089 - Dalle specifiche di qualità allo STARD
Rivista: Riv Med Lab - JLM, Vol. 5, N. 3-S1, 2004 (SIRSE Srl ed.)
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.
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