089 - Dalle specifiche di qualità allo STARD

R.M. Dorizzi , E. Esposito Summary. The metrology international organizations developed the concept of uncertainty of measurement, a parameter that characterizes the dispersion of the values that could be reasonably attributed to the measurand. It is a property of the result not of the procedure of measurement and the analytical measurement represents one of the several components of the uncertainty. The Guide to the Uncertainty of Measurement (GUM) yields a model for expressing the uncertainty of measurement which expresses the random error and the bias. DE 98/79 (traceability of values assigned to calibrators and/or control materials must be assured through available reference measurement procedure and/or available reference materials of a higher order), ISO 15189 (5.6.2 The laboratory shall determine the uncertainty of results) and relevant international organizations extensively discuss these topics confirming their importance. Recently Antwerp Conference Consensus Statements made some relevant and urgent points: defining quality from the user’s point of view is needed; the introduction of GUM into medical laboratories should be done with the recognition of the particularities of this field; measurements results for reference materials, calibrators and control materials must be accompanied by an uncertainty statement estimated and expressed according to GUM; uncertainty of measurements on routine samples should only be evaluated where relevant and possible. In 2003 was published a checklist (named STARD) of 25 items with a flow diagram providing information on the setting up and the interpretation of a diagnostic study. The research in analytical and diagnostic accuracy increasingly requires a structured method, evidences and the definition of a reference standard against which the new standard or test is evaluated. ...