Diagnostic performance of hemozoin-based magneto-optical detection assay and RDT: a prospective observational study.

Early detection and effective management of malaria are crucial for elimination efforts. Microscopy and rapid diagnostic tests (RDTs) have been the main diagnostic methods for over fifteen years, but they have limitations, especially in cases of low parasite density or deletions of target markers (HRP2/3). This study compares the diagnostic performance of a novel hemozoin-based diagnostic assay (Hz-MOD) with RDTs for detecting malaria in febrile patients in southwestern India. A prospective observational study involved 480 patients screened with Hz-MOD, RDT, microscopy, and nested PCR. Among the samples, 121 were positive by both microscopy and PCR. The sensitivity of Hz-MOD was 94.21% compared to microscopy and 91.74% compared to PCR. For RDTs, sensitivity was 90.91% compared to microscopy and 87.60% compared to PCR. In terms of specificity, Hz-MOD showed 98.61% compared to microscopy and 97.77% compared to PCR, while RDTs had 100% specificity against microscopy and 98.89% against PCR. These results suggest that the hemozoin-based test demonstrates similar sensitivity to RDTs and could serve as an effective screening tool for malaria detection.