RecruitingNCT07221097

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

Sponsor

BioFire Defense LLC

Enrollment

1,500 participants

Start Date

Sep 29, 2025

Study Type

OBSERVATIONAL

Conditions

Coronavirus COVID Respiratory Infection

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.

Eligibility

Inclusion Criteria3

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 Criteria3

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

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Interventions

DEVICEInvestigational 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.