Evaluation of the clinical performance of the improved BIOCREDIT malaria antigen Pf/Pv (pLDH/pLDH) for malaria diagnosis in Indonesia and Sudan

Plasmodium lactate dehydrogenase (pLDH)-based rapid diagnostic tests (RDTs) can detect Plasmodium falciparum and P. vivax , but their sensitivity is often limited. This study evaluated the clinical performance of the improved BIOCREDIT Malaria Ag Pf/Pv (pLDH/pLDH) RDT in Indonesia and Sudan. A prospective, cross-sectional, multicentre diagnostic accuracy study was conducted at primary healthcare centers in Indonesia (n = 399) and Sudan (n = 280). Patients with symptoms suggestive of malaria were enrolled consecutively. Capillary blood was tested using the BIOCREDIT Pf/Pv RDT, while venous blood was collected for repeat testing and comparator assays, including Pf/Pan RDT, microscopy, and nested PCR as the reference standard. In Indonesia, 279 (69.9%) participants were PCR-positive, including P. falciparum (n = 81, 29.0%) , P. vivax (n = 87, 31.3%) , mixed infections (P.falciparum/P.vivax) (n=37, 13.3%), and the rest being other species or other species mixed infections. Submicroscopic parasitemia was observed in 26% of the samples. In Sudan, 115 (41%) participants were PCR-positive, with 4.3% submicroscopic infections. Using PCR as a reference test, the BIOCREDIT Pf/Pv RDT showed 75.9% sensitivity (95% CI 70.4–80.7) and 100% specificity (95% CI 96.9–100) for detecting any malaria infection in Indonesia. In Sudan, sensitivity and specificity were 95.7% (95% CI 90.2–98.1) and 100% (95% CI 97.7–100.0), respectively. Similar results were observed with venous blood. Sensitivity of the PvLDH line was 53% in Indonesia and 77% in Sudan, with 100% specificity; agreement with PCR was 0.51 in Indonesia and 0.85 in Sudan. The improved BIOCREDIT Malaria Antigen Pf/Pv (pLDH/pLDH) RDT demonstrated enhanced pLDH-based malaria detection in both countries and met WHO recommendations for detecting any malaria infection. The sensitivity of the P. vivax line was optimal in Sudan, while in Indonesia it was lower, likely due to high rates of submicroscopic parasitemia and cross-reactivity with other species. ClinicalTrials.Gov registration The study was registered in the registry of clinical trials at ClinicalTrials.gov (NCT05085301).