Agappe Diagnostics LTD.: in Vitro

The document outlines the intended use and clinical significance of a reagent for the quantitative determination of SGPT in serum or plasma, highlighting its relevance in diagnosing liver diseases. It includes details on the materials provided, calibration, quality control, and performance metrics, as well as safety and storage instructions. Additionally, it specifies the necessary reagents and interferences, along with guidelines for proper laboratory practices.

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Agappe Diagnostics LTD.: in Vitro

Uploaded by

Mohammed Eldebany

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Available Formats

Download as PDF, TXT or read online on Scribd

4 x 50/2 x 30 mL

SGPT 12006020

Intended Use Materials provided

This reagent is intended for in vitro quantitative determination of SGPT in serum SGPT R1 & R2 Reagent
or plasma.
-IFCC recommended methodology
Reagents required but not provided
Multicalibrator (Product Code: 11610001), Qualicheck Norm (Product Code:
-Linear up to 1000 U/L.
11601003), Qualicheck Path ( Product Code: 11601002)
Clinical Significance
Unit Conversion
It is present in most of the tissues, but mainly found in the liver. Increased levels
Conversion from
are found in hepatitis, cirrhosis, obstructive jaundice & other hepatic disease. SGPT Trad itional Unit SI Unit
Trad itional to SI
activity is markedly elevated even before clinical signs of jaundice become apparent
in disease associated with hepatic necrosis. Slight elevations are also found in U/L µKat/L x 0.017
myocardial infraction. Calibration
Agappe Multicalibrator (Product Code: 11610001) is recommended for calibration
Principle
of the assay.
Kinetic determination of SGPT based on the following reaction.
ALT Quality Control
L-Alanine + α− ketoglutarate —————————> Pyruvate + L-Glutamate It is recommended to use Qualicheck Norm (Product Code: 11601003) or Qualicheck
Path (Product Code: 11601002) to verify the performance of the measurement
LDH
Pyruvate +NADH+ H+ ——————————————> L-Lactate + NAD+ procedure.
ALT – Alanine aminotransferase Each Laboratory has to establish its own internal quality control scheme and
LDH - Lactate dehydrogenase procedures for corrective action if controls do not recover within the acceptable
tolerance.
Kit Components
Reference Range
Reagent/ Product Code Description
It is recommended that each laboratory should establish its own reference values.
Component 12006020
The following value may be used as guide line.
SGPT R1 4 x 50 mL Tris Buffer (pH 7.5) 110 mmol/L Serum up to 49 U/L
L-Alanine 600 mmol/L Results obtained for patient samples are to be correlated with clinical findings of
LDH >1500 U/L patient for interpretation and diagnosis.
SGPT R2 2 x 30 mL α -ketoglutarate 16 mmol/L
NADH 0.24 mmol/L Performance
1. Linearity
Risk & Safety The reagent is linear up to 1000 U/L. If the concentration is greater than linearity
Material Safety data sheets (MSDS) will be provided on request (1000 U/L), dilute the sample with normal saline and repeat the assay. Multiply the
result with dilution factor.
Reagent Preparation 2. Comparison
SGPT R1 & R2 Reagents are ready to use.
A comparison study has been performed between Agappe reagent and another
Reagent Storage and Stability internationally available reagent yielded a correlation coefficient of r2= 0.9854 and
The sealed reagents are stable upto the expiry date stated on the label, when stored a regression equation of y = 0.9806x.
at 2-8OC. 3. Precision
Intra Run Inter Run
Open Vial Stability
Control Level 1 Level 2 Level 1 Level 2
Once opened the reagents are stable up to 60 days if contamination is avoided.
n 20 20 20 20
On-board Calibration Stability Mean (U/L) 38.5 119.3 37.9 116.2
Calibration is stable for 20 days. SD 1.07 3.32 1.25 2.5
Reagent Deterioration CV(%) 2.78 2.78 3.30 2.15
Turbidity or precipitation in any kit component indicates deterioration and the
component must be discarded. Values outside the recommended acceptable range Accuracy (U/L)
for the Agappe Qualicheck Norm & Path control may also be an indication of
Control Expected Value Measured Value
reagent instability and associated results are invalid. Sample should be retested
using fresh vial of reagent. Control Level 1 28 ± 10.2 30.2
Control Level 2 98.5 ± 25 101.2
Precaution
Qualicheck Norm 48 ± 9.8 49.2
To avoid contamination, use clean laboratory wares. Close reagent bottles
immediately after use. Avoid direct exposure of reagent to light. Do not blow into Qualicheck Path 125 ± 30 129
the reagent bottles.
This reagent is only for IVD use and follow the normal precautions required for 4. Sensitivity
handling all laboratory reagents. Lower detection Limit is 0.5 U/L
Waste Management Bibliography
Reagents must be disposed off in accordance with local regulations. 1. Clin, Chim, Acta 105,147-172 (1980).
Sample 2. Thefeld,W. [Link].,[Link].99,343 (1994)
Serum/Plasma (Do not use lipemic or hemolysed sample)
Interferences
No interference for
Bilirubin up to 10 mg/dL
Ascorbic acid up to 500 mg/dL
Haemoglobin up to 1000 mg/dL

SYMBOLS USED ON THE LABELS

IN VITRO DIAGNOSTIC USE SEE PACKAGE INSERT FOR PROCEDURE LOT NUMBER MANUFACTURER’S ADDRESS MANUFACTURING DATE EXPIRY DATE TEMPERATURE LIMIT