title: Evaluation of the FilmArray® system for detection of Bacillus anthracis, Francisella tularensis and Yersinia pestis.
abstract: OBJECTIVE
  To evaluate the sensitivity and specificity of the BioFire Diagnostics FilmArray(®) system in combination with their Biothreat Panel for the detection of Bacillus anthracis (Ba), Francisella tularensis (Ft) and Yersinia pestis (Yp) DNA, and demonstrate the detection of Ba spores.
  
  
  RESULTS
  DNA samples from Ba, Ft and Yp strains and near-neighbours, and live Ba spores were analysed using the FilmArray(®) Biothreat Panel, a multiplexed PCR-based assay for 17 pathogens and toxins. Sensitivity studies with DNA indicate that the limit of detection is 250 genome equivalents (GEs) per sample or lower. Furthermore, the identification of Ft, Yp or Bacillus species was made in 63 of 72 samples tested at 25 GE or less. With samples containing 25 CFU of Ba Sterne spores, at least one of the two possible Ba markers was identified in all samples tested. We observed no cross-reactivity with near-neighbour DNAs.
  
  
  CONCLUSIONS
  Our results indicate that the FilmArray(®) Biothreat Panel is a sensitive and selective assay for detecting the genetic signatures of Ba, Ft and Yp.
  
  
  CONCLUSIONS
  The FilmArray(®) platform is a complete sample-to-answer system, combining sample preparation, PCR and data analysis. This system is particularly suited for biothreat testing where samples need to be analysed for multiple biothreats by operators with limited training.
authors.affiliation: Pacific Northwest National Laboratory, Chemical and Biological Signature Science Group, National Security Directorate, Richland, WA 99354, USA.
authors.forename: D R
authors.initials: DR
authors.lastname: Seiner
authors.forename: H A
authors.initials: HA
authors.lastname: Colburn
authors.forename: C
authors.initials: C
authors.lastname: Baird
authors.forename: R A
authors.initials: RA
authors.lastname: Bartholomew
authors.forename: T
authors.initials: T
authors.lastname: Straub
authors.forename: K
authors.initials: K
authors.lastname: Victry
authors.forename: J R
authors.initials: JR
authors.lastname: Hutchison
authors.forename: N
authors.initials: N
authors.lastname: Valentine
authors.forename: C J
authors.initials: CJ
authors.lastname: Bruckner-Lea
mesh_terms: D001408:Bacillus anthracis / Q000235:genetics / Q000302:isolation & purification*; D004269:DNA, Bacterial / Q000302:isolation & purification; D005604:Francisella tularensis / Q000235:genetics / Q000302:isolation & purification*; D060885:Multiplex Polymerase Chain Reaction / Q000379:methods*; D012680:Sensitivity and Specificity; D013171:Spores, Bacterial / Q000302:isolation & purification; D015010:Yersinia pestis / Q000235:genetics / Q000302:isolation & purification*
chemical_list: D004269:DNA, Bacterial