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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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  • Summary
  • Abstract
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Problems solved by technology

Although these methods have many advantages, they still need to be further improved in terms of detection sensitivity, specificity, and stability.

Method used

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Embodiment Construction

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

[0022] A hepatitis B virus surface antigen quantitative assay kit comprises HBsAg magnetic particles, HBsAg tracer conjugates, calibrator, analysis buffer, and sample diluent. The magnetic particles for measuring HBsAg are magnetic particles marked with HBsAb monoclonal antibodies; the tracer conjugate for measuring HBsAg is isoluminol marked with HBsAb polyclonal antibodies; the analysis buffer and sample diluent are respectively containing bovine serum albumin Phosphate buffer saline; the calibrator is a solution with a low content of surface antigen and a solution with a high content of surface antigen, which are used for the calibration of the master curve stored in the analyzer.

[0023] The preparation method ...

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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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