Actively Recruiting
Prospective Clinical Evaluation of the BioFire Emerging Coronavirus Panel for Detection of COVID-19 and Other Coronaviruses
Led by BioFire Defense LLC · Updated on 2025-10-27
1500
Participants Needed
6
Research Sites
8 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
Researchers are evaluating the accuracy of the BioFire Emerging Coronavirus (ECoV) Panel, a nucleic acid test designed to detect coronaviruses, including COVID-19, from nasopharyngeal swab samples. This observational, non-interventional study aims to measure how well the BioFire ECoV Panel identifies coronaviruses compared to standard testing methods, across multiple clinical sites in the U.S. The study is sponsored by BioFire Defense LLC and focuses on individuals with signs or symptoms of respiratory infection. The study involves testing leftover nasopharyngeal swab specimens that were originally collected for standard care respiratory infection analysis. These residual specimens are analyzed using the BioFire ECoV Panel to validate its diagnostic performance. The specimens must meet specific storage and volume requirements before testing, and test results will not affect patient care or management. Participants contribute indirectly by providing residual specimens from their standard care tests. Researchers will assess the positive and negative agreement between the BioFire ECoV Panel and comparator methods to determine diagnostic accuracy. The primary outcome measure is device performance during the study period from September 2025 to August 2026. No direct interventions or treatments are given to participants, and the study does not involve additional visits or procedures beyond standard care.
CONDITIONS
Brief 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 left over from standard care respiratory pathogen testing.
- Specimen has been stored at room temperature for 4 hours or less, or at 4°C for 72 hours or less before enrollment.
- At least 1.7 mL of specimen remains after standard testing and is available for use in the study.
You will not qualify if you...
- Specimen cannot be tested within the defined storage parameters.
- Insufficient specimen volume for testing.
- Transport medium type is unknown.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (specimen collection)
Duration - Up to 72 hours after specimen collection
Participants' leftover nasopharyngeal swab specimens from standard of care respiratory testing are tested using the BioFire Emerging Coronavirus Panel to evaluate diagnostic accuracy.
Specimen testing without additional participant visits
Duration - Through study completion (September 2025 to August 2026)
Concordance between the BioFire ECoV Panel assays and comparator methods is monitored through the study completion.
No participant visits; data collection only
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
D
David Rabiger, PhD
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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