Sulopenem Disk Development, Quality Control Range, and MIC to Disk Result Correlation for Enterobacterales Isolates

Area of Science:

• Microbiology
• Clinical Pharmacy
• Infectious Diseases

Background:

• Sulopenem is a novel carbapenem antibiotic.
• Accurate antimicrobial susceptibility testing (AST) is crucial for guiding treatment decisions.
• Standardized methods for sulopenem AST are needed.

Purpose of the Study:

• To evaluate the performance of sulopenem disk diffusion for AST.
• To establish quality control (QC) parameters for sulopenem disk diffusion.

Main Methods:

• Disk diffusion and broth microdilution methods were used.
• Error-rate bounding analysis was performed according to CLSI guideline M23.
• An eight-laboratory quality control study was conducted.

Main Results:

• The 2-μg sulopenem disk showed high accuracy with very few interpretive errors among 2,856 Enterobacterales isolates.
• Quality control testing demonstrated 99.0% of results within the acceptable range (24-30 mm).
• A CLSI-established QC range for Escherichia coli 29522 was determined (24-30 mm).

Conclusions:

• The 2-μg sulopenem disk is a reliable method for AST of Enterobacterales.
• The established QC range ensures consistent and accurate testing.
• This method supports effective sulopenem utilization in clinical settings.