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MALDI-TOF Mass Spectrometry for Pathogen Identification: A Review of Accuracy and Clinical Effectiveness

Last updated: October 16, 2015
Project Number: RD0030-000
Product Line: Rapid Response
Research Type: Other Diagnostics
Report Type: Peer-reviewed summary with critical appraisal
Result type: Report

Question

  1. What is the accuracy and reproducibility of MALDI-TOF MS for the identification of organisms from cultures on solid media?
  2. What is the accuracy and reproducibility of MALDI-TOF MS for the identification of organisms from blood cultures?
  3. What is the clinical effectiveness of using MALDI-TOF MS for pathogen species identification?
  4. 4. What is the cost-effectiveness of using MALDI-TOF MS for pathogen species identification?

Key Message

The diagnostic accuracy with MALDI-TOF mass spectrometry against established methods of identifying microbes is high and well established, with the exception of a few organisms (depending on the system and database interrogated) that still require additional testing, and those rare organisms not well represented in the various databases in use. MALDI-TOF reduces the time from positive culture or isolate to identification by at least 24 hours in most cases, though that depends upon the organism, the system and database used, and on individual laboratory workflow modifications. There is limited direct evidence on the effect of this reduction on clinical outcomes, with no randomized controlled trial data and sparse observational evidence on improvement of outcomes such as 30-day mortality, length of hospital stay, length of ICU stay, and recurrence and readmission. In addition, to translate the reduced time to identification to quicker and more specific therapy there must be effective communication between laboratory, ID specialists, and treating physicians. Studies of costs are limited to cost calculations and budget impacts, without considering cost-effectiveness or system updates.