Data di Pubblicazione:
2013
Citazione:
Defining acceptable limits for the metrological traceability of specific measurands / R. Bais, D. Armbruster, R.T.P. Jansen, G. Klee, M. Panteghini, J. Passarelli, K.A. Sikaris. - In: CLINICAL CHEMISTRY AND LABORATORY MEDICINE. - ISSN 1434-6621. - 51:5(2013 May), pp. 973-979. [10.1515/cclm-2013-0122]
Abstract:
Although manufacturers are compelled by the European
IVD Directive, 98/79/EC, to have traceability of the values
assigned to their calibrators if suitable higher order reference
materials and/or procedures are available, there is still
no equivalence of results for many measurands determined
in clinical laboratories. The adoption of assays with metrological
traceable results will have a significant impact on
laboratory medicine in that results will be equivalent across
different laboratories and different analytical platforms.
The IFCC WG on Allowable Errors for Traceable Results
has been formed to define acceptable limits for metrological
traceability chains for specific measurands in order to
promote the equivalence of patient results. These limits are
being developed based on biological variation for the specific
measurands. Preliminary investigations have shown
that for some measurands, it is possible for manufacturers
to assign values to assay calibrators with a measurement
uncertainty that allows the laboratory enough combined
uncertainty for their routine measurements. However, for
other measurands, e.g., plasma sodium, current assays are
too imprecise to fulfil limits based on biological variation.
Although an alternative approach based on probability
theory is being investigated, the most desirable approach
would be for industry to improve measurement methods so
that they meet clinical requirements
Tipologia IRIS:
01 - Articolo su periodico
Keywords:
IFCC ; metrological traceability ; result equivalence ; standardization
Elenco autori:
R. Bais, D. Armbruster, R.T.P. Jansen, G. Klee, M. Panteghini, J. Passarelli, K.A. Sikaris
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