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EBOLA Ag K-SeT rapid test: field evaluation in Sierra Leone.
Colavita, F; Biava, M; Mertens, P; Gilleman, Q; Borlon, C; Delli Guanti, M; Petrocelli, A; Cataldi, G; Kamara, A T; Kamara, S A; Konneh, K; Vincenti, D; Castilletti, C; Abdurahman, S; Mirazimi, A; Capobianchi, M R; Ippolito, G; Miccio, R; Di Caro, A.
Afiliación
  • Colavita F; National Institute for Infectious Diseases 'L. Spallanzani' IRCCS, Rome, Italy.
  • Biava M; National Institute for Infectious Diseases 'L. Spallanzani' IRCCS, Rome, Italy.
  • Mertens P; Coris BioConcept, Gembloux, Belgium.
  • Gilleman Q; Coris BioConcept, Gembloux, Belgium.
  • Borlon C; Coris BioConcept, Gembloux, Belgium.
  • Delli Guanti M; EMERGENCY Onlus NGO, Milan, Italy.
  • Petrocelli A; EMERGENCY Onlus NGO, Milan, Italy.
  • Cataldi G; EMERGENCY Onlus NGO, Milan, Italy.
  • Kamara AT; EMERGENCY Onlus NGO, Milan, Italy; Diagnostic Ebola Virus Diseases Laboratory, 'Princess Christian Maternity Hospital', Freetown, Sierra Leone.
  • Kamara SA; EMERGENCY Onlus NGO, Milan, Italy; Diagnostic Ebola Virus Diseases Laboratory, 'Princess Christian Maternity Hospital', Freetown, Sierra Leone.
  • Konneh K; EMERGENCY Onlus NGO, Milan, Italy; Diagnostic Ebola Virus Diseases Laboratory, 'Princess Christian Maternity Hospital', Freetown, Sierra Leone.
  • Vincenti D; National Institute for Infectious Diseases 'L. Spallanzani' IRCCS, Rome, Italy.
  • Castilletti C; National Institute for Infectious Diseases 'L. Spallanzani' IRCCS, Rome, Italy.
  • Abdurahman S; Public Health Agency of Sweden, Stockholm, Sweden.
  • Mirazimi A; Public Health Agency of Sweden, Stockholm, Sweden; National Veterinary Institute, Uppsala, Sweden; Department of Medicine, Karolinska Institute, Stockholm, Sweden.
  • Capobianchi MR; National Institute for Infectious Diseases 'L. Spallanzani' IRCCS, Rome, Italy.
  • Ippolito G; National Institute for Infectious Diseases 'L. Spallanzani' IRCCS, Rome, Italy.
  • Miccio R; EMERGENCY Onlus NGO, Milan, Italy.
  • Di Caro A; National Institute for Infectious Diseases 'L. Spallanzani' IRCCS, Rome, Italy. Electronic address: antonino.dicaro@inmi.it.
Clin Microbiol Infect ; 24(6): 653-657, 2018 Jun.
Article en En | MEDLINE | ID: mdl-29107122
OBJECTIVES: Efficient interruption of Ebola virus disease (EVD) transmission chains critically depends on reliable and fast laboratory diagnosis. We evaluated the performance of the EBOLA Virus Antigen Detection K-SeT (EBOLA Ag K-SeT), a new rapid diagnostic antigen test in field settings. METHODS: The study was conducted in a field laboratory located in Freetown (Sierra Leone) by the Italian National Institute for Infectious Diseases 'L. Spallanzani' and the EMERGENCY Onlus NGO. The EBOLA Ag K-SeT was tested on 210 residual plasma samples (EVD prevalence 50%) from patients hospitalized at the EMERGENCY Ebola treatment center in Goderich (Freetown), comparing the results with quantitative real-time PCR. RESULTS: Overall, the sensitivity of EBOLA Ag K-SeT was 88.6% (95% confidence interval (CI), 82.5-94.7), and the corresponding specificity was 98.1% (95% CI, 95.5-100.7). The positive and negative predictive values were 97.9% (95% CI, 95.0-100.8) and 89.6% (95% CI, 84-95.2), respectively. The sensitivity strongly increased up to 98.7% (95% CI, 96.1-101.2) for those samples with high virus load (≥6.2 log RNA copies/mL). CONCLUSIONS: Our results suggest that EBOLA Ag K-SeT could represent a new effective diagnostic tool for EVD, meeting a need for resource-poor settings and rapid diagnosis for individuals with suspected EVD.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Proteínas de la Matriz Viral / Fiebre Hemorrágica Ebola / Ebolavirus / Antígenos Virales Tipo de estudio: Diagnostic_studies / Prognostic_studies / Risk_factors_studies Límite: Female / Humans / Male País/Región como asunto: Africa Idioma: En Revista: Clin Microbiol Infect Asunto de la revista: DOENCAS TRANSMISSIVEIS / MICROBIOLOGIA Año: 2018 Tipo del documento: Article País de afiliación: Italia Pais de publicación: Reino Unido
Texto completo
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XML
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Proteínas de la Matriz Viral / Fiebre Hemorrágica Ebola / Ebolavirus / Antígenos Virales Tipo de estudio: Diagnostic_studies / Prognostic_studies / Risk_factors_studies Límite: Female / Humans / Male País/Región como asunto: Africa Idioma: En Revista: Clin Microbiol Infect Asunto de la revista: DOENCAS TRANSMISSIVEIS / MICROBIOLOGIA Año: 2018 Tipo del documento: Article País de afiliación: Italia Pais de publicación: Reino Unido