Analytical evaluation of the Bio-Rad variant II automated HbA(1C) analyzer

Clin Biochem. 2001 Jul;34(5):361-5. doi: 10.1016/s0009-9120(01)00229-6.

Abstract

Objectives: To evaluate the analytical performance of the Bio-Rad Variant II HbA(1C) analyzer (a completely automated system for the quantification of glycohemoglobin [HbA(1C)] in blood).

Design and methods: The analytical parameters of precision, linearity and analytical range were assessed and HbA(1C) results from the Variant II were compared to HbA(1C) results from the Bio-Rad Variant (a method certified by the National Glycohemoglobin Standardization Program). The effect of a variety of hemoglobin variants on HbA(1C) obtained on the system was investigated.

Results: Total imprecision was less than 5% and the results compared well with those from an established method. The method has a wide analytical range with no carryover between specimens.

Conclusion: The HbA(1C) method on the Variant II gives acceptable analytical performance.

Publication types

  • Comparative Study
  • Evaluation Study

MeSH terms

  • Automation
  • Blood Chemical Analysis / instrumentation
  • Chemistry Techniques, Analytical / methods
  • Chromatography, High Pressure Liquid
  • Diabetes Mellitus / blood
  • Fetal Hemoglobin / analysis
  • Freeze Drying
  • Genetic Variation
  • Glycated Hemoglobin A / analysis*
  • Hemoglobin E / analysis
  • Hemoglobin J / analysis
  • Hemoglobins, Abnormal / analysis
  • Humans
  • Reference Values
  • Regression Analysis
  • Reproducibility of Results
  • Statistics as Topic

Substances

  • Glycated Hemoglobin A
  • Hemoglobins, Abnormal
  • hemoglobin D
  • Hemoglobin J
  • Hemoglobin E
  • Fetal Hemoglobin