RLO: ACCE Framework

• Introduction
• Analytical Validity
• Clinical Validity
• Gene-Environment Activity
• Clinical Utility
• Ethical, Social & Legal Issues
• Assessment

Analytical Validity

Analytical validity defines the ability of a genetic test to measure accurately and reliably the genotype of interest. This part of the evaluation is concerned with assessing test performance in the laboratory as opposed to the clinic.

Analytical validity can be considered in three parts: pre-analytical, analytical and post- analytical.

Pre-analytical is the stage, which includes obtaining the sample, transporting, labelling and entering details on the laboratory database.

The analytical stage involves preparation of the sample for and carrying out the analysis.

The post analytical stage includes result interpretation and reporting.

All of these stages need to be considered quite thoroughly in order to evaluate the analytical validity of a particular test.