NCT07221097

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

Prospective Clinical Evaluation of the BioFire Emerging Coronavirus Panel - Sponsor's Protocol

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,500 (estimated)
• Sponsor: BioFire Defense LLC · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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).

Conditions

• Coronavirus
• Respiratory Infection
• COVID

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-09-29
• Primary completion: 2026-06-01
• Completion: 2026-08-01
• First posted: 2025-10-27
• Last updated: 2025-10-27

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated device study