Analysis of false-negative rapid diagnostic tests for symptomatic malaria in the Democratic Republic of the Congo.

摘要: The majority of Plasmodium falciparum malaria diagnoses in Africa are made using rapid diagnostic tests (RDTs) that detect histidine-rich protein 2. Increasing reports false-negative RDT results due to parasites with deletions the pfhrp2 and/or pfhrp3 genes (pfhrp2/3) raise concern about existing strategies. We previously identified pfhrp2-negative among asymptomatic children Democratic Republic Congo (DRC), but their impact on diagnosis symptomatic is unknown. performed a cross-sectional study RDTs subjects 2017. Parasites were characterized by microscopy; RDT; pfhrp2/3 genotyping and species-specific PCR assays; bead-based immunoassay for antigens; whole-genome sequencing. Among 3627 subjects, 427 (11.8%) had RDT-/microscopy + results. from eight (0.2%) samples initially classified as putative PCR, antigen testing sequencing confirmed presence intact genes. 56.8% PCR-confirmed malaria. Non-falciparum co-infection P. was common (13.2%). Agreement between HRP2-based satisfactory (Cohen's kappa = 0.66) superior microscopy (0.33). Symptomatic pfhrp2/3-deleted not observed. Ongoing use appropriate detection DRC.