 168 6.3 - 30.1 60 years 40 - 120 7.2 - 21.5



Darmstadt: GIT Verlag; 2001; p. 34-5. 2. Thomas L. Clinical Laboratory Diagnostics. 1st ed. Frankfurt: TH-Books

Verlagsgesellschaft; 1998. p. 273-5. 3. Wick M. Iron metabolism and its disorders. In: Thomas L, editor.

Clinical laboratory diagnostics. 1st ed. Frankfurt: TH-Books Verlagsgesellschaft; 1998. p. 268-73.

4. Fairbanks VF, Klee GG. Biochemical aspects of hematology. In: Burtis CA, Ashwood ER, editors. Tietz Textbook of Clinical Chemistry. 3rd ed. Philadelphia: W.B Saunders Company; 1999. p. 1642-1710.

5. Higgins T. Novel chromogen for serum iron determinations. Clin Chem 1981; 27: 1619.

6. Artiss JD, Vinogradov S, Zak B. Spectrophotometric study of several sensitive reagents for serum iron. Clin Biochem 1981; 14: 311-15.



Iron FS




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Analytical ConditionsR1 volume 80R2e volume 0R2 volume 20R1 diluent vol 0R2e diluent vol 0R2 diluent vol 0Sample vol (S) 5.0Sample vol (U) 5Reagent 1 mix weakReagent 2e mix weakReagent 2 mix weakReaction time 10

Sub-analy. ConditionsName FEDigits 2M-wave L. 596S-wave.L 694Analy.mthd. EPACalc.mthd. STDQualit. judge No



Ferritin FS*

Diagnostic reagent for quantitative in vitro determination of ferritin in serum or plasma on BioMajesty JCA-BM6010/C


Method Particle enhanced immunoturbidimetric test

Principle Determination of the concentration of ferritin by photometric measurement of antigen-antibody-reaction of latex-particles coated with antibodies to ferritin with ferritin present in the sample.

Reagents Components and Concentrations R1: Glycine pH 8.3 170 mmol/L NaCl 100 mmol/L Bovine serum albumin 5 g/LR2: Latex particles coated with

anti-ferritin antibody 0.7 g/L

Glycine pH 7.3 170 mmol/L NaCl 100 mmol/L

Storage Instructions and Reagent Stability The reagents are stable up to the end of the indicated month of expiry, if stored at 2 – 8 °C, protected from light and contamination is avoided. Do not freeze the reagents! Warnings and Precautions 1. The reagents contain sodium azide (0.9 g/L) as preservative.

Do not swallow! Avoid contact with skin and mucous membranes.


Waste Management Please refer to local legal requirements. Reagent Preparation The reagents are ready to use. The bottles are placed directly into the reagent trays.

Specimen Serum or plasma (EDTA, Heparin, citrate) Stability [1]: 7 days at 20 - 25 °C 7 days at 4 - 8 °C 1 year at -20 °C Only freeze once! Discard contaminated specimens.

Calibrators and Controls For calibration, the DiaSys TruCal Ferritin calibrator set is recommended. For internal quality control a DiaSys TruLab Protein control should be assayed. Each laboratory should establish corrective action in case of deviations in control recovery.

Performance Characteristics Measuring range up to 1000 µg/L (2247 pmol/L) ferritin, at least up to the concentration of the highest calibrator. (in case of higher concentrations re-measure samples after manual dilution or use rerun function) Limit of detection** 5 µg/L (11.2 pmol/L) ferritin No prozone effect up to 30000 µg/L (67410 pmol/L) ferritin On-board stability 12 weeks Calibration stability 12 weeks

Interferences < 10% by Ascorbate up to 50 mg/dL Bilirubin (conjugated and unconjugated) up to 30 mg/dL Hemoglobin up to 500 mg/dL Lipemia (triglycerides) up to 400 mg/dL (Ferritin conc. 61 µg/L) Lipemia (triglycerides) up to 800 mg/dL (Ferritin conc. 199 µg/L)

Precision

Within run (n=20) Sample 1 Sample 2 Sample 3 Mean [µg/L] 15.2 103 394 Mean [pmol/L] 34.2 231 885 Coefficient of variance [%] 5.73 0.88 0.75

Between run (n=20) Sample 1 Sample 2 Sample 3 Mean [µg/L] 76.6 109 527 Mean [pmol/L] 172 245 1184 Coefficient of variance [%] 3.19 2.14 1.63

Method comparison (n=97) Test x DiaSys Ferritin FS (Hitachi 917) Test y DiaSys Ferritin FS (BioMajesty JCA 6010/C) Slope 0.957 Intercept 0.724 µg/L (1.63 pmol/L) Coefficient of correlation 0.9995


Conversion factor Ferritin [µg/L] x 2.247 = Ferritin [pmol/L] Ferritin [µg/L] = Ferritin [ng/mL]

Reference Range [2] Children 15 – 120 µg/L 33.7 – 270 pmol/LAdults Men 30 – 300 µg/L 67.4 – 674 pmol/L Women < 50y 10 – 160 µg/L 22.5 – 360 pmol/L Women > 50y Increase to male values



Darmstadt: GIT Verlag; 2001; p. 28-9. 2. Wick M, Pingerra W, Lehmann P. Iron metabolism: diagnosis

and therapy of anemias. 3rd ed. Vienna, New York: Springer Verlag,1996.

3. Worwood M. The laboratory assessment of iron status – an update. Clin Chim Acta 1997; 259: 3-23.

4. Kaltwasser JP, Werner E. Diagnosis and clinical evaluation of iron overload. Baillieres Clin Haematol 1989; 2; 363-89.

5. Baynes RD, Cook JD. Current issues in iron deficiency. Curr Opin Hematol 1996; 3:145-9.

6. Lee MH, Means RT Jr. Extremely elevated serum ferritin levels in a university hospital: associated diseases and clinical significance. Am J Med 1996; 98: 566-71.


Cat. No. Kit size TruCal Ferritin (4 Levels) 1 7050 99 10 058 4 x 1 mL TruLab Protein 1 5 9500 99 10 046 3 x 1 mL TruLab Protein 2 5 9510 99 10 046 3 x 1 mL

IVD


Ferritin FS Chemistry code 10 705 Application for serum and plasma samples This application was set up and evaluated by DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by unqualified personnel.

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Sub-analy. Conditions Name FERR Digits 1 M-wave L. 571 S-wave.L **** Analy.mthd. IMA Calc.mthd. MSTD Qualit. judge No



Reaction Rate Method Cycle 2 Factor 2 E2 corre Not do Blank (u) 9.999 Blank (d) -9.999 Sample (u) 9.999 Sample (d) -9.999 Prozone Prozone form Prozone formula Prozone limit 0.034 Prozone judge Upper limit Judge limit 0.003 M-DET.P.m 23 M-DET.P.n 23 S-DET.P.p 22 S-DET.P.r 22


FV Reac. smp.

vol. Dil. method Dil. smp.

vol. Diluent vol. Diluent pos. STD H STD L

BLK # 4.0 No dil 0 0 0 9.999 -9.999 1 # 4.0 No dil 0 0 0 9.999 -9.999 2 # 4.0 No dil 0 0 0 9.999 -9.999 3 # 4.0 No dil 0 0 0 9.999 -9.999 4 # 4.0 No dil 0 0 0 9.999 -9.999

IMA Setting Blank (u) Blank (d) Sample (u) Sample (d) Prozone value

Calibrator Set 4 0 4 0 4 D.P. set l 22 22 22 3 22

D.P. set m 0 0 23 23 23 Factor d 1.50 0.20 0.095 0.00 1.05

Automatic setting Not do Not do Not do Not do Do


Gamma-GT FS* Szasz mod./IFCC stand. Diagnostic reagent for quantitative in vitro determination of gamma-glutamyltransferase (gamma-GT) in serum or plasma on BioMajesty JCA-BM6010/C


Method Kinetic photometric test according to Szasz/Persijn [1]. The test has also been standardized to the method according to IFCC (International Federation of Clinical Chemistry) [2]. Results according to IFCC are obtained using the calibrator value given for the IFCC method.

Principle Gamma-GT catalyzes the transfer of glutamic acid to acceptors like glycylglycine in this case. This process releases 5-amino-2-nitrobenzoate, which can be measured photometrically. The increase in absorbance is directly related to the activity of gamma-GT. L-Gamma-glutamyl-3-carboxy-4-nitranilide + Glycylglycine

Gamma-GT

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

Reagents Components and Concentrations R1: TRIS pH 8.25 135 mmol/L Glycylglycine 135 mmol/L R2: L-Gamma-glutamyl-3-carboxy-4-nitroanilide 22 mmol/L







Specimen Serum or heparin plasma Stability [3]: at least 1 week between -20 °C and +25 °C Discard contaminated specimens.


For calibration DiaSys TruCal U calibrator is recommended. For internal quality control DiaSys TruLab N and P controls should be assayed. Each laboratory should establish corrective action in case of deviations in control recovery.

Performance Characteristics Measuring range up to 1200 U/L (20 µkat/L) gamma-GT (in case of higher activities re-measure samples after manual dilution or use rerun function) Limit of detection** 1.2 U/L (0.02 µkat/L) gamma-GT On-board stability 6 weeks Calibration stability 6 weeks


Precision

Within run (n=20) Sample 1 Sample 2 Sample 3 Mean [U/L] 57.2 113 213 Mean [µkat/L] 0.953 1.88 3.55 Coefficient of variation [%] 1.79 1.34 1.22


Method comparison (n=100) Test x Competitor Gamma-GT Test y DiaSys Gamma-GT FS Slope 1.036 Intercept 1.02 U/L (0.017 µkat/L) Coefficient of correlation 0.999


Conversion factor Gamma-GT [U/L] x 0.0167 = Gamma-GT [µkat/L]

Reference Range

According to Szasz [4] Women < 32 U/L 0.53 µkat/L Men < 49 U/L 0.82 µkat/L

According to IFCC Female Male

U/L U/L Adults [2] < 38 < 55 Children/adolescents [5] 1 day – 6 months 15 – 132 12 – 122 6 months – 1 year 1 – 39 1 – 39 1 – 12 year(s) 4 – 22 3 – 22 13 – 18 years 4 - 24 2 - 42

Female Male µkat/L µkat/L Adults [2] < 0.63 < 0.92 Children/adolescents [5] 1 day – 6 months 0.25 – 2.20 0.20 – 2.03 6 months – 1 year 0.017 – 0.65 0.017 – 0.65 1 – 12 year(s) 0.067 – 0.37 0.05 – 0.37 13 – 18 years 0.067 – 0.40 0.03 – 0.70



Reagent Information

Literature 1. Persijn JP, van der Silk W. A new method for the determination of

gamma-glutamyltransferase in serum. J Clin Chem Clin Biochem 1976; 14: 421-7.

2. Schumann G, Bonora R, Ceriotti F, Férard G et al. IFCC primary reference procedure for the measurement of catalytic activity concentrations of enzymes at 37 °C. Part 5: Referen ce procedure for the measurement of catalytic concentration of γ-glutamyltransferase. Clin Chem Lab Med 2002; 40: 734-8.

3. Guder WG, Zawta B et al. The Quality of Diagnostic Samples. 1st ed. Darmstadt: GIT Verlag; 2001; p. 30-1.

4. Fischbach F, Zawta B. Age-dependent reference limits of several enzymes in plasma at different measuring temperatures. Klin Lab 1992; 38: 555-61.

5. Thomas L. Clinical Laboratory Diagnostics. 1st ed. Frankfurt: TH-Books Verlagsgesellschaft;1998. p. 80-6.

6. Szasz G. Gamma-Glutamyltranspeptidase. In: Bergmeyer HU. Methoden der enzymatischen Analyse. Weinheim: Verlag Chemie, 1974. p. 757.


IVD


Gamma-GT FS (Szasz mod./IFCC stand.)




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Endpoint method Re.absorb (u) 9.999 Re. Absorb (d) -9.999 Calculation Method Setting M-DET.P.I 21 M-DET.P.m 25 M-DET.P.n 40 S-DET.P.p 0 S-DET.P.r 0 Check D.P.I. 21 Limit value 0.003 Variance 10 Reac.type Inc Reaction Rate Method Cycle 2 Factor 2 E2 corre Do Blank (u) 9.999 Blank (d) -9.999 Sample (u) 9.999 Sample (d) -9.999 Standards Setting FV # BLK H 9.999 BLK L -9.999 STD H 9.999 STD L -9.999


Sub-analy. Conditions Name GGT Digits 2 M-wave L. 410 S-wave.L 694 Analy.mthd. RRA Calc.mthd. STD Qualit. judge No


Reagent information *fluid stable

Glucose Hexokinase FS*

Diagnostic reagent for quantitative in vitro determination of glucose in serum, plasma or urine on BioMajesty JCA-BM6010/C


Method Enzymatic UV test using hexokinase

Principle Glucose + ATP HK > Glucose-6-phosphate + ADP

Glucose-6-phosphate + NAD+ G6P-DH > Gluconate-6-P + NADH + H+

Reagents

Components and Concentrations R1: TRIS buffer pH 7.8 100 mmol/L Mg2+ 4 mmol/L ATP 2.1 mmol/L NAD 2.1 mmol/L R2: Mg2+ 4 mmol/L Hexokinase (HK) ≥ 7.5 kU/L Glucose-6-phosphatedehydrogenase (G6P-DH) ≥ 7.5 kU/L







Specimen Serum, heparin plasma, urine Separate at the latest 1h after blood collection from cellular contents. Stability in plasma after addition of a glycolytic inhibitor (Fluoride, monoiodacetate, mannose) [1]: 2 days at 20 – 25 °C 7 days at 4 – 8 °C 1 day at -20 °C Stability in serum (separated from cellular contents, hemolysis free) without adding a glycolytic inhibitor [2,3]: 8 h at 25 °C 72 h at 4 °C Stability in urine [1]: 2 h at 20 - 25 °C 2 h at 4 – 8 °C Discard contaminated specimens.

