1. Analysis of External Quality Assessment of Maternal Serum Prenatal Screening for Down Syndrome in the First Trimester in China
- Author
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Zhiguo Wang, Kun Zhong, Shuai Yuan, Falin He, Wei Wang, and Yuxuan Du
- Subjects
medicine.medical_specialty ,Down syndrome ,China ,Obstetrics ,business.industry ,Coefficient of variation ,medicine.disease ,General Biochemistry, Genetics and Molecular Biology ,First trimester ,Pregnancy Trimester, First ,Prenatal screening ,Human chorionic gonadotropin - free beta ,Pregnancy ,Prenatal Diagnosis ,External quality assessment ,medicine ,Humans ,Pregnancy-Associated Plasma Protein-A ,Chorionic Gonadotropin, beta Subunit, Human ,Female ,Down Syndrome ,business ,Risk assessment ,Biomarkers ,Serum markers - Abstract
BACKGROUND We analyzed the 2019 external quality assessment (EQA) results to evaluate the analytical performance of maternal serum prenatal screening for Down Syndrome (DS) in the first trimester in China. METHODS In each round, five lyophilized EQA samples with detailed clinical information were distributed to participants and used to test the concentration of human chorionic gonadotropin free beta subunits (free β-HCG) and pregnancy-associated plasma protein-A (PAPP-A) to calculate the risk value of DS. The robust coefficient of variability (CV) was calculated or test results for free β-HCG and PAPP-A using analytes and major measurement platforms. For DS risk values, the robust CV was calculated using a professional calculation platform. Failed EQA results were analyzed using serum marker testing results and DS risk values. RESULTS EQA results were collected from 242 laboratories in round 1 and 239 laboratories in round 2. Total acceptable rates of testing results for free β-HCG and PAPP-A ranged from 95.04% to 97.91%. Overall acceptable rates of DS risk values ranged from 97.52% to 97.90%. The proportion of laboratories exhibiting satisfactory performance was higher in round 2 than in round 1 for serum marker testing results and DS risk values. The robust CV for risk values for each sample were significantly higher than those of serum markers. Three EQA result failure types were found, including result reporting errors, serum marker concentration testing errors, and DS risk calculation errors. CONCLUSIONS The analytical performance of maternal serum prenatal screening for DS in the first trimester in China can be improved further.
- Published
- 2021