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Celiac HLA DQ Association
Clinical Genetic Test
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offered by
Laboratory Corporation of America Holdings
View lab's test page
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GTR Test Accession: Help GTR000570819.3
CAP
IMMUNOLOGYINHERITED DISEASEDIGESTIVE SYSTEM ... View more
Last updated in GTR: 2024-08-27
View version history
Last annual review date for the lab: 2024-08-27 LinkOut
At a Glance
Test purpose: Help
Diagnosis; Risk Assessment
Conditions (1): Help
Celiac disease
Genes (2): Help
HLA-DQA1 (6p21.32); HLA-DQB1 (6p21.32)
Methods (1): Help
Molecular Genetics - Sequence analysis of select exons: SSO
Target population: Help
Aids in the diagnosis of celiac disease. The HLA DQ …
Clinical validity: Help
Not provided
Clinical utility: Help
Not provided
Ordering Information
Offered by: Help
Laboratory Corporation of America Holdings
View lab's website
View lab's test page
Specimen Source: Help
  • Buccal swab
  • Lavender-top (EDTA) tube
Test Order Code: Help
167082
View other test codes
Lab contact: Help
Ruth Koester, PhD, D(ABHI), Lab Director
koester@labcorp.com
3364367310
How to Order: Help
Order URL
Informed consent required: Help
No
Pre-test genetic counseling required: Help
No
Post-test genetic counseling required: Help
No
Recommended fields not provided:
Contact policy, Test strategy, Test development
Conditions Help
Total conditions: 1
Condition/Phenotype Identifier
Test Targets
Genes Help
Total genes: 2
Gene Associated Condition Germline or Somatic Allele (Lab-provided) Variant in NCBI
Methodology
Total methods: 1
Method Category Help
Test method Help
Instrument *
Sequence analysis of select exons
SSO
* Instrument: Not provided
Clinical Information
Test purpose: Help
Diagnosis; Risk Assessment
Target population: Help
Aids in the diagnosis of celiac disease. The HLA DQ Association test provides genotyping for detection of HLA-DQ2 (DQA1*05:01 or 05:05 and DQB1*02:01 or 02:02) and HLA-DQ8 (DQB1*03:02). Patients with DQ2, half DQ2 and/or DQ8 are predisposed to celiac disease. A negative result essentially rules out celiac disease. In addition … View more
View citations (3)
  • Pietzak MM, Schofield TC, McGinniss MJ, Nakamura RM. Stratifying risk for celiac disease in a large at-risk United States population by using HLA alleles. Clin Gastroenterol Hepatol. 2009;7(9):966-71. doi:10.1016/j.cgh.2009.05.028. Epub 2009 Jun 23. PMID: 19500688.
  • Sapone A, Bai JC, Ciacci C, Dolinsek J, Green PH, Hadjivassiliou M, Kaukinen K, Rostami K, Sanders DS, Schumann M, Ullrich R, Villalta D, Volta U, Catassi C, Fasano A. Spectrum of gluten-related disorders: consensus on new nomenclature and classification. BMC Med. 2012;10:13. doi:10.1186/1741-7015-10-13. Epub 2012 Feb 07. PMID: 22313950.
  • Taylor AK, Lebwohl B, Snyder C, Green PHR. Celiac Disease. In: Pagon RA et al., editors. GeneReviews® [Internet]. Seattle (WA): University of Washington, Seattle; 1993-2016. 2008 Jul 3 [updated 2015 Sep 17]. PubMed 20301720
Recommended fields not provided:
Clinical validity, Clinical utility, What is the protocol for interpreting a variation as a VUS?, Are family members with defined clinical status recruited to assess significance of VUS without charge?, Will the lab re-contact the ordering physician if variant interpretation changes?, Is research allowed on the sample after clinical testing is complete?, Sample negative report, Sample positive report
Technical Information
Test Procedure: Help
Sequence specific oligonucleotide probes (SSO) and Sanger sequencing as needed to provide desired resolution.
Test Comments: Help
Contact HLA Customer Service at HLACS@labcorp.com for questions.
Availability: Help
Tests performed
Entire test performed in-house
Analytical Validity: Help
The HLA DQ Association test detects celiac disease-associated alleles that predispose to the disorder but is not diagnostic of celiac disease. More than 95% of celiac disease patients are positive for DQ2, half DQ2, or DQ8, but many individuals with these genetic results do not develop celiac disease. Even with … View more
Proficiency testing (PT):
Is proficiency testing performed for this test? Help
Yes

Method used for proficiency testing: Help
Formal PT program

PT Provider: Help
College of American Pathologists, CAP
Recommended fields not provided:
Test Confirmation, Assay limitations, Description of internal test validation method, Citations for Analytical validity, Description of PT method, Major CAP category, CAP category, CAP test list
Regulatory Approval
FDA Review: Help
Not provided
Additional Information

IMPORTANT NOTE: NIH does not independently verify information submitted to GTR; it relies on submitters to provide information that is accurate and not misleading. NIH makes no endorsements of tests or laboratories listed in GTR. GTR is not a substitute for medical advice. Patients and consumers with specific questions about a genetic test should contact a health care provider or a genetics professional.