The Global Fever Panel, a diagnostic test panel for four infectious diseases developed by the U.S. Army Medical Materiel Development Activity (USAMMDA) in collaboration with the National Institute of Allergy and Infectious Diseases, is now commercially available from industry partner BioFire Defense.
The Global Fever Panel is a single-use, fully enclosed test for use with the BioFire® FilmArray 2.0 instrument to aid in the diagnosis of malaria, dengue fever, chikungunya fever and leptospirosis. Although these diseases are rare in the United States, they are common in other parts of the world where U.S. Service Members are or may be deployed.
The product received Food and Drug Administration (FDA) approval in November 2020; BioDefense launched the product on July 16, 2021 and is now taking orders. Orders will come from many Department of Defense (DoD) organizations, other U.S. government organizations such as the Department of State, and from commercial customers.
"BioFire Defense is marketing the Global Fever Panel commercially, so the civilian populations, both U.S. and international, will also be able to benefit," said Dr. Clifford Snyder, product manager and contracting officer's representative for the USAMMDA's Warfighter Protection and Acute Care Project Management Office. "It has taken about eight months to achieve readiness for commercial production, which included transfer of instructions to a manufacturing environment and validating system performance. During this period, the DoD kept the company very busy with work on several products, including manufacturing hundreds of thousands of COVID-19 tests."
A blood sample is taken from the patient, loaded onto the Global Fever Panel, and analyzed using BioFire's FilmArray 2.0 automated biodetection system. Within 50 minutes, the device reports either "Detected" or "Not Detected" for the nucleic acids of the organisms that cause these diseases - ihformation that previously would have taken days or weeks to obtain. The DoD owns hundreds of FilmArray instruments and each of them can run the Global Fever Panel.
Physicians will use the testing results, along with other information, to prescribe treatment and document medical condition, in accordance with the indications for use, which say, "Results are meant to be used in conjunction with other clinical, epidemiologic, and laboratory data, in accordance with the guidelines provided by the relevant public health authorities."
In clinical studies of the product performed by Army and Navy research organizations, Positive Percent Agreement with specially developed comparator methods ranged from 93% to 100%, and Negative Percent Agreement ranged from 99% to 100%.
Multiple Army organizations and labs contributed to this technology transfer effort, Snyder said. USAMMDA provided acquisition program management and quality oversight; the U.S. Army Medical Research and Development headquarters provided regulatory consulting and human research protection oversight; the U.S. Army Medical Research Institute for Infectious Diseases provided scientific support; and the Walter Reed Army Institute of Research provided clinical research services at the Armed Forces Research Institute for Medical Sciences in Thailand and U.S. Army Medical Research Directorate-Africa.
View product details: https://www.biofiredefense.com/products/filmarray/#BFglobalfever