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PLoS One. 2015 Nov 3;10(11):e0141350. doi: 10.1371/journal.pone.0141350. eCollection 2015.

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

Author information

1
Medical College of Wisconsin, Milwaukee, WI, United States of America.
2
Medical College of Wisconsin, Milwaukee, WI, United States of America; Wisconsin Diagnostic Laboratory, Milwaukee, WI, United States of America.
3
Wisconsin Diagnostic Laboratory, Milwaukee, WI, United States of America.
4
Laboratory Alliance of Central New York, Fayetteville, NY, United States of America.
5
Laboratory Alliance of Central New York, Fayetteville, NY, United States of America; SUNY Upstate Medical University, Syracuse, NY, United States of America.
6
Cleveland Clinic, Cleveland, OH, United States of America.
7
Kaiser Permanente SCPMG Regional Reference Laboratories, North Hollywood, CA, United States of America.
8
Tricore Reference Laboratories, Albuquerque NM, United States of America.
9
Tricore Reference Laboratories, Albuquerque NM, United States of America; Department of Pathology UNMHSC, Albuquerque, NM, United States of America.

Abstract

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.

PMID:
26529504
PMCID:
PMC4631355
DOI:
10.1371/journal.pone.0141350
[Indexed for MEDLINE]
Free PMC Article

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