Multicentre evaluation of the Tosoh HbA1c G8 analyser

Clin Chem Lab Med. 2010 Mar;48(3):365-71. doi: 10.1515/CCLM.2010.062.

Abstract

Background: We report a Dutch-Belgian multicentre evaluation of the Tosoh HLC-723G8 glycohaemoglobin analyser, an ion-exchange HPLC instrument for the separation and quantification of haemoglobin A1c (HbA1c) in whole blood.

Methods: We evaluated the analytical performances of the Tosoh G8 analyser and compared the results for blood samples with its predecessor, the Tosoh G7, and with two other widely used analysers, the Bio-Rad Variant II and Adams Arkray HA-8160.

Results: Within- and between-batch imprecision [coefficient of variation (CVs)] was <0.5% and 2%, respectively, and compared favourably with the G7. The excellent performances in terms of speed (1.6 min/analysis) did not result in increased variability of the results or carry-over between samples. The method shows no interference from carbamylated haemoglobin, and recognises the presence of haemoglobinopathies, which triggers the correction of the HbA1c result. Comparison with established methods showed good correlation, not only with the G7 but also with the Variant II and HA-8160 systems.

Conclusions: With respect to reproducibility, chromatographic resolution, speed of analysis and identification of Hb variants, the Tosoh G8 analyser can be considered to be state of the art.

Publication types

  • Evaluation Study
  • Multicenter Study

MeSH terms

  • Blood Chemical Analysis / instrumentation
  • Blood Chemical Analysis / methods
  • Blood Chemical Analysis / standards
  • Calibration
  • Chromatography, High Pressure Liquid*
  • Glycated Hemoglobin / analysis*
  • Humans
  • Phenotype
  • Protein Isoforms / analysis
  • Reproducibility of Results

Substances

  • Glycated Hemoglobin A
  • Protein Isoforms
  • hemoglobin A1c protein, human