YY/T 1248-2014
Hepatitis B virus surface antibody (HBsAb) detection reagent (kit) (Chemiluminescent immunoassay) (English Version)
- Standard No.
- YY/T 1248-2014
- Language
- Chinese, Available in English version
- Release Date
- 2014
- Published By
- Professional Standard - Medicine
- Latest
- YY/T 1248-2014
- Scope
- This standard specifies the technical requirements, test methods, identification, labels, instructions for use, packaging, transportation and storage of hepatitis B virus surface antibody determination reagents (kits) (chemiluminescence immunoassay). This standard is applicable to reagents (kits) for the qualitative or quantitative determination of hepatitis B virus surface antibodies (hereinafter referred to as "HBsAb") in human serum and plasma using chemiluminescence analysis technology and the principle of double-antigen sandwich method. Including methods such as chemiluminescence, electrochemiluminescence and time-resolved fluorescence. This standard does not apply to: a) Hepatitis B virus surface antibody calibrators and hepatitis B virus surface antibody quality control products intended to be sold separately; b) Biochips based on the principle of chemiluminescent immunoassay.
YY/T 1248-2014 history
- 2014 YY/T 1248-2014 Hepatitis B virus surface antibody (HBsAb) detection reagent (kit) (Chemiluminescent immunoassay)
