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Clinical Chemistry and Laboratory Medicine (CCLM)

Published in Association with the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM)

Editor-in-Chief: Plebani, Mario

Editorial Board Member: Gillery, Philippe / Lackner, Karl J. / Lippi, Giuseppe / Melichar, Bohuslav / Schlattmann, Peter / Tate, Jillian R. / Tsongalis, Gregory J.

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Multicentre evaluation of the Tosoh HbA1c G8 analyser

Jean-Paul Chapelle1 / Jelda Teixeira1 / Diane Maisin2 / Hans Assink3 / Gerhard Barla3 / An K. Stroobants4 / Barend Delzenne4 / Wouter van den Eshof4

1Centre Hospitalier Universitaire de Liège, Laboratoire de Chimie médicale, Liège, Belgium (Centre 1)

2Cliniques Universitaires Saint-Luc Bruxelles, Département de Biologie clinique et d'Anatomie pathologique, Bruxelles, Belgium (Centre 2)

3Medisch Laboratorium LabNoord, Groningen, The Netherlands (Centre 3)

4Academisch Medisch Centrum, Amsterdam, The Netherlands (Centre 4)

Corresponding author: Jean-Paul Chapelle, Centre Hospitalier Universitaire de Liège, Laboratoire de Chimie médicale, Bâtiment 35, Sart Tilman, 4000 Liège 1, Belgium Phone: +32 (4) 3667684, Fax: +32 (4) 3667666,

Citation Information: Clinical Chemistry and Laboratory Medicine. Volume 48, Issue 3, Pages 365–371, ISSN (Online) 1437-4331, ISSN (Print) 1434-6621, DOI: 10.1515/CCLM.2010.062, December 2009

Publication History

Received:
2009-07-17
Accepted:
2009-10-19
Published Online:
2009-12-18

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.

Clin Chem Lab Med 2010;48:365–71.

Keywords: diabetes; evaluation; glycated haemoglobin; HbA1c; Hb variants; multicentre study

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