NCT07221097

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,091

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2025

Shorter than P25 for all trials

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 29, 2025

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

October 22, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 27, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2026

Completed
Last Updated

August 27, 2026

Status Verified

August 1, 2026

Enrollment Period

6 months

First QC Date

October 22, 2025

Last Update Submit

August 25, 2026

Conditions

CoronavirusRespiratory InfectionCOVID

Keywords

in vitro diagnosticpandemic preparednessmedical devicemolecular diagnosticcoronavirus

Outcome Measures

Primary Outcomes (1)

  • Device Performance

    Positive Percent Agreement and Negative Percent Agreement for Panel Targets

    Through study completion; September 2025-August 2026

Study Arms (1)

Suspected respiratory infection

NPS specimens leftover from SOC testing for a suspected respiratory infection as determined by a health care provider

Device: Investigational IVD for coronaviruses

Interventions

Investigational IVD for coronavirusesDEVICE

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

Also known as: BIOFIRE ECoV Panel
Suspected respiratory infection

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients suspected of a respiratory infection by their healthcare provider

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

George Washington University

Washington D.C., District of Columbia, 20037, United States

Location

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Emory University Hospital

Atlanta, Georgia, 30032, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157-1042, United States

Location

University of Texas Medical Branch

Galveston, Texas, 77550, United States

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

nasopharyngeal swabs (NPS) eluted in transport medium

MeSH Terms

Conditions

Coronavirus InfectionsRespiratory Tract Infections

Condition Hierarchy (Ancestors)

Coronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfectionsRespiratory Tract Diseases

Study Officials

  • Brittany C Collins, PhD

    BioFire Defense LLC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2025

First Posted

October 27, 2025

Study Start

September 29, 2025

Primary Completion

March 31, 2026

Study Completion

April 30, 2026

Last Updated

August 27, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations

US(6)