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

NCT07221097 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1500

Last updated 2025-10-27

No results posted yet for this study

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

Interventions

DEVICE

Investigational IVD for coronaviruses

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

Sponsors & Collaborators

  • Children's Hospital Los Angeles

    collaborator OTHER

  • George Washington University

    collaborator OTHER

  • Wake Forest University Health Sciences

    collaborator OTHER

  • Tampa General Hospital

    collaborator OTHER

  • The University of Texas Medical Branch, Galveston

    collaborator OTHER

  • Emory University

    collaborator OTHER

  • BioFire Defense LLC

    lead INDUSTRY

Principal Investigators

  • Brittany C Collins, PhD · BioFire Defense LLC

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-29
Primary Completion
2026-06-30
Completion
2026-08-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07221097 on ClinicalTrials.gov