Data di Pubblicazione:
2011
Citazione:
Is the accuracy of serum albumin measurements suitable for clinical application of the test? / I. Infusino, F. Braga, R. Mozzi, C. Valente, M. Panteghini. - In: CLINICAL CHEMISTRY AND LABORATORY MEDICINE. - ISSN 1434-6621. - 49:Suppl.1(2011), pp. S805-S805. (Intervento presentato al convegno IFCC - WordLab - EuroMedLab tenutosi a Berlin nel 2011) [10.1515/CCLM.2011.530].
Abstract:
Background. Albumin is the major protein in plasma and the determination of its concentrations is used for the prognostic assessment
of several diseases. Using the information on the biological variation of the analyte, the degree of albumin measurement
uncertainty for clinical laboratories should stay within ±3.90% or ±5.85% (desirable or minimum quality level, respectively). We
checked the performance of the albumin immunoturbidimetric assay (Tina-quant Albumin Gen. 2, Roche Diagnostics), carried out
on the Cobas c 501 platform.
Methods. To estimate the uncertainty of albumin measurement, we employed the imprecision and bias data obtained by measurements
of IRMM ERM-DA 470k/IFCC Human Serum Proteins reference material. The material was measured in duplicate for
three consecutive days, in two identical experiments carried out 5 months apart, using the analytical system in accordance with
the manufacturer’s instructions.
Results. The relative standard uncertainty (uc) of imprecision was 1.88%; the bias uc, derived from the difference (-6.18%) between
the obtained mean of the means (34.9 g/L) and the target value (37.2 g/L), the bias variability (0.95%) and the uc of the
certified value of reference material (1.61%), was 6.42%. Thesegave a combined uc of 6.69%.
Conclusions. As the requested analytical quality for albumin measurement in serum is high, the performance of field methods
should be extremely good to permit their application in clinical setting. Our results seem to demonstrate that, at least for some
commercial assays, problems with standardization of these measurements still persist, even if highly specific and relatively expensive
immunochemical methods are used.
Tipologia IRIS:
01 - Articolo su periodico
Elenco autori:
I. Infusino, F. Braga, R. Mozzi, C. Valente, M. Panteghini
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