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

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

doi:10.1089/hs.2019.0038

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.

Highlights

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
The results indicated that the RedLine Alert test for the presumptive identification of B. anthracis is highly robust, specific, and sensitive

Summary

Introduction

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 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. PhD, is Director, Office of Laboratory Science and Safety, FDA Office of the Commissioner, Department of Health and Human Services, Silver Spring, MD. 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. The most recent outbreak of injectional anthrax was believed to be the result of contaminated heroin that originated in Pakistan or Iran.[18]

Objectives

Methods

Results

Conclusion