Abstract
BackgroundCare for malaria patients in endemic areas has been improved through the increasing use of Rapid Diagnostic Tests (RDTs). Most RDTs target the histidine-rich protein-2 antigen (PfHRP2) to detect P. falciparum, as it is abundant and shows great heat stability. However, their use in South America has been widely questioned following a recent publication that pinpoints the high prevalence of Peruvian field isolates lacking the gene encoding this protein. In the remote rural health centers of French Guiana, RDTs are the main diagnosis tools. Therefore, a study of PfHRP2 RDT performances and pfhrp2 genotyping was conducted to determine whether a replacement of the current pLDH-based kit could be considered.MethodsThe performance study compared the SD Malaria Ag test P.f/Pan® kit with the current gold standard diagnosis by microscopy. The prevalence of pfhrp2 and pfhrp3 deletions were evaluated from 221 P. falciparum isolates collected between 2009 and 2011 in French Guiana.ResultsBetween January 2010 and August 2011, 960 suspected cases of malaria were analyzed using microscopy and RDTs. The sensitivity of the SD Malaria Ag test P.f/Pan® for detection of P. falciparum was 96.8% (95% CI: 90.9–99.3), and 86.0% (95% CI: 78.9–91.5) for the detection of P. vivax. No isolates (95% CI: 0–4.5) lacking either exon of the pfhrp2 gene were identified among the 221 P. falciparum isolates analyzed, but 7.4% (95% CI: 2.8–15.4) lacked the exon 2 part of the pfhrp3 gene.ConclusionsField isolates lacking either exon of the pfhrp2 gene are absent in this western part of South America. Despite its sensibility to detect P. vivax, the SD Malaria Ag test P.f/Pan® kit is a satisfying alternative to microscopy in remote health centers, where it is difficult to provide highly skilled microscopists and to maintain the necessary equipment.
Highlights
In the late 1990’s, the introduction of Rapid Diagnosis Tests (RDT) for malaria provided a rapid, accurate and accessible diagnostic tool that reduced clinical diagnosis in endemic areas where skills and materials are lacking
None of the 140 Isolates Lacked the Entire pfhrp2 Gene We amplified either exon of the pfhrp2 gene of 140 P. falciparum isolates collected from different parts of the country in 2009 (Figure 1)
The prospective study to evaluate the performances of the SD Malaria Ag P.f/PanH kit was conducted from July 2010 to July 2011
Summary
In the late 1990’s, the introduction of Rapid Diagnosis Tests (RDT) for malaria provided a rapid, accurate and accessible diagnostic tool that reduced clinical diagnosis in endemic areas where skills and materials are lacking. WHO evaluated the performances of a wide panel of commercial kits, using a standardized procedure in order to compare performances between them The results of these evaluations have been published and included in general guidance for health workers [1,2,3,4]. Most RDTs target the histidine-rich protein-2 antigen (PfHRP2) to detect P. falciparum, as it is abundant and shows great heat stability. Their use in South America has been widely questioned following a recent publication that pinpoints the high prevalence of Peruvian field isolates lacking the gene encoding this protein. A study of PfHRP2 RDT performances and pfhrp genotyping was conducted to determine whether a replacement of the current pLDH-based kit could be considered
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