Comprehensive Laboratory Evaluation of a Specific Lateral Flow Assay for the Presumptive Identification of Francisella tularensis in Suspicious White Powders and Aerosol Samples

Segaran P Pillai; Lindsay DePalma; Kristin W Prentice; Jason G Ramage; Carol Chapman; Jawad Sarwar; Nishanth Parameswaran; Jeannine Petersen; Brook Yockey; John Young; Ajay Singh; Christine A Pillai; Gowri Manickam; Nagarajan Thirunavkkarasu; Julie R Avila; Shashi Sharma; Stephen A Morse; Kodumudi Venkateswaran; Kevin Anderson; David R Hodge

doi:10.1089/hs.2019.0151

Comprehensive Laboratory Evaluation of a Specific Lateral Flow Assay for the Presumptive Identification of Francisella tularensis in Suspicious White Powders and Aerosol Samples

Health Secur. 2020 Mar/Apr;18(2):83-95. doi: 10.1089/hs.2019.0151.

Authors

Segaran P Pillai¹, Lindsay DePalma¹, Kristin W Prentice¹, Jason G Ramage¹, Carol Chapman¹, Jawad Sarwar¹, Nishanth Parameswaran¹, Jeannine Petersen¹, Brook Yockey¹, John Young¹, Ajay Singh¹, Christine A Pillai¹, Gowri Manickam¹, Nagarajan Thirunavkkarasu¹, Julie R Avila¹, Shashi Sharma¹, Stephen A Morse¹, Kodumudi Venkateswaran¹, Kevin Anderson¹, David R Hodge¹

Affiliation

¹ Segaran P. Pillai, PhD, is Director, Office of Laboratory Science and Safety, FDA Office of the Commissioner, Silver Spring, MD. Lindsay DePalma, MS, is a Staff Life Scientist, Booz Allen Hamilton, McLean, VA. Kristin W. Prentice, MS, is an Associate, Booz Allen Hamilton, Rockville, MD. Jason G. Ramage, MS, MBA, PMP, is Assistant Vice Chancellor for Research and Innovation and Director of Research Compliance, University of Arkansas, Fayetteville, AR. Carol Chapman, MS, is a Microbiologist, Geneva Foundation, Contractor Support to the Naval Medical Research Center, Silver Spring, MD. Jawad Sarwar, MS, is a Senior Research Scientist, and Nishanth Parameswaran is a Research Scientist; both at Omni Array Biotechnology, Rockville, MD. Jeannine Petersen, PhD, Brook Yockey, and John Young are Microbiologists; all with DHHS/CDC/OID/NCEZID/DVBD/BDB, Fort Collins, CO. Ajay Singh, PhD, is a Research Scientist, Laulima Government Solutions, Contractor Support to USAMRICD, Neurobiological Toxicology Branch, Analytical Toxicology Division, Aberdeen Proving Ground, MD. Christine A. Pillai and Gowri Manickam, PhD, are ORISE Fellow Research Scientists; Nagarajan Thirunavvukarasu, PhD, is an ORISE Fellow; and Shashi K. Sharma, PhD, is a Research Microbiologist; all at the FDA Center for Food Safety and Applied Nutrition, Molecular Methods Development Branch, Division of Microbiology, Office of Regulatory Science, College Park, MD. Julie R. Avila, MS, is a Scientific Associate, Lawrence Livermore National Laboratory, Biosciences and Biotechnology Division, Livermore, CA. Stephen A. Morse, MSPH, PhD, is a Senior Advisor, CDC Division of Select Agents and Toxins, and is currently with IHRC, Inc., Atlanta, GA. Kodumudi Venkateswaran, PhD, is Chief Scientist, Tetracore, Inc., Rockville, MD. Kevin Anderson, PhD, and David R. Hodge, PhD, are Program Managers, Science and Technology Directorate, US Department of Homeland Security, Washington, DC.

Abstract

We conducted a comprehensive, multi-phase laboratory evaluation of the Tularemia BioThreat Alert^® (BTA) test, a lateral flow assay (LFA) for the rapid detection of Francisella tularensis. The study, conducted at 2 sites, evaluated the limit of detection (LOD) of this assay using the virulent SchuS4 strain and the avirulent LVS strain of F. tularensis. In 6-phase evaluation (linear dynamic range and reproducibility, inclusivity, near-neighbor, environmental background, white powder, and environmental filter extract), 13 diverse strains of F. tularensis, 8 Francisella near neighbors, 61 environmental background organisms, 26 white powders, and a pooled aerosol extract were tested. In the 937 tests performed, the Tularemia BTA demonstrated an LOD of 10⁷ to 10⁸ cfu/mL, with a sensitivity of 100.00%, specificity of 98.08%, and accuracy of 98.84%. These performance data are important for accurate interpretation of qualitative results arising from screening suspicious white powders in the field.

Keywords: Environmental detection; Lateral flow assay; Rapid detection; Tularemia.

MeSH terms

Aerosols / analysis*
Biological Assay / methods*
Bioterrorism
Francisella tularensis / isolation & purification*
Powders / analysis*
Reproducibility of Results
Sensitivity and Specificity

Substances

Aerosols
Powders