Hepatitis B virus (HBV) is a family of hepadnaviruses with obvious species and hepatotoxic properties that can cause persistent viral infections. Hepatitis B caused by hepatitis B virus infection is a major health hazard facing humans. About one million people worldwide suffer from hepatitis B. In China, 300,000 people die each year from chronic liver disease, of which about 130,000 are primary liver cancer patients. What is particularly serious is that about 30% of mothers carrying hepatitis B virus can transmit the virus to babies, and the infants are most likely to develop hepatitis B virus carriers due to impaired immune function after infection. They will develop chronic hepatitis and cirrhosis in adulthood. Primary liver cancer. After HBV infects the body, the envelope and nucleocapsid antigen of HBV acts as a foreign antigenic substance to stimulate the body to produce cellular and humoral immune responses against it. Most people do not have clinical manifestations, but HBsAg can be detected in the blood. Therefore, the detection of HBsAg in serum is one of the early diagnostic indicators of hepatitis B.
To prevent the spread of hepatitis B virus and reduce the incidence of hepatitis B, a key link is to develop a hbsag strip test
that can quickly and accurately diagnose the presence of hepatitis B virus infection in patients. The invention relates to a rapid diagnosis kit for a pre-S1 antigen of hepatitis B virus and a preparation method thereof, which mainly comprises hbsag strip tests, and a hbsag strip test is sequentially pasted on a liner by a sample pad, a gold standard pad, a reaction film, and a water absorption layer. Up and then load into the cartridge. The gold standard pad is prepared by loading a colloidal gold-labeled anti-HBs polyclonal antibody on a glass fiber mat; the reaction film is prepared by coating an anti-S1 monoclonal antibody on a glass fiber mat-attached detection carrier nitrocellulose membrane. Into the test line, at the same time coated with recombinant hepatitis B surface antigen to make a quality control line. In the present invention, when the sample to be tested contains the pre-S1 antigen, two purple-red lines of the detection line and the quality control line are formed, and the result is positive; otherwise, there is only one purple-red line, which is negative. The invention is used for detecting hepatitis B virus pre-S1 antigen in human serum or plasma and has the advantages of simple operation, rapid diagnosis, high specificity, and high sensitivity.