Background Malaria rapid diagnostic tests have become a primary and critical tool for malaria diagnosis in malaria-endemic countries where Plasmodium falciparum Histidine Rich Protein 2-based rapid diagnostic tests ( Pf HRP2-based RDTs) are widely used. However, in the last decade, the accuracy of Pf HRP2-based RDTs has been challenged by the emergence of P. falciparum strains harbouring deletions of the P. falciparum histidine rich protein 2 ( pf hrp2) gene, resulting in false-negative results. In the Democratic Republic of Congo (D.R. Congo), little is known about the prevalence of the pfhrp2 gene deletion among P. falciparum isolates infecting symptomatic patients, especially in low to moderate transmission areas where pfhrp2 deletion parasites are assumed to emerge and spread. Here we determine the local prevalence and factors associated with pfhrp2 gene deletions among symptomatic malaria patients in the Kwilu Province of the D.R. Congo. Methods We used secondary data from a prospective health facility-based cross-sectional study conducted in 2018. Blood was collected for microscopy, Pf HRP2-RDT, and spotted onto Whatman filter paper for downstream genetic analysis. Genomic DNA was extracted and used to perform PCR assays for the detection and confirmation of pf hrp2 gene deletions. Fischer’s exact and the Kruskal–Wallis tests were applied to look for associations between potential explanatory variables and the pf hrp2 gene deletion with a level of statistical significance set at P < 0.05. Results Of the 684 enrolled symptomatic patients, 391 (57.7%) were female. The majority (87.7%) reported the presence of mosquito breeding sites within the household’s compound, and fever was the most reported symptom (81.6%). The overall prevalence of the pf hrp2 gene deletion was 9.2% (95% CI : 6.7%–12.1%). The deletion of the pfhrp2 gene was associated with health zone of origin ( P = 0.012) and age ( P = 0.019). Among false-negative Pf HRP2-RDT results, only 9.9% were due to pfhrp2 gene deletion. Conclusions P. falciparum isolates with pfhrp2 gene deletions are relatively common among symptomatic patients in Kwilu province. Further investigations are needed to provide enough evidence for policy change. Meanwhile, the use of RDTs targeting Pf HRP2 and parasite lactate dehydrogenase (pLDH) antigens could limit the spread of deleted isolates. Graphic Abstract
【저자키워드】 Rapid diagnostic test, False negative, gene deletion, symptomatic patient, Plasmodium falciparum histidine rich protein 2,