Calibrators and Controls For calibration DiaSys TruCal U calibrator is recommended. For internal quality control DiaSys TruLab N, TruLab P and TruLab Urine controls should be assayed. Each laboratory should establish corrective action in case of deviations in control recovery.


Performance Characteristics Measuring range up to 500 mg/dL (30 mmol/L) glucose (in case of higher concentrations re-measure samples after manual dilution or use rerun function) Limit of detection** 1 mg/dL (0.05 mmol/L) glucose On-board stability 6 weeks Calibration stability 6 weeks



Within run (n=20) Sample 1 Sample 2 Sample 3 Mean [mg/dL] 77.5 91.9 267 Mean [mmol/L] 4.30 5.10 14.8 Coefficient of variance [%] 0.73 0.87 0.57

Between run (n=20) Sample 1 Sample 2 Sample 3 Mean [mg/dL] 57.3 111 331 Mean [mmol/L] 3.18 6.17 18.4 Coefficient of variance [%] 1.42 1.50 1.13

Method comparison (Serum/plasma; n=124) Test x Competitor Glucose HK Test y DiaSys Glucose HK FS Slope 1.000 Intercept 1.80 mg/dL (0.100 mmol/L) Coefficient of correlation 0.999

Precision (Urine)

Within run (n=20) Sample 1 Sample 2 Sample 3 Mean [mg/dL] 27.9 98.9 274 Mean [mmol/L] 1.55 5.49 15.2 Coefficient of variance [%] 0.82 1.31 0.82

Between run (n=20) Sample 1 Sample 2 Sample 3 Mean [mg/dL] 27.9 99.4 272 Mean [mmol/L] 1.55 5.52 15.1 Coefficient of variance [%] 1.81 1.62 0.99

Method comparison (Urine; n=100) Test x Competitor Glucose HK Test y DiaSys Glucose HK FS Slope 0.985 Intercept -0.38 mg/dL (-0.021 mmol/L) Coefficient of correlation 1.000


Conversion factor Glucose [mg/dL] x 0.05551 = Glucose [mmol/L]

Reagent information

Reference Range [4]

[mg/dL] [mmol/L] Newborns: Cord blood 63 - 158 3.5 - 8.8 1 h 36 - 99 2.0 – 5.5 2 h 36 – 89 2.2 – 4.9 5 – 14 h 34 – 77 1.9 – 4.3 10 – 28 h 46 – 81 2.6 – 4.5 44 – 52 h 48 – 79 2.7 – 4.4 Children (fasting): 1 – 6 years 74 – 127 4.1 – 7.0 7 – 19 years 70 – 106 3.9 – 5.9 Adults (fasting): Venous plasma 70 – 115 3.9 – 6.4

Urine: ≤ 15 mg/dL (0.84 mmol/L) (Value is based on an average quantity of urine of 1350 mL/day)



Darmstadt: GIT Verlag; 2001; p. 30-1, 50-1. 2. Sacks DB. Carbohydrates. In: Burtis CA, Ashwood ER, editors. Tietz

Textbook of Clinical Chemistry. 3rd ed. Philadelphia: W.B Saunders Company; 1999. p. 750-808.

3. Sacks DB, Bruns DE, Goldstein DE, Mac Laren NK, Mc Donald JM, Parrott M. Guidelines and recommendations for laboratory analysis in the diagnosis and management of diabetes mellitus. Clin Chem 2002; 48: 436-72.

4. Thomas L. Clinical Laboratory Diagnostics. 1st ed. Frankfurt: TH-Books Verlagsgesellschaft; 1998. p. 131-7, 1368.


IVD


Glucose Hexokinase FS




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Sub-analy. Conditions Name GLUHK Digits 2 M-wave L. 340 S-wave.L 410 Analy.mthd. EPA Calc.mthd. STD Qualit. judge No



HDL-C Immuno FS*

Diagnostic reagent for quantitative in vitro determination of high density lipoprotein cholesterol (HDL-C) in serum or plasma on BioMajesty JCA-BM6010/C


Method Previous HDL-cholesterol determinations were performed by time consuming precipitation methods [1]. HDL-C Immuno FS is a homogeneous method for HDL-cholesterol measurement without centrifugation steps. Antibodies against human lipoproteins are used to form antigen-antibody complexes with LDL, VLDL and chylomicrons in a way that only HDL-cholesterol is selectively determined by an enzymatic cholesterol measurement [2].

Principle

LDL, VLDL, Chylomicrons Anti-human β-lipoprotein antibodies

Antigen-antibody complexes + HDL

HDL-cholesterol + H2O + O2 CHE & CHO

Cholest-4-en-3-one + fatty acid + H2O2

H2O2 + F-DAOS + 4-Aminoantipyrine POD Blue complex + H2O

Reagents

Components and Concentrations R1: Good’s buffer pH 7.0 25 mmol/L 4-Aminoantipyrine 0.75 mmol/L Peroxidase (POD) 2 kU/L Ascorbate oxidase 2.25 kU/L Anti-human β-lipoprotein antibody (sheep) R2: Good’s buffer pH 7.0 30 mmol/L Cholesterol esterase (CHE) 4 kU/L Cholesterol oxidase (CHO) 20 kU/L N-Ethyl-N-(2-hydroxy-3-sulfopropyl)- 3,5-dimethoxy-4-

fluoroaniline, sodium salt (F-DAOS) 0.8 mmol/L

Storage Instructions and Reagent Stability The reagents are stable up to the end of the indicated month of expiry, if stored at 2 – 8 °C protected from light and contami nation is avoided. Do not freeze the reagents!

Warnings and Precautions 1. Reagent R1 is irritating. R43: May cause sensitisation by skin contact.

S24: Avoid contact with skin. S37: Wear suitable gloves. 2. Please refer to the safety data sheets and take the necessary




Specimen Serum or heparin plasma

Stability [3]: 2 days at 20 - 25 °C 7 days at 4 – 8 °C 3 months at -20 °C Discard contaminated specimens.

Calibrators and Controls For calibration, DiaSys TruCal HDL/LDL has to be used. For internal quality control, DiaSys TruLab L control should be assayed. Each laboratory should establish corrective action in case of deviations in control recovery.

Cat. No. Kit size TruCal HDL/LDL 1 3520 99 10 065 3 x 3 mL TruLab L Level 1 5 9020 99 10 065 3 x 3 mL TruLab L Level 2 5 9030 99 10 065 3 x 3 mL

Performance Characteristics Measuring range up to 180 mg/dL (4.7 mmol/L) HDL-C (in case of higher concentrations re-measure samples after manual dilution or use rerun function) Limit of detection** 1 mg/dL HDL-C On-board stability 6 weeks Calibration stability 6 weeks

Interferences < 10% by Ascorbate up to 30 mg/dL Hemoglobin up to 500 mg/dL Bilirubin (conjugated and unconjugated) up to 60 mg/dL Lipemia (triglycerides) up to 1400 mg/dL

Precision

Within run (n=20) Sample 1 Sample 2 Sample 3 Mean [mg/dL] 35.6 54.7 68.9 Mean [mmol/L] 0.92 1.42 1.78 Coefficient of variation [%] 1.01 0.67 1.18

Between run (n=20) Sample 1 Sample 2 Sample 3 Mean [mg/dL] 41.4 58.3 67.9 Mean [mmol/L] 1.07 1.51 1.76 Coefficient of variation [%] 1.79 1.77 1.52

Method comparison (n=99) Test x DiaSys HDL-C Immuno FS

Hitachi 917 Test y DiaSys HDL-C Immuno FS

BioMajesty JCA-BM6010C Slope 0.965 Intercept 2.47 mg/dL (0.064 mmol/L) Coefficient of correlation 0.998


Conversion factor Cholesterol [mg/dL] x 0.02586 = Cholesterol [mmol/L]

Reference Range [4] ≥ 35 mg/dL (≥ 0.9 mmol/L)

Each laboratory should check if reference ranges are transferable to its own patient population and determine own reference ranges if necessary.

Clinical Interpretation Epidemiological studies have observed that low HDL-cholesterol concentrations < 39 mg/dL (1.0 mmol/L) in men and < 43 mg/dL (1.0 mmol/L) in women, especially if associated with fasting triglycerides > 180 mg/dL (2,0 mmol/L), predict a high risk of coronary heart disease [5].

Literature 1. Wiebe DA, Warnick GR. Measurement of high-density lipoprotein

cholesterol. In: Rifai N, Warnick GR, Dominiczak MH, eds. Handbook of lipoprotein testing. Washington: AACC Press, 1997. p. 127-44.

2. Nauck M, Maerz W, Wieland H. New immunoseparation-based homogenous assay for HDL-cholesterol compared with three homogenous and two heterogeneous methods for HDL-cholesterol. Clin Chem 1998; 44: 1443-51.


4. Schaefer EJ, McNamara J. Overview of the diagnosis and treatment of lipid disorders. In: Rifai N, Warnick GR, Dominiczak MH, eds. Handbook of lipoprotein testing. Washington: AACC Press; 1997 p. 25-48.




IVD


HDL-C Immuno FS




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Analytical ConditionsR1 volume 80R2e volume 0R2 volume 20R1 diluent vol 0R2e diluent vol 0R2 diluent vol 0Sample vol (S) 1.0Sample vol (U) 1Reagent 1 mix weakReagent 2e mix weakReagent 2 mix weakReaction time 10

Sub-analy. ConditionsName HDLCDigits 2M-wave L. 596S-wave.L 694Analy.mthd. EPACalc.mthd. STDQualit. judge No



Immunoglobulin E FS*

Diagnostic reagent for quantitative in vitro determination of immunoglobulin E (IgE) in serum or plasma on BioMajesty JCA-BM6010/C


Method Particle enhanced immunoturbidimetric test

Principle Determination of the IgE concentration by photometric measurement of antigen-antibody-reaction between antibodies to human IgE and IgE present in the sample.

Reagents Components and Concentrations R1: Glycine pH 8.3 170 mmol/L NaCl 100 mmol/L Stabilizers R2: Glycine pH 7.3 170 mmol/L Latex particles coated with anti-human IgE

monoclonal antibody 1.3 g/L

NaCl 100 mmol/LStorage Instructions and Reagent Stability The reagents are stable up to the end of the indicated month of expiry if, after opening, stored at 2 – 8 °C, protected from light and contamination is avoided. Do not freeze the reagents! Warnings and Precautions 1. The reagents contain sodium azide (0.95 g/L) as

preservative. Do not swallow! Avoid contact with skin and mucous membranes!


Waste Management Please refer to local legal requirements. Reagent Preparation The reagents are ready to use. The bottles are placed directly into the reagent trays.

Specimen Serum, heparin plasma or EDTA plasma Stability [1]: 7 days at 20 – 25 °C 7 days at 4 – 8 °C 6 months at -20 °C Freeze only once! Discard contaminated specimens.

Calibrators and Controls For calibration the DiaSys TruCal IgE calibrator set is recommended. For internal quality control DiaSys TruLab Protein controls should be assayed. Each laboratory should establish corrective action in case of deviations in control recovery.

Cat. No. Kit size TruCal IgE 1 7230 99 10 059 5 x 1 mL TruLab Protein Level 1 5 9500 99 10 046 3 x 1 mL TruLab Protein Level 2 5 9510 99 10 046 3 x 1 mL

Performance Characteristics Measuring range from 65 up to 1000 IU/mL IgE, at least up to the concentration of the highest calibrator. (in case of higher concentrations re-measure samples after manual dilution or use rerun function) Limit of detection** 10 IU/mL IgE No prozone effect up to 15000 IU/mL IgE On-board stability 9 weeks Calibration stability 4 weeks

Interferences < 10% by Ascorbate up to 50 mg/dL Bilirubin up to 30 mg/dL Hemoglobin up to 500 mg/dL Lipemia (Triglycerides) up to 800 mg/dL

Within run (n=20) Sample 1 Sample 2 Sample 3 Mean [IU/mL] 52.3 101 413 Coefficient of variation [%] 4.43 2.62 1.66

Between run (n=20) Sample 1 Sample 2 Sample 3 Mean [IU/mL] 51.0 151 523 Coefficient of variation [%] 3.62 2.11 1.19

Method comparison (n=84) Test x DiaSys IgE FS (Hitachi 917) Test y DiaSys IgE FS (BioMajesty JCA-BM6010/C) Slope 1.01 Intercept 1.69 IU/mL Coefficient of correlation 0.9998


Reference Range [2,3] Upper limit of the normal

range (95th percentile) Adults 100 IU/mL



Darmstadt: GIT Verlag; 2001. p. 34-5. 2. Ringel KP, Dati F, Buchholz E. IgE-Normalwerte bei Kindern.

