Evaluation of CareStart™ Malaria HRP2/pLDH (Pf/pan) Combo Test in a malaria low transmission region of Senegal

Background: This study was initiated from the observation that prevalence of malaria obtained with rapid diagnostic test (RDT) (CareStart (TM) Malaria HRP2/pLDH Combo Test) was higher than in microscopy in a malaria low transmission area of Senegal. PCR was then performed to evaluate the performance of the RDT compared to microscopy in clinical settings. Methods: The study included 215 patients suspected of malaria in two peri-urban area of Dakar. Finger-pick blood samples were tested using RDT (CareStart (TM) Malaria HRP2/pLDH Combo Test). Venous blood samples were collected for light microscopy and PCR (gold standard). Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were calculated as performance characteristics. Results: Considering PCR as the gold standard, CareStart (TM) RDT showed high sensitivity (97.3%) and specificity (94.1%) with PPV and NPV of 97.3 and 94.1%, respectively, while microscopy had a sensitivity and specificity of 93.2 and 100%, respectively, and PPV and NPV of 100 and 87.2%, respectively. Conclusions: Malaria CareStart (TM) RDT test demonstrated a superior sensitivity compared to microscopy, which is the gold standard for malaria diagnosis. CareStart (TM) RDT could be a useful tool in individuals suspected of malaria even in areas where prevalence is low.