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T-Cell Clonality Test
Clinical Genetic Test
Help
offered by
Duzen Laboratories
GTR Test Accession: Help GTR000595928.1
INHERITED DISEASECANCERHEMATOLOGY ... View more
Registered in GTR: 2021-09-08
View version history
Last annual review date for the lab: 2023-09-15 Past due LinkOut
At a Glance
Test purpose: Help
Monitoring
Conditions (4): Help
B-cell chronic lymphocytic leukemia; Acute lymphoid leukemia; Classic Hodgkin lymphoma more...
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
Duzen Laboratories
View lab's website
Test Order Code: Help
3920
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:
How to Order, Specimen source, Lab contact for this test, Contact policy, Test strategy, Test development
Conditions Help
Total conditions: 4
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
* Instrument: Not provided
Clinical Information
Test purpose: Help
Monitoring
Recommended fields not provided:
Clinical validity, Clinical utility, Target population, What is the protocol for interpreting a variation as a VUS?, 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
Diagnostic accuracy of targeted regions is at least 96% if the cancer cell clone blast percentage/ cancer-associated mutation rate is greater than 10%
Proficiency testing (PT):
Is proficiency testing performed for this test? Help
No
Recommended fields not provided:
Test Confirmation, Assay limitations, Description of internal test validation method, Citations for Analytical validity, PT Provider, Description of PT method, Major CAP category, CAP category, CAP test list
Regulatory Approval
FDA Review: Help
Not provided
Additional Information

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