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Electrophoresis, Vol.38, No.17, 2210-2218, 2017
Capillarys 2 Flex Piercing: Analytical performance assessment according to CLSI protocols for HbA(1c) quantification
HbA(1c) is used for monitoring diabetic balance. In this paper we report an assessment of the analytical performances of Capillarys 2 Flex Piercing (C2FP) for HbA(1c) measurement using CE (Capillary Electrophoresis). CLSI (Clinical and Laboratory Standard Institute) protocols are used for the evaluation of apparatus performances: precision, linearity, method comparison, trueness and common interferences. HbA(1c) CVs average in intra-assay was 1.6% between run imprecision CV ranged from 0.1 to 1.8%. The linearity was demonstrated between 4.7 and 15.0%. The comparison study revealed that Bland Altman plot mean difference was equal to -0.03 (CI 95% (-0.05 to -0.0003)) and Passing-Bablok regression intercept was -0.05, CI95%(-0.13 - -0.05); slope: 1.00, CI95%[1.00-1.01]. A strong correlation (r>0.99) was proved. No significant effects of hemoglobin variants were seen with CE on HbA(1c) measurement. No problem related to sample-to-sample carry over was noted. No interferences of LA(1c) and cHb were observed. CE allowed quantification of HbA(1c) even at low level of total hemoglobin (40 g/L) in contrast to HPLC. Furthermore, this analyzer offered the opportunity of quantifying the HbA(2) simultaneously with HbA(1c). This evaluation showed that C2FP is a convenient system for the control of diabetes and the detection of hemoglobinopathies.