CLSI Publishes Guideline and Supplement for Antifungal Disk Diffusion Susceptibility Testing of Yeasts.

WAYNE, Pa. -- Clinical and Laboratory Standards Institute (CLSI) updated the document Method for Antifungal Disk Diffusion Susceptibility Testing of Yeasts; Approved Guideline--Second Edition (M44-A2). This guidance helps fulfill the need for an alternative simple, rapid, and cost-effective approach to determine susceptibility of yeasts to various classes of antifungal agents and will make antifungal susceptibility testing more readily available to the clinical microbiology laboratory.

M44-A2 provides newly established methodology for disk diffusion testing of Candida spp., criteria for quality control testing, and interpretive criteria.

Barbara D. Alexander, MD, MHS, Director, Transplant Infectious Diseases Services and the Clinical Mycology Laboratory, Duke University Medical Center, and chairholder of the working group that developed the document, says, "Disk diffusion susceptibility testing for Candida species provides a less labor-intense and quicker means for the laboratory to provide answers for clinicians. M44-A has been updated to keep pace with the changing armamentarium of antifungal agents used in patient care. Importantly, M44-A2 provides testing guidelines for caspofungin as well as interpretive criteria for caspofungin and voriconazole, two of the most common antifungal agents in use today."

There are currently more than 10 systemically active antifungal agents, and it is expected that this document will further encourage the development of disk diffusion testing for at least some of these drugs. John H. Rex, MD, FACP, Vice President, Clinical Infection, AstraZeneca, explains, "Disk diffusion methods are often preferred by laboratories due to their simplicity. By providing a solid point of reference for drug sponsors, device manufacturers, and regulatory authorities, the M44 methodology should facilitate the development and deployment of such methods."

This guideline is intended for use by, but not limited to, health care, academic, government, industry, or independent research organizations that perform antifungal susceptibility testing of yeasts.

Zone Diameter Interpretive Standards, Corresponding Minimal Inhibitory Concentration (MIC) Interpretive Breakpoints, and Quality Control Limits for Antifungal Disk Diffusion Susceptibility Testing of Yeasts; Third Informational Supplement (M44-S3), providing new quality control limits for CLSI document M44-A2, is also available for purchase.

For additional information on CLSI or for further information regarding this release, visit the CLSI website at www.clsi.org or call +610.688.0100.

CLSI, formerly NCCLS, is a global, nonprofit, membership-based organization dedicated to developing standards and guidelines for the health care and medical testing community. CLSI's unique consensus process facilitates the creation of standards and guidelines that are reliable, practical, and achievable for an effective quality system.