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Genetic Labs

Houston, Texas

Genetic Laboratory
Medical Genetics Laboratories
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Medical Genetics Test Details

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Comprehensive B-Cell Clonality Analysis - FFPE
Test Information: The Comprehensive B-Cell Clonality Analysis test is based on the detection of rearrangements of the immunoglobulin heavy and light chain receptor genes that occur during B lymphocyte development. Both the Immunoglobulin Heavy Chain gene (IGH@) and the Light Chain gene (IGK@) rearrangements generate DNA segments that are unique in length and sequence for a specific lymphocyte clone. Polymerase chain reaction (PCR) assays can be used to identify lymphocyte populations derived from a single cell (monoclonal populations) by detecting the unique gene rearrangements present within both antigen receptor loci. Reactive lymphocytic proliferations show a polyclonal rearrangement profile.The identification of a monoclonal population in the right clinical and pathological scenario, suggests the presence of a lymphoid neoplasm (leukemia or lymphoma). Non-neoplastic lymphocytic proliferations can also present with monoclonal populations. This test is used to detect the vast majority of clonal B malignancies. The combination of both IGH@ and IGK@ gene rearrangement assay is reported to identify > 98%of mature B-cell malignancies (Evans et al. Leukemia 2007, 21:207-214).
Test Details
Test Code: 9240
Special Notes: The Immunoglobuling Heavy and Kappa Light Chains are available as separate tests. Please see test codes #9205 (PB, BM, T) and #9220 (FFPE) for Heavy Chain rearrangements and test codes #9210 (PB, BM, T) and 9230 (FFPE) for Kappa Light Chain rearrangements.

If the cell lineage is not known, this test can be combined with the Comprehensive T-Cell Clonality Analysis for detection of clonal T-cell proliferations. Please see test codes #9217 (PB, BM, T) and #9245 (FFPE).

To order this test on Peripheral Blood, Bone Marrow or Fresh Tissue, please see test code #9202.
Technical Information
Methodology: This assay employs multiple consensus DNA primers that target conserved genetic regions within the IGH@ and IGK@ gene loci. The methodology used (Invivoscribe ASR reagents, IGH@ VDJ recombination and IGK@ VJ, VKde recombination) is based on data produced by independent testing centers throughout Europe in a collaborative study known as the BIOMED-2 Concerted Action. Unique rearrangements products are amplified by PCR followed by size determination using capillary electrophoresis. A clonal population of cells will produced one or two prominent amplicons within the expected size range. In contrast, DNA from normal polyclonal populations will produce amplicon products that reflect the heterogeneous population of rearrangements in a Gaussian distribution.
Sample & Shipping Information
Test Requisition: Tumor Analysis
Specimen Type: FFPE - Slide(s)
Requirements: 1 H&E stained slide and 10 unstained 10um thick FFPE slides (non-charged, non-coated) containing adequate amounts of tumor to be analyzed**. Air dry. Do not oven dry. Please include a copy of corresponding surgical pathology report. Store specimen at ambient temperature (18-25C/64-77F).
Shipping Conditions: Ship at ambient temperature (18-25C/64-77F) in an insulated container by overnight courier. If shipping during the summer months please include a cold-pack to avoid extreme temperatures. Do not heat or freeze.

Specimen Type: FFPE - Tumor Block
Requirements: Paraffin-embedded, formalin-fixed tissue block. Please include a copy of corresponding surgical pathology report. Store specimen at ambient temperature (18-25C/64-77F).
Shipping Conditions: Ship at ambient temperature (18-25C/64-77F) in an insulated container by overnight courier. If shipping during the summer months please include a cold-pack to avoid extreme temperatures. Do not heat or freeze.

Turn Around Time: 4 - 7 days
Billing Information
List Price: *For Insurance or Institutional Prices, please call.
CPT Codes: 81261x1, 81264x1


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