USAMMDA Announces Availability of FDA-Approved Diagnostic Test Panel for Four Infectious Diseases
Recently, the U.S. Army Medical Materiel Development Activity’s Warfighter Protection and Acute Care Project Management Office, along with its commercial partner BioFire Defense, announced the U.S. Food and Drug Administration had granted marketing approval for the Global Fever Panel, which is used to analyze specimens of human blood for the pathogens that cause four infectious diseases of military significance. The use of the Global Fever provides answers within an hour after test initiation.
Dr. Clifford Snyder, product manager and contracting officer’s representative for USAMMDA’s WPAC PMO, heads the Global Fever Panel program. As the Department of Defense’s primary resource for military medical solutions, USAMMDA is responsible for developing and delivering military medical products to protect and preserve the lives of our nation’s Service members. These products include drugs, vaccines, biologics, devices and medical support equipment intended to maximize survival of casualties on the battlefield.
Snyder recently sat down with USAMMDA’s public affairs office to discuss the importance of the Global Fever Panel, and offered his thoughts on the future availability and use of this critical diagnostic test.
Q: Please describe the Global Fever Panel – what is it, and why is it important?
CS: The Global Fever Panel is an in vitro diagnostic used to analyze specimens of human blood in conjunction with the BioFire FilmArray, an instrument found in many DOD “brick and mortar” hospital labs as well as on Navy ships and in Army and Air Force deployable lab units. As the FDA says, “In vitro diagnostics are tests done on samples such as blood or tissue that have been taken from the human body. In vitro diagnostics can detect diseases or other conditions, and can be used to monitor a person’s overall health to help cure, treat, or prevent diseases.”
The Global Fever Panel is used when a health care provider suspects that an individual may be infected with the viruses, bacteria, or protozoa that cause Chikungunya, Dengue, Leptospirosis, or Malaria. The system provides “Detected” or “Not Detected” signals within 50 minutes after specimen loading. While these infectious agents are rare in the United States, they are threats to the health of forces deployed to South America, Africa, and Asia.
The “value proposition” of the Global Fever Panel is that it provides rapid, highly reliable test results using an instrument present in hundreds of DOD facilities and at thousands of locations worldwide.
Q: The Global Fever Panel received FDA marketing approval in November 2020, so is it being used currently? If so, by whom?
CS: BioFire Defense launched this product on July 16, 2021; they are now taking orders. 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.
Orders will come from many DOD organizations and from other U.S. government organizations, such as the Department of State. Orders will also come from commercial customers.
Q: How will this help our Warfighters? Or the civilian population?
CS: Consider this scenario: A Soldier in Asia, Africa, or South America has fever, shaking, chills, headache, muscle aches, and fatigue. They might also have nausea, vomiting, and diarrhea.
Does that Soldier have Malaria? Or Dengue Fever? Or Chikungunya or Leptospirosis? The Global Fever Panel will help answer this question.
If a facility with a BioFire FilmArray is available, a tech will load a blood sample from that Soldier into a Global Fever Panel. They will then place the Global Fever Panel into the FilmArray, and in 50 minutes the test results will come back. Medical staff will use the results to help make a diagnosis and prescribe treatment.
Bottom line: The Global Fever Panel can provide test results quickly anywhere there is a FilmArray. The DOD has hundreds of FilmArrays in medical facilities all over the world. What used to take days or weeks can now be done in minutes or hours.
BioFire Defense is marketing the Global Fever Panel commercially, so the civilian populations, both U.S. and international, will also be able to benefit.
Q: Please describe the test process.
CS: The specimen for testing is whole venous blood to which an anti-clotting agent has been added. The technologist uses the materials provided in the Global Fever Panel kit to load the specimen into the Global Fever Panel, which is a disposable chemistry pouch that uses polymerase chain reaction technology to amplify specific multiplexed pathogen nucleic acid sequences, yielding duplex DNA when a pathogen is present that can be detected and identified by fluorescence. The pouch is loaded into the BioFire FilmArray instrument. About 50 minutes later, the instrument provides “Detected” or “Not Detected” information for each pathogen to the computer linked to the FilmArray.
Q: What have been the results in clinical tests thus far?
CS: Development of this product included clinical studies performed by Army and Navy research organizations in the United States, Central and South America, Africa, and Southeast Asia. They obtained 1,875 specimens from males and females, ranging in age from under five to over 50 years, who had fevers. As expected, almost all of the specimens from the United States tested negative. The clinical specimens were analyzed with the Global Fever Panel and the results were compared to those obtained by using specially developed molecular comparator methods to analyze nucleic acids extracted from the same clinical specimens. The development of those molecular comparator methods was a significant task; it was necessary since no “gold standard” molecular comparator methods were commercially available. Overall, Positive Percent Agreement ranged from 93 percent to 100 percent, and Negative Percent Agreement ranged from 99 percent to 100 percent.
Q: What USAMRDC organizations and labs have been involved in this effort?
CS: 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.
Q: What is the future for this product/device?
The Global Fever Panel will be available as long as there is sufficient demand from government or commercial sectors. The field of In Vitro Diagnostics seems to change quite rapidly when compared to therapeutics or prophylaxes such as vaccines. There seems to be a trend toward development of products that can be used in conjunction with handheld devices like smart phones. At this time, the FilmArray System is in use by the military in testing for over 100 other pathogens, and the Global Fever Panel adds to this capability for these more rare diseases. So, I cannot readily predict how long the Global Fever Panel will be part of the Military Health System.
Q: Are there any thoughts or comments that you would like to add regarding this effort?
CS: It has been very gratifying to see the contributions made by so many people, both within the DOD as well as our development partner, BioFire Defense, mature into an FDA-approved product that will deliver significant value to human health.
USAMMDA is a subordinate command of the U.S. Army Medical Research and Development Command, under the Army Futures Command. As the premier developer of world-class military medical capabilities, USAMMDA is responsible for developing and delivering critical products designed to protect and preserve the lives of Warfighters across the globe.These products include drugs, vaccines, biologics, devices and medical support equipment intended to maximize survival of casualties on the battlefield.