YY/T 1946-2024Gene mutation in tumor tissue detection kit (high-throughput sequencing) (English PDF)
肿瘤组织基因突变检测试剂盒(高通量测序法)
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
September 29, 2024
Implementation date
October 15, 2025
Scope
YY/T 1946-2024 is the English-translated version of 肿瘤组织基因突变检测试剂盒(高通量测序法).
YY/T 1946-2024 is the Chinese standard "Gene mutation in tumor tissue detection kit (high-throughput sequencing)". Its scope clause reads: 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").
It specifies relevant requirements, labels and instructions for use as well as packaging, transportation and storage, and describes the corresponding test methods.
This document applies to kits that use high-throughput sequencing based on probe capture or multiplex PCR for the detection of tumors. Single nucleotide variants (SNVs), insertion/deletion variants (Indels), Copy number variations (CNAs), gene fusions, tumor mutation burden (TMB), and/or microsatellite instability (MSI).
The kit is also suitable for paired detection of tumor tissue and control samples. This document does not apply to kits that use whole exome sequencing and single molecule sequencing technology to detect tumor gene mutations.
Note. The control sample may be whole blood or adjacent tissue sample, which is mainly used to distinguish germline mutations in tumor FFPE tissue sample testing. Its clauses include terms and definitions.
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Document preview — YY/T 1946-2024
National Standard of the People's Republic of China
- ICS
- 11.100.10
- Classification
- C44
Issued by: National Medical Products Administration
Contents
- 1 Scope1
- 2 Normative references1
- 7 Packaging, transportation and storage7
- References25
1 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").
It specifies relevant requirements, labels and instructions for use as well as packaging, transportation and storage, and describes the corresponding test methods.
This document applies to kits that use high-throughput sequencing based on probe capture or multiplex PCR for the detection of tumors.
Single nucleotide variants (SNVs), insertion/deletion variants (Indels),
Copy number variations (CNAs), gene fusions, tumor mutation burden (TMB), and/or microsatellite instability (MSI).
The kit is also suitable for paired detection of tumor tissue and control samples.
This document does not apply to kits that use whole exome sequencing and single molecule sequencing technology to detect tumor gene mutations.
Note. The control sample may be whole blood or adjacent tissue sample, which is mainly used to distinguish germline mutations in tumor FFPE tissue sample testing.
2 Normative references
The contents of the following documents constitute the essential clauses of this document through normative references in this document.
For referenced documents without a date, only the version corresponding to that date applies to this document; for referenced documents without a date, the latest version (including all amendments) applies to
This document.
GB/T 191 Pictorial markings for packaging, storage and transportation
GB/T 29791.2 Information provided by the manufacturer of in vitro diagnostic medical devices (labeling) Part 2.Professional in vitro diagnostic reagents
3 Terms and definitions
The following terms and definitions apply to this document.
3.1 High-throughput sequencing
Different from traditional dideoxy (Sanger) sequencing, a technology that can perform parallel sequencing of a large number of nucleic acid molecules at one time,
Usually one sequencing reaction can produce no less than 100Mb of sequencing data.
[Source. GB/T 40664-2021, 3.8]
3.2 Single-nucleotide variants; SNVs
A type of variation caused by the substitution of a single nucleotide base at the same position in the genome.
3.3 Insertion and deletion alterations; Indels
A type of variation that occurs when one or more bases are inserted or deleted in the genome.
Note. Usually refers to 1 to 50 bases.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 11 pages — is available in the English PDF.
Referenced standards
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