Conventional and High-Sensitivity Malaria Rapid Diagnostic Test Performance in 2 Transmission Settings: Haiti 2017

J Infect Dis. 2020 Feb 18;221(5):786-795. doi: 10.1093/infdis/jiz525.

Abstract

Accurate malaria diagnosis is foundational for control and elimination, and Haiti relies on histidine-rich protein 2 (HRP2)-based rapid diagnostic tests (RDTs) identifying Plasmodium falciparum in clinical and community settings. In 2017, 1 household and 2 easy-access group surveys tested all participants (N = 32 506) by conventional and high-sensitivity RDTs. A subset of blood samples (n = 1154) was laboratory tested for HRP2 by bead-based immunoassay and for P. falciparum 18S rDNA by photo-induced electron transfer polymerase chain reaction. Both RDT types detected low concentrations of HRP2 with sensitivity estimates between 2.6 ng/mL 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 high-sensitivity RDT provided a significantly higher number of positive tests, but this represented a very small proportion (<0.2%) of all participants. These data show that a high-sensitivity RDT may have limited utility in a malaria elimination setting like Haiti.

Keywords: Plasmodium falciparum; HRP2; Haiti; malaria elimination; rapid diagnostic test.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Antigens, Protozoan / blood
  • Antigens, Protozoan / immunology
  • Child
  • Child, Preschool
  • DNA, Protozoan / blood
  • DNA, Protozoan / genetics
  • DNA, Ribosomal / blood
  • DNA, Ribosomal / genetics
  • Diagnostic Tests, Routine / methods*
  • Enzyme-Linked Immunosorbent Assay / methods
  • Female
  • Haiti / epidemiology
  • Humans
  • Infant
  • Malaria, Falciparum / diagnosis*
  • Malaria, Falciparum / epidemiology
  • Malaria, Falciparum / parasitology
  • Malaria, Falciparum / transmission*
  • Male
  • Plasmodium falciparum / genetics*
  • Plasmodium falciparum / immunology*
  • Polymerase Chain Reaction / methods
  • Protozoan Proteins / blood
  • Protozoan Proteins / immunology
  • Sensitivity and Specificity

Substances

  • Antigens, Protozoan
  • DNA, Protozoan
  • DNA, Ribosomal
  • HRP-2 antigen, Plasmodium falciparum
  • Protozoan Proteins