YY/T 1596-2017Influenza A virus nucleic acid detection kit(fluorescent PCR) (English PDF)
甲型流感病毒核酸检测试剂盒（荧光PCR法）
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
December 5, 2017
Implementation date
December 1, 2018
Scope
YY/T 1596-2017 is the English-translated version of 甲型流感病毒核酸检测试剂盒（荧光PCR法）.
YY/T 1596-2017 is the Chinese pharmaceutical industry standard for the influenza A virus nucleic acid detection kit based on fluorescent PCR.
It gives the terms and definitions, the requirements, the test methods, the labels and instructions and the rules for packaging, transport and storage, covering the detection limit, the specificity against other respiratory viruses, the accuracy against reference materials, the repeatability, the internal control and the stability.
It applies to kits for the qualitative detection of influenza A in nasopharyngeal swabs and other respiratory specimens. Issued on 5 December 2017, it has applied since 1 December 2018.
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Document preview — YY/T 1596-2017
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 references
- 3 Terms and definitions
- 4 Requirements
- 5 test methods
- 6 labels and instructions
- 7 Packaging, transportation and storage
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
1 Scope
This standard specifies the terms and definitions of influenza A nucleic acid detection kit (fluorescence PCR method) (hereinafter referred to as "kit"), to Requirements, test methods, labels and instructions, as well as packaging, shipping and storage.
This standard applies to fluorescent PCR method for the principle of qualitative detection of human nasopharyngeal swab or other respiratory secretions samples of influenza A Viral nucleic acid kit.
This standard does not apply to the principle of constant temperature amplification, qualitative detection of human nasal, throat swab or other respiratory secretions samples of influenza A Viral nucleic acid kit.
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version applies to this document. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 191 Packaging - Pictorial signs
GB/T 29791.2 Information provided by manufacturers of in vitro diagnostic medical devices (LABEL) SECTION 2. PROFESSIONAL IN VITRO DIAGNOSTIC AGENTS
3 Terms and definitions
The following terms and definitions apply to this document.
3.1 Fluorescent PCR method
Also known as real-time fluorescent PCR, the change in fluorescence energy released by the fluorescent dye during PCR directly reflects the PCR amplification yield Fluctuations in volume, fluorescence signal variables and amplification products is proportional to the variable, and through the collection and analysis of fluorescence in order to achieve the original template Line analysis of PCR.
4 Requirements
4.1 Appearance
The appearance of the product should be consistent.
a) kit should meet the appearance requirements of the manufacturer;
b) The kit should be complete components, packaging, clean appearance, no leakage, no damage; signs, labels and clear writing.
4.2 Positive reference coincidence rate
With the national positive reference or the standard positive reference for testing, the results should be consistent with the corresponding reference requirements. The standardized positive reference should meet the following requirements.
a) include influenza genotypes of not less than the national positive reference;
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 24 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
GB/T 29791.2-2013 — In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 2: In vitro diagnostic reagents for professional use
YY/T 0297-2026 — General requirements for clinical investigation of medical devices
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YY/T 1596-2017
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