Evaluation of the impact of standardization process on the quality of seruma creatinine determination in Italian laboratories
Poster
Data di Pubblicazione:
2013
Citazione:
Evaluation of the impact of standardization process on the quality of seruma creatinine determination in Italian laboratories / I. Infusino, A. Carobene, F. Ceriotti, E. Frusciante, M. Panteghini. - In: BIOCHIMICA CLINICA. - ISSN 0393-0564. - 37:suppl. 13(2013), pp. T260.S421-T260.S421. ((Intervento presentato al convegno EUROMEDLAB tenutosi a Milano nel 2013.
Abstract:
Background: Creatinine determination in serum is the key
indicator of kidney glomerular function. A reference
measurement system for standardization of creatinine
measurements is available and virtually all IVD manufacturers
have recently aligned their creatinine assays to this system.
The aim of this work was to verify if and how these
standardization efforts have improved the state of the art of
creatinine determination in Italy.
Methods: An analysis of Prolarit EQAS results using control
materials with target values assigned by a traceable method
(enzymatic assay calibrated against the NIST SRM 967) was
carried out.
Results: Results obtained during 2006, 2010, and 2011
schemes by participating laboratories showed a general good
alignment at creatinine concentrations ~2.00 mg/dL, with 2011
results – except for one method group – well inside the
desirable bias (±4%). At higher concentrations, whereas the
overall bias was small in 2010, for some groups using alkaline
picrate (AP) methods it became significantly negative in 2011.
The performance markedly worsens at creatinine physiologic
concentrations, where a significant positive bias (up to ~20%)
is still present for most of the AP-based analytical systems.
Unexpectedly, with few exceptions, no evident improvement in
individual assay bias was noted from pre- (2006) to poststandardization
(2011) periods. The enzymatic method groups
were the only always presenting an acceptable bias for all
concentration levels, in addition to showing the lowest
between-laboratory variability. The number of laboratories
using enzymatic methods, however, still remains only 7% of
the total.
Conclusions: Our EQAS performance data indicate that most
of the current “standardized” creatinine methods based on AP
reaction do not perform well, mainly at the lower creatinine
concentrations. This inaccuracy of creatinine measurements
can adversely impact the estimation of glomerular filtration rate
by equations and the evaluation of kidney function in pediatrics.
Tipologia IRIS:
01 - Articolo su periodico
Elenco autori:
I. Infusino, A. Carobene, F. Ceriotti, E. Frusciante, M. Panteghini
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