This standard specifies the requirements, test methods, identification, labels and instructions, packaging, transportation and storage of rubella virus IgG/IgM antibody detection reagents (kits) [hereinafter referred to as "reagents (kits)"]. This standard is suitable for the qualitative detection of human serum/plasma rubella virus IgG/IgM antibody detection reagent (box) (enzyme-linked immunoassay), rubella virus IgG/IgM antibody detection reagent (box) (chemiluminescence method), rubella virus IgG/ IgM antibody detection reagent (box) (immunofluorescence method), rubella virus IgG/IgM antibody detection reagent (box) (immunoblotting method), etc.