GB/T 40999-2021 Active National standards

GB/T 40999-2021 Quality assessment requirements for Severe Acute Respiratory Syndrome Coronavirus 2(SARS-CoV-2) total antibody detection kit

Publish Date: 2021-11-26 Implement Date: 2022-03-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: GB/T 40999-2021

Standard Type: National standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical laboratory equipment

ICS Name: Laboratory medicine

Publish Date: 2021-11-26

Implement Date: 2022-03-01

Pages: 9 pages

Scope

This document specifies the quality requirements, test methods, labels and instructions, packaging, transportation, and storage involved in the quality evaluation of novel coronavirus (total) antibody detection kits. This document is applicable to kits that use the principles of immunoassay, enzyme-linked immunosorbent assay, and chemiluminescence to conduct in vitro qualitative detection of novel coronavirus-specific antibodies (including IgM, IgG, and other antibody types) in human serum, plasma, and whole blood.