Laboratoriumsblätter 1982;32:26-34. 3. Dati F, Ringel KP. Reference values for serum IgE in healthy non-atopic

children and adults. Clin Chem 1982; 28:1556. 4. Thomas L. Clinical Laboratory Diagnostics. 1st ed. Frankfurt: TH-Books

Verlagsgesellschaft; 1998. p. 667-78,774-85.


IVD


Immunoglobulin E FS Chemistry code 10 723 Application for serum and plasma samples This application was set up and evaluated by DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by unqualified personnel.

# entered by user


Sub-analy. Conditions Name IgE Digits 1 M-wave L. 571 S-wave.L **** Analy.mthd. EPA Calc.mthd. MSTD Qualit. judge No



Reaction Rate Method Cycle 2 Factor 2 E2 corre Not do Blank (u) 9.999 Blank (d) -9.999 Sample (u) 9.999 Sample (d) -9.999 Prozone Prozone form Prozone formula Prozone limit 0.2 Prozone judge Upper limit Judge limit 0.003 M-DET.P.m 24 M-DET.P.n 24 S-DET.P.p 21 S-DET.P.r 21

MULTI-STD Setting Formula Spline Axis Conv No conv Blank passes Points 6

FV Reac.

smp. vol. Dil.

method Dil. smp.

vol. Diluent

vol. Diluent

pos. STD H STD L



Immunoglobulin G FS*

Diagnostic reagent for quantitative in vitro determination of immunoglobulin G (IgG) in serum or plasma on BioMajesty JCA-BM6010/C



Principle Determination of the concentration IgG by photometric measurement of antigen-antibody-reaction between antibodies to human IgG and IgG present in the sample.

Reagents

Components and Concentrations R1: TRIS pH 7.5 100 mmol/L NaCl 150 mmol/L Polyethylenglycol (PEG) Detergents, stabilizers R2: TRIS pH 8.0 100 mmol/L NaCl 300 mmol/L Anti-human IgG antibody (goat) with stabilizers








Stability [1]: 3 months at 20 – 25 °C 3 months at 4 – 8 °C 6 months at -20 °C Only freeze once! Discard contaminated specimens.

Calibrators and Controls For calibration the DiaSys TruCal Protein calibrator set is recommended. For internal quality control DiaSys TruLab Protein controls should be assayed. Each laboratory should establish corrective actions in case of deviations in control recovery.

Cat. No. Kit size TruCal Protein (5 levels) 5 9200 99 10 039 5 x 1 mL TruLab Protein Level 1 5 9500 99 10 046 3 x 1 mL TruLab Protein Level 2 5 9510 99 10 046 3 x 1 mL

Performance Characteristics Measuring range up to 3200 mg/dL (214 µmol/L) IgG, at least up to the concentration of the highest calibrator. (in case of higher concentrations re-measure samples after manual dilution or rerun function) Limit of detection** 1 mg/dL (0.07 µmol/L) d’IgG No prozone effect up to 8000 mg/dL (534 µmol/L) IgG On-board stability 6 weeks Calibration stability 4 weeks

Interferences < 10% by Conjugated Bilirubin up to 60 mg/dL Unconjugated Bilirubin up to 60 mg/dL Hemoglobin up to 900 mg/dL Lipemia (triglycerides) up to 2000 mg/dL No cross reaction with IgA and IgM was observed.

Precision

Within run (n=20) Sample 1 Sample 2 Sample 3 Mean [mg/dL] 925 986 2366 Mean [µmol/L] 61.7 65.8 158 Coefficient of variation [%] 2.01 1.54 1.20

Between run (n=20) Sample 1 Sample 2 Sample 3 Mean [mg/dL] 906 1691 2327 Mean [µmol/L] 60.4 113 155 Coefficient of variation [%] 2.75 2.58 2.37

Method comparison (n=51) Test x Competitor Immunoglobulin G Test y DiaSys Immunoglobulin G FS Slope 1.015 Intercept -16.6 mg/dL (-1.11 µmol/L) Coefficient of correlation 0.998


Conversion factor IgG [mg/dL] x 0.067 = IgG [µmol/L]

Reference Range Adults [2] 700 – 1600 mg/dL 46.9 – 107 µmol/L Children [3] Newborns 700 – 1600 mg/dL 46.9 – 107 µmol/L 1 – 3 month(s) 250 – 750 mg/dL 16.8 – 50.3 µmol/L 4 – 6 months 180 – 800 mg/dL 12.3 – 53.6 µmol/L 7 – 12 months 300 – 1000 mg/dL 20.1 – 67.0 µmol/L 2 years 350 – 1000 mg/dL 23.5 – 67.0 µmol/L 3 – 5 years 500 – 1300 mg/dL 33.5 – 87.1 µmol/L 6 – 9 years 600 – 1300 mg/dL 40.2 – 87.1 µmol/L 10 – 13 years 700 – 1400 mg/dL 46.9 – 93.8 µmol/L


Literature 1. Guder WG, Narayanan S et al. List of Analytes; Preanalytical

Variables. 1st ed. Darmstadt: Git Verlag, 1996: 16-7. 2. Dati F, Schumann G, Thomas L, Aguzzi F, Baudner S, Bienvenu J et

al. Consensus of a group of professional societies and diagnostic companies on guidelines for interim reference ranges for 14 proteins in serum based on the standardization against the IFCC/BCR/CAP reference material (CRM 470). Eur J Clin Chem Clin Biochem 1996;34:517-20.

3. Heil R, Koberstein R, Zawta B. Referenzbereiche für Kinder und Erwachsene. Roche Diagnostics 2004. p. 46 - 47.



6. Bartl R, Hoechtlen-Vollmar W, Thomas L. Monoclonal immunoglobulins. In: Thomas L. Clinical Laboratory Diagnostics. 1st ed. Frankfurt: TH-Books Verlagsgesellschaft; 1998. p. 742-58.

Manufacturer DiaSys Diagnostic Systems GmbH Alte Strasse 9 65558 Holzheim German IVD


Immunoglobulin G FS




# entered by user


Sub-analy. ConditionsName IGGDigits 2M-wave L. 571S-wave.L ****Analy.mthd. EPACalc.mthd. MSTDQualit. judge No







FV Reac.smp. vol.

Dil.method

Dil. smp.vol.

Diluentvol.

Diluentpos.

STD H STD L



Immunoglobulin M FS*

Diagnostic reagent for quantitative in vitro determination of immunoglobulin M (IgM) in serum or plasma onBioMajesty JCA-BM6010/C


MethodImmunoturbidimetric test

PrincipleDetermination of the IgM concentration by photometricmeasurement of antigen-antibody-reaction between antibodies tohuman IgM and IgM present in the sample.

Reagents


R1: TRIS pH 7.5 100 mmol/LNaCl 150 mmol/LPolyethylenglycol (PEG)Detergents, stabilizers

R2: TRIS pH 8.0 100 mmol/LNaCl 1150 mmol/LAnti-human IgM antibody (goat)with stabilizers




1. The reagents contain sodium azide (0.95 g/L) aspreservative. Do not swallow! Avoid contact with skin andmucous membranes!


Waste Management


Reagent Preparation



Stability [1]:7 days at 20 – 25 °C3 months at 4 – 8 °C6 months at -20 °COnly freeze once!

Discard contaminated specimens!

Calibrators and ControlsFor calibration, DiaSys TruCal Protein calibrator set isrecommended. For internal quality control DiaSys TruLab Proteincontrols should be assayed. Each laboratory should establishcorrective action in case of deviations in control recovery.

Cat. No. Kit sizeTruCal Protein (5 Level) 5 9200 99 10 039 5 x 1 mLTruLab Protein Level 1 5 9500 99 10 046 3 x 1 mLTruLab Protein Level 2 5 9510 99 10 046 3 x 1 mL

Performance CharacteristicsMeasuring range up to 750 (7.73 µmol/L) mg/dL IgM, at least up to theconcentration of the highest calibrator.(in case of higher concentrations re-measure samples after manualdilution or use rerun function)Limit of detection** 1 mg/dL (0.01 µmol/L) IgMNo prozone effect up to 8000 mg/dL (82.4 µmol/L) d’IgMOn-board stability 6 weeksCalibration stability 6 weeks

Interferences < 10% byConjugated Bilirubin up to 60 mg/dLUnconjugated Bilirubin up to 60 mg/dLHemoglobin up to 800 mg/dLLipemia (triglycerides) up to 2000 mg/dL

No cross reaction with IgA and IgG was observed.

Precision

Within run (n=20) Sample 1 Sample 2 Sample 3Mean [mg/dL] 64.9 129 195Mean [µmol/L] 0.67 1.33 2.01Coefficient of variation [%] 1.75 1.20 0.99


Mean [mg/dL] 64.0 134 191Mean [µmol/L] 0.66 1.38 1.97Coefficient of variation [%] 3.17 2.05 2.25

Method comparison (n=99)Test x Competitor Immunoglobulin MTest y DiaSys Immunoglobulin M FSSlope 0.976Intercept -4.8 mg/dL (-0.05 µmol/L)Coefficient of correlation 0.993

** lowest measurable concentration which can be distinguished from zeromean + 3 SD (n = 20) of an analyte free specimen

Conversion factor

IgM [mg/dL] x 0.0103 = IgM [µmol/L]

Reference RangeAdults [2] 40 – 230 mg/dL 0.41 – 2.37 µmol/LChildren [3] Newborns 10 – 30 mg/dL 0.10 – 0.31 µmol/L

1 – 3 month(s) 10 – 70 mg/dL 0.10 – 0.72 µmol/L4 – 6 months 20 – 100 mg/dL 0.21 – 1.03 µmol/L

7 – 12 months 30 – 100 mg/dL 0.31 – 1.03 µmol/L2 years 40 – 140 mg/dL 0.41 – 1.44 µmol/L

3 – 5 years 40 – 180 mg/dL 0.41 – 1.85 µmol/L6 – 9 years 40 – 160 mg/dL 0.41 – 1.65 µmol/L

10 – 13 years 40 – 150 mg/dL 0.41 – 1.55 µmol/L


Literature1. Guder WG, Narayanan S et al. List of Analytes; Preanalytical

Variables. 1st ed. Darmstadt: Git Verlag, 1996: 16-7.2. Dati F, Schumann G, Thomas L, Aguzzi F, Baudner S, Bienvenu J et

al. Consensus of a group of professional societies and diagnosticcompanies on guidelines for interim reference ranges for 14 proteins inserum based on the standardization against the IFCC/BCR/CAPreference material (CRM 470). Eur J Clin Chem Clin Biochem 1996;34: 517-20.

3. Heil R, Koberstein R, Zawta B. Referenzbereiche für Kinder undErwachsene. Roche Diagnostics 2004. p. 48 - 49.

4. Thomas L. Clinical Laboratory Diagnostics. 1st ed. Frankfurt: TH-BooksVerlagsgesellschaft; 1998. p. 667-78.

5. Johnson AM, Rohlfs EM, Silverman LM. Proteins. In: Burtis CA,Ashwood ER. editors. Tietz textbook of clinical chemistry. 3rd ed.Philadelphia: W. B. Saunders Company; 1999. p. 507-12.

6. Bartl R, Hoechtlen-Vollmar W, Thomas L. Monoclonalimmunoglobulins. In: Thomas L. Clinical Laboratory Diagnostics. 1st

ed. Frankfurt: TH-Books Verlagsgesellschaft; 1998. p. 742-58.



Immunoglobulin M FS




# entered by user


Sub-analy. ConditionsName IGMDigits 2M-wave L. 410S-wave.L 700Analy.mthd. EPACalc.mthd. MSTDQualit. judge No







FV Reac.smp. vol.

Dil.method

Dil. smp.vol.

Diluentvol.

Diluentpos.

STD H STD L



Lactate FS*

Diagnostic reagent for quantitative in vitro determination of lactate in plasma on DiaSysBioMajesty JCA-BM6010/C


MethodEnzymatic UV test with lactate dehydrogenase (LDH)

Principle

L-Lactate + NAD+ < LDH > Pyruvate + NADH + H+

In the presence of NAD lactate is converted by the lactatedehydrogenase. This procedure releases NADH which ismeasured at 340 nm. The absorbance of the produced NADH isproportional to the lactate concentration in the sample.

Reagents


R1: Buffer pH 9.0 500 mmol/LLDH ≥ 25 kU/L

R2: NAD 20 mmol/L


The reagents are stable up to the end of the indicated month ofexpiry, if stored at 2 – 8 °C, protected from light and contaminationis avoided. Do not freeze the reagents.


1. The reagents contain sodium azide (0.95 g/L) as preservative.Do not swallow! Avoid contact with skin and mucousmembranes.


Waste Management


Reagent Preparation


SpecimenPlasma (no serum)As anticoagulants use glycolytic inhibitors e.g. fluoride/oxalate orfluoride/heparin.Stability in plasma [1]:8 hours at 20 – 25 °C14 days at 2 – 8 °C.Discard contaminated specimens.

Calibrators and ControlsFor calibration the DiaSys TruCal U calibrator is recommended.For internal quality control DiaSys TruLab N and P controls shouldbe assayed. Each laboratory should establish corrective action incase of deviations in control recovery.

