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YY/T 1836-2021: Multiple respiratory viral nucleic acids detection kit
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| YY/T 1836-2021 | English | 139 |
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Multiple respiratory viral nucleic acids detection kit
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YY/T 1836-2021
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Basic data | Standard ID | YY/T 1836-2021 (YY/T1836-2021) | | Description (Translated English) | Multiple respiratory viral nucleic acids detection kit | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C44 | | Word Count Estimation | 7,795 | | Issuing agency(ies) | State Drug Administration | YY/T 1836-2021: Multiple respiratory viral nucleic acids detection kit---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Multiple respiratory viral nucleic acids detection kit
ICS 11:100:10
CCSC44
People's Republic of China Pharmaceutical Industry Standard
Respiratory Virus Multiplex Nucleic Acid Detection Kit
Published on 2021-12-06
2022-12-01 Implementation
Released by the State Drug Administration
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:
Please note that some content of this document may be patented: Publication of this document
Institutions do not assume responsibility for identifying patents:
This document is proposed by the State Drug Administration:
This document is under the jurisdiction of the National Standardization Technical Committee for Medical Clinical Laboratory and In Vitro Diagnostic Systems (SAC/TC136):
This document is drafted by: China National Institute for Food and Drug Control, Beijing Medical Device Inspection Institute, Merieux Diagnostic Products (Shanghai) Co:, Ltd:
Company, Hangzhou Jieyi Biotechnology Co:, Ltd:, Guangzhou Weiyuan Gene Technology Co:, Ltd:, Shanghai Jienuo Biotechnology Co:, Ltd:, Shengxiang Biological
Technology Co:, Ltd:, Suzhou Xinbo Biotechnology Co:, Ltd:, Sun Yat-sen University Daan Gene Co:, Ltd:
The main drafters of this document: Zhou Haiwei, Liu Donglai, Wang Ruixia, Wang Shaoying, Han Xu, Xu Teng, Cheng Luxiang, Ren Xiaomei, Deng Mingwen, Jiang Xiwen:
Respiratory Virus Multiplex Nucleic Acid Detection Kit
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;
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