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Automated Microbial Diagnostics01:24

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Automated diagnostic analyzers have transformed clinical microbiology by providing rapid and reliable methods for pathogen identification and antibiotic susceptibility testing. Among these systems, the Vitek 2 is widely used because it automates the traditionally labor-intensive processes of microbial identification (ID) and antibiotic susceptibility testing (AST), delivering standardized and timely results that are essential for effective patient care.Microbial Identification with ID CardsThe...

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Sulbactam-durlobactam susceptibility test method development and quality control ranges for MIC and disk diffusion

Sarah M McLeod1, Nicole M Carter1, Michael D Huband2

  • 1Entasis Therapeutics Inc. (an affiliate of Innoviva Specialty Therapeutics, Inc.), Waltham, Massachusetts, USA.

Journal of Clinical Microbiology
|December 14, 2023
PubMed
Summary

New antimicrobial susceptibility testing methods for sulbactam-durlobactam were established. These methods accurately detect resistance in multidrug-resistant Acinetobacter baumannii, aiding treatment of hospital-acquired pneumonia.

Keywords:
quality controlsulbactam-durlobactamsusceptibility testing

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Area of Science:

  • Microbiology
  • Clinical Laboratory Science

Background:

  • Sulbactam-durlobactam is a novel combination therapy targeting hospital-acquired and ventilator-associated bacterial pneumonia caused by Acinetobacter baumannii-calcoaceticus complex (ABC).
  • Durlobactam, a potent β-lactamase inhibitor, restores sulbactam's activity against multidrug-resistant ABC by inhibiting Ambler classes A, C, and D serine β-lactamases.

Purpose of the Study:

  • To establish validated antimicrobial susceptibility testing (AST) methods for sulbactam-durlobactam.
  • To define quality control (QC) ranges for broth microdilution (MIC) and disk diffusion tests.

Main Methods:

  • Evaluated sulbactam-durlobactam combinations using genetically characterized A. baumannii isolates.
  • Determined optimal MIC testing concentrations and disk diffusion criteria for discriminating susceptible and resistant strains.
  • Conducted multi-laboratory QC studies using A. baumannii NCTC 13304 according to CLSI M23 Tier 2 criteria.

Main Results:

  • MIC testing with doubling dilutions of sulbactam and a fixed 4 µg/mL durlobactam concentration showed optimal discrimination.
  • A 10/10 µg sulbactam/durlobactam disk concentration demonstrated the best discrimination and MIC correlation.
  • CLSI-approved QC ranges were established: 0.5/4-2/4 µg/mL for MIC and 24-30 mm for disk diffusion.

Conclusions:

  • Established accurate and reproducible AST methods for sulbactam-durlobactam.
  • These validated methods will support clinical laboratories in identifying patients who may benefit from sulbactam-durlobactam treatment.
  • The defined QC ranges ensure reliable susceptibility testing for Acinetobacter baumannii infections.