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Quality Control and Reference Guidelines for CLSI Broth Microdilution Susceptibility Method (M38-A Document) for Amphotericin B, Itraconazole, Posaconazole, and Voriconazole

VCU Medical Center, Richmond, Virginia,¹ University of Texas Health Science Center, San Antonio, Texas,² Case Western Reserve University, Cleveland, Ohio,³ Wayne State University, Detroit, Michigan,⁴ University of Texas-Houston Medical School, Houston, Texas,⁵ University of Iowa College of Medicine, Iowa City, Iowa,⁶ Duke University, Durham, North Carolina,⁷ National Cancer Institute, Bethesda, Maryland⁸

Received 28 March 2005/ Returned for modification 15 May 2005/ Accepted 30 June 2005

Although standard conditions are available for testing the susceptibilities of filamentous fungi to antifungal agents by the Clinical and Laboratory Standards Institute (CLSI; formerly National Committee for Clinical Laboratory Standards) broth microdilution assay, quality control (QC) MIC limits have not been established for any mold-agent combination. This multicenter (eight-center) study documented the reproducibility of tests for one isolate of Paecilomyces variotii ATCC MYA-3630 and 11 other mold isolates (three isolates of Aspergillus fumigatus; two isolates of A. terreus; one isolate each of A. flavus, A. nidulans, Fusarium moniliforme, and F. solani; and two isolates of Scedosporium apiospermum) by the CLSI reference broth microdilution method (M38-A document). Control limits (amphotericin B, 1 to 4 µg/ml; itraconazole, 0.06 to 0.5 µg/ml; posaconazole, 0.03 to 0.25 µg/ml; voriconazole, 0.015 to 0.12 µg/ml) for the selected QC P. variotii ATCC MYA-3630 were established by the analysis of replicate MIC results. Reference isolates and corresponding MIC ranges were also established for 6 of the 12 molds evaluated. MIC limits were not proposed for the other five molds tested due to low testing reproducibility for these isolates.

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