[Evaluation of the new kit HbA(1c) Analyzer 2.0 Variant II Turbo (Bio-Rad)]

Ann Biol Clin (Paris). 2011 Sep-Oct;69(5):561-9. doi: 10.1684/abc.2011.0614.
[Article in French]

Abstract

The evaluation of glycated hemoglobin (HbA(1c)) is used in daily practice for monitoring the diabetes mellitus. HbA(1c) may be assayed by different methods, among which high-pressure liquid chromatography (HPLC). We have evaluated a new kit 2.0 available on HPLC Variant II(®) Turbo analyzer (Bio-Rad), which is characterized by an elution buffer containing sodium perchlorate. The correlation with the routine method used in our laboratory (HPLC Variant II(®) analyzer equipped with the NU kit) is good (r² = 0.997). Intra- and inter-assay coefficients of variation are respectively lower than 0.6 and 1.6%. Linearity is excellent from 3.2% (11 mmol/mol) to 18.3% (177 mmol/mol). There is no inter-sample contamination. This method provides a result quickly (96 seconds), but does not allow separating labile HbA(1c) from carbamylated hemoglobin, contrary to the NU kit. As the control of analytical quality is a major concern for validation and clinical use of HbA(1c) results, the characteristics of this new kit make it a well-suited tool for daily laboratory practice.

Publication types

  • Evaluation Study

MeSH terms

  • Anticoagulants / adverse effects
  • Anticoagulants / pharmacology
  • Automation
  • Blood Chemical Analysis / instrumentation
  • Blood Chemical Analysis / methods*
  • Blood Chemical Analysis / trends
  • Child
  • Chromatography, High Pressure Liquid / methods
  • Diabetes Mellitus / blood
  • Diabetes Mellitus / diagnosis
  • Drug Contamination / statistics & numerical data
  • Efficiency
  • Glycated Hemoglobin / analysis*
  • Hospitals, Pediatric
  • Humans
  • Reagent Kits, Diagnostic* / trends
  • Reproducibility of Results
  • Sensitivity and Specificity
  • Time Factors
  • Validation Studies as Topic

Substances

  • Anticoagulants
  • Glycated Hemoglobin A
  • Reagent Kits, Diagnostic
  • hemoglobin A1c protein, human