Kit for detecting hepatitis B surface antigen and detection method and application of kit

A surface antigen, hepatitis B virus technology, applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve the problems of inaccurate sensitivity and low sensitivity of samples with extremely high antigen concentration

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

[0011] However, the hepatitis B in vitro diagnostic reagents in the conventional technology have the problem of inaccurate or low sensitivity to samples with extremely high antigen concentration

Method used

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  • Kit for detecting hepatitis B surface antigen and detection method and application of kit
  • Kit for detecting hepatitis B surface antigen and detection method and application of kit
  • Kit for detecting hepatitis B surface antigen and detection method and application of kit

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0073] A test kit for detecting the surface antigen of hepatitis B virus, comprising the following components:

[0074] 1) Magnetic microsphere system: a magnetic microsphere solution coated with anti-HBsAg monoclonal antibody 1.

[0075] Among them, the working concentration of the magnetic microspheres: 0.5 mg / ml, and the working concentration of the anti-HBsAg monoclonal antibody 1: 10 μg / ml.

[0076] 2) First marker system: Anti-HBsAg polyclonal antibody 2 solution labeled with N-(4-aminobutyl)-N-ethylisoluminol (ABEI).

[0077] Among them, the working concentration of ABEI: 200ng / ml, the working concentration of anti-HBsAg polyclonal antibody 2: 2000ng / ml.

[0078] 3) Second marker system: ABEI-linked anti-HBsAg polyclonal antibody 2 solution.

[0079] Among them, the working concentration of ABEI: 100ng / ml, the working concentration of anti-HBsAg polyclonal antibody 2: 1000ng / ml.

[0080] 4) Calibrator solution: a low point calibrator solution with an HBsAg concentrat...

Embodiment 2

[0106] A test kit for detecting the surface antigen of hepatitis B virus is basically the same as the test kit in Example 1, except that:

[0107] 1) Magnetic microsphere system:

[0108] A magnetic microsphere solution coated with streptavidin (SA), wherein: the working concentration of the magnetic microspheres: 0.5 mg / ml, and the working concentration of the streptavidin: 10 μg / ml.

[0109] Biotin-labeled anti-HBsAg monoclonal antibody 1 solution, wherein: the working concentration of anti-HBsAg monoclonal antibody 1: 2000ng / ml, and the working concentration of biotin: 200ng / ml.

[0110] 2) The first marker system:

[0111] Anti-HBsAg polyclonal antibody 2 solution labeled with biotin, wherein: working concentration of biotin: 200ng / ml, working concentration of anti-HBsAg polyclonal antibody 2: 2000ng / ml.

[0112] ABEI-labeled streptavidin solution, wherein: ABEI working concentration: 200ng / ml, streptavidin working concentration: 2000ng / ml.

[0113] 3) The second marker...

Embodiment 3

[0133] A test kit for detecting the surface antigen of hepatitis B virus is basically the same as the test kit in Example 1, except that:

[0134] 1) Magnetic microsphere system:

[0135] Magnetic microsphere solution coated with sheep anti-FITC (fluorescein isothiocyanate) polyclonal antibody, wherein: the working concentration of magnetic microspheres: 0.5 mg / ml, the working concentration of sheep anti-FITC polyclonal antibody: 10 μg / ml.

[0136] FITC-labeled anti-HBsAg monoclonal antibody 1 solution, wherein: the working concentration of anti-HBsAg monoclonal antibody 1: 2000ng / ml, and the working concentration of FITC: 200ng / ml.

[0137] 2) The first marker system:

[0138] Anti-HBsAg polyclonal antibody 2 solution labeled with biotin, wherein: working concentration of biotin: 200ng / ml, working concentration of anti-HBsAg polyclonal antibody 2: 2000ng / ml.

[0139] ABEI-labeled streptavidin solution, wherein: ABEI working concentration: 200ng / ml, streptavidin working conc...

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Abstract

The invention discloses a kit for detecting a hepatitis B surface antigen and a detection method and application of the kit, belonging to the technical field of in vitro diagnosis and detection. The kit comprises the following components: (1) a magnetic micro-spherical system which comprises magnetic microspheres directly connected or indirectly connected with an antiBsAg antibody 1, (2) a first marker system which comprises an anti-HBsAg antibody 2 directly or indirectly connected with a first tracer or a second tracer, and (3) a second marker system which comprises an anti-HBsAg antibody 2 directly or indirectly connected with the first tracer or the second tracer or an anti-HBsAg antibody 3 directly or indirectly connected with the first tracer or the second tracer. The kit and the detection method can be used for detecting the hepatitis B surface antigen and have the advantages of high sensitivity and no HOOK effect.

Description

technical field [0001] The invention relates to the technical field of in vitro diagnosis and detection, in particular to a kit for detecting the surface antigen of hepatitis B virus and its detection method and application. Background technique [0002] Viral hepatitis B (referred to as hepatitis B) is a disease caused by hepatitis B virus (HBV), which can lead to liver inflammatory lesions and damage to multiple organs. Hepatitis B is widely prevalent in all countries in the world, mainly invading children and young adults, and a small number of patients can transform into liver cirrhosis or liver cancer. Therefore, it has become a worldwide disease that seriously threatens human health, and it is also the most widespread and most harmful disease in my country. [0003] Hepatitis B virus is called hepatitis B virus for short. It is a DNA virus belonging to the hepadnavividae family. Hepatitis B virus surface antigen (HBsAg) is the coat protein of hepatitis B virus, whic...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/577G01N21/63
CPCG01N33/56983G01N33/5764G01N2333/02
Inventor 饶微陈益付金秋余慧玲何苗袁锦云李婷华
Owner SHENZHEN NEW INDS BIOMEDICAL ENG
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