It is a major science and technology project of the national “Tenth Five-Year Plan”, a “Innovation Fund Project for Small and Medium-sized Technological Enterprises” of the Ministry of Science and Technology, and a “Demonstration Project of the Industrialization of Biotechnology and Biomedical Engineering” of the National Development and Reform Commission. It was approved to be listed at the end of 2006 and is the first HCV antigen detection kit in China.

It was approved to be listed in 2008. It is the first test kit in China to detect HCV antibody by double antigen sandwich method. It can detect IgG subtypes and IgM of all types of HCV infection at the same time, for achieving early diagnosis. Two specific reactions were carried out to antibodies to reduce the false positive caused by indirect enzyme-labeled antibodies and improve the accuracy of detection.

It was listed in August 2019 and listed in the 863 Program of the 11th Five Year Plan (gkfcz [2006] No. 501). This kit adopts the principle of enzyme-linked immunosorbent assay with double antibody sandwich method and double antigen sandwich method. The recombinant chimeric antigen of HCV and the monoclonal antibody of HCV core antigen were pre coated on the enzyme labeled strip, and other reagents such as biotin labeled antigen, horseradish peroxidase labeled antibody, horseradish peroxidase labeled streptavidin and TMB chromogenic reagent were used to detect the core antigen of hepatitis C virus and the antibody of hepatitis C virus in human serum or plasma. The whole course of hepatitis C diagnosis has been truly covered.