Performance CharacteristicsMeasuring range up to 115 mg/dL lactate (12.8 mmol/L)(in case of higher concentrations re-measure samples after manualdilution or use rerun function)Limit of detection** 1 mg/dL lactate (0.1 mmol/L)On-board stability 8 daysCalibration stability 8 days

Interferences < 10% byAscorbate up to 30 mg/dLHemoglobin up to 1000 mg/dLBilirubin (conjugated and unconjugated) up to 60 mg/dLLipemia (triglycerides) up to 2000 mg/dLDopamin up to 10 mg/LL-Dopamin up to 20 mg/LMethyldopamine up to 10 mg/LGlycolic acid up to 1200 mg/L

Precision





Method comparison (n=100)Test x Competitor LactateTest y DiaSys Lactate FSSlope 0.992Intercept -0.108 mg/dL (-0.012 mmol/L)Coefficient of correlation 0.9973


Conversion factorLactate [mg/dL] x 0.1109 = Lactate [mmol/L]

Reference Range [2]

Plasma:Venous 4.5 – 19.8 mg/dL (0.5 – 2.2 mmol/L)Arterial 4.5 – 14.4 mg/dL (0.5 – 1.6 mmol/L)


Literature1. Westgard JO, Lahmeyer BL, Birnbaum ML. Use of the Du

Pont “Automatic Clinical Analyzer” in Direct Determination ofLactic Acid in Plasma Stabilized with Sodium Fluoride. ClinChem 1972; 18: 1334-8.

2. Section I – General Clinical Tests In: Tietz NW, editor. ClinicalGuide to Laboratory Tests. 3rd ed. Philadelphia: Saunders;1995. p. 382-3.

3. Thomas L. Clinical Laboratory Diagnostics. 1st ed. Frankfurt:TH-Books Verlagsgesellschaft; 1998. p. 160-166.

4. David B. Sacks, M.B., Ch.B., F.A.C.P. Carbohydrates In:Burtis CA, Ashwood ER, editors. Tietz Textbook of ClinicalChemistry. 3rd ed. Philadelphia: W.B Saunders Company;1999. p. 787-790.


Cat. No. Kit size

TruCal U 5 9100 99 10 063 20 x 3 mL5 9100 99 10 064 6 x 3 mL

TruLab N 5 9000 99 10 062 20 x 5 mL5 9000 99 10 061 6 x 5 mL

TruLab P 5 9050 99 10 062 20 x 5 mL5 9050 99 10 061 6 x 5 mL

IVD


Lactate FS


Application for plasma samples


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Sub-analy. Conditions Name LACT Digits 2 M-wave L. 340 S-wave.L 805 Analy.mthd. EPA Calc.mthd. STD Qualit. judge No


Reagent Information

LDH FS* IFCC Diagnostic reagent for quantitative in vitro determination of lactate dehydrogenase (LDH) in serum or plasma on BioMajesty JCA-BM6010/C


Method Optimized UV-test according to IFCC (International Federation of Clinical Chemistry and Laboratory Medicine) and DGKC (German Society of Clinical Chemistry)

Principle L-Lactate + NAD+

LDH

Pyruvate + NADH + H+

Reagents Components and Concentrations R1: N-Methyl-D-Glucamine pH 9.40 420 mmol/L L-Lactate 65 mmol/L R2: NAD+ 50 mmol/L


Warnings and Precautions Please refer to the safety data sheets and take the necessary precautions for the use of laboratory reagents.



Specimen Serum, heparin plasma or EDTA plasma Stability [1]: 4 days at 20 - 25 °C 6 weeks at 4 - 8 °C Discard contaminated specimens.


For calibration DiaSys TruCal U calibrator is recommended. For internal quality control DiaSys TruLab N and P controls should be assayed. Each laboratory should establish corrective action in case of deviations in control recovery.


Performance Characteristics Measuring range up to 1200 U/L (20 µkat/L) LDH (in case of higher activities re-measure samples after manual dilution or use rerun function) Limit of detection** 6 U/L (0.1 µkat/L) LDH On-board stability 4 weeks Calibration stability 2 weeks

Interferences < 10% by Ascorbate up to 30 mg/dL Conjugated bilirubin up to 55 mg/dL Unconjugated bilirubin up to 40 mg/dL Lipemia (triglycerides) up to 1800 mg/dL Hemoglobin interferes at low concentrations; indicates destruction of erythrocytes and therefore release of LDH

Precision

Within run (n=20) Sample 1 Sample 2 Sample 3 Mean [U/L] 122 183 416 Mean [µkat/L] 2.04 3.04 6.94 Coefficient of variation [%] 2.05 0.95 0.89

Between run (n=20) Sample 1 Sample 2 Sample 3 Mean [U/L] 175 356 393 Mean [µkat/L] 2.92 5.93 6.55 Coefficient of variation [%] 1.88 1.33 1.88

Method comparison (n=100) Test x Competitor LDH Test y DiaSys LDH FS IFCC Slope 1.03 Intercept -17.0 U/L (-0.284 µkat/L) Coefficient of correlation r = 0.998


Conversion factor LDH [U/L] x 0.0167= LDH [µkat/L]

Reference Range Female Male

Adults [2] < 247 U/L < 248 U/L Children [3] 1 - 30 day(s) 145 - 765 U/L 125 - 735 U/L 31 days - 1 year 190 - 420 U/L 170 - 450 U/L 1 - 3 year(s) 165 - 395 U/L 155 - 345 U/L 4 - 6 years 135 - 345 U/L 155 - 345 U/L 7 - 9 years 140 - 280 U/L 145 - 300 U/L 10 - 12 years 120 - 260 U/L 120 - 325 U/L 13 - 15 years 100 - 275 U/L 120 - 290 U/L 16 - 18 years 105 - 230 U/L 105 - 235 U/L

Female Male Adults [2] < 4.12 µkat/L < 4.14 µkat/L Children [3] 1 - 30 day(s) 2.42 – 12.8 µkat/L 2.09 – 12.3 µkat/L 31 days - 1 year 3.17 – 7.01 µkat/L 2.84 – 7.52 µkat/L 1 - 3 year(s) 2.76 – 6.60 µkat/L 2.59 – 5.76 µkat/L 4 - 6 years 2.25 – 5.76 µkat/L 2.59 – 5.76 µkat/L 7 - 9 years 2.34 – 4.68 µkat/L 2.42 – 5.01 µkat/L 10 - 12 years 2.00 – 4.34 µkat/L 2.00 – 5.43 µkat/L 13 - 15 years 1.67 – 4.59 µkat/L 2.00 – 4.84 µkat/L 16 - 18 years 1.75 – 3.84 µkat/L 1.75 – 3.92 µkat/L


Reagent Information

Literature


2. Schumann G, Bonora R, Ceriotti F, Férard G et al. IFCC primary reference procedure for the measurement of catalytic activity concentrations of enzymes at 37 °C. Part 3: Referen ce procedure for the measurement of catalytic concentration of lactate dehydrogenase. Clin Chem Lab Med 2002; 40: 643-48.

3. Soldin JS, Hicks JM. Pediatric reference ranges. Washington: AACC Press. 1995: p. 95.

4. Deutsche Gesellschaft für Klinische Chemie. (German Society for Clinical Chemistry). Recommendation for the determinaion of the catalytic concentration of lactate dehydrogenase at 37 °C. Eur J Clin Chem Clin Biochem 1993; 31: 897-9.

5. Thomas L. Clinical laboratory diagnostics. 1st ed. Frankfurt: TH-Books Verlagsgesellschaft; 1998. p. 89-94.

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



LDH FS IFCC




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Sub-analy. ConditionsName LDHDigits 2M-wave L. 340S-wave.L 410Analy.mthd. RRACalc.mthd. STDQualit. judge No



LDL-C Select FS*

Diagnostic reagent for quantitative in vitro determination of low density lipoprotein cholesterol (LDL-C) in serum or plasma on BioMajesty JCA-BM6010/C


Method Previous LDL-cholesterol determinations were performed indirectly by calculation from the combined results of total cholesterol, HDL cholesterol and triglycerides using the Friedewald equation [1]. LDL-C Select FS is a homogeneous method without centrifugation steps for the direct measurement of LDL-cholesterol. In a first step, LDL is selectively protected while non-LDL-lipoproteins are enzymatically processed. In a second step, LDL is released and LDL-cholesterol selectively determined in a color producing enzymatic reaction.

Principle

1) LDL + reagent 1 protected LDL

HDL, VLDL, Chylomicrons CHE & CHO Cholestenone + H2O2

H2O2 Catalase H2O

2) Protected LDL + reagent 2 LDL

LDL-C CHE & CHO Cholestenone + H2O2

H2O2 + 4-Aminoantipyrine + H-DAOS POD Color

Reagents

Components and Concentrations R1: Good’s buffer pH 6.8 20 mmol/L Cholesterol esterase (CHE) ≥ 2.5 kU/L Cholesterol oxidase (CHO) ≥ 2.5 kU/L N-(2-hydroxy-3-sulfopropyl)-

3,5-dimethoxyaniline (H-DAOS) 0.5 mmol/L

Catalase ≥ 500 kU/L R2: Good’s buffer pH 7.0 25 mmol/L 4-Aminoantipyrine 3.4 mmol/L Peroxidase (POD) ≥ 15 kU/L

Storage Instructions and Reagent Stability The reagents are stable up to the end of the indicated month of expiry, if stored at 2 – 8 °C and contamination is avoided. Do not freeze the reagents! R1 and R2 must be protected from light.

Warnings and Precautions 1. Reagent 2 contains sodium azide (0.95 g/L). Do not swallow! Avoid

contact with skin and mucous membranes. 2. Artificial lipid mixtures (e.g. Intralipid®) may interfere with the test.

Serum samples from patients treated with such solutions should not be used.

3. Patient samples with a rare type of Hyperlipoproteinemia (Hyperlipoproteinemia Type III) can bring false results.




Specimen Serum or heparin plasma Stability [2]: 1 day at 20 – 25 °C 7 days at 4 – 8 °C 3 months at -20 °C Discard contaminated specimens.

Calibrators and Controls For calibration, DiaSys TruCal HDL/LDL or TruCal Lipid calibrators are recommended. For internal quality control a DiaSys TruLab L control should be assayed. Each laboratory should establish corrective action in case of deviations in control recovery.

Cat. No. Kit size TruCal HDL/LDL 1 3520 99 10 065 3 x 3 mL TruCal Lipid 1 3570 99 10 045 3 x 2 mL TruLab L Level 1 5 9020 99 10 065 3 x 3 mL TruLab L Level 2 5 9030 99 10 065 3 x 3 mL

Performance Characteristics Measuring range up to 400 mg/dL (10.3 mmol/L) LDL-C (in case of higher concentrations re-measure samples after manual dilution or use rerun function) Limit of detection** 1 mg/dL (0.03 mmol/L) LDL-C On-board stability 4 weeks Calibration stability 4 weeks

Interferences < 10% by Ascorbate up to 30 mg/dL Hemoglobin up to 500 mg/dL Bilirubin (conjugated and unconjugated) up to 60 mg/dL Lipemia (triglycerides) up to 1000 mg/dL

Precision



Method comparison (n=29) Test x DiaSys LDL-C Select FS

Hitachi 917 Test y DiaSys LDL-C Select FS

BioMajesty JCA-BM6010/C Slope 1.03 Intercept 1.20 mg/dL (0.031 mmol/L) LDL-C Coefficient of correlation 0.997


Conversion factor LDL-C [mg/dL] x 0,02586 = LDL-C [mmol/L]

Reference Range [3] Desirable ≤ 130 mg/dL (3.4 mmol/L) Borderline high risk 130 –160 mg/dL (3.4 – 4.1 mmol/L) High risk > 160 mg/dL (> 4.1 mmol/L)


Clinical Interpretation 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) [4].

Literature 1. Bachorik PS. Measurement of low-density lipoprotein cholesterol. In:

Rifai N, Warnick GR, Dominiczak MH, eds. Handbook of lipoprotein testing. Washington: AACC Press; 1997. p. 145-60.


3. Schaefer EJ, McNamara J. Overview of the diagnosis and treatment of lipid disorders. In: Rifai N, Warnick GR, Dominiczak MH, eds. Handbook of lipoprotein testing. Washington: AACC Press; 1997. p. 25-48.





LDL-C Select FS




# entered by user


Calculation Method SettingM-DET.P.I 0M-DET.P.m 41M-DET.P.n 42S-DET.P.p 17S-DET.P.r 18Check D.P.I. 0Limit value 0,003Variance 10Reac.type Inc


Standards SettingFV #BLK H 9.999BLK L -9,999STD H 9.999STD L -9,999


Sub-analy. ConditionsName LDLCDigits 2M-wave L. 596S-wave.L 694Analy.mthd. EPACalc.mthd. STDQualit. judge No


Reagent Information * direct color ** fluid stable

Lipase DC* FS**

Diagnostic reagent for quantitative in vitro determination of lipase in serum or plasma on BioMajesty JCA-BM6010/C


Method Enzymatic color test A synthetically produced lipase substrate (1,2-o-dilauryl-rac-glycero-3-glutaric acid-(6-methylresorufin) ester) in a micro-emulsion is specifically split by lipase in the presence of colipase and bile acids. This combination of lipase and bile acids is specific and reliable for pancreatic lipase without any reaction due to lipolytic enzymes or esterases. The reagent composition has been thoroughly optimized to avoid serum matrix effects. The generated methylresorufin-ester is spontaneously degraded to methylresorufin. The absorbance by this red dye is directly proportional to the lipase activity in the sample.

