YY/T 1443-2016 in English
VALIDInfluenza A virus antigen detection kit(immunochromatographic assay)
- Issued on:2016-01-01
- Implemented on:2017-01-01
- File Format:PDF
- Delivery:Via email within 1~3 business days
$127.00
本标准规定了甲型流感病毒抗原检测试剂盒(免疫层析法)的术语和定义、要求、实验方法、标识、标签、使用说明书、包装、运输和贮存。
本标准适用于通过胶体金或乳胶颗粒等免疫层析法原理,定性检测呼吸道分泌物及其培养物中的甲型流感病毒,以快速检出甲型流感病毒抗
Scope
This standard specifies the terms and definitions, requirements, experimental methods, identification, labels, instructions for use, packaging, transportation and storage of influenza A virus antigen detection kits (immunochromatography). This standard is applicable to diagnostic kits for rapid detection of influenza A virus antigens by qualitatively detecting influenza A viruses in respiratory secretions and their cultures through immunochromatographic principles such as colloidal gold or latex particles. This standard does not apply to kits used for auxiliary diagnosis of influenza A based on the basic principle of enzyme-related immunochromatography.

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