Rapid Presumptive Identification of Bacillus anthracis Isolates Using the Tetracore RedLine Alert™ Test

Segaran P Pillai; Kristin W Prentice; Jason G Ramage; Lindsay DePalma; Jawad Sarwar; Nishanth Parameswaran; Melissa Bell; Andrea Plummer; Alan Santos; Ajay Singh; Christine A Pillai; Nagarajan Thirunavvukarasu; Gowri Manickam; Julie R Avila; Shashi K Sharma; Alex Hoffmaster; Kevin Anderson; Stephen A Morse; Kodumudi Venkat Venkateswaran; David R Hodge

doi:10.1089/hs.2019.0038

Rapid Presumptive Identification of Bacillus anthracis Isolates Using the Tetracore RedLine Alert™ Test

Health Secur. 2019 Jul/Aug;17(4):334-343. doi: 10.1089/hs.2019.0038.

Authors

Segaran P Pillai¹, Kristin W Prentice², Jason G Ramage³, Lindsay DePalma², Jawad Sarwar⁴, Nishanth Parameswaran⁴, Melissa Bell⁵, Andrea Plummer⁶, Alan Santos⁶, Ajay Singh⁷, Christine A Pillai⁸, Nagarajan Thirunavvukarasu⁸, Gowri Manickam⁸, Julie R Avila⁹, Shashi K Sharma⁸, Alex Hoffmaster⁵, Kevin Anderson¹⁰, Stephen A Morse¹¹, Kodumudi Venkat Venkateswaran⁶, David R Hodge¹⁰

Affiliations

¹ Segaran P. Pillai, PhD, is Director, Office of Laboratory Science and Safety, FDA Office of the Commissioner, Department of Health and Human Services, Silver Spring, MD.
² Kristin W. Prentice, MS, is an Associate, and Lindsay DePalma, MS, is a Staff Life Scientist; both at Booz Allen Hamilton, Rockville, MD.
³ Jason G. Ramage, MS, MBA, PMP, is Assistant Vice Chancellor for Research and Innovation and Director of Research Compliance, University of Arkansas, Fayetteville, AR.
⁴ Jawad Sarwar, MS, is a Senior Research Scientist, and Nishanth Parameswaran is a Research Scientist; both at Omni Array Biotechnology, Rockville, MD.
⁵ Melissa Bell, MS, is a Microbiologist, and Alex Hoffmaster, PhD, is Chief, Bacterial Special Pathogens Branch; both in the National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, GA.
⁶ Andrea Plummer and Alan Santos are Microbiologists, and Kodumudi Venkat Venkateswaran, PhD, is Chief Scientist; all at Tetracore, Inc., Rockville, MD.
⁷ Ajay Singh, PhD, is a Research Scientist, Laulima Government Solutions, Contractor Support to USAMRICD Neurobiological Toxicology Branch, Analytical Toxicology Division, Aberdeen Proving Ground, MD.
⁸ Christine A. Pillai, Nagarajan Thirunavvukarasu, PhD, and Gowri Manickam, PhD, are ORISE Fellow Research Scientists, and Shashi K. Sharma, PhD, is a Research Microbiologist; all with the FDA Center for Food Safety and Applied Nutrition, Molecular Methods Development Branch, Division of Microbiology, Office of Regulatory Science, College Park, MD.
⁹ Julie R. Avila, MS, is a Scientific Associate, Biosciences and Biotechnology Division, Lawrence Livermore National Laboratory, Livermore, CA.
¹⁰ Kevin Anderson, PhD, and David R. Hodge, PhD, are Program Managers, Science and Technology Directorate, US Department of Homeland Security, Washington, DC.
¹¹ Stephen A. Morse, MSPH, PhD, is a Senior Advisor, CDC Division of Select Agents and Toxins, and is currently with IHRC, Inc., Atlanta, GA.

Abstract

A comprehensive laboratory evaluation of the Tetracore RedLine Alert test, a lateral flow immunoassay (LFA) for the rapid presumptive identification of Bacillus anthracis, was conducted at 2 different test sites. The study evaluated the sensitivity of this assay using 16 diverse strains of B. anthracis grown on sheep blood agar (SBA) plates. In addition, 83 clinically relevant microorganisms were tested to assess the specificity of the RedLine Alert test. The results indicated that the RedLine Alert test for the presumptive identification of B. anthracis is highly robust, specific, and sensitive. RedLine Alert is a rapid test that has applicability for use in a clinical setting for ruling-in or ruling-out nonhemolytic colonies of Bacillus spp. grown on SBA medium as presumptive isolates of B. anthracis.

Keywords: Anthrax; Lateral flow assay; Rapid diagnostics.

MeSH terms

Animals
Anthrax* / diagnosis
Anthrax* / microbiology
Bacillus anthracis / isolation & purification*
Diagnostic Tests, Routine*
Humans
Immunoassay*
Sensitivity and Specificity
Sheep