The GlycoMark Test Validation

The GlycoMark test is a ten minute, two-step enzymatic kinetic assay that measures 1,5-Anhydroglucitol (1,5-AG) in serum or EDTA plasma.

  • Linearity: Linearity is established using the 50 µg/ml calibration standard. Linearity between 0 and 50 µg/ml is desirable; 50 µg/ml is beyond the upper normal range for 1,5-AG and values less than 10 µg/ml are diagnostic in diabetes. Intermediate points are not required but can be assessed by either diluting the 50 µg/ml standard or multiple patient samples with known 1,5-AG values.

  • Precision: Precision is established within assay and between assay using multiple patient samples. CVs are determined from the means and SDs.
  • Accuracy: Accuracy is established using the high and low control set, and/or by running patient samples and sending the samples to another validated reference lab for correlation comparisons.

For validation or technical assistance, please contact us

Validation:

The GlycoMark test can be run on any appropriate open channel laboratory analyzer, including the Hitachi 917, Abbott Architect C Series, and Beckman AU series analyzers. Please contact GlycoMark Technical Support to obtain information and instrument settings for these and other laboratory analyzers.

The GlycoMark test is an FDA-cleared, non-fasting serum or plasma test for monitoring blood glucose variability in people with diabetes. The GlycoMark test provides quantitative measurement of 1,5-anhydroglucitol (1,5-AG) in serum or plasma. The test is for professional use, and is indicated for the intermediate term monitoring of glycemic control in people with diabetes.

Copyright © 2023 Glycomark.