scope:

This guideline provides recommendations for clinical laboratory professionals for verification of commercial microbial identification systems (MIS) and US Food and Drug Administration (FDA)-cleared antimicrobial susceptibility testing systems (ASTS) to fulfill regulatory or QA requirements for use in diagnostic testing. Recommendations for postverification QA are also included. This guideline focuses on instrument-based systems commonly used in clinical laboratories, but the recommendations may also be applicable to manual methods for microbial identification (ID) and antimicrobial susceptibility testing (AST), including disk diffusion and gradient diffusion strips.

This guideline is not intended to provide guidance to manufacturers of in vitro diagnostic devices. A manufacturer must perform many studies during the research and development phases and the manufacturing validation phase that are unique to the design of the test system and the manufacturing processes. These studies go beyond the scope of this document. See Appendix A for a description of the FDA requirements for MIS and ASTS clearance.

This document does not address verification of chromogenic media, laboratory-developed methods, or systems using nucleic acid detection methods.

Appendix B addresses studies that may be used to implement alternative interpretive criteria (breakpoints) for ASTS.