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

J M Zhang ¹, X T Chen ¹, W Wang ²

⁰National Center for Clinical Laboratories, Beijing Hospital/National Center of Gerontology/Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing 100730, China Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100730, China.

Zhonghua Yu Fang Yi Xue Za Zhi [chinese Journal of Preventive Medicine] +

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May 15, 2025

View abstract on PubMed

Summary

Maternal mid-trimester serum screening quality in China varies significantly by detection method, testing system, and province. Laboratories with higher annual sample volumes demonstrated better quality control for screening markers.

Area Of Science

Clinical Chemistry and Laboratory Medicine
Prenatal Diagnostics
Quality Assurance in Healthcare

Context

Maternal serum screening is crucial for detecting fetal aneuploidies and neural tube defects.
The quality of these screening tests directly impacts diagnostic accuracy and patient outcomes.
Inter-laboratory quality assessment programs are essential for standardizing and monitoring screening quality.

Purpose

To evaluate the quality of maternal mid-trimester serum prenatal screening in China between 2019 and 2023.
To identify variations in screening quality based on detection methods, testing systems, and geographical location.
To assess the correlation between laboratory sample volume and quality control indicator performance.

Summary

Analysis of data from 806 laboratories across China revealed significant variations in median multiple of the median (mMoM) out-of-control rates (15.8%-31.3%).
Initial positive rates differed significantly across screening protocols, provinces, and testing systems, with chemiluminescence methods showing higher rates than time-resolved fluorescence.
Log-linear regression indicated that higher annual sample volumes were associated with lower out-of-control rates for AFP, hCG, and uE3 mMoM values.

Impact

Highlights substantial disparities in prenatal screening quality across different regions and methodologies within China.
Suggests that laboratory experience, indicated by sample volume, positively influences screening accuracy and quality control.
Provides evidence for targeted quality improvement initiatives to standardize maternal serum screening nationwide.