B-Cell Gene Rearrangement Profile, IgH and IgK

Test Code
LAB1188


Alias/See Also
LAB1188
LabCorp TC: 481222
IgH Clonality Assay
IgH Gene Rearrangement Assay
IgK Clonality Assay
IgK Gene Rearrangement Assay


CPT Codes
81261, 81264

Preferred Specimen
5 mL Lavender (EDTA) - Whole Blood


Minimum Volume
0.5 mL Lavender (EDTA) - Whole Blood


Other Acceptable Specimens
Dark Green Top (Sodium Heparin) - Whole Blood
Yellow Top (ACD)
1 mL bone marrow, five unstained slides at 10uM or fomalin-fixed, paraffin-embedded tissue block, tissue in RPMI or frozen.


Transport Temperature
Refrigerated: Blood, Bone Marrow, Tissue in RPMI
Room Temperature: FFPE specimens


Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Frozen whole blood/bone marrow; quantity not sufficient for analysis; tumor tissue; broken or stained slides


Methodology
Polymerase Chain Reaction (PCR)

Report Available
5-7 days


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.


Clinical Significance
This profile can be used to detect clonal B-cell immunoglobulin heavy chain (IgH) and immunoglobulin κ light chain (IgK) gene rearrangements in blood, bone marrow, and tissue specimens with combined B-cell clonality detection rate of 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 condition. Thus, the results of these studies can assist in the diagnosis of lymphoproliferative disorders.
 


Performing Laboratory
LabCorp
 



The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.