Comprehensive Laboratory Evaluation of a Lateral Flow Assay for the Detection of Yersinia pestis

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

doi:10.1089/hs.2019.0094

Comprehensive Laboratory Evaluation of a Lateral Flow Assay for the Detection of Yersinia pestis

Health Secur. 2019 Nov/Dec;17(6):439-453. doi: 10.1089/hs.2019.0094.

Authors

Kristin W Prentice¹, Lindsay DePalma¹, Jason G Ramage¹, Jawad Sarwar¹, Nishanth Parameswaran¹, Jeannine Petersen¹, Brook Yockey¹, John Young¹, Mrinmayi Joshi¹, Nagarajan Thirunavvukarasu¹, Ajay Singh¹, Carol Chapman¹, Julie R Avila¹, Christine A Pillai¹, Gowri Manickam¹, Shashi K Sharma¹, Stephen A Morse¹, Kodumudi Venkat Venkateswaran¹, Kevin Anderson¹, David R Hodge¹, Segaran P Pillai¹

Affiliation

¹ Kristin W. Prentice, MS, is an Associate, Booz Allen Hamilton, Rockville, MD. Lindsay DePalma, MS, is a Staff Life Scientist, Booz Allen Hamilton, McLean, VA. Jason G. Ramage, MS, MBA, PMP, is Assistant Vice Chancellor for Research and Innovation and Director of Research Compliance, University of Arkansas, Fayetteville, AR. Jawad Sarwar, MS, is a Senior Research Scientist, and Nishanth Parameswaran and Mrinmayi Joshi, MS, are Research Scientists; all 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. Nagarajan Thirunavvukarasu, PhD, is an ORISE Fellow; Christine A. Pillai and Gowri Manickam, PhD, are ORISE Fellow Research Scientists; 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. Ajay Singh, PhD, is a Research Scientist, Laulima Government Solutions, Contractor Support to USAMRICD, Neurobiological Toxicology Branch, Analytical Toxicology Division, Aberdeen Proving Ground, MD. Carol Chapman, MS, is a Microbiologist, Geneva Foundation, Contractor Support to the Naval Medical Research Center, Silver Spring, 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 Venkat 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. Segaran P. Pillai, PhD, is Director, Office of Laboratory Science and Safety, FDA Office of the Commissioner, Silver Spring, MD.

Abstract

We conducted a comprehensive, multiphase laboratory evaluation of the Plague BioThreat Alert^® (BTA) test, a lateral flow immunoassay (LFA), for the rapid detection of Yersinia pestis. The study was conducted in 7 phases at 2 sites to assess the performance of the LFA. The limit of detection (LOD) was determined using both a virulent and avirulent strain of Y. pestis, CO99-3015 (10⁵ CFU/ml) and A1122 (10⁴ CFU/ml), respectively. In the other phases, 18 Y. pestis strains, 20 phylogenetic near-neighbor strains, 61 environmental background microorganisms, 26 white powders, and a pooled aerosol sample were also tested. A total of 1,110 LFA test results were obtained, and their analysis indicates that this LFA had a sensitivity of 97.65% and specificity of 96.57%. These performance data are important for accurate interpretation of qualitative results arising from testing suspicious white powders and aerosol samples in the field. Any positive specimen in this assay is considered presumptive positive and should be referred to the Centers for Disease Control and Prevention Laboratory Response Network for additional testing, confirmation, and characterization for an appropriate public health response.

Keywords: Lateral flow immunoassay; Rapid detection; Yersinia pestis, Plague.

Publication types

Evaluation Study

MeSH terms

Bioterrorism / prevention & control*
Humans
Immunoassay / methods*
Plague / prevention & control*
Sensitivity and Specificity
Yersinia pestis / isolation & purification*