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YY/T 1865-2022General technical requirements for BRCA mutation detection kit and database(High-throughput sequencing) (English PDF)

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Issued by

State Drug Administration

Level / Type

National · Recommended

Issue date

October 17, 2022

Implementation date

October 1, 2023

Scope

YY/T 1865-2022 (General technical requirements for BRCA mutation detection kit and database(High-throughput sequencing)) is available as an English-translated PDF.

YY/T 1865-2022 — This standard specifies the kit requirements for BRCA gene mutation detection kits and databases, the data composition of the database, the data specifications of the database, and the data management and interpretation standards of the database.

This standard is applicable to the quality control of BRCA gene germline mutation detection kit, BRCA gene mutation detection database and BRCA gene mutation interpretation.

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Document preview — YY/T 1865-2022

National Standard of the People's Republic of China

Issued by: State Drug Administration

What this standard covers1
Document data2

What this standard covers

This standard specifies the kit requirements for BRCA gene mutation detection kits and databases, the data composition of the database, the data specifications of the database, and the data management and interpretation standards of the database. This standard is applicable to the quality control of BRCA gene germline mutation detection kit, BRCA gene mutation detection database and BRCA gene mutation interpretation. This standard does not apply to the detection of BRCA gene somatic mutations and the detection of BRCA gene mutations by the dideoxy method (Sanger).

Document data

Estimated length of the Chinese original: 22,270 words.

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.

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