This document specifies the requirements, test methods, identification, labeling and instructions for use, packaging, transportation and storage of hepatitis B virus surface antigen detection kit (immunochromatographic method). This document is applicable to hepatitis B virus surface antigen detection reagents for qualitative detection of hepatitis B virus surface antigen (hereinafter referred to as HBsAg) in human serum, plasma or whole blood using immunochromatographic methods such as colloidal gold method and latex method. box. This document does not apply to hepatitis B virus surface antigen detection kits using enzyme-linked immunoassay, chemiluminescence immunoassay, time-resolved immunofluorescence and other methodologies.
YY/T 1890-2023 history
2023YY/T 1890-2023 Hepatitis B virus surface antigen detection kit (immunochromatography)