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

摘要

Background The present study evaluated CareStart pLDH Malaria, a three-band rapid diagnostic test detecting Plasmodium falciparum-specific parasite lactate dehydrogenase (Pf-pLDH) and pan Plasmodium-specific pLDH (pan-pLDH) in a reference setting. Methods CareStart pLDH was retrospectively and prospectively assessed with a panel of stored (n?=?498) and fresh (n?=?77) blood samples obtained in international travelers suspected of malaria. Both panels comprised all four Plasmodium species; the retrospective panel comprised also Plasmodium negative samples. The reference method was microscopy corrected by PCR. The prospective panel was run side-to-side with OptiMAL (Pf-pLDH/pan-pLDH) and SDFK60 (histidine-rich protein-2 (HRP-2)/pan-pLDH). Results In the retrospective evaluation, overall sensitivity for P. falciparum samples (n?=?247) was 94.7%, reaching 98.7% for parasite densities?>?1,000/μl. Most false negative results occurred among samples with pure gametocytaemia (2/12, 16.7%) and at parasite densities?≤?100/μl (7/12, 58.3%). None of the Plasmodium negative samples (n?=?96) showed visible test lines. Sensitivities for Plasmodium vivax (n?=?70), Plasmodium ovale (n?=?69) and Plasmodium malariae (n?=?16) were 74.3%, 31.9% and 25.0% respectively. Wrong species identification occurred in 10 (2.5%) samples and was mainly due to P. vivax samples reacting with the Pf-pLDH test line. Overall, Pf-pLDH test lines showed higher line intensities compared to the pan-pLDH lines (67.9% and 23.0% medium and strong line intensities for P. falciparum). In the prospective panel (77 Plasmodium-positive samples), CareStart pLDH showed higher sensitivities for P. falciparum compared to OptiMAL (p?=?0.008), lower sensitivities for P. falciparum as compare to SDFK60 (although not reaching statistical significance, p?=?0.08) and higher sensitivities for P. ovale compared to both OptiMAL (p?=?0.03) and SDFK60 (p?=?0.01). Inter-observer and test reproducibility were good to excellent. Conclusion CareStart pLDH performed excellent for the detection of P. falciparum, well for P. vivax, but poor for P. ovale and P. malariae.