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Houston, Texas

Genetic Laboratory
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Medical Genetics Test Details

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Comprehensive B-Cell Clonality Analysis
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: 9202
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 FFPE samples, please see test code #9240.
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: Bone Marrow
Requirements: Draw bone marrow in a EDTA (purple-top) tube(s) and send 3-5 cc (Adults/Children) or 2 cc (Infant< 2 years).
Shipping Conditions: Ship at ambient temperature (18-25C/64-77F) in an insulated container by overnight courier. Specimen should arrive in the laboratory within 24 hrs of collection. Do not heat or freeze.

Specimen Type: Fresh Frozen Tissue
Requirements: 150 mg (0.5-2.0 cm3) fresh tissue snap frozen at -20C**. Please include a copy of corresponding surgical pathology report. Store at -20C.
Shipping Conditions: Ship on minimum of 10 lbs. of dry ice in an insulated container by overnight courier.

Specimen Type: Peripheral Blood
Requirements: Draw peripheral blood in an EDTA (purple-top) tube(s) and send 3-5 cc (Adults/Children) or 2 cc (Infant<2yrs).
Shipping Conditions: Ship at ambient temperature (18-25C/64-77F) in an insulated container by overnight courier. Specimen should arrive in the laboratory within 24 hrs of collection. 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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