An observational study in Coronavirus, Respiratory Infection and COVID, sponsored by BioFire Defense LLC. Completed at 6 sites in United States. Per ClinicalTrials.gov, last updated 2026-08-27.
Sponsored by BioFire Defense LLC · Observational
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.
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).
929 studies on the registry are indexed under Coronavirus Infections; 50 are open to participants now.
This study's enrollment of 2,091 is above the median of 300 across 334 observational studies indexed under Coronavirus Infections.
Browse Coronavirus Infections studies →BioFire Defense LLC is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
patients suspected of a respiratory infection by their healthcare provider
Exclusion Criteria:
NPS specimens leftover from SOC testing for a suspected respiratory infection as determined by a health care provider
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.
Also known as: BIOFIRE ECoV Panel
Device Performance
Positive Percent Agreement and Negative Percent Agreement for Panel Targets
Time frame: Through study completion; September 2025-August 2026
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
BioFire Defense LLC