Hemoglobin A1c with eAG with Reflex to 1,5-Anhydroglucitol (1,5-AG)

Cleveland HeartLab H, Test

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NEW YORK DOH APPROVED: YES
CPT Code: 83036
Order Code: 10379
Includes: If Hemoglobin A1c result is ≥6.5% or ≤8.0%, then 1,5-Anhydroglucitol (1,5-AG), Intermediate Glycemic Control will be performed at an additional charge (CPT Code: 84378).
ABN Requirement: No

Specimen Requirements:
Submit two separate specimens:

Preferred: Whole blood from a full EDTA (lavender-top) tube AND 1.0 mL SST serum
Alternative: Whole blood from a full EDTA (lavender-top) tube AND 1.0 mL EDTA plasma

Minimum Volume: 0.5 mL for each sample type

Collection:

EDTA Whole Blood:

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

AND

SST Serum:

  1. Collect and label SST tube 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.

OR

EDTA Plasma:

  1. Collect and label a separate EDTA tube according to standard protocols.
    Note: If not collecting SST tube, two EDTA tubes must be collected.
  2. Gently invert tube 8-10 times immediately after draw. Do not shake.
  3. Centrifuge for 10 minutes.
  4. Pre-squeeze transfer pipet bulb and draw off approximately 2/3 of upper plasma layer.
    Note: This ensures that the buffy coat and red cells remain undisturbed.
  5. Aliquot plasma into transport tube labeled as ‘EDTA plasma’ and cap rightly.
  6. Discard original tube.

 

Transport: Transport samples at either refrigerated (2-8°C) or room temperature and ship the same day per packaging instructions included with the provided shipping box.

Stability:

Ambient (15-25°C): 7 days
Refrigerated (2-8°C): 7 days
Frozen (-20°C): 28 days

Causes for Rejection: Improper labeling; samples not stored properly; samples older than stability limits; sodium fluoride/oxalate (gray-top) tube; heparinized plasma; unspun serum separator tube (SST)

Methodology: Immunoassay

Turn Around Time: 2 to 5 days

Reference Range: See individual tests

Clinical Significance:
Hemoglobin A1c: 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. Interpretative ranges are based on ADA guidelines.

1,5-Anhydroglucitol (1,5-AG): Diazyme 1,5-anhydroglucitol (1,5-AG) Assay is an enzymatic method intended for the quantitative determination of 1,5-anhydroglucitol (1,5-AG) in serum or plasma. The 1,5-AG Assay is for the intermediate term (preceding 1-2 weeks) monitoring of glycemic control in people with diabetes.

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.