Evaluation of the analytical performances of the Cobas c513 analyser for HbA1c assay

Stéphane Jaisson, Nathalie Leroy, Michel Soulard, Aurore Desmons, Emmanuelle Guillard, Philippe Gillery
2018 Biochemia Medica  
Haemoglobin A 1c (HbA 1c ) is considered to be the gold standard for the follow-up of glycaemic control in patients with diabetes mellitus and is also a diagnostic tool. Accordingly, reliable and efficient methods must be used for its quantification. Roche Diagnostics have recently adapted the Tina-quant® HbA 1c Third Generation immunoassay on a fully dedicated analyser, the Cobas c513, which allows a high throughput of up to 400 samples per hour. The present article deals with the evaluation
more » ... th the evaluation of the analytical performances of this system which has been recently introduced to the market. Materials and methods: Precision, comparison with two ion-exchange high-performance liquid chromatography (HPLC) methods (Variant II and D-100 systems, BioRad Laboratories) using Passing Bablok and Bland-Altman analyses, accuracy and interference of the most frequent haemoglobin (Hb) variants on HbA 1c measurement were evaluated. Results: Precision was high, with coefficients of variation lower than 1.1% (HbA 1c values expressed in National Glycohemoglobin Standardization Program units, 1.7% for values expressed in International Federation of Clinical Chemistry and Laboratory Medicine [IFCC] units). The comparison study showed similar results with the two HPLC systems. The analysis of samples with IFCC-assigned values showed high methodological accuracy. Finally, no interference of bilirubin, triglycerides and common Hb variants (Hb AC, AD, AE, AS) was observed. Conclusions: This evaluation showed that the analytical performance of the Cobas c513 analyser for HbA 1c assay makes it suitable for a routine use in clinical chemistry laboratories.
doi:10.11613/bm.2018.030708 fatcat:yjla3msaibavlebu3liucxf3oi