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Prospective Clinical Evaluation of the BioFire Emerging Coronavirus Panel for the Detection of COVID-19 and Other Coronaviruses
Sponsor: BioFire Defense LLC
Summary
The Biomedical Advanced Research and Development Authority (BARDA) has contracted BioFire Defense (BFDf) to develop the BioFire Emerging Coronavirus (ECoV) Panel, a nucleic acid test capable of detecting coronaviruses from nasopharyngeal swab (NPS) in transport medium. This study aims to evaluate the diagnostic accuracy of the assays comprising the BioFire ECoV Panel. It is hypothesized that the BioFire ECoV Panel assays will be highly sensitive and specific for the detection of the coronaviruses included on the panel.
Official title: Prospective Clinical Evaluation of the BioFire Emerging Coronavirus Panel - Sponsor's Protocol
Key Details
Gender
All
Age Range
Any - Any
Study Type
OBSERVATIONAL
Enrollment
1500
Start Date
2025-09-29
Completion Date
2026-08
Last Updated
2025-10-27
Healthy Volunteers
No
Conditions
Interventions
Investigational IVD for coronaviruses
Device testing on prospectively collected specimens leftover from standard of care for IVD validation only; results will not influence patient care/management.
Locations (6)
Children's Hospital Los Angeles
Los Angeles, California, United States
George Washington University
Washington D.C., District of Columbia, United States
Tampa General Hospital
Tampa, Florida, United States
Emory University Hospital
Atlanta, Georgia, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
University of Texas Medical Branch
Galveston, Texas, United States