Regarding commercial systems (manual test kits or automated) utilized in the medical microbiology laboratory:
- Delays in manufacturer device communications to microbiology laboratories are common (for many reasons), and may include delays in updating databases.22
- Breakpoints may not have been updated for these systems if FDA approval was granted a long time in the past.
- Compendiums (print catalogs or online profiles) may not use the current jargon.
Automated systems, such as MALDI-TOF MS (matrix-assisted laser desorption ionization-time of flight mass spectrometry), may promote the use of an Internet link to provide instrumentation software and database updates.
Additional limitations may exist if:
- The lab is not linked due to institution firewalls and security requirements (i.e., connectivity concerns).
- The lab is not current on required verifications. New verifications must be performed whenever software and database updates occur. For example, the laboratory information system must be checked to be sure the correct (new) organism name crosses over the interface(s) as expected.
