Hepatitis C virus antigen-antibody combined detection kit and detection method

Abstract

The invention discloses a hepatitis C virus (HCV) antigen-antibody combined detection kit. The kit comprises a microwell plate coated with an HCV chimeric antigen and an HCV monoclonal antibody, a sample diluent, an HCV antigen-antibody combined detection enzyme working fluid, an HCV abzyme working fluid, an HCV antigen enzyme working fluid, a substance A fluid, a substance B fluid, a 20-times concentrated washing fluid and a stopping fluid. The invention also discloses preparation and usage of the key components of the kit, such as the microwell plate of the HCV chimeric antigen and the HCV monoclonal antibody, the sample diluent, and the diluent of enzyme working fluid. The kit and detection method, disclosed by the invention, are able to be used for detecting the HCV antigen and antibody at the same time, or individually detecting the situation of the HCV antigen during the early hepatitis c or the acute infection period, or before the antibody is produced, or when an antigen-antibody compound is produced, or individually detecting the situation of the HCV antibody after the antibody is produced; the kit and detection method can be applied to early HCV detection and therapy evaluation, so as to provide important detection evaluation index for clinical guideline.

Description

technical field [0001] The invention belongs to the technical field of immunoassay, and specifically relates to a hepatitis C virus (HCV) antigen-antibody combined detection kit and a detection method thereof. Background technique [0002] Hepatitis C is a global infectious disease caused by hepatitis C virus (HCV) infection. It is estimated that there are currently 170 million hepatitis C virus-infected people in the world, and the hepatitis C infection rate in my country is about 3.2%. At present, there are at least 40-60 million hepatitis C patients. The incidence of chronicity of hepatitis C is significantly higher than that of hepatitis B, and it is more prone to early liver cirrhosis than hepatitis B, leading to liver cancer and higher mortality rate, especially the early diagnosis of HCV is very important for screening the source of infection of HCV and guiding clinical practice. Treatment and prognosis are of great significance. Therefore, it is necessary to find a...

AI Technical Summary

Problems solved by technology

[0005] 1. Hepatitis C antibody detection: It is the most widely used detection method at present, but its disadvantage is that there is a "window period". 66 days on average), at this time, blood donors have been infected and are infectious, and cannot be detected by current antibody detection reagents, this stage is called the window period before seroconversion (perseroconversion window phase, PWP).PWP The existence of HCV is one of the important threats to blood transfusion safety, so that blood recipients still have the risk of HCV infection after transfusion of blood that is negative for anti-HCV screening

[0006] 2. HCV RNA detection: It is mainly used for the selection of antiviral therapy and efficacy monitoring, but it needs to be operated in strict accordance with the PCR operating procedures, and the testing personnel need to be professionally trained and have corresponding qualifications, and the quality control requirements of the samples are high. Submit for inspection under low temperature conditions within 2 hours, and extract RNA aseptically, which is prone to errors caused by instruments, reagents, personnel, and the environment, resulting in false positives and false negatives

[0018] 1. Coating problem: Because the corresponding antigen and antibody are coated on the microwell plate at the same time, even if they do not react with each other, one protein will cover or dominate the other protein, and the other protein will be overwhelmed. The capture ability is greatly weakened, which greatly affects the target of simultaneous detection of hepatitis C antigen antibody

[0023] 3. If the test sample is positive, it is impossible to confirm whether it is hepatitis C antigen positive, hepatitis C antibody positive, or both positive, and it needs to be tested with other independent detection kits

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