B-Cell, IGK Gene Rearrangements

Also known as: IGK Gene Clonality Assay

Clinical Use

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

Not provided.

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.

Test Details

Methodology

PCR-based (PCR)

Biomarkers

LOINC Codes

Order Codes

21748-9 - Kappa LC gene Rear Bld/T Ql

Result Codes

21748-9 - Kappa LC gene Rear Bld/T Ql
72486-4 - Lab director name Provider
49549-9 - Ref lab test method

Result Turnaround Time

5-7 days

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.