Dataset Information

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.

SUBMITTER: Faron ML

PROVIDER: S-EPMC4631355 | biostudies-literature | 2015

REPOSITORIES: biostudies-literature

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

Faron Matthew L ML Buchan Blake W BW Hyke Josh J Madisen Neil N Lillie Jennifer L JL Granato Paul A PA Wilson Deborah A DA Procop Gary W GW Novak-Weekley Susan S Marlowe Elizabeth E Cumpio Joven J Griego-Fullbright Christen C Kindig Sandra S Timm Karen K Young Stephen S Ledeboer Nathan A NA

PloS one 20151103 11

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 ...[more]

PMID: 26529504

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Project description:BluePoint MoldID can identify 43 fungal species through nucleic acid array hybridization and matrix-assisted laser desorption ionization-time of flight mass spectrometry (MALDI-TOF MS) can identify 247 filamentous fungi through mass spectrometry. First, 43 standard isolates from the Bioresource Collection and Research Center, Taiwan, and the College of American Pathologists and 41 clinical Aspergillus species isolates confirmed by rDNA-ITS sequencing were analyzed using BluePoint MoldID and Bruker MALDI-TOF MS. BluePoint MoldID accurately identified 79% (34/43) of the standard isolates to the species level but failed to recognize nine isolates absent from its database; additionally, 87.8% (36/41) of the clinical isolates were identified at the species level, with 80.5% (33/41) accuracy. MALDI-TOF MS identified 86% (37/43) of the standard isolates, with 81.4% (35/43) accurately identified at the species level and two at the genus level, and identified all the clinical isolates, with 92.6% (38/41) accurately identified at the species level. Next, we analyzed 93 clinical Aspergillus species and compared the results by rDNA-ITS sequencing. BluePoint MoldID identified 87.1% (81/93) of the isolates at the species level, with 80.6% (75/93) accuracy. MALDI-TOF MS identified 97.8% (91/93) of the isolates, including some uncommon species, with 90.3% (84/93) accuracy at the species level. BluePoint MoldID and MALDI-TOF MS had turnaround times of 8 and 2 h, respectively, significantly reducing the time needed to identify filamentous fungi.ImportanceThe BluePoint MoldID kit is an oligonucleotide array used for the identification of filamentous fungi, and it has not yet been mentioned in recent studies. We used a BluePoint MoldID kit to identify standard and clinical filamentous fungal isolates and compared its performance with that of Bruker MALDI-TOF MS. The former accurately identified 80.2% of the isolates (142/177), and the latter identified 92.6% of the isolates (164/177). The performance of the BluePoint MoldID kit was slightly inferior to that of Bruker MALDI-TOF MS because of the smaller database. However, the BluePoint MoldID kit can cover most clinically common opportunistic fungal infections; thus, it offers an alternative method for laboratories that lack MALDI-TOF MS equipment, as the device is less expensive.

Project description:The spread of carbapenemase-producing Enterobacterales (CPE) is emerging as a significant clinical concern in tertiary hospitals and, in particular, long-term care facilities with deficiencies in infection control. This study aims to evaluate an advanced matrix-assisted laser desorption/ionization (A-MALDI) mass spectrometry method for the identification of carbapenemases and further discrimination of their subtypes in clinical isolates. The A-MALDI method was employed to detect CPE target proteins. Enhancements were made to improve detectability and mass accuracy through the optimization of MALDI-TOF settings and internal mass calibration. A total of 581 clinical isolates were analyzed, including 469 CPE isolates (388 Klebsiella pneumoniae carbapenemases [KPC], 51 NDM, 40 OXA, and 2 GES) and 112 carbapenemase-negative isolates. Clinical evaluation of the A-MALDI demonstrated 100% accuracy and precision in identifying all the collected CPE isolates. Additionally, A-MALDI successfully discriminated individual carbapenemase subtypes (KPC-2 or KPC-3/KPC-4, OXA-48 or OXA-181 or OXA-232, GES-5 or GES-24) and also differentiated co-producing carbapenemase strains (KPC and NDM, KPC and OXA, KPC and GES, and NDM and OXA), attributed to its high mass accuracy and simultaneous detection capability. A-MALDI is considered a valuable diagnostic tool for accurately identifying CPE and carbapenemase's subtypes in clinical isolates. It may also aid in selecting appropriate antibiotics for each carbapenemase subtype. Ultimately, we expect that the A-MALDI method will contribute to preventing the spread of antibiotic resistance and improving human public health.ImportanceA-MALDI clearly demonstrated excellent ability to identify CPEs such as KPC, NDM, OXA, and GES when carbapenemase is present in the strain (100% accuracy and precision). The method also successfully discriminated carbapenemase subtypes and simultaneous detection of co-producing multiple carbapenemases in a single strain. This is the first report for simultaneous and multiple detection of intact carbapenemases of KPC, NDM, OXA, and GES using matrix-assisted laser desorption/ionization mass spectrometry in a clinical isolate.

Dataset Information

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

Publications

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

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