Evaluation Studies
GlycoMark provides a quantitative measurement of 1,5 anhydro-D-glucitol (1,5 –AG) in either serum or EDTA plasma. GlycoMark is designed for an automated open chemistry analyzer.
A comprehensive evaluation of the GlycoMark assay is described by Nowatzke W. et al. (Evaluation of an assay for serum 1,5-anhydroglucitol [GlycoMark] and determination of reference intervals on the Hitachi 917 analyzer. Clinca Chimica Acta 2004;350:201-9). This study showed that the assay was stable and linear from 0.49 to 110 ug/ml. The intra- and interassay imprecision ranged from 1.3 to 3.8% and 0.79% to 3.7%, respectively. Similar intra- and interassay precision results are reported by the manufacturers using the Hitachi 917.
The analytical sensitivity of the GlycoMark assay is estimated at 0.2 ug/ml, defined as the mean 1,5-AG concentration plus one standard deviation.
