Clinical Trial

Prospective Clinical Evaluation of the BioFire Emerging Coronavirus Panel for the Detection of COVID-19 and Other Coronaviruses

Recruiting
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Record status
This record was last updated October 27, 2025 (before its estimated June 2026 completion). Its status may not reflect the trial's current state.
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.
Trial Details
NCT Number NCT07221097
Lead Sponsor BioFire Defense LLC
Collaborators: Children's Hospital Los Angeles, George Washington University, Wake Forest University Health Sciences, Tampa General Hospital, The University of Texas Medical Branch, Galveston, Emory University
Conditions Coronavirus, Respiratory Infection, COVID
Enrollment 1,500 participants
Start Date 2025-09-29
Primary Completion 2026-06 (estimated)
Study Completion 2026-08 (estimated)
Updated on ClinicalTrials.gov 2025-10-27