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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: Skin & Mucosa
Disease State: B Cell Non-Hodgkin Lymphoma (not otherwise classified)
CPT Code(s): 81261; 88381 may apply; G0452 may apply. The CPT codes provided 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 payer being billed.
Turnaround Time: Within 3-5 business days of receipt
Schedule: Monday - Friday
• 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)