Status:
RECRUITING
Prospective Clinical Evaluation of the BioFire Emerging Coronavirus Panel for the Detection of COVID-19 and Other Coronaviruses
Lead Sponsor:
BioFire Defense LLC
Collaborating Sponsors:
Children's Hospital Los Angeles
George Washington University
Conditions:
Coronavirus
Respiratory Infection
Eligibility:
All Genders
Brief 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 detect...
Detailed Description
The primary objective of this observational, non-interventional study is to evaluate the diagnostic accuracy of the assays comprising the BioFire ECoV Panel when used to test NPS obtained from individ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Specimen is unable to be tested within the defined storage parameters
- Insufficient specimen volume for testing
- Transport medium type is unknown
Key Trial Info
Start Date :
September 29 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
1500 Patients enrolled
Trial Details
Trial ID
NCT07221097
Start Date
September 29 2025
End Date
August 1 2026
Last Update
October 27 2025
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
2
George Washington University
Washington D.C., District of Columbia, United States, 20037
3
Tampa General Hospital
Tampa, Florida, United States, 33606
4
Emory University Hospital
Atlanta, Georgia, United States, 30032