Principle Lipase catalyzes the reaction: 1,2-o-Dilauryl-rac-glycero-3-glutaric acid(6-methylresorufin) ester

Lipase / Colipase

1,2-o-Dilauryl-rac-glycerin + Glutaric acid-(6-methylresorufin)-ester

Glutaric acid-(6-methylresorufin)-ester

spontaneous degradation

Glutaric acid + Methylresorufin The increase in absorbance is measured photometrically.

Reagents Components and Concentrations R1: Goods buffer pH 8.0 50 mmol/L Taurodesoxycholate 4.3 mmol/L Desoxycholate 8.0 mmol/L Calcium chloride 15 mmol/L Colipase 2.2 mg/L Detergent, preservative R2: Tartrate buffer pH 4.0 7.5 mmol/L Taurodesoxycholate 17.2 mmol/L Color substrate 0.65 mmol/L Coemulgator, stabilizer, preservative

Storage Instructions and Reagent Stability The reagents are stable up to the end of the indicated month of expiry, if stored at 2 – 8 °C, protected from light and contamination is avoided. Do not freeze the reagent!

Warnings and Precautions 1. Many other clinical reagents contain lipase or high

concentrations of detergents. Avoid contamination and carry over! For lipase determination thoroughly cleaned cuvettes only must be used. Special care should be taken in combination with triglycerides, HDL and LDL reagents. The contamination pairs should be programmed in the Contamination Set window of the analyzer.




Specimen Serum or heparin plasma Stability [1]: 7 days at 20 - 25 °C 7 days at 4 - 8 °C 1 year at -20 °C Discard contaminated specimens.

Calibrators and Controls For the calibration the DiaSys TruCal U calibrator is recommended. For internal quality control DiaSys TruLab N and P controls should be assayed. Each laboratory should establish corrective action in case of deviations in control recovery.


Performance Characteristics Measuring range up to 300 U/L (5 µkat/L) lipase (in case of higher activities re-measure samples after manual dilution or use rerun function) Limit of detection*** 3 U/L (0.05 µkat/L) lipase On-board stability 12 weeks Calibration stability 12 weeks

Interferences < 10% by Ascorbate up to 30 mg/dL Hemoglobin up to 500 mg/dL Conjugated Bilirubin up to 60 mg/dL Unconjugated Bilirubin up to 54 mg/dL Lipemia (triglycerides) up to 1000 mg/dL

Precision

Within run (n=20) Sample 1 Sample 2 Sample 3 Mean [U/L] 33.2 46.1 132 Mean [µkat/L] 0.56 0.77 2.21 Coefficient of variation [%] 1.49 1.71 1.72


Method comparison (n=100) Test x Competitor Lipase Test y DiaSys Lipase DC FS Slope 0.984 Intercept -1.02 U/L (-0.017 µkat/L) Coefficient of correlation 0.9998

*** lowest measurable activity which can be distinguished from zero mean + 3 SD (n=20) of an analyte free specimen

Conversion factor Lipase [U/L] x 0,0167= Lipase [µkat/L]

Reagent Information

Reference Range [2]

≤ 60 U/L ≤ 1.00 µkat/L



Darmstadt: GIT Verlag; 2001; p. 36-7. 2. Junge W, Abicht K, Goldman J. Evaluation of the colorimetric liquid

assay for pancreatic lipase on Hitachi analyzers in 7 clinical centres in Europe. Clin Chem Lab Med 1999;37, Special suppl: 469.

3. Lorentz K. Lipase. In: Thomas L, editor. Clinical laboratory diagnostics. 1st ed. Frankfurt: TH-Books Verlagsgesellschaft; 1998. p. 95-7.

4. Moss DW, Henderson AR. Digestive enzymes of pancreatic origin. In: Burtis CA, Ashwood ER, editors. Tietz Textbook of Clinical Chemistry. 3rd ed. Philadelphia: W.B Saunders Company; 1999. p. 689-708.

5. Tietz N, Shuey DF. Lipase in serum – the elusive enzyme: an overview. Clin Chem 1993; 39: 746-56.

6. Lott J, Patel ST, Sawhney AK, Kazmierczak SC, Love JE. Assays of serum lipase: analytical and clinical considerations. Clin Chem 1986; 32: 1290-1302.

7. Leybold A, Junge W. Importance of colipase for the measurement of serum lipase activity. Adv Clin Enzymol 1986; 4: 60-7.

8. Borgström B. The action of bile salts and other detergents on pancreatic lipase and the interaction with colipase. Biochimica et Biophysika Acta 1977; 488: 381-91.

9. Gargouri Y, Julien R, Bois A, Verger R, Sarda L. Studies on the detergent inhibition of pancreatic lipase activity. J of Lipid Research 1983; 24: 1336-42.

Manufacturer 65558 Holzheim Deutschland DiaSys Diagnostic Systems GmbH Alte Strasse 9 65558 Holzheim Germany

IVD


Lipase DC FS


Application for serum, plasma samples


# entered by user


Calculation Method SettingM-DET.P.I 21M-DET.P.m 28M-DET.P.n 34S-DET.P.p 0S-DET.P.r 0Check D.P.I. 21Limit value 0,003Variance 10Reac.type Inc




Sub-analy. ConditionsName LPSDigits 2M-wave L. 571S-wave.L 805Analy.mthd. RRACalc.mthd. STDQualit. judge No



Lp(a) 21 FS*

Diagnostic reagent for quantitative in vitro determination of lipoprotein (a) [Lp(a)] in serum or plasma on BioMajesty JCA-BM6010/C


Method Particle enhanced Immunoturbidimetric test

Principle Determination of the Lp(a) concentration by photometric measurement of antigen-antibody-reaction between antibodies against Lp(a) bound to particles and Lp(a) present in the sample.

Reagents

Components and Concentrations R1: Buffer Glycine <1.5% R2 Glycine <1.5% Latex particles coated with anti-human

lipoprotein (a) antibody (rabbit)

Storage Instructions and Reagent Stability The reagents are stable up to the end of the indicated month of expiry, if stored at 2 – 8 °C and contamination is avoided. Do not freeze the reagents!






Specimen Serum, heparin plasma or EDTA plasma Stability [1]: 2 days at 20 - 25 °C 2 weeks at 4 - 8 °C 3 months at -20 °C Freeze only once! Discard contaminated specimens.


For calibration DiaSys TruCal Lp(a) 21 calibrator set is recommended. For internal quality control a DiaSys TruLab Lp(a) control should be assayed. Each laboratory should establish corrective action in case of deviations in control recovery.

Performance Characteristics Measuring range from up to 125 mg/dL Lp(a), at least up to the concentration of the highest calibrator. (in case of higher concentrations re-measure samples after manual dilution or use rerun function). Limit of detection** 1 mg/dL Lp(a) No prozone effect up to 400 mg/dL Lp(a) On-board stability 6 weeks Calibration stability 3 weeks

Interferences < 10% by Bilirubin up to 60 mg/dL Hemoglobin up to 500 mg/dL Rheumatoid factor up to 500 IU/mL Lipemia (triglycerides) up to 2000 mg/dL

Precision

Within run (n=20) Sample 1 Sample 2 Sample 3 Mean [mg/dL] 12.1 45.7 79.2 Coefficient of variation [%] 2.00 1.82 1.29

Between run (n=20) Sample 1 Sample 2 Sample 3 Mean [mg/dL] 13.0 66.7 84.2 Coefficient of variation [%] 1.96 1.99 2.11

Method comparison (n=80) Test x DiaSys Lp(a) 21 FS (Hitachi 917) Test y DiaSys Lp(a) 21 FS (BM6010/C) Slope 0.962 Intercept -0.591 mg/dL Coefficient of correlation 0.9925


Reference Range [2]

< 30 mg/dL



Darmstadt: GIT Verlag; 2001; p. 36-7. 2. Riesen WF. Lipid metabolism. In: Thomas L, editor. Clinical laboratory

diagnostics. 1st ed. Frankfurt: TH-Books Verlagsgesellschaft; 1998. p. 174-5.


4. Marcovina SM, Koschinsky ML. Lipoprotein (a): Structure, measurement and clinical significance. In: Rifai N, Warnick GR, Dominiczak MH, eds. Handbook of lipoprotein testing. Washington: AACC Press; 1997. p. 283-313.


Cat. No. Kit size TruCal Lp(a) 21 (5 levels) 1 7140 99 10 059 5 x 1 mL TruLab Lp(a) Level 1 5 9830 99 10 046 3 x 1 mL TruLab Lp(a) Level 2 5 9840 99 10 046 3 x 1 mL

IVD


Lp(a) 21 FS


# entered by user


Sub-analy. Conditions Name LP(a) Digits 2 M-wave L. 694 S-wave.L **** Analy.mthd. EPA Calc.mthd. MSTD Qualit. judge No





FV Reac.

smp. vol. Dil.

method Dil. smp.

vol. Diluent

vol. Diluent

pos. STD H STD L



Magnesium XL FS*

Diagnostic reagent for quantitative in vitro determination of magnesium in serum, plasma or urine on BioMajesty JCA-BM6010/C

Order Information Cat. No. 1 4610 99 10 961 6 x 160 tests

Method Photometric test using xylidyl blue

Principle Magnesium ions form a purple colored complex with xylidyl blue in alkaline solution. In presence of GEDTA, which complexes calcium ions, the reaction is specific. The intensity of the purple color is proportional to the magnesium concentration.

Reagents Components and Concentrations Reagent: Ethanolamine pH 11.0 750 mmol/L GEDTA (Glycoletherdiamine tetraacetic acid) 60 µmol/L Xylidyl blue 110 µmol/L Detergents

Storage Instructions and Reagent Stability The reagent is stable up to the end of the indicated month of expiry, if stored at 2 – 8 °C and contamination is avoided. Do not freeze the reagent!

Warnings and Precautions 1. Reagent S25: Avoid contact with eyes. 2. Please refer to the safety data sheets and take the necessary



Reagent Preparation The reagent is ready to use. The bottles are placed directly into the reagent trays.

Specimen Serum, plasma or urine (do not use EDTA plasma!) Stability [1]: in serum/plasma 7 days at 20 - 25 °C 7 days at 4 - 8 °C 1 year at -20 °C In urine: 3 days at 20 - 25 °C 3 days at 4 - 8 °C 1 year at -20 °C Acidify urine with some drops of conc. HCl to pH 3 - 4. Dilution 1+4 with water is automatically done by the instrument. Discard contaminated specimens.

Calibrators and Controls For calibration, DiaSys TruCal U calibrator is recommended. For internal quality control DiaSys TruLab N and P or TruLab Urine controls should be assayed. Each laboratory should establish corrective action in case of deviations in control recovery.

Performance Characteristics Measuring range up to 5 mg/dL (2 mmol/L) magnesium (in case of higher concentrations re-measure samples after manual dilution or use rerun function) Limit of detection** 0.03 mg/dL (0.012 mmol/L)

magnesium On-board stability 4 weeks Calibration stability 12 days

Interferences < 10% by Ascorbate up to 30 mg/dL ΒΒΒΒilirubin (conjugated and unconjugated) up to 60 mg/dL Calcium up to 25 mg/dL Lipemia (triglycerides) up to 2000 mg/dL Hemolysis interferes because magnesium is released by erythrocytes

Precision (Serum)

Within run (n=20) Sample 1 Sample 2 Sample 3 Mean [mg/dL] 1.46 2.95 4.28 Mean [mmol/L] 0.60 1.21 1.76 Coefficient of variance [%] 1.31 0.80 0.98

Between run (n=20) Sample 1 Sample 2 Sample 3 Mean [mg/dL] 2.20 4.12 4.59 Mean [mmol/L] 0.90 1.69 1.89 Coefficient of variance [%] 1.32 1.00 0.99

Method comparison (Serum; n=95) Test x Competitor Magnesium Test y DiaSys Magnesium XL FS Slope 0.942 Intercept 0.058 mmol/L (0.141 mg/dL) Coefficient of correlation r = 0.992

Precision (Urine)

Within run (n=20) Sample 1 Sample 2 Sample 3 Mean [mg/dL] 2.93 6.19 10.0 Mean [mmol/L] 1.20 2.55 4.13 Coefficient of variance [%] 1.16 1.31 0.52

Between run (n=20) Sample 1 Sample 2 Sample 3 Mean [mg/dL] 2.95 6.13 10.1 Mean [mmol/L] 1.21 2.52 4.17 Coefficient of variance [%] 1.44 0.97 1.16

Method comparison (Urine; n=40) Test x Competitor Magnesium Test y DiaSys Magnesium XL FS Slope 0.982 Intercept -0.053 mg/dL (-0.0217 mmol/L) Coefficient of correlation 0.9996


Conversion factor Magnesium [mg/dL] x 0.4114 = Magnesium [mmol/L] Magnesium in Urine [mg/24 h] x 0.0411 = Magnesium [mmol/24 h]


Reagent information

Reference Range [2,3] Serum/Plasma: Neonates 1.2 – 2.6 mg/dL (0.48 – 1.05 mmol/L) Children 1.5 – 2.3 mg/dL (0.60 – 0.95 mmol/L) Women 1.9 – 2.5 mg/dL (0.77 – 1.03 mmol/L) Men 1.8 – 2.6 mg/dL (0.73 – 1.06 mmol/L)

Urine: 73 – 122 mg/24 h (3 – 5 mmol/24 h)


Literature 1. Guder WG, Zatwa B et al. The quality of Diagnostic Samples. 1st ed.

