Abstract

IntroductionThe emergence of Plasmodium falciparum resistance to artemisinin combination therapy (ACT) is a worrying development. It calls for close surveillance to monitor the efficacy of the drugs. The objectives of this study were to determine the performance of SD Bioline malaria AgPf(HRP-2/pLDH) 3 band Rapid Diagnostic Test (RDT) against Giemsa-stained blood smear and evaluate the suitability of this test in assessing the therapeutic efficacy of ACT in pediatric malaria patients in the Democratic Republic of the Congo (DRC).MethodsFive hundred and one patients with malaria symptoms were screened for P. falciparum in Kinshasa, DRC. Of the 166 patients who tested positive for P. falciparum at recruitment (day 0), 103 consented to participate in this study and were followed up and retested for P. falciparum on day 3, day 7, day 14, day 21 and day 28.ResultsSensitivity and specificity of the test were significantly high on day 0 and so were their positive and negative predictive values. Higher proportions of false positive cases were observed on the HRP-2 band irrespective of patient parasite densities during the follow up but these were barely seen on the pLDH band. Some patients turned positive during follow up but pLDH readings remained consistent with blood smear readings.ConclusionSD Bioline malaria AgPf(HRP-2/pLDH) RDT demonstrated high performance in DRC. Thus, the test can be employed to assess the efficacy of ACT in pediatric malaria patients and prioritize areas that require the deployment of advanced testing like polymerase chain reaction (PCR).

Highlights

  • The emergence of Plasmodium falciparum resistance to artemisinin combination therapy (ACT) is a worrying development

  • Available rapid diagnostic tests (RDTs) are numerous in the market. They all fall into three categories: (i) Rapid Diagnostic Test (RDT) that detect the Plasmodium falciparum antigen histidine-rich protein 2 (HRP-2), (ii) RDTs that detect lactate dehydrogenase from P. falciparum and (iii) RDTs that detect P. vivax aldolase in human whole blood [1]

  • It is known that P. falciparum (Pf) HRP-2 remains in the bloodstream for an extended time following a successful clearance of the parasite, contributing to false positive results and limiting specificity of the test category that targets PfHRP-2 [2]

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Summary

Introduction

The emergence of Plasmodium falciparum resistance to artemisinin combination therapy (ACT) is a worrying development. The objectives of this study were to determine the performance of SD Bioline malaria AgPf(HRP-2/pLDH) 3 band Rapid Diagnostic Test (RDT) against Giemsa-stained blood smear and evaluate the suitability of this test in assessing the therapeutic efficacy of ACT in pediatric malaria patients in the Democratic Republic of the Congo (DRC). It is known that P. falciparum (Pf) HRP-2 remains in the bloodstream for an extended time following a successful clearance of the parasite, contributing to false positive results and limiting specificity of the test category that targets PfHRP-2 [2]. In order to monitor the success of an anti-malarial drug therapy, in the presence of fever, pLDH-based tests seem to be more useful since they become negative soon after parasites are cleared from the blood [3]. Literature on the performance of the RDT in Kinshasa, DRC is scanty

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