Evaluation of the BioFire Emerging Coronavirus Panel for Detecting COVID-19 and Other Coronaviruses Using Nasopharyngeal Swab Samples

What this Trial Is About

Researchers are evaluating the accuracy of the BioFire Emerging Coronavirus ECoV Panel, a nucleic acid test designed to detect coronaviruses, including COVID-19, from nasopharyngeal swab samples. This observational, non-interventional study aims to measure how well the BioFire ECoV Panel identifies coronaviruses compared to standard testing methods, across multiple clinical sites in the U.S. The study is sponsored by BioFire Defense LLC and focuses on individuals with signs or symptoms of respiratory infection. The study involves testing leftover nasopharyngeal swab specimens that were originally collected for standard care respiratory infection analysis. These residual specimens are analyzed using the BioFire ECoV Panel to validate its diagnostic performance. The specimens must meet specific storage and volume requirements before testing, and test results will not affect patient care or management. Participants contribute indirectly by providing residual specimens from their standard care tests. Researchers will assess the positive and negative agreement between the BioFire ECoV Panel and comparator methods to determine diagnostic accuracy. The primary outcome measure is device performance during the study period from September 2025 to August 2026. No direct interventions or treatments are given to participants, and the study does not involve additional visits or procedures beyond standard care.

Prospective Clinical Evaluation of the BioFire Emerging Coronavirus Panel for the Detection of COVID-19 and Other Coronaviruses