CLSI VET02 A3 : 3ED 2008

Abstract
Committee Membership
Foreword
1 Scope
2 Definitions
3 General Considerations and Time Sequence
  3.1 Subcommittee Requirements
  3.2 Time Sequence for Presentation
  3.3 Presentation Format
  3.4 Acceptability of Data
  3.5 Use of Data Derived From Previously Accepted Reference
      Methods
  3.6 Reassessment of Breakpoints/Interpretive Criteria and
      QC Parameters
  3.7 Development of Interpretive Criteria for Generic or
      Older Compounds
4 Data Generation and Establishment of QC Limits
  4.1 Preliminary QC Testing (Tier 1 Preliminary QC Study)
  4.2 Requirements for Establishing Acceptable QC Ranges
      (Tier 2 QC Study)
  4.3 Confirmation and Reassessment of QC Ranges (Tier 3
      QC Monitoring)
5 Data to Provide to Establish Breakpoints and Interpretive
  Criteria
  5.1 Clinical Effectiveness Studies
  5.2 Isolate Collections and Susceptibility Test Data
      Presentation
  5.3 Cross-Resistance Studies
  5.4 Comparison of Dilution Test Methods for Aerobic
      Bacteria
  5.5 Use of Commercially Prepared Microdilution Panels
  5.6 Pharmacology
6 Process of Establishing Breakpoints and Interpretive
  Criteria
  6.1 Decision Tree for Setting Breakpoints
  6.2 Evaluation of Dilution MIC and Disk Diffusion Data
  6.3 Final Determination of Breakpoints and Interpretive
      Criteria
References
Appendix A. Information to Appear on Presentation Coverage Page
Appendix B. Drug "X" MIC vs Zone Diameter (495 challenge
            organisms)
Appendix C. The Use of PK and PD Relationships in the Setting
            of Susceptibility Breakpoints for Veterinary
            Antimicrobial Agents
The Quality Management System Approach
Related CLSI Reference Materials

Provides the required and recommended data needed for selection of appropriate interpretive standards and quality control guidance for new veterinary antimicrobial agents.

This document offers guidance for the development of quality control (QC) limits and interpretive criteria for antimicrobial susceptibility testing (AST), performed by disk diffusion and dilution testing with bacteria isolated from animals, for subcommittee review and, upon approval, inclusion in CLSI document M31.1 The guidance in this document applies to therapeutic antimicrobial agents intended for the treatment or controlof systemic or organ-specific infectious disease processes in domestic animals (terrestrial or aquatic). Antimicrobial agents used for growth promotion or prophylaxis (disease prevention) are not included in this document. (See the discussion in CLSI document M311 for more details regarding this issue.) However, the testing methodology described for the development of QC standards may be applicable for those antimicrobial agents that are tested for epidemiological survey or other purposes for which a validated test is required. The subcommittee recognizes that antimicrobial agents are used to treat a variety of enteric infections in animals; thus, a concerted attempt to include them within CLSI document M311 should be made to guide practitioners in the proper selection of agents. NOTE: The guidelines do not apply to directly applied topical antimicrobials such as lotions, cream, ointments, or eye drops. Since not all antimicrobial agents have veterinary-specific breakpoints or interpretive criteria, the subcommittee has imported breakpoints and zone diameters from CLSI document M1005 (ie, human treatments) into Table 1, Group B of CLSI document M31,1 and designated them by gray shaded listing. Since these breakpoints and interpretive criteria have been developed for human treatment applications, there is uncertainty as to how they apply to specific animal species and disease treatments. To facilitate moving CLSI document M1005 interpretive criteria to veterinary-specific approved status, the Working Group on Generics will provide a gatekeeper function to ensure that presentations to the full subcommittee conform as much as possible to VET02 requirements. This will allow for a consistent approach to address those situations where veterinary-specific data are not readily available within the public domain or where sponsors (ie, manufacturers) are not able or willing to provide data on their products. Additionally, should there be a need to reevaluate previously established breakpoints or interpretive criteria, a process is outlined in Section 3.6.