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Multicenter evaluation of Tosoh glycohemoglobin analyzer
I Gibb1, A Parnham, M Fonfrède
1Department of Clinical Biochemistry, Royal Victoria Infirmary, Newcastle upon Tyne, NE1 4LP United Kingdom. iangibbrvi@compuserve.com
Clinical Chemistry
|October 3, 1999
Summary
The new Tosoh HLC-723 GHb V analyzer accurately measures hemoglobin A1c (HbA1c) and eliminates interferences found in older methods. The 3.0-minute protocol is recommended for routine clinical use.
Area of Science:
- Clinical Chemistry
- Analytical Chemistry
- Hematology
Background:
- Evaluation of a novel Anglo-French automated analyzer for glycohemoglobin.
- Focus on the Tosoh HLC-723 GHb V, a HPLC instrument with advanced features.
Purpose of the Study:
- To assess the performance of the Tosoh HLC-723 GHb V analyzer.
- Compare its results with established methods (Bio-Rad Diamat and Variant).
- Evaluate two analytical protocols (2.2 and 3.0 min).
Main Methods:
- Utilized HPLC technology for glycohemoglobin analysis.
- Employed primary blood tube sampling with bar-code reading and cap piercing.
- Analyzed samples from diabetic and nondiabetic subjects.
- Compared results against Bio-Rad Diamat and Variant analyzers.
Main Results:
- Demonstrated excellent within- and between-batch imprecision (<2% CV).
- Showed good linearity up to 15.9% HbA1c.
- The 3.0-min protocol provided clearer detection of hemoglobinopathies.
- Exhibited strong correlation with established methods (r=0.993 to 0.995).
Conclusions:
- The Tosoh analyzer overcomes limitations of older instruments, including manual sample preparation and interference.
- Eliminates interference from labile HbA1c and carbamylated hemoglobin.
- The 3.0-minute protocol is recommended for routine clinical application.