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A high-throughput test for diabetes care: An evaluation of the next generation Roche Cobas c 513 hemoglobin A1C assay

Jessica L Gifford1,2, Trefor Higgins3,4, S M Hossein Sadrzadeh1,2

  • 1Calgary Laboratory Services, 9, 3535 Research Rd NW, Calgary, AB, T2L 2K8, Canada.

Practical Laboratory Medicine
|December 5, 2019
PubMed

Insights

The Roche Cobas c 513 analyzer demonstrates excellent precision and accuracy for glycated hemoglobin A (HbA1C) testing. This automated, high-throughput instrument is suitable for large diagnostic laboratories monitoring diabetes.

Area of Science:

  • Clinical chemistry
  • Diagnostic instrumentation
  • Diabetes diagnostics

Background:

  • Glycated hemoglobin A (HbA1C) is the gold standard for diabetes mellitus monitoring.
  • Accurate and efficient HbA1C measurement is crucial for effective diabetes management.
  • Evaluating new analytical platforms is essential for laboratory efficiency.

Purpose of the Study:

  • To assess the analytical performance of the Roche Diagnostics Cobas c 513 analyzer for HbA1C determination.
  • To validate the c 513 as a reliable standalone immunoassay analyzer.

Main Methods:

  • Analytical performance evaluated for imprecision, accuracy, linearity, and method comparison.
  • Specimen stability, interference from hemoglobin variants (Hb variants) and hemoglobin F (HbF), and throughput were assessed.
  • Comparison performed against the Roche Cobas Integra 800 CTS system.

Main Results:

  • Excellent precision with within-run CVs of 0.5-0.7% and between-run CVs of 0.8-1.3%.
  • Good correlation with the Integra system (R=0.998) and minimal bias (-1.6% on average).
  • Negligible interference from Hb variants; a negative bias observed with HbF ≥10%. High throughput of 340 samples/hour.

Conclusions:

  • The Cobas c 513 is a precise and accurate automated analyzer for HbA1C.
  • Its high throughput makes it suitable for large-volume clinical laboratories.
  • The analyzer provides reliable results for diabetes monitoring.
Abstract

Keywords:
Automated analyzerCAP, College of American PathologistsCI, confidence intervalCLSI, Clinical Laboratory Standards InstituteCV, coefficient of variationDiabetes mellitusHPLC, high-performance liquid chromatographyHb, hemoglobinHbA, adult hemoglobinHbA1C, glycated hemoglobin A1CHemoglobin A1CHigh through-putIFCC, International Federation of Clinical Chemistry and Laboratory MedicineImmunoassayLoB, Limit of BlankLoD, Limit of DetectionMethod evaluationNGSP, National Glycohemoglobin Standardization ProgramTE, total error

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