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B-Cell Gene Rearrangement Profile, IgH and IgK
Test CodeLAB1188
Alias/See Also
LAB1188
LabCorp TC: 481222
IgH Clonality Assay
IgH Gene Rearrangement Assay
IgK Clonality Assay
IgK Gene Rearrangement Assay
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.
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
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.
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