BioFire Diagnostics, LLC (BioFire; a bioMerieux company), has developed a multiplexed
molecular-based in vitro diagnostic platform for infectious disease testing known as the
FilmArray. The FilmArray Respiratory Panel (RP) EZ is a test designed for use with the
FilmArray 2.0 EZ Configuration instrument that identifies common bacterial and viral
microorganisms associated with respiratory tract infections from a nasopharyngeal swab (NPS)
specimen collected in viral transport media (VTM). The RP EZ was granted CLIA-waived
classification by the FDA in October 2016 and is the first highly-multiplexed molecular test
to receive this designation.
The purpose of this study is to measure patient outcomes following implementation of the RP
EZ test and to also gather data about physician office workflow and user interactions with
the device. These data will be used to understand how the adoption of such tests may
influence patient care in the CLIA-waived setting.