Standard No.:	YY/T 1865-2022
English Name:	General technical requirements for BRCA mutation detection kit and database (High-throughput sequencing)
Chinese Name:	BRCA基因突变检测试剂盒及数据库通用技术要求（高通量测序法）
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
Issued by:	National Medical Products Adminstration
Issued on:	2022-10-17
Implemented on:	2023-10-1
Status:	valid
Language:	English
File Format:	PDF
Word Count:	10500 words
Price(USD):	315.00
Delivery:	via email in 1~5 business day

本文件规定了BRCA基因突变检测试剂盒及数据库的试剂盒要求、数据库的数据构成、数据库的数据规范、数据库的数据管理和解读标准。
本文件适用于BRCA基因胚系突变检测试剂盒、BRCA基因突变检测数据库和BRCA基因突变解读的质量控制。
本文件不适用于BRCA基因体细胞突变检测以及双脱氧法（Sanger）对BRCA基因突变进行检测。