Evaluation of three parasite lactate dehydrogenase-based rapid diagnostic tests for the diagnosis of falciparum and vivax malaria

Hdl Handle:
http://hdl.handle.net/10144/114141
Title:
Evaluation of three parasite lactate dehydrogenase-based rapid diagnostic tests for the diagnosis of falciparum and vivax malaria
Authors:
Ashley, Elizabeth A; Touabi, Malek; Ahrer, Margareta; Hutagalung, Robert; Htun, Khayae; Luchavez, Jennifer; Dureza, Christine; Proux, Stephane; Leimanis, Mara; Lwin, Myo Min; Koscalova, Alena; Comte, Eric; Hamade, Prudence; Page, Anne-Laure; Nosten, François; Guerin, Philippe J
Journal:
Malaria Journal
Abstract:
BACKGROUND: In areas where non-falciparum malaria is common rapid diagnostic tests (RDTs) capable of distinguishing malaria species reliably are needed. Such tests are often based on the detection of parasite lactate dehydrogenase (pLDH). METHODS: In Dawei, southern Myanmar, three pLDH based RDTs (CareStart Malaria pLDH (Pan), CareStart Malaria pLDH (Pan, Pf) and OptiMAL-IT)were evaluated in patients presenting with clinically suspected malaria. Each RDT was read independently by two readers. A subset of patients with microscopically confirmed malaria had their RDTs repeated on days 2, 7 and then weekly until negative. At the end of the study, samples of study batches were sent for heat stability testing. RESULTS: Between August and November 2007, 1004 patients aged between 1 and 93 years were enrolled in the study. Slide microscopy (the reference standard) diagnosed 213 Plasmodium vivax (Pv) monoinfections, 98 Plasmodium falciparum (Pf) mono-infections and no malaria in 650 cases. The sensitivities (sens) and specificities (spec), of the RDTs for the detection of malaria were- CareStart Malaria pLDH (Pan) test: sens 89.1% [CI95 84.2-92.6], spec 97.6% [CI95 96.5-98.4]. OptiMal-IT: Pf+/- other species detection: sens 95.2% [CI95 87.5-98.2], spec 94.7% [CI95 93.3-95.8]; non-Pf detection alone: sens 89.6% [CI95 83.6-93.6], spec 96.5% [CI95 94.8-97.7]. CareStart Malaria pLDH (Pan, Pf): Pf+/- other species: sens 93.5% [CI95 85.4-97.3], spec 97.4% [95.9-98.3]; non-Pf: sens 78.5% [CI95 71.1-84.4], spec 97.8% [CI95 96.3-98.7]. Inter-observer agreement was excellent for all tests (kappa > 0.9). The median time for the RDTs to become negative was two days for the CareStart Malaria tests and seven days for OptiMAL-IT. Tests were heat stable up to 90 days except for OptiMAL-IT (Pf specific pLDH stable to day 20 at 35 degrees C). CONCLUSION: None of the pLDH-based RDTs evaluated was able to detect non-falciparum malaria with high sensitivity, particularly at low parasitaemias. OptiMAL-IT performed best overall and would perform best in an area of high malaria prevalence among screened fever cases. However, heat stability was unacceptable and the number of steps to perform this test is a significant drawback in the field. A reliable, heat-stable, highly sensitive RDT, capable of diagnosing all Plasmodium species has yet to be identified.
Affiliation:
Epicentre, Paris, France; Department of Microbiology, Hammersmith Hospital, Imperial College NHS Trust, London, UK; Médecins sans Frontières, Switzerland; Médecins sans Frontières, Myanmar; Research Institute for Tropical Medicine, Alabang, Muntinlupa City, Philippines; Shoklo Malaria Research Unit, Mae Sot, Thailand; Mahidol-Oxford Tropical Medicine Research Unit (MORU), Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine, Nuffield Department of Clinical Medicine, University of Oxford, UK; Médecins sans Frontières Malaria Working Group, UK; Malaria Consortium, London, UK
Issue Date:
27-Oct-2009
URI:
http://hdl.handle.net/10144/114141
DOI:
10.1186/1475-2875-8-241
PubMed ID:
19860920
Additional Links:
http://www.malariajournal.com/content/8/1/241
Type:
Article
Language:
en
ISSN:
1475-2875
Appears in Collections:
Malaria

