YY/T 1526-2017 Detection kit for human immunodeficiency virus 1 type(HIV-1) p24 antigen and antibodies to human immunodeficiency virus(chemiluminescence immuno-assay)
YY/T 1526-2017 Detection kit for human immunodeficiency virus 1 type(HIV-1) p24 antigen and antibodies to human immunodeficiency virus(chemiluminescence immuno-assay)
Basic Information
Scope
This standard specifies the requirements, test methods, marking, labeling, and user manuals, packaging, transportation, and storage for combined detection kits of human immunodeficiency virus antigens and antibodies (luminescence type).
This standard applies to kits used for qualitative detection of human immunodeficiency virus (HIV) type 1 p24 antigen and anti-HIV antibodies (including HIV-1 and HIV-2) in human serum and/or plasma, based on the sandwich assay principle and the generation of light sources stimulated by specific substances (including chemiluminescence assay, immunofluorescence assay, and time-resolved immunofluorescence assay). These kits are known as combined detection kits of human immunodeficiency virus antigens and antibodies.