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

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07221097

Enrollment

2091

Registered

2025-10-27

Start date

2025-09-29

Completion date

2026-04-30

Last updated

2026-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronavirus, COVID, Respiratory Infection

Keywords

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

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).

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.

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

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

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORBrittany C Collins, PhD

BioFire Defense LLC

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 28, 2026