YY/T 1657-2019 Active

This standard specifies the naming and classification, technical requirements, testing methods, labeling and user manuals, packaging, transportation, and storage of pre-implantation chromosomal aneuploidy detection kits (sequencing method). This standard applies to the quality control of pre-implantation testing kits that detect chromosomal aneuploidy and large segment deletions or duplications in pre-implantation embryos through low-depth high-throughput gene sequencing, thereby selecting normal embryos for implantation. Pre-implantation chromosomal aneuploidy detection kits typically include whole-genome amplification and library construction reagents, and may contain high-throughput sequencing reagents. If the pre-implantation chromosomal aneuploidy detection kits do not contain high-throughput sequencing reagents, the manufacturer shall provide instructions or specify compatible high-throughput sequencing kits. This standard applies to pre-implantation chromosomal aneuploidy detection kits used in clinical screening.