Evaluation of IVD 3.0 Vitek MS matrix-assisted laser desorption ionization-time of flight mass spectrometry for identification of Mycobacterium tuberculosis and nontuberculous mycobacteria and its use in routine diagnostics.

Rapid and accurate identification of Mycobacterium tuberculosis (MT) and nontuberculous mycobacteria (NTM) is essential for diagnosis, appropriate therapy, and infection control. Matrix-assisted laser desorption ionization-time of flight (MALDI-TOF) mass spectrometry (MS), widely used for identification of bacteria and yeasts, has been applied also to mycobacteria. Recent studies evaluated the performance of the new CE-IVD released IVD 3.0 Vitek MS for the identification of MT and NTM isolates from strain collections or from positive cultures of clinical specimens, demonstrating its utility in clinical practice in different geographic areas. We evaluated the performance of the IVD 3.0 Vitek MS in the identification of 82 well-characterized MT and NTM isolates, recovered in our institution during a 24-mpnth period and stored in our strain collection. The results obtained were comported with those obtained with conventional methods. The impact of inclusion of IVD 3.0 Vitek MS in our laboratory workflow was also evaluated. IVD 3.0 Vitek MS represent a valuable tool for MT and, importantly, NTM identification. It can be performed immediately on positive liquid cultures, resulting in a significant reduction in time to report.