Management Aspects of Real-time PCR based Assay Development, Validation, Verification and Implementation

There are significant risks associated with the introduction of new diagnostic assays based on real-time PCR. A consistent approach to the management of the development, validation, verification and implementation of such assays is essential to meet good practice. Adoption of a strategic framework which is followed rigorously by the team is important to ensure that the project is successful. The project core team must have clearly defined roles and produce adequate documentation that can be assessed by a separate review team. Project planning should include aspects such as setting clear objectives, identification of materials and the resources required to complete the project. Of particular importance for real-time PCR diagnostics is the inclusion of adequate positive controls. Tools for the selection of appropriate positive controls are presented and discussed here as a key aspect of diagnostic PCR project management. Following the introduction of assays to practice it is vital to maintain the standard operating procedure to ensure that it is followed consistently and so that any necessary changes are documented and adequately validated. The users of diagnostic assays must be aware of the contents of the project dossiers or have other means to verify their provenance and performance. Project documentation should be maintained to ensure that the quality of the validation data is strengthened over time.