Clinical Genetic Test
offered by
GTR Test Accession:
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GTR000500479.4
NYS CLEP
Last updated in GTR:
2023-07-31
View version history
GTR000500479.4,
last updated:
2023-07-31
GTR000500479.3,
last updated:
2023-07-17
GTR000500479.2,
last updated:
2020-08-10
GTR000500479.1,
registered in GTR:
2013-12-02
Last annual review date for the lab: 2024-07-12
LinkOut
At a Glance
Test purpose:
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Diagnosis;
Risk Assessment
Conditions (1):
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Ankylosing spondylitis
Genes (1):
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HLA-B (6p21.33)
Methods (1):
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Molecular Genetics - Targeted variant analysis: Polymerase Chain Reaction/Fluorescence Monitoring
Target population: Help
Patients symptomatic for ankylosing spondylitis
Clinical validity:
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Not provided
Clinical utility:
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Not provided
Ordering Information
Offered by:
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Test short name:
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HLAB27 PCR
Specimen Source:
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- Peripheral (whole) blood
- View specimen requirements
Who can order: Help
- Genetic Counselor
- Health Care Provider
- Licensed Dentist
- Licensed Physician
- Nurse Practitioner
- Physician Assistant
- Public Health Mandate
- Registered Nurse
Test Order Code:
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50392
View other test codes
View other test codes
Contact Policy:
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Laboratory can only accept contact from health care providers. Patients/families are encouraged to discuss genetic testing options with their health care provider.
Informed consent required:
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Based on applicable state law
Pre-test genetic counseling required:
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Decline to answer
Post-test genetic counseling required:
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Decline to answer
Recommended fields not provided:
How to Order,
Lab contact for this test,
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 *
Targeted variant analysis
Polymerase Chain Reaction/Fluorescence Monitoring
* Instrument: Not provided
Clinical Information
Test purpose:
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Diagnosis;
Risk Assessment
Target population:
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Patients symptomatic for ankylosing spondylitis
Variant Interpretation:
What is the protocol for interpreting a variation as a VUS?
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N/A
N/A
Are family members with defined clinical status recruited to assess significance of VUS without charge?
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N/A
N/A
Will the lab re-contact the ordering physician if variant interpretation changes?
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Not provided. N/A
Not provided. N/A
Research:
Is research allowed on the sample after clinical testing is complete?
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N/A
N/A
Recommended fields not provided:
Clinical validity,
Clinical utility,
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?,
Sample negative report,
Sample positive report
Technical Information
Availability:
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Tests performed
Entire test performed in-house
Entire test performed in-house
Analytical Validity:
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Analytical sensitivity and specificity: 99%
View citations (1)
- HLA-B27 typing: evaluation of an allele-specific PCR melting assay and two flow cytometric antigen assays. Seipp MT, et al. Cytometry B Clin Cytom. 2005;63(1):10-5. doi:10.1002/cyto.b.20039. PMID: 15624199.
Assay limitations:
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Rare alleles present in less than 1 percent of most populations will not be detected. Diagnostic errors can occur due to rare sequence variations.
Proficiency testing (PT):
Is proficiency testing performed for this test?
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Yes
Method used for proficiency testing: Help
Intra-Laboratory
Yes
Method used for proficiency testing: Help
Intra-Laboratory
VUS:
Software used to interpret novel variations
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N/A
Laboratory's policy on reporting novel variations Help
N/A
N/A
Laboratory's policy on reporting novel variations Help
N/A
Recommended fields not provided:
Test Confirmation,
Description of internal test validation method,
PT Provider,
Description of PT method,
Major CAP category, CAP category, CAP test list
Regulatory Approval
FDA Review:
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Not provided
NYS CLEP Approval:
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Number:
4196
Status: Approved
Status: Approved
Additional Information
Reviews:
Clinical resources:
Consumer resources:
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.