4.7 Article

Automated preparation for identification and antimicrobial susceptibility testing: evaluation of a research use only prototype, the BD Kiestra IdentifA/SusceptA system

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ELSEVIER SCI LTD
DOI: 10.1016/j.cmi.2020.07.007

关键词

Automated prototype; IdentifA; Kiestra TLA; MALDI-TOF; SusceptA

资金

  1. BD Life Sciencesd-Integrated Diagnostic Solutions, Sparks, MD, USA
  2. BD

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The study compared the performance of the current BD Kiestra (TM) TLA system and a fully automated research-use-only prototype, BD Kiestra (TM) IdentifA/SusceptA, in a clinical setting. Results showed high agreement between the two systems, with the automated prototype demonstrating potential advantages for clinical microbiology laboratories.
Objective: The current BD Kiestra (TM) total laboratory automation (TLA) system automates specimen inoculation, incubation, and digital visualization of cultures prior to initiation of manual or semi-automated identification (ID) and antimicrobial susceptibility testing (AST). The current study aimed to compare the performance, in a clinical setting, of a fully automated research-use-only prototype, BD Kiestra (TM) IdentifA/SusceptA (automated system), to our current BD Kiestra (TM) TLA which utilizes manual or semi-automated IDs and ASTs (current system). Methods: Clinical samples yielding significant growth after processing by the BD Kiestra (TM) TLA were tested in parallel for ID and AST by both systems. IDs and ASTs were determined by Bruker matrix-assisted laser desorption/ionization time-of-flight (MALDI-TOF) mass spectrometry and BD Phoenix, respectively, with data stored and managed in the BD EpiCenter (TM). The automated system used a common inoculum preparation for both tests, whereas the current system used separate inocula. Results were compared to assess agreement between the systems. Results: On initial testing, 89% of IDs (466/523) and 92.4% of IDs (484/523) for the automated and current ID systems, respectively, yielded acceptable MALDI-TOF log scores of >= 1.7. On repeat testing, the respective acceptable scores were 97.1% (508/523) and 98.1% (513/523). For initial ASTs, the automated and current systems yielded 97.5% categorical agreement for 7325 drug-organism tests. After omitting discrepant MICs that differed by only one dilution and categorical discrepancies that were not reproducible, 0.2% unresolved discrepancies remained thus (99.8% categorical agreement). Conclusions: The automated prototype is suitable for development into technology that will provide clinical microbiology laboratories with significant advantages such as improved efficiency, standardization, reproducibility, reduced technical error and greater safety. (C) 2020 The Author(s). Published by Elsevier Ltd on behalf of European Society of Clinical Microbiology and Infectious Diseases.

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