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New test aims to spot coronaviruses faster and more accurately

NCT ID NCT07221097

Diagnosis Sponsor: BioFire Defense LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 28, 2026 · Updated 3 times

Summary

This study is testing a new diagnostic panel called the BioFire ECoV Panel, designed to detect coronaviruses from leftover nose swab samples. Researchers will enroll 1,500 people and compare the panel's results to standard tests to see how accurate it is. The test is not being used to guide patient care during the study—it's only to check if the device works well.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BioFire ECoV Panel (a diagnostic test device)
What this could lead to
If successful, this could provide a faster, more accurate way to detect coronaviruses, helping doctors diagnose infections sooner.
What could go wrong
This is an early validation study, not a treatment trial. The test may not prove accurate enough in real-world use, and results won't affect patient care during the study.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

2,091 people

The number who actually took part.

Started

Sep 2025

Finished

Apr 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

patients suspected of a respiratory infection by their healthcare provider

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Coronavinae infectious disease COVID-19 respiratory tract infectious disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Coronavirus COVID Respiratory infection

Contacts and locations

Locations

  • Children's Hospital Los Angeles

    Los Angeles, California, 90027, United States

  • Emory University Hospital

    Atlanta, Georgia, 30032, United States

  • George Washington University

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

  • Tampa General Hospital

    Tampa, Florida, 33606, United States

  • University of Texas Medical Branch

    Galveston, Texas, 77550, United States

  • Wake Forest University Health Sciences

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

More trials for these conditions

Other studies related to the condition(s) this trial covers.