| Autor: |
Jinming Zhang, Xingtong Chen, Jiaming Wu, Penghui Feng, Wei Wang, Kun Zhong, Shuai Yuan, Yuxuan Du, Chuanbao Zhang, Falin He |
| Jazyk: |
angličtina |
| Rok vydání: |
2024 |
| Předmět: |
|
| Zdroj: |
Practical Laboratory Medicine, Vol 41, Iss , Pp e00422- (2024) |
| Druh dokumentu: |
article |
| ISSN: |
2352-5517 |
| DOI: |
10.1016/j.plabm.2024.e00422 |
| Popis: |
Objectives: We aimed to evaluate the analytical performance of second-trimester maternal serum screening in China, and to compare if there are differences in sigma levels across different methods and months. Methods: A retrospective study was conducted to assess the analytical quality levels of laboratories by calculating the Sigma metrics with prenatal screening biomarkers: AFP, Total β-hCG, free β-hCG, uE3. Data from 591 laboratories were selected. Sigma metrics were computed using the formula: Sigma metrics(σ) = (%TEa - |%Bias|)/%CV. The Friedman test and Mann-Whitney test were used to compare differences across various methods and different months. The Hodges–Lehmann was used for determining 95 % confidence intervals of pseudo-medians. Results: Only uE3 showed significant monthly variations in sigma calculations. However, around 8 % of laboratories across all four analytes demonstrated sigma levels both above 6 and below 3 in different months. Laboratories utilizing time-resolved fluorescence methods significantly outperformed those using chemiluminescence in sigma level. For AFP, the pseudo-median difference between these methods lies within a 95 % confidence interval of (−3.22, −1.93), while for uE3, it is at (−2.30, −1.40). Notably, the median sigma levels for all analytes reached the 4-sigma threshold, with free β-hCG even attaining the 6-sigma level. Conclusion: With current standards, China's second-trimester maternal serum screening is of relatively high analytical quality, and variations in sigma levels exist across different months and methods. |
| Databáze: |
Directory of Open Access Journals |
| Externí odkaz: |
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