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Clinical Chemistry 45: 1833-1841, 1999;
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(Clinical Chemistry. 1999;45:1833-1841.)
© 1999 American Association for Clinical Chemistry, Inc.

Articles

Multicenter Evaluation of Tosoh Glycohemoglobin Analyzer

Ian Gibb1,a, Angela Parnham1, Michele Fonfrède2 and Freddy Lecock3

1 Department of Clinical Biochemistry, Royal Victoria Infirmary, Newcastle upon Tyne, NE1 4LP United Kingdom.

2 Biochemistry Laboratory, Salpêtrière Hospital, 47 Boulevard de l'Hôpital, F-75651 Paris Cedex 13, France.

3 Eurogenetics, Transportstraat 4, Industrieterrein Ravenshout 5253, B-3980 Tessenderlo, Belgium.
a Author for correspondence. Fax 44-191-2824006; e-mail iangibbrvi{at}compuserve.com

Background: We describe an Anglo-French evaluation of a new analyzer.

Methods: The Tosoh HLC-723 GHb V, A1c2.2 glycohemoglobin analyzer is an HPLC instrument with primary blood tube sampling, bar-code reading, cap piercing, and the ability to chromatographically separate labile hemoglobin A1c (HbA1c). We evaluated two analytical protocols, 2.2 and 3.0 min, and compared results for blood samples collected from diabetic and nondiabetic subjects with those obtained with Bio-Rad Diamat and Variant analyzers.

Results: Within- and between batch-imprecision (CVs) was <2% with linearity to at least 15.9% HbA1c. Although some hemoglobinopathies were detected in the 2.2-min chromatography, clearer evidence of abnormality was visible in the 3.0-min version. Comparison with established methods showed good correlation (r = 0.993; n = 316 with Diamat; and r = 0.995; n = 133 with Variant) but highlighted calibration differences.

Conclusions: The problems of manual blood sample preparation, labile HbA1c, and carbamylated hemoglobin interference associated with the older instruments have been eliminated in the new Tosoh analyzer. The 3.0-min protocol is preferred for routine use.




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