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.
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.
Jason G
JG
Ramage
Kristin W
KW
Prentice
Lindsay
L
DePalma
Kodumudi S
KS
Venkateswaran
Sruti
S
Chivukula
Carol
C
Chapman
Melissa
M
Bell
Shomik
S
Datta
Ajay
A
Singh
Alex
A
Hoffmaster
Jawad
J
Sarwar
Nishanth
N
Parameswaran
Mrinmayi
M
Joshi
Nagarajan
N
Thirunavkkarasu
Viswanathan
V
Krishnan
Stephen
S
Morse
Julie R
JR
Avila
Shashi
S
Sharma
Peter L
PL
Estacio
Larry
L
Stanker
David R
DR
Hodge
Segaran P
SP
Pillai
D001408:Bacillus anthracis / Q000302:isolation & purification*; D023482:Bioterrorism / Q000517:prevention & control*; D002959:Civil Defense / Q000379:methods; D007118:Immunoassay / Q000295:instrumentation / Q000379:methods*; D011208:Powders; D011934:Reagent Strips; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D013171:Spores, Bacterial / Q000302:isolation & purification*
D011208:Powders; D011934:Reagent Strips
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