Celiac Disease Diagnostics Panel

Cleveland HeartLab C, Test

NEW YORK DOH APPROVED: YES
CPT Code: 83516 (x4), 82784
Order Code: C1547

Includes: Tissue Transglutaminase Ab (IgG), Tissue Transglutaminase Ab (IgA), Gliadin (Deamidated Peptide) Ab (IgG, IgA), Immunoglobulin A (IgA)

ABN Requirement:  No
Specimen: Serum
Volume:  5.0 mL
Minimum Volume:  2.5 mL
Container: Gel-barrier tube (SST, Tiger Top)

Collection:

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

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

Stability:

Ambient (15-25°C): 72 hours
Refrigerated (2-8°C): 7 days
Frozen (-20°C): 30 days

Causes for Rejection: Specimens other than serum; improper labeling; samples not stored properly; samples older than stability limits; gross hemolysis; gross lipemia

Turn Around Time: 5 to 6 days

Reference Range:

Test Age Reference Range
Tissue Transglutaminase, IgG All Ages

<6 U/mL
No antibody detected

≥6 U/mL
Antibody detected

Tissue Transglutaminase Ab, IgA All Ages <4 U/mL
No antibody detected≥4 U/mL
Antibody detected
 Gliadin (Deamidated Peptide) Ab IgG All Ages <20 Units
Antibody not detected≥20 Units
Antibody detected
 Gliadin (Deamidated Peptide) Ab IgA All Ages <20 Units
Antibody not detected≥20 Units
Antibody detected
 IgA, Serum Cord Blood 1-3 mg/dL
1-28 days 2-40 mg/dL
1-3 months 3-40 mg/dL
4-6 months 7-47 mg/dL
7-11 months 12-53 mg/dL
1 year 20-73 mg/dL
2 years 20-99 mg/dL
3-5 years 22-140 mg/dL
6-8 years 31-180 mg/dL
9-11 years 33-200 mg/dL
12-16 years 36-220 mg/dL
17-60 years 47-310 mg/dL
61 years or older 20-320 mg/dL


Clinical Significance: 
Tissue Transglutaminase Antibody IgG and IgA are useful in diagnosing gluten-sensitive enteropathies, such as Celiac Sprue Disease, and an associated skin condition, dermatitis herpetiformis in patients who are IgG- or IgA-deficient.

Detection of antibodies to gliadin, one of the major protein components of gluten, is a sensitive assay useful in diagnosing celiac disease. However, gliadin antibodies may be found in individuals without celiac disease; thus, gliadin antibody assays are less specific than assays measuring antibodies to endomysium and transglutaminase. Recent work has revealed that gliadin-reactive antibodies from celiac patients bind to a very limited number of specific epitopes on the gliadin molecule. Further, deamination of gliadin results in enhanced binding of gliadin antibodies. Based on this information, assays using deamidated gliadin peptides bearing the celiac-specific epitopes have much higher diagnostic accuracy for celiac disease when compared to standard gliadin antibody assays.

Increased IgA is associated with monoclonal IgA myeloma, respiratory, and gastrointestinal infections, and malabsorption; decreased IgA is found in selective IgA deficiency and in ataxia telangiectasia.

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.