title: Multicenter Evaluation of the Bruker MALDI Biotyper CA System for the Identification of Clinical Aerobic Gram-Negative Bacterial Isolates.
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.
authors.affiliation: Medical College of Wisconsin, Milwaukee, WI, United States of America.
authors.forename: Matthew L
authors.initials: ML
authors.lastname: Faron
authors.affiliation: Medical College of Wisconsin, Milwaukee, WI, United States of America; Wisconsin Diagnostic Laboratory, Milwaukee, WI, United States of America.
authors.forename: Blake W
authors.initials: BW
authors.lastname: Buchan
authors.affiliation: Wisconsin Diagnostic Laboratory, Milwaukee, WI, United States of America.
authors.forename: Josh
authors.initials: J
authors.lastname: Hyke
authors.affiliation: Wisconsin Diagnostic Laboratory, Milwaukee, WI, United States of America.
authors.forename: Neil
authors.initials: N
authors.lastname: Madisen
authors.affiliation: Laboratory Alliance of Central New York, Fayetteville, NY, United States of America.
authors.forename: Jennifer L
authors.initials: JL
authors.lastname: Lillie
authors.affiliation: Laboratory Alliance of Central New York, Fayetteville, NY, United States of America; SUNY Upstate Medical University, Syracuse, NY, United States of America.
authors.forename: Paul A
authors.initials: PA
authors.lastname: Granato
authors.affiliation: Cleveland Clinic, Cleveland, OH, United States of America.
authors.forename: Deborah A
authors.initials: DA
authors.lastname: Wilson
authors.affiliation: Cleveland Clinic, Cleveland, OH, United States of America.
authors.forename: Gary W
authors.initials: GW
authors.lastname: Procop
authors.affiliation: Kaiser Permanente SCPMG Regional Reference Laboratories, North Hollywood, CA, United States of America.
authors.forename: Susan
authors.initials: S
authors.lastname: Novak-Weekley
authors.affiliation: Kaiser Permanente SCPMG Regional Reference Laboratories, North Hollywood, CA, United States of America.
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Marlowe
authors.affiliation: Kaiser Permanente SCPMG Regional Reference Laboratories, North Hollywood, CA, United States of America.
authors.forename: Joven
authors.initials: J
authors.lastname: Cumpio
authors.affiliation: Tricore Reference Laboratories, Albuquerque NM, United States of America.
authors.forename: Christen
authors.initials: C
authors.lastname: Griego-Fullbright
authors.affiliation: Tricore Reference Laboratories, Albuquerque NM, United States of America.
authors.forename: Sandra
authors.initials: S
authors.lastname: Kindig
authors.affiliation: Tricore Reference Laboratories, Albuquerque NM, United States of America.
authors.forename: Karen
authors.initials: K
authors.lastname: Timm
authors.affiliation: Tricore Reference Laboratories, Albuquerque NM, United States of America; Department of Pathology UNMHSC, Albuquerque, NM, United States of America.
authors.forename: Stephen
authors.initials: S
authors.lastname: Young
authors.affiliation: Medical College of Wisconsin, Milwaukee, WI, United States of America; Wisconsin Diagnostic Laboratory, Milwaukee, WI, United States of America.
authors.forename: Nathan A
authors.initials: NA
authors.lastname: Ledeboer
mesh_terms: D015373:Bacterial Typing Techniques / Q000295:instrumentation / Q000379:methods; D006088:Gram-Negative Aerobic Bacteria / Q000145:classification* / Q000235:genetics; D006801:Humans; D012680:Sensitivity and Specificity; D019032:Spectrometry, Mass, Matrix-Assisted Laser Desorption-Ionization / Q000295:instrumentation / Q000379:methods