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False positivity of non-targeted infections in malaria rapid diagnostic tests: the case of human African trypanosomiasis

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Show simple item record Gillet, P. en_US Mumba Ngoyi, D. en_US Lukuka, A. en_US Kande, V. en_US Atua, B. en_US van Griensven, J. en_US Muyembe, J. J. en_US Jacobs, J. en_US Lejon, V. en_US 2014-09-25T13:39:15Z 2014-09-25T13:39:15Z 2013 en_US
dc.identifier.issn 1935-2727 en_US
dc.identifier.doi en_US
dc.identifier.other ITG-C1A; ITG-C6A; ITG-C8A; ITG-CLA; ITG-BLA; MULTI; DCS; U-TLM; U-INFDIS; DBM; U-PARDIA; JIF; DOI; FTA; E-only; Abstract; UPD56 en_US
dc.description.abstract BACKGROUND: In endemic settings, diagnosis of malaria increasingly relies on the use of rapid diagnostic tests (RDTs). False positivity of such RDTs is poorly documented, although it is especially relevant in those infections that resemble malaria, such as human African trypanosomiasis (HAT). We therefore examined specificity of malaria RDT products among patients infected with Trypanosoma brucei gambiense. METHODOLOGYPRINCIPAL FINDINGS: Blood samples of 117 HAT patients and 117 matched non-HAT controls were prospectively collected in the Democratic Republic of the Congo. Reference malaria diagnosis was based on real-time PCR. Ten commonly used malaria RDT products were assessed including three two-band and seven three-band products, targeting HRP-2, Pf-pLDH and/or pan-pLDH antigens. Rheumatoid factor was determined in PCR negative subjects. Specificity of the 10 malaria RDT products varied between 79.5 and 100% in HAT-negative controls and between 11.3 and 98.8% in HAT patients. For seven RDT products, specificity was significantly lower in HAT patients compared to controls. False positive reactions in HAT were mainly observed for pan-pLDH test lines (specificities between 13.8 and 97.5%), but also occurred frequently for the HRP-2 test line (specificities between 67.9 and 98.8%). The Pf-pLDH test line was not affected by false-positive lines in HAT patients (specificities between 97.5 and 100%). False positivity was not associated to rheumatoid factor, detected in 7.6% of controls and 1.2% of HAT patients. CONCLUSIONSSIGNIFICANCE: Specificity of some malaria RDT products in HAT was surprisingly low, and constitutes a risk for misdiagnosis of a fatal but treatable infection. Our results show the importance to assess RDT specificity in non-targeted infections when evaluating diagnostic tests. en_US
dc.language English en_US
dc.subject Protozoal diseases en_US
dc.subject Trypanosomiasis, African en_US
dc.subject Sleeping sickness en_US
dc.subject Trypanosoma brucei gambiense en_US
dc.subject Vectors en_US
dc.subject Tsetse flies en_US
dc.subject Glossina morsitans en_US
dc.subject Diagnosis en_US
dc.subject Evaluation en_US
dc.subject Performance en_US
dc.subject Rapid diagnostic tests en_US
dc.subject Malaria en_US
dc.subject Specificity en_US
dc.subject False-positive en_US
dc.subject HRP-2 en_US
dc.subject Congo-Kinshasa en_US
dc.subject Africa, Central en_US
dc.title False positivity of non-targeted infections in malaria rapid diagnostic tests: the case of human African trypanosomiasis en_US
dc.type Article-E en_US
dc.citation.issue 4 en_US
dc.citation.jtitle PLoS Neglected Tropical Diseases en_US
dc.citation.volume 7 en_US
dc.citation.pages e2180 en_US
dc.identifier.pmid en_US
dc.citation.jabbreviation PLoS Negl Trop Dis en_US

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