ABSTRACT
This chapter presents the interplay between analytical and clinical validation from an infectious disease laboratory diagnostic perspective. Diagnostic laboratories play increasingly important roles in supporting modern health care delivery by establishing the presence of pathogens or illness in an individual, either through the direct detection of an agent or through the detection of a specific immune response. The chapter illustrates the complex interrelationship of laboratory and clinical validation by describing how the components of pre-analytical, analytical and post-analytical test validation help to ensure that laboratories provide accurate and effective diagnostic, monitoring and epidemiological support. Analytical quality control and assurance involves confirming that test reagents function according to manufacturers’ specifications, abnormal results are recognized, and control measures are implemented to ensure that the analytical testing process is both accurate and reproducible. The chapter highlights the complexity of analytical procedures and the challenges in ensuring run-to-run and lot-to-lot test kit reproducibility.
