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  • BSI
    BS EN ISO 16256:2021 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
    Edition: 2021
    $435.35
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Description of BS EN ISO 16256:2021 2021

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.



Standard NumberBS EN ISO 16256:2021
TitleClinical 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
StatusDefinitive
Publication Date2021-10-27
ReplacesBS EN ISO 16256:2012
Identical National Standard OfEN ISO 16256, ISO 16256
DescriptorsBiological analysis and testing, Measurement, Terminology, Accuracy, Reproducibility, Medical equipment, Quality assurance, Calibration, Samples, Clinical investigation instruments, Statistical methods of analysis, Reliability, Laboratories, Safety measures, Documents, Precision, Diagnosis (medical), Data processing
ICS11.100.10 In vitro diagnostic test systems
CommitteeCH/212
ISBN978 0 539 14268 6
PublisherBSI
Pages28

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About BSI

BSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses.
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