BS EN ISO 16256:2021 – TC
$186.33
Tracked Changes. Clinical laboratory testing and in vitro diagnostic test systems. Broth micro-dilution reference method for testing the in vitro activity of antimicrobial agents against yeast fungi involved in infectious diseases
| Published By | Publication Date | Number of Pages |
| BSI | 2021 | 66 |
This document describes a method for testing the susceptibility to antifungal agents of yeasts, including Candida spp. and Cryptococcus neoformans, that cause infections. The reference method described here has not been used in studies of the yeast forms of dimorphic fungi, such as Blastomyces dermatitidis and/or Histoplasma capsulatum variety capsulatum. Moreover, testing filamentous fungi (moulds) introduces several additional problems in standardization not addressed by the current procedure. Those methods are beyond the scope of this document.
This document describes the broth micro-dilution reference method, which can be implemented by either of two pathways. One pathway involves visual determination of MICs (CLSI method)[ 1 ][ 5 ]; the second pathway involves spectrophotometric determination of MICs (EUCAST method)[ 2 ][ 10 ]. 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 antifungal resistance mechanisms. In addition, MIC distributions can be used to define wild type or non-wild type fungal populations. Clinical interpretation of the MIC value is beyond the scope of this document; interpretive category breakpoints specific to the CLSI- and EUCAST-derived methods can be found by consulting the latest interpretive tables provided by the organizations[ 5 ][ 15 ]. Routine susceptibility testing methods or diagnostic test devices can be compared with this reference method in order to ensure comparable and reliable results for validation or registration purposes.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 40 | National foreword |
| 42 | European foreword |
| 44 | Foreword |
| 46 | Introduction |
| 47 | 1 Scope 2 Normative references 3 Terms and definitions |
| 48 | 3.2 Antifungal agents — properties 3.7 Susceptibility testing method |
| 49 | 4 Test procedures 4.1 General 4.1.1 Trays and method 4.1.2 Conditions for use of disposable micro-dilution trays 4.2 Medium 4.2.1 General |
| 50 | 4.2.2 Visual reading pathway 4.2.3 Spectrophotometric reading pathway 4.3 Antifungal agents 4.3.1 General 4.3.2 Preparation of stock solutions |
| 52 | 4.3.3 Preparation of working solutions |
| 53 | 4.4 Preparation of broth micro-dilution trays 4.4.1 Preparation for tests read visually – Visual reading pathway 4.4.2 Preparation for tests read by spectrophotometer – Spectrophometric reading pathway 4.5 Storage of micro-dilution trays |
| 54 | 4.6 Preparation of inoculum 4.6.1 General 4.6.2 Preparation of inoculum for visual test reading 4.6.3 Preparation of inoculum for spectrophotometric test reading 4.7 Inoculation of micro-dilution trays |
| 55 | 4.8 Incubation of micro-dilution trays 4.8.1 General 4.8.2 Visual pathway 4.8.3 Spectrophotometric pathway 4.9 Reading MIC results 4.9.1 General 4.9.2 Visual reading method 4.9.3 Spectrophotometric reading methods |
| 56 | 4.10 Interpretation of MICs 5 Quality Control (QC) |
| 60 | Annex A (informative) RPMI-1640 medium |
| 62 | Annex B (informative) McFarland 0,5 barium sulfate turbidity standard |
| 63 | Bibliography |
