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

Prospective Clinical Evaluation of the BioFire Emerging Coronavirus Panel - Sponsor's Protocol

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).

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