Evaluation of the rapid diagnostic test CareStart pLDH Malaria (Pf-pLDH/pan-pLDH) for the diagnosis of malaria in a reference setting.
Malar J
; 11: 204, 2012 Jun 18.
Article
em En
| MEDLINE
| ID: mdl-22704733
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/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.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Plasmodium
/
Testes Diagnósticos de Rotina
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Malária
Tipo de estudo:
Diagnostic_studies
/
Evaluation_studies
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Prognostic_studies
Limite:
Adolescent
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Adult
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Aged
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Child
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Child, preschool
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Female
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Humans
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Infant
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Male
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Middle aged
Idioma:
En
Ano de publicação:
2012
Tipo de documento:
Article