Harmonization of measurement results of the alcohol biomarker carbohydrate-deficient transferrin by use of the toolbox of technical procedures of the International Consortium for Harmonization of Clinical Laboratory Results.
Clin Chem
; 60(7): 945-53, 2014 Jul.
Article
em En
| MEDLINE
| ID: mdl-24691685
ABSTRACT
BACKGROUND:
The need for equivalent results of routine measurement procedures for the alcohol biomarker carbohydrate-deficient transferrin (CDT) has been recognized by the IFCC. This article describes a project to harmonize CDT as conducted by an IFCC working group initiated for this purpose.METHODS:
We used procedures for achieving harmonization as developed by the Consortium for Harmonization of Clinical Laboratory Results to assess the suitability of a candidate reference measurement procedure (cRMP), candidate reference materials (cRMs), and the success of efforts to achieve harmonization.RESULTS:
CDT measurement procedures in routine use showed good reproducibility (CV 1.1%-2.8%) and linearity (r > 0.990) with variable slopes (0.766-1.065) and intercepts (-0.34 to 0.92) compared to the cRMP. Heterogeneity after simulated harmonization was 4.7%. cRMs of frozen human native sera demonstrated commutability and 3-year stability for routine measurement procedures. The cRMP provided reproducible value assignment to cRMs with an expanded uncertainty (k = 2) of 0.03% at the 1.2% CDT level and 0.06% at the 4.4% CDT level. Harmonization efforts reduced the intermeasurement CV from 8.8% to 3.4%, allowed 99% recovery of the values assigned with the cRMP, and demonstrated 99% of results within the desirable allowable total error. Harmonization was less successful in samples with low CDT and high trisialotransferrin concentrations.CONCLUSIONS:
Harmonization of CDT is possible with frozen human native sera as cRMs with values assigned by use of the cRMP. We propose the cRMP as a candidate international conventional reference measurement procedure and cRMs as candidate international calibrators.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Consumo de Bebidas Alcoólicas
/
Transferrina
Limite:
Humans
Idioma:
En
Revista:
Clin Chem
Ano de publicação:
2014
Tipo de documento:
Article