Prospective Clinical Evaluation of the BioFire Emerging Coronavirus Panel for the Detection of COVID-19 and Other Coronaviruses
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Investigational IVD for coronaviruses.
- Who it may be relevant to
- Registry conditions: Coronavirus, Respiratory Infection, COVID. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prospective Clinical Evaluation of the BioFire Emerging Coronavirus Panel - Sponsor's Protocol
Overview
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).
Interventions
- Device 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.
Primary outcome measures
- Device Performance [Time frame: Through study completion; September 2025-August 2026]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
United States · 6 centers
- Children's Hospital Los Angeles — Los Angeles
- George Washington University — Washington D.C.
- Tampa General Hospital — Tampa
- Emory University Hospital — Atlanta
- Wake Forest University Health Sciences — Winston-Salem
- University of Texas Medical Branch — Galveston
Identifiers
NCT: NCT07221097 · DF-SDY-034538 · 75A50122C00073