SGOT KIT

(IFCC METHOD)
Code No. Product Name Packing (Content)
STORAGE & STABILITY :
Z25 SGOT (10x10 ml) R1 : 10x10 ml, R2 : 2x50 ml
1. Unopened reagent : Stable for 24 months at 2-8°C, protect from
Z25A SGOT (4x50 ml) R1 : 4x50 ml, R2 : 4x50 ml light.
2. Dissolved reagent : Stable up to 7 days at 2-8°C, protect from
INTENDED USE: light.
In vitro test for the quantitative determination of Aspartate SPECIMEN COLLECTION AND HANDLING :
Aminotranferase (AST) in human serum and plasma.
Only the specimens listed below were tested and found acceptable.
CLINICAL SIGNIFICANCE: For specimen collection and preparation, only use suitable tubes or
Aspartate aminotransferase (AST) (formerly referred to as collection containers.
glutamate oxalacetate transaminase, GOT) belongs to the
transaminases, which catalyze the interconversion of amino acids Specimen: Serum sample on an empty stomach are the recommended
and a-ketoacids by transfer of amino groups. Aspartate specimen.
aminotransferase is commonly found in human tissue. Although
heart muscle is found to have the most activity of enzyme, Serum: Collect fresh serum using standard sampling tubes.
significant activity has also been seen in the brain, liver, gastric If processing samples in primary tubes, follow the instructions of the tube
mucosa, adipose tissue, skeletal muscle and kidney. AST is manufacturer.
present in both the cytoplasm and mitochondria of cells. In cases
involving mild tissue injury, the predominant form of AST is that For sample with absorbance interference, including samples of hemolysis
from the cytoplasm, with a smaller amount coming from the and turbidity, may affect the test results. Sample recollection is
mitochondria. Several tissue damage results in more of the recommended.
mitochondrial enzyme released. Elevated levesl of the
transaminases can signal myocardial infarction, hepatic disease, Stability: Store serum less than 2 days at 2-8°C, 1 month at -20-15°C.
muscular dystrophy and organ damage. AST is a sensitive Protected from light and avoid repeated freeze thaw cycles.
indicator of hepatic damage, Including hepatitis, cirrhosis and
necrosis. It is often elevated before clinical signs and symptoms of Centrifuge samples containing precipitate before performing the assay.
liver disease appear. The determination of serum AST activity
has also been used in the diagnosis and prognosis of myocardial
PROCEDURE :
infarction, muscular dystrophy and dermatomyositis. Elevated Reagent Preparation : Reagent 1 & Reagent 2: Ready to use.
levels hve also been observed in cases where infectious Wavelength : 340 nm
mononucleosis, acute pancreatitis, traumatic muscle injury and Temperature : 37°C
hemolytic disease have been diagnosed. Cuvette : 1 cm
Dissolve one bottle of Reagent 1 with Reagent 2 (refer to Reagent 1 Label)
PRINCIPLE: as working solution.
In the reaction, AST catalyzed the reaction of a-ketoglutarate and Blank Sample
L-aspartate to L- glutamate and oxalacetate. Malate Working reagent 1 ml 1 ml
dehydrogenase (MDH) catalyzes the oxidation of NADH to NAD.
The rate of decrease in absorbance of the reaction mixture at 340 Distilled Water 100 µl -
nm, due to the oxidation of NADH is directly proportional to the Sample - 100 µl
AST activity of the sample AST. Mix thoroughly and incubate at reaction temperature for 60 seconds.
REACTION: Read the initial absorbance and the change of absorbance at 1,2 and 3
AST minutes.. Determine the change of absorbance per minute (DA/min).
a-Ketoglutarate + L - Aspartate L-Glutamate + Oxaloacetate
+
MDH CALIBRATION :
Oxaloacetate + NADH + H L-Malate + NAD+ + H2O
Traceability : This method has been standardized against the original
CONTENTS: formulation and procedures recommended by the IFCC using calibrated
pipettes together with a manual photometer providing absolute value and
Reagent 1 : SGOT (Enzyme/Co-Enzyme) the substrate-specific absorptivity.
Reagent 2 : SGOT (Buffer)
Use K factor (refer to Parameter Sheet) for reagent blank calibration.
COMPONENTS: QUALITY CONTROL :
Reagent Component Concentration It is recommended to use two levels of controls at least once a day.
a-ketoglutaric acid 12 mmol/L Values obtained should fall within a specified range.
Reagent 1 NADH 0.18 mmol/L
Malic dehydrogenase (MDH) Each laboratory should establish its own internal Quality control scheme
->1000 U/L and procedures for corrective action if controls do not recover within the
Lactic dehydrogenase (LDH) ->5000 U/L acceptable tolerances.
Reagent 2 Tris Buffer 80 mmol/L
L-aspartic acid 240 mmol/L
CALCULATION :
SGOT Conc. = (DAsample/min - DAblank/min) x K
Vtotal
K = X 1000 = 1746
Vsample x Extinction coefficient
Millimolar extinction coefficient of NADH at 340nm is 6.3.
Expected Range :
Healthy adult -< 40 U/L
The reference range should be determined by each
laboratory based on characteristics of the region.
LIMITATIONS AND INTERFERENCE :
1. Lipemia (Intralipid) : No interference up to 125 mg/dl.
2. Hemolysis : Interference with the test result.
3. Vc : No interference up to 100 mg/dl.
4. Bilirubin : No interference up to 40 mg/dl.
The results may vary with different analyzers or calibrations.
For diagnostics purposes, the results should always be assessed in
conjunction with the patient’s medical history, clinical
examination and other findings.
PERFORMANCE CHARACTERISTICS :
The following performance data was obtained using analyzer at
37°C. Results obtained in individual laboratories may differ.
10. For acids, include appropriate warning for spills such
as “wipe up spills immediately and flush with water and
“should the reagent contact eyes and skins, flush with
copious amount of water and consult physicians.
11. For biological spills, indicate appropriate disinfectants
and disinfection procedure.
12. Dispose of all specimens and components of the kit as
potentially infectious agents.
13. Do not use the kit or any kit components past the
indicated expiry date.
14. Do not use any other reagents from different lots in this
test, unless the reagent is designated to be used with
other lots of the same kit.
15. Avoid microbial contamination of reagents.
16. The reagent must be used only for the purpose intended
by suitably qualified laboratory personnel, under
appropriate laboratory conditions.
DEFINITION OF SYMBOLS :
USE BY (LAST DAY OF THE MONTH)
BATCH CODE LOT
DATE OF MANUFACTURE

