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Deceased donor Class I and II DNA Typing
Clinical Genetic Test
Help
offered by
HLA Laboratory
GTR Test Accession: Help GTR000569837.1
INHERITED DISEASE
Registered in GTR: 2020-01-02
View version history
Last annual review date for the lab: 2024-08-01 LinkOut
At a Glance
Test purpose: Help
Screening
Conditions (1): Help
Hla modifier
Genes (10): Help
HLA-A (6p22.1); HLA-B (6p21.33); HLA-C (6p21.33); HLA-DPB1 (6p21.32); HLA-DQA1 (6p21.32) more...
Methods (2): Help
Molecular Genetics - Sequence analysis of select exons: Sequence based typing (SBT); ...
Target population: Help
Not provided
Clinical validity: Help
Not provided
Clinical utility: Help
Not provided
Ordering Information
Offered by: Help
HLA Laboratory
Specimen Source: Help
  • Peripheral (whole) blood
Who can order: Help
  • Health Care Provider
  • Licensed Physician
Contact Policy: Help
Laboratory can only accept contact from health care providers. Patients/families are encouraged to discuss genetic testing options with their health care provider.
Test service: Help
Histocompatibility
Test development: Help
FDA-reviewed (has FDA test name)
Informed consent required: Help
Decline to answer
Pre-test genetic counseling required: Help
Decline to answer
Post-test genetic counseling required: Help
Decline to answer
Recommended fields not provided:
Test Order Code, How to Order, Lab contact for this test, Test strategy
Conditions Help
Total conditions: 1
Condition/Phenotype Identifier
Test Targets
Genes Help
Total genes: 10
Gene Associated Condition Germline or Somatic Allele (Lab-provided) Variant in NCBI
Methodology
Total methods: 2
Method Category Help
Test method Help
Instrument *
Sequence analysis of select exons
Sequence based typing (SBT)
Targeted variant analysis
Sequence specific oligonucleotide probe (SSOP, SSO)
* Instrument: Not provided
Clinical Information
Test purpose: Help
Screening
Recommended fields not provided:
Clinical validity, Clinical utility, Target population, 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: Help
Tests performed
Entire test performed in-house
Analytical Validity: Help
The SSO-CWD Test is an IVD approved test and validated in our laboratory using ASHI approved guidelines for HLA SSO based typing. 15 previously typed samples were tested at the A,B,C and DRB1 loci and compared to historic samples. The SSO-CWD typing was fully concordant with all evaluable genotypes in … 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
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: Help
Category: IVD - In Vitro Device.
FDA Review of (Item reviewed): Test kit(s)
FDA Regulatory Status: FDA cleared/approved
Application number: BK120024

Category: IVD - In Vitro Device.
FDA Review of (Item reviewed): Test kit(s)
FDA Regulatory Status: FDA cleared/approved
Application number: BK110038
Additional Information
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.