NCT07221097 Prospective Clinical Evaluation of the BioFire Emerging Coronavirus Panel for the Detection of COVID-19 and Other Coronaviruses
| NCT ID | NCT07221097 |
| Status | Recruiting |
| Phase | — |
| Sponsor | BioFire Defense LLC |
| Condition | Coronavirus |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,500 participants |
| Start Date | 2025-09-29 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,500 participants in total. It began in 2025-09-29 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * Specimen is unable to be tested within the defined storage parameters * Insufficient specimen volume for testing * Transport medium type is unknown
Contact & Investigator
Brittany C Collins, PhD
PRINCIPAL INVESTIGATOR
BioFire Defense LLC
Frequently Asked Questions
Who can join the NCT07221097 clinical trial?
This trial is open to participants of all sexes, studying Coronavirus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07221097 currently recruiting?
Yes, NCT07221097 is actively recruiting participants. Contact the research team at brittany.collins@biofiredefense.com for enrollment information.
Where is the NCT07221097 trial being conducted?
This trial is being conducted at Los Angeles, United States, Washington D.C., United States, Tampa, United States, Atlanta, United States and 2 additional locations.
Who is sponsoring the NCT07221097 clinical trial?
NCT07221097 is sponsored by BioFire Defense LLC. The principal investigator is Brittany C Collins, PhD at BioFire Defense LLC. The trial plans to enroll 1,500 participants.