Evolving to Meet Your Needs: BIOFIRE® FILMARRAY® System Software Updates
The BIOFIRE FILMARRAY System platform is constantly evolving to meet the changing needs of laboratories and clinicians. In September 2021, we released a software update that grew directly out of customer feedback. These features were intended to improve the customer experience and enhance security.
The software update is for BIOFIRE® FILMARRAY® 2.0 and BIOFIRE® FILMARRAY® TORCH Systems that use the Microsoft Windows® 10 Operating System. Here are some of the new, beneficial features that are included in the update:
New Features of the BIOFIRE FILMARRAY Software
Bidirectional LIS connectivity. One of the most impactful features of the software update is new functionality for bidirectional LIS connectivity. This allows the software to communicate with a data manager using HL7, an industry-standard messaging format.
This bidirectional communication enables the BIOFIRE FILMARRAY System to associate test results with a specific order and provide this linked information to a data manager, receive information about testing orders, and check that the order matches the Pouch Type.
The ability to view melt curves on the BIOFIRE TORCH System. The BIOFIRE FILMARRAY Systems use melt curve data to analyze results and make a “Detected” or “Not Detected” call for each panel menu target. TheBIOFIRE 2.0 system has always offered the ability to view the melt curve data for each pouch run. The new software update gives the same ability to BIOFIRE TORCH users. This ability to view melt curve data enables users to trend internal controls and enhances confidence in run results.
Improved operator management. The software update offers the ability to easily export and import BIOFIRE FILMARRAY System users. This functionality is helpful when an institution has more than one BIOFIRE System or when transitioning from one BIOFIRE System to another (for example, from the BIOFIRE 2.0 to the BIOFIRE TORCH). With the export and import feature, users don’t have to reestablish usernames and passwords when they move from one BIOFIRE System to another within their institution.
Furthermore, operators no longer need to insert a pouch into the BIOFIRE 2.0 system to add, remove, and modify operator information.
The ability to map to a network drive. This update for the BIOFIRE TORCH adds a new “Map Network Drive” option on the Settings menu. This feature is helpful for sites that are unable to utilize USB drives.
The ability to view and export control values. The BIOFIRE 2.0 system has always provided the ability to view internal pouch control values. With the new software update, this feature is now available on the BIOFIRE TORCH. Additionally, the control values can now be exported to a .CSV file on both systems.
File encryption. With this security feature, exported and archived files are now encrypted. Import and Restore options can ingest these encrypted files. Previously archived files (.FAZ) can be imported into the new software.
How to Obtain the Software Update
The BIOFIRE FILMARRAY System IVD software update is available for download on BIOFIRE’s e-labeling site, and customers can perform the update on their own. Customer Support can also assist you with performing the software update over the phone. Additionally, customers in the US can request an FAS to perform the software update. Outside the US, customers may request an FAS/FSE to perform the update, depending on the local cluster/subsidiary policies.
Lab Verification
All software components have been extensively tested to ensure that there are no impacts to the analytical performance of BIOFIRE’s IVD tests. Laboratories should consider an internal risk analysis to determine if verification testing is needed prior to reporting patient results. Additionally, the laboratory may consult applicable laboratory accrediting agencies for further guidance.
The following protocols may serve as a guideline; however, laboratory verification protocols are ultimately the responsibility of the Laboratory Director.
- For non-interfaced systems: Run a few known specimens or routine QC.
- For interfaced systems: Run a few known specimens or routine QC and ensure results transmit as expected.
Reach Out for Support
We are committed to offering world-class customer technical service and support. Don’t hesitate to reach out If you have any questions or concerns regarding the BIOFIRE FILMARRAY System IVD software update. Our support team is here to ensure customers are successful and get the most accurate syndromic infectious disease testing results. Get in touch with our team on the Contact Us page.
Microsoft and Windows are either registered trademarks or trademarks of Microsoft Corporation in the United States and/or other countries.
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