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TORCH-IgM antibody mixed quality control product

A technology of antibody mixing and quality control products, which is applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve the problems that quality control products cannot be purchased, the price is unacceptable, and it is difficult to buy, so as to achieve easy reconstitution and mixing , low cost, simple effect

Inactive Publication Date: 2019-01-22
AUTOBIO DIAGNOSTICS CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] For the TORCH series of testing items, the biggest difficulty in the current indoor quality control is that it is impossible to purchase suitable commercial quality control products. Bole Company has TORCH mixed quality control products, but the price is unacceptable, and there is no domestic number, so it is difficult to buy

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] Example 1 Preparation of TORCH-IgM Antibody Quality Control

[0024] The TORCH-IgM antibody quality control prepared in this example takes nine levels of TORCH-IgM antibody as an example (level 1 is negative, level 2 to level 9 is positive and the concentration increases sequentially). The nine-level quality control products are freeze-dried products made of matrix diluent and TORCH-IgM antibody. It is a white powdery solid after lyophilization.

[0025] The specific preparation method is as follows:

[0026] The first step is to select healthy adults who are negative for infectious markers of biological pathogens such as HBsAg, anti-HCV, anti-specific TP, and anti-HIV in the blood as qualified blood donors, and collect TORCH-IgM antibody-negative mixed plasma; Treat TORCH-IgM antibody-negative mixed plasma in a 60°C water bath for 1 hour, then centrifuge it in a high-speed centrifuge (3500r / min≤speed≤8000r / min) for 10 minutes, and store it at 2-8°C after returning to...

Embodiment 2

[0031] Example 2 Performance determination of the TORCH-IgM antibody quality control product prepared in Example 1

[0032] 1. Uniformity test

[0033] Detect the homogeneity of the quality control product that embodiment 1 prepares according to the routine method of this industry:

[0034] Take 10 bottles of each level of quality control products of the same batch number, and test each bottle of quality control products once with the corresponding reagent. The test result of level 1 is negative; level 2, level 3, level 4, level 5, level 6, level 7 , Level 8, and Level 9 respectively calculate the average value of 10 test results ( ) and standard deviation S1;

[0035] Level 2, level 3, level 4, level 5, level 6, level 7, level 8, and level 9 respectively use one of the above 10 bottles of quality control products for 10 consecutive tests, and calculate the average value of the 10 test results ( ) and standard deviation S2; calculate the variation (CV%) between bottles ac...

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PUM

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Abstract

The invention discloses a TORCH-IgM antibody mixed quality control product, comprising a freeze dried product formed by a matrix diluent and five antibodies of toxoplasma gondii IgM, rubella virus IgM, cytomegalovirus IgM, type-1 herpes simplex virus IgM and type-2 herpes simplex virus IgM. The invention has the advantages that the prepared TORCH-IgM antibody mixed quality control product has gooduniformity and stability, is not influenced by transportation, temperature and other factors, has longer stabilization time in the detection process after being redissolved, has detection repeatability and high accuracy, can meet the quality control requirement of clinic on TORCH-IgM antibody detection, and can increase the accuracy of detection results of clinic samples.

Description

technical field [0001] The invention relates to biological product technology, in particular to a TORCH-IgM antibody mixed quality control product. Background technique [0002] Five types of TORCH including toxoplasma gondii (TOX) IgM, rubella virus (RV) IgM, cytomegalovirus (CMV) IgM, herpes simplex virus type 1 (HSV-1) IgM, and herpes simplex virus type 2 (HSV-2) IgM Microbial infections have a common feature, which can cause mother-to-child infection. Pregnant women are prone to primary infection due to endocrine changes or decreased immunity, and the latent virus in pregnant women who have been infected before is also prone to reactivation and recurrent infection. When viremia occurs in pregnant women, the virus can be transmitted through the placenta or birth canal to infect the fetus, causing premature birth, miscarriage, stillbirth or teratosis, as well as causing damage to multiple systems and organs of the newborn, resulting in symptoms such as mental retardation ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/558G01N21/76G01N33/569
CPCG01N21/76G01N33/558G01N33/56983
Inventor 于鹏鹤王汝化王万利王春霞郑业焕渠海刘功成付光宇
Owner AUTOBIO DIAGNOSTICS CO LTD
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