Celiac Gluten Free Panel




Test Mnemonic

CELGLU

CPT Codes

  • 81382 - QTY (2)

Aliases

  • Celiac disease genotyping

Performing Laboratory

n/a


Specimen Requirements

Volume Type Container Collect Temperature Transport Temperature Special Instructions
2 mLSerumSST (Gold) RefrigeratedThis assay requires multiple specimen types
4 mLWhole blood    

Alternate Specimen Requirements

Volume Type Container Collect Temperature Transport Temperature Special Instructions
2 mLSerumNo additive (Red) RefrigeratedThis assay requires multiple specimen types
7 mLWhole bloodACD A or B (Yellow) Ambient 

Stability

Environmental Condition Description
AmbientSerum: 24 hours; Whole Blood: 1 week
RefrigeratedSerum: 7 days; Whole blood: 1 week
Frozen14 days, up to 2 freeze/thaw cycles

Days Performed

Mon - Fri

Turnaround Time

1 - 4 days

Methodology

Name Description
Enzyme-Linked Immunosorbent Assay (ELISA) 
Nephelometry (NEPH) 
Polymerase Chain Reaction (PCR) 
Sequence Specific Oligonucleotide Probe (SSOP) 
Immunoturbidometric Assay 

Reference Range

Special Info

Multiple freeze thaw cycles from serum are not recommended.

Clinical Info

The Celiac Gluten Free panel is ordered in patients already on a gluten free diet. In such patients the antibody levels and the morphologic findings on biopsy may be diminished and only the HLA testing may be useful. HLA-DQ genotyping HLA-DQA1: ------ HLA-DQB1: ------ Interpretation: The HLA-DQ genotype of the patient is/is NOT associated with increased risk of celiac disease. The strongest reported HLA associations with celiac disease include DQ2 (DQ2.5 or DQA1*05-DQB1*0201 & DQ2.2 or DQA1*02:01-DQB1*02:02) and DQ8 (DQA1*0301/DQB1*0302)1-3. This test is useful for family members of celiac patients and patients with negative serology results. This testing can rule out celiac disease with high negative predictive value (NPV) of 95 - 100% depending on the ethnic background. HLA typing should only be attempted in patients who are already on gluten-free diet prior to serological diagnosis and/or those with equivocal biopsy results.

Clinical Limitation

The identification of one of these HLA-DQ genotypes is not, by itself, sufficient for the diagnosis of celiac disease, since both DQ2 and DQ8 are relatively common in the general population.