YY/T 1868-2023
Hepatitis B virus core antibody detection kit (luminescence immunoassay) (English Version)

Standard No.
YY/T 1868-2023
Language
Chinese, Available in English version
Release Date
2023
Published By
Professional Standard - Medicine
Latest
YY/T 1868-2023
Scope
This document specifies the technical requirements, test methods, signs, labels, instructions for use, packaging, transportation and storage of hepatitis B virus core antibody detection kit (luminescence immunoassay). This document is applicable to kits that use the principles of competition method, indirect method, and sandwich method, and use luminescence immunoassay technology to qualitatively or quantitatively detect hepatitis B virus core antibodies in human serum and plasma. Including methods such as chemiluminescence, microparticle chemiluminescence, electrochemiluminescence, photostimulated chemiluminescence and time-resolved fluorescence. This document does not apply to: a) hepatitis B virus core antibody calibrators and hepatitis B virus core antibody quality control products intended to be sold separately; b) biochips based on luminescence immunoassay.

YY/T 1868-2023 history

  • 2023 YY/T 1868-2023 Hepatitis B virus core antibody detection kit (luminescence immunoassay)



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