YY/T 1247-2014
Hepatitis B virus surface antigen (HBsAg) detection reagent(kit) (Chemiluminescent immunoassay) (English Version)
- Standard No.
- YY/T 1247-2014
- Language
- Chinese, Available in English version
- Release Date
- 2014
- Published By
- Professional Standard - Medicine
- Latest
- YY/T 1247-2014
- Scope
- This standard specifies the technical requirements, test methods, identification, labels, instructions for use, packaging, transportation and storage of hepatitis B virus surface antigen determination reagents (kits) (chemiluminescence immunoassay). This standard is applicable to reagents (kits) for the qualitative or quantitative determination of hepatitis B virus surface antigen (hereinafter referred to as "HBsAg") in human serum and plasma using chemiluminescence analysis technology and the double-antibody sandwich method principle. Including methods such as chemiluminescence, electrochemiluminescence and time-resolved fluorescence. This standard does not apply to: a) Hepatitis B virus surface antigen calibrators and hepatitis B virus surface antigen quality control products intended to be sold separately; b) Biochips based on the principle of chemiluminescent immunoassay.
YY/T 1247-2014 history
- 2014 YY/T 1247-2014 Hepatitis B virus surface antigen (HBsAg) detection reagent(kit) (Chemiluminescent immunoassay)
