Abstract
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/mul. Most false negative results occurred among samples with pure gametocytaemia (2/12, 16.7%) and at parasite densities [less than or equal to] 100/ul (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.
Original language | English |
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Journal | Malaria Journal |
Volume | 11 |
Issue number | 204 |
Pages (from-to) | 1-10 |
Number of pages | 10 |
ISSN | 1475-2875 |
DOIs | |
Publication status | Published - 2012 |
Keywords
- Protozoal diseases
- Malaria
- Plasmodium falciparum
- Plasmodium vivax
- Plasmodium ovale
- Plasmodium malariae
- Vectors
- Mosquitoes
- Anopheles
- Evaluation
- Performance
- Rapid diagnostic tests
- Lactate dehydrogenase
- Sensitivity
- Specificity
- Detection
- Laboratory techniques and procedures