BS EN ISO 20776-2:2021

What is ISO 20776-2 - Performance of antimicrobial susceptibility test device about? 

ISO 20776-2 is a standard that covers the performance of antimicrobial susceptibility test device, ensuring stable operability, safety and accuracy in the clinical laboratory and vitro diagnostic system applications. 

ISO 20776-2 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. 

ISO 20776-2 requirements for AST devices and procedures for assessing the performance of such devices. It defines how a performance evaluation of an AST device is to be conducted. 

ISO 20776-2 has been developed to guide manufacturers in the conduct of performance evaluation studies. 

Who is ISO 20776-2 - Performance of antimicrobial susceptibility test device for? 

ISO 20776-2 on performance of antimicrobial susceptibility test device applies to: 

• Manufacturers of antimicrobial susceptibility test devices 
• Dealers, importers and suppliers of antimicrobial susceptibility test devices 
• Testing houses and laboratories 
• Quality assurance services 

Why should you use ISO 20776-2 - Performance of antimicrobial susceptibility test device? 

In vitro antimicrobial susceptibility tests are performed on bacteria suspected of causing disease, particularly if the isolate is thought to belong to a species that can exhibit resistance to frequently used antimicrobial agents. An antimicrobial susceptibility test device is used to obtain test results to allow MIC determination of bacteria with specific antimicrobial agents. 

ISO 20776-2 provides users guidance on test methods for evaluating the performance of MIC tests such as reference method, strain selection, quality control, QC of reference method, isolate testing protocol, inoculum preparation and discrepancy resolution testing, enabling users to ensure stable operability and functioning of antimicrobial susceptibility test devices. 

ISO 20776-2 provides users guidance on data analysis and acceptance criteria, including accuracy of test device, quality control of test device, reproducibility, and documents related to study, enabling users to develop a framework for effective functioning and consistency of antimicrobial susceptibility test devices. 

With obedience and compliance to ISO 20776-2, users can develop and assess the performance of antimicrobial susceptibility test devices to ensure accuracy and performance, enabling accuracy in the determination of bacterial growth. 

What’s changed since the last update? 

BS EN ISO 20776-2:2021 supersedes BS EN ISO 20776-2:2007, which is now withdrawn. 

Changes in BS EN ISO 20776-2:2021 include: 

• Addition of an Introduction 
• Added definition for contemporary isolate (3.11.1), and removed definitions for fresh isolate, recent isolate 
• Added definition for the qualitative test (3.7) and removed definition for breakpoint test 
• Added definition for the qualitative test (3.7) and removed definition for breakpoint test 
• Revised definitions for minimum inhibitory concentration test (3.4), breakpoint (3.6), quality control (3.8), discrepancy (3.10.1)