Clinical Performance of sFlt‐1/PlGF Ratio Triage in Suspected Preeclampsia: A Prospective Interventional Multicenter Study in South Africa: the TSHEPPO Trial

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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 adapted for African descent cohorts. Design and Setting: Prospective, interventional, multicenter study across four tertiary hospitals in South Africa, allocation by systematic alternation. Sample 555 women with suspected pre-eclampsia were enrolled. Methods sFlt-1/PlGF ratio (Elecsys®, Roche Diagnostics) performed and comprehensive clinical data collected. Main Outcome Measures Diagnostic 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 (HIV adjusted). Results Fourty six percent were diagnosed with PE. sFlt-1/PLGF ratio discriminated PE with an AUC 0.775, 95% CI 0.730–0.819). A cut-off of ≥33—pre-specified to reflect African epidemiology—yielded sensitivity 67.05%, specificity 90.2%, PPV 92.13%, NPV 61.79.4%, accuracy 75.68.0%. At ≥38, sensitivity was 62.46%, specificity 90.29%, PPV 91.60%, NPV 58.68%, accuracy 72.79%. In short term prediction, both thresholds showed high sensitivity (0.86) for PE within 7 days preserving high specificities and PPV’s with good NPV’s of 82.9% and 83.72%. Conclusion The sFlt-1/PlGF ratio is a strong biomarker for PE triage in South Africa. A context-specific threshold of ≥33 improved case detection while maintaining high specificity, making it suitable for diagnostic rule-in. The ≥38 threshold provided slightly greater short-term predictive accuracy. These findings support region-adapted cut-offs, highlighting the utility of biomarker-guided triage in African settings.

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