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Background  Malaria Rapid Diagnostic Tests (RDTs) are widely used for diagnosing malaria. The present retrospective study evaluated the CareStart™ Malaria HRP-2/pLDH (Pf/pan) Combo Test targeting the  Plasmodium falciparum  specific antigen histidine-rich protein (HRP-2) and the pan- Plasmodium  antigen lactate dehydrogenase (pLDH) in a reference setting.    Methods  The CareStart™ Malaria HRP-2/pLDH (Pf/pan) Combo Test was evaluated on a collection of samples obtained in returned international travellers using microscopy corrected by PCR as the reference method. Included were  P. falciparum  (n = 320),  Plasmodium vivax  (n = 76),  Plasmodium ovale  (n = 76),  Plasmodium malariae  (n = 23) and  Plasmodium  negative samples (n = 95).    Results  Overall sensitivity for the detection of  P. falciparum  was 88.8%, increasing to 94.3% and 99.3% at parasite densities above 100 and 1,000/μl respectively. For  P. vivax, P. ovale  and  P. malariae , overall sensitivities were 77.6%, 18.4% and 30.4% respectively. For  P. vivax  sensitivity reached 90.2% for parasite densities above 500/μl. Incorrect species identification occurred in 11/495 samples (2.2%), including 8/320 (2.5%)  P. falciparum  samples which generated only the pan-pLDH line. For  P. falciparum  samples, 205/284 (72.2%) HRP-2 test lines had strong or medium line intensities, while for all species the pan-pLDH lines were less intense, especially in the case of  P. ovale . Agreement between observers was excellent (kappa values > 0.81 for positive and negative readings) and test results were reproducible. The test was easy to perform with good clearing of the background.    Conclusion  The CareStart™ Malaria HRP-2/pLDH (Pf/pan) Combo Test performed well for the detection of  P. falciparum  and  P. vivax , but sensitivities for  P. ovale  and  P. malariae  were poor.

Evaluation of a rapid diagnostic test (CareStart™ Malaria HRP-2/pLDH (Pf/pan) Combo Test) for the diagnosis of malaria in a reference setting