Capillarys 2 Flex Piercing: Analytical performance assessment according to CLSI protocols for HbA 1c quantification

• Published in: Electrophoresis Vol. 38; no. 17; pp. 2210 - 2218
• Main Authors: Doggui, Radhouene, Abdelhafidh Sahli, Chaïma, Aissa, Wassef Lotfi, Hammami, Maroua, Ben Sedrine, Maha, Mahjoub, Rahma, Zouaoui, Khemais, Daboubi, Rim, Siala, Hajer, Messaoud, Taieb, Bibi, Amina
• Format: Journal Article
• Language: English
• Published: Germany 01.09.2017
• Subjects: Diabetes Mellitus - blood; Diabetes Mellitus - metabolism; Electrophoresis, Capillary - methods; Electrophoresis, Capillary - standards; Glycated Hemoglobin A - analysis; Humans; Linear Models; Reproducibility of Results; Tunisia; Hemoglobinopathies; Diabetes; Capillary electrophoresis; Tunisia; Analytical evaluation
• ISSN: 0173-0835; 1522-2683
• DOI: 10.1002/elps.201600423

HbA 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 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 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 measurement. No problem related to sample-to-sample carry over was noted. No interferences of LA and cHb were observed. CE allowed quantification of HbA even at low level of total hemoglobin (40 g/L) in contrast to HPLC. Furthermore, this analyzer offered the opportunity of quantifying the HbA simultaneously with HbA . This evaluation showed that C2FP is a convenient system for the control of diabetes and the detection of hemoglobinopathies.