CPT Code: 84378
Order Code: C155
ABN Requirement: Yes
Specimen: Serum or EDTA Plasma
Volume: 1.0 mL
Minimum Volume: 0.5 mL
Preferred Tube Type: Gel-barrier tube (SST, Tiger Top)
Alternate Tube Type: EDTA (Lavender Top)
- Collect and label sample according to standard protocols.
- Gently invert tube 10 times immediately after draw. DO NOT SHAKE.
- Allow blood to clot 30 minutes.
- Centrifuge at 1300 rcf for 10 minutes.
- Draw and gently invert 8 to 10 times.
- Centrifuge immediately for 10 minutes at 1300 RCF at room temperature.
- Pre-squeeze transfer pipet bulb and draw off approximately 2/3 of the upper plasma layer.
Note: This ensures that the buffy coat and red cells remain undisturbed.
- Aliquot plasma into labeled transport tube labeled as “EDTA plasma” and cap tightly. Discard original tube.
- Store transport tube frozen at -20°C until ready to ship.
Transport: Store serum or EDTA plasma at 2°C to 8°C after collection and ship the same day per packaging instructions provided with the Cleveland HeartLab, Inc. shipping box.
Ambient (15-25°C): not acceptable
Refrigerated (2-8°C): 7 days
Frozen (-20°C): >7 days
Deep Frozen (-70°C): >7 days
Causes for Rejection: Specimens other than serum or EDTA plasma; improper labeling; samples not stored properly; samples older than stability limits
Methodology: Enzymatic Assay
Turn Around Time: 1 to 5 days
|Males, All Ages||10.7-32.0|
|Females, All Ages||6.8-29.3|
Glycemic control goal for diabetic patients: >10 µg/mL. GlycoMark® reference ranges only apply to individuals without diabetes.
Intended Use: The GlycoMark® test may be performed monthly on individuals with moderately controlled diabetes and HbA1c of 6-8% to detect glucose excursions, and to monitor efficacy of therapy changes in diabetic individuals with high HbA1c (>8%).
- The GlycoMark® test helps identify patients with more frequent and extreme hyperglycemic excursions over the previous 2 week time period, despite similar HbA1c levels, and indicates the need for more frequent self-blood glucose monitoring or continuous glucose monitoring.
- Approximately 40% of individuals with diabetes who are “controlled” for glucose and HbA1c testing have significant post-prandial glucose variablility1. In fact, the average blood glucose in an individual with an HbA1c of 7% can range from 123 to 185 mg/dL2.
- Low levels of 1,5-AG are associated with the presence of diabetes complications. For example, low circulating levels of 1,5-AG are associated with elevated levels of urinary albumin and N-acetylglucosaminidase, both markers of renal damage3.
- Bonora E et al. Prevalence and correlates of post-prandial hyperglycemia in a large sample of patients with type 2 diabetes. Diabetologia. 2006; 49: 846-854.
- Nathan DM et al. Translating the A1C assay into estimated average glucose values. Diabetes Care. 2008; 31: 1473-1478.
- Yamanouchi T et al. Relationship between serum 1,5-anhydroglucitol and urinary excretion of N-acetlyglucosaminidase and albumin determined at onset of NIDDM with 3-year follow-up. Diabetes Care. 1998; 21: 619-624.