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

NCT07221097

CompletedN/A

Sponsor: BioFire Defense LLC

Conditions: Coronavirus, Respiratory Infection, COVID

Interventions: Investigational IVD for coronaviruses

Countries: United States

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.

Eligibility overview

Sex: ALL

Healthy volunteers: No

Study type: OBSERVATIONAL

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

Locations (6)

Los Angeles, California, United States
Washington D.C., District of Columbia, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Winston-Salem, North Carolina, United States
Galveston, Texas, United States