PLOS Global Public Health (Jan 2022)

Performance of highly sensitive and conventional rapid diagnostic tests for clinical and subclinical Plasmodium falciparum infections, and hrp2/3 deletion status in Burundi.

  • David Niyukuri,
  • Denis Sinzinkayo,
  • Emma V Troth,
  • Colins O Oduma,
  • Mediatrice Barengayabo,
  • Mireille Ndereyimana,
  • Aurel Holzschuh,
  • Claudia A Vera-Arias,
  • Yilekal Gebre,
  • Kingsley Badu,
  • Joseph Nyandwi,
  • Dismas Baza,
  • Elizabeth Juma,
  • Cristian Koepfli

DOI
https://doi.org/10.1371/journal.pgph.0000828
Journal volume & issue
Vol. 2, no. 7
p. e0000828

Abstract

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Rapid diagnostic tests (RDTs) are a key tool for the diagnosis of malaria infections among clinical and subclinical individuals. Low-density infections, and deletions of the P. falciparum hrp2/3 genes (encoding the HRP2 and HRP3 proteins detected by many RDTs) present challenges for RDT-based diagnosis. The novel Rapigen Biocredit three-band Plasmodium falciparum HRP2/LDH RDT was evaluated among 444 clinical and 468 subclinical individuals in a high transmission setting in Burundi. Results were compared to the AccessBio CareStart HRP2 RDT, and qPCR with a sensitivity of <0.3 parasites/μL blood. Sensitivity compared to qPCR among clinical patients for the Biocredit RDT was 79.9% (250/313, either of HRP2/LDH positive), compared to 73.2% (229/313) for CareStart (P = 0.048). Specificity of the Biocredit was 82.4% compared to 96.2% for CareStart. Among subclinical infections, sensitivity was 72.3% (162/224) compared to 58.5% (131/224) for CareStart (P = 0.003), and reached 88.3% (53/60) in children <15 years. Specificity was 84.4% for the Biocredit and 93.4% for the CareStart RDT. No (0/362) hrp2 and 2/366 hrp3 deletions were observed. In conclusion, the novel RDT showed improved sensitivity for the diagnosis of P. falciparum.