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YY/T 1178-2010 English PDF (YYT1178-2010)

YY/T 1178-2010 English PDF (YYT1178-2010)

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YY/T 1178-2010: Carbohydrate antigen CA19-9 quantitative detection reagent(kit) - Chemiluminescent immunoassay
This standard specifies the classification, requirements, test method, identification, labels, instructions, packaging, transportation and storage of the carbohydrate antigen CA19-9 quantitative detection reagent (kit) (chemiluminescent immunoassay). This standard is applicable to test carbohydrate antigen (CA19-9) reagent (kit), based on the principles of chemiluminescent immunoassay. It includes the enzymatic and non-enzymatic chemiluminescent immunoassay detection reagent (kit) with the carriers of microwell plates, tubes, magnetic particles, micro-beads and plastic beads. This standard is not applicable to: a) The tumor marker calibrators and tumor marker control materials are intended for separate sales; b) Biochip in the principle of chemiluminescent immunoassay.

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