Retrospective analysis of quality results of mid-trimester serum screening in China from 2019 to 2023
10.3760/cma.j.cn112150-20240624-00494
- VernacularTitle:2019—2023年我国孕中期母血清产前筛查质量分析
- Author:
Jinming ZHANG
1
;
Xingtong CHEN
;
Wei WANG
;
Kun ZHONG
;
Shuai YUAN
;
Yuxuan DU
;
Chuanbao ZHANG
;
Falin HE
Author Information
1. 北京医院国家卫生健康委临床检验中心 国家老年医学中心 中国医学科学院老年医学研究院，北京100730
- Publication Type:Journal Article
- Keywords:
Maternal serum screening tests;
Quality management;
Down syndrome;
Cross-sectional studies
- From:
Chinese Journal of Preventive Medicine
2025;59(5):628-633
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To analyze the quality level of maternal mid-trimester serum prenatal screening in China from 2019 to 2023.Methods:A questionnaire survey was conducted to collect information from laboratories participating in the National Health Commission′s Clinical Laboratory Center inter-laboratory quality assessment program for prenatal screening from 2019 to 2023. The collected data included screening protocols, detection methods, testing systems, and monthly laboratory screening quality indicators. The Chi-square test was used to compare the initial screening positive rates among different screening protocols, provinces, detection methods, and testing systems. A log-transformed linear regression analysis was performed to evaluate the relationship between the average annual sample size and the out-of-control rate of various median multiple of the median (mMoM) values.Results:This study included 806 laboratories from 29 provinces (including autonomous regions and municipalities). The five-year average out-of-control rates for mMoM values across indicators ranged from 15.8% to 31.3%. The initial positive rates of dual, triple, and quadruple screening protocols were statistically different ( χ2=760.2, P<0.001). The initial positive rates across different provinces ranged from 4.7% to 10.3%, with statistically significant differences ( χ2=35 388.0, P<0.001). There were also statistically significant differences in initial positive rates between different testing systems ( χ2=2 493.2, P<0.001). Testing systems using chemiluminescence methods had significantly higher initial positive rates compared to systems using time-resolved fluorescence methods (7.2% vs. 6.5%, χ2=533.6, P<0.001). Log-linear regression analysis showed that testing systems with larger annual average sample sizes had lower out-of-control rates for mMoM values (AFP: β=-0.100, P=0.005; hCG: β=-0.123, P=0.008; uE3: β=-0.139, P=0.007). Conclusion:There are significant differences in the quality of maternal mid-trimester serum screening across different detection methods, testing systems and provinces in China.
