Prospective Clinical Evaluation of the BioFire Emerging Coronavirus Panel for the Detection of COVID-19 and Other Coronaviruses
Recruiting now
Conditions studied: Coronavirus, Respiratory Infection, COVID
In brief
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.
Key facts
- Study ID
- NCT07221097
- Run by
- BioFire Defense LLC
- People needed
- 1500
- Starts
- 2025-09-29
- Expected to finish
- 2026-08-01
- Last updated by the study team
- 2025-10-27
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Specimen is residual NPS in transport medium (VTM or UTM) left over from standard of care testing under clinician order for respiratory pathogen analysis.
- Specimen has been held at room temperature for less than or equal to 4 hours or 4°C for less than or equal to 72 hours before enrollment.
- At least 1.7 mL of specimen is remaining after standard of care testing and available for use in the study
You may not qualify if…
- Specimen is unable to be tested within the defined storage parameters
- Insufficient specimen volume for testing
- Transport medium type is unknown
Where it is running
- Children's Hospital Los Angeles — Los Angeles, California, United States (enrolling)
- George Washington University — Washington D.C., District of Columbia, United States (enrolling)
- Emory University Hospital — Atlanta, Georgia, United States (enrolling)
- Tampa General Hospital — Tampa, Florida, United States
- Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States
- University of Texas Medical Branch — Galveston, Texas, United States
Full record on ClinicalTrials.gov
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