Epidemiological Cutoff Value (ECV) Raw Data Submission for Antifungals

The Working Group on Antifungal Epidemiological Cutoff Values is requesting submission of raw antifungal susceptibility testing data for yeasts and filamentous fungi using the protocols provided in the most current editions of CLSI documents M27, Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts and M38, Reference Method for Broth Dilution Antifungal Susceptibility Testing of Filamentous Fungi. This request is only for reference broth microdilution and should not include data generated using commercially available panels. Because the data will be combined with data from other laboratories, even a small amount of data is useful, especially for the more infrequently identified species. All species should be identified using a molecular assay or matrix-assisted laser desorption/ionization time-of-flight mass spectrometry.

Please submit data using the Antifungal Data Submission Sheet. Instructions are provided below. Submit completed worksheets to CLSI at standard@clsi.org.

Instructions

• Fill out the laboratory information worksheet.
• Use a blank worksheet for each species/antifungal agent combination.
• Fill in the genus and species.
• Fill in the antifungal agent used.
• Cells A6 to A24 consist of the values of the general minimal inhibitory concentration (MIC) range. Indicate the range tested by removing the “0s” in column C that correspond to values in column A outside the tested range.
  • EXAMPLE: If the range is 0.06 to 128 µg/mL, remove all of the “0s” except for those in cells C12 to C23.
• In cells C6 to C24, enter the number of isolates whose MIC values correspond to the values in column A.
  • EXAMPLE: If eight isolates have an MIC value of 0.25 µg/mL, enter “8” in cell C14.
• Leave a “0” for those values for which there are no data and/or no corresponding isolates.
• If the data are less than or greater than a value on the table, change the MIC value in column A accordingly.
  • EXAMPLE: If an isolate has a value less than the lowest value of 0.125 µg/mL, in cell A12 change the value from 0.06 to < 0.125.
  • EXAMPLE: If an isolate has a value higher than the highest value of 8 µg/mL, in cell A20 change the value from 16 to < 8.
• Add additional data sheets, as needed, per the number of species/antifungal agent combinations.

Quality Control Instructions*

• Provide quality control (QC) results for each antifungal agent.
• Include sequential QC results (all results collected during the testing period, if available).
• Include data representing performance at the time patient isolates were tested.

If QC data are not available from the time period when patient isolates were tested, include recent data and a comment explaining whether or not there have been any significant shifts in QC results. A QC data sheet is included for Candida isolates C. parapsilosis ATCC®† 22019 and C. krusei ATCC® 6258. If other isolates were used, please change the name on the sheet.

* In order to ensure QC of all results, CLSI requests your QC results for the time of testing.

† ATCC® is a registered trademark of the American Type Culture Collection.