Istituto di Fisiologia Clinica     
Lonati S., Novembrino C., Della Noce C., Campolo J., Troonen H., Galli C., Accinni R., Ippolito S., Lunghi G., Bamonti-Catena F. Analytical performance and method comparison study of the total homocysteine fluorescence polarization immunoassay (FPIA) on the AxSYM analyzer. In: Clinical Chemistry and Laboratory Medicine, vol. 42 (02) pp. 228 - 234. walter de gruyter, 2004.
A fluorescence polarization immunoassay (FPIA) has been commercially released for routine large-scale testing of total homocysteine (tHcy) on the AxSYM analyzer. We evaluated the analytical performance of the AxSYM tHcy FPIA and compared it with the well established high-performance liquid chromatography (HPLC) and IMx tHcy FPIA methods. Homocysteine concentrations were measured by AxSYM and IMx tHcy FPIA and by a rapid isocratic HPLC method with fluorescence detection. Coefficient of variation (CV) of total imprecision for AxSYM tHcy was F5%, mean dilution recovery 102%, analytical sensitivity 0.70 mmol/l and linearity was good up to 1:8 dilution. Spearman rank correlations, rho, were 0.83 (p-0.0001) for AxSYM vs. HPLC, 0.97 (p-0.0001) for AxSYM vs. IMx and 0.83(p -0.0001) for IMx vs. HPLC. Passing and Bablok regression Y-intercepts and slopes were: 2.944/0.937 (AxSYM vs. HPLC), y0.367/ 1.142 (AxSYM vs. IMx) and 2.632/0.805 (IMx vs. HPLC). Corresponding mean differences (AxSYMComparison Assay) recorded over a 5-50 mmol/l measured range were 1.80, y0.73and 2.53 mmol/l. AxSYM tHcy FPIA's first rate precision, supported by the complete automation of the AxSYM analyzer, makes it fit for routine use and suitable for laboratories requiring homocysteine high-throughput testing capabilities.
URL: http://www.degruyter.de/journals/cclm/2004/pdf/42_228.pdf
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