Prospective Clinical Evaluation of the BioFire Emerging Coronavirus Panel for the Detection of COVID-19 and Other Coronaviruses
Prospective Clinical Evaluation of the BioFire Emerging Coronavirus Panel - Sponsor's Protocol
BioFire Defense LLC
1,500 participants
Sep 29, 2025
OBSERVATIONAL
Conditions
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.
Eligibility
Plain Language Summary
Simplified for easier understanding
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Interventions
Device testing on prospectively collected specimens leftover from standard of care for IVD validation only; results will not influence patient care/management.
Locations(6)
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NCT07221097