Verification of Automated Urinalysis Instrumentation: Analytical and Clinical Considerations

Course overview

Automated methods for urinalysis promise greater efficiency, increased throughput, and improved accuracy and precision over conventional methods. This presentation provides a brief overview of urinalysis methods and describes an approach to method validation of automated urinalysis instrumentation. Learning Objectives: 1. Describe the chemical and physical principles behind conventional (manual) and automated methods for urinalysis testing. 2. List the studies required to document method performance required by CLIA. 3. Apply CLIA requirements for method validation/verification to document performance characteristics of automated urinalysis methods.