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Abstract

Multicenter Evaluation of an Improved Immunoturbidimetric Assay for the Determination of HbAlc on Clinical Chemistry Analyzers by D. L. Bakkeren, P. Bonvicini, M. Buxeda, T. Funke, P. Gillery, H. R. Henrichs, N. Holland-Moritz, K. Lande, C. Lemke, K. Miedema, Ch. M. Niederau, L. Praße, H. Reinauer, P. Wolf, D. Engel, P. Lehmann, J. Jarausch, D. Raab

An improved second generation HbA1c assay (Tina-quant® [a] HbA1c II) was evaluated in 10 European laboratories on different Boehringer Mannheim/Hitachi analysis systems. The assay is based on the specific immunoturbidimetric determination of HbA1c. Glycated hemoglobin is calculated in relation to total hemoglobin, which is determined photometrically. CV values ranged from 0.4 - 3.4% within-run and from 0.5 - 5.1% between-day. A recovery of 97.2% was obtained for the normal range control and of 93.9% for the pathological range control. Method comparison studies between the Tina-quant® [a] HbA1c II assay and different HPLC methods generally revealed a good correlation.

DOI: Clin. Lab. 1999;45:123-137