Clinical Performance of sFlt-1/PlGF Ratio Triage in Suspected Preeclampsia: A Prospective, Observational Multicenter Diagnostic-Triage Study in South Africa (TsHEPPO Study)

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Objective To evaluate the diagnostic and short-term predictive performance of the sFlt-1/PlGF ratio for triaging suspected preeclampsia (PE) in South Africa, comparing the established ≥38 threshold with an exploratory cut-off of ≥33 in a predominantly African ancestry population Design and Setting Prospective, observational diagnostic-triage multicenter study across four tertiary hospitals in South Africa. Sample 555 women with suspected preeclampsia with complete outcome data were enrolled Methods The sFlt-1/PlGF ratio (Elecsys®, Roche Diagnostics) was measured at presentation and comprehensive clinical and delivery outcome data were collected. Main Outcome Measures Diagnostic and short-term predictive performance for sFlt‐1/PlGF thresholds (≥33 and ≥38) were assessed using sensitivity, specificity, positive predictive value, negative predictive value, receiver operating characteristics (ROC) and associated area under the curve (AUC) and odds ratios. Results Forty-six percent of women were diagnosed with PE. The sFlt-1/PlGF ratio showed moderate discrimination for PE (AUROC 0.78, 95% CI 0.7–0.8). At the pooled diagnostic thresholds, ≥33 yielded sensitivity 67.1%, specificity 90.3%, PPV 92.1%, NPV 61.8%, and accuracy 75.7%, compared with 62.5%, 90.3%, 91.6%, 58.7%, and 72.8% at ≥38. Relative to ≥38, the ≥33 cut-off improved sensitivity without loss of specificity and identified 16 additional women as test-positive (p<0.0001). In short-term prediction, both thresholds showed high sensitivity (86.5%) for PE within 7 days while specificity/PPV were 77.3%/81.8% at ≥33 and 81.8%/84.9% at ≥38, with NPVs of 82.9% and 83.7%, respectively. By 28 days, NPVs declined to 62% and 64%. Conclusion The sFlt-1/PlGF ratio is a clinically useful biomarker primarily as a rule-in triage tool for suspected PE in South Africa. The exploratory ≥33 threshold improved case detection relative to ≥38 while maintaining high specificity, whereas both thresholds showed limited rule-out performance beyond short follow-up supporting the need for reassessment and repeat testing where clinically indicated. These findings support consideration of region-adapted thresholds and highlight the value of biomarker-guided triage in African settings.

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