YY/T 1462-2016Influenza A virus H1N1 pdm09 RNA detection kit(fluorescent PCR) (English PDF)
甲型H1N1流感病毒RNA检测试剂盒（荧光PCR法）
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
January 26, 2016
Implementation date
January 1, 2017
Scope
YY/T 1462-2016 is the English-translated version of 甲型H1N1流感病毒RNA检测试剂盒（荧光PCR法）.
YY/T 1462-2016 is the Chinese pharmaceutical industry standard for the kit that detects the RNA of the influenza A virus H1N1 pdm09 by fluorescent PCR.
It specifies the terminology and definitions, the requirements, the test methods, the labelling, the instruction manual and the rules for packaging, transport and storage, covering the detection limit, the specificity against related viruses, the agreement with reference materials, the repeatability, the internal control that guards against inhibition and the stability.
It applies to the qualitative detection of the virus in nasal and throat swabs and in other respiratory secretions. Issued on 26 January 2016, it has applied since 1 January 2017.
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Document preview — YY/T 1462-2016
National Standard of the People's Republic of China
- ICS
- 11.100
- Classification
- C 44
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- 1 Scope
- 2 Normative reference documents
- 3 Terms and definitions
- 4 Requirements
Foreword
This standard is drafted in accordance with the rules given in GB/T 1.1-2009.
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 document. 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
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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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 21 pages — is available in the English PDF.
Referenced standards
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Related Standards
GB/T 191-2025 — Graphical symbols marking for handling and storage of packages
YY/T 0466.1-2009 — Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
YY/T 0466.1-2016 — Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
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YY/T 1462-2016
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