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.
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
Specimen is unable to be tested within the defined storage parameters
Insufficient specimen volume for testing
Transport medium type is unknown
patients suspected of a respiratory infection by their healthcare provider
Case-only
Prospective
Investigational IVD for coronaviruses
DeviceDevice testing on prospectively collected specimens leftover from standard of care for IVD validation only; results will not influence patient care/management.
Device Performance
Positive Percent Agreement and Negative Percent Agreement for Panel Targets
Click on the lead sponsor to view all of their trials.
BioFire Defense LLC
Lead sponsor
Children's Hospital Los Angeles
Collaborator
George Washington University
Collaborator
Wake Forest University Health Sciences
Collaborator
Tampa General Hospital
Collaborator
The University of Texas Medical Branch, Galveston
Collaborator
Emory University
Collaborator
