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YY/T 1801-2021: Fetal trisomy 21, trisomy 18 and trisomy 13 of chromosomal aneuploidies detection kit (high-throughput sequencing)
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| YY/T 1801-2021 | English | 339 |
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Fetal trisomy 21, trisomy 18 and trisomy 13 of chromosomal aneuploidies detection kit (high-throughput sequencing)
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YY/T 1801-2021
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Basic data | Standard ID | YY/T 1801-2021 (YY/T1801-2021) | | Description (Translated English) | Fetal trisomy 21, trisomy 18 and trisomy 13 of chromosomal aneuploidies detection kit (high-throughput sequencing) | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C44 | | Word Count Estimation | 17,173 | | Issuing agency(ies) | State Drug Administration | YY/T 1801-2021: Fetal trisomy 21, trisomy 18 and trisomy 13 of chromosomal aneuploidies detection kit (high-throughput sequencing)
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Fetal trisomy 21, trisomy 18 and trisomy 13 of chromosomal aneuploidies detection kit (high-throughput sequencing)
ICS 11:100:10
C44
People's Republic of China Pharmaceutical Industry Standard
Fetal chromosomal aneuploidy, trisomy 21, trisomy 18, and
13 Trisomy Detection Kit (High Throughput Sequencing)
Published on 2021-12-06
2023-05-01 Implementation
Released by the State Drug Administration
directory
Preface III
1 Scope 1
2 Normative references 1
3 Terms and Definitions 1
4 Requirement 1
5 Test method 3
6 Labels and Instructions for Use 3
7 Packaging, transport and storage3
Appendix A (Informative Appendix) National Reference for Peripheral Blood Fetal Chromosomal Aneuploidy (T21, T18 and T13) for High-throughput Sequencing 5
Reference 13
foreword
This standard was drafted in accordance with the rules given in GB/T 1:1-2009:
Please note that some content of this document may be patented: The issuing authority of this document assumes no responsibility for identifying these patents:
This standard is proposed by the State Drug Administration:
This standard is under the jurisdiction of the National Standardization Technical Committee of Medical Clinical Laboratory and In Vitro Diagnostic System (SAC/TC136):
This standard was drafted by: China National Institute for Food and Drug Control, Shenzhen Huada Life Science Research Institute, Guangzhou Darui Biotechnology Co:, Ltd:
Co:, Ltd:, Dongguan Boao Muhua Gene Technology Co:, Ltd:, Hangzhou Berry Hekang Gene Diagnostic Technology Co:, Ltd:, Beijing Medical Device Inspection Co:, Ltd:
laboratory:
The main drafters of this standard: Qu Shoufang, Chen Fang, Zhang Yanyan, Wu Yingsong, Huang Quanfei, Zhang Jianguang, Wang Ruixia, Huang Jie:
Fetal chromosomal aneuploidy, trisomy 21, trisomy 18, and
13 Trisomy Detection Kit (High Throughput Sequencing)
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 article
pieces: 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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