Performance Standards for Antifungal Susceptibility Testing of Filamentous Fungi - Version 3rd edition - guidance for minimal inhibitory concentration breakpoints and quality control tables

Oct 7, 2026

Clinical and Laboratory Standards Institute document M38M515 provides performance standards for antifungal susceptibility testing of filamentous fungi, including minimal inhibitory concentration breakpoints and quality control tables. The MIC data and quality control results are valid only when laboratories follow the specified methodologies described in CLSI documents M38 and M51. The document instructs users to replace previously published tables with the updated versions, and highlights table changes from the prior edition in bold typeface.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages36

Reading Time1 h 31 min

AccessFree to download

Performance Standards for Antifungal Susceptibility Testing of Filamentous Fungi

Consensus Process

Commenting on Documents

Appeal Process

Abstract

Suggested Citation

M38M⁵1S # Performance Standards for AntifungalSusceptibility Testing of Filamentous Fungi T is document includes minimal inhibitory concentrationbeakpoints and quality control tables for the Clinical andLaboratory Standards Institute antifungal susceptibility testingdocuments M38 and M51. Clinical and Laboratory Standards Institute Setting the standard forquality in medical laboratory testing around the world. The Clinical and Laboratory Standards Institute(CLSI)is a not-for-profit membership organization that bringstogether the varied perspectives and expertise of the worldwide laboratory community for the advancement of acommon cause:to foster excellence in laboratory medicine by developing and implementing medical laboratorystandards and guidelines that help laboratories fulfll their responsibilities with efficiency,effectiveness,and globalapplicability. ## Consensus Process Consensus-the substantial agreement by materially affected,competent,and interested parties-is core to thedevelopment ofall CLSI documents.It does not always connote unanimous agreement but does mean that theparticipants in the development of a consensus document have considered and resolved all relevant objectionsand accept the resulting agreement. ## Commenting on Documents CLSI documents undergo periodicevaluation and modification to keep pace with advances in technologies,procedures,methods,and protocols affecting the laboratory or health care. CLSI's consensus process depends on experts who volunteer to serve as contributing authors and/or as participantsin the reviewing and commenting process.At the end of each comment period,the committee that developedthe document is obligated to review all comments,respond in writing toall substantive comments,and revise thedraft document as appropriate. Comments on published CLSI documents are equally essential and may be submitted by anyone,at any time,onany document.All comments are managed according to the consensus process by a committee of experts. ## Appeal Process When it is believed that an objection has not been adequately considered and responded to,the process forappeal,documented in the CLSI Standards Development Policies and Processes,is followed. All comments and responses submitted on draft and published documents are retained on fle at CLSI and areavailable upon request. Get Involved-Volunteer! Do you use CLSi documents in your workplace?Do you see room for improvement?Would you like to getinvolved in the revision process?Or maybe you see a need to develop a new document for an emergingtechnology?CLSI wants to hear from you.We are always looking for volunteers.By donating your time and talentsto improve the standards that affect your own work,you will play an active role in improving public health acrossthe globe. For additional information on committee participation or to submit comments,contact CLSI. Clinical and Laboratory Standards instituteP:+1.610.688.0100 F:+1.610.688.0700www.clsi.orgstandard@clsi.org # Performance Standards for Antifungal Susceptibility Testingof Filamentous Fungi Gary W.Procop,MD,MS Philippe J.Dufresne,PhD,RMCCMElizabeth Berkow,PhDSharon K.Cullen,BS,RACJeff Fuller,PhD,FCCM,D(ABMM)Kimberly E.Hanson,MD,MHSNicole M.Holliday,BASixto M.Leal,MD,PhD Audrey N.Schuetz,MD,MPH,D(ABMM)Paul E.Verweij,MD,FECMMNathan P.Wiederhold,PharmDAdrian M.Zelazny,PhD,D(ABMM) ## Abstract Clinical and Laboratory Standards Institute document M38M515-Performance Standards for AntifungalSusceptibility Testing of Filamentous Fungi includes minimal inhibitory concentration and quality control tablesdeveloped following the guidance in CLSI documents M381 and M51.2 The data in the tables are valid only whenthe methodologies in CLSI documents M38 and M51²are followed.Users should replace previously publishedtables with these new tables.Changes in the tables since the previous edition was published appear in boldfacetype. Clinical and Laboratory Standards Inst

FAQs

What does CLSI M38M515 provide for antifungal susceptibility testing?

It provides minimal inhibitory concentration breakpoints and quality control tables for antifungal susceptibility testing of filamentous fungi.

When are the breakpoints and quality control tables considered valid?

The data are valid only when the laboratory follows the methodologies specified in CLSI documents M38 and M51.

What should users do compared with previously published tables?

Users should replace previously published tables with the new tables, and review changes from the previous edition shown in bold type.

Oct 7, 2026

Uploaded by Aria Callaghan