TY - JOUR
T1 - 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
AU - Ramage, Jason G.
AU - Prentice, Kristin W.
AU - Depalma, Lindsay
AU - Venkateswaran, Kodumudi S.
AU - Chivukula, Sruti
AU - Chapman, Carol
AU - Bell, Melissa
AU - Datta, Shomik
AU - Singh, Ajay
AU - Hoffmaster, Alex
AU - Sarwar, Jawad
AU - Parameswaran, Nishanth
AU - Joshi, Mrinmayi
AU - Thirunavkkarasu, Nagarajan
AU - Krishnan, Viswanathan V
AU - Morse, Stephen
AU - Avila, Julie R.
AU - Sharma, Shashi
AU - Estacio, Peter L.
AU - Stanker, Larry
AU - Hodge, David R.
AU - Pillai, Segaran P.
PY - 2016/10/1
Y1 - 2016/10/1
N2 - 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 106 spores/mL (ca. 1.5 × 105 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.
AB - 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 106 spores/mL (ca. 1.5 × 105 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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U2 - 10.1089/hs.2016.0041
DO - 10.1089/hs.2016.0041
M3 - Article
C2 - 27661796
AN - SCOPUS:84989182902
VL - 14
SP - 351
EP - 365
JO - Health security
JF - Health security
SN - 2326-5094
IS - 5
ER -