YY/T 1801-2021 English PDF

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YY/T 1801-2021: Fetal trisomy 21, trisomy 18 and trisomy 13 of chromosomal aneuploidies detection kit (high-throughput sequencing)
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 1801-2021	339	Add to Cart	4 days	Fetal trisomy 21, trisomy 18 and trisomy 13 of chromosomal aneuploidies detection kit (high-throughput sequencing)	Valid

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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)

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
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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