9.6. Overview of Hevylite assay validation

Chapter 9

During the development and production of Hevylite assays there is a rigorous validation process to ensure that the assays perform correctly and provide the correct diagnostic information. The validation protocols used follow those set out by the Clinical and Laboratory Standards Institute (CLSI), and are outlined in Section 5.6. These include assessment of assay precision, sensitivity, linearity, stability, comparison to predicate devices (serum protein electrophoresis and serum immunofixation electrophoresis) and confirmation of the normal reference range.