Recommended Principles and Practices for Validating Clinical Molecular Pathology Tests

Medical Lab Advances Courses

Medical Lab General Courses

Target Level

Laboratory professionals working in molecular diagnostics. clinical molecular biologists. quality managers. molecular laboratory department supervisors.

Description

• 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:

-Is a given test ready to be implemented in the clinical laboratory? -Practical Applications of Molecular Diagnostics -Total Laboratory Testing Process -Definitions of FDA-approved/cleared tests and laboratory-developed tests -Required performance characteristics with suggested studies needed before implementation of FDA-approved/cleared tests and laboratory-developed tests -Regulatory considerations -Establishment of Performance Specifications for laboratory-developed Tests -Establishment of Performance Specifications for FDA-approved/cleared tests -Verification versus validation. -Analytical  Validation versus Clinical Validation -Comparison of Test Parameters That Need to Be Addressed for Quantitative and Qualitative Tests -The lower limit of quantitation (LLQ) and upper limit of quantitation (ULQ).   -Performance Specifications for Analytical Validation:

• Analytic accuracy
• Precision
• Analytic sensitivity (limit of detection, LOD
• Analytic specificity (interferences)
• Reportable range
• Reference range

  -Recommended Approach to Test Validation. -Waived Tests. -Complications –Gold Standard” Problems.

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

Target group