Charting Uncharted Territory: a Review of the Verification and Implementation Process for Matrix-Assisted Laser Desorption Ionization–Time of Flight Mass Spectrometry (MALDI-TOF MS) for Organism Identification

Abstract: The advent of matrix-assisted laser desorption ionization–time of flight mass spectrometry (MALDI-TOF MS) for organism identification is changing the paradigm for laboratory diagnosis of infectious diseases. As a result of the improved speed, quality, and affordability provided by MALDI-TOF, laboratories have begun transitioning to this method for routine organism identifications. Currently, there are two manufacturers that produce MALDI-TOF MS systems for organism identification and that are actively pursuing Food and Drug Administration clearance, and both databases are currently labeled research use only. However, there is no formal guidance on what is specifically required to verify the performance of these systems. The goal of this document is to establish some basic guidance for those laboratories seeking to verify MALDI-TOF. To this end, product selection, aspects of verification, and implementation are discussed.
Source: Clinical Microbiology Newsletter - Category: Microbiology Authors: Source Type: news