CoronavirusNCT07221097
Prospective Clinical Evaluation of the BioFire Emerging Coronavirus Panel for the Detection of COVID-19 and Other Coronaviruses
An observational study of Coronavirus and Respiratory Infection, run by BioFire Defense LLC at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronavirus, Respiratory Infection, COVID
- What is being tested?
- Investigational IVD for coronaviruses
- Type of treatment
- Medical device
- How many people
- 2,091 participants
- Where
- 6 sitesUnited States
- Study dates
- 29 Sep 2025to 30 Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients suspected of a respiratory infection by their healthcare provider
Who may be able to join
- 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
Who cannot join
- Specimen is unable to be tested within the defined storage parameters
- Insufficient specimen volume for testing
- Transport medium type is unknown
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Emory University Hospital
Atlanta, Georgia, 30032
University of Texas Medical Branch
Galveston, Texas, 77550
Children's Hospital Los Angeles
Los Angeles, California, 90027
Tampa General Hospital
Tampa, Florida, 33606
George Washington University
Washington D.C., District of Columbia, 20037
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157-1042
About this study
Official title: Prospective Clinical Evaluation of the BioFire Emerging Coronavirus Panel - Sponsor's Protocol
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.
Read the 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).
- Conditions
- Coronavirus, Respiratory Infection, COVID
- Being tested
- Investigational IVD for coronaviruses
- Keywords
- in vitro diagnostic, pandemic preparedness, medical device, molecular diagnostic, coronavirus
- Medical subject headings
- Coronavirus Infections, Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational IVD for coronavirusesDevice
Also called BIOFIRE ECoV Panel
Device testing on prospectively collected specimens leftover from standard of care for IVD validation only; results will not influence patient care/management.
| Study group | Role | What they receive |
|---|---|---|
| Suspected respiratory infection | NPS specimens leftover from SOC testing for a suspected respiratory infection as determined by a health care provider Receives: Device: Investigational IVD for coronaviruses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device Performance
Positive Percent Agreement and Negative Percent Agreement for Panel Targets
Measured: Through study completion; September 2025-August 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2025
- Study start29 Sep 2025
- Primary completion31 Mar 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoronavirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 2,091 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioFire Defense LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Children's Hospital Los Angeles, George Washington University, Wake Forest University Health Sciences, Tampa General Hospital, The University of Texas Medical Branch, Galveston, Emory University
- Responsible party
- Sponsor
- Investigators
- Brittany C Collins, PhD, Principal investigator, BioFire Defense LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07221097
- Sponsor's protocol ID
- DF-SDY-034538
- Other IDs
- 75A50122C00073
- Status last verified
- Aug 2026
- First submitted
- 22 Oct 2025
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical Evaluation of the BioFire Emerging Coronavirus Panel - Sponsor's Protocol
- ClinicalTrials.gov ID
- NCT07221097
- Acronym / sponsor ID
- DF-SDY-034538
- Conditions
- Coronavirus, Respiratory Infection, COVID
- Keywords
- in vitro diagnostic, pandemic preparedness, medical device, molecular diagnostic, coronavirus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,091 participants (actual)
- Lead sponsor
- BioFire Defense LLCIndustry (pharma, biotech, devices)
- Collaborators
- Children's Hospital Los Angeles, George Washington University, Wake Forest University Health Sciences, Tampa General Hospital, The University of Texas Medical Branch, Galveston, Emory University
- Study start
- 29 Sep 2025 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 27 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Suspected respiratory infection | – | Device: Investigational IVD for coronavirusesNPS specimens leftover from SOC testing for a suspected respiratory infection as determined by a health care provider |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients suspected of a respiratory infection by their healthcare provider
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Specimen is unable to be tested within the defined storage parameters
- Insufficient specimen volume for testing
- Transport medium type is unknown
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Investigational IVD for coronavirusesAlso: BIOFIRE ECoV PanelDevice testing on prospectively collected specimens leftover from standard of care for IVD validation only; results will not influence patient care/management. | Device | Suspected respiratory infection |
Primary outcome
Device Performance
Time frame: Through study completion; September 2025-August 2026
Positive Percent Agreement and Negative Percent Agreement for Panel Targets
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brittany C Collins, PhD principal investigator
BioFire Defense LLC
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronavirus and Respiratory Infection, run by BioFire Defense LLC at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device Performance (time frame: Through study completion; September 2025-August 2026). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.