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Hepatitis C virus antibody quick diagnosis test paper and its preparation method

A hepatitis C virus, rapid diagnosis technology, applied in the direction of measuring devices, instruments, scientific instruments, etc., to achieve the effect of improving sensitivity, strong specificity, and high sensitivity

Inactive Publication Date: 2008-03-26
天津中新科炬生物制药股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

Similar to ELISA, lysine is also an important molecule for the combination of protein and colloidal gold, but in addition to lysine, there are two important molecules for the combination of colloidal gold and protein, tryptophan and cysteine, so it is different from antigen and colloidal gold. Theoretically, it is feasible to use the double-antigen sandwich method to develop HCV antibody rapid diagnostic reagents for the enzyme-linked HRP, but it is necessary to select a good matching antigen and master the process

Method used

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  • Hepatitis C virus antibody quick diagnosis test paper and its preparation method

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Embodiment 1

[0022] Embodiment 1: the preparation of HCV antibody rapid diagnostic test paper

[0023] 1 main material

[0024] 1.1 Mixed recombinant antigen: CORE of HCV, NS3 fusion antigen: products of Biotech Atlantic Inc (BBI) and the Academy of Military Medical Sciences of the United States, respectively used for coating and labeling of test paper; anti-HCV antibody: product of BBI company; chloroauric acid: Sigma Company products, nitrocellulose (NC) membrane: products of Millipore; bovine serum albumin (BSA), polyethylene glycol (PEG) 20000, hydrolyzed casein: products of Sigma. Other commonly used reagents are analytical reagents.

[0025] 1.2 National reference product of HCV antibody (colloidal gold): developed by China Institute for the Control of Pharmaceutical and Biological Products. Including 20 positive sera, numbered P1-P20, 20 negative sera, numbered N1-N20, 4 sensitivity sera, numbered L1_1, L1_2, L2_1, L2_2, 1 precision serum, numbered J.

[0026] 2 methods

[0027]...

Embodiment 2

[0034] Embodiment 2: Performance analysis of HCV antibody rapid diagnostic test paper

[0035] 1 main material

Embodiment 1

[0038] See embodiment one for specific instructions;

[0039] 1.3 Serum containing interfering substances: including 50 serums of common interfering substances hyperlipidemia, hemolysis, and jaundice, 50 serums each containing positive antibodies to related infectious diseases HAV, HBV, HIV, TP, and HP, and containing different anticoagulants heparin, EDTA, and 20 copies of sodium citrate plasma were collected, verified and preserved by our company in relevant hospitals in Tianjin. The above serum or plasma were tested by more than two ELISAs and all were HCV antibody-negative serum.

[0040] 1.4 The clinical serum was collected by the company in relevant hospitals in Tianjin, a total of 1180 samples were collected for outpatient testing.

[0041] 1.5 HCV antibody diagnostic kit (ELISA): Shanghai Kehua Bioengineering Co., Ltd., Beijing Wantai Bio-Pharmaceutical Co., Ltd. and Pusheng (Tianjin) Technology Co., Ltd.

[0042] 2 methods

[0043] 2.1 Sample detection method: see E...

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Abstract

This invention discloses a kind of immunity chromatography test paper and its preparation method which can diagnose the type-C hepatitis virus fast, the said test paper includes the sampling tray, the gold size tray has labeled HCV mix antigen which links one end of the sampling tray closely, the pyroxylin film which links the other end of the gold size tray closely, and the suction sampling tray which links the other end of the pyroxylin film closely, the film encrusts the test (T) line and the quality control (C) line which are separate with each other, the sampling tray, the gold size tray, the film and the suction sampling tray are affixed in the plastic shoe plate to form the test paper, the said T line is the HCV mix antigen which is entrusted in the NC film, the said gold size tray has HCV recombination mix antigen, the said C line is the antibody of the HCV mix antigen entrusted in the film, it is used to test or clinical diagnosis of the HVC antigen, has the merits that the sensitive is high, the specificity is good, the operation is simple, the reaction is fast, it is fit to test in local and it is economical and useful.

Description

technical field [0001] The invention relates to a diagnostic reagent for hepatitis C virus (HCV) antibody, in particular to a rapid diagnostic test paper for hepatitis C virus antibody prepared by a double-antigen sandwich method and a preparation method thereof. Background technique [0002] Hepatitis C virus (HCV) was first discovered in 1989 by American Choo et al. from infected chimpanzee blood samples. It is mainly transmitted by blood and body fluids, accounting for 70% of post-transfusion hepatitis. According to the World Health Organization, an estimated 170 million people worldwide are infected with HCV. The chronicity rate of hepatitis C is 50%-85%, and 20% of them can develop into liver fibrosis, which is very harmful. There are about 40 million HCV antibody carriers in my country. So far there is neither an effective vaccine nor an effective treatment for hepatitis C, and prevention of infection is the only effective way. HCV antibody inspection, hepatitis B s...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/576G01N33/558G01N33/532
Inventor 李洲杨发青
Owner 天津中新科炬生物制药股份有限公司
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