YY/T 1248-2014 Active Industry standards-Medicine

YY/T 1248-2014 Hepatitis B virus surface antibody(HBsAb) detection reagent(kit)(Chemiluminescent immunoassay)

Publish Date: 2014-06-17 Implement Date: 2015-07-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1248-2014

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical laboratory equipment

ICS Name: Laboratory medicine

Publish Date: 2014-06-17

Implement Date: 2015-07-01

Pages: 9 pages

Scope

This standard specifies the technical requirements, testing methods, marking, labeling, user manuals, packaging, transportation, and storage for hepatitis B virus surface antibody assay reagents (kits) (chemiluminescence immunoassay).
This standard applies to reagents (kits) used to qualitatively or quantitatively determine hepatitis B virus surface antibodies (hereinafter referred to as "HBsAb") in human serum and plasma by chemiluminescence analysis technology, employing the principle of double antigen sandwich assay. Methods include chemiluminescence, electrochemiluminescence, and time-resolved fluorescence.