Reagent Blank absorbance : A -

>1.000, DA/min<0.009 TEMPERATURE LIMITS
-
Accuracy: -
<-+15%
CONSULT INSTRUCTIONS FOR USE
Measuring Range : 10-600 U/L
HANDLE WITH CARE
Determine the samples with higher concentrations via the rerun
function. UPWARDS LAY

Analytical Sensitivity : 10 U/L KEEP DRY

The lower detection limit represents the lowest measurable

analyte level that can be distinguished from zero. It is calculated KEEP AWAY FROM SUNLIGHT
as three standard deviations of 21 replicates of lowest standard.
IN VITRO DIAGNOSTIC MEDICAL DEVICE
Precision range :
Within-run CV<5%
- CATALOGUE NUMBER REF
Between-run R<6%-
Reproducibility was determined using human samples or controls SUFFICIENT FOR
in an internal protocol (n=21)
Precautions and Warning : MANUFACTURER

1. For in vitro diagnostic use.

2. Avoid skin and eye contact. Avoid ingestion.
3. Disposal of used material in accordance with local BIBLIOGRAPHY :
guidelines. Avoid pollution and reuse.
1. J. Clin. Chem. Clin. Biochem., 1986, Vol 24:497-508 wallnofer H,
4. Do not use the products if interior package is damaged
E Schmidt, F W Schmidt, eds.
during shipment.
2. Synopsis der Leberkrankheiten, Geoarge Thieme Verlag,
5. The possibility of reagents instability or deterioration may
Stuttgart, 1974.
be considered if there is precipitation, visible exudate,
3. Thefeld W, et al. Dtsch Med.m Wschr, 1974, 99:343.
turbidity, microorganism growth, calibration results do not
meet the appropriate standard specification or control
values out of range.
6. Exercise the normal precautions required for handling all IVD www.jas-anz.com.au/register

ISO 9001:2015 ISO 13485:2003

laboratory reagents.
7. Wear protective clothing and disposable gloves while
handling the kit reagents.
8. Wash hands thoroughly after performing the test.
9. Use in ventilated area.