title: RAZOR EX Anthrax Air Detection System for detection of Bacillus anthracis spores from aerosol collection samples: collaborative study.
abstract: The RAZOR EX Anthrax Air Detection System was validated in a collaborative study for the detection of Bacillus anthracis in aerosol collection buffer. Phosphate-buffered saline was charged with 1 mg/mL standardized dust to simulate an authentic aerosol collection sample. The dust-charged buffer was spiked with either B. anthracis Ames at 2000 spores/mL or Bacillus cereus at 20 000 spores/mL. Twelve collaborators participated in the study, with four collaborators at each of three sites. Each collaborator tested 12 replicates of B. anthracis in dust-charged buffer and 12 replicates of B. cereus in dust-charged buffer. All samples sets were randomized and blind-coded. All collaborators produced valid data sets (no collaborators displayed systematic errors) and there was only one invalid data point. After unblinding, the analysis revealed a cross-collaborator probability of detection (CPOD) of 1.00 (144 positive results from 144 replicates, 95% confidence interval 0.975-1.00) for the B. anthracis samples and a CPOD of 0.00 (0 positive results from 143 replicates, 95% confidence interval 0.00-0.0262) for the B. cereus samples. These data meet the requirements of AOAC Standard Method Performance Requirement 2010.003, developed by the Stakeholder Panel on Agent Detection Assays.
authors.affiliation: MRIGlobal, Palm Bay, FL 32909-2211, USA.
authors.forename: Ted
authors.initials: T
authors.lastname: Hadfield
authors.forename: Valorie
authors.initials: V
authors.lastname: Ryan
authors.forename: Usha K
authors.initials: UK
authors.lastname: Spaulding
authors.forename: Kristine M
authors.initials: KM
authors.lastname: Clemens
authors.forename: Irene M
authors.initials: IM
authors.lastname: Ota
authors.forename: Sharon L
authors.initials: SL
authors.lastname: Brunelle
mesh_terms: D000336:Aerosols / Q000032:analysis*; D000881:Anthrax / Q000517:prevention & control*; D001408:Bacillus anthracis / Q000302:isolation & purification*; D001431:Bacteriological Techniques / Q000379:methods / Q000592:standards*; D004391:Dust; D006801:Humans; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D013171:Spores, Bacterial / Q000302:isolation & purification*
chemical_list: D000336:Aerosols; D004391:Dust