Celiac Gluten Free Panel
Test Mnemonic
CELGLU
CPT Codes
- 81382 - QTY (2)
Aliases
- Celiac disease genotyping
Performing Laboratory
Cleveland Clinic Laboratories
Specimen Requirements
| Volume | Type | Container | Collect Temperature | Transport Temperature | Special Instructions |
|---|---|---|---|---|---|
| 2 mL | Serum | SST (Gold) | Refrigerated | This assay requires multiple specimen types | |
| 4 mL | Whole blood |
Alternate Specimen Requirements
| Volume | Type | Container | Collect Temperature | Transport Temperature | Special Instructions |
|---|---|---|---|---|---|
| 2 mL | Serum | No additive (Red) | Refrigerated | This assay requires multiple specimen types | |
| 7 mL | Whole blood | ACD A or B (Yellow) | Ambient |
Stability
| Environmental Condition | Description |
|---|---|
| Ambient | Serum: 24 hours; Whole Blood: 1 week |
| Refrigerated | Serum: 7 days; Whole blood: 1 week |
| Frozen | 14 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.