Hepatitis B surface antigen chemiluminiscence immune detection reagent kit and application thereof

A technology of chemiluminescence immunization and HBsAg, applied in chemiluminescence/bioluminescence, analysis through chemical reaction of materials, biological testing, etc., can solve the problem of low detection ability of HBsAg mutant strains, and improve Sensitivity and accuracy, high sensitivity, high affinity effects
CN108344869AActive Publication Date: 2018-07-31SUZHOU HYBIOME BIOMEDICAL ENG CO LTD
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Patent Information

Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
SUZHOU HYBIOME BIOMEDICAL ENG CO LTD
Publication Date
2018-07-31

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Abstract

The invention relates to a hepatitis B surface antigen chemiluminiscence immune detection reagent kit and application thereof. The reagent kit comprises a magnetic particle reagent indirectly connected with an anti-HBsAg antibody 1, an HBsAg antibody 2 solution marked by a chemiluminiscence marker, a chemiluminiscence substrate solution and a cleaning solution; the anti-HBsAg antibody 1 at least comprises two antibodies or immune reaction fragments of antibodies, and at least comprises an anti-S-protein monoclonal antibody 1, the anti-HBsAg antibody 2 at least comprises two antibodies or immune reaction fragments of the antibodies and at least comprises an anti-S-protein monoclonal antibody 2, the epitopes of HBsAg corresponding to the anti-S-protein monoclonal antibody 1 and the anti-S-protein monoclonal antibody 2 are different, the reagent kit is the first case internationally and has the high sensitivity and accuracy during HBsAg detection, the HBsAg mutant strain detection capability is greatly improved, and the safety for the clinic blood transfusion, operation and the like is remarkably improved.
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Description

technical field

[0001] The invention relates to a hepatitis B surface antigen chemiluminescence immunoassay kit and application thereof, belonging to the technical field of in vitro detection. Background technique

[0002] Hepatitis B surface antigen (HBsAg) is the first serological marker to appear after hepatitis B virus (HBV) infection. The HBV replication cycle is fast and the polymerase is prone to mismatch, and the hepatitis B vaccine and antiviral therapy are widely used. HBsAg mutations are very common in patients with chronic HBV infection. HBsAg mutations can lead to negative HBsAg test results in patients, but HBV DNA still exists in their serum or liver, that is, occult HBV infection (OBI). If OBI patients are used as blood donors or liver transplant donors, they will pose a major risk to the safety of blood transfusion and surgery. At the same time, HBsAg mutation will accelerate the progression of occult hepatitis B to cirrhosis or liver cancer, and trigger H...

Claims

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