b'Gel & Capillary | CE-IVD Assays TCRB + TCRG T-Cell Clonality AssaysGel and CapillaryAssaysTCRB + TCRG T-Cell Clonality AssaysAssay Description methodologies are used with all of our gene clonality assays. This The IdentiClone TCRB + TCRG T-Cell Clonality Assays are in vitroimproves consistency and facilitates cross-training on a broad range diagnostic products intended for PCR-based detection of clonal T-cellof different assays.receptor beta and gamma chain gene rearrangements in patientsPerformance Characteristics with suspect lymphoproliferations. Data from two independent studies that tested more than 300 Specifically, the IdentiClone TCRB + TCRG T-Cell Clonality Assays canpatient samples of varying types suggests the diagnostic accuracybe used to: of selected IdentiClone tests to be 96%. In both peer-reviewed studies, there were no clear false-positive results generated using Identify clonality in suspected lymphoproliferations the IdentiClone tests, and there was a high level of precision. 2 Support a differential diagnosis between reactive lesions andThe clinico-histopathological diagnosis correlated well with PCR results in a higher number of patients when compared withT-cell and some immature B-cell malignancies Southern Blot (SB) results, as seen below: Determine lineage involvement in mature 1 PCR/SB concordance: lymphoproliferative disorders IGH:93% sensitivity / 92% specificityMonitor and evaluate disease recurrence IGK: 90% sensitivity / 90% specificity IGL: 86% sensitivity / 92% specificity TRB: 86% sensitivity / 98% specificitySummary and Explanation of the TestTRG: 89% sensitivity / 94% specificity The Invivoscribe CE-marked IdentiClone Assays represent a uniqueTRD: 83% sensitivity / 95% specificityapproach to PCR-based clonality testing. These standardizedPCR vs. SB analysis relative to histopathology and final diagnosis:assays were carefully optimized testing positive and negative controlPCR/SB concordance: 2PCR sensitivity: SB sensitivity: samples using multiplex master mixes. Assay development wasIGH + IGK: 85% 98% 39% followed by extensive validation including the testing of more thanTRB: 85% 96% 35%400 clinical samples using Revised European/American Lymphoma (REAL) Classification. Testing was done at more than thirty prominentReferenceindependent testing centers throughout Europe in a collaborative study1. JJM van Dongen et al., Leukemia 17:2257-2317 (2003). known as the BIOMED-2 Concerted Action. Results from this BIOMED-22. Y Sandberg et al., J. Mol. Diag. 7(4):495-503 (2005).study appear in Leukemia, a leading peer-reviewed journal.3. Van Krieken, JHJM et al., Leukemia 21:201 - 206 (2007).These kits include six master mixes to test for rearrangements of both TRB (formerly known as TCRB) and TRG (formerly known as TCRG). TCRB Tubes A and B target framework regions within the variable region, and the joining region of the TCR beta chain locus. TCRB Tube C targets the diversity and joining regions of the TCR beta chain locus. TCRG Tube A contains primers that target the V1-8 + V10 genes and J1.1, J1.3, J2.1, and J2.3 genes (also known as JP1, J1, JP2, and J2 respectively). TCRG Tube B contains primers that target the V9 +V11 genes and J1.1, J1.3, J2.1, and J2.3 genes. For best sensitivity itis recommended to test suspect T-cell malignancies for both TRGand TRB. 3The Specimen Control Size Ladder master mix includedFigure Legend: Simplified diagram of a representative rearranged T-cell targets multiple genes and generates a series of amplicons ofreceptor beta gene and the T-cell receptor gamma gene showing the approximately 100, 200, 300, 400, and 600 base pairs to ensureapproximate placement of the upstream and downstream DNA primers. The that the quality and quantity of input DNA is adequate to yield anumbers of primers and their specificity are listed for master mix TCRB Tubes A, valid result. A single thermal cycler program and similar detectionB, and C and TCRG Tubes A and B. (The V1f primer is a consensus primer that targets V 1 through V 8).This assay is based on the EuroClonality/BIOMED-2 Concerted Action BMH4-CT98-3936.66'