Kit for detecting hepatitis c virus antibody as well as detection method and application thereof

A technology of hepatitis C virus and reagent kit, which is applied in the direction of measuring devices, analysis by making materials undergo chemical reactions, instruments, etc., can solve the problems of insensitivity and specificity chemiluminescence immunodiagnostic reagents, etc., and achieve automatic detection, Improved sensitivity and specificity

Active Publication Date: 2015-06-10
SHENZHEN NEW INDS BIOMEDICAL ENG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] However, there is currently no chemiluminescent immunodiagnostic reagent with high sensitivity and specificity, which can be used as a substitute for ELISA reagents and other reagents for the diagnosis of hepatitis C

Method used

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  • Kit for detecting hepatitis c virus antibody as well as detection method and application thereof
  • Kit for detecting hepatitis c virus antibody as well as detection method and application thereof
  • Kit for detecting hepatitis c virus antibody as well as detection method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0055] A test kit for detecting hepatitis C virus antibody, comprising the following components:

[0056] 1) Magnetic microsphere system:

[0057] A solution of magnetic microspheres coated with streptavidin, wherein: the working concentration of the magnetic microspheres: 0.5 mg / ml, and the working concentration of streptavidin: 10 μg / ml.

[0058] HCV antigen solution of labeled biotin, wherein: the working concentration of biotin: 500ng / ml, the working concentration of HCV antigen: 50ng / ml.

[0059] 2) Marker system:

[0060] N-(4-aminobutyl)-N-ethylisoluminol (ABEI) labeled fusion protein antibody solution, wherein: ABEI working concentration: 200ng / ml, fusion protein antibody working concentration: 2000ng / ml.

[0061] HCV fusion antigen solution with Flag-tagged protein, wherein: working concentration of HCV fusion antigen with Flag-tagged protein: 500ng / ml.

[0062] The fusion protein antibody is an antibody to the tag protein in the HCV fusion antigen with tag protein...

experiment example

[0118] Experimental comparisons were carried out using the kit for detecting hepatitis C virus antibody and the detection method thereof in the above-mentioned examples and comparative examples.

[0119] The test samples included: national standard anti-HCV reagents purchased from China National Institute for the Control of Pharmaceutical and Biological Products (batch number: 901), and 114 clinical samples of hepatitis B collected from a hospital in Shenzhen (tested by Abbott anti-HCV ELISA). Using the Maglumi 2000 automatic chemiluminescence analyzer developed and produced by Shenzhen New Industry Biomedical Engineering Co., Ltd., the results are as follows.

[0120] Table 1. Results of determination of national standard products

[0121]

[0122]

[0123]

[0124] The detection requirements of the national standard products of HCV antibody test reagents are: the coincidence rate of negative national reference products (N1-N30) reaches ≥29 / 30; the coincidence rate o...

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Abstract

The invention discloses a kit for detecting a hepatitis c virus antibody as well as a detection method and an application thereof, and belongs to the technical field of in vitro diagnosis and detection. The kit consists of the following components: (1) a magnetic microsphere system: including a magnetic microsphere and an HCV antigen in indirect connection by virtue of a first bridged compound; and (2) a marker system: including an HCV fusion antigen and a marking tracer which are in indirect connection by virtue of a second bridged compound, wherein the HCV antigen and the HCV fusion antigen are combined with an HCV antibody on different sites. The kit and the detection method, by detecting the hepatitis c virus antibody through chemiluminescence immunoassay, have the advantages of high sensitivity, good specificity and broad detection scope.

Description

technical field [0001] The invention relates to the technical field of in vitro diagnosis and detection, in particular to a kit for detecting hepatitis C virus antibody, a detection method and application thereof. Background technique [0002] Viral hepatitis C is an infectious disease caused by hepatitis C virus (HCV), which can be transmitted through blood, drug abuse, mother to child and sexual transmission. Studies have shown that 20% to 50% of HCV-infected patients will undergo spontaneous viral clearance, but 50% to 80% of infected patients will continue to be infected, and 85% of them will progress to chronic hepatitis. After 10 to 30 years, some Chronic hepatitis C patients (especially older patients) develop liver cirrhosis, and may develop hepatocellular carcinoma after 2 to 10 years. Compared with chronic hepatitis B, hepatitis C is more hidden, with an incubation period of 2 to 26 weeks; symptoms are less obvious, and up to 75% of infected people have no symptom...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N21/76G01N33/576G01N33/569
Inventor 饶微李婷华陈益罗凯何苗付金秋袁锦云
Owner SHENZHEN NEW INDS BIOMEDICAL ENG
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