YY/T 1178-2010
Carbohydrate antigen CA19-9 quantitative detection reagent(kit).Chemiluminescent immunoassay (English Version)
- Standard No.
- YY/T 1178-2010
- Language
- Chinese, Available in English version
- Release Date
- 2010
- Published By
- Professional Standard - Medicine
- Latest
- YY/T 1178-2010
- Scope
- This standard specifies the classification, requirements, test methods, identification, labels, instructions for use, packaging, transportation and storage of carbohydrate antigen CA19-9 quantitative determination reagents (kits) (chemiluminescence immunoassay). This standard is applicable to the quantitative determination of carbohydrate antigen (CA19-9) reagent (kit) based on the principle of chemiluminescence immunoassay [hereinafter referred to as "CA19-9 reagent (kit)"]. 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 1178-2010 history
- 2010 YY/T 1178-2010 Carbohydrate antigen CA19-9 quantitative detection reagent(kit).Chemiluminescent immunoassay
