Abstract
BackgroundMalaria Rapid Diagnostic Tests (RDTs) are widely used to diagnose malaria. The present study evaluated a new RDT, the Clearview® Malaria pLDH test targeting the pan-Plasmodium antigen lactate dehydrogenase (pLDH).MethodsThe Clearview® Malaria pLDH test was evaluated on fresh samples obtained in returned international travellers using microscopy corrected by PCR as the reference method. Included samples were Plasmodium falciparum (139), Plasmodium vivax (22), Plasmodium ovale (20), Plasmodium malariae (7), and 102 negative.ResultsOverall sensitivity for the detection of Plasmodium spp was 93.2%. For P. falciparum, the sensitivity was 98.6%; for P. vivax, P. ovale and P. malariae, overall sensitivities were 90.9%, 60.0% and 85.7% respectively. For P. falciparum and for P. vivax, the sensitivities increased to 100% at parasite densities above 100/μl. The specificity was 100%. The test was easily to perform and the result was stable for at least 1 hour.ConclusionThe Clearview® Malaria pLDH was efficient for the diagnosis of malaria. The test was very sensitive for P. falciparum and P. vivax detection. The sensitivities for P. ovale and P. malariae were better than other RDTs
Highlights
Malaria Rapid Diagnostic Tests (RDTs) are widely used to diagnose malaria
Study design The Clearview Malaria Plasmodium antigen lactate dehydrogenase (pLDH) (Orgenics) was evaluated on fresh blood samples received for analysis and obtained from international travellers suspected of malaria
All discordant results between microscopy and the Clearview Malaria pLDH test were analysed by polymerase chain reaction (PCR) and test characteristics were recalculated according to the PCR-corrected results
Summary
Malaria Rapid Diagnostic Tests (RDTs) are widely used to diagnose malaria. The present study evaluated a new RDT, the Clearview® Malaria pLDH test targeting the pan-Plasmodium antigen lactate dehydrogenase (pLDH). Methods: The Clearview® Malaria pLDH test was evaluated on fresh samples obtained in returned international travellers using microscopy corrected by PCR as the reference method. Traditional standard diagnosis of malaria is based on microscopic examination of stained blood smears and it requires considerable training and experience. Most laboratories in non-endemic countries lack sufficient samples to enable building-up and maintenance of microscopic expertise [2]. Malaria rapid diagnostic tests (malaria RDTs) may be a complement to microscopic malaria diagnosis to non-expericenced laboratory staff in non-endemic setting. Malaria RDTs are immunochromatographic tests targeting specific antigens of one or
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