Evaluation Of An Assay For Serum 1,5-Anhydroglucitol (Glycomark (Tm)) And Determination Of Reference Intervals On The Hitachi 917 Analyzer

Background: 1,5-Anhydroglucitol (1,5-AG) is a glucose analogue, which is decreased in hyperglycemic individuals. We report the technical performance of an assay (GlycoMark(TM)) on a chemistry analyzer, evaluation of analyte stability and determination of reference intervals for 1,5-AG in a non-diabetic US population.Methods: NCCLS protocols were followed to evaluate the reagent on a Hitachi 917 chemistry analyzer.Results: Intra- and interassay imprecision ranged from 1.3% to 3.8% and 0.79% to 3.7%, respectively. The assay was linear to 110 mug/ml. Interference from triglyceride, hemoglobin and bilirubin was <10% to concentrations of 12.6 mmol/l, 12.1 and 911.4 mumol/l, respectively. Correlation coefficients between lot numbers on the Hitachi 917 and between analyses on the Hitachi 917 and the Hitachi 7170 analyzers were >0.99. The lowest limit of detection was 0.49 mug/ml (mean+/-2 S.D.). 1,5-AG was stable at 4 degreesC for 7 days, at 22 degreesC for 5 days, at -80 degreesC for 14 days and for three freeze-thaw cycles at -80 degreesC. The US reference intervals (nonparametric 2.5th-97.5th percentiles) were 10.2-33.8 mug/ml (males) and 5.9-31.8 mug/ml (females).Conclusions: The performance of the GlycoMark(TM) assay for the measurement of 1,5-AG was acceptable on the Hitachi 917 analyzer. (C) 2004 Elsevier B.V. All rights reserved.