Health security · 2016
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.
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Ramage Jason G, Prentice Kristin W, DePalma Lindsay, Venkateswaran Kodumudi S, Chivukula Sruti, Chapman Carol, Bell Melissa, Datta Shomik, Singh Ajay, Hoffmaster Alex, Sarwar Jawad, Parameswaran Nishanth, Joshi Mrinmayi, Thirunavkkarasu Nagarajan, Krishnan Viswanathan, Morse Stephen, Avila Julie R, Sharma Shashi, Estacio Peter L, Stanker Larry, Hodge David R, Pillai Segaran P
Аннотация
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.