[Retrospective analysis of quality results of mid-trimester serum screening in China from 2019 to 2023]

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.