The Continued Value of Disk Diffusion for Assessing Antimicrobial Susceptibility in Clinical Laboratories: Report
Romney M Humphries1, Susan Kircher2, Andrea Ferrell2
1Accelerate Diagnostics, Tucson, Arizona, USA rhumphries@axdx.com.
Abstract:
Expedited pathways to antimicrobial agent approval by the U.S. Food and Drug Administration (FDA) have led to increased delays between drug approval and the availability of FDA-cleared antimicrobial susceptibility testing (AST) devices. Antimicrobial disks for use with disk diffusion testing are among the first AST devices available to clinical laboratories. However, many laboratories are reluctant to implement disk diffusion testing for a variety of reasons, including dwindling proficiency with this method, interruptions of the laboratory workflow, uncertainty surrounding the quality and reliability of disk diffusion tests, and a perceived need to report MIC values to clinicians. This minireview provides a report from the Clinical and Laboratory Standards Institute Methods Development and Standardization Working Group on the current standards and clinical utility of disk diffusion testing.
Insights
Antimicrobial susceptibility testing (AST) device availability lags behind drug approval. This review examines disk diffusion testing standards and clinical use, addressing laboratory concerns about proficiency and workflow.
Area of Science:
- Clinical Microbiology
- Antimicrobial Resistance
- Diagnostic Device Development
Background:
- Expedited antimicrobial drug approval by the U.S. Food and Drug Administration (FDA) creates delays in the availability of cleared antimicrobial susceptibility testing (AST) devices.
- Antimicrobial disks for disk diffusion testing are often among the first AST devices available, yet face implementation barriers in clinical laboratories.
- Laboratory reluctance stems from decreased proficiency, workflow disruption, quality concerns, and a perceived need for Minimum Inhibitory Concentration (MIC) values.
Purpose of the Study:
- To report on current standards for disk diffusion testing.
- To assess the clinical utility of disk diffusion testing in the context of delayed AST device availability.
- To address laboratory concerns regarding the implementation and reliability of disk diffusion methods.
Main Methods:
- This minireview synthesizes information from the Clinical and Laboratory Standards Institute (CLSI) Methods Development and Standardization Working Group.
- It focuses on existing standards and clinical data related to disk diffusion testing.
- The review addresses common laboratory challenges and perceptions of the method.
Main Results:
- Disk diffusion testing remains a relevant and accessible method for AST, often available before other device types.
- Despite challenges, established standards provide a framework for reliable disk diffusion testing.
- The review acknowledges but also implicitly counters concerns regarding proficiency and workflow by focusing on standards and utility.
Conclusions:
- Disk diffusion testing, supported by CLSI standards, offers a valuable and timely approach to AST.
- Addressing laboratory concerns and emphasizing adherence to standards can enhance the implementation and reliability of this method.
- Disk diffusion testing plays a crucial role in guiding antimicrobial therapy, especially when newer AST devices are delayed.
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