Serum soluble fms-like tyrosine kinase and placental growth factor ratio on Elecsys immunoassay platform predicts preeclampsia with severe features in hospitalized women with hypertensive disorders of pregnancy.
Publication/Presentation Date
11-11-2025
Abstract
OBJECTIVE: Prior single center studies conducted in the US in women with suspected preeclampsia indicated that serum sFlt-1/PlGF ratio values greater than 38 measured on a widely available Elecsys immunoassay platform during third trimester predicted the development of preeclampsia with severe features (sPE) and adverse outcomes within two weeks of testing. We sought to validate the Elecsys sFlt-1/PlGF ratio test for the prediction of sPE in a US population using the prospective Preeclampsia Risk Assessment: Evaluation of Cut-offs to Improve Stratification (PRAECIS) cohort that recruited women with hypertensive disorder of pregnancy (HDP) (gestational hypertension, chronic hypertension, de novo and superimposed preeclampsia) across 18 tertiary and community hospitals throughout the US.
STUDY DESIGN: We measured sFlt-1/PlGF ratios using the Elecsys platform in archived serum samples from the PRAECIS study that recruited hospitalized women with HDP between 23+0 and 34+6/7 weeks of gestation. The primary study outcome was prediction of sPE within two weeks after testing. Secondary outcomes included a composite of adverse maternal and fetal/neonatal outcomes and prediction of delivery within 2 weeks.
RESULTS: In the validation cohort of the PRAECIS study (N=556 enrollments), serum sFlt-1/PlGF ratio at cut-off value of >38 demonstrated 67% positive predictive value (95% CI, 61% to 73%) and 95% negative predictive value (95% CI, 92% to 97%) for the progression to sPE within 2 weeks. Among women presenting < 30 weeks (N=188), serum sFlt-1/PlGF ratio at cut-off value of >38 demonstrated 78% positive predictive value (95% CI, 68% to 86%%) and 100% negative predictive value (95% CI, 96% to 100%) for the progression to sPE within 2 weeks. The Elecsys sFlt-1/PlGF ratio performed better than standard-of-care clinical measures, with an area under the receiver-operating characteristic curve of 0.92 (95% CI, 0.89 to 0.90) for sFlt-1/PlGF ratio versus < 0.70 for standard-of-care tests such as liver enzymes, platelet count and serum creatinine (P< 0.001). Compared to women with a ratio at or below 38, women with a ratio above 38 had a higher risk for developing adverse maternal (relative risk 4.9; 95% CI, 2.6 to 9.9, P< 0.001) and fetal/neonatal (relative risk 3.2; 95% CI, 2.6 to 4.0, P< 0.001) outcomes, and were more likely to deliver within 2 weeks (adjusted hazard ratio 3.3; 95% CI, 2.7 to 4.0; P< 0.001).
CONCLUSIONS: The sFlt-1/PlGF ratio >38 measured on the Elecsys platform predicted the development of sPE, delivery, and adverse maternal and fetal/neonatal outcomes within two weeks of testing among preterm pregnant women hospitalized with HDP. (Funded by Cedars-Sinai Medical Center and Roche Diagnostics).
ISSN
1097-6868
Published In/Presented At
Berg, A. H., Calsavara, V. F., Hund, M., Ge, G., Rana, S., Costantine, M. M., Espinoza, J., Boggess, K., Wylie, B. J., Moore Simas, T. A., Louis, J. M., Gaw, S. L., Murtha, A., Wiegand, S., Gollin, Y., Singh, D., Silver, R. M., Durie, D. E., Panda, B., Norwitz, E. R., … Karumanchi, S. A. (2025). Serum soluble fms-like tyrosine kinase and placental growth factor ratio on Elecsys immunoassay platform predicts preeclampsia with severe features in hospitalized women with hypertensive disorders of pregnancy. American journal of obstetrics and gynecology, S0002-9378(25)00828-2. Advance online publication. https://doi.org/10.1016/j.ajog.2025.11.006
Disciplines
Medicine and Health Sciences
PubMedID
41232788
Department(s)
Department of Obstetrics and Gynecology
Document Type
Article