Valutazione del sistema Capillarys 2 Flex Piercing per la misura dell'emoglobina A1c = Evaluation of the Capillarys 2 Flex Piercing system for the determination of hemoglobin A1c (HbA1c)

The Capillarys HbA1c kit implemented on the Capillarys 2 Flex Piercing platform uses capillary electrophoresis to separate and quantify HbA1c in human blood. We performed an evaluation of this system by checking imprecision, relative bias and robustness respect to the analysis of samples with variable total hemoglobin concentrations. Intra-assay CVs were between 1.1% and 2.8% for HbA1c values between 35.8 mmol/mol and 96.4 mmol/mol. Inter-assay CVs, evaluated on control materials, were 2.0% and 2.4 % for high (68.6 mmol/mol) and low (36.8 mmol/mol) control levels, respectively. Results in three blood samples with various concentrations of HbA1c (36, 60 and 87 mmol/mol) were not affected by variation in total hemoglobin concentrations (between 40 to 180 g/L). Only at very low total hemoglobin concentration, the imprecision was slightly higher (CV 3.1%). The results obtained by capillary electrophoresis (y-method) were well correlated with those obtained by the HPLC Tosoh G8 (x-method) (y = 0.73 + 0.978x, r=0.998, n=100).