Hepatitis B virus surface antigen quantitative determination kit and preparation method thereof

A technology of hepatitis B virus and surface antigen, which is applied in the field of immunodiagnosis, can solve problems that need to be further improved, and achieve good specificity and high sensitivity.

Inactive Publication Date: 2014-10-08
威海威高生物科技有限公司
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  • Abstract
  • Description
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Problems solved by technology

Although these methods have many advantages, they still need to be furthe

Method used

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[0021] The kit of the invention adopts microparticle chemiluminescence immunoassay technology to detect whether there is surface antigen in serum or plasma. The surface antigen quantitative assay kit and its preparation method are specifically described below.

[0022] A quantitative determination kit for hepatitis B virus surface antigen comprises magnetic particles for measuring HBsAg, a tracer conjugate for measuring HBsAg, a calibration substance, an analysis buffer, and a sample diluent. The HBsAg detection magnetic particles are magnetic particles labeled with HBsAb monoclonal antibody; the HBsAg tracer conjugate is isoluminol labeled with HBsAb polyclonal antibody; the analysis buffer and sample diluent are respectively containing bovine serum albumin phosphate buffer; the calibrators are a solution of low surface antigen content and a solution of high surface antigen content, which are used for the calibration of the master curve stored in the analyzer.

[0023] The s...

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Abstract

The invention belongs to the technical field of immunologic diagnosis, and particularly relates to a hepatitis B virus surface antigen quantitative determination kit and a preparation method thereof by a microparticle chemiluminescence method. The kit consists of magnetic particles for testing HBsAg (hepatitis B virus surface antigen), a tracer conjugate for testing HBsAg, a calibrator, an analysis buffer solution and sample diluent. The invention also discloses a preparation method of the quantitative determination kit. By adopting a microparticle chemiluminescence immuno assay, compared with the ELISA (enzyme-linked immuno sorbent assay), the sensitivity and specificity are higher, and the hepatitis B virus surface antigen quantitative determination kit and the method are suitable for the clinical auxiliary diagnosis of hepatitis B.

Description

technical field [0001] The invention relates to an immunodiagnostic technique, in particular to a hepatitis B virus surface antigen quantitative assay kit with magnetic particles as a carrier and a preparation method thereof. Background technique [0002] my country is a large hepatitis country with a large number of patients, and the number of hepatitis B virus infections alone reaches 120 million. Accounting for about 10% of the total population in our country, the course of hepatitis B is protracted, and if it is not treated in time and effectively, it will develop into liver cirrhosis or even liver cancer, which is commonly referred to as the "trilogy of hepatitis B development". Statistics show that 1 million people die every year due to hepatitis B virus infection worldwide, accounting for the ninth cause of global disease death. It can be seen that hepatitis B is one of the diseases that seriously endanger human health. [0003] Hepatitis B virus transmission route: ...

Claims

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Application Information

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IPC IPC(8): G01N33/576G01N33/543G01N21/76
CPCG01N33/5764G01N33/54326G01N33/56983
Inventor 赵海英王成军许文姣王晓伟吴晗琪
Owner 威海威高生物科技有限公司
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