BACKGROUND: Carbohydrate-deficient transferrin measurement is currently used for the routine monitoring of excessive alcohol intake, thus playing a fundamental role in the management of alcohol consumption disorders as well as for medico-legal purposes. The aim of the present paper is to report the results obtained from the first performance evaluation of a new CDT quantification assay, and to assess its suitability in routine work. METHODS: We assessed the analytical performances of the multi-capillary electrophoresis analyser Helena Biosciences' V8 E-class and compared the results obtained with those from the HPLC BioRad Ready-Prep CDT assay. Furthermore, we evaluated the robustness of the system in a routine work conditions. RESULTS: Within laboratory imprecision CV% (n=40) using four commercially available quality control materials and two serum pool samples with different concentrations of CDT were <11.2%. The comparison made with the established method was CDT [V8capillary electrophoresis]=0.84 × CDT [HPLC]+0.03, with a Pearson coefficient of r=0.970, and with the Bland-Altman plot showing a significant bias -0.3 (-0.4 to -0.22, 95% CI). The obtained accuracy was highly satisfactory. CONCLUSIONS: The findings made in the present study indicated that the proposed analytical system is a valid alternative to other CDT screening assays currently proposed for routine use in clinical laboratories, since it is precise, accurate and robust, with a high throughput. Moreover, investment in the training of staff is of fundamental importance in ensuring correct interpretation of the electrophoretic pattern, thus providing reliable CDT results.
First evaluation of a multi-capillary electrophoresis CDT assay on Helena Biosciences' V8 analyser.
MARINOVA, MARIELA IVANOVA;ARTUSI, CARLO;ZANINOTTO, MARTINA;PLEBANI, MARIO
2014
Abstract
BACKGROUND: Carbohydrate-deficient transferrin measurement is currently used for the routine monitoring of excessive alcohol intake, thus playing a fundamental role in the management of alcohol consumption disorders as well as for medico-legal purposes. The aim of the present paper is to report the results obtained from the first performance evaluation of a new CDT quantification assay, and to assess its suitability in routine work. METHODS: We assessed the analytical performances of the multi-capillary electrophoresis analyser Helena Biosciences' V8 E-class and compared the results obtained with those from the HPLC BioRad Ready-Prep CDT assay. Furthermore, we evaluated the robustness of the system in a routine work conditions. RESULTS: Within laboratory imprecision CV% (n=40) using four commercially available quality control materials and two serum pool samples with different concentrations of CDT were <11.2%. The comparison made with the established method was CDT [V8capillary electrophoresis]=0.84 × CDT [HPLC]+0.03, with a Pearson coefficient of r=0.970, and with the Bland-Altman plot showing a significant bias -0.3 (-0.4 to -0.22, 95% CI). The obtained accuracy was highly satisfactory. CONCLUSIONS: The findings made in the present study indicated that the proposed analytical system is a valid alternative to other CDT screening assays currently proposed for routine use in clinical laboratories, since it is precise, accurate and robust, with a high throughput. Moreover, investment in the training of staff is of fundamental importance in ensuring correct interpretation of the electrophoretic pattern, thus providing reliable CDT results.
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