Two Influenza test kits receive FDA clearance for use in JBAIDS

Sep 30 2011

Last week, the U.S. Army Office of the Surgeon General received Food and Drug Administration (FDA) clearance of two Influenza test kits for use on the Joint Biological Agent Identification and Diagnostic System (JBAIDS). Idaho Technology, Inc. (ITI), developer and manufacturer of the JBAIDS instrument, performed the optimization and analytical testing of the Center for Disease Control and Prevention-designed influenza assays for work on the JBAIDS. The assays were converted from a traditional wet chemistry to Idaho Technology's proprietary freeze-dried reagent formulations. This 16-month effort continues ITI's collaborative efforts with the DoD and other agencies to significantly increase JBAIDS diagnostic capabilities.

The Influenza A/B detection kit identifies Influenza A and B, two viruses that cause seasonal flu. The Influenza A subtyping kit is used detect and differentiate Influenza A subtypes (seasonal H1, seasonal H3 and 2009 H1N1). Both kits identify viral nucleic acids isolated and purified from nasopharyngeal swabs and nasopharyngeal washes from patients with signs and symptoms of respiratory infection.

"It's very rewarding to see a mature product like the JBAIDS continue to grow in capability. When we designed the system we knew it was capable of so much more than testing for bio-threat agents. We look forward to our continued work with DoD on designing and optimizing additional tests for the system," said Kirk Ririe, chief executive officer of ITI.