Abstract
IntroductionHaemoglobin 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 methodsPrecision, 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.ResultsPrecision 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.ConclusionsThis 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.
Highlights
Haemoglobin A1c (HbA1c) is considered to be the gold standard for the follow-up of glycaemic control in patients with diabetes mellitus and is a diagnostic tool
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)
No interference of bilirubin, triglycerides and common Hb variants (Hb AC, AD, AE, AS) was observed. 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
Summary
The analyser and reagents used for this evaluation were provided by Roche Diagnostics (Mannheim, Germany) and were used according to manufacturer’s instructions. Cobas c 513 is a fully dedicated HbA1c assay analyser with a high throughput, owing the use of ready-to-use reagents in a large kit size. The polyhaptens contained in the reagent react with excess anti-HbA1c antibodies and form an insoluble antibody-polyhapten complex, which is measured by turbidimetry at 340 nm (the higher the HbA1c concentration, the lower the turbidity). The output of this method is linear from 23 mmol/ mol (4.3%) to 196 mmol/mol (20.1%). Quality control (QC) samples (PreciControlA1c Norm and PreciControlA1c Path), blood samples with International Federation of Clinical Chemistry and Laboratory Medicine (IFCC)-assigned values and blood samples with Hb variants were provided by Roche Diagnostics
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