Capillarys 3 Octa®: Analytical Performance Assessment for HbA1c Quantification

Abstract

Objective: Determination of HbA1c level is a precious indicator for therapeutic follow-up of patients with type 1 or type 2 diabetes. Our study aimed to evaluate the analytical characteristics of Capillarys 3 Octa® HbA1c measurement by capillary electrophoresis. Materials and Methods: Our study involved 265 venous whole blood specimens repeatability, intermediate fidelity, accuracy, linearity, and correlation with the Arkray HA-8180 analyzer which uses HPLC as a dosing method. We studied interferences such as hematocrit, triglycerides, total bilirubin, labile fraction, and hemoglobin abnormalities. Results: The linearity correlation was between 4.4% and 20.3%. There was a strong correlation with HPLC (r > 0.99, P< 0.0001). No interference from hematocrit (20-93%) (P: 0.888), triglycerides (until 25 mmol/L) (P: 0.388), total bilirubin (< 587 µmol/L) (P: 0.993), and labile fraction was observed. No problem related to inter-sample contamination was observed. The sensitivity was zero for homozygous sickle cell disease and S/C composite hemoglobinosis. However, sensitivity was high for heterozygous forms (69% for A/S and 60% for A/C). The analyzer was able to separate and quantify HbA2 fraction, allowing ß-thalassemia accidental detection. Conclusion: Capillarys 3 Octa® based on capillary electrophoresis proved to be precise and a linear instrument for HbA1c measurement. Several clinical interferences and Hb variants had no effect on the results. The results of this evaluation suggest that this analyzer is suitable for routine use in clinical chemistry laboratories.