BXC0203A BXC0203D BXC0203F For In Vitro Diagnostics Use Only

Lot Number
1x100ml 2x100ml 5x100ml Catalogue Number
Storage Temperature
AST (GOT) STORE AT 2-8°C
Expiry Date (Year / Month)
PRODUCT CODE: BXC0203 Warning, Read Enclosed Documents
INSTRUCTIONS FOR USE
Instructions For Use

FOR IN-VITRO DIAGNOSTIC USE ONLY Manufactured By

The International Federation of Clinical Chemistry (IFCC) Manual Procedure:

AST (GOT) recommended in 1977 and 1980 standardized procedures for AST
determination, including optimization of substrate concentrations,
Wavelength
Hg 334 nm,
Temperature Cuvette Measurement

IFCC UV (LIQUID STABLE) – A25/A15 APPLICATION employment of TRIS* buffers, preincubation of combined buffer and 340 nm or Hg +30oC/+ 37oC 1 cm light path
Against Air /
serum to allow side reactions with NADH to occur, substrate start, and Distilled Water
365 nm
optional pyridoxal phosphate activation.
Kit Contents: BXC0203A BXC0203D BXC0203F This method is derived from the IFCC reference method. Pipette into test tubes as follows:
R1 Enzyme Reagent 1 x 100 ml 2 x 100 ml 5 x 100 ml *TRIS = Tris(hydroxymethyl)-aminomethane Sample Calibrator
R2 Oxoglutarate/ 1 x 20 ml 2 x 20 ml 1 x 100 ml Working Reagent 1000 µl 1000 µl
coenzyme Reagent Concentration: Sample 100 µl ---
Tris Buffer pH 7.8 80 mmol/l Calibrator --- 100 µl
Intended Use: L-Aspartate 200 mmol/l Mix gently, incubate for 1 min. at assay temperature, measure initial
R1
In vitro test for the quantitative determination of aspartate amino- LDH ≥ 800 U/l absorbance and start stopwatch simultaneously. Read again after
transferase (AST) in human serum and plasma. MDH ≥ 600 U/l exactly 1, 2 and 3 minutes.
NADH 0.18 mmol/l
Test Principle: R2
Oxoglutarate 12 mmol/l Calculation:
Method recommended by the IFCC: Hg340 nm A/min x 1746
Reagent Handling and Preparation: Hg 334 nm A/min x 1780
GOT Mix contents of each bottle by gentle swirling before use. Hg 365 nm A/min x 3235
2-Oxoglutarate + L-Aspartate Glutamate + Oxaloacetate Mix 1 volume of enzyme reagent /R2 with 5 volumes
MDH of R1. Wait at least for 5 minutes before use. Linearity:
Oxaloacetate + NADH + H+ Malate + NAD+ This solution is stable: 35 days at +2 to +8°C. Up to 410 U/l
Samples with higher values should to be diluted with 0.9% NaCI or
Summary: Specimen: distilled/deionised water (e.g. 1+9). Multiply the result by the
Aspartate aminotransferase (glutamate oxaloacetate transaminase) Collect serum using standard sampling tubes. appropriate dilution factor (e.g. factor 10).
belongs to the transaminases, which catalyze the interconversion of Heparin or EDTA plasma.
amino acids and -ketoacids by transfer of amino groups. Aspartate Sensitivity:
aminotransferase is commonly found in human tissue. Although heart Detection limit: 4 U/l
24 hours at +20°C to +25°C
muscle is found to have the most activity of the enzyme, significant Stability: The lower detection limit represents the lowest measurable AST
7 days at +2°C to +8°C
activity has also been seen in the brain, liver, gastric mucosa, adipose concentration that can be distinguished from zero.
tissue, skeletal muscle, and kidneys. Separate serum/plasma from clot/cells within 8 hours at room
AST is present in both the cytoplasm and mitochondria of cells. In cases Imprecision:
temperature or 48 hours at +2°C to +8°C.
involving mild tissue injury, the predominant form of AST is that from the Reproducibility was determined using controls. The following results
Centrifuge samples containing precipitate before performing the
cytoplasm, with a smaller amount coming from the mitochondria. were obtained:
assay.
Severe tissue damage results in more of the mitochondrial enzyme Intra Assay – Within run
being released. Elevated levels of the transaminases can signal Testing Procedure: Mean SD CV
Sample (n=20)
myocardial infarction, hepatic disease, muscular dystrophy, and organ Materials Provided: U/l U/l %
damage.  Working Solutions as described above Sample 1 56.41 2.04 3.62
Additional Materials Required: Sample 2 196.72 2.70 1.38
In 1955, Karmen et al described the first kinetic determination of AST  Controls as indicated below
activity in serum. Inter Assay – Between Run
 0.9% NaCI
Mean SD CV
Sample (n=10)
U/l U/l %
Sample 1 55.42 1.52 2.75
Sample 2 188.24 4.15 2.21

