B-Cell, IGK Gene Rearrangements
Also known as: IGK Gene Clonality Assay
Use
This assay can be used to detect clonal immunoglobulin receptor kappa-chain gene rearrangements in blood, bone marrow and tissue specimens with combined B-cell clonality detection rate of 94% to 99%. The presence of a monoclonal gene rearrangement usually, but not always, reflects the presence of a B-lymphocytic neoplasm, while polyclonal gene rearrangement patterns are found in benign reactive conditions. Thus, the results of these studies can assist in the diagnosis of lymphoproliferative disorders.
Special Instructions
Please direct any questions regarding this test to customer service at 800-345-4363.
Limitations
This PCR assay can detect a clonal DNA population at a sensitivity of 5% in a background of polyclonal DNA. The test was developed and its performance characteristics determined by Labcorp. It has not been cleared or approved by the Food and Drug Administration.
Methodology
PCR-based (PCR)
Biomarkers
LOINC Codes
- 21748-9
- 21748-9
- 72486-4
- 49549-9
Result Turnaround Time
5-7 days
Related Documents
For more information, please review the documents below
Specimen
Whole Blood
Volume
3 to 5 mL
Minimum Volume
0.5 mL
Container
Lavender-top (EDTA) tube, yellow-top (ACD) tube, green-top (heparin) tube, tan-top (K2-EDTA) tube, pink-top (K2-EDTA) tube
Collection Instructions
Fresh tissue should be placed in RPMI medium or shipped frozen on dry ice. Small samples (e.g., punch biopsies, fine-needle aspirates) will also be accepted. To avoid delays in turnaround time when requesting multiple tests on frozen samples, please submit separate specimens for each test requested.
Storage Instructions
Maintain whole blood, bone marrow or tissue in RPMI at 2°C to 8°C; FFPE specimens at room temperature; frozen tissue at -80°C.
Causes for Rejection
Frozen whole blood/bone marrow; quantity not sufficient for analysis; tumor block containing no tumor tissue; broken or stained slides