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

Stéphane Jaisson1, Nathalie Leroy1, Michel Soulard2

  • 1Biochemistry Department, University Hospital of Reims, Reims, France.

Biochemia Medica
|November 16, 2018
PubMed

Insights

The Cobas c513 analyser demonstrates high precision and accuracy for Haemoglobin A1c (HbA1c) testing. This evaluation confirms its suitability for routine clinical chemistry laboratory use in monitoring diabetes.

Area of Science:

  • Clinical Chemistry
  • Laboratory Diagnostics
  • Diabetes Mellitus Management

Background:

  • Haemoglobin A1c (HbA1c) is the gold standard for monitoring diabetes control and diagnosis.
  • Accurate HbA1c quantification requires reliable and efficient measurement methods.
  • The Cobas c513 analyser with Tina-quant® HbA1c Third Generation immunoassay offers high throughput (400 samples/hour).

Purpose of the Study:

  • To evaluate the analytical performance of the Cobas c513 analyser for HbA1c measurement.
  • To assess the suitability of the Cobas c513 for routine clinical laboratory use.

Main Methods:

  • Evaluated precision using coefficients of variation.
  • Compared results with two ion-exchange high-performance liquid chromatography (HPLC) methods (BioRad Variant II and D-100).
  • Assessed accuracy using Passing Bablok and Bland-Altman analyses with IFCC-assigned values and tested for interference from common Hb variants, bilirubin, and triglycerides.

Main Results:

  • Achieved high precision with coefficients of variation <1.1% (NGSP units) and <1.7% (IFCC units).
  • Demonstrated excellent agreement with both HPLC methods.
  • Showed high methodological accuracy and no significant interference from common Hb variants or common analytes.

Conclusions:

  • The Cobas c513 analyser exhibits excellent analytical performance for HbA1c assays.
  • The system is well-suited for routine use in clinical chemistry laboratories for diabetes monitoring.
Abstract

Keywords:
HbA1cdiabetesevaluationimmunoassay

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