Darmstadt: Git Verlag, 2001: 38-39, 50-51. 2. Thomas L. Clinical Laboratory Diagnostics. 1st ed. Frankfurt: TH-Books

Verlagsgesellschaft; 1998. p. 231-41. 3. Sitzmann FC. Normalwerte. München: Hans Marseille Verlag GmbH:

1986. p. 166. 4. Endres DB, Rude RK. Mineral and bone metabolism. In: Burtis CA,

Ashwood ER, editors. Tietz Textbook of Clinical Chemistry. 3rd ed. Philadelphia: W.B Saunders Company; 1999. p. 1395-1457.

5. Mann CK, Yoe JH. Spectrophotometric determination of magnesium with 1-Azo-2-hydroxy-3-(2.4-dimethylcarboxanilido)-naphthalene-1’-(2-hydroxybenzene). Anal Chim Acta 1957; 16 : 155-60.

6. Bohoun C. Microdosage du magnesium dans divers milieux biologiques. Clin Chim Acta 1962; 7: 811-7.


IVD


Magnesium XL FS


Application for serum, plasma, CSF, urine samples


# entered by user



Sub-analy. Conditions Name MG Digits 2 M-wave L. 545 S-wave.L 694 Analy.mthd. EPA Calc.mthd. STD Qualit. judge No



Phosphate FS*

Diagnostic reagent for quantitative in vitro determination of phosphorus in serum, plasma or urine onBioMajesty JCA-BM6010/C


MethodPhotometric UV test with endpoint determination

PrincipleAmmonium molybdate + Sulphuric acid + Phosphate

inorg. phosphorus molybdate complex

Maximum complex absorption is 340 nm.

Reagents


R1: Glycine buffer 50 mmol/LSulphuric acidDetergent

R2: Glycine buffer 50 mmol/LAmmonium molybdate 1.75 mmol/L


The reagents are stable up to the end of the indicated month ofexpiry, if stored at 2 – 8 °C and contamination is avoided. Do notfreeze the reagents!


1. Reagent 1: S24/25: Avoid contact with skin and eyes.2. Please refer to the safety data sheets and take the necessary


Waste Management


Reagent Preparation


SpecimenSerum, heparin plasma or urine

Stability [1]:in serum/plasma: 1 day at 20 – 25 °C

4 days at 4 – 8 °C1 year at -20 °C

in urine: 2 days at 20 – 25 °C at pH < 5


For collection of 24 h urine add 10 mL of 10 g/dL HCl into thecollection bottle to avoid phosphate precipitations.

Calibrators and ControlsFor calibration the DiaSys TruCal U calibrator is recommended.For internal quality control DiaSys TruLab N and P or TruLab Urinecontrols should be assayed. Each laboratory should establishcorrective action in case of deviations in control recovery.

Performance CharacteristicsAll concentrations given in mg/dL (mmol/L) refer to phosphorus.

Measuring range up to 30 mg/dL (9.69 mmol/L) phosphorus(in case of higher concentrations re-measure samples after manualdilution or use rerun function)Limit of detection** 0.2 mg/dL (0.06 mmol/L) phosphorusOn-board stability 5 weeksCalibration stability 2 weeks

Interferences < 10% byAscorbate up to 30 mg/dLConjugated Bilirubin up to 60 mg/dLUnconjugated Bilirubin up to 60 mg/dLHemoglobin up to 1000 mg/dLLipemia (triglycerides) up to 1800 mg/dL




Between run (n=20) Sample 1 Sample 2 Sample 3Mean [mg/dL] 1.80 3.31 8.35Mean [mmol/L] 0.58 1.07 2.70Coefficient of variation [%] 1.87 1.19 1.39

Method comparison (Serum/plasma; n=100)Test x Competitor PhosphateTest y DiaSys Phosphate FSSlope 1.000Intercept 0.155 mg/dL (0.05 mmol/L)Coefficient of correlation 0.998

Precision (Urine)

Within run (n=20) Sample 1 Sample 2 Sample 3Mean [mg/dL] 14.3 23.4 47.4Mean [mmol/L] 4.60 7.56 15.3Coefficient of variation [%] 0.57 0.99 0.40




Test x Competitor PhosphateTest y DiaSys Phosphate FSSlope 0.997Intercept 0.526 mg/dL (0.170 mmol/L)Coefficient of correlation 0.9993



5 9100 99 10 064 6 x 3 mLTruLab N 5 9000 99 10 062 20 x 5 mL

5 9000 99 10 061 6 x 5 mLTruLab P 5 9050 99 10 062 20 x 5 mL



5 9180 99 10 061 6 x 5 mL

Reagent Information

Conversion factor

Serum/plasma:Phosphorus [mg/dL] x 0.323 = Phosphorus [mmol/L]

Urine:Phosphorus [g/24 h] x 32.3 = Phosphorus [mmol/24 h]

Reference Range [2]

Phosphorus[mg/dL] [mmol/L]

Serum/plasma [2]:Adults 2.6 - 4.5 0.84 - 1.45Children / Adolescents:1 - 30 day(s) 3.9 - 7.7 1.25 - 2.501 - 12 month(s) 3.5 - 6.6 1.15 - 2.151 - 3 year(s) 3.1 - 6.0 1.00 - 1.954 - 6 years 3.3 - 5.6 1.05 - 1.807 - 9 years 3.0 - 5.4 0.95 - 1.7510 - 12 years 3.2 - 5.7 1.05 - 1.8513 - 15 years 2.9 - 5.1 0.95 - 1.6516 - 18 years 2.7 - 4.9 0.85 - 1.60

Urine [4]:0.4 – 1.3 g/24 h (12.9 – 42.0 mmol/24 h)



sted.

Darmstadt: GIT Verlag; 2001; p. 40-1.2. Thomas L. Clinical Laboratory Diagnostics. 1st ed. Frankfurt: TH-Books

Verlagsgesellschaft; 1998. p. 241-7.3. Endres DB, Rude RK. Mineral and bone metabolism. In: Burtis CA,

Ashwood ER, editors. Tietz Textbook of Clinical Chemistry. 3rd

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

4. Burtis CA, Ashwood ER, editors. Tietz Textbook of Clinical Chemistry.3

rded. Philadelphia: W.B Saunders Company; 1999. p. 1829.



Phosphate FS




# entered by user






Sub-analy. ConditionsName PO3Digits 2M-wave L. 340S-wave.L 658Analy.mthd. EPACalc.mthd. STDQualit. judge No

Analysis Test Condition Setting (M)Sample Type Serum UrineReac. sample vol. 1 1Diluent method No dil With dilUndil. sample vol. 0 5Diluent volume 0 50Diluent position 0 0


Rheumatoid factor FS*

Diagnostic reagent for quantitative in vitro determination of rheumatoid factor (RF) in serum or plasma on BioMajesty JCA-BM6010/C



Principle Determination of the concentration of RF by means of photometric measurement of antigen-antibody-reaction among heat aggregated IgG and rheumatoid factors present in the sample.

Reagents Components and Concentrations R1: Phosphate buffer pH 7.4 50 mmol/LR2: Heat aggregated human IgG ≤ 0.4 mg/mLStorage Instructions and Reagent Stability The reagents are stable up to the end of the indicated month of expiry, if stored at 2 – 8 °C, protected from light and contamination is avoided. Do not freeze the reagents! Warnings and Precautions 1. The reagents contain sodium azide (0.95 g/L) as

preservative. Do not swallow! Avoid contact with skin. 2. Take the necessary precautions for the use of laboratory

reagents. Waste Management Please refer to local legal requirements. Reagent Preparation The reagents are ready to use. The bottles are placed directly into the reagent trays.

Specimen Serum, heparin plasma or EDTA plasma Do not use sodium fluoride blood collection tubes. Stability [1]: 1 day at 20 - 25 °C 3 days at 4 – 8 °C 4 weeks at - 20 °C Discard contaminated specimens.

Calibrators and Controls For the calibration the DiaSys TruCal RF calibrator set is recommended. For internal quality control a DiaSys TruLab Protein control should be assayed. Each laboratory should establish corrective action in case of deviations in control recovery.

Performance Characteristics Measuring range from 10 IU/mL up to 500 IU/mL RF, at least up to the concentration of the highest calibrator (in case of higher concentrations re-measure samples after manual dilution or use the rerun function). Limit of detection** 2 IU/mL RF No prozone effect up to 3000 IU/mL RF On-board stability 21 days Calibration stability 7 days


Precision

Within run (n=20) Sample 1 Sample 2 Sample 3 Mean [IU/mL] 45.5 89.8 256 Coefficient of variation [%] 0.70 0.78 0.46

Between run (n=20) Sample 1 Sample 2 Sample 3 Mean [IU/mL] 14.8 71.7 252 Coefficient of variation [%] 4.20 1.73 1.89

Method comparison (n=88) Test x DiaSys Rheumatoid factor FS

(Hitachi 912) Test y DiaSys Rheumatoid factor FS

(BioMajesty JCA-BM6010/C) Slope 0.961 Intercept 3.11 IU/mL Coefficient of correlation 0.9999


Reference Range In a healthy population the RF values are usually expected to be < 15 IU/mL (95th percentile). In a study, a cut-off value of 19 IU/ml was defined for optimum sensitivity (82.4 %) and specificity (95.9 %) for rheumatoid arthritis [2]. Each laboratory should define its own reference range for the relevant population to take into account all affecting factors.

Literature 1. Guder WG, Zatwa B et al. The quality of Diagnostic Samples. 1st ed.

Darmstadt: Git Verlag, 2001: 42-3. 2. Ulvestad E, Kanestrom A, Madland TM, Thomassen E, Haga HJ.

Clinical utility of diagnostic tests for rheumatoid factor. Scandinavian Journal of Rheumatology 2001; 30: 87-91.

3. Moore TL, Dorner RW. Rheumatoid factors. Clin Biochem 1993; 26: 75-84.

4. Winchester RJ. Characterization of IgG complexes in patients with rheumatoid arthritis. Ann N Y Acad Sci 1975; 256: 73-81.

5. Shmerling RH, Delbanco TL. The rheumatoid factor: an analysis of clinical utility. Am J Med 1991; 91: 528-34.

6. Mannik M. Rheumatoid factors in the pathogenesis of rheumatoid arthritis. J Rheumatol Suppl 1992; 32: 46-9.

7. Mierau R, Genth E.. Autoantibodies in rheumatoid arthritis. In: Thomas L, editor. Clinical laboratory diagnostics. 1st ed. Frankfurt: TH-Books Verlagsgesellschaft; 1998. p. 810-3.


Cat. No. Kit size TruCal RF (5 levels) 1 7020 99 10 059 5 x 1 mL TruLab Protein Level 1 5 9500 99 10 046 3 x 1 mL TruLab Protein Level 2 5 9510 99 10 046 3 x 1 mL

IVD


Rheumatoid factor FS Chemistry code 10 702 Application for serum and plasma samples This application was set up and evaluated by DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by unqualified personnel.

# entered by user


Sub-analy. Conditions Name RF Digits 2 M-wave L. 340 S-wave.L 694 Analy.mthd. EPA Calc.mthd. MSTD Qualit. judge No





FV Reac.

smp. vol. Dil.

method Dil. smp.

vol. Diluent

vol. Diluent

pos. STD H STD L



Total protein FS*

Diagnostic reagent for quantitative in vitro determination of total protein in serum or plasma onBioMajesty JCA-BM6010/C


MethodPhotometric test according to biuret method

PrincipleTogether with copper ions, proteins form a violet blue colorcomplex in alkaline solution. The absorbance of the color is directlyproportional to the concentration.

Reagents


R1: Sodium hydroxide 100 mmol/LPotassium sodium tartrate 17 mmol/L

R2: Sodium hydroxide 500 mmol/LPotassium sodium tartrate 80 mmol/LPotassium iodide 75 mmol/LCopper sulphate 30 mmol/L


The reagents are stable up to the end of the indicated month ofexpiry, if stored at 2 – 25 °C, protected from light andcontamination is avoided. Do not freeze the reagents!


1. Reagents S24/25: Avoid contact with skin and eyes.2. Reagent 2 is irritating. R36/38: Irritating to eyes and skin.

R52/53: Harmful to aquatic organisms, may cause long-termadverse effects in the aquatic environment. S2: Keep out ofthe reach of children. S26: In case of contact with eyes, rinseimmediately with plenty of water and seek medical advice.S37/39: Wear suitable gloves and eye/face protection.S61: Avoid release to the environment. Refer to specialinstructions/safety data sheets.


4. In serum or plasma from patients who have received largeintravenous amounts of polydextrans too high values can bemeasured with the biuret method. In such cases analternative method (e.g. Kjeldahl) has to be used.

Waste Management


Reagent Preparation


SpecimenSerum or plasma

Stability [1]:6 days at 20 – 25 °C4 weeks at 4 – 8 °Cat least one year at -20 °C


Calibrators and ControlsFor calibration, DiaSys TruCal U calibrator is recommended. Forinternal quality control DiaSys TruLab N and P controls should beassayed. Each laboratory should establish corrective action incase of deviations in control recovery.