Full metadata record

DC FieldValue Language
dc.contributor.authorAshley, Elizabeth Aen
dc.contributor.authorTouabi, Maleken
dc.contributor.authorAhrer, Margaretaen
dc.contributor.authorHutagalung, Roberten
dc.contributor.authorHtun, Khayaeen
dc.contributor.authorLuchavez, Jenniferen
dc.contributor.authorDureza, Christineen
dc.contributor.authorProux, Stephaneen
dc.contributor.authorLeimanis, Maraen
dc.contributor.authorLwin, Myo Minen
dc.contributor.authorKoscalova, Alenaen
dc.contributor.authorComte, Ericen
dc.contributor.authorHamade, Prudenceen
dc.contributor.authorPage, Anne-Laureen
dc.contributor.authorNosten, Françoisen
dc.contributor.authorGuerin, Philippe Jen
dc.date.accessioned2010-10-29T15:13:58Z-
dc.date.available2010-10-29T15:13:58Z-
dc.date.issued2009-10-27-
dc.identifier.citationMalar. J. 2009;8:241en
dc.identifier.issn1475-2875-
dc.identifier.pmid19860920-
dc.identifier.doi10.1186/1475-2875-8-241-
dc.identifier.urihttp://hdl.handle.net/10144/114141-
dc.description.abstractBACKGROUND: In areas where non-falciparum malaria is common rapid diagnostic tests (RDTs) capable of distinguishing malaria species reliably are needed. Such tests are often based on the detection of parasite lactate dehydrogenase (pLDH). METHODS: In Dawei, southern Myanmar, three pLDH based RDTs (CareStart Malaria pLDH (Pan), CareStart Malaria pLDH (Pan, Pf) and OptiMAL-IT)were evaluated in patients presenting with clinically suspected malaria. Each RDT was read independently by two readers. A subset of patients with microscopically confirmed malaria had their RDTs repeated on days 2, 7 and then weekly until negative. At the end of the study, samples of study batches were sent for heat stability testing. RESULTS: Between August and November 2007, 1004 patients aged between 1 and 93 years were enrolled in the study. Slide microscopy (the reference standard) diagnosed 213 Plasmodium vivax (Pv) monoinfections, 98 Plasmodium falciparum (Pf) mono-infections and no malaria in 650 cases. The sensitivities (sens) and specificities (spec), of the RDTs for the detection of malaria were- CareStart Malaria pLDH (Pan) test: sens 89.1% [CI95 84.2-92.6], spec 97.6% [CI95 96.5-98.4]. OptiMal-IT: Pf+/- other species detection: sens 95.2% [CI95 87.5-98.2], spec 94.7% [CI95 93.3-95.8]; non-Pf detection alone: sens 89.6% [CI95 83.6-93.6], spec 96.5% [CI95 94.8-97.7]. CareStart Malaria pLDH (Pan, Pf): Pf+/- other species: sens 93.5% [CI95 85.4-97.3], spec 97.4% [95.9-98.3]; non-Pf: sens 78.5% [CI95 71.1-84.4], spec 97.8% [CI95 96.3-98.7]. Inter-observer agreement was excellent for all tests (kappa > 0.9). The median time for the RDTs to become negative was two days for the CareStart Malaria tests and seven days for OptiMAL-IT. Tests were heat stable up to 90 days except for OptiMAL-IT (Pf specific pLDH stable to day 20 at 35 degrees C). CONCLUSION: None of the pLDH-based RDTs evaluated was able to detect non-falciparum malaria with high sensitivity, particularly at low parasitaemias. OptiMAL-IT performed best overall and would perform best in an area of high malaria prevalence among screened fever cases. However, heat stability was unacceptable and the number of steps to perform this test is a significant drawback in the field. A reliable, heat-stable, highly sensitive RDT, capable of diagnosing all Plasmodium species has yet to be identified.en
dc.language.isoenen
dc.relation.urlhttp://www.malariajournal.com/content/8/1/241en
dc.rightsPublished by BioMed Central, [url]http://www.malariajournal.com/[/url] Archived on this site by Open Access permissionen
dc.subject.meshAdolescenten
dc.subject.meshAdulten
dc.subject.meshAgeden
dc.subject.meshAged, 80 and overen
dc.subject.meshAnimalsen
dc.subject.meshBlood Specimen Collectionen
dc.subject.meshChilden
dc.subject.meshChild, Preschoolen
dc.subject.meshDiagnostic Tests, Routineen
dc.subject.meshFemaleen
dc.subject.meshHumansen
dc.subject.meshInfanten
dc.subject.meshInfant, Newbornen
dc.subject.meshL-Lactate Dehydrogenaseen
dc.subject.meshMalaria, Falciparumen
dc.subject.meshMalaria, Vivaxen
dc.subject.meshMaleen
dc.subject.meshMicroscopyen
dc.subject.meshMiddle Ageden
dc.subject.meshMyanmaren
dc.subject.meshPlasmodium falciparumen
dc.subject.meshPlasmodium vivaxen
dc.subject.meshPolymerase Chain Reactionen
dc.subject.meshPredictive Value of Testsen
dc.subject.meshProspective Studiesen
dc.subject.meshReagent Kits, Diagnosticen
dc.subject.meshSensitivity and Specificityen
dc.subject.meshYoung Adulten
dc.titleEvaluation of three parasite lactate dehydrogenase-based rapid diagnostic tests for the diagnosis of falciparum and vivax malariaen
dc.typeArticleen
dc.contributor.departmentEpicentre, Paris, France; Department of Microbiology, Hammersmith Hospital, Imperial College NHS Trust, London, UK; Médecins sans Frontières, Switzerland; Médecins sans Frontières, Myanmar; Research Institute for Tropical Medicine, Alabang, Muntinlupa City, Philippines; Shoklo Malaria Research Unit, Mae Sot, Thailand; Mahidol-Oxford Tropical Medicine Research Unit (MORU), Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine, Nuffield Department of Clinical Medicine, University of Oxford, UK; Médecins sans Frontières Malaria Working Group, UK; Malaria Consortium, London, UKen
dc.identifier.journalMalaria Journalen

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