Prospective Clinical Evaluation of the BioFire Emerging Coronavirus Panel for the Detection of COVID-19 and Other Coronaviruses
NCT ID: NCT07221097
Last Updated: 2025-10-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1500 participants
OBSERVATIONAL
2025-09-29
2026-08-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Suspected respiratory infection
NPS specimens leftover from SOC testing for a suspected respiratory infection as determined by a health care provider
Investigational 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.
Interventions
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Investigational 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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Insufficient specimen volume for testing
* Transport medium type is unknown
ALL
No
Sponsors
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Children's Hospital Los Angeles
OTHER
George Washington University
OTHER
Wake Forest University Health Sciences
OTHER
Tampa General Hospital
OTHER
The University of Texas Medical Branch, Galveston
OTHER
Emory University
OTHER
BioFire Defense LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Brittany C Collins, PhD
Role: PRINCIPAL_INVESTIGATOR
BioFire Defense LLC
Locations
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Children's Hospital Los Angeles
Los Angeles, California, United States
George Washington University
Washington D.C., District of Columbia, United States
Tampa General Hospital
Tampa, Florida, United States
Emory University Hospital
Atlanta, Georgia, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
University of Texas Medical Branch
Galveston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Other Identifiers
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75A50122C00073
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
DF-SDY-034538
Identifier Type: -
Identifier Source: org_study_id
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