Izvorni znanstveni članak

https://doi.org/10.11613/BM.2018.030708

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

Stéphane Jaisson ; Biochemistry Department, University Hospital of Reims, Reims, France
Nathalie Leroy ; Biochemistry Department, University Hospital of Reims, Reims, France
Michel Soulard ; Bio Paris Ouest Laboratory, Levallois, France
Aurore Desmons ; Biochemistry Department, University Hospital of Reims, Reims, France
Emmanuelle Guillard ; Biochemistry Department, University Hospital of Reims, Reims, France
Philippe Gillery ; Biochemistry Department, University Hospital of Reims, Reims, France

Sažetak

Introduction: Haemoglobin A1c (HbA1c) 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® HbA1c 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 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 HbA1c measurement were evaluated.
Results: Precision was high, with coefficients of variation lower than 1.1% (HbA1c 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 HbA1c assay makes it suitable for a routine use
in clinical chemistry laboratories.

Ključne riječi

diabetes; evaluation; HbA1c; immunoassay

Hrčak ID:

206660

URI

https://hrcak.srce.hr/206660

Datum izdavanja:

15.10.2018.

Posjeta: 788 *