The Biomedical Advanced Research and Development Authority (BARDA) has contracted BioFireDefense (BFDf) to develop the BioFire Emerging Coronavirus (ECoV) Panel, a nucleic acidtest capable of detecting coronaviruses from nasopharyngeal swab (NPS) in transportmedium.This study aims to evaluate the diagnostic accuracy of the assays comprising the BioFireECoV Panel. It is hypothesized that the BioFire ECoV Panel assays will be highlysensitive and specific for the detection of the coronaviruses included on the panel.
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).
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.
Other Name: BIOFIRE ECoV Panel
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
Children's Hospital Los Angeles
Los Angeles 5368361, California 5332921, United States
George Washington University
Washington D.C. 4140963, District of Columbia 4138106, United States
Tampa General Hospital
Tampa 4174757, Florida 4155751, United States
Emory University Hospital
Atlanta 4180439, Georgia 4197000, United States
Wake Forest University Health Sciences
Winston-Salem 4499612, North Carolina 4482348, United States
University of Texas Medical Branch
Galveston 4692883, Texas 4736286, United States
Brittany C Collins, PhD
801-262-3592
brittany.collins@biofiredefense.com
David Rabiger, PhD
801-262-3592
david.rabiger@biofiredefense.com
Brittany C Collins, PhD, Principal Investigator
BioFire Defense LLC