GTR Test Accession:
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GTR000570852.3
CAP
Last updated in GTR:
2024-08-27
View version history
GTR000570852.3,
last updated:
2024-08-27
GTR000570852.2,
last updated:
2023-08-22
GTR000570852.1,
registered in GTR:
2022-09-13
Last annual review date for the lab: 2024-08-27
LinkOut
At a Glance
Test purpose:
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Diagnosis
Conditions (1):
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Spondyloarthropathy, susceptibility to, 1
Genes (1):
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HLA-B (6p21.33)
Methods (1):
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Molecular Genetics - Sequence analysis of select exons: sequence-specific oligonucleotide probes (SSOP)
Target population: Help
HLA-B27 is strongly associated with ankylosing spondylitis (Marie-Strumpell disease). A …
Clinical validity:
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Not provided
Clinical utility:
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Not provided
Ordering Information
Offered by:
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Specimen Source:
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- Buccal swab
- Dried blood spot (DBS) card
- Peripheral (whole) blood
- View specimen requirements
Test Order Code:
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006924
View other test codes
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Lab contact:
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How to Order:
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Follow direction at https://www.labcorp.com/tests/006924/hla-b27-disease-association
Order URL
Order URL
Informed consent required:
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No
Pre-test genetic counseling required:
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No
Post-test genetic counseling required:
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No
Recommended fields not provided:
Contact policy,
Test strategy,
Test development
Conditions
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Total conditions: 1
Condition/Phenotype | Identifier |
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Test Targets
Genes
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Total genes: 1
Gene | Associated Condition | Germline or Somatic | Allele (Lab-provided) | Variant in NCBI |
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Methodology
Total methods: 1
Method Category
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Test method
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Instrument *
Sequence analysis of select exons
sequence-specific oligonucleotide probes (SSOP)
* Instrument: Not provided
Clinical Information
Test purpose:
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Diagnosis
Target population:
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HLA-B27 is strongly associated with ankylosing spondylitis (Marie-Strumpell disease). A patient with consistent clinical and radiographic findings who is B27-positive has a greater chance of having or developing ankylosing spondylitis than a negative patient. The antigen is not causative, however, and 10% of normal subjects are B27-positive. This test should …
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View citations (6)
- Striking prevalence of ankylosing spondylitis in "healthy" w27 positive males and females. Calin A, et al. N Engl J Med. 1975;293(17):835-9. doi:10.1056/NEJM197510232931701. PMID: 126380.
- The Second International Simmons Center Conference on HLA-B27-Related Disorders. Lipsky PE, et al. Arthritis Rheum. 1991;34(11):1476-82. doi:10.1002/art.1780341120. PMID: 1953825.
- Molecular mimicry in HLA-B27-related arthritis. Yu DT, et al. Ann Intern Med. 1989;111(7):581-91. doi:10.7326/0003-4819-111-7-581. PMID: 2672931.
- The HLA histocompatibility system in autoimmune states. Braun WE, et al. Clin Lab Med. 1988;8(2):351-72. PMID: 3284701.
- Reiter's syndrome and reactive arthritis in perspective. Keat A, et al. N Engl J Med. 1983;309(26):1606-15. doi:10.1056/NEJM198312293092604. PMID: 6358890.
- Diagnostic value of HLA-B27 testing ankylosing spondylitis and Reiter's syndrome. Khan MA, et al. Ann Intern Med. 1982;96(1):70-6. doi:10.7326/0003-4819-96-1-70. PMID: 7053711.
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:
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Polymerase chain reaction (PCR)/sequence-specific oligonucleotide probes (SSOP). Detects B27 at an antigen level. Positive samples may be further sequenced to determine the HLA B27 allele.
Test Confirmation:
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Positive samples may be further sequenced to determine the HLA B27 allele. All positives are reprepped and confirmed.
Availability:
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Tests performed
Entire test performed in-house
Entire test performed in-house
Analytical Validity:
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HLA-B27 is strongly associated with ankylosing spondylitis (Marie-Strumpell disease). A patient with consistent clinical and radiographic findings who is B27-positive has a greater chance of having or developing ankylosing spondylitis than a negative patient. The antigen is not causative, however, and 10% of normal subjects are B27-positive. This test should …
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Proficiency testing (PT):
Is proficiency testing performed for this test?
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No
Method used for proficiency testing: Help
Formal PT program
PT Provider: Help
College of American Pathologists, CAP
No
Method used for proficiency testing: Help
Formal PT program
PT Provider: Help
College of American Pathologists, CAP
Recommended fields not provided:
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:
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Not provided
Additional Information
Reviews:
Clinical resources:
Molecular resources:
Consumer resources:
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