| Autor: |
Faron ML; Medical College of Wisconsin, Milwaukee, WI, United States of America., Buchan BW; Medical College of Wisconsin, Milwaukee, WI, United States of America; Wisconsin Diagnostic Laboratory, Milwaukee, WI, United States of America., Hyke J; Wisconsin Diagnostic Laboratory, Milwaukee, WI, United States of America., Madisen N; Wisconsin Diagnostic Laboratory, Milwaukee, WI, United States of America., Lillie JL; Laboratory Alliance of Central New York, Fayetteville, NY, United States of America., Granato PA; Laboratory Alliance of Central New York, Fayetteville, NY, United States of America; SUNY Upstate Medical University, Syracuse, NY, United States of America., Wilson DA; Cleveland Clinic, Cleveland, OH, United States of America., Procop GW; Cleveland Clinic, Cleveland, OH, United States of America., Novak-Weekley S; Kaiser Permanente SCPMG Regional Reference Laboratories, North Hollywood, CA, United States of America., Marlowe E; Kaiser Permanente SCPMG Regional Reference Laboratories, North Hollywood, CA, United States of America., Cumpio J; Kaiser Permanente SCPMG Regional Reference Laboratories, North Hollywood, CA, United States of America., Griego-Fullbright C; Tricore Reference Laboratories, Albuquerque NM, United States of America., Kindig S; Tricore Reference Laboratories, Albuquerque NM, United States of America., Timm K; Tricore Reference Laboratories, Albuquerque NM, United States of America., Young S; Tricore Reference Laboratories, Albuquerque NM, United States of America; Department of Pathology UNMHSC, Albuquerque, NM, United States of America., Ledeboer NA; Medical College of Wisconsin, Milwaukee, WI, United States of America; Wisconsin Diagnostic Laboratory, Milwaukee, WI, United States of America. |
| Abstrakt: |
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. |
