Clinical evaluation of the BioFire FilmArray® BioThreat-E test for the diagnosis of Ebola Virus Disease in Guinea.
J Clin Virol
; 92: 20-24, 2017 07.
Article
em En
| MEDLINE
| ID: mdl-28505570
ABSTRACT
BACKGROUND:
The recent West Africa Ebola outbreak highlighted the need to provide access to rapid, safe and reliable Ebola Virus Disease diagnostics.OBJECTIVES:
The objective of this field study was to assess the clinical performance of the FilmArray® BioThreat-E test for the detection of Ebola Zaïre virus in whole blood in symptomatic patients suspected of Ebola Virus Disease in Conakry (Guinea) from March to July 2015. STUDYDESIGN:
The BioThreat-E test was compared to the two RT-PCRs, using serum, implemented at Donka Hospital in the emergency context an in-house developed quantitative one-step RT-PCR adapted from the Weidmann technique, and the RealStar® Filovirus RT-PCR Kit 1.0 (Altona-Diagnostics). We also assessed the performance of this assay in noninvasive specimens (urine and saliva) to detect infected patients.RESULTS:
Of 135 patients enrolled and eligible for performance assessment on whole blood, the sensitivity was 95.7% [95% CI 85.5-99.5] and specificity 100% [95% CI 95.9-100]. Of the 37 symptomatic infected patients able to provide saliva and/or urine samples, 34 of the 35 saliva samples and all 3 of the urine samples were positive with the BioThreat-E test.CONCLUSIONS:
This study showed that the FilmArray BioThreat-E test performs comparably to conventional molecular tests under field conditions, providing results and interpretation in approximately 1h. Due to its operational characteristics, it can be easily deployed in the field during an epidemic and could also be a useful tool for post-outbreak surveillance.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Doença pelo Vírus Ebola
/
Técnicas de Diagnóstico Molecular
/
Ebolavirus
Tipo de estudo:
Diagnostic_studies
/
Evaluation_studies
Limite:
Adult
/
Female
/
Humans
/
Male
País/Região como assunto:
Africa
Idioma:
En
Revista:
J Clin Virol
Assunto da revista:
VIROLOGIA
Ano de publicação:
2017
Tipo de documento:
Article