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B-Cell Clonality Screening (IgH and IgK) by PCR
Clinical Genetic Test
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offered by
Baylor Genetics
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GTR Test Accession: Help GTR000570803.1
CANCERDIGESTIVE SYSTEMHEMATOLOGY ... View more
Registered in GTR: 2020-02-10
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Last annual review date for the lab: 2023-07-21 Past due LinkOut
At a Glance
Test purpose: Help
Diagnosis
Conditions (1): Help
Gastric lymphoma
Analytes (1): Help
Aid in diagnosis and monitoring of B-cell lymphoproliferative disorders and in differentiating malignant from reactive lymphoid proliferations.
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
Baylor Genetics
View lab's website
View lab's test page
Test Order Code: Help
9202
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: 1
Condition/Phenotype Identifier
Test Targets
Analytes Help
Total analytes: 1
Analyte Associated Condition
Methodology
Total methods: 1
Method Category Help
Test method Help
Instrument *
Targeted variant analysis
PCR
* Instrument: Not provided
Clinical Information
Test purpose: Help
Diagnosis
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
Interpretation performed both in-house and at an outside lab
Report generated both in-house and at an outside lab
Specimen preparation performed at an outside lab
Wet lab work performed at an outside lab

Test performance comments
Samples received will be tested by ARUP.
Analytical Validity: Help
For point mutations, our assay sensitivity and specificity are about 95% and 97% respectively; for small indel mutations, our assay sensitivity and specificity are about 85% and 71% respectively. In addition, our assay can mosaicism at the level of > 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

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.