Biorex Diagnostics Limited, Unit 2C Antrim Technology Park, Muckamore, BT41 1QS (United Kingdom)
Tel: +44 (0) 2894 468786 | Fax: +44 (0) 2894 469933 | Website: www.biorexdiagnostics.com BXC0203 – AST (GOT) | Revision No.10 MAY/11 | Page 1 of 2
Normal Values: 8. Schmidt FW. Ref Med Ges, Marburg/Lahn, December 1959.
According to the IFCC method. 9. Thefeld W et al. Dtsch med Wschr 1974;99:343.
10. Tietz NW (Hrsg.). Clinical Guide to Laboratory Tests, 3.
30oC 37oC Auflage. Philadelphia, PA: WB Saunders, 1995:76

Women up to 22 U/l up to 31 U/l

Men up to 26 U/l up to 38 U/l BIOSYSTEMS A25/A15 APPLICATION:
Each laboratory should investigate the transferability of the
expected values to its own patient population and if necessary
determine its own reference range. For diagnostic purposes, the AST A 25 A 15
results should always be assessed in conjunction with the patient’s
TEST NAME AST AST
medical history, clinical examination and other findings.
ANALYSIS MODE MON.KINETIC MON.KINETIC
SAMPLE TYPE SERUM SERUM
Use on Automated Analysers:
This reagent is suitable for use on a range of automated analysers. UNITS U/L U/L
GENERAL
Specific instructions for these applications are available on request REACTION TYPE DECREASING DECREASING
from our technical department. DECIMALS 1 1
For automated use we recommend a serum based calibrator to NO.OF REPLICATES 1 1
eliminate any matrix bias which may be observed with the aqueous TEST NAME IN PT REP
standard.
PROCEDURE READING MONOCH MONOCH
Biorex Calibration Serum cat. No BXC0321K/ L/ M
VOLUMES SAMPLE 25 25
Quality Control: REAGENT 1 300 300
Biorex Normal Bovine Assayed Control Cat No BXC0313A (10x5ml) REAGENT 2
Biorex Elevated Bovine Assayed Control Cat No BXC0313B (10x5ml) WASHING 1.2 1.2
Biorex Normal Human Assayed Control Cat No BXC0312A (10x5ml) PREDIL FACTOR
Biorex Elevated Human Assayed Control Cat No BXC0312B (10x5ml POST DIL FACTOR 2 2
FILTERS MAIN 340 340
Biorex Calibrator Cat No BXC0321K/L/M REFERENCE
The control intervals and limits must be adapted to the individual TIMES READING 1 90s 90s
laboratory and country-specific requirements. Values obtained should
READING 2 255s 255s
fall within established limits. Each laboratory should establish corrective
measures to be taken if values fall outside the limits. REAGENT 2
CALIBRATION TYPE MULTIPLE MULTIPLE
Health & Safety: CALIBRATOR REPLICATES 3 3
This kit is designed for use by suitably qualified laboratory personnel CALIBRATION
BLANK REPLICATES 3 3
only. Exercise the normal precautions required for the handling of
CALIBRATION CURVE
laboratory reagents. Do not ingest the material. Dispose of material
according to local guidelines. BLANK ABS LIMIT 1.100 1.100
OPTIONS KINETIC BLANK LIMIT
References: LINEARITY LIMIT 400 400
1. International Federation of Clinical Chemistry, Scientific
committee. J Clin Chem clin Biochem 1980 18: 521-534.
2. Bablok W et al. A General Regression Procedure for Method
Transformation. J Clin Chem Clin Biochem 1988;26:783-790.
3. Bergmeyer HU, Herder M, Rej R. Approved recommendation
(1985) on IFCC methods for the measurement of catalytic
concentration of enzymes. Part 2. IFCC Method for aspartate
aminotransferase. J Clin Chem Clin Biochem 1986;24:49.
4. Glick MR, Ryder KW, Jackson SA. Graphical Comparisons of
Interferences in Clinical Chemistry Instrumentation. Clin Chem 1
986;32:470-474.
5. Greiling H, Gressner AM (Hrsg.). Lehrbuch der Klinischen Chemie
und Pathobiochemie,3. Auflage. Stuttgart/New York: Schattauer
Verlag, 1995
6. Karmen A et al. J Clin Invest 1955;24:126.
7. Passing H, Bablok W. A New Biometrical Procedure for Testing the
Equality of Measurements from Two Different Analytical Methods.
J Clin Chem Clin Biochem 1983;21:709-720.

Biorex Diagnostics Limited, Unit 2C Antrim Technology Park, Muckamore, BT41 1QS (United Kingdom)
Tel: +44 (0) 2894 468786 | Fax: +44 (0) 2894 469933 | Website: www.biorexdiagnostics.com BXC0203 – AST (GOT) | Revision No.10 MAY/11 | Page 2 of 2