Evidence map›Paper›PMID 26529504›Full record

ArticlePloS one2015

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

Matthew L Faron, Blake W Buchan, Josh Hyke, Neil Madisen, Jennifer L Lillie, Paul A Granato, Deborah A Wilson, Gary W Procop, Susan Novak-Weekley, Elizabeth Marlowe and 6 more

Abstract readComparative StudyEvaluation StudyMulticenter Study
In one paragraph

Article in PloS one, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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  12. Limitation ofJournal of clinical microbiology · 2022
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  17. Green synthesis of silver nanoparticles usingInternational journal of nanomedicine
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors.

Matthew L FaronMedical College of Wisconsin, Milwaukee, WI, United States of America.
Blake W BuchanMedical College of Wisconsin, Milwaukee, WI, United States of America; Wisconsin Diagnostic Laboratory, Milwaukee, WI, United States of America.
Josh HykeWisconsin Diagnostic Laboratory, Milwaukee, WI, United States of America.
Neil MadisenWisconsin Diagnostic Laboratory, Milwaukee, WI, United States of America.
Jennifer L LillieLaboratory Alliance of Central New York, Fayetteville, NY, United States of America.
Paul A GranatoLaboratory Alliance of Central New York, Fayetteville, NY, United States of America; SUNY Upstate Medical University, Syracuse, NY, United States of America.
Deborah A WilsonCleveland Clinic, Cleveland, OH, United States of America.
Gary W ProcopCleveland Clinic, Cleveland, OH, United States of America.
Susan Novak-WeekleyKaiser Permanente SCPMG Regional Reference Laboratories, North Hollywood, CA, United States of America.
Elizabeth MarloweKaiser Permanente SCPMG Regional Reference Laboratories, North Hollywood, CA, United States of America.
Joven CumpioKaiser Permanente SCPMG Regional Reference Laboratories, North Hollywood, CA, United States of America.
Christen Griego-FullbrightTricore Reference Laboratories, Albuquerque NM, United States of America.
Sandra KindigTricore Reference Laboratories, Albuquerque NM, United States of America.
Karen TimmTricore Reference Laboratories, Albuquerque NM, United States of America.
Stephen YoungTricore Reference Laboratories, Albuquerque NM, United States of America; Department of Pathology UNMHSC, Albuquerque, NM, United States of America.
Nathan A LedeboerMedical College of Wisconsin, Milwaukee, WI, United States of America; Wisconsin Diagnostic Laboratory, Milwaukee, WI, United States of America.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

Indexed as

Bacterial Typing TechniquesSpectrometry, Mass, Matrix-Assisted Laser Desorption-IonizationGram-Negative Aerobic BacteriaHumansSensitivity and Specificity

Identifiers

PMID26529504
PMCPMC4631355

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.