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

Authors: RAMAGE, JASON - Us Deparment Of Homeland Security; PRENICE, KRISTIN - Booz Allen Hamilton Inc; DEPALMA, LINDSAY - Booz Allen Hamilton Inc; VENKATESWARAN, KODUMUDI - Omniarray; CHIVUKULA, SRUTI - Booz Allen Hamilton Inc; CHAPMAN, CAROL - Noblis; BELL, MELISSA - Centers For Disease Control And Prevention (CDC) - United States; DATTA, SHOMIK - Centers For Disease Control And Prevention (CDC) - United States; SINGH, AJAY - Centers For Disease Control And Prevention (CDC) - United States; HOFFMASTER, ALEX - Centers For Disease Control And Prevention (CDC) - United States; SARWAR, JAWAD - Omniarray; PARAMESWARAN, NISHANTH - Omniarray; MRINMAY, JOSHI - Omniarray; THIRUNAVKKARASU, NAGARAJAN - Food And Drug Administration(FDA); KRISHNAN, VISWANATHAN - University Of California; MORSE, STEPHEN - Centers For Disease Control And Prevention (CDC) - United States; AVILA, JULIE - Lawrence Livermore National Laboratory; SHARMA, SHASHI - Food And Drug Administration(FDA); ESTACIO, PETER - Lawrence Berkeley National Laboratory; Stanker, Larry; HODGE, DAVID - Us Deparment Of Homeland Security; PILLAI, SEGARAN - Food And Drug Administration(FDA)

Submitted to: Health Security
Publication Type: Peer Reviewed Journal
Publication Acceptance Date: 6/20/2016
Publication Date: 10/1/2016
Citation: Ramage, J.G., Prenice, K.W., Depalma, L., Venkateswaran, K.S., Chivukula, S., Chapman, C., Bell, M., Datta, S., Singh, A., Hoffmaster, A., Sarwar, J., Parameswaran, N., Mrinmay, J., Thirunavkkarasu, N., Krishnan, V., Morse, S., Avila, J.R., Sharma, S., Estacio, P.L., Stanker, L.H., Hodge, D.R., Pillai, S.P. 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. Health Security. 14(5):351-365. https://doi.org/10.1089/hs.2016.0041.
DOI: https://doi.org/10.1089/hs.2016.0041

Interpretive Summary: Anthrax, caused by the bacterium Bacillus anthracis is primarily a disease of herbivores although all mammals, including humans are susceptible. In the 2001 anthrax attacks in the United States, there were 22 total cases of which 11 were cases of cutaneous anthrax. The most dangerous form is the biphasic respiratory or inhalation anthrax. Differential diagnosis presents a challenge because initial symptoms including fever, malaise and a dry cough, are non-specific and resemble influenza-like symptoms. The CDC classifies B. anthracis as a Tier 1 agent due to its ease of dispersal and high mortality rate although it is not transmissible from person to person. The purpose of the present study was to determine the sensitivity, specificity, reproducibility and limitations of a Lateral Flow Immunoassay (LFA) Anthrax BioThreat Alert® Test Strip, Tetracore®, Inc., Rockville, MD) that can be used in the field to screen for the presence of B. anthracis spores. The primary outcome of this evaluation demonstrates the utility of such an assay allowing for appropriate and effective decisions by first responders and public health professionals.

Technical Abstract: We conducted a comprehensive, multi-phase 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 two 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 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.