Combat & Casualty Care

Q1 2016

Military Magazines in the United States and Canada, Covering Combat and Casualty Care, first responders, rescue and medical products programs and news\Tactical Defense Media

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Page 5 of 35 4 | Combat & Casualty Care | Spring 2016 By David Norwood, Ph.D., Chief, Diagnostic Systems Division, USAMRIID M edical diagnosis is the process by which clinicians attempt to determine the cause of a particular disease or disorder in a sick individual. The goal of diagnosis is to assist in making correct medical decisions about the treatment and prognosis of the patient. For infectious diseases, laboratory tests represent one piece of the diagnostic puzzle, which also includes physical and clinical findings and the patient's medical history. All of these pieces are critical to accurate diagnosis, and getting the right answer must always take priority over getting a quick answer. As defined by the U.S. Food and Drug Administration (FDA), in vitro diagnostics are "those reagents, instruments, and systems intended for use in diagnosis of disease or other conditions…in order to cure, mitigate, treat, or prevent disease or its sequelae. Such products are intended for use in the collection, preparation, and examination of specimens taken from the human body." As such, the FDA has oversight and regulatory authority to clear in vitro diagnostic tests (medical devices) for commercial sale and use. Diagnostic assays for infectious diseases, therefore, are subject to regulatory compliance in order to be used for patient care. The quality of the clinical laboratory doing the testing is regulated by the Clinical Laboratory Improvement Amendments (CLIA), which were passed in 1988, while in vitro diagnostic tests are regulated by section 210(h) of the Federal Food, Drug, and Cosmetic Act. For laboratory assays, two critical elements must meet minimal standards to be considered regulatory compliant: the laboratory performing the test must be qualified and the test being performed must be validated. The combination of a CLIA-accredited laboratory performing regulatory compliant test results in a diagnostic result that can be used for treatment and prognosis of the patient. For the Department of Defense (DoD), maintaining regulatory compliance in performing in vitro diagnostic tests in a deployed environment is a requirement that poses significant challenges. The U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), Fort Detrick, Md., is the agency charged with developing regulatory compliant diagnostics for biological threats. USAMRIID's diagnostic expertise spans the pathway from assay development through FDA clearance. While this expertise was exemplified during the recent Ebola virus disease outbreak in Western Africa, USAMRIID's diagnostic capability provides the DoD and the nation a critical resource that can be leveraged for any infectious disease should the need arise. Diagnostics for Human Use USAMRIID's Diagnostic Systems Division develops medical diagnostics for defense against biological warfare agents and naturally occurring agents of military importance. The division conducts research to develop diagnostic strategies, procedures, capabilities, products, training and information. In addition, the diagnostics program supports advanced development of diagnostic capabilities and provides operational and confirmatory testing for the DoD and the nation. To achieve these goals, USAMRIID maintains core capabilities in assay and reagent development, sample processing, pathogen characterization, platform evaluation, and transitional and operational diagnostics. Epidemic Management and Prevention Critical Diagnosis: USAMRIID and the First Line of Defense Work being done at the U.S. Army's famed Medical Research Institute of Infectious Diseases (USAMRIID) is often recognized as the difference. Dr. David Norwood USAMRIID's Field Identifcation of Biological Warfare Agents (FIBWA) course provides hands-on training in performing diagnostic assays under feld laboratory conditions. (Photo by SPC Patrick Sjoding, USAMRIID)

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