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YY/T 1462-2016 English PDF

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YY/T 1462-2016: Influenza A virus H1N1 pdm09 RNA detection kit(fluorescent PCR)
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YY/T 1462-2016English159 Add to Cart 3 days [Need to translate] Influenza A virus H1N1 pdm09 RNA detection kit(fluorescent PCR) Valid YY/T 1462-2016

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Basic data

Standard ID YY/T 1462-2016 (YY/T1462-2016)
Description (Translated English) Influenza A virus H1N1 pdm09 RNA detection kit(fluorescent PCR)
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C44
Classification of International Standard 11.100
Word Count Estimation 8,891
Date of Issue 2016-01-26
Date of Implementation 2017-01-01
Regulation (derived from) China Food and Drug Administration Bulletin 2016 No.25
Issuing agency(ies) State Food and Drug Administration

YY/T 1462-2016: Influenza A virus H1N1 pdm09 RNA detection kit(fluorescent PCR)

---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.
Influenza A virus H1N1 pdm09 RNA detection kit (fluorescent PCR) ICS 11.100 C44 People's Republic of China Pharmaceutical Industry Standard Influenza A H1N1 influenza virus RNA detection kit (Fluorescent PCR) 2016-01-26 release 2017-01-01 Implementation State Food and Drug Administration issued

Foreword

This standard is drafted in accordance with the rules given in GB/T 1.1-2009. Please note that some of the contents of this document may involve patents. The release of this document The Agency does not assume responsibility for identifying these patents. This standard is proposed by the State Food and Drug Administration. This standard by the National Medical Laboratory Laboratory and in vitro diagnostic system Standardization Technical Committee (SAC/TC136) centralized. The drafting of this standard. China Food and Drug Research Institute, Sun Yat-sen University of Science and Technology Co., Ltd., Beijing Jinhao Pharmaceutical shares Limited company. The main drafters of this standard. Shi Dawei, Shen Shu, Zhang Chuntao, Gao Xuxian, Zhang Yong. Influenza A H1N1 influenza virus RNA detection kit (Fluorescent PCR)

1 Scope

This standard specifies the terminology and definitions, requirements, test methods, labeling, labeling, labeling, labeling, labeling, labeling, labeling, Manual, packaging, shipping and storage. This standard is applicable to the principle of fluorescence PCR method, qualitative detection of human nasal, throat swab or other respiratory secretions in the sample type H1N1 Influenza Virus RNA Diagnostic Kit.

2 normative reference documents

The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this article Pieces. For undated references, the latest edition (including all modifications) applies to this document. GB/T 191 packaging and storage icon YY/T 0466.1 Symbols for medical devices for labeling, labeling and providing information on medical devices - Part 1. General requirements

3 terms and definitions

The following terms and definitions apply to this document. 3.1 Influenza A H1N1 influenza virus influenzaAvirusH1N1pdm09 The virus belongs to the orthomyxoviridae, the influenza A virus is a single strand of negative RNA virus, the genome is about 13.6kb, Ranging from 8 separate pieces of size. The virus led to a global pandemic from.2009 to.2010, containing swine flu, Bird flu and human influenza three influenza virus gene fragments of the new reassortant virus, and.2009 before the popular seasonal influenza virus Than its antigenic occurrence of a large change. Note. The virus in.2009 after the influenza pandemic was seasonal epidemic, and other H3 subtype influenza virus, influenza B virus in the crowd together popular. 3.2 Fluorescence PCR Also known as real-time PCR. The change in the fluorescence signal released by the fluorescent dye during the PCR process directly reflects the PCR amplification The change in volume, the fluorescence signal variable is proportional to the amount of amplified product, and through the collection and analysis of fluorescence to achieve the original template volume Row analysis of PCR. [YY/T 1182-2010, definition 3.4]

4 requirements

4.1 appearance 4.1.1 packaging appearance clean, no leakage, no damage; signs, label writing clear. 4.1.2 The kit should be complete, should include the required primers, probes, reaction solution and internal control (internal standard) and external control and so on.

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