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. STUDY DESIGN: 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.
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. STUDY DESIGN: 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 infectedpatients. 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 infectedpatients 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.
Authors: R Barbieri; M Signoli; D Chevé; C Costedoat; S Tzortzis; G Aboudharam; D Raoult; M Drancourt Journal: Clin Microbiol Rev Date: 2020-12-09 Impact factor: 26.132
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Authors: Basilua Andre Muzembo; Kei Kitahara; Ayumu Ohno; Ngangu Patrick Ntontolo; Nlandu Roger Ngatu; Keinosuke Okamoto; Shin-Ichi Miyoshi Journal: Bull World Health Organ Date: 2022-06-01 Impact factor: 13.831
Authors: Melanie L Yarbrough; Jennie H Kwon; Meghan A Wallace; Tiffany Hink; Angela Shupe; Victoria J Fraser; Erik R Dubberke; C A Burnham Journal: J Clin Microbiol Date: 2018-05-25 Impact factor: 5.948
Authors: Mostafa Bentahir; Mamadou Diouldé Barry; Kekoura Koulemou; Jean-Luc Gala Journal: Int J Environ Res Public Health Date: 2022-09-14 Impact factor: 4.614
Authors: Chantal B Reusken; Ramona Mögling; Pieter W Smit; Roland Grunow; Giuseppe Ippolito; Antonino Di Caro; Marion Koopmans Journal: Euro Surveill Date: 2018-05