ISO 20776-1:2019 PDF

Scope: This document describes one reference method, broth micro-dilution, for determination of MICs. The MIC can be a guide for the clinician, and reflects the activity of the drug under the described test conditions, by taking into account other factors, such as drug pharmacology, pharmacokinetics, or bacterial resistance mechanisms. This allows categorisation of bacteria as “susceptible” (S), “intermediate” (I), or “resistant” (R). In addition, MIC distributions can be used to define wild type or non-wild type bacterial populations. Although clinical interpretation of the MIC value is beyond the scope of this document, modifications of the basic method are required for certain antimicrobial agent - bacteria combinations to facilitate clinical interpretation. These modifications are included in a separate annex of this document. It is necessary to compare other susceptibility testing methods (e.g. disc diffusion or diagnostic test devices) with this reference method for validation, in order to ensure comparable and reliable results.

ISO 20776-1:2019 history

2019 ISO 20776-1:2019 Clinical laboratory testing and in vitro diagnostic test systems — Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices — Part 1: Refe
2006 ISO 20776-1:2006 Clinical laboratory testing and in vitro diagnostic test systems - Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices - Part 1: Reference method for testing the in vitro activity of antim