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T-Cell Clonality Assay
Clinical Genetic Test
Help
offered by
UCSF DP Specialty Lab
GTR Test Accession: Help GTR000591892.2
CAP
CANCERHEMATOLOGY
Last updated in GTR: 2024-07-15
View version history
Last annual review date for the lab: 2024-07-15 LinkOut
At a Glance
Test purpose: Help
Diagnosis
Conditions (1): Help
Lymphoma
Genes (2): Help
TRB (7q34); TRG (7p14.1)
Methods (1): Help
Molecular Genetics - Targeted variant analysis: PCR
Target population: Help
Not provided
Clinical validity: Help
Not provided
Clinical utility: Help
Not provided
Ordering Information
Offered by: Help
UCSF DP Specialty Lab
View lab's website
Test short name: Help
TCRB and TCRG
Specimen Source: Help
  • Isolated DNA
  • Paraffin block
Who can order: Help
  • Health Care Provider
  • Licensed Physician
Test Order Code: Help
TCRG and TCRB clonality
CPT codes: Help
**AMA CPT codes notice

Copyright: 2023 American Medical Association. All rights reserved.

Lab contact: Help
Jeffrey North, MD, ABD, FAAD, Lab Director
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.
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:
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
Targeted variant analysis
PCR
Applied Biosystems 3730 capillary sequencing instrument
Clinical Information
Test purpose: Help
Diagnosis
Variant Interpretation:
What is the protocol for interpreting a variation as a VUS? Help
N/A

Will the lab re-contact the ordering physician if variant interpretation changes? Help
Not provided.
Recommended fields not provided:
Clinical validity, Clinical utility, Target population, 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
For clonal rearrangement of the TCRB gene, genomic DNA is amplified using three master mixes that target the conserved regions within the variable (V), diversity (D) and the joining (J) regions of the TCR beta chain locus. These regions flank the unique, hypervariable, antigen-binding, complementarity determining region 3 (CDR3). For … View more
View citations (1)
  • van Krieken JH, Langerak AW, Macintyre EA, Kneba M, Hodges E, Sanz RG, Morgan GJ, Parreira A, Molina TJ, Cabeçadas J, Gaulard P, Jasani B, Garcia JF, Ott M, Hannsmann ML, Berger F, Hummel M, Davi F, Brüggemann M, Lavender FL, Schuuring E, Evans PA, White H, Salles G, Groenen PJ, Gameiro P, Pott Ch, Dongen JJ. Improved reliability of lymphoma diagnostics via PCR-based clonality testing: report of the BIOMED-2 Concerted Action BHM4-CT98-3936. Leukemia. 2007;21(2):201-6. doi:10.1038/sj.leu.2404467. Epub 2006 Dec 14. PMID: 17170732.
Availability: Help
Tests performed
Entire test performed in-house
Analytical Validity: Help
This PCR assay is able to detect a clonal DNA population in a background of polyclonal DNA with a sensitivity of 15% .
View citations (1)
  • Design and standardization of PCR primers and protocols for detection of clonal immunoglobulin and T-cell receptor gene recombinations in suspect lymphoproliferations: report of the BIOMED-2 Concerted Action BMH4-CT98-3936. van Dongen JJ, et al. Leukemia. 2003;17(12):2257-317. doi:10.1038/sj.leu.2403202. PMID: 14671650.
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, 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.