FDA clears JBAIDS avian influenza (H5N1) detection kit
August 5, 2010
The U.S. Army Surgeon General's Office received U.S. Food and Drug Administration clearance July 6 to bring avian influenza (Influenza A/H5) diagnostic capability to Department of Defense laboratories and provides worldwide medical diagnostic capability to support the Warfighter.
This new FDA clearance adds bird flu diagnostic capability for the DoD on the Joint Biological Agent Identification and Diagnostic System platform, deployed worldwide.
Expanding the utility of a system developed for Chemical Biological Radiological Nuclear defense, this success adds additional infectious disease diagnostic capability to what previously was limited to biological warfare agents, and complements the current effort by the Chemical Biological Medical Systems Joint Project Management Office-Biosurveillance to integrate an FDA-cleared expanded influenza test capability on the JBAIDS instrument, ensuring an adequate diagnostic capability in the event of a bird flu (H5N1) outbreak, similar to the 2009 swine flu (H1N1) pandemic.
This new assay increases the DoD's readiness posture for emerging infectious diseases. The completion of the expanded influenza test capability is anticipated in FY2011.
The Armed Forces Health Surveillance Center/Global Emerging Infections Surveillance System funded this successful development program with collaboration between CBMS-BSV, the Centers for Disease Control and Prevention, the U.S. Army Medical Institute of Infectious Disease, and the U.S. Army Medical Materiel Development Activity. The contributions and excellent teamwork among these agencies indicates the continued effort to address the National Strategy for Countering Biological Threats.
The JBAIDS is a ruggedized diagnostic system, which is the first and only DoD biological warfare agent detection device cleared by the FDA to provide medical professionals with a means to rapidly diagnose infections in humans.
The system will detect and diagnose both bacterial and viral diseases, as well as biothreat agents.
Over 300 JBAIDS systems have been fielded to all Services, including deployed units around the world.
The newly formed Biosurveillance Office of CBMS oversees the advanced development of products and tools for chemical and biological defense, providing the technologies to enable effective biosurveillance.
Chemical Biological Medical Systems, a subordinate office to the Joint Program Executive Office for Chemical and Biological Defense (JPEO-CBD), is responsible for the development, procurement, fielding, and sustainment of premier medical protection and treatment capabilities against chemical and biological warfare agents for the Warfighter. Idaho Technology, Inc., under contract to CBMS JPMO, developed the JBAIDS analyzer and the JBAIDS Influenza A/H5 Detection Kit, using CDC designed assays.