In the United States, the instruments discussed fall under the purview of the FDA for regulatory clearance. Both the VITEK® MS and the Bruker microflex® (MALDI Biotyper®) have been granted clearance for select microorganisms.
The VITEK® MS MALDI-TOF Mass Spectrometry System for pathogen identification was granted 510(k) clearance in August 2013 for 192 microorganisms, including yeast (Candida, Cryptococcus, Malassezia groups) and bacteria from the Staphylococcaceae, Streptococcaceae, Enterobacteriaceae, Pseudomonadineae, and Bacteroidaceae families. It received additional clearance for the expanded identification of mycobacteria, Nocardia, and molds. The database update also includes important clinical pathogens such as Brucella species, Candida auris, and Elizabethkingia anophelis. There are more than 15,000 distinct microorganism strains in the VITEK MS database.6
The Bruker Biotyper® system was approved in November 2013 with a claim for the identification of 40 gram negative species or species groups. FDA clearance in April 2015 heralded an additional 170 species and species groups, representing 180 clinically relevant species of aerobic gram positives, fastidious gram negatives, Enterobacteriaceae, anaerobic bacteria, and yeasts. Now there are three different libraries available:7
- Reference library includes thousands of strains for 4,194 species including the common clinical species and also rare microorganisms. A library extension covers 5 species from 5 genera and allows for early detection of highly pathogenic microorganisms in the workflow.
- Filamentous Fungi library facilitates the identification of 222 species and species groups of filamentous fungi.
- Mycobacteria which consists of an expanded Mycobacteria reference spectrum library. It includes 182 of the currently known 201 mycobacteria species.
Both systems have expanded their databases since inception and interested readers are encouraged to consult the respective websites.
