Validace metody průkazů oligoklonálních volných lehkých řetězců podle IVD-R

Abstract

This thesis focuses on the validation of an in-house method for multiple sclerosis conducted at the Institute of Laboratory Medicine of FN Ostrava. Multiple sclerosis is a chronic demyelinating disease of the central nervous system that requires precise diagnosis for the timely initiation of effective treatment. Due to the absence of commercially available methods for some analytes, laboratories are compelled to develop their own in-house methods. This work describes the validation process for the determination of oligoclonal free light chains in serum and cerebrospinal fluid, which are one of the biomarkers for the diagnosis of multiple sclerosis. The determination is performed using isoelectric focusing followed by affinity immunoblotting. The method was developed in accordance with the regulatory requirements of the EU Regulation on in vitro diagnostic medical devices (IVDR) 2017/746, and includes thorough comparison with the laboratory gold standard. The thesis also discusses the legislative and normative aspects of diagnostic devices and in-house methods, and addresses the evaluation of the clinical utility and effectiveness of the new method. The validation results suggest that the developed method meets all necessary criteria for safe and effective clinical use.