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A method for improving reagent stability, and its stable reagent

The technology of a reagent and a kit is applied in the field of reagents for the determination of alanine aminotransferase, which can solve the problems of difficulty in detecting serum ALT, inability to evaluate stability, and accelerated stability experiments.

Active Publication Date: 2022-05-20
BEIJING BEIJIAN XINCHUANGYUAN BIOLOGICAL TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This process also cannot avoid changes in temperature and humidity, and the sample is exposed to air after opening the cover, facing oxidation factors
Therefore, in this case, the accelerated stability test cannot evaluate the stability of other aspects (ISO standard 23640-2011, In vitro diagnostic medical devices-Evaluation of stability of in vitro diagnostic reagents)
[0008] At present, the double-reagent enzyme-coupled continuous detection method is mostly used in the market to detect serum ALT. Due to the presence of enzyme and NADH in the reagent, the reagent is unstable during transportation and when the bottle cap is opened for operation on the machine. ALT brings difficulty

Method used

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  • A method for improving reagent stability, and its stable reagent
  • A method for improving reagent stability, and its stable reagent
  • A method for improving reagent stability, and its stable reagent

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0063] Embodiment 1: the preparation of comparison kit

[0064] First Reagent R1:

[0065]

[0066] Second reagent R2:

[0067] TRIS, pH6.5 100mmol / L

[0068] L-alanine 1500mmol / L

[0069] α-ketoglutarate 45mmol / L

Embodiment 2

[0070] Embodiment 2: the preparation of test kit

[0071] The preparation method of the second reagent R2 is the same as in Example 1; the preparation method of the first reagent R1 is shown in Table 1.

[0072] Table 1. R1 reagent composition of different test kits

[0073]

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Abstract

The invention provides a method for improving reagent stability and a stable reagent thereof. The reagent of the present disclosure contains a specific combination of surfactants, protein stabilizers, and preservatives, thereby effectively improving the thermal stability, airborne stability, and transportation stability of the NADH indicator system in vitro diagnostic reagents, and can effectively prolong the preservation of the kit time.

Description

technical field [0001] This application relates to the fields of biochemistry and clinical testing. More specifically, the present application relates to a reagent for assaying alanine aminotransferase. Background technique [0002] Alanine aminotransferase (ALT) mainly exists in blood and related tissues. The intracellular concentration is 1000 to 3000 times higher than the serum concentration. As long as 1% of the liver tissue is destroyed, the serum concentration can be doubled. It is recommended by the World Health Organization as the most sensitive detection index of liver function damage. Determination of ALT activity on toxic hepatitis, viral hepatitis, active liver cirrhosis, liver cancer, obstructive jaundice, fatty liver, cholangitis and cholecystitis, myocardial infarction, myocarditis, cardiovascular disease, skeletal muscle disease, internal organs and muscles The diagnosis of inflammatory necrosis etc. has important value ("Clinical Liver Disease Experimental...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N21/75
CPCY02A50/30
Inventor 姜敏
Owner BEIJING BEIJIAN XINCHUANGYUAN BIOLOGICAL TECH