YY/T 1836-2021Multiple respiratory viral nucleic acids detection kit (English PDF)

Foreword

This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for Standardization Work Part 1: Structure and Drafting Rules of Standardization Documents" drafted:

1 Scope

This document specifies the requirements, test methods, labels and use of multiple nucleic acid detection kits for respiratory viruses (hereinafter referred to as "kits"):

Instructions, packaging, transportation and storage:

This document is applicable to the quality control of respiratory virus multiple nucleic acid detection kits: The sample types applicable to the kits include but are not limited to:

Nasopharyngeal swabs, nasal swabs, throat swabs, bronchoalveolar lavage fluid, sputum or other respiratory secretions; applicable respiratory viruses to be tested include: A Influenza virus (InfluenzaA, IFVA), influenza B virus (InfluenzaB, IFVB), respiratory syncytial virus (Respiratory syncytial virus)

Syncytial Virus (RSV), Parainfluenza Virus (PIV), Human Metapneumovirus (Human Metapneumovirus, hMPV), adenovirus (Adenovirus, Adv), respiratory tract infection enterovirus (enterovirus/rhinovirus) (En- terovirus, EV/Rhinovirus, RhV), coronavirus (Coronavirus, CoV); applicable detection methods include: fluorescent PCR, liquid Phase/solid phase chip method, PCR melting curve method, isothermal amplification method, PCR capillary electrophoresis fragment analysis method and second-generation sequencing technology, etc:

2 Normative references

The contents of the following documents constitute essential provisions of this document through normative references in the text: Among them, dated citations documents, only the version corresponding to that date applies to this document; for undated references, the latest edition (including all amendments) applies to this document:

GB/T 191 Graphical signs of packaging, storage and transportation

GB/T 29791.1 Information provided by manufacturers of in vitro diagnostic medical devices (labeling) Part 1: Terms, definitions and general Require

GB/T 29791.2 Information provided by manufacturers of in vitro diagnostic medical devices (labeling) Part 2: In vitro diagnostic reagents for professional use

3 Terms and Definitions

The terms and definitions defined in GB/T 29791.1 apply to this document:

4 Requirements

4:1 Appearance The appearance should meet the following requirements:

a) The components of the kit should be complete and complete, and the liquid should not leak;

b) Chinese packaging labels should be clear and undamaged:

4:2 Nucleic acid extraction function The nucleic acid extraction function should meet the following requirements:

a) For kits containing nucleic acid extraction components, the manufacturer shall make appropriate requirements for nucleic acid extraction and verify the nucleic acid extraction function;

b) Kits for which samples need to be extracted but do not contain nucleic acid extraction components shall be described or specified by the manufacturer of the extraction kits, and test kits shall be provided: certificate or confirmation;