YY/T 1801-2021 Active Industry standards-Medicine

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

Publish Date: 2021-12-06 Implement Date: 2023-05-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1801-2021

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical laboratory equipment

ICS Name: Biology, botany, and zoology

Publish Date: 2021-12-06

Implement Date: 2023-05-01

Pages: 20 pages

Scope

This standard specifies the terms and definitions, requirements, test methods, labels and user manuals, packaging, transportation, and storage for fetal chromosomal aneuploidy 21-trisomy, 18-trisomy, and 13-trisomy detection kits (high-throughput sequencing method).
This standard applies to kits used for fetal chromosomal aneuploidy 21-trisomy, 18-trisomy, and 13-trisomy detection using low-depth whole-genome high-throughput sequencing methods, where the sequencing depth is insufficient to accurately detect single-base variants. The kits are used clinically for prenatal screening and diagnosis of fetal free DNA in maternal peripheral blood.
This standard does not apply to kits used for fetal chromosomal aneuploidy 21-trisomy, 18-trisomy, and 13-trisomy detection using other high-throughput sequencing methods, such as high-depth target segment sequencing, single-nucleotide polymorphism (SNP) site sequencing, and methylation gene site sequencing.