Testing the BioFire Emerging Coronavirus Panel to detect COVID-19 and other coronaviruses
Prospective Clinical Evaluation of the BioFire Emerging Coronavirus Panel - Sponsor's Protocol
This project will test whether the BioFire Emerging Coronavirus Panel can accurately detect COVID-19 and other coronaviruses in leftover nasopharyngeal swab samples from people with respiratory symptoms.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1500 (estimated) |
| Sex | All |
| Sponsor | BioFire Defense LLC Industry-sponsored |
| Locations | 6 sites (Los Angeles, California and 5 other locations) |
| Trial ID | NCT07221097 on ClinicalTrials.gov |
What this trial studies
This observational, non-interventional project will test the BioFire Emerging Coronavirus (ECoV) Panel on residual nasopharyngeal swab (NPS) specimens collected from people with signs or symptoms of respiratory infection. Multiple geographically distinct clinical sites in the U.S. will submit coded leftover NPS specimens that meet the study's storage and volume requirements. Results from the BioFire ECoV Panel will be compared to established comparator methods and concordance will be reported as positive and negative percent agreement (PPA and NPA). The study uses only de-identified residual specimens and does not change patient care.
Who should consider this trial
Good fit: Ideal candidates are residual nasopharyngeal swab specimens taken from people with respiratory symptoms that have sufficient remaining volume and were stored within the specified time and temperature limits.
Not a fit: People who did not have a nasopharyngeal swab collected, whose specimens were stored outside the defined time/temperature windows, or whose samples lack sufficient volume will not be eligible and will not benefit from participation.
Why it matters
Potential benefit: If successful, the panel could provide faster and reliable detection of COVID-19 and related coronaviruses to support clinical decision-making and public health response.
How similar studies have performed: Similar multiplex molecular respiratory panels, including other BioFire respiratory assays, have demonstrated high sensitivity and specificity for respiratory viruses, though this specific ECoV panel is newly deployed and is being validated.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Los Angeles, California and 5 other locations
- Children's Hospital Los Angeles — Los Angeles, California, United States (Recruiting)
- George Washington University — Washington D.C., District of Columbia, United States (Recruiting)
- Tampa General Hospital — Tampa, Florida, United States (Not_yet_recruiting)
- Emory University Hospital — Atlanta, Georgia, United States (Recruiting)
- Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States (Not_yet_recruiting)
- University of Texas Medical Branch — Galveston, Texas, United States (Not_yet_recruiting)
Study contacts
- Principal investigator: Brittany C Collins, PhD — BioFire Defense LLC
- Study coordinator: Brittany C Collins, PhD
- Email: brittany.collins@biofiredefense.com
- Phone: 801-262-3592
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.