YY/T 1801-2021Fetal trisomy 21, trisomy 18 and trisomy 13 chromosomal aneuploidies detection kit (high-throughput sequencing) (English PDF)
胎儿染色体非整倍体21三体、18三体和13三体检测试剂盒（高通量测序法）
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
December 6, 2021
Implementation date
May 1, 2023
Scope
YY/T 1801-2021 is the English-translated version of 胎儿染色体非整倍体21三体、18三体和13三体检测试剂盒（高通量测序法）.
YY/T 1801-2021 is the Chinese pharmaceutical industry standard for kits that detect fetal trisomy 21, trisomy 18 and trisomy 13 by high-throughput sequencing of the cell-free DNA in the pregnant woman's blood.
It gives the terms and definitions, the requirements, the test methods, the labelling and instructions for use and the rules for packaging, transport and storage, covering the fetal fraction and how it is determined, the sequencing depth and data quality, the sensitivity and specificity against reference samples, the repeatability and the stability.
It applies to kits that use low-depth whole-genome sequencing, whose depth is not sufficient to call single base variants. Issued on 6 December 2021, it has applied since 1 May 2023.
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Document preview — YY/T 1801-2021
National Standard of the People's Republic of China
- Classification
- C 44
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Preface
- 1 Scope
- 2 Normative references
- 3 Terms and Definitions
- 4 Requirement
- 5 Test method
- 6 Labels and Instructions for Use
- 7 Packaging, transport and storage
- Appendix A (Informative Appendix) National Reference for Peripheral Blood Fetal Chromosomal Aneuploidy (T21, T18 and T13) for High-throughput Sequencing
- Reference
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
1 Scope
This standard specifies the terminology of fetal chromosomal aneuploidy trisomy 21, trisomy 18 and trisomy 13 detection kits (high-throughput sequencing method) and definitions, requirements, test methods, labelling and instructions for use, packaging, transportation and storage.
This standard is applicable to the use of low-depth whole-genome high-throughput sequencing methods with insufficient sequencing depth to accurately detect single-base variants.
A kit for the detection of chromosomal aneuploidy trisomy 21, trisomy 18 and trisomy 13. The kit is clinically used for fetal swimming in peripheral blood of pregnant women DNA prenatal screening and diagnosis.
This standard does not apply to the use of high-depth target fragment sequencing, single nucleotide polymorphism (SNP) locus sequencing and methylation loci A kit for detecting fetal chromosomal aneuploidy with trisomy 21, trisomy 18 and trisomy 13 by other high-throughput sequencing methods such as spot sequencing.
2 Normative references
The following documents are essential for the application of this document. For dated references, only the dated version applies to this document. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 191 Graphical signs of packaging, storage and transportation
GB/T 29791.2 Information provided by manufacturers of in vitro diagnostic medical devices (labeling) Part 2. In vitro diagnostic reagents for professional use
3 Terms and Definitions
The following terms and definitions apply to this document.
3.1 Low-depth genome-wide detection of fetal chromosomal aneuploidy for trisomy 21, trisomy 18 and trisomy
13 fortrisomy21,trisomy18andtrisomy13detectionbylow-coveragewholegenomesequencing Detection of fetal cell-free DNA (cel-freefetalDNA, cffDNA) in the peripheral blood of pregnant women, to evaluate the number of fetal chromosomes.
The cell-free DNA of maternal peripheral blood was not processed or subjected to fragment selection for library construction, and low-depth whole-genome high-throughput sequencing was used.
Finally, the chromosome number evaluation results were obtained by bioinformatics analysis of the data. Periphery of pregnant women with Down syndrome fetuses When the blood cell-free DNA data is analyzed, the total cell-free DNA of chromosome 21 will increase in a certain proportion, and the bioinformatics credits will be used.
The number of cell-free DNA fragments of chromosome 21 was counted, and compared with the reference set composed of a large number of samples, through statistical analysis The algorithm can realize the assessment of fetal trisomy 21 risk. This method cannot replace the open neural tube defect screen in traditional screening Check and so on.
3.2 Chromosomalmicrodeletion/microduplication
Small deletions and/or duplications that occur in parts of a chromosome.
Note: The size of the microdeletion and microrepeat fragment in this standard is expressed in the unit of Mb, and 1Mb represents a fragment of 1,000,000 bp in length.
4 Requirements
4.1 Appearance
The components of the kit should be complete and complete without liquid leakage.
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 25 pages — is available in the English PDF.
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Related Standards
GB/T 191-2025 — Graphical symbols marking for handling and storage of packages
GB/T 29791.2-2013 — In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 2: In vitro diagnostic reagents for professional use
YY/T 0297-2026 — General requirements for clinical investigation of medical devices
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