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Evaluating the BioFire Emerging Coronavirus Panel for COVID-19 and Other Coronaviruses

This study is evaluating a new test called the BioFire Emerging Coronavirus (ECoV) Panel. This test is designed to find different coronaviruses, including the one that causes COVID-19, from a nose swab. Researchers want to see how accurate this test is compared to other methods. They will use leftover nose swab samples from people who already had a test for a respiratory infection. The results from this study will not affect your medical care. The study aims to enroll 1500 participants and will measure how well the BioFire ECoV Panel performs until around August 2026. Anyone can participate if their leftover nose swab sample meets certain storage conditions.

Study design
This is an observational study, meaning researchers will look at existing data from leftover samples. It aims to enroll 1500 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The device performance will be measured through study completion, which is planned for September 2025 to August 2026.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07221097

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

Completed
Not specifiedAll AgesObservational
BioFire Defense LLC
~2,091 participants
Updated 2026-08-27 on ClinicalTrials.gov
What's tested:Investigational IVD for coronaviruses

At a glance

Recruiting sites
0 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Device Performance
Measured over Through study completion; September 2025-August 2026

Conditions

Coronavirus
Respiratory Infection
COVID

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Coronavirus InfectionCOVID-19 InfectionRespiratory tract infection

Where it's being run

6 sites across 6 states
California1
District of Columbia1
Florida1
Georgia1
North Carolina1
Texas1

Study leadership

  • Brittany C Collins, PhD · PRINCIPAL_INVESTIGATOR · BioFire Defense LLC

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Device PerformanceThrough study completion; September 2025-August 2026

    Positive Percent Agreement and Negative Percent Agreement for Panel Targets