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Background  The present study evaluated the SD Bioline Malaria Ag 05FK40 (SDFK40), a three-band RDT detecting  Plasmodium falciparum -specific parasite lactate dehydrogenase (Pf-pLDH) and pan  Plasmodium -specific pLDH (pan-pLDH), in a reference setting.    Methods  The SDFK40 was retrospectively and prospectively tested against a panel of stored (n = 341) and fresh (n = 181) whole blood samples obtained in international travelers suspected of malaria, representing the four  Plasmodium  species as well as  Plasmodium  negative samples, and compared to microscopy and PCR results. The prospective panel was run together with OptiMAL (Pf-pLDH/pan-pLDH) and SDFK60 (histidine-rich protein-2 (HRP-2)/pan-pLDH).    Results  Overall sensitivities for  P. falciparum  tested retrospectively and prospectively were 67.9% and 78.8%, reaching 100% and 94.6% at parasite densities >1,000/μl. Sensitivity at parasite densities ≤ 100/μl was 9.1%. Overall sensitivities for  Plasmodium vivax  and  Plasmodium ovale  were 86.7% and 80.0% (retrospectively) and 92.9% and 76.9% (prospectively), reaching 94.7% for both species (retrospective panel) at parasite densities >500/μl. Sensitivity for  Plasmodium malariae  was 21.4%. Species mismatch occurred in 0.7% of samples (3/411) and was limited to non- falciparum  species erroneously identified as  P. falciparum . None of the  Plasmodium  negative samples in the retrospective panel reacted positive. Compared to OptiMAL and SDFK60, SDFK40 showed lower sensitivities for  P. falciparum , but better detection of  P. ovale . Inter-observer agreement and test reproducibility were excellent, but lot-to-lot variability was observed for pan-pLDH results in case of  P. falciparum .    Conclusion  SDFK40 performance was poor at low (≤ 100/μl) parasite densities, precluding its use as the only diagnostic tool for malaria diagnosis. SDFK40 performed excellent for  P. falciparum  samples at high (>1,000/μl) parasite densities as well as for detection of  P. vivax  and  P. ovale  at parasite densities >500/μl.

Evaluation of the rapid diagnostic test SDFK40 (Pf-pLDH/pan-pLDH) for the diagnosis of malaria in a non-endemic setting