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).

Background: Rapid Diagnostic Tests (RDTs) have become the cornerstone for the management of malaria in many endemic settings, but their use is constrained for several reasons: (i) persistent malaria antigen (histidine-rich protein 2; HRP2) leading to false positive test results; (ii) hrp2 deletions leading to false negative PfHRP2 results; and (iii) limited sensitivity with a detection threshold of around 100 parasites/μl blood (pLDH- and HRP2-based) leading to false negative tests. Microscopy is still the gold standard for malaria diagnosis, and allows for species determination and quantitation, but requires trained microscopists, maintained microscopes and has detection limit issues. Consequently, there is a pressing need to develop and evaluate more sensitive and accurate diagnostic tests.

Implementing a regional integrated laboratory proficiency testing scheme for peripheral health facilities in East Africa.

Introduction: Regular participation in external quality assessment (EQA) is critical for maintaining laboratory performance and is required for laboratory accreditation. Proficiency testing (PT) is effective for providing EQA, but available schemes rarely address the range of tests performed by peripheral laboratories in resource-limited settings. The East African Regional External Quality Assessment Scheme (EA-REQAS) was established in 2004 to address this need.