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See Chinese contents: YY/T 1176-2010 YY/T 1176-2010: Cancer antigen CA 15-3 quantitative detection reagent (kit) - Chemiluminescent immunoassay
This standard specifies the classification, requirements, test method, identification, labels, instructions, packaging, transportation and storage of the cancer antigen CA15-3 quantitative detection reagent (kit) (chemiluminescent immunoassay). This standard is applicable to test cancer antigen CA15-3 reagent (kit), based on the principles of chemiluminescent immunoassay. It includes the enzymatic and non-enzymatic chemiluminescent immunoassay detection reagent (kit) with carriers of microwell plates, tubes, magnetic particles, micro-beads and plastic-beads. The Standard is not applicable to: a) The tumor marker calibrators and tumor marker control materials that are intended for separate sales. b) Biochip that uses the principle of chemiluminescent immunoassay.
