YY/T 1791-2021 Active Industry standards-Medicine

YY/T 1791-2021 Hepatitis B virus e antibody (HBeAb) detection reagent kit(luminescent immunoassay)

Publish Date: 2021-12-06 Implement Date: 2023-05-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1791-2021

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical laboratory equipment

ICS Name: Laboratory medicine

Publish Date: 2021-12-06

Implement Date: 2023-05-01

Pages: 16 pages

Scope

This standard specifies the technical requirements, test methods, marking, labeling, user manuals, packaging, transportation, and storage for hepatitis B virus e antibody detection kits (luminescent immunoassay method).
This standard applies to kits that use principles such as competitive assay and employ luminescent analysis technology to quantitatively or qualitatively detect hepatitis B virus e antibody (hereinafter referred to as "HBeAb") in human serum and plasma. Methods include chemiluminescence, microparticle chemiluminescence, electrochemiluminescence, photoactivated chemiluminescence, and time-resolved fluorescence.
This standard does not apply to:
a) Hepatitis B virus e antibody calibrators and Hepatitis B virus e antibody quality control products intended for separate sale;
b) Biochips based on the principle of luminescent immunoassay.