Exciting news! The BIOFIRE® FILMARRAY® Gastrointestinal (GI) Panel that you know and love now offers a new feature called C. difficile Select!* What is C. difficile Select? C. difficile Select is a feature that allows users running the BIOFIRE GI Panel on either the BIOFIRE® FILMARRAY® TORCH or the BIOFIRE® FILMARRAY® 2.0 Systems to choose between a pouch module that reports C. difficile or does not report C. difficile.
Can I toggle between reporting C. difficile results? Unfortunately, no, not at this time. With this feature, a user can choose to always have C. difficile results reported by using the existing default pouch module or choose to never have C. difficile results reported depending on the pouch module that is installed.
Will I need to redo verification studies? If your institution decides to install the new pouch module without C. difficile results, we do not recommend additional verification studies as this does not change the performance of the test; however, any decision to complete additional verification studies is ultimately up to the laboratory director at your institution. With that said, updates to laboratory documentation, like the IQCP, may be needed and should be evaluated prior to installation.
My instrument is connected to an LIS. Will I need to update the software? Possibly, yes. There isn’t any need to update BIOFIRE® FILMARRAY® Link Software that connects your BIOFIRE® System with your Laboratory Information Systems (LIS); however, the LIS software configuration at your institution may need to be modified. We recommend consulting with your in-house IT and/or LIS experts to see if a modification is needed. bioMérieux is also happy to assist, if needed. Give our Technical Support Team a call at 1-801-736-6354 option 5.
Will this new feature impact reimbursement? Possibly, yes. Many policies surrounding outpatient reimbursement are tied to the number of targets or the targets tested. Prior to downloading and installing the pouch module without C. difficile results, we encourage you to review the possible implications with your internal billing department and other relevant stakeholders within your institution.
*C. difficile Select is available only to customers in the US.