Abstract

BackgroundIn the Peruvian Amazon, Plasmodium falciparum and Plasmodium vivax malaria are endemic in rural areas, where microscopy is not available. Malaria rapid diagnostic tests (RDTs) provide quick and accurate diagnosis. However, pfhrp2 gene deletions may limit the use of histidine-rich protein-2 (PfHRP2) detecting RDTs. Further, cross-reactions of P. falciparum with P. vivax-specific test lines and vice versa may impair diagnostic specificity.MethodsThirteen RDT products were evaluated on 179 prospectively collected malaria positive samples. Species diagnosis was performed by microscopy and confirmed by PCR. Pfhrp2 gene deletions were assessed by PCR.ResultsSensitivity for P. falciparum diagnosis was lower for PfHRP2 compared to P. falciparum-specific Plasmodium lactate dehydrogenase (Pf-pLDH)- detecting RDTs (71.6% vs. 98.7%, p<0.001). Most (19/21) false negative PfHRP2 results were associated with pfhrp2 gene deletions (25.7% of 74 P. falciparum samples). Diagnostic sensitivity for P. vivax (101 samples) was excellent, except for two products. In 10/12 P. vivax-detecting RDT products, cross-reactions with the PfHRP2 or Pf-pLDH line occurred at a median frequency of 2.5% (range 0%–10.9%) of P. vivax samples assessed. In two RDT products, two and one P. falciparum samples respectively cross-reacted with the Pv-pLDH line. Two Pf-pLDH/pan-pLDH-detecting RDTs showed excellent sensitivity with few (1.0%) cross-reactions but showed faint Pf-pLDH lines in 24.7% and 38.9% of P. falciparum samples.ConclusionPfHRP2-detecting RDTs are not suitable in the Peruvian Amazon due to pfhrp2 gene deletions. Two Pf-pLDH-detecting RDTs performed excellently and are promising RDTs for this region although faint test lines are of concern.

Highlights

  • In Peru, malaria is mainly endemic in the Amazon region, where it is the primary cause of morbidity in adults and the fourth in children [1]

  • According to the recommendations of the World Health Organization (WHO), diagnosis and treatment should be based on parasitological confirmation by either microscopy or malaria rapid diagnostic tests (RDTs) [2]

  • Patients and samples From December 2010–July 2011, 182 patients were included, in three patients malaria was not confirmed by microscopy nor by PCR

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Summary

Introduction

In Peru, malaria is mainly endemic in the Amazon region, where it is the primary cause of morbidity in adults and the fourth in children [1]. Thick blood films (TBFs) of malaria suspected patients are sent for analysis to the most nearby health center, but this process takes several days and patients are often treated presumptively [3]. In such conditions RDTs could be useful, providing quick and accurate diagnosis, thereby leading to timely and correct treatment and reducing the severity and economic burden of disease. In the Peruvian Amazon, Plasmodium falciparum and Plasmodium vivax malaria are endemic in rural areas, where microscopy is not available. Cross-reactions of P. falciparum with P. vivax-specific test lines and vice versa may impair diagnostic specificity

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