Assessment of two malaria rapid diagnostic tests in children under five years of age, with follow-up of false-positive pLDH test results, in a hyperendemic falciparum malaria area, Sierra Leone.

Hdl Handle:
http://hdl.handle.net/10144/91160
Title:
Assessment of two malaria rapid diagnostic tests in children under five years of age, with follow-up of false-positive pLDH test results, in a hyperendemic falciparum malaria area, Sierra Leone.
Authors:
Gerstl, Sibylle; Dunkley, Sophie; Mukhtar, Ahmed; De Smet, Martin; Baker, Samuel; Maikere, Jacob
Journal:
Malaria Journal
Abstract:
ABSTRACT: BACKGROUND: Most malaria rapid diagnostic tests (RDTs) use HRP2 detection, including Paracheck-Pf(R), but their utility is limited by persistent false positivity after treatment. PLDH-based tests become negative more quickly, but sensitivity has been reported below the recommended standard of 90%. A new pLDH test, CareStartTM three-line P.f/PAN-pLDH, claims better sensitivity with continued rapid conversion to negative. The study aims were to 1) compare sensitivity and specificity of CareStartTM to Paracheck-Pf(R) to diagnose falciparum malaria in children under five years of age, 2) assess how quickly false-positive CareStartTM tests become negative and 3) evaluate ease of use and inter-reader agreement of both tests. METHODS: Participants were included if they were aged between two and 59 months, presenting to a Medecins Sans Frontieres community health centre in eastern Sierra Leone with suspected malaria defined as fever (axillary temperature > 37.5degreesC) and/or history of fever in the previous 72 hours and no signs of severe disease. The same capillary blood was used for the RDTs and the blood slide, the latter used as the gold standard reference. All positive participants were treated with supervised artesunate and amodiaquine treatment for three days. Participants with a persistent false-positive CareStartTM, but a negative blood slide on Day 2, were followed with repeated CareStartTM and blood slide tests every seven days until CareStartTM became negative or a maximum of 28 days. RESULTS: Sensitivity of CareStartTM was 99.4% (CI 96.8-100.0, 168/169) and of Paracheck-Pf(R), 98.8% (95% CI 95.8-99.8, 167/169). Specificity of CareStartTM was 96.0% (CI 91.9-98.4, 167/174) and of Paracheck-Pf(R), 74.7% (CI 67.6-81.0, 130/174) (p<0.001). Neither test showed any change in sensitivity with decreasing parasitaemia. Of the 155 eligible follow-up CareStartTM participants, 63.9% (99/155) had a false-positive test on day 2, 21.3% (33/155) on day 7, 5.8% (9/155) on day 14, 1.9% (3/155) on day 21 and 0.6% (1/155) on day 28. The median time for test negativity was seven days. CareStartTM was as easy to use and interpret as Paracheck-Pf(R) with excellent inter-reader agreement. CONCLUSIONS: Both RDTs were highly sensitive, met WHO standards for the detection of falciparum malaria monoinfections where parasitaemia was >100 parasites/mul and were easy to use. CareStartTM persistent false positivity decreased quickly after successful anti-malarial treatment, making it a good choice for a RDT for a hyperendemic falciparum malaria area.
Issue Date:
21-Jan-2010
URI:
http://hdl.handle.net/10144/91160
DOI:
10.1186/1475-2875-9-28
PubMed ID:
20092620
Language:
en
ISSN:
1475-2875
Appears in Collections:
Malaria

Full metadata record

DC FieldValue Language
dc.contributor.authorGerstl, Sibylleen
dc.contributor.authorDunkley, Sophieen
dc.contributor.authorMukhtar, Ahmeden
dc.contributor.authorDe Smet, Martinen
dc.contributor.authorBaker, Samuelen
dc.contributor.authorMaikere, Jacoben
dc.date.accessioned2010-02-04T21:22:54Z-
dc.date.available2010-02-04T21:22:54Z-
dc.date.issued2010-01-21-
dc.identifier.citationAssessment of two malaria rapid diagnostic tests in children under five years of age, with follow-up of false-positive pLDH test results, in a hyperendemic falciparum malaria area, Sierra Leone. 2010, 9 (1):28notMalar Jen
dc.identifier.issn1475-2875-
dc.identifier.pmid20092620-
dc.identifier.doi10.1186/1475-2875-9-28-
dc.identifier.urihttp://hdl.handle.net/10144/91160-
dc.description.abstractABSTRACT: BACKGROUND: Most malaria rapid diagnostic tests (RDTs) use HRP2 detection, including Paracheck-Pf(R), but their utility is limited by persistent false positivity after treatment. PLDH-based tests become negative more quickly, but sensitivity has been reported below the recommended standard of 90%. A new pLDH test, CareStartTM three-line P.f/PAN-pLDH, claims better sensitivity with continued rapid conversion to negative. The study aims were to 1) compare sensitivity and specificity of CareStartTM to Paracheck-Pf(R) to diagnose falciparum malaria in children under five years of age, 2) assess how quickly false-positive CareStartTM tests become negative and 3) evaluate ease of use and inter-reader agreement of both tests. METHODS: Participants were included if they were aged between two and 59 months, presenting to a Medecins Sans Frontieres community health centre in eastern Sierra Leone with suspected malaria defined as fever (axillary temperature > 37.5degreesC) and/or history of fever in the previous 72 hours and no signs of severe disease. The same capillary blood was used for the RDTs and the blood slide, the latter used as the gold standard reference. All positive participants were treated with supervised artesunate and amodiaquine treatment for three days. Participants with a persistent false-positive CareStartTM, but a negative blood slide on Day 2, were followed with repeated CareStartTM and blood slide tests every seven days until CareStartTM became negative or a maximum of 28 days. RESULTS: Sensitivity of CareStartTM was 99.4% (CI 96.8-100.0, 168/169) and of Paracheck-Pf(R), 98.8% (95% CI 95.8-99.8, 167/169). Specificity of CareStartTM was 96.0% (CI 91.9-98.4, 167/174) and of Paracheck-Pf(R), 74.7% (CI 67.6-81.0, 130/174) (p<0.001). Neither test showed any change in sensitivity with decreasing parasitaemia. Of the 155 eligible follow-up CareStartTM participants, 63.9% (99/155) had a false-positive test on day 2, 21.3% (33/155) on day 7, 5.8% (9/155) on day 14, 1.9% (3/155) on day 21 and 0.6% (1/155) on day 28. The median time for test negativity was seven days. CareStartTM was as easy to use and interpret as Paracheck-Pf(R) with excellent inter-reader agreement. CONCLUSIONS: Both RDTs were highly sensitive, met WHO standards for the detection of falciparum malaria monoinfections where parasitaemia was >100 parasites/mul and were easy to use. CareStartTM persistent false positivity decreased quickly after successful anti-malarial treatment, making it a good choice for a RDT for a hyperendemic falciparum malaria area.en
dc.languageENG-
dc.language.isoenen
dc.rightsPublished by BioMed Central, [url]http://www.malariajournal.com/[/url] Archived on this site by Open Access permissionen
dc.titleAssessment of two malaria rapid diagnostic tests in children under five years of age, with follow-up of false-positive pLDH test results, in a hyperendemic falciparum malaria area, Sierra Leone.en
dc.identifier.journalMalaria Journalen

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