Infectious disease marker composite quality control product, detection reagent and detection kit

An infectious disease and marker technology, applied in the field of biological inspection, can solve the problems of complicated operation, high price, and high cost of imported quality control products, and achieve the effect of improving operation efficiency and high degree of compounding.

Pending Publication Date: 2020-12-11
郑州标源生物科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] At present, most of the existing infectious disease marker control products on the market are single-item quality control products, which are cumbersome to operate and lack commercialized multi-item composite quality control products.
And most of the brands currently on the market are imported brands, the purchase cycle is long and imported quality control products are expensive
Due to the differences of different detection systems, quality control products for infectious diseases currently on the market cannot meet the needs of a variety of mainstream detection instruments
For example, quality controls for infectious diseases produced by Roche Diagnostics (hepatitis B virus surface antigen quality control, hepatitis B virus e antigen quality control, human immunodeficiency virus antigen antibody quality control, hepatitis C virus antibody quality control , Treponema pallidum antibody quality control) and infectious disease quality control produced by Abbott Diagnostics (hepatitis B virus surface antigen quality control, hepatitis B virus e antigen quality control, human immunodeficiency virus antigen antibody quality control, Hepatitis C virus antibody quality control products, Treponema pallidum antibody quality control products) are single quality control products, which are expensive and cannot meet the quality control requirements of multiple detection systems

Method used

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  • Infectious disease marker composite quality control product, detection reagent and detection kit
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  • Infectious disease marker composite quality control product, detection reagent and detection kit

Examples

Experimental program
Comparison scheme
Effect test

preparation example Construction

[0042] The preparation method of the infectious disease marker composite quality control product provided by the present invention includes the following specific preparation steps:

[0043] (1) Prepare the infectious disease marker composite quality control buffer system, add fresh calf serum, 0.01%-10% Proclin300, 0.1%-30% glycerol (glycerol), 0.05%-5% Ampicillin sodium, 0.01%-10% trixon-100, 0.01%-30% bovine serum albumin, mixed evenly, stored at 4°C;

[0044] (2) Take the prepared matrix solution to detect and analyze the various pathogenic markers in it, determine the background situation of the matrix solution, and verify whether there is an obvious matrix effect;

[0045] (3) Conduct a preliminary experiment to determine the proportion of positive substances used for each infectious disease marker;

[0046]

[0047] (4) Design the level of quality control products for the detection system of mainstream instrument manufacturers (this invention can be applied to mains...

preparation example 1

[0064] Concrete preparation steps are as follows:

[0065] (1) Prepare infectious disease marker composite quality control buffer system, add fresh calf serum, 0.01% Proclin300, 1% glycerol (glycerol), 5% ampicillin sodium, 5% trixon-100 to the buffer , 30% bovine serum albumin, after mixing evenly, store at 4°C;

[0066] (2) Take the prepared matrix solution to detect and analyze the various pathogenic markers in it, determine the background situation of the matrix solution, and verify whether there is an obvious matrix effect;

[0067] (3) Conduct a preliminary experiment to determine the proportion of positive substances used for each infectious disease marker;

[0068]

[0069] (4) Design the level of quality control products for the detection systems of mainstream instrument manufacturers (Auto Lumo A2000, Auto Lumo A2000Plus, AutoLumo A2000 PlusB, Auto Lumo A1000, Roche Cobas e601, Abbott i2000SR, SysmexHISCL-5000); , Roche, Abbott, Sysmex and other mainstream lumin...

preparation example 2

[0073] Concrete preparation steps are as follows:

[0074] (1) Prepare infectious disease marker composite quality control buffer system, add fresh calf serum, 10% Proclin300, 15% glycerol (glycerol), 0.05% ampicillin sodium, 1% trixon-100 to the buffer , 15% bovine serum albumin, after mixing evenly, store at 4°C;

[0075] (2) Take the prepared matrix solution to detect and analyze the various pathogenic markers in it, determine the background situation of the matrix solution, and verify whether there is an obvious matrix effect;

[0076] (3) Conduct a preliminary experiment to determine the proportion of positive substances used for each infectious disease marker;

[0077]

[0078] (4) Design the level of quality control products for the detection systems of mainstream instrument manufacturers (Auto Lumo A2000, Auto Lumo A2000Plus, AutoLumo A2000 PlusB, Auto Lumo A1000, Roche Cobas e601, Abbott i2000SR, SysmexHISCL-5000); , Roche, Abbott, Sysmex and other mainstream lum...

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Abstract

The invention relates to the field of biological examination, in particular to an infectious disease marker composite quality control product, a detection reagent and a detection kit. The quality control product is high in compounding degree, a protein buffer solution is selected as a matrix, raw materials and auxiliary materials used in the preparation process are inactivated, and harm of variouspotential pathogenic microorganisms is eliminated. Meanwhile, the quality control product is designed to be applicable to instruments of mainstream manufacturers on the market, is wide in applicationrange and can meet the detection requirements of infectious disease markers on the market. The quality control product can be used for quality control of five infectious disease markers in the detection process at the same time, and an accurate basis is provided for diagnosis of clinical diseases; and moreover, the uniformity and the stability are good, the clinical operation is facilitated, thepossibility of misoperation is reduced, the cost is saved, and reliable guarantee is provided for the accuracy of a clinical examination result.

Description

technical field [0001] The invention relates to the field of biological testing, in particular to a composite quality control product of infectious disease markers, a detection reagent and a detection kit. Background technique [0002] Hepatitis has always been one of the important global public health problems. According to the latest data from the World Health Organization, there are 2 billion people infected with hepatitis virus in the world, of which about 500 million people (one-twelfth of the world's population) are infected with chronic hepatitis, and about 1 million people die from it every year. Hepatitis virus infection includes hepatitis virus carriers and hepatitis patients, and hepatitis B (HBV) is the main type of hepatitis. [0003] my country's hepatitis C (HCV) infection is nearly 40 million, and it is a high-endemic area of ​​HCV. The infection rate is between 0.9% and 5.1%, and the average is 3.1%. The south is higher than the north, the adult is higher t...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/576G01N33/569G01N33/571
CPCG01N33/5764G01N33/5762G01N33/56988G01N33/5767G01N33/571G01N2333/186G01N2333/20G01N2469/10G01N2469/20
Inventor 周家兴李妍王新明刘功成于婷
Owner 郑州标源生物科技有限公司
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