Preparation method of hepatitis c virus antigen and antibody combined detection reagent, and detection card

Abstract

The invention relates to the field of hepatitis c virus detection, and discloses a preparation method of a hepatitis c virus antigen and antibody combined detection reagent, and a detection card. A double antibody and double antigen sandwich method is used for detecting hepatitis c virus antigen and antibody, a to-be-detected sample is mixed with a sample diluent, a HCV antibody and a HCV core antigen in the sample respectively react with a biotin-labeled antigen and a biotin-labeled antibody, then, the mixed sample is added in a test strip one time, thus, combined detection for the HCV antigen and the HCV antibody is realized. With the method and the detection card provided by the invention, mutual interference between the HCV antigen and the HCV antibody is avoided, and HCV antigen positive, HCV antibody positive or both positive can be distinguished, accuracy and sensitivity of the HCV detection are improved, and the method and the detection card can be used for early screening andclinical auxiliary diagnosis of the HCV so as to remedy missing detection of a HCV antibody diagnosis kit in an infection 'window period', can realize a complementary effect of the HCV antibody detection and the HCV antigen detection, not only improve working efficiency, but also save cost.

Description

technical field [0001] The invention relates to the field of detection of hepatitis C virus, and more specifically relates to a method for preparing a combined detection reagent of hepatitis C virus antigen and antibody and a detection card. Background technique [0002] Hepatitis C virus (HCV) is a non-A, non-B hepatitis virus discovered in 1989. It is mainly transmitted through blood transfusion, intravenous injection, etc., which is harmful and has a high mortality rate. Since there is no vaccine for prevention in the market, it is of great significance to develop a rapid and widely applicable detection method for HCV. [0003] At present, the detection of hepatitis C virus antibody is the most widely used detection method, but its disadvantage is that there is a long "window period", and there is a long period of about 40-70 days after HCV infection and before the production of HCV antibody 66 days on average), when the blood donors are already infected and infectious,...

AI Technical Summary

Problems solved by technology

[0006] Publication No. CN102928595A Chinese invention patent "Hepatitis C virus antigen antibody combined detection kit and its preparation method" uses three independently packaged enzyme working solutions, namely HCV antigen antibody combined detection enzyme working solution, HCV antigen and enzyme working solution Liquid and HCV antibody enzyme working solution can be used to distinguish whether the detected sample is positive for HCV antigen, positive for HCV antibody, or both are positive. Although it solves a problem, it cannot be completed in the same experiment by adding a sample once, and it increases detection cost

Secondly, the patent only considers the blocking of human anti-mouse IgG, and does not mention the use of a more sensitive biotin-streptavidin amplification detection system

[0007] The Chinese invention patent with the publication number CN104237520A "a combined detection kit for hepatitis C virus antigen and antibody and its preparation method" uses horseradish peroxidase to label HCV chimeric antigen and alkaline phosphatase to label HCV monoclonal antibody The detection of HCV antigen and antibody is realized by two luminescent substrates, but adding the second substrate is one more washing step than the first substrate, so multiple washings will have a certain impact on the catalytic sensitivity of the second substrate

Secondly, the patent does not mention the stability of the kit and how to avoid the non-specific reaction of abnormal IgG

[0008] The Chinese invention patent with the publication number CN104914244A "a kit for combined detection of hepatitis C virus antigen-antibody by chemiluminescence method" uses chemiluminescence method to jointly detect HCV antigen and antibody, and cannot distinguish whether the test sample is positive for HCV antigen or positive for HCV antibody , or both are positive, and the operation steps are cumbersome

Secondly, the patent does not mention the stability of the kit and how to avoid the non-specific reaction of abnormal IgG

[0009] None of the above patents mentioned testing whole blood samples

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