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| Intended Use | The GlycoMark test provides quantitative measurements 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. |
| Reference Range* | Normal: 10-31 µg/mL Abnormal: <10 µg/mL |
| Sample Type | Serum, EDTA plasma |
| Sample Storage/Transport | Samples should be transported under refrigeration and tested within one week of collection. For storage longer than one week, freezing of the serum sample is recommended. Aliquots of frozen samples may be thawed and re-frozen for up to three cycles. |
| Sample Stability | Studies have shown that serum samples are stable at 2-8°C for up to one week |
| Saline Reagent Blank | 0.9% NaCl in deionized water |
| Chemistry Analyzer | 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. See list of validated instruments in Laboratory Specifications. |
| Storage / Stability - Kits, Controls and Calibrators | The GlycoMark kit reagents are stable at refrigerated temperatures (2-8°C) until the expiration date noted on the outer box. Once the reagents have been opened, they are stable for 30 days (at 2-8°C). |
| Proficiency Material | Available from the College of American Pathologists (CAP) at 847-832-7000 or cap.org Order Code “AG” |
Laboratory Specifications [PDF]
| Reference Interval µg/mL | |
| Males | 10.7 - 32.0 |
| Females | 6.8 - 29.3 |
| Overall | 10 - 31 |
*Normal GlycoMark results are lower in females than in males.
Please refer to the product package insert for additional information.
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.