Journal Article

Multicenter Evaluation of the Bruker MALDI Biotyper CA System for the Identification of Clinical Aerobic Gram-Negative Bacterial Isolates

Granato, Paul A., Marlowe, Elizabeth, Procop, Gary W., Lillie, Jennifer L., Wilson, Deborah A., Faron, Matthew L., Griego-Fullbright, Christen, Young, Stephen, Kindig, Sandra, Ledeboer, Nathan A., Cumpio, Joven, Buchan, Blake W., Timm, Karen, Hyke, Josh, Madisen, Neil, Novak-Weekley, Susan

2015

Overview

The prompt and accurate identification of bacterial pathogens is fundamental to patient health and outcome. Recent advances in matrix-assisted laser desorption/ionization time-of-flight mass spectrometry (MALDI-TOF MS) have revolutionized bacterial identification in the clinical laboratory, but uniform incorporation of this technology in the U.S. market has been delayed by a lack of FDA-cleared systems. In this study, we conducted a multicenter evaluation of the MALDI Biotyper CA (MBT-CA) System (Bruker Daltonics Inc, Billerica, MA) for the identification of aerobic gram-negative bacteria as part of a 510(k) submission to the FDA. A total of 2,263 aerobic gram negative bacterial isolates were tested representing 23 genera and 61 species. Isolates were collected from various clinical sources and results obtained from the MBT-CA System were compared to DNA sequencing and/or biochemical testing. Isolates that failed to report as a \"high confidence species ID\" [log(score) ≥2.00] were re-tested using an extraction method. The MBT-CA System identified 96.8% and 3.1% of isolates with either a \"high confidence\" or a \"low confidence\" [log(score) value between 1.70 and <2.00] species ID, respectively. Two isolates did not produce acceptable confidence scores after extraction. The MBT-CA System correctly identified 99.8% (2,258/2,263) to genus and 98.2% (2,222/2,263) to species level. These data demonstrate that the MBT-CA System provides accurate results for the identification of aerobic gram-negative bacteria.

• Publisher: Public Library of Science,Public Library of Science (PLoS)
• Subject: Bacteria / Bacterial infections / Bacterial Typing Techniques - instrumentation / Bacterial Typing Techniques - methods / Care and treatment / Deoxyribonucleic acid / Desorption / Development and progression / DNA / DNA sequencing / Electromagnetic radiation / Evaluation / Gene sequencing / Genetic aspects / Gram-Negative Aerobic Bacteria - classification / Gram-Negative Aerobic Bacteria - genetics / Gram-negative bacteria / Health aspects / Humans / Ionization / Ions / Laboratories / Lasers / Mass spectrometry / Mass spectroscopy / Sensitivity and Specificity / Species / Spectrometry, Mass, Matrix-Assisted Laser Desorption-Ionization - instrumentation / Spectrometry, Mass, Matrix-Assisted Laser Desorption-Ionization - methods