B-Cell Gene Rearrangements Profile, IGH and IGK
Also known as: IgH Clonality Assay, IgH Gene Rearrangement Assay, IgK Clonality Assay, IgK Gene Rearrangement Assay
Use
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.
Special Instructions
Not provided.
Limitations
This PCR assay can detect a clonal DNA population at a sensitivity of 5% within a polyclonal DNA background. The test was developed and its performance determined by Labcorp, but has not been cleared or approved by the FDA.
Methodology
PCR-based (PCR)
Biomarkers
No genes
Gene
LOINC Codes
- 104272-0 - IgH+IgK gene status Spec
- 21747-1 - HC gene Rear Bld/T Ql
- 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
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
Storage Instructions
Maintain blood, bone marrow or tissue in RPMI at 2°C to 8°C; FFPE specimens at room temperature; tissue at -80°C.
Causes for Rejection
Frozen whole blood/bone marrow; quantity not sufficient for analysis; tumor tissue; broken or stained slides
Other tests from different labs that may be relevant