학술논문

Comprehensive Laboratory Evaluation of a Highly Specific Lateral Flow Assay for the Presumptive Identification of Bacillus anthracis Spores in Suspicious White Powders and Environmental Samples
Document Type
article
Source
Health Security. 14(5)
Subject
Health Services and Systems
Public Health
Health Sciences
Emerging Infectious Diseases
Prevention
Vaccine Related
Biodefense
Anthrax
Rare Diseases
Infectious Diseases
Bacillus anthracis
Bioterrorism
Civil Defense
Immunoassay
Powders
Reagent Strips
Reproducibility of Results
Sensitivity and Specificity
Spores
Bacterial
Health services and systems
Public health
Language
Abstract
We conducted a comprehensive, multiphase laboratory evaluation of the Anthrax BioThreat Alert(®) test strip, a lateral flow immunoassay (LFA) for the rapid detection of Bacillus anthracis spores. The study, conducted at 2 sites, evaluated this assay for the detection of spores from the Ames and Sterne strains of B. anthracis, as well as those from an additional 22 strains. Phylogenetic near neighbors, environmental background organisms, white powders, and environmental samples were also tested. The Anthrax LFA demonstrated a limit of detection of about 10(6) spores/mL (ca. 1.5 × 10(5) spores/assay). In this study, overall sensitivity of the LFA was 99.3%, and the specificity was 98.6%. The results indicated that the specificity, sensitivity, limit of detection, dynamic range, and repeatability of the assay support its use in the field for the purpose of qualitatively evaluating suspicious white powders and environmental samples for the presumptive presence of B. anthracis spores.