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IgH (B cell) gene rearrangement pin


IgH (B cell) gene rearrangement

Alternate Test Names:
B cell (IgH) clonality

Methodology: PCR

Clinical Significance:
The IgH Clonality Assay is a multiplex fluorescent PCR assay based on the pan-European collaborative study (BIOMED-2). This assay uses the framework 1, 2, and 3 primer sets (FR1, FR2, and FR3) utilized by BIOMED-2 for the analysis of IgH gene rearrangements. Importantly, this test should be interpreted in the context of clinical, histologic, and immunophenotypic information and should not be used in isolation in the evaluation of possible B cell lymphoproliferative disorders. Clinical indications for the test include:

• Any suspect B cell proliferation when morphology and immunophenotyping are not conclusive
• Lymphoproliferations in immunodeficient patients
• Evaluation of the clonal relationship between two B lymphoid malignancies in one patient or discrimination between a relapse and a second malignancy
• Occasionally, staging of B cell lymphomas
• Aid in minimum residual disease detection

Type: PCR/Capillary Electrophoresis, Qualitative

Organ: Blood/Bone Marrow, Body Fluids, Lymph Node / Spleen, Skin & Mucosa

Disease State: B Cell NHL with Plasmacytoid Differentiation, B Cell Non-Hodgkin Lymphoma (not otherwise classified), Burkitt's Lymphoma, Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma (CLL/SLL), Diffuse Large B Cell Lymphoma, Follicular Lymphoma, Lymphoplasmacytic Lymphoma, Mantle Cell Lymphoma, Marginal Zone/MALT Lymphoma, Nodular Lymphocyte-Predominant Hodgkin Lymphoma, Plasma Cell Myeloma/Neoplasm, Post-Transplant Lymphoproliferative Disorders

CPT Code(s): 81261; 88381 may apply; G0452 may apply (reference only; CPTs may vary)

Turnaround Time: Within 3-5 business days of receipt

Schedule: Monday - Friday

Specimen Requirements:
• Peripheral blood, Preferred: 5 ml in EDTA (purple top) / Acceptable: 5 ml in sodium heparin (green top) - OR -
• Bone marrow aspirate, Preferred: 1-2 ml in EDTA (purple top) / Acceptable: 1-2 ml in sodium heparin (green top) - OR -
• Fresh tissue in RPMI - OR -
• Formalin-fixed, paraffin-embedded tissue (FFPE)