{"database":"biostudies-literature","file_versions":[],"scores":{"citationCount":0,"reanalysisCount":0,"viewCount":49,"searchCount":0},"additional":{"omics_type":["Unknown"],"volume":["10(11)"],"submitter":["Faron ML"],"pubmed_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."],"journal":["PloS one"],"pagination":["e0141350"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC4631355"],"repository":["biostudies-literature"],"pubmed_title":["Multicenter Evaluation of the Bruker MALDI Biotyper CA System for the Identification of Clinical Aerobic Gram-Negative Bacterial Isolates."],"pmcid":["PMC4631355"],"pubmed_authors":["Procop GW","Cumpio J","Lillie JL","Buchan BW","Kindig S","Griego-Fullbright C","Faron ML","Hyke J","Novak-Weekley S","Wilson DA","Timm K","Young S","Madisen N","Marlowe E","Granato PA","Ledeboer NA"],"view_count":["49"],"additional_accession":[]},"is_claimable":false,"name":"Multicenter Evaluation of the Bruker MALDI Biotyper CA System for the Identification of Clinical Aerobic Gram-Negative Bacterial Isolates.","description":"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.","dates":{"release":"2015-01-01T00:00:00Z","publication":"2015","modification":"2021-02-21T02:04:31Z","creation":"2019-03-26T22:56:15Z"},"accession":"S-EPMC4631355","cross_references":{"pubmed":["26529504"],"doi":["10.1371/journal.pone.0141350"]}}