A comparative study of Tosoh G11 and Bio-Rad D-100 analyzers for HbA1c analysis

Sammanfattning: Diabetes mellitus is one of the most common diseases worldwide. The continued prevalence increase, together with the complexity of the disease with severe long-term complications makes efficient diagnostical and monitorial methods very important. The determination of glycated hemoglobin, HbA1c, plays an important role in both, underlying the importance of high-quality analytical instruments. Whenever a new instrument is introduced into routine clinical use an evaluation is needed. This study evaluated the agreement between the new Tosoh G11 HbA1c high performance liquid chromatography system as a replacement for the Bio-Rad D-100 at the Chromatographic Department of the Institute of Laboratory Medicine, Faculty of Medicine, University of Debrecen. In total, 66 samples were analyzed using both analyzers and a Bland-Altman comparison was performed together with a correlation study. Additionally, a linearity check, optimal error and routine error testing was carried out specifically for the Tosoh G11. The results showed high agreement between measurements, r=0.9975 (p<0.001) for HbA1c mmol/mol and r=0.9971 (p<0.001) for HbA1c %. High repeatability and accuracy were observed of the Tosoh G11 with the highest variation coefficient of 1.50 % and linearity r =0.9999. The conducted study supports the replacement of the Bio-Rad D-100 to the Tosoh G11.