5 9100 99 10 064 6 x 3 mLTruLab N 5 9000 99 10 062 20 x 5 mL

5 9000 99 10 061 6 x 5 mLTruLab P 5 9050 99 10 062 20 x 5 mL

5 9050 99 10 061 6 x 5 mL

Performance CharacteristicsMeasuring range up to 14 g/dL (140 g/L) protein(in case of higher concentrations re-measure samples after manualdilution or use rerun function)Limit of detection** 0.05 g/dL (0.5 g/L) proteinOn-board stability 6 weeksCalibration stability 2 weeks

Interferences < 10% byAscorbate up to 30 mg/dLHemoglobin up to 500 mg/dLBilirubin (conjugated and unconjugated) up to 60 mg/dLLipemia (triglycerides) up to 1000 mg/dL

Precision


Mean [g/dL] 4.78 6.17 7.40Mean [g/L] 47.8 61.7 74.0Coefficient of variation [%] 0.57 0.52 0.35


Mean [g/dL] 5.97 6.63 7.13Mean [g/L] 59.7 66.3 71.3Coefficient of variation [%] 1.00 1.00 1.15

Method comparison (n=100)Test x Competitor Total proteinTest y DiaSys Total protein FSSlope 1.00Intercept 0.040 g/dL (0.40 g/L)Coefficient of correlation 0.998


Reference Range [2]

[g/dL]Adults 6.6 - 8.8Children Female Male1 - 30 day(s) 4.2 - 6.2 4.1 - 6.31 - 6 month(s) 4.4 - 6.6 4.7 - 6.76 months - 1 year 5.6 - 7.9 5.5 - 7.01 - 18 year(s) 5.7 - 8.0 5.7 - 8.0



sted.

Darmstadt: GIT Verlag; 2001; p. 42-3.2. Thomas L. Clinical Laboratory Diagnostics. 1st ed. Frankfurt: TH-Books

Verlagsgesellschaft; 1998. p. 644-7.3. Johnson Am, Rohlfs EM, Silverman LM. Proteins. In: Burtis CA,

Ashwood ER, editors. Tietz Textbook of Clinical Chemistry. 3rd ed.Philadelphia: W.B Saunders Company; 1999. p. 477-540.



Total protein FS




# entered by user






Sub-analy. ConditionsName TPDigits 2M-wave L. 545S-wave.L ****Analy.mthd. EPACalc.mthd. STDQualit. judge No



Transferrin FS*

Diagnostic reagent for quantitative in vitro determination of transferrin (Trf) in serum or plasma on BioMajesty JCA-BM6010/C



Principle Determination of concentration of transferrin by photometric measurement of antigen-antibody-reaction among antibodies to transferrin and transferrin present in the sample.

Reagents

Components and Concentrations R1: TRIS pH 7.5 100 mmol/L NaCl 180 mmol/L Polyethylenglycol (PEG) Detergents, stabilizers R2: TRIS pH 8.0 100 mmol/L NaCl 300 mmol/L Anti-human Trf antibody (goat) with stabilizers






Reagent Preparation The reagents are ready to use. The bottles are placed directly into the reagent rotor.

Specimen Serum, heparin plasma or EDTA plasma Stability [1]: 8 days at 20 – 25 °C 8 days at 4 – 8 °C 6 months at -20 °C Freeze only once! Discard contaminated specimens.


For the calibration the DiaSys TruCal Protein calibrator set is recommended. For internal quality control a DiaSys TruLab Protein control should be assayed. Each laboratory should establish corrective action in case of deviations in control recovery.

Performance Characteristics Measuring range up to 7.7 g/L (97.0 µmol/L) transferrin, at least up to the concentration of the highest calibrator. (in case of higher concentrations re-measure samples after manual dilution or use rerun function) Limit of detection** 0.01 g/L (0.126 µmol/L) transferrin No prozone effect up to 19.9 g/L (251 µmol/L) transferrin On-board stability 6 weeks Calibration stability 6 weeks

Interferences < 10% by Conjugated Bilirubin up to 60 mg/dL Unconjugated Bilirubin up to 60 mg/dL Hemoglobin up to 800 mg/dL Lipemia (triglycerides) up to 2000 mg/dL

Precision

Within run (n=20) Sample 1 Sample 2 Sample 3 Mean [g/L] 1.65 2.65 4.11 Mean [µmol/L] 20.8 33.4 51.8 Coefficient of variance [%] 1.69 1.50 2.15

Between run (n=20) Sample 1 Sample 2 Sample 3 Mean [g/L] 1.63 2.46 3.14 Mean [µmol/L] 20.5 31.0 39.6 Coefficient of variance [%] 2.24 3.45 2.31

Method comparison (n=100) Test x Competitor Transferrin Test y DiaSys Transferrin FS Slope 1.02 Intercept -0.012 g/L (-0.151 µmol/L) Coefficient of correlation 0.999


Conversion factor Transferrin [g/L] x 12.6 = Transferrin [µmol/L]

Reference Range [2]

2,0 – 3,6 g/L (25,2 – 45,4 µmol/L)



Darmstadt: GIT Verlag; 2001; p. 22-3. 2. Dati F, Schumann G, Thomas L, Aguzzi F, Baudner S, Bienvenu J et


3. Wick M, Pingerra W, Lehmann P. Iron metabolism: diagnosis and therapy of anemias. 3rd ed. Vienna, New York: Springer Verlag, 1996.

4. Fairbanks VF, Klee GG. Biochemical aspects of hematology. In: Burtis CA, Ashwood ER, editors. Tietz Textbook of Clinical Chemistry. 3rd ed. Philadelphia: W.B Saunders Company; 1999. p. 1642-1710.


Cat. No. Kit size TruCal Protein (5 levels) 5 9200 99 10 039 5 x 1 mL TruLab Protein Level 1 5 9500 99 10 046 3 x 1 mL TruLab Protein Level 2 5 9510 99 10 046 3 x 1 mL

IVD


Transferrin FS




# entered by user


Sub-analy. ConditionsName TRFDigits 2M-wave L. 571S-wave.L ****Analy.mthd. EPACalc.mthd. MSTDQualit. judge No







FV Reac.smp. vol.

Dil.method

Dil. smp.vol.

Diluentvol.

Diluentpos.

STD H STD L



Triglycerides FS*

Diagnostic reagent for quantitative in vitro determination of triglycerides in serum or plasma on BioMajesty JCA-BM6010/C

Order Information Cat. No. Tests 1 5710 99 10 960 R 4 x 530 tests 1 5710 99 10 967 R 6 x 350 tests

Method Colorimetric enzymatic test using glycerol-3-phosphate-oxidase (GPO)

Principle Determination of triglycerides after enzymatic splitting with lipoprotein lipase. Indicator is quinoneimine which is generated from 4-aminoantipyrine and 4-chlorophenol by hydrogen peroxide under the catalytic action of peroxidase. Triglycerides LPL Glycerol + fatty acid

Glycerol + ATP GK Glycerol-3-phosphate + ADP

Glycerol-3-phosphate + 02 GPO Dihydroxyaceton phosphate + H2O2

2 H2O2 + Aminoantipyrine + 4-Chlorophenol

POD Quinoneimine + HCl + 4 H2O

Reagent

Components and Concentrations Good's buffer pH 7.2 50 mmol/L 4-Chlorophenol 4 mmol/L ATP 2 mmol/L Mg2+ 15 mmol/L Glycerokinase (GK) ≥ 0.4 kU/L Peroxidase (POD) ≥ 2 kU/L Lipoprotein lipase (LPL) ≥ 2 kU/L 4-Aminoantipyrine 0.5 mmol/L Glycerol-3-phosphate-oxidase (GPO) ≥ 0.5 kU/L

Storage Instructions and Reagent Stability Reagent is stable up to the end of the indicated month of expiry, if stored at 2 – 8 °C, protected from light and contamination is avoided. Do not freeze the reagent!

Warnings and Precautions 1. The reagent contains sodium azide (0.95 g/L) as preservative. Do not

swallow! Avoid contact with skin and mucous membranes. 2. Please refer to the safety data sheet and take the necessary



Reagent Preparation The reagent is ready to use. The bottles are placed directly into the reagent tray.


Stability [1]: 2 days at 20 - 25 °C 7 days at 4 - 8 °C at least one year at -20 °C Discard contaminated specimens.

Calibrators and Controls For calibration the DiaSys TruCal U calibrator is recommended. For internal quality control DiaSys TruLab N and P or TruLab L controls should be assayed. Each laboratory should establish corrective action in case of deviations in control recovery.

Cat. No. Kit size TruCal U 5 9100 99 10 063 20 x 3 mL 5 9100 99 10 064 6 x 3 mL TruLab N 5 9000 99 10 062 20 x 5 mL 5 9000 99 10 061 6 x 5 mL TruLab P 5 9050 99 10 062 20 x 5 mL 5 9050 99 10 061 6 x 5 mL TruLab L Level 1 5 9020 99 10 065 3 x 3 mL TruLab L Level 2 5 9030 99 10 065 3 x 3 mL

Performance Characteristics Measuring range up to 1000 mg/dL (12 mmol/L) triglycerides (in case of higher concentrations re-measure samples after manual dilution or use rerun function) Limit of detection** 0.5 mg/dL (0.006 mmol/L) triglycerides On-board stability 6 weeks Calibration stability 6 weeks

Interferences < 10% by Ascorbate up to 6 mg/dL Hemoglobin up to 400 mg/dL Conjugated bilirubin up to 30 mg/dL Unconjugated bilirubin up to 12 mg/dL

Precision

Within run (n=20) Sample 1 Sample 2 Sample 3 Mean [mg/dL] 63.7 138 231 Mean [mmol/L] 0.717 1.55 2.60 Coefficient of variation [%] 0.94 0.74 0.82

Between run (n=20) Sample 1 Sample 2 Sample 3 Mean [mg/dL] 76.5 114 177 Mean [mmol/L] 0.861 1.28 1.99 Coefficient of variation [%] 1.71 1.08 1.00

Method comparison (n=100) Test x Competitor Triglycerides Test y DiaSys Triglycerides FS Slope 1.000 Intercept -0.89 mg/dL (-0.01 mmol/L) Coefficient of correlation 0.999


Conversion factor Triglycerides [mg/dL] x 0.01126 = Triglycerides [mmol/L]

Reference Range [2] Desirable: < 200 mg/dL (fasting) (2.3 mmol/L) Borderline high: 200 - 400 mg/dL (2.3 - 4.5 mmol/L) Elevated: > 400 mg/dL (4.5 mmol/L)


Clinical Interpretation [3] Epidemiological studies have observed that a combination of plasma triglycerides > 180 mg/dL (> 2.0 mmol/L) and HDL-cholesterol < 40 mg/dL (1.0 mmol/L) predict a high risk of CHD. Borderline levels (> 200 mg/dL) should always be regarded in association with other risk factors for CHD.


Darmstadt: GIT Verlag; 2001; p. 46-7. 2. Cole TG, Klotzsch SG, McNamara J. Measurement of triglyceride

concentration. In: Rifai N, Warnick GR, Dominiczak MH, eds. Handbook of lipoprotein testing. Washington: AACC Press, 1997. p. 115-26.




IVD


Triglycerides FS




# entered by user



Sub-analy. Conditions Name TRIG Digits 2 M-wave L. 505 S-wave.L 694 Analy.mthd. EPA Calc.mthd. STD Qualit. judge No



Uric acid FS* TOOS

Diagnostic reagent for quantitative in vitro determination of uric acid in serum or plasma or urine onBioMajesty JCA-BM6010/C


MethodEnzymatic photometric test using TOOS (N-ethyl-N-(hydroxy-3-sulfopropyl)-m-toluidin)

PrincipleUric acid is oxidized to allantoin by uricase. The generatedhydrogen peroxide reacts with 4-aminoantipyrine andN-ethyl-N-(hydroxy-3-sulfopropyl)-m-toluidin (TOOS) to a blueviolet dye. Ascorbate oxidase avoids interference by ascorbic acidand other reducing substances.

Uric acid + H2O + O2Uricase Allantoin + CO2 + H2O2

TOOS + 4-Aminoantipyrine + 2 H2O2POD

Indamine + 3 H2O

Reagents


R1: Phosphate buffer pH 7.0 100 mmol/LTOOS 1.25 mmol/LAscorbate oxidase 1,2 kU/L

R2: Phosphate buffer pH 7.0 100 mmol/L4-Aminoantipyrine 1.5 mmol/LK4[Fe(CN)6] 50 µmol/LPeroxidase (POD) 5 kU/LUricase 250 U/L






Waste Management


Reagent Preparation


SpecimenSerum, heparin plasma, EDTA plasma or urine

Stability [1]in serum/plasma:3 days at 20 – 25 °C7 days at 4 – 8 °C6 months at -20 °Cin urine:4 days at 20 – 25 °C


Calibrators and ControlsFor calibration the DiaSys TruCal U calibrator is recommended.For internal quality control DiaSys TruLab N, TruLab P and TruLabUrine controls should be assayed. Each laboratory shouldestablish corrective actions in case of deviations in controlrecovery.


