YY/T 1836-2021 Active Industry standards-Medicine

YY/T 1836-2021 Multiple respiratory viral nucleic acids detection kit

Publish Date: 2021-12-06 Implement Date: 2022-12-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1836-2021

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical laboratory equipment

ICS Name: Pharmaceutical Science

Publish Date: 2021-12-06

Implement Date: 2022-12-01

Pages: 12 pages

Scope

This document specifies the requirements, test methods, labels and user manuals, packaging, transportation, and storage for respiratory virus multiplex nucleic acid detection kits (hereinafter referred to as "kits").
This document applies to the quality control of respiratory virus multiplex nucleic acid detection kits. The types of samples suitable for the kits include, but are not limited to: nasopharyngeal swabs, nasal swabs, pharyngeal swabs, alveolar lavage fluid, sputum, or other respiratory secretions; the respiratory viruses suitable for detection include: influenza A virus (IFV A), influenza B virus (IFV B), respiratory syncytial virus (RSV), parainfluenza virus (PIV), human metapneumovirus (hMPV), adenovirus (Adv), respiratory tract infection enterovirus (enterovirus/rhinovirus) (EV/RhV), and coronavirus (CoV); the detection methods suitable for use include: fluorescence PCR, liquid/solid-phase chip method, PCR melting curve method, isothermal amplification, PCR capillary electrophoresis fragment analysis, and second-generation sequencing technology, etc.