Phase 3 evaluation of an innovative simple molecular test for the diagnosis of malaria in different endemic and health settings in sub- Saharan Africa (DIAGMAL)

Rapid Diagnostic Tests (RDTs) are widely used for malaria diagnosis but face limitations such as false positives from persistent HRP2 antigens, false negatives due to hrp2 gene deletions, and low sensitivity. While microscopy remains the gold standard, it requires skilled personnel and equipment. To address these challenges, a new direct-on-blood mini PCR-NALFIA test has been developed, offering higher sensitivity and accuracy with minimal infrastructure, making it suitable for low-resource settings.

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