Actively Recruiting
Prospective Clinical Evaluation of the BioFire Emerging Coronavirus Panel for the Detection of COVID-19 and Other Coronaviruses
Led by BioFire Defense LLC · Updated on 2025-10-27
1500
Participants Needed
6
Research Sites
43 weeks
Total Duration
On this page
Sponsors
B
BioFire Defense LLC
Lead Sponsor
C
Children's Hospital Los Angeles
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Prospective Clinical Evaluation of the BioFire Emerging Coronavirus Panel for the Detection of COVID-19 and Other Coronaviruses
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Specimen is residual nasopharyngeal swab in transport medium (VTM or UTM) leftover from clinician-ordered standard respiratory pathogen testing.
- Specimen has been held at room temperature for 4 hours or less, or at 4°C for 72 hours or less prior to enrollment.
- At least 1.7 mL of specimen remains after standard of care testing and is available for study use.
You will not qualify if you...
- Specimen cannot be tested within the defined storage time and temperature limits.
- Specimen volume is insufficient for testing.
- Transport medium type of the specimen is unknown.
AI-Screening
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Trial Site Locations
Total: 6 locations
1
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
Actively Recruiting
2
George Washington University
Washington D.C., District of Columbia, United States, 20037
Actively Recruiting
3
Tampa General Hospital
Tampa, Florida, United States, 33606
Not Yet Recruiting
4
Emory University Hospital
Atlanta, Georgia, United States, 30032
Actively Recruiting
5
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157-1042
Not Yet Recruiting
6
University of Texas Medical Branch
Galveston, Texas, United States, 77550
Not Yet Recruiting
Research Team
B
Brittany C Collins, PhD
CONTACT
D
David Rabiger, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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