Verification of in vitro medical diagnostics (IVD) metrological traceability: Responsibilities and strategies

Abstract

To be accurate and equivalent, laboratory results should be traceable to higher-order references. Furthermore, their analytical performance should fulfill acceptable measurement uncertainty criteria defined to fit the intended clinical use. With this aim, In Vitro Diagnostics (IVD) manufacturers should define a calibration hierarchy to assign traceable values to their system calibrators and to fulfill during this process uncertainty limits for calibrators, which should represent a proportion of the uncertainty budget allowed for laboratory results. It is important that end-users may know and verify how manufacturers have implemented the traceability of their calibrators and estimated the corresponding uncertainty. However, full information about traceability and combined uncertainty of calibrators is currently not available. Important tools for IVD traceability surveillance are the verification by laboratories of the consistency of declared performance during daily operations performed in accordance with the manufacturer's instructions and the organization of appropriately structured External Quality Assessment (EQA) programs. The former activity should be accomplished by analyzing system control materials and confirming that current measurements are in the manufacturer's established control range. With regard to EQA, it is mandatory that target values for materials are assigned with reference procedures by accredited laboratories, that materials are commutable and that a clinically allowable inaccuracy for participant's results is defined.