Recommended Principles and Practices for Validating Clinical Molecular Pathology Tests
- 2 days (3 days can be customized)
- Course fee
Laboratory professionals working in molecular diagnostics. clinical molecular biologists. quality managers. molecular laboratory department supervisors.
- The use of DNA- and RNA-based tests continues to grow for applications as varied as inherited disease, infectious disease, cancer, identity testing, human leukocyte antigen typing, and pharmacogenetics.
- Progress is driven in part by the huge growth in knowledge about the molecular basis of disease coupled with advancements in technological capabilities.
- In addition to requirements for clinical utility, every molecular test also may have limitations that must be carefully considered before clinical implementation.
- Analytic and clinical performance characteristics as well as test limitations are established and documented through the process of test validation.
- The steps involved in test validation are meant to answer one main question—is a given test ready to be implemented in the clinical laboratory? In order to answer this question, the clinical utility (ie, usefulness) of the test must be established, along with its analytic performance characteristics and limitations.
- To understand these issues, one needs to define the intended use of the test and identify and quantify the possible sources of error as well as sources of analytic variation and biologic variation.
- A few heading of the outlines:
- Analytic accuracy
- Analytic sensitivity (limit of detection, LOD
- Analytic specificity (interferences)
- Reportable range
- Reference range
Objectives and Expected Results
- To describe the established principles of test validation, along with relevant regulations, in order to provide a rational approach to introducing molecular tests into the clinical laboratory.
- To provide practical guidance for laboratorians with respect to regulatory requirements established principles, and realistic approaches to test validation for both FDA-approved tests and laboratory.
- Analogous requirements exist for some clinical laboratories outside of the United States.
Others Training Materials
Workshop, Sheets, and case studies paper will be conducted and implemented during training