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One-day Workflow Scheme for Bacterial Pathogen Detection and Antimicrobial Resistance Testing from Blood Cultures

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

Sailaja Puttagunta¹, Steven I Aronin¹, Jeanna DiFranco-Fisher²

¹Iterum Therapeutics, Old Saybrook, Connecticut, USA.

Journal of Clinical Microbiology

|June 26, 2023

Summary

The 2-μg sulopenem disk demonstrates accurate and reproducible performance for antimicrobial susceptibility testing of Enterobacterales. This antibiotic susceptibility testing method showed minimal errors and reliable quality control results.

Keywords:

antibacterial agent antimicrobial susceptibility testing disk diffusion sulopenem susceptibility

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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.