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

Sulopenem disk masses of 2, 5, 10, and 20 μg were evaluated by susceptibility testing isolates by broth microdilution and disk diffusion. A 2-μg disk was chosen, and error-rate bounding analysis in accordance with Clinical and Laboratory Standards Institute (CLSI) guideline M23 was conducted using a proposed sulopenem susceptible/intermediate/resistant (S/I/R) interpretive criterion of ≤0.5/1/≥2 μg/mL. Among the evaluated Enterobacterales ( n  = 2,856), very few interpretive errors were observed (no very major errors and only one major error). An eight-laboratory quality control (QC) study was performed using the 2-μg disk, and 99.0% (470/475) of results were within a 7-mm range of 24 to 30 mm. Results were similar by disk lot and media, and no outlier sites were observed. A sulopenem 2-μg disk QC range for Escherichia coli 29522 of 24 to 30 mm was established by the CLSI. A 2-μg sulopenem disk performs accurately and reproducibly for testing of Enterobacterales .
Competing Interests: The authors declare a conflict of interest. S.I.A. and S.P. are Full-time employees and own stocks: Iterum Therapeutics.