Evaluation of the rapid diagnostic test SDFK40 (Pf-pLDH/pan-pLDH) for the diagnosis of malaria in a non-endemic setting
Abstract 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...
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ftdoajarticles:oai:doaj.org/article:ee32c6e931d74f5bb450dce4c5cdb587 2023-05-15T15:15:22+02:00 Evaluation of the rapid diagnostic test SDFK40 (Pf-pLDH/pan-pLDH) for the diagnosis of malaria in a non-endemic setting Van Esbroeck Marjan Bottieau Emmanuel Cnops Lieselotte Gillet Philippe Maltha Jessica Bruggeman Cathrien Jacobs Jan 2011-01-01T00:00:00Z https://doi.org/10.1186/1475-2875-10-7 https://doaj.org/article/ee32c6e931d74f5bb450dce4c5cdb587 EN eng BMC http://www.malariajournal.com/content/10/1/7 https://doaj.org/toc/1475-2875 doi:10.1186/1475-2875-10-7 1475-2875 https://doaj.org/article/ee32c6e931d74f5bb450dce4c5cdb587 Malaria Journal, Vol 10, Iss 1, p 7 (2011) Arctic medicine. Tropical medicine RC955-962 Infectious and parasitic diseases RC109-216 article 2011 ftdoajarticles https://doi.org/10.1186/1475-2875-10-7 2022-12-31T01:52:25Z Abstract 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. Article in Journal/Newspaper Arctic Directory of Open Access Journals: DOAJ Articles Arctic Malaria Journal 10 1 |
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Directory of Open Access Journals: DOAJ Articles |
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ftdoajarticles |
language |
English |
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Arctic medicine. Tropical medicine RC955-962 Infectious and parasitic diseases RC109-216 |
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Arctic medicine. Tropical medicine RC955-962 Infectious and parasitic diseases RC109-216 Van Esbroeck Marjan Bottieau Emmanuel Cnops Lieselotte Gillet Philippe Maltha Jessica Bruggeman Cathrien Jacobs Jan Evaluation of the rapid diagnostic test SDFK40 (Pf-pLDH/pan-pLDH) for the diagnosis of malaria in a non-endemic setting |
topic_facet |
Arctic medicine. Tropical medicine RC955-962 Infectious and parasitic diseases RC109-216 |
description |
Abstract 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. |
format |
Article in Journal/Newspaper |
author |
Van Esbroeck Marjan Bottieau Emmanuel Cnops Lieselotte Gillet Philippe Maltha Jessica Bruggeman Cathrien Jacobs Jan |
author_facet |
Van Esbroeck Marjan Bottieau Emmanuel Cnops Lieselotte Gillet Philippe Maltha Jessica Bruggeman Cathrien Jacobs Jan |
author_sort |
Van Esbroeck Marjan |
title |
Evaluation of the rapid diagnostic test SDFK40 (Pf-pLDH/pan-pLDH) for the diagnosis of malaria in a non-endemic setting |
title_short |
Evaluation of the rapid diagnostic test SDFK40 (Pf-pLDH/pan-pLDH) for the diagnosis of malaria in a non-endemic setting |
title_full |
Evaluation of the rapid diagnostic test SDFK40 (Pf-pLDH/pan-pLDH) for the diagnosis of malaria in a non-endemic setting |
title_fullStr |
Evaluation of the rapid diagnostic test SDFK40 (Pf-pLDH/pan-pLDH) for the diagnosis of malaria in a non-endemic setting |
title_full_unstemmed |
Evaluation of the rapid diagnostic test SDFK40 (Pf-pLDH/pan-pLDH) for the diagnosis of malaria in a non-endemic setting |
title_sort |
evaluation of the rapid diagnostic test sdfk40 (pf-pldh/pan-pldh) for the diagnosis of malaria in a non-endemic setting |
publisher |
BMC |
publishDate |
2011 |
url |
https://doi.org/10.1186/1475-2875-10-7 https://doaj.org/article/ee32c6e931d74f5bb450dce4c5cdb587 |
geographic |
Arctic |
geographic_facet |
Arctic |
genre |
Arctic |
genre_facet |
Arctic |
op_source |
Malaria Journal, Vol 10, Iss 1, p 7 (2011) |
op_relation |
http://www.malariajournal.com/content/10/1/7 https://doaj.org/toc/1475-2875 doi:10.1186/1475-2875-10-7 1475-2875 https://doaj.org/article/ee32c6e931d74f5bb450dce4c5cdb587 |
op_doi |
https://doi.org/10.1186/1475-2875-10-7 |
container_title |
Malaria Journal |
container_volume |
10 |
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1 |
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1766345728749207552 |