Conventional and High-Sensitivity Malaria Rapid Diagnostic Test Performance in Two Transmission Settings: Haiti 2017

Abstract

Abstract Accurate malaria diagnosis is foundational for control and elimination, and Haiti relies on HRP2-based rapid diagnostic tests (RDTs) identifying Plasmodium falciparum in clinical and community settings. In 2017, one household and two easy-access group (EAG) surveys tested all participants (N=32,506) by conventional and high-sensitivity RDTs (cRDT/hsRDT). A subset of blood samples (n=1,154) were laboratory tested for HRP2 by bead-based immunoassay and for P. falciparum 18S rDNA by PET-PCR. Both RDT types detected low concentrations of HRP2 with sensitivity estimates between 2.6 and 14.6 ng/mL. Compared to the predicate HRP2 laboratory assay,, RDT sensitivity ranged from 86.3% to 96.0% between tests and settings, and specificity from 90.0% to 99.6%. In the household survey, the hsRDT provided a significantly higher number of positive tests, but this represented a very small proportion (<0.2%) of all participants. These data show an hsRDT may have limited utility in a malaria elimination setting like Haiti.