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YY/T 1596-2017: Influenza A virus nucleic acid detection kit(fluorescent PCR)
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| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1596-2017 | English | 199 |
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Influenza A virus nucleic acid detection kit(fluorescent PCR)
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YY/T 1596-2017
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Basic data | Standard ID | YY/T 1596-2017 (YY/T1596-2017) | | Description (Translated English) | Influenza A virus nucleic acid 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 | 10,180 | | Date of Issue | 2017-12-05 | | Date of Implementation | 2018-12-01 | | Issuing agency(ies) | State Food and Drug Administration | YY/T 1596-2017: Influenza A virus nucleic acid 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 nucleic acid detection kit (fluorescent PCR)
ICS 11.100
C44
People's Republic of China pharmaceutical industry standards
Influenza A virus nucleic acid test kit
(Fluorescent PCR method)
2017-12-05 Published
2018-12-01 implementation
State Food and Drug Administration released
Directory
Foreword Ⅲ
1 Scope 1
2 Normative references 1
3 Terms and definitions 1
4 Requirements 1
5 test methods 2
6 labels and instructions 3
7 Packaging, transportation and storage 3
Reference 4
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some of this document may be patentable. The issuing agencies of this document do not bear the responsibility of identifying these patents.
This standard proposed by the State Food and Drug Administration.
This standard by the National Medical Clinical Laboratory and in vitro diagnostic system standardization Technical Committee (SAC/TC136) centralized.
This standard was drafted unit. China Institute of Food and Drug Control, Shanghai Jiang Biological Technology Co., Ltd., Jiangsu master Biotechnology
Co., Ltd., Beijing Huada Ji Bi love Biotechnology Co., Ltd.
The main drafters of this standard. Zhouhai Wei, Shi Dawei, Zhu Qinwei, Liu Zhonghua, Liu Cheng, Shen Shu, Zhang Chun Tao.
Influenza A virus nucleic acid test kit
(Fluorescent PCR method)
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 article
Pieces. 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 fluorescencepolymerasechainreaction
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;
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