YY/T 1946-2024 Active Industry standards-Medicine

YY/T 1946-2024 Gene mutation in tumor tissue detection kit(high-throughput sequencing)

Publish Date: 2024-09-29 Implement Date: 2025-10-15 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1946-2024

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical laboratory equipment

ICS Name: -

Publish Date: 2024-09-29

Implement Date: 2025-10-15

Pages: 32 pages

Scope

This document defines the terms and definitions of the tumor tissue gene mutation detection kit (high-throughput sequencing method) (hereinafter referred to as the "kit"), stipulates the relevant requirements, labels, and user manuals, as well as packaging, transportation, and storage, and describes the corresponding experimental methods.
This document applies to kits using probe capture or multiplex PCR for high-throughput sequencing, which are used to detect single nucleotide variants (SNVs), insertion-deletion variants (Indels), copy number variants (CNAs), gene fusions (Fusions), tumor mutation burden (TMB), and/or microsatellite instability (MSI) in formalin-fixed, paraffin-embedded (FFPE) tissue samples from tumor patients. This document also applies to kits for paired tumor tissue-control sample detection.
This document does not apply to kits used for tumor gene mutation detection using whole exome sequencing and single-molecule sequencing technologies.
Note: The control samples may be whole blood or cancer-adjacent tissue samples, mainly used to distinguish germline mutations in the detection of tumor FFPE tissue samples.