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Comprehensive Laboratory Evaluation of a Specific Lateral Flow Assay for the Presumptive Identification of Francisella tularensis in Suspicious White Powders and Aerosol Samples.
Pillai, Segaran P; DePalma, Lindsay; Prentice, Kristin W; Ramage, Jason G; Chapman, Carol; Sarwar, Jawad; Parameswaran, Nishanth; Petersen, Jeannine; Yockey, Brook; Young, John; Singh, Ajay; Pillai, Christine A; Manickam, Gowri; Thirunavkkarasu, Nagarajan; Avila, Julie R; Sharma, Shashi; Morse, Stephen A; Venkateswaran, Kodumudi; Anderson, Kevin; Hodge, David R.
Affiliation
  • Pillai SP; 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. Ram
  • DePalma L; 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. Ram
  • Prentice KW; 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. Ram
  • Ramage JG; 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. Ram
  • Chapman C; 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. Ram
  • Sarwar J; 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. Ram
  • Parameswaran N; 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. Ram
  • Petersen J; 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. Ram
  • Yockey B; 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. Ram
  • Young J; 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. Ram
  • Singh A; 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. Ram
  • Pillai CA; 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. Ram
  • Manickam G; 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. Ram
  • Thirunavkkarasu N; 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. Ram
  • Avila JR; 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. Ram
  • Sharma S; 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. Ram
  • Morse SA; 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. Ram
  • Venkateswaran K; 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. Ram
  • Anderson K; 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. Ram
  • Hodge DR; 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. Ram
Health Secur ; 18(2): 83-95, 2020.
Article in En | MEDLINE | ID: mdl-32324068
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.
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Powders / Biological Assay / Aerosols / Francisella tularensis Type of study: Diagnostic_studies / Prognostic_studies / Qualitative_research Language: En Journal: Health Secur Year: 2020 Document type: Article
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Powders / Biological Assay / Aerosols / Francisella tularensis Type of study: Diagnostic_studies / Prognostic_studies / Qualitative_research Language: En Journal: Health Secur Year: 2020 Document type: Article