GB/T 40982-2021 Active National standards

GB/T 40982-2021 Quality assessment requirements for severe acute respiratory syndrome coronavirus 2(SARS-CoV-2) nucleic acid 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 40982-2021

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 evaluation requirements, test methods, labels and instructions, packaging, transportation, and storage for novel coronavirus nucleic acid detection kits. This document applies to the quality evaluation of nucleic acid amplification detection kits for qualitatively detecting novel coronavirus nucleic acid in samples such as pharyngeal swabs, nasopharyngeal swabs, alveolar lavage fluid, sputum, respiratory tract lavage fluid, aspirate, or other respiratory secretions. Note: Nucleic acid amplification methods include polymerase chain reaction (PCR) technology and isothermal nucleic acid amplification technology, etc.