| Summary: | <p>Abstract</p> <p>Background</p> <p>Palutop+4 (All. Diag, Strasbourg, France), a four-band malaria rapid diagnostic test (malaria RDT) targeting the histidine-rich protein 2 (HRP-2), <it>Plasmodium vivax-</it>specific parasite lactate dehydrogenase (Pv-pLDH) and pan <it>Plasmodium</it>-specific pLDH (pan-pLDH) was evaluated in a non-endemic setting on stored whole blood samples from international travellers suspected of malaria.</p> <p>Methods</p> <p>Microscopy corrected by PCR was the reference method. Samples include those infected by <it>Plasmodium falciparum </it>(n = 323), <it>Plasmodium vivax </it>(n = 97), <it>Plasmodium ovale </it>(n = 73) and <it>Plasmodium malariae </it>(n = 25) and 95 malaria negative samples.</p> <p>Results</p> <p>The sensitivities for the diagnosis of <it>P. falciparum</it>, <it>P. vivax, P. malariae </it>and <it>P. ovale </it>were 85.1%, 66.0%, 32.0% and 5.5%. Sensitivities increased at higher parasite densities and reached 90.0% for <it>P. falciparum </it>>100/μl and 83.8% for <it>P. vivax </it>> 500/μl. Fourteen <it>P. falciparum </it>samples reacted with the Pv-pLDH line, one <it>P. vivax </it>sample with the HRP-2 line, and respectively two and four <it>P. ovale </it>and <it>P. malariae </it>samples reacted with the HRP-2 line. Two negative samples gave a signal with the HRP-2 line. Faint and weak line intensities were observed for 129/289 (44.6%) HRP-2 lines in <it>P. falciparum </it>samples, for 50/64 (78.1%) Pv-pLDH lines in <it>P. vivax </it>samples and for 9/13 (69.2%) pan-pLDH lines in <it>P. ovale </it>and <it>P. malariae </it>samples combined. Inter-observer reliabilities for positive and negative readings were excellent for the HRP-2 and Pv-pLDH lines (overall agreement > 92.0% and kappa-values for each pair of readers ≥ 0.88), and good for the pan-pLDH line (85.5% overall agreement and kappa-values ≥ 0.74).</p> <p>Conclusions</p> <p>Palutop+4 performed moderately for the detection of <it>P. falciparum </it>and <it>P. vivax</it>, but sensitivities were lower than those of three-band malaria RDTs.</p>
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