GTR Test Accession:
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GTR000569607.2
Last updated in GTR:
2019-12-05
View version history
GTR000569607.2,
last updated:
2019-12-05
GTR000569607.1,
registered in GTR:
2019-11-26
Last annual review date for the lab: 2024-10-02
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At a Glance
Methods (1):
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Molecular Genetics - Sequence analysis of select exons: Next-Generation (NGS)/Massively parallel sequencing (MPS)
Target population: Help
11 Locus typing of Human Leukocyte Antigens(HLA) Used for Solid …
Clinical validity:
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Not provided
Clinical utility:
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Not provided
Ordering Information
Offered by:
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Allogen Laboratories-Cleveland Clinic
Test short name:
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NGSHLA
Specimen Source:
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- Peripheral (whole) blood
Who can order: Help
- Health Care Provider
Test Order Code:
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NGSHLA
CPT codes:
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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.
How to Order:
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This test can be ordered through Cleveland Clinic Electronic Medical Record-EPIC.
Test service:
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Histocompatibility
Informed consent required:
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Decline to answer
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:
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: 11
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
Next-Generation (NGS)/Massively parallel sequencing (MPS)
* Instrument: Not provided
Clinical Information
Test purpose:
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Screening
Target population:
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11 Locus typing of Human Leukocyte Antigens(HLA)
Used for Solid Organ and Peripheral Blood Stem Cell transplantation
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
Availability:
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Tests performed
Interpretation performed in-house
Report generated in-house
Specimen preparation performed in-house
Wet lab work performed in-house
Interpretation performed in-house
Report generated in-house
Specimen preparation performed in-house
Wet lab work performed in-house
Analytical Validity:
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Test was developed and validated using ASHI approved validation guidelines for HLA NGS based typing and compared at least (20) samples to historic samples tested by SBT Sequenced Based typing.
Proficiency testing (PT):
Is proficiency testing performed for this test?
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Yes
Method used for proficiency testing: Help
Formal PT program
PT Provider: Help
American Society for Histocompatibility and Immunogenetics
Yes
Method used for proficiency testing: Help
Formal PT program
PT Provider: Help
American Society for Histocompatibility and Immunogenetics
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:
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Not provided
Additional Information
Reviews:
Clinical resources:
Molecular resources:
Consumer resources:
IMPORTANT NOTE:
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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.