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 antimicrobial agents against rapidly growing aerobic bacteria involved in infectious diseases (ISO 20776-1:2006)
Abstract
ISO 20776-1:2006 describes one reference method, broth microdilution, for determination of MICs. The MIC reflects the activity of the drug under the described test conditions, and can be interpreted for clinical management purposes by taking into account other factors, such as drug pharmacology or bacterial resistance mechanisms. This allows categorization 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 ISO 20776-1:2006, modifications of the basic method are required for certain antimicrobial agent – bacteria combinations to facilitate clinical interpretation. These modifications are included in a separate table. It is advisable to compare other susceptibility testing methods (e.g. routine methods or diagnostic test devices) with this reference method for validation, in order to ensure comparable and reliable results.
DIN EN ISO 20776-1:2007-02 (E)
Clinical laboratory testing and in vitro diagnostic test systems – Susceptibility testing
of infectious agents and evaluation of performance of antimicrobial susceptibility
test device s – Part 1: Reference method for testing the in vitro activity of
antimicrobial agents against rapidly growing aerobic bacteria involved in infectious
diseases (ISO 20776-1:2006)
Contents Page
Foreword………………………………………………………………………………………………………………………………………..
Introduction …………………………………………………………………………………………………………………………………….
Scope ………………………………………………………………………………………………………………………………….
Terms and definitions…………………………………………………………………………………………………………..
Test procedures …………………………………………………………………………………………………………………..
Medium ……………………………………………………………………………………………………………………………….
.
General………………………………………………………………………………………………………………………………..
Antimicrobial agents ……………………………………………………………………………………………………………
Preparation of inoculum …………………………………………………………………………………………………….
Inoculation of microdilution trays……………………………………………………………………………………….
Incubation of microdilution trays………………………………………………………………………………………..
Special test situations where the MIC result might give unreliable results …………………………..
Reading results ………………………………………………………………………………………………………………….
Quality control…………………………………………………………………………………………………………………….
Annex A (normative) Requirements for Mueller-Hinton broth……………………………………………………………
Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 98/79 ……………………………………………………………………………………. 22
Bibliography ……………………………………………………………………………………………………………….