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Multicentre evaluation of the Tosoh HbA1c G8 analyser
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Jean-Paul Chapelle
Published/Copyright:
December 18, 2009
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.
Received: 2009-7-17
Accepted: 2009-10-19
Published Online: 2009-12-18
Published in Print: 2010-03-01
©2010 by Walter de Gruyter Berlin New York
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Keywords for this article
diabetes;
evaluation;
glycated haemoglobin;
HbA1c;
Hb variants;
multicentre study
Articles in the same Issue
- Editorial
- Standardization of assays for clinically important enzymes that have high biologic variation: what is all the fuss about?
- Minireview
- Standardization in clinical enzymology: a challenge for the theory of metrological traceability
- Review
- Laboratory reporting of hemostasis assays: the final post-analytical opportunity to reduce errors of clinical diagnosis in hemostasis?
- Opinion Paper
- The underestimated problem of using serum magnesium measurements to exclude magnesium deficiency in adults; a health warning is needed for “normal” results
- Genetics and Molecular Diagnostics
- Integrated PCR amplification and detection processes on a Lab-on-Chip platform: a new advanced solution for molecular diagnostics
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