Method Validation and Verification

Course overview

Short description: This presentation will provide an understanding of the fundamental concepts of method/assay verification and validation. Which studies are required by CLIA regulations based on waved versus nonwaived test categorization will be defined, as well as best laboratory practices for meeting each of the requirements. Practical application of these concepts will be demonstrated using a recent example of an assay that was implemented at University Hospital laboratory. Objectives: 1. Identify the difference between method validation and method verification. 2. Describe the studies required to document method performance. 3. Interpret method performance data and statistical data outcomes.