Implementation of traceability and uncertainty in in-vitro diagnostic products—Results of the Roche workshop In Vitro Diagnostics Directive': Practical applications of uncertainty calculations

摘要

The European Commission (EC) Directive on in vitro diagnostic medical devices requires—amongst other obligations—manufacturers to establish metrological traceability of values assigned to calibrators to available measurement procedures and/or available reference materials of a higher order. Manufacturers use different procedures to accomplish this task and to indicate uncertainties of assigned values. Medical laboratories may want to calculate the uncertainties of their results or accreditation bodies may require them to do so. For this purpose some practical approaches are presented and some examples discussed.