Evaluation of the Clearview® malaria pLDH malaria rapid diagnostic test in a non-endemic setting

<p>Abstract</p> <p>Background</p> <p>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-<it>Plasmodium </it>antigen lactate dehydrogenase (pLDH).</p> <p>Methods</p> <p>The 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 <it>Plasmodium falciparum </it>(139), <it>Plasmodium vivax </it>(22), <it>Plasmodium ovale </it>(20), <it>Plasmodium malariae </it>(7), and 102 negative.</p> <p>Results</p> <p>Overall sensitivity for the detection of <it>Plasmodium </it><it>spp </it>was 93.2%. For <it>P. falciparum</it>, the sensitivity was 98.6%; for <it>P. vivax</it>, <it>P. ovale </it>and <it>P. malariae</it>, overall sensitivities were 90.9%, 60.0% and 85.7% respectively. For <it>P. falciparum </it>and for <it>P. vivax</it>, 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.</p> <p>Conclusion</p> <p>The Clearview^®Malaria pLDH was efficient for the diagnosis of malaria. The test was very sensitive for <it>P. falciparum </it>and <it>P. vivax </it>detection. The sensitivities for <it>P. ovale </it>and <it>P. malariae </it>were better than other RDTs</p