YY/T 1735-2021 Active Industry standards-Medicine

YY/T 1735-2021 Hepatitis c virus antibody (Anti-hcv) detection reagent (kit) (Chemiluminescent immunoassay)

Publish Date: 2021-03-09 Implement Date: 2022-04-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1735-2021

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical laboratory equipment

ICS Name: Laboratory medicine

Publish Date: 2021-03-09

Implement Date: 2022-04-01

Pages: 12 pages

Scope

This standard specifies the requirements, testing methods, marking, labeling, user manuals, packaging, transportation, and storage for hepatitis C virus antibody detection reagents (kits) (chemiluminescence immunoassay method).
This standard applies to reagents (kits) used for qualitative detection of hepatitis C virus antibodies in human serum and plasma using chemiluminescence analysis technology, employing the principles of indirect assay or double antigen sandwich assay. Methods include chemiluminescence, electrochemiluminescence, and time-resolved fluorescence.
This standard does not apply to:
a) Hepatitis C virus antibody calibrators and quality control products intended for separate sale;
b) Biochips based on the principle of chemiluminescence immunoassay.