This standard specifies the terms and definitions, classification, requirements, test methods, identification, labels, instructions for use, packaging, transportation and storage of hepatitis E virus IgG antibody detection kit (enzyme-linked immunosorbent assay). This standard applies to kits that apply the principle of indirect enzyme-linked immunosorbent assay and use hepatitis E virus (HEV) antigen-coated microplates and enzyme-labeled anti-human IgG and other reagents for the detection of human serum or plasma samples. Hepatitis E virus IgG antibodies.
YY/T 1259-2015 history
2015YY/T 1259-2015 Diagnostic kit for IgG antibody to hepatitis E virus (ELISA)