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See Chinese contents: YY/T 1162-2009 YY/T 1162-2009: Alpha-fetoprotein quantitative detection reagent (kit) (Chemiluminescent immunoassay)
This standard specifies the terms and definitions, classification, requirements, test methods, inspection rules, identification, labels, instructions, packaging, transportation and storage of alpha-fetoprotein quantitative detection reagent (kit) (chemiluminescence immunoassay). This standard is applicable to the quantitative detection of the alpha-fetoprotein quantitative detection reagent (kit) in the human blood matrix or other body fluid components, based on the principle of chemiluminescence immunoassay. It includes the enzymatic and non-enzymatic chemiluminescence immunoassay detection reagent (kit) in carriers of micro-plates, tubes, magnetic particles, micro-beads and plastic beads. This standard is not applicable to the requirements of calibrators and quality control products in the kit.
