b'Gel & Capillary | RUO AssaysGel and CapillaryTCRB Gene Clonality AssaysResearch Use Only (RUO) AssayTCRB Gene Clonality AssaysAssay Use Background TCRB Gene Clonality Assays are useful for studies involving: The human T-cell receptor beta (TRB, formerly known as TCRB) gene locus on chromosome 7 (7q34, formerly 7q35) includes 64-67 variable Identification clonal T-cell populations highly suggestive of (V) gene segments (belonging to 30 subgroups), two diversity (D)T-cell malignancies gene segments, and 13 joining (J) gene segments, spread over 685 Lineage determination of leukemias and lymphomas kilobases. The diversity of this locus has complicated PCR-based testing and extended dependence on Southern blot analysis in many Monitoring and evaluation of disease recurrence testing centers. However, this standardized multiplex PCR assay Detection and assessment of residual disease detects the vast majority of clonal TRB gene rearrangements using Evaluation of new research and methods in malignancy studies only three multiplex master mixes. 1This assay provides rapid TCR clonality assessment, reducingSummary and Explanation of the Testor completely eliminating the number of Southern blot tests performed in the laboratory. The detection rate of clonal TRBThree multiplex master mixes target conserved regions within thegene rearrangements using this assay is exceptionally high. 1 variable (V), diversity (D), and the joining (J) regions that flank the unique hypervariable, antigen-binding, complementarity determining region 3 (CDR3) of the T-cell receptor beta locus. Specimen RequirementsTube A contains 23 V primers, six J1 primers, and three J2 primers.Tube B contains 23 V and four J2 primers. Tube C contains two D5 mL of peripheral blood, bone marrow biopsy, or bone marrow and 13 J primers. Positive and negative DNA controls, as wellas a Specimen Control Size Ladder Master Mix, are included. aspirate anti-coagulated with heparin or EDTA; or,PCR products can be analyzed by capillary electrophoresis Minimum 5 mm cube of tissue; or,or heteroduplex analysis. Clonality is indicated, if any one of the2 g of genomic DNA; or,master mixes generates clonal products. Formalin-fixed, paraffin-embedded (FFPE) tissue or slides.Reference1.M Bruggemann et al., Leukemia 17: 2283-2289 (2003).2. JJM van Dongen et al., Leukemia 17: 2257-2317 (2003).This assay is based on the EuroClonality/BIOMED-2 Concerted Action BMH4-CT98-3936.Figure Legend: Simplified diagram of a representative rearranged T-cell receptor beta gene showing the approximate placement of the upstream and downstream DNA primers. The numbers of primers and their specificity are listed for Master Mix Tubes A, B, and C.108'