2015 AACC

Concepts in Method Evaluation: Validation of Lab-Developed Tests, Modified Non-Waived Tests, and Highly Complex Tests-192006 (Room Georgia World Congress Center - B215)

26 Jul 15
1:30 PM - 4:00 PM

Tracks: Quality Assurance, Testing Methods

Speaker(s): Nils Person, Siemens Healthcare Diagnostics; Sten Westgard, Director of Client Services and Technology, Westgard QC, Inc.

After this session, participants will be able to: 1) establish clinically-based performance goals for methods; 2) describe the studies necessary to effectively compare performance to the clinical goals and meet regulatory requirements; 3) utilize the performance data obtained to effectively guide monitoring method performance over time; and 4) reference CLSI guidelins (EP5, EP9, etc) for method validation protocols.