Antibody to hepatitis C virus time resolution detection kit and preparation method thereof

Abstract

The invention discloses an antibody to hepatitis C virus time resolution detection kit, wherein s specific recombinant antigen is selected to coat and mark, thereby optimizing a sealing process and improving the specificity of the kit; after signs are systematically optimized by utilizing biotin species and sign process, the sensitivity of the kit is further improved; therefore, the sensitivity is high, the specificity is good, and meanwhile, compared with the imported luminescence reagent, the detection cost is largely reduced.

Description

technical field [0001] The invention relates to the technical field of virus protein immune analysis, in particular to a time-resolved detection kit for hepatitis C virus antibody and a preparation method thereof. Background technique [0002] Viral hepatitis C is an infectious disease caused by the hepatitis C virus (HCV), which can be transmitted through blood, drug abuse, mother to child and sexual transmission. Studies have shown that 20% to 50% of HCV-infected patients will undergo spontaneous viral clearance, but 50% to 80% of infected patients will continue to be infected, and 85% of them will progress to chronic hepatitis. After 10 to 30 years, some Chronic hepatitis C patients (especially older patients) develop liver cirrhosis, and may develop hepatocellular carcinoma after 2 to 10 years. Compared with chronic hepatitis B, hepatitis C is more hidden, with an incubation period of 2 to 26 weeks; symptoms are less obvious, and up to 75% of infected people have no sym...

AI Technical Summary

Problems solved by technology

[0004] The advantages of EIA lie in its non-pollution, simple operation, long validity period of reagents, and good specificity, but due to its relatively low sensitivity and relatively narrow measurement range, etc.

Most of the enzyme immunoassay kits and chemiluminescent hepatitis C antibody kits use the indirect method, which has poor specificity and a high probability of false positives. The double-antigen sandwich method can improve the specificity of the kit, but the sensitivity is relatively indirect. Therefore, it is particularly important to develop a double-antigen sandwich method HCV antibody detection kit with high sensitivity and specificity.

[0005] The first step of the indirect method kit is to detect the specific binding of the antibody in the sample to the antigen coated on the microwell plate, and the second step is the combination of goat anti-human or mouse anti-human antibody and human anti-HCV antibody. Binding, the binding specificity of the second step is poorer than the binding specificity of the first step, so the probability of false positive results in the indirect method kit is higher; most of the recombinant antigen fragments used in the double antigen sandwich method kits are shorter, and the The activity of the antigen is greatly reduced after the labeled recombinant antigen is labeled with the enzyme, resulting in a further reduction in the sensitivity of the kit

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