Laboratory Accreditation Compliance Sheet:

Version 1.01
Date: January '95
BM-GOT IFCC, 37°C Page 1 of 8

BM/Hitachi 917

Laboratory Accreditation
Compliance Sheet

BM-GOT IFCC Intended use

BM/Hitachi 917 Determination of GOT in
Catalogue No.: 1552481 human blood (respectively
Package size: Btl. 1: 6 x 66 ml serum/plasma) on
Btl. 2: 6 x 16.5 ml BM/Hitachi 917 at 37°C

This sheet provides all necessary product data to comply with the requirements of laboratory
accreditation standards.

This sheet is an uncontrolled copy.

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 Laboratory Accreditation Compliance Sheet:
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Date: January '95
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BM/Hitachi 917

Laboratory Accreditation Compliance Sheet

BM-GOT IFCC

Content:

1. Test principle

2. Sample preparation

3. Reagent

4. Calibration

5. Quality control

6. Instrument settings

7. Method validation
7.1 Linearity
7.2 Accuracy
7.3 Precision
7.4 Traceability, method comparison
7.5 Interferences

8. Reference range

9. Health and safety, warnings, precautions

10. Literature reference

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Version 1.01
Date: January '95
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BM/Hitachi 917

1. Test principle

GOT
α-oxoglutarate + L-aspartate L-Glutamate + oxaloacetate

MDH
oxaloacetate + NADH + H+ L-malate + NAD+

For reference see point 10. Literature

2. Sample preparation

Use serum or plasma, treated with heparin or EDTA.

Stability: Activity dereases in serum after 3 days:

at +4°C: 8 %
at +25°C: 10 %

3. Reagent

The unopened bottles are stable up to the expiry date printed on the label.
Reagent preparation and stability of solutions:
R1:
Connect one bottle 1 to one bottle 1a using the enclosed adapter and dissolve
the granulate completely in the buffer.
Stable for 4 weeks in the instrument (at approx. +10°C).
R2:
Use contents as supplied.
Stable for 3 months in the instrument (at approx. +10°C).
Reagent concentrations in the bottles:
R1: - Tris buffer: 100 mmol/l
- pH 7.8
- L-aspartate: 288 mmol/l
- NADH: 0.23 mmol/l
- MDH ≥ 0.53 U/ml
- LDH ≥ 0.75 U/ml
R2: - α-oxoglutarate: 75 mmol/l

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 Laboratory Accreditation Compliance Sheet:
Version 1.01
Date: January '95
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BM/Hitachi 917

Final concentrations in the test:

- TRIS buffer: 80 mmol/l

- pH 7.8
- L-aspartate: 240 mmol/l
- NADH: 0.18 mmol/l
MDH ≥ 0.42 U/ml
- LDH ≥ 0.60 U/ml
- alpha-oxoglutarate: 12 mmol/l

4. Calibration

Use calibrator for automated systems (Cfas) Ident. No.: 759350 for 10x 3 ml

Preparation of calibrator:

Open a bottle 1 very carefully, avoiding any loss of the lyophilized material, and
add exactly 3 ml of diluent from a bottle 2. Close bottle carefully and dissolve
contents completely within 30 minutes by swirling gently, avoiding the formation
of foam. Do not shake.

Stability: - 8 hours hours at 25°C

- 2 days at 4°C
- 1 month at -20°C (if frozen only once)

Use calibrator solution according to "sample volume" specified in "Instrument

settings".

5. Quality control

Use Precinorm U for the normal range respectively Precipath U for the
pathological range for accuracy and precision with the specified values for the
cholesterol GOT IFCC method.

All above mentioned quality control material may be stored until the expiration
date and at conditions given on the product.

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 Laboratory Accreditation Compliance Sheet:
Version 1.01
Date: January '95
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BM/Hitachi 917

Reconstituted control material should be stored as follows:

- 12 hours at +25°C
- 5 days at +4°C
- 1 month at -20°C (if frozen only once)

Please always take note of the annotation made in the package insert!

6. Instrument settings

Prepare the reagent solutions as directed in the package insert. For selection of
the appropriate assay data stored on the application disk enter the application
number printed in the box alongside the Catalogue Number on the bar-code
label.

If the bar-code cannot be read into the analyzer, enter manually the series of
numbers given beneath the bar-code.

Application

Code number: GOT IFCC: 253 (Application disk 1.00)

7. Method validation

7.1 Linearity

Lower detection limit (according to Kaiser): 1.62 U/l 0.03 (µKat/l)

Dilution threshold (first run): 400 U/l 6.68 (µKat/l)

In case of a rerun (2 µl sample instead of 15 µl) the linearity is extended to

3000 U/l (50.1 µKat/l).

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BM/Hitachi 917

7.2 Accuracy

Mean of recovery in control sera which were included in the day-to-day

precision run (n = 21).

Target Mean Recovery in

U/l U/l %

PNU 178992 55.7 56.1 100.7

PPU 183148 125 132 105.6

7.3 Precision

Precision within run

Sample Mean (U/l) CV (%) n

Human serum 27.8 1.9 21

Control sera
Precinorm U 57.3 1.2 21
Precipath U 137 0.6 21
Precision between run/from day to day*
Sample Mean (U/l) CV (%) n

Human serum 21.9 4.1 21

Control sera
Precinorm U 56.4 2.6 21
Precipath U 132 1.7 21

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BM/Hitachi 917

7.4 Traceability, method comparison

- x = BM-GOT IFCC, BM/Hit 717

- y = BM-GOT IFCC, BM/Hit 917
- Patient material was tested with low, middle and high level of GOT
- measuring range: 3.70 - 460 U/l (0.06 - 7.68 µKat/l)
- n = 124
- Regression equation: y = 1.056 + 0.995x; r = 1.000

7.5 Interferences

Substance: (endogenous) No interference up Direction of

to deviation in
serum index case of
BM/Hit 917** interference
Bilirubin* I 62 -
Hemoglobin* H 66 ↑
Triglycerides (humanserum) L 100 ↑

* measured according to Glick

** The index for Bili and Hb corresponds approximately to mg/dl and for Intralipid to
turbidity at 660/700 nm expressed as Abs x 10000
Substance: (exogenous) No interference up to
no data available

8. Reference range

GOT IFCC
men < 38 U/l < 0.65 µKat/l
women < 32 U/l < 0.55 µKat/l

For reference see point 10. Literature

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 Laboratory Accreditation Compliance Sheet:
Version 1.01
Date: January '95
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BM/Hitachi 917

9. Health and safety, warnings, precautions

No hazardous ingredients which are necessary to be declared.

10. Literature reference

to point 1: Test principle

Bergmeyer, H. U., et al. (1986).

J. Clin. Chem. Clin. Biochem. 24:497

to point 8: Reference range

Wallnöfer, H., E. Schmidt, and F. W. Schmidt, eds. (1974).

Synopsis der Leberkrankheiten. Georg Thieme Verlage, Stuttgart.

Thefeld, W., et al. (1974). Dtsch. med. Wschr. 99:343.

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