Prospective Clinical Evaluation of the BioFire Emerging Coronavirus Panel for the Detection of COVID-19 and Other Coronaviruses

NCT07221097 | Recruiting FDA Device

• 2 other identifiers: DF-SDY-03453875A50122C00073
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 6

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.

Conditions

Coronavirus; Respiratory Infection; COVID

Keywords

in vitro diagnostic; pandemic preparedness; medical device; molecular diagnostic; coronavirus

Outcome Measures

Primary Outcomes (1)

• Device Performance

  Positive Percent Agreement and Negative Percent Agreement for Panel Targets

  Through study completion; September 2025-August 2026

Study Arms (1)

Suspected respiratory infection

NPS specimens leftover from SOC testing for a suspected respiratory infection as determined by a health care provider

Device: Investigational IVD for coronaviruses

Interventions

Investigational IVD for coronaviruses DEVICE

Device testing on prospectively collected specimens leftover from standard of care for IVD validation only; results will not influence patient care/management.

Also known as: BIOFIRE ECoV Panel

Suspected respiratory infection

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients suspected of a respiratory infection by their healthcare provider

You may qualify if:

• 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

You may not qualify if:

• Specimen is unable to be tested within the defined storage parameters
• Insufficient specimen volume for testing
• Transport medium type is unknown

Sponsors & Collaborators

• BioFire Defense LLC: lead
• Children's Hospital Los Angeles: collaborator
• George Washington University: collaborator
• Wake Forest University Health Sciences: collaborator
• Tampa General Hospital: collaborator
• The University of Texas Medical Branch, Galveston: collaborator
• Emory University: collaborator

Study Sites (6)

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

RECRUITING

George Washington University

Washington D.C., District of Columbia, 20037, United States

RECRUITING

Tampa General Hospital

Tampa, Florida, 33606, United States

NOT YET RECRUITING

Emory University Hospital

Atlanta, Georgia, 30032, United States

RECRUITING

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157-1042, United States

NOT YET RECRUITING

University of Texas Medical Branch

Galveston, Texas, 77550, United States

NOT YET RECRUITING

Related Links

• Related Info

Biospecimen

Retention: SAMPLES WITH DNA

nasopharyngeal swabs (NPS) eluted in transport medium

MeSH Terms

Conditions

Coronavirus Infections; Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Diseases

Study Officials

• Brittany C Collins, PhD

  BioFire Defense LLC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brittany C Collins, PhD

CONTACT

801-262-3592; brittany.collins@biofiredefense.com

David Rabiger, PhD

CONTACT

801-262-3592; david.rabiger@biofiredefense.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2025
• First Posted: October 27, 2025
• Study Start: September 29, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: October 27, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)