title: Evaluation of the Biofire FilmArray BioThreat-E Test (v2.5) for Rapid Identification of Ebola Virus Disease in Heat-Treated Blood Samples Obtained in Sierra Leone and the United Kingdom.
abstract: Rapid Ebola virus (EBOV) detection is crucial for appropriate patient management and care. The performance of the FilmArray BioThreat-E test (v2.5) using whole-blood samples was evaluated in Sierra Leone and the United Kingdom and was compared with results generated by a real-time Ebola Zaire PCR reference method. Samples were tested in diagnostic laboratories upon availability, included successive samples from individual patients, and were heat treated to facilitate EBOV inactivation prior to PCR. The BioThreat-E test had a sensitivity of 84% (confidence interval [CI], 64% to 95%) and a specificity of 89% (CI, 73% to 97%) in Sierra Leone (n = 60; 44 patients) and a sensitivity of 75% (CI, 19% to 99%) and a specificity of 100% (CI, 97% to 100%) in the United Kingdom (n = 108; 70 patients) compared to the reference real-time PCR. Statistical analysis (Fisher's exact test) indicated there was no significant difference between the methods at the 99% confidence level in either country. In 9 discrepant results (5 real-time PCR positives and BioThreat-E test negatives and 4 real-time PCR negatives and BioThreat-E test positives), the majority (n = 8) were obtained from samples with an observed or probable low viral load. The FilmArray BioThreat-E test (v2.5) therefore provides an attractive option for laboratories (either in austere field settings or in countries with an advanced technological infrastructure) which do not routinely offer an EBOV diagnostic capability.
authors.affiliation: Defence Science and Technology Laboratory, Ministry of Defence, Porton Down, Salisbury, United Kingdom sweller@dstl.gov.uk.
authors.forename: Simon A
authors.initials: SA
authors.lastname: Weller
authors.affiliation: Rare and Imported Pathogens Laboratory, Public Health England, Porton Down, Salisbury, United Kingdom.
authors.forename: Daniel
authors.initials: D
authors.lastname: Bailey
authors.affiliation: Centre of Defence Pathology, Royal Centre of Defence Medicine, Edgbaston, Birmingham, United Kingdom.
authors.forename: Steven
authors.initials: S
authors.lastname: Matthews
authors.affiliation: Rare and Imported Pathogens Laboratory, Public Health England, Porton Down, Salisbury, United Kingdom.
authors.forename: Sarah
authors.initials: S
authors.lastname: Lumley
authors.affiliation: Rare and Imported Pathogens Laboratory, Public Health England, Porton Down, Salisbury, United Kingdom.
authors.forename: Angela
authors.initials: A
authors.lastname: Sweed
authors.affiliation: Public Health Laboratory London, London, United Kingdom.
authors.forename: Derren
authors.initials: D
authors.lastname: Ready
authors.affiliation: Newcastle Molecular Laboratory, Public Health England, Royal Victoria Infirmary, Newcastle Upon Tyne, United Kingdom.
authors.forename: Gary
authors.initials: G
authors.lastname: Eltringham
authors.affiliation: MEHT Microbiology, NHS Trust, Broomfield Hospital, Chelmsford, United Kingdom.
authors.forename: Jade
authors.initials: J
authors.lastname: Richards
authors.affiliation: Rare and Imported Pathogens Laboratory, Public Health England, Porton Down, Salisbury, United Kingdom.
authors.forename: Richard
authors.initials: R
authors.lastname: Vipond
authors.affiliation: Defence Science and Technology Laboratory, Ministry of Defence, Porton Down, Salisbury, United Kingdom.
authors.forename: Roman
authors.initials: R
authors.lastname: Lukaszewski
authors.affiliation: Defence Science and Technology Laboratory, Ministry of Defence, Porton Down, Salisbury, United Kingdom.
authors.forename: Phillippa M
authors.initials: PM
authors.lastname: Payne
authors.affiliation: Rare and Imported Pathogens Laboratory, Public Health England, Porton Down, Salisbury, United Kingdom.
authors.forename: Emma
authors.initials: E
authors.lastname: Aarons
authors.affiliation: Rare and Imported Pathogens Laboratory, Public Health England, Porton Down, Salisbury, United Kingdom.
authors.forename: Andrew J
authors.initials: AJ
authors.lastname: Simpson
authors.affiliation: Centre of Defence Pathology, Royal Centre of Defence Medicine, Edgbaston, Birmingham, United Kingdom.
authors.forename: Emma J
authors.initials: EJ
authors.lastname: Hutley
authors.affiliation: Rare and Imported Pathogens Laboratory, Public Health England, Porton Down, Salisbury, United Kingdom.
authors.forename: Tim
authors.initials: T
authors.lastname: Brooks
mesh_terms: D001769:Blood / Q000821:virology*; D029043:Ebolavirus / Q000235:genetics / Q000302:isolation & purification*; D019142:Hemorrhagic Fever, Ebola / Q000175:diagnosis* / Q000821:virology; D006358:Hot Temperature; D006801:Humans; D025202:Molecular Diagnostic Techniques / Q000379:methods*; D012680:Sensitivity and Specificity; D012807:Sierra Leone; D013048:Specimen Handling / Q000379:methods*; D013997:Time Factors; D006113:United Kingdom