4.7 Article

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

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SCIENTIFIC REPORTS
卷 11, 期 1, 页码 -

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NATURE PORTFOLIO
DOI: 10.1038/s41598-021-85913-z

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  1. Global Fund to Fight AIDS, Tuberculosis, and Malaria
  2. National Institutes of Allergy and Infectious Diseases [R01AI132547, R21AI148579]
  3. National Institute of General Medical Sciences [T32GM008719]
  4. Doris Duke Charitable Foundation

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

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