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Single-Tube Multimarker Assay for Estimating the Risk to Develop Preeclampsia
Kaspar Ratnik1,2, Kristiina Rull1,3,4, Ele Hanson3,4
1Institute of Biomedicine and Translational Medicine, University of Tartu, Tartu 50411, Estonia.
The Journal of Applied Laboratory Medicine
|May 13, 2020
Summary
A new multiplex assay significantly improves prediction of preeclampsia (PE) in pregnant women. This innovative test shows higher accuracy than the standard sFlt-1/PlGF test for early PE risk estimation.
Area of Science:
- Biomarker discovery
- Maternal-fetal medicine
- Diagnostic assay development
Background:
- Preeclampsia (PE) affects 2-8% of pregnancies globally.
- Current prediction tests for PE have limited accuracy (<40% within 4 weeks).
- Need for improved diagnostic tools for timely PE intervention.
Purpose of the Study:
- To develop and evaluate a novel multiplex assay for enhanced prediction of preeclampsia.
- To compare the performance of the new assay against existing methods.
Main Methods:
- Developed a 6PLEX assay measuring ADAM12, sENG, leptin, PlGF, sFlt-1, and PTX3 on the Luminex® xMAP platform.
- Evaluated assay performance on 61 serum samples from pregnant women (PE cases, PE onset cases, controls).
- Compared 6PLEX assay results with the B·R·A·H·M·S Kryptor sFlt-1/PlGF test and developed prediction formulae.
Main Results:
- High correlation (r=0.93) between 6PLEX and B·R·A·H·M·S sFlt-1/PlGF measurements.
- 6PLEX assay combined with clinical parameters achieved AUC 0.99 (95% CI 0.97-1.00), 100% sensitivity, and 96.9% specificity.
- 6PLEX assay demonstrated significantly higher prognostic yield (96.5%) compared to the sFlt-1/PlGF test (73.7%).
Conclusions:
- The developed single-tube multimarker assay offers high prognostic yield for PE risk estimation.
- The 6PLEX assay shows superior performance and improved prediction accuracy over the standard sFlt-1/PlGF test.
- This innovative assay holds promise for earlier and more accurate preeclampsia diagnosis.

