Standard No.:	YY/T 1801-2021
English Name:	Fetal trisomy 21 , trisomy 18 and trisomy 13 of chromosomal aneuploidies detection kit (high-throughput sequencing)
Chinese Name:	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）
Chinese Classification:	C44    Medical laboratory equipment
Professional Classification:	YY    Professional Standard - Pharmaceutics
ICS Classification:	11.040.30 11.040.30    Surgical instruments and materials 11.040.30
Issued by:	National Medical Products Adminstration
Issued on:	2021-12-06
Implemented on:	2023-5-1
Status:	valid
Language:	English
File Format:	PDF
Word Count:	8500 words
Price(USD):	255.00
Delivery:	via email in 1~3 business day

本标准规定了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）的术语和定义、要求、试验方法、标签和使用说明书、包装、运输和贮存。
本标准适用于采用测序深度不足以准确检测单碱基变异的低深度全基因组高通量测序法进行胎儿染色体非整倍体21三体、18三体和13三体检测的试剂盒。
该试剂盒在临床上用于孕妇外周血胎儿游离DNA产前筛查与诊断。本标准不适用于采用高深度目标片段测序法、单核苷酸多态性（SNP）位点测序法和甲基化基因位点测序法等其他高通量测序法进行胎儿染色体非整倍体21三体、18三体和13三体检测的试剂盒。