Survey and evaluation of the quality of preimplantation aneuploidy testing results in China in 2024
10.3760/cma.j.cn101441-20250224-00086
- VernacularTitle:我国2024年胚胎植入前非整倍体检测结果质量调查与评价
- Author:
Xingtong CHEN
1
;
Jinming ZHANG
;
Zhongli DU
;
Jiaming WU
;
Wei WANG
;
Kun ZHONG
;
Shuai YUAN
;
Yuxuan DU
;
Falin HE
Author Information
1. 北京医院国家老年医学中心 国家卫生健康委临床检验中心 北京市临床检验工程技术研究中心 中国医学科学院老年医学研究院，北京 100730
- Publication Type:Journal Article
- Keywords:
Preimplantation genetic testing for aneuploidies;
Quality control;
External quality assessment
- From:
Chinese Journal of Reproduction and Contraception
2025;45(7):715-719
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To investigate the current status of preimplantation genetic testing for aneuploidies (PGT-A) in China in 2024 and to provide recommendations for ensuring the consistency of PGT-A results.Methods:This study was a nationwide external quality assessment research. The National Center for Clinical Laboratories of the National Health Commission conducted two surveys in June and December 2024, with participation from 31 laboratories across China. During each survey, quality control samples of varying concentrations were distributed: the first survey distributed 6 samples (Batch Nos. 202401-202406) and the second survey distributed 3 samples (Batch Nos. 202431-202433). Participating laboratories were required to submit information including detection platforms, single-cell amplification methods, library construction methods, sequencing instruments, and test results. Collected data were statistically analyzed using Microsoft Excel to evaluate laboratories' PGT-A testing capabilities and determine whether results met predefined quality control requirements.Results:All 31 laboratories submitted results for both surveys. In the first survey, 90.3% (28/31) met qualification criteria with a 9.7% failure rate (3/31). For individual batches, pass rates were 90.3% (28/31) for batches 202401-202403 and 100% (31/31) for batches 202404-202406. The second survey achieved 100% (31/31) compliance across all three batches (202431-202433), with each batch maintaining a 100% pass rate.Conclusion:The detection quality of PGT-A in China is generally good, but with differences, and factors such as sample concentration, transportation conditions and detection methods affect the consistency of the results. The study highlights the urgent need for nationwide external quality assessment of PGT-A in China. This will help identify issues in laboratories in a timely manner and ensure the consistency of PGT-A test results.
