•FebriDx is not intended to diagnose any specific bacteria or virus, including SARS-CoV-2.
•The test is intended for professional use and should be used in conjunction with other clinical evidence including laboratory, radiographic, and epidemiological information.
•Negative results do not preclude respiratory infection and should not be used as the sole basis for diagnosis, treatment, or other clinical and patient management decisions. In addition to utilizing radiography and clinical presentation to aid in diagnosis, additional laboratory testing (e.g., bacterial and viral culture, immunofluorescence, and polymerase chain reaction [PCR]) may be used to confirm the presence of a specific respiratory pathogen.
1. O’Neill J, et al. Antimicrobial Resistance: Tackling a Crisis for the Health and Wealth of Nations; The Review on Antimicrobial Resistance: London, UK, 2014.
2. Harris AM, Hicks LA, Qaseem A. Appropriate antibiotic use for acute respiratory tract infection in adults. Ann Intern Med. 2016;165(9):674.
3. Renati S, Linder J. Necessity of office visits for acute respiratory infections in primary care. Fam Pract 2016;33(3):312-17.
5. Dick K, Schneider J. Economic Evaluation of FebriDx®: A novel rapid, point-of-care test for differentiation of viral versus bacterial acute respiratory infection in the United States. JHEOR 2021;8(2)68-74.
6. Palms DL, Hicks LA, Bartoces M, et al. Comparison of antibiotic prescribing in retail clinics, urgent care centers, emergency departments, and traditional ambulatory care settings in the United States. JAMA Intern Med 2018;178(9):1267-9.
9. Llor C, Bjerrum L. Antimicrobial resistance: risk associated with antibiotic overuse and initiatives to reduce the problem. Ther Adv Drug Saf 2014;5(6): 229-41.
10. Shehab N, Patel PR, Srinivasan A, Budnitz DS. Emergency department visits for antibiotic-associated adverse events. Clin Infect Dis 2008;47:735-43.
11. Shapiro NI, Self WH, Rosen J, et al. A prospective, multi-centre US clinical trial to determine accuracy of FebriDx point-of-care testing for acute upper respiratory infections with and without a confirmed fever. Ann Med 2018;50(5):420-9.