CLSI Publishes Guideline for In Vitro Susceptibility Testing Criteria and Quality Control Parameters for Veterinary Antimicrobial Agents.WAYNE, Pa. -- Clinical and Laboratory Standards Institute (CLSI CLSI Clinical and Laboratory Standards Institute (Wayne, PA) CLSI Cisco Link Services Interface ) recently published an updated document, Development of In Vitro in vitro /in vi·tro/ (in ve´tro) [L.] within a glass; observable in a test tube; in an artificial environment. in vi·tro adj. In an artificial environment outside a living organism. Susceptibility Testing Criteria and Quality Control Parameters Control parameters In a nonlinear dynamic system, the coefficient of the order parameter; the determinant of the influence of the order parameter on the total system. See: Order Parameter. for Veterinary Antimicrobial Agents Antimicrobial agents Chemical compounds biosynthetically or synthetically produced which either destroy or usefully suppress the growth or metabolism of a variety of microscopic or submicroscopic forms of life. ; Approved Guideline--Third Edition (M37-A3), which offers guidance for developing agar disk diffusion zones of inhibition, dilution MIC breakpoints, and quality control limits for antimicrobial susceptibility testing of aerobic bacteria Aerobic bacteria Bacteria which require oxygen in order to grow and survive. Mentioned in: Aminoglycosides, Flesh-Eating Disease aerobic bacteria Bacteria that grow in the presence of O2 isolated from animals. Jeffrey L. Watts, PhD, RM(AAM n. 1. A Dutch and German measure of liquids, varying in different cities, being at Amsterdam about 41 wine gallons, at Antwerp 36½, at Hamburg 38¼. ), M(ASCP ASCP American Society of Clinical Pathologists. ), Director, Livestock Pharmaceuticals, Pfizer Animal Health, who served as chairholder for the committee that developed the document, says, "M37-A3 provides specific information to sponsors regarding the data requirements for the development of veterinary-specific clinical breakpoints including, for the first time, an algorithm for evaluating the various components used to set clinical breakpoints." M37-A3 is intended to be used in establishing interpretive and quality control criteria for CLSI antimicrobial susceptibility testing standards for antimicrobial agents intended for veterinary use. Host-specific pharmacokinetics, in vitro drug characteristics, distributions of microorganisms, and correlation of test results with outcome statistics are addressed from the perspective of interpretation of test results. In addition, this document addresses clinical confirmation of interpretive criteria and quality control limits. This document, originally adapted from CLSI/NCCLS document Development of In Vitro Susceptibility Testing Criteria and Quality Control Parameters (M23), has been modified to include: * a new paradigm New Paradigm In the investing world, a totally new way of doing things that has a huge effect on business. Notes: The word "paradigm" is defined as a pattern or model, and it has been used in science to refer to a theoretical framework. to establish primary interpretive criteria; and * a new appendix that provides more rationale for the process of establishing breakpoints and interpretive criteria. CLSI document M37-A3 is intended to offer guidance for sponsors (corporate or individual) that want to list interpretive criteria and quality control information in CLSI/NCCLS document Performance Standards for Antimicrobial Disk and Dilution Susceptibility Tests for Bacteria Isolated From Animals (M31) for a new and/or approved veterinary antimicrobial agent. CLSI welcomes presentations for antimicrobial agents originating from any country, not just the United States. Data developed according to M37, using relevant testing methods in other CLSI documents, are used by the Subcommittee on Veterinary Antimicrobial Susceptibility Testing (VAST) as the basis for establishing interpretive and quality control criteria for inclusion in the CLSI standard M31. 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 NCCLS National Committee for Clinical Laboratory Standards , 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. |
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