Renata Paleari1, Graziella Bonetti2, Cinzia Callà3, Mariarosa Carta4, Ferruccio Ceriotti5, Nicola Di Gaetano6, Marilisa Ferri7, Elena Guerra8, Gabriella Lavalle9, Claudia Lo Cascio10, Francesca Gabriela Martino11, Martina Montagnana12, Marco Moretti13, Gabriele Santini6, Donata Scribano3, Roberto Testa14, Anna Vero15, Andrea Mosca16. 1. Dip. di Fisiopatologia Medico-Chirurgica e dei Trapianti and Centro per la Riferibilità Metrologica in Medicina di Laboratorio (CIRME), Università degli Studi di Milano, Milano, Italy. 2. Laboratorio Analisi Chimico Cliniche, ASST Spedali Civili, Brescia, Italy. 3. Polo Scienze delle Immagini, di Laboratorio ed Infettivologiche. Fondazione Policlinico Universitario A. Gemelli, Università Cattolica Sacro Cuore, Roma, Italy. 4. Laboratorio Analisi, Ospedale S. Bortolo, Vicenza, Italy. 5. Central Laboratory, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Milan, Italy. 6. Instrumentation Laboratory - A Werfen Company, R&D Department, Milano, Italy. 7. Laboratorio Analisi di Urbino, Azienda Sanitaria Unica Regione Marche Area Vasta 1, Fano, PU, Italy. 8. Laboratorio di Standardizzazione, Servizio Medicina di Laboratorio, Ospedale S. Raffaele, Milano, Italy. 9. Laboratorio Analisi, Ospedale Padre Pio di Bracciano, Roma, Italy. 10. UOC Laboratorio Analisi, Azienda Ospedaliera Universitaria Integrata Verona, Italy. 11. U.O.C. Patologia Clinica (HB 5 Regionale) P.O. San Filippo Neri ASL ROMA A, Italy. 12. Sezione di Biochimica Clinica, Dip. di Neuroscienze, Biomedicina e Movimento, Università degli Studi di Verona, Verona, Italy. 13. Patologia Clinica Azienda Ospedaliera Ospedali Riuniti Marche Nord Pesaro, Italy. 14. Modelli di Integrazione Multidisciplinare in Patologia Clinica, INRCA-IRCCS, Ancona, Italy. 15. Laboratorio di Analisi Chimico-Clinica, Azienda Ospedaliera Pugliese Ciaccio, Catanzaro, Italy. 16. Dip. di Fisiopatologia Medico-Chirurgica e dei Trapianti and Centro per la Riferibilità Metrologica in Medicina di Laboratorio (CIRME), Università degli Studi di Milano, Milano, Italy. Electronic address: andrea.mosca@unimi.it.
Abstract
BACKGROUND: The use of glycated albumin (GA) has been proposed as an additional glycemic control marker particularly useful in intermediate-term monitoring and in situation when HbA1c test is not reliable. METHODS: We have performed the first multicenter evaluation of the analytical performance of the enzymatic method quantILab Glycated Albumin assay implemented on the most widely used clinical chemistry analyzers (i.e. Abbott Architect C8000, Beckman Coulter AU 480 and 680, Roche Cobas C6000, Siemens ADVIA 2400 and 2400 XPT). RESULTS: The repeatability of the GA measurement (expressed as CV, %) implemented in the participating centers ranged between 0.9% and 1.2%. The within-laboratory CVs ranged between 1.2% and 1.6%. A good alignment between laboratories was found, with correlation coefficients from 0.996 to 0.998. Linearity was confirmed in the range from 7.6 to 84.7%. CONCLUSION: The new enzymatic method for glycated albumin evaluated by our investigation is suitable for clinical use.
BACKGROUND: The use of glycated albumin (GA) has been proposed as an additional glycemic control marker particularly useful in intermediate-term monitoring and in situation when HbA1c test is not reliable. METHODS: We have performed the first multicenter evaluation of the analytical performance of the enzymatic method quantILab Glycated Albumin assay implemented on the most widely used clinical chemistry analyzers (i.e. Abbott Architect C8000, Beckman Coulter AU 480 and 680, Roche Cobas C6000, Siemens ADVIA 2400 and 2400 XPT). RESULTS: The repeatability of the GA measurement (expressed as CV, %) implemented in the participating centers ranged between 0.9% and 1.2%. The within-laboratory CVs ranged between 1.2% and 1.6%. A good alignment between laboratories was found, with correlation coefficients from 0.996 to 0.998. Linearity was confirmed in the range from 7.6 to 84.7%. CONCLUSION: The new enzymatic method for glycated albumin evaluated by our investigation is suitable for clinical use.