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

Recruiting

• Conditions: Coronavirus; Respiratory Infection; COVID

• Registration Number: NCT07221097
• Lead Sponsor: BioFire Defense LLC

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.

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 individuals with signs and/or symptoms of respiratory infection. Multiple geographically distinct clinical sites in the U.S. will participate in testing. Enrollment will consist of residual, coded NPS specimens leftover from standard of care testing for a suspected respiratory infection as determined by a health care provider. Concordance between the BioFire ECoV Panel assays and comparator methods will be measured using positive and negative percent agreement (PPA and NPA).

Study Timeline

• Study Start: 2025-09-29
• Status Verified: 2025-10
• Study First Submitted: 2025-10-22
• Study First Submitted QC: 2025-10-23
• Last Update Submitted: 2025-10-23
• Study First Posted: 2025-10-27
• Last Update Posted: 2025-10-27
• Primary Completion: 2026-06
• Study Completion: 2026-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Device Performance	Through study completion; September 2025-August 2026	Positive Percent Agreement and Negative Percent Agreement for Panel Targets

Trial Locations

Locations (6)

Children's Hospital Los Angeles; 🇺🇸 Los Angeles, California, United States

George Washington University; 🇺🇸 Washington D.C., District of Columbia, United States

Tampa General Hospital; 🇺🇸 Tampa, Florida, United States

Emory University Hospital; 🇺🇸 Atlanta, Georgia, United States

Wake Forest University Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States

University of Texas Medical Branch; 🇺🇸 Galveston, Texas, United States