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- IGK Gene Clonality Assay
Special Instructions
Please direct any questions regarding this test to customer service at 800-345-4363.
Expected Turnaround Time
5 - 7 days
Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.
Related Information
Specimen Requirements
Specimen
Whole blood, bone marrow, formalin-fixed, paraffin-embedded (FFPE) tissue block or slides, fresh or frozen tissue
Volume
3 to 5 mL whole blood, 1 to 2 mL bone marrow, five unstained slides at 10 µM or formalin-fixed, paraffin-embedded tissue block, tissue in RPMI or frozen
Minimum Volume
0.5 mL whole blood or 0.5 mL bone marrow, two unstained slides at 10 µM
Container
Lavender-top (EDTA) tube, yellow-top (ACD) tube, green-top (heparin) tube, tan-top (K2-EDTA) tube and pink-top (K2-EDTA) tube, FFPE tissue block or slides, tissue in RPMI or frozen
Collection
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 test 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
Test Details
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.
Limitations
This PCR assay is able to detect a clonal DNA population at the sensitivity of 5% in a background of polyclonal DNA.
This test was developed and its performance characteristics determined by Labcorp. It has not been cleared or approved by the Food and Drug Administration.
Methodology
Polymerase chain reaction (PCR)
References
Bruggemann M, White H, Gaulard P, et al. Powerful strategy for polymerase chain reaction-based clonality assessment in T-cell malignancies Report of the BIOMED-2 Concerted Action BHM4 CT98-3936. Leukemia. 2007 Feb;21(2):215-22117170730
Langerak AW, Groenen PJ, Bruggemann M, et al. EuroClonality/BIOMED-2 guidelines for interpretation and reporting of Ig/TCR clonality testing in suspected lymphoproliferations. Leukemia. 2012 Oct;26(10):2159-2171.22918122
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