Abstract

BackgroundSurveillance programmes often use malaria rapid diagnostic tests (RDTs) to determine the proportion of the population carrying parasites in their peripheral blood to assess the malaria transmission intensity. Despite an increasing number of reports on false-negative and false-positive RDT results, there is a lack of systematic quality control activities for RDTs deployed in malaria surveillance programmes.MethodsThe diagnostic performance of field-deployed RDTs used for malaria surveys was assessed by retrospective molecular analysis of the blood retained on the tests.ResultsOf the 2865 RDTs that were collected in 2018 on Bioko Island and analysed in this study, 4.7% had a false-negative result. These false-negative RDTs were associated with low parasite density infections. In 16.6% of analysed samples, masked pfhrp2 and pfhrp3 gene deletions were identified, in which at least one Plasmodium falciparum strain carried a gene deletion. Among all positive RDTs analysed, 28.4% were tested negative by qPCR and therefore considered to be false-positive. Analysing the questionnaire data collected from the participants, this high proportion of false-positive RDTs could be explained by P. falciparum histidine rich protein 2 (PfHRP2) antigen persistence after recent malaria treatment.ConclusionMalaria surveillance depending solely on RDTs needs well-integrated quality control procedures to assess the extent and impact of reduced sensitivity and specificity of RDTs on malaria control programmes.

Highlights

  • Surveillance programmes often use malaria rapid diagnostic tests (RDTs) to determine the proportion of the population carrying parasites in their peripheral blood to assess the malaria transmission intensity

  • Households were assigned scores based on the type of assets and amenities they own to derive a surrogate of their socio-economic status (SES), using principal component analysis (PCA)

  • Integration of molecular diagnostic methods into the national malaria control programme to assess the performance of malaria RDTs In total, 2865 RDTs (21.2%) collected during the 2018 malaria indicator survey (MIS) were included in this study

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Summary

Introduction

Surveillance programmes often use malaria rapid diagnostic tests (RDTs) to determine the proportion of the population carrying parasites in their peripheral blood to assess the malaria transmission intensity. The test-treat-track strategy advised by WHO is one of the backbones of current malaria control and elimination programmes [3]. This strategy entails every suspected malaria case be tested, every confirmed case be treated, and the disease be tracked through surveillance systems [4]. RDTs are point-of-care tests that detect circulating antigens, such as the P. falciparum-specific histidine rich protein 2 (PfHRP2) or histidine rich protein 3 (PfHRP3), as well as the pan-Plasmodium spp. enzymes, lactate dehydrogenase (pLDH) or aldolase [6]. When individuals are asymptomatic with low parasite densities, RDTs often fail to detect the parasites due to low antigen concentrations [9, 10]

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