Tetracore Inc. this week announced the successful completion of an extensive study and validation of its BioThreat Alert Lateral Flow Assay (LFA) and BioThreat Alert LFA Reader by the Department of Homeland Security (DHS) for detection of the bioterrorism agent ricin.
Public safety and health concerns lead DHS to perform a comprehensive laboratory validation study of a commercially available LFA for the rapid detection of ricin. When suspect environmental samples, including unknown white powders, are discovered in the field authorities are tasked to determine if ricin or another biological threat agent is present. The goal of this study was to provide a reliable rapid field test for ricin, to enable more informed decision-making by first responders and public health officials.
The study was coordinated by DHS scientists Dr. David Hodge and Dr. Segaran Pillai with collaborative support from the Centers for Disease Control, Food and Drug Administration, Biological Advanced Research and Development Authority, Federal Bureau of Investigation, Secret Service and the Department of Agriculture.
The detection system was evaluated at five different testing locations, which included state-level public health laboratories in Massachusetts, Texas and Virginia. The study consisted of seven phases to thoroughly test each performance aspect of the LFA, including a repeatability study, an inclusivity panel, an informational panel, a lectin panel, a near-neighbor panel, a white powder panel and testing of BioWatch filter extract.
This extensive testing and independent validation is unprecedented for commercial lateral flow assays developed for field screening of ricin.
“Tetracore respects our on-going collaboration with DHS and will continue to validate our BioThreat Alert LFA products rigorously, so that public health laboratories and first responders have confidence in screening for biological threats,” stated Dr.Tom O’Brien, Vice President of Tetracore, Inc.