Standard No.:	YY/T 1596-2017
English Name:	Influenza A virus nucleic acid detection kit(fluorescent PCR)
Chinese Name:	甲型流感病毒核酸检测试剂盒（荧光PCR法）
Chinese Classification:	C44    Medical laboratory equipment
Professional Classification:	YY    Professional Standard - Pharmaceutics
Source Content Issued by:	China Food and Drug Adminstration
Issued on:	2017-12-05
Implemented on:	2018-12-1
Status:	valid
Target Language:	English
File Format:	PDF
Word Count:	5500 words
Translation Price(USD):	160.00
Delivery:	via email in 1~3 business day

本标准规定了甲型流感病毒核酸检测试剂盒（荧光PCR法）的术语和定义、要求、试验方法、标签和说明书，以及包装、运输和贮存。
本标准适用于以荧光PCR法为原理，定性检测人鼻、咽拭子或其他呼吸道分泌物样本中甲型流感病毒核酸的试剂盒。
本标准不适用于以恒温扩增法为原理，定性检测人鼻、咽拭子或其他呼吸道分泌物样本中甲型流感病毒核酸的试剂盒。