YY/T 1179-2010 (English Version) PDF

Scope: This standard specifies the classification, requirements, test methods, identification, labels, instructions for use, packaging, transportation and storage of carbohydrate antigen CA50 quantitative determination reagents (kits) (chemiluminescence immunoassay). This standard is applicable to the quantitative determination of human carbohydrate antigen CA50 reagent (kit) [hereinafter referred to as "CA50 reagent (kit)"] based on the principle of chemiluminescence immunoassay. Including enzymatic and non-enzymatic chemiluminescence immunoassay assay reagents (boxes) using microplates, tubes, magnetic particles, microbeads and plastic beads as carriers. This standard does not apply to: a) Tumor marker calibrators and tumor marker substance control substances intended to be sold separately; b) Biochips based on chemiluminescence immunoassay.

YY/T 1179-2010 Referenced Document

GB/T 21415-2008 In vitro diagnostic medical devices.Measurement of quantities in biological samples.Metrological traceability of values assigned to calibrators and control materials

2010 YY/T 1179-2010 Carbohydrate antigen CA50 quantitative detection reagent(kit).Chemiluminescent immunoassay