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Composition suitable for improving stability of immunoturbidimetric reagent

A technology of immunoturbidimetry and composition, which is applied in the field of medical testing, can solve the problems of affecting the stability of antibodies, affecting the stability of reagents, and low stability, so as to achieve the effects of improving stability, prolonging the use time, and improving stability

Pending Publication Date: 2022-01-28
ZYBIO INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Due to the instability of the structure of the antibody itself or the environmental conditions (such as oxygen, carbon dioxide, light or temperature) in the reagent preparation process may affect the stability of the antibody in the reagent, and then affect the stability of the reagent. Therefore, the current Ordinary immunoturbidimetric kits generally have the problem of low stability

Method used

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  • Composition suitable for improving stability of immunoturbidimetric reagent
  • Composition suitable for improving stability of immunoturbidimetric reagent
  • Composition suitable for improving stability of immunoturbidimetric reagent

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1A

[0025] The preparation of embodiment 1AAT detection kit

[0026] The α1-antitrypsin detection kit of the present invention includes reagent R1 and reagent R2 two-liquid components that are independent of each other.

[0027] 1. Preparation of AAT detection kit

[0028] (1) Preparation of reagent R1

[0029] Prepare according to the following formula, stir and mix thoroughly, and store at 2-8°C.

[0030] Reagent R1:

[0031]

[0032] The solvent is purified water

[0033] (2) Preparation of reagent R2

[0034]

[0035] The solvent is purified water

[0036] 2. How to use the AAT detection kit

[0037] In this embodiment, a fully automatic biochemical analyzer (Hitachi 7180) is used to carry out sample detection with the kit of the present invention, and the specific steps are as follows:

[0038] 1. Instrument parameter setting

[0039] (a) Mix the sample to be tested with reagent R1 and reagent R2 (the volume ratio of the sample to be tested, reagent R1 and reage...

Embodiment 2

[0045] Embodiment 2 kit performance test

[0046] (1) Accuracy: Use the kit to test the accuracy of the two groups of quality control products, set 3 repetitions, read the signal through the automatic biochemical analyzer, and calculate the relative deviation between the measured mean value and the target value. Experimental results show that the relative deviation between the test value of the kit of the present invention and the target value of the quality control product can be controlled within 1.5%, which has high accuracy.

[0047](2) Repeatability: Select clinical AAT low-value samples, middle-value samples, and high-value samples, use the kit to test the samples, set 10 repetitions, read the signal through a fully automatic biochemical analyzer, and calculate the average and standard values ​​respectively Difference. Experimental results show that the coefficient of variation of the kit of the present invention can be controlled within 2% when detecting low-value samp...

Embodiment 3

[0049] Example 3 Test Kit Stability Verification

[0050] 1. The influence of adding 4 kinds of compositions on the stability of the kit

[0051] In order to verify that the addition of specific surfactants, glucose, amino acids, and alcohol compositions to the reagent R2 of the AAT detection kit can effectively improve the thermal stability and bottle-opening stability of the reagent, a total of 4 sets of kits were set up for performance verification. The difference between the preparation method of the 4 groups of kits and the preparation method of the kit in Example 1 is only the specific types of carbohydrates, alcohols, amino acids and surfactants in the reagent R2 and whether they are added or not. The specific settings are as follows:

[0052] Table 1

[0053]

[0054]

[0055] Note: "√" indicates that the component is added; "-" indicates that the component is not added.

[0056] (1) thermal stability verification

[0057] For the above-mentioned 4 groups of k...

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Abstract

The invention discloses a composition suitable for improving the stability of an immunoturbidimetric reagent. The composition comprises a surfactant, a carbohydrate, an alcohol substance and amino acid, specifically, the surfactant is selected from at least one of Tween-80, Tween-20 or Triton X-100; the carbohydrate is selected from at least one of glucose, cane sugar or trehalose; the alcohol substance is selected from at least one of sorbitol, mannitol or glycerol; and the amino acid is selected from at least one of glutamine, glycine or glutamic acid. According to the composition disclosed by the invention, the stability of the antibody in the reagent R2 can be improved by adding a specific combination of saccharides, amino acids, alcohols and surfactants into the immunoturbidimetric reagent R2, so that the stability (including thermal stability and bottle opening stability) of the reagent is remarkably improved, and the service time of the reagent is prolonged.

Description

technical field [0001] The invention relates to the field of medical testing, in particular to a composition suitable for improving the stability of immune turbidimetric reagents. Background technique [0002] Immunoturbidimetric Assays is a dynamic assay for antigen-antibody binding. The basic principle is: when the antigen and the antibody react in a special dilution system and the ratio is appropriate (generally, the antibody is excessive), the soluble immune complex formed is under the action of the polymerization accelerator (polyethylene glycol, etc.) in the dilution system. , It precipitates from the liquid phase to form particles, which makes the reaction solution appear turbid. In the case of slightly excess and immobilized antibodies, the formation of immune complexes increases with the increase in the amount of antigen, and the turbidity of the reaction solution also increases, that is, the amount of antigen to be tested is positively correlated with the turbidit...

Claims

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Application Information

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IPC IPC(8): G01N33/573G01N33/68
CPCG01N33/573G01N33/68G01N33/5306G01N2333/8125G01N2333/775
Inventor 殷冲姚浩赵威
Owner ZYBIO INC
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