5 9100 99 10 064 6 x 3 mLTruLab N 5 9000 99 10 062 20 x 5 mL

5 9000 99 10 061 6 x 5 mLTruLab P 5 9050 99 10 062 20 x 5 mL



5 9180 99 10 061 6 x 5 mL

Performance CharacteristicsMeasuring range up to 20 mg/dL (1200 µmol/L) uric acid(in case of higher concentrations re-measure samples after manualdilution or use rerun function)Limit of detection** 0.24 mg/dL (14.5 µmol/L) uric acidOn-board stability 6 weeksCalibration stability 6 weeks



Within run (n=20) Sample 1 Sample 2 Sample 3Mean [mg/dL] 3.14 6.20 9.95Mean [µmol/L] 187 369 592Coefficient of variation [%] 0.92 0.47 0.75

Between run (n=20) Sample 1 Sample 2 Sample 3Mean [mg/dL] 3.14 5.26 8.64Mean [µmol/L] 187 313 514Coefficient of variation [%] 1.11 1.63 1.36

Method comparison (Serum/plasma; n=100)Test x Competitor Uric acidTest y DiaSys Uric acid FS TOOSSlope 0.982Intercept -0.011 mg/dL (-0.643 µmol/L)Coefficient of correlation 0.998

Precision (Urine)






Test x Competitor Uric acidTest y DiaSys Uric acid FS TOOSSlope 1.007Intercept 0.488 mg/dL (0.029 mmol/L)Coefficient of correlation 0.997


Reagent Information

Conversion factor

Uric acid [mg/dL] x 59.48 = Uric acid [µmol/L]Uric acid [mg/dL] x 0.05948 = Uric acid [mmol/L]

Reference RangeFemale Male

mg/dL (µmol/L) mg/dL (µmol/L)Adults [2] 2.6 - 6.0 (155-357) 3.5 – 7.2 (208 – 428)Children [3]0 - 5 days 1.9 - 7.9 (113-470) 1.9 - 7.9 (113 - 470)1 - 4 year(s) 1.7 - 5.1 (101-303) 2.2 - 5.7 (131 - 340)5 - 11 years 3.0 - 6.4 (178-381) 3.0 - 6.4 (178 - 381)12 - 14 years 3.2 - 6.1 (190-363) 3.2 - 7.4 (190 - 440)15 – 17 years 3.2 - 6.4 (190-381) 4.5 - 8.1 (268 - 482)

Urine [3] 800 mg/24h (4.76 mmol/24h) assuming normal diet

600 mg/24h (3.57 mmol/24h) assuming low purinediet



Darmstadt: GIT Verlag; 2001; p. 48-9, 52-3.2. Newman JD, Price PC. Renal function and nitrogen metabolites. In:

Burtis CA, Ashwood ER, editors. Tietz Textbook of Clinical Chemistry.3rd ed. Philadelphia: W.B Saunders Company; 1999. p. 1250.

3. Thomas L. Clinical Laboratory Diagnostics. 1st

ed. Frankfurt: TH-BooksVerlagsgesellschaft; 1998. p. 208.

4. Newman DJ, Price CP. Renal function and nitrogen metabolites. In:Burtis CA, Ashwood ER, editors. Tietz Textbook of Clinical Chemistry.3rd ed. Philadelphia: W.B Saunders Company; 1999. p. 1204-70.

ManufacturerDiaSys Diagnostic Systems GmbHAlte Strasse 9 65558 Holzheim German

IVD


Uric acid FS TOOS




# entered by user






Sub-analy. ConditionsName UADigits 2M-wave L. 545S-wave.L 694Analy.mthd. EPACalc.mthd. STDQualit. judge No

Analysis Test Condition Setting (M)Sample Type Serum UrineReac. sample vol. 1.6 1.6Diluent method No dil With dilUndil. sample vol. 0 5Diluent volume 0 50Diluent position 0 0


UIBC FS*

Diagnostic reagent for quantitative in vitro determination of the unsaturated iron binding capacity in serum or plasma on BioMajesty JCA-BM6010/C

Order information Cat. No. 1 1921 99 10 964 R1: 6 x 90 tests R2: 6 x 90 tests

Method Photometric test using Ferene

Principle A known ferrous ion concentration incubated with serum, binds specifically with transferrin at unsaturated iron binding sites. Remaining unbound ferrous ions are measured with the ferene reaction. The difference between the amount of excess iron and the total amount added to the serum is equivalent to the quantity bound to transferrin. This is the UIBC (unsaturated iron binding capacity) of the sample. 2 Fe2+ (known) + Transferrin Transferrin (Fe3+) + Fe2+ (excess) Fe2+(excess) + 3 Ferene Ferrous Ferene (blue complex)

Reagents Components and Concentrations R1: Buffer pH 8.7 100 mmol/L Ammonium iron (II) sulfate 13 µmol/L Thiourea 120 mmol/L R2: Ascorbic acid 240 mmol/L Ferene 6 mmol/L Thiourea 125 mmol/L

Storage Instructions and Reagent Stability The reagents are stable up to the end of the indicated month of expiry, if stored at 2 - 8 °C, and contamination is avoided. D o not freeze the reagents! Reagent 1 and 2 should be protected from light.

Warnings and Precautions 1. Reagent 1 contains sodium azide (0.95 g/L) as preservative. Do not

swallow! Avoid contact with skin and mucous membranes! 2. Reagent 2: S25: Avoid contact with eyes. 3. Please refer to the safety data sheets and take the necessary




Specimen Serum, heparin plasma Separate serum/plasma at the latest 2 h after blood collection to avoid hemolysis.

Stability [3] in serum: 5 days at 20 - 25 °C 1 month at 2 - 8 °C 1 month at -20 °C in plasma: 1 month at 2 - 8 °C 1 month at -20 °C Discard contaminated specimens!

Calibrators and Controls For calibration the DiaSys TruCal UIBC calibrator is recommended. For internal quality control DiaSys TruLab N control should be assayed. Each laboratory should establish corrective action in case of deviations in control recovery.

Performance Characteristics Measuring range up to 625 µg/dL (112 µmol/L) UIBC (in case of higher concentrations re-measure samples after manual dilution or use rerun function) Limit of detection** 14 µg/dL (2.5 µmol/L) UIBC On-board stability 6 weeks Calibration stability 2 weeks


Precision

Within run (n=20) Sample 1 Sample 2 Sample 3 Mean [µg/dL] 141 232 421 Mean [µmol/L] 25.2 41.5 75.4 Coefficient of variation [%] 1.07 0.81 1.42

Between run (n=20) Sample 1 Sample 2 Sample 3 Mean [µg/dL] 143 231 422 Mean [µmol/L] 25.6 41.4 75.7 Coefficient of variation [%] 2.08 1.05 1.36

Method comparison (n=129) Test x DiaSys UIBC FS (Hitachi 917) Test y DiaSys UIBC FS (BM JCA-BM6010/C) Slope 1.01 Intercept -6.14 µg/dL (-1.1 µmol/L) Coefficient of correlation 0.999


Conversion factor UIBC [µg/dL] x 0.1791 = UIBC [µmol/L]

Reference Range [4,5] Taking into account reference values for iron and transferrin the following reference range results for UIBC: 120 - 470 µg/dL (21 - 84 µmol/L)


Literature 1. Fairbanks VF, Klee GG. Biochemical aspects of hematology. In: Burtis

CA, Ashwood ER, editors. Tietz Textbook of Clinical Chemistry. 3rd ed. Philadelphia: W.B Saunders Company; 1999. p. 1642-1710.

2. Wick M, Pingerra W, Lehmann P. Clinical aspects and laboratory. Iron metabolism, anemias. 5th ed. Wien, New York: Springer; 2003.

3. Data on file at DiaSys Diagnostic Systems GmbH. 4. Dati F, Schumann G, Thomas L, Aguzzi F, Baudner S, Bienvenu J et




Cat. No. Kit size TruCal UIBC 1 1920 99 10 046 3 x 1 mL TruLab N 5 9000 99 10 062 20 x 5 mL 5 9000 99 10 061 6 x 5 mL

IVD


UIBC FS


Application for serum, plasma samples


# entered by user



Reaction Rate MethodCycle 2Factor 2E2 corre Not doBlank (u) 9,999Blank (d) -9.999Sample (u) 9.999Sample (d) -9.999

Standards SettingFV #BLK H 9.999BLK L -9,9990STD H 9.999STD L -9.999


Sub-analy. ConditionsName UIBCDigits 1M-wave L. 596S-wave.L 694Analy.mthd. EPACalc.mthd. STDQualit. judge No



Urea FS*

Diagnostic reagent for quantitative in vitro determination of urea in serum, plasma or urine on BioMajesty JCA-BM6010/C


Method “Urease – GLDH“: enzymatic UV test

Principle Urea + 2 H2O Urease 2 NH4

+ + 2 HCO3-

2-Oxoglutarate + NH4+ + NADH GLDH L-Glutamate + NAD+ + H2O

GLDH: Glutamate dehydrogenase

Reagents Components and Concentrations R1: TRIS pH 7.8 150 mmol/L 2-Oxoglutarate 9 mmol/L ADP 0.75 mmol/L Urease ≥ 7 kU/L GLDH (Glutamate dehydrogenase) ≥ 1 kU/L R2: NADH 1.3 mmol/L







Specimen Serum, plasma (no ammonium heparin!), fresh urine Stability [1] in serum or plasma: 7 days at 20 – 25 °C 7 days at 4 – 8 °C 1 year at -20 °C in urine: 2 days at 20 – 25 °C 7 days at 4 – 8 °C 1 month at -20 °C Discard contaminated specimens.

Calibrators and Controls For calibration the DiaSys TruCal U calibrator is recommended. For internal quality control DiaSys TruLab N, TruLab P and TruLab Urine controls should be assayed. Each laboratory should establish corrective action in case of deviations in control recovery.


Performance Characteristics

Measuring range up to 300 mg/dL (50 mmol/L) urea (in case of higher concentrations re-measure samples after manual dilution or use rerun function) Limit of detection** 2 mg/dL (0.35 mmol/L) urea On-board stability 6 weeks Calibration stability 6 weeks

Interferences < 10% by Ascorbate up to 30 mg/dL Hemoglobin up to 500 mg/dL Conjugated bilirubin up to 60 mg/dL Unconjugated bilirubin up to 60 mg/dL Lipemia (triglycerides) up to 2000 mg/dL Ammonium ions interfere, therefore do not use ammonium heparin as anticoagulant for collection of plasma!




Method comparison (Serum/plasma; n=100) Test x Competitor Urea Test y DiaSys Urea FS Slope 1.000 Intercept -0,30 mg/dL (-0.05 mmol/L) Coefficient of correlation 0.999

Precision (Urine)

Within run (n=20) Sample 1 Sample 2 Sample 3 Mean [mg/dL] 509 931 1886 Mean [mmol/L] 84.7 155 314 Coefficient of variation [%] 2.07 1.55 0.91

Between run (n=20) Sample 1 Sample 2 Sample 3 Mean [mg/dL] 516 937 1904 Mean [mmol/L] 85.9 156 317 Coefficient of variation [%] 2.47 1.50 1.18

Method comparison (Urine; n=100) Test x Competitor Urea Test y DiaSys Urea FS Slope 1.011 Intercept 21.4 mg/dL (3.57 mmol/L) Coefficient of correlation 0.999


Reagent Information

Conversion factor Urea [mg/dL] x 0.1665 = Urea [mmol/L]

Urea [mg/dL] x 0.467 = BUN [mg/dL]

BUN [mg/dL] x 2.14 = Urea [mg/dL]

(BUN: Blood urea nitrogen)

Reference Range Serum/Plasma [2] [mg/dL] [mmol/L] Adults Global 17 - 43 2.8 - 7.2 Women < 50 years 15 - 40 2.6 - 6.7 Women > 50 years 21 - 43 3.5 - 7.2 Men < 50 years 19 - 44 3.2 - 7.3 Men > 50 years 18 - 55 3.0 - 9.2 Children 1 - 3 year(s) 11 - 36 1.8 - 6.0 4 - 13 years 15 - 36 2.5 - 6.0 14 - 19 years 18 - 45 2.9 - 7.5

Urea/Creatinine ratio [2] 25 – 40 [(mmol/L)/(mmol/L)] 20 – 35 [(mg/dL)/(mg/dL)]

Urea in Urine [3] 26 – 43 g/24h (0.43 – 0.72 mol/24h)



Darmstadt: GIT Verlag; 2001; p. 48-9, 52-3. 2. Thomas L. Clinical Laboratory Diagnostics. 1st ed. Frankfurt: TH-Books

Verlagsgesellschaft; 1998. p. 374-7. 3. Burtis CA, Ashwood ER, editors. Tietz Textbook of Clinical Chemistry.

3rd ed. Philadelphia: W.B Saunders Company; 1999. p. 1838. 4. Talke H, Schubert GE. Enzymatische Harnstoffbestimmung in Blut und

Serum im optischen Test nach Warburg (Enzymatic determination of urea in blood and serum with the optical test according to Warburg). Klin Wschr 1965; 43: 174-5.


IVD


Urea FS




# entered by user

Endpoint method Re.absorb (u) 9.999 Re. Absorb (d) -9.999 Calculation Method Setting M-DET.P.I 21 M-DET.P.m 23 M-DET.P.n 29 S-DET.P.p 0 S-DET.P.r 0 Check D.P.I. 21 Limit value 0.003 Variance 10 Reac.type Dec Reaction Rate Method Cycle 2 Factor 2 E2 corre Do Blank (u) 9.999 Blank (d) -9.999 Sample (u) 9.999 Sample (d) -9.999 Standards Setting FV # BLK H 9.999 BLK L -9.999 STD H 9.999 STD L -9.999


Sub-analy. Conditions Name UREA Digits 2 M-wave L. 340 S-wave.L 410 Analy.mthd. RRA Calc.mthd. STD Qualit. judge No


Documents

Albumin in Urine/CSF FS* (Microalbumin) - Asterisco...Albumin in Urine/CSF FS* (Microalbumin) Diagnostic reagent for quantitative in vitro determination of albumin in urine, CSF, serum