When a clinical laboratory implements an assay approved for in vitro diagnostic (IVD) use, and before reporting any patient test results, the lab must verify the assay performs according to specifications.
In this presentation, we will discuss the ClearLLab 10C System, the first FDA-cleared 10-color Leukemia and Lymphoma* immunophenotyping system, the AQUIOS CL flow cytometer with Tetra (T, B, NK) immunophenotyping application, and the requirements for verification of these IVD systems.
- Understand the difference between validation and verification
- Recognize the five quality pillars of clinical flow cytometry
- Be able to reduce errors and variance to increase flow quality testing
- Identify opportunities to drive workflow efficiency
- Ensure verification is done correctly to pass inspection
- Learn some important QC tips
Speakers from Beckman Coulter Life Sciences:
- Sandra Hernandez, Global Clinical Flow Cytometry Marketing Manager
- Marilyne Levadouz-Martin, Ph.D., Manager of Flow Cytometry Applications Scientists