ISO 20776-2:2021
Clinical laboratory testing and in vitro diagnostic test systems — Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices — Part 2: Evaluation of performance of antimicrobial susceptibility t
This document establishes acceptable performance criteria for antimicrobial susceptibility test (AST) devices that are used to determine minimum inhibitory concentrations (MIC) of bacteria to antimicrobial agents in medical laboratories.
This document specifies requirements for AST devices and procedures for assessing performance of such devices. It defines how a performance evaluation of an AST device is to be conducted.
This document has been developed to guide manufacturers in the conduct of performance evaluation studies.
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Test methods
4.1 General
4.2 Methods
4.2.1 Reference method
4.2.2 Strain selection
4.2.3 Quality control (QC)
4.2.4 Quality control (QC) of the reference method
4.2.5 Reproducibility testing of test device
4.2.6 Isolate testing protocol
4.2.7 Inoculum preparation
4.2.8 Discrepancy resolution testing
4.2.9 System under evaluation
5 Data analysis and acceptance criteria
5.1 Accuracy of test device
5.1.1 General
5.1.2 MIC devices
5.1.3 Qualitative AST devices
5.2 Quality control (QC) of test device
5.3 Reproducibility of test device
5.4 Documents related to study
Annex A (informative) Evaluating the performance of MIC tests
Annex B (informative) Rationale for bias analysis
Annex C (informative) Sensitivity and specificity analyses for qualitative tests
Bibliography
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Test methods
4.1 General
4.2 Methods
4.2.1 Reference method
4.2.2 Strain selection
4.2.3 Quality control (QC)
4.2.4 Quality control (QC) of the reference method
4.2.5 Reproducibility testing of test device
4.2.6 Isolate testing protocol
4.2.7 Inoculum preparation
4.2.8 Discrepancy resolution testing
4.2.9 System under evaluation
5 Data analysis and acceptance criteria
5.1 Accuracy of test device
5.1.1 General
5.1.2 MIC devices
5.1.3 Qualitative AST devices
5.2 Quality control (QC) of test device
5.3 Reproducibility of test device
5.4 Documents related to study
Annex A (informative) Evaluating the performance of MIC tests
Annex B (informative) Rationale for bias analysis
Annex C (informative) Sensitivity and specificity analyses for qualitative tests
Bibliography