ABSTRACT
This chapter focuses on analytical validation of in vitro diagnostic devices (IVDs), as the foundation for IVDs’ clinical use. In broadest terms, analytical validation is the process through which one gains assurance that the data
CONTENTS
3.1 Introduction ..................................................................................................33 3.2 Prerequisites for Analytical Validation ....................................................35 3.3 Analytical/Clinical Interface ......................................................................36 3.4 Analytical Validation of Tests Based on Novel Biomarkers
and Measurement Technologies ................................................................ 37 3.5 Analytical Validation Resources ................................................................ 39 3.6 Practical Analytical Validation ..................................................................40
