Clinical evaluation of the BioFire FilmArray® BioThreat-E test for the diagnosis of Ebola Virus Disease in Guinea

Journal of Clinical Virology : the Official Publication of the Pan American Society for Clinical Virology
F Gay-AndrieuMark Miller

Abstract

The recent West Africa Ebola outbreak highlighted the need to provide access to rapid, safe and reliable Ebola Virus Disease diagnostics. 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. 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. 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. This study showed that the FilmArray BioThreat-E test performs comparably to conventional molecu...Continue Reading

Citations

May 17, 2018·Euro Surveillance : Bulletin Européen Sur Les Maladies Transmissibles = European Communicable Disease Bulletin·Chantal B ReuskenMarion Koopmans
Apr 16, 2020·Trends in Analytical Chemistry : TRAC·Yu-Min WangWenwan Zhong
Dec 11, 2020·Clinical Microbiology Reviews·R BarbieriM Drancourt
Oct 27, 2020·African Journal of Laboratory Medicine·Devy M EmperadorCassandra Kelly-Cirino
Aug 1, 2021·Ticks and Tick-borne Diseases·Sophie RothSören L Becker

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