Hemoglobin A1C (HbA1c) with Reflex to GlycoMark®

Cassandra Greaves H, Test

NEW YORK DOH APPROVED: YES

CPT Code: If Hemoglobin A1c (CPT 83036) is between 6.5% and 8.0% then GlycoMark will be performed at an additional charge (CPT 84378).
Order Code: C522
Includes: HbA1c, Estimated Average Glucose, and GlycoMark (if reflexed)
ABN Requirement:  No
Specimen: EDTA whole blood and serum
Volume: 1.0 mL EDTA Whole Blood and 1.0 mL SST Serum
Minimum Volume: 0.5 mL EDTA Whole Blood and 0.5 mL SST Serum
Container: EDTA Whole Blood (Lavender Top tube) and Gel-barrier Serum Tube (SST)

Collection:

EDTA Whole Blood:

  1. Collect and label sample according to standard protocols.
  2. Gently invert EDTA whole blood tube 8-10 times immediately after draw. DO NOT SHAKE.
  3. Do not centrifuge.

Serum:

  1. Collect and label sample according to standard protocols.
  2. Gently invert tube 5 times immediately after draw. DO NOT SHAKE.
  3. Allow blood to clot 30 minutes.
  4. Centrifuge for 10 minutes.

Transport: Store EDTA whole blood and serum at 2°C to 8°C after collection and ship the same day per packaging instructions included with the provided shipping box.

Stability:

Hemoglobin A1c:
Ambient (15-25°C):
7 days
Refrigerated (2-8°C): 7 days
Frozen (-20°C): 6 months

GlycoMark:
Ambient (15-25°C):
Not Acceptable
Refrigerated (2-8°C): 7 days
Frozen (-20°C): >7 days

Causes for Rejection: Specimens other than EDTA whole blood and serum; improper labeling; samples not stored properly; samples older than stability limits; sodium fluoride/oxalate (gray top) tube; heparinized plasma

Methodology: Enzymatic Assay

Turn Around Time: 1 to 3 days

Relative Risk:

Hemoglobin A1c:

AgeLow Risk
%

Moderate Risk
%

High Risk
%

All Ages<5.75.7-6.4>6.4

eAG (Estimated Average Glucose):

AgeLow Risk
mg/dL


Moderate Risk
mg/dL


High Risk
mg/dL

All Ages<117117-137>137

HbA1c Reflex Value for GlycoMark:

Age%


All Ages6.5-8.0

GlycoMark Reference Range:

Age/Sexµg/mL

All Ages, Male10.7-32.0
All Ages, Female6.8-29.3

For additional information on the GlycoMark test, please see www.clevelandheartlab.com/tests/glycomark/

Clinical Significance: To assist with control of blood glucose levels, the American Diabetes Association (ADA) has recommended glycated hemoglobin testing (HbA1c) twice a year for patients with stable glycemia, and quarterly for patients with poor glucose control. Interpretive ranges are based on ADA guidelines.

The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.