Comprehensive Laboratory Evaluation of a Highly Specific Lateral Flow Assay for the Presumptive Identification ofBacillus anthracisSpores in Suspicious White Powders and Environmental Samples
Author(s) -
Jason G. Ramage,
Kristin Prentice,
Lindsay DePalma,
Kodumudi S. Venkateswaran,
Sruti Chivukula,
Carol Chapman,
Melissa E. Bell,
Shomik Datta,
Ajay Singh,
Alex R. Hoffmaster,
Jawad Sarwar,
Nishanth Parameswaran,
Mrinmayi Joshi,
Nagarajan Thirunavkkarasu,
V. V. Krishnan,
Stephen Morse,
Julie R. Avila,
Shashi K. Sharma,
Peter L. Estacio,
Larry H. Stanker,
David R. Hodge,
Segaran P. Pillai
Publication year - 2016
Publication title -
health security
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.705
H-Index - 37
eISSN - 2326-5108
pISSN - 2326-5094
DOI - 10.1089/hs.2016.0041
Subject(s) - bacillus anthracis , spore , microbiology and biotechnology , repeatability , immunoassay , detection limit , biology , bacillus (shape) , chromatography , chemistry , bacteria , antibody , immunology , genetics
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.
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