Standard No.:	YY/T 1226-2022
English Name:	Detection and genotyping kits for human papillomavirus nucleic acid
Chinese Name:	人乳头瘤病毒核酸(分型)检测试剂盒
Chinese Classification:	C44    Medical laboratory equipment
Professional Classification:	YY    Professional Standard - Pharmaceutics
ICS Classification:	11.100.10 11.100.10    In vitro diagnostic test systems 11.100.10
Source Content Issued by:	National Medical Products Adminstration
Issued on:	2022-05-18
Implemented on:	2023-6-1
Status:	valid
Superseding:	YY/T 1226-2014 Human papillomavirus nucleic acid(genotyping)detection kit
Target Language:	English
File Format:	PDF
Word Count:	7500 words
Translation Price(USD):	225.0
Delivery:	via email in 1~3 business day

本文件规定了人乳头瘤病毒核酸（分型）检测试剂盒的术语和定义、技术要求、试验方法、标识、标签和使用说明书、包装、运输、贮存等。
本文件适用于预期用途为人乳头瘤病毒核酸（Human papillomavirus,HPV）感染的辅助诊断和（或）宫颈癌筛查用的人乳头瘤病毒核酸（分型）检测试剂盒，适用的检测方法包括PCR荧光法、PCR-反向杂交法、杂交捕获-化学发光法、酶切信号放大法、基因芯片法、高通量测序等。