Multicenter evaluation of Tosoh glycohemoglobin analyzer.
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.
Gibb
I
I
Department of Clinical Biochemistry, Royal Victoria Infirmary, Newcastle upon Tyne, NE1 4LP United Kingdom. iangibbrvi@compuserve.com
Parnham
A
A
Fonfrède
M
M
Lecock
F
F
D000328:Adult; D001322:Autoanalysis; D002851:Chromatography, High Pressure Liquid; D002852:Chromatography, Ion Exchange; D003920:Diabetes Mellitus / Q000097:blood; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis*; D006453:Hemoglobinopathies / Q000097:blood; D006801:Humans; D008297:Male; D008875:Middle Aged; D012016:Reference Values
D006442:Glycated Hemoglobin