Validation of molecular diagnostic assays and quality assurance and control in the veterinary laboratory.

Abstract

This chapter describes the process of validating in-house molecular assays although the principles described are equally relevant to all diagnostic assays. The best practice principles described below are based on the In Vitro Diagnostic Medical Devices Directive (IVDD) and associated documentation. Although compliance with these regulations is not required for diagnostic reagents used on animals, the principles are equally relevant to validation of all diagnostic assays, whatever their purpose.