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Hepatitis C virus antibody diagnostic kit and preparation method thereof

A technology of hepatitis C virus and diagnostic kit, which is applied in the field of immunodiagnosis to achieve good specificity and high sensitivity

Active Publication Date: 2011-05-25
威海威高生物科技有限公司
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Problems solved by technology

However, there is no microparticle chemiluminescence diagnostic reagent for hepatitis C antibody detection in China at present, and there is an urgent need for microparticle chemiluminescence diagnostic reagents 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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Embodiment Construction

[0014] The kit of the invention adopts microparticle chemiluminescence immunoassay technology to detect whether there is HCV antibody in serum. The HCV antibody diagnostic kit and its preparation method are specifically described below.

[0015] A hepatitis C virus antibody diagnostic kit, which comprises anti-HCV magnetic particles, anti-HCV tracer conjugates, anti-HCV sample diluent, and quality control products. The anti-HCV magnetic microparticles are magnetic microparticles labeled with hepatitis C virus-specific recombinant multi-antigen components (including gene fragments covering Core, NS3, NS4, and NS5); the anti-HCV tracer conjugates are labeled with specific anti- Human IgG isoluminol; Anti-HCV sample diluent is phosphate buffer containing bovine serum albumin; quality control products traceable to national reference materials, including quality control products 1 and 2, of which quality control product 1 is low The serum with high content of HCV antibody, and the...

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Abstract

The invention belongs to the technical field of immunodiagnosis, in particular relates to a hepatitis C virus (HCV) antibody diagnostic kit adopting a micro particle chemiluminescence method, and a preparation method thereof. The kit consists of anti-HCV detecting magnetic micro particles, an anti-HCV detecting tracer conjugate, anti-HCV sample diluted solution and a quality control material. Theinvention also discloses the preparation method of the diagnostic kit, which adopts micro particle chemiluminescence immunoassay technology, has higher sensitivity and specificity than enzyme-linked immuno sorbent assay (ELISA), is suitable for clinical HCV auxiliary diagnosis and blood donor screening, and makes up the blank of the domestic production of the diagnostic kits for detecting the anti-HCV by the micro particle chemiluminescence method.

Description

technical field [0001] The invention relates to an immunodiagnostic technology, in particular to a hepatitis C virus antibody diagnostic kit with magnetic particles as a carrier and a preparation method thereof. Background technique [0002] Viral hepatitis C is an infectious disease caused by hepatitis C virus (HCV). It is distributed all over the world and is mainly transmitted through blood transfusion or blood products. Contaminated wounds containing HCV blood and other close contact transmission, and confirmed that it can also be transmitted through mother to child. Studies have shown that 20%-50% of HCV-infected patients will undergo spontaneous viral clearance, 50%-80% of infected patients will continue to be infected, and 85% of them will progress to chronic hepatitis. After 10-30 years, some chronic hepatitis C patients (especially Older patients) develop cirrhosis, which may develop into hepatocellular carcinoma 2 to 10 years later. Compared with chronic hepatiti...

Claims

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Application Information

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IPC IPC(8): G01N33/576G01N33/569G01N33/558G01N21/76G01N33/532G01N33/531
Inventor 贾向阳郭兰英蒙红胜姚继承周雷
Owner 威海威高生物科技有限公司
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