This document specifies the kit requirements for BRCA gene mutation detection kits and databases, the data structure of the database, the data specifications of the database, and the data management and interpretation standards of the database. This document applies to the quality control of BRCA gene germline mutation detection kits, BRCA gene mutation detection databases and BRCA gene mutation interpretation. This document does not apply to BRCA gene somatic mutation detection and dideoxy method (Sanger) detection of BRCA gene mutations.
YY/T 1865-2022 history
2022YY/T 1865-2022 General technical requirements for BRCA gene mutation detection kits and databases (high-throughput sequencing method)