b'Gel & Capillary | CE-IVD Assays TCRB Gene Clonality AssaysGel and CapillaryAssaysTCRB Gene Clonality AssaysAssay Description 400, and 600 base pairs to ensure that the quality and quantity of The IdentiClone TCRB Gene Clonality Assays are in vitro diagnosticinput DNA is adequate to yield a valid result. A single thermal cycler products intended for PCR-based detection of clonal T-cellprogram and similar detection methodologies are used with all of our receptor beta chain gene rearrangements in patients with suspectGene Clonality Assays. This improves consistency and facilitates cross-lymphoproliferations. training on a broad range of different assays.Specifically, the IdentiClone TCRB Gene Clonality Assay can be Performance Characteristics used to:Data from two independent studies that tested more than 300 Identify clonality in suspected lymphoproliferations patient samples of varying types suggests the diagnostic accuracySupport a differential diagnosis between reactive lesions andof selected IdentiClone tests to be 96%. In both peer-reviewed studies, there were no clear false-positive results generated using T-cell and some immature B-cell malignancies the IdentiClone tests, and there was a high level of precision. 2 Determine lineage involvement in matureThe clinico-histopathological diagnosis correlated well with PCR lymphoproliferative disorders results in a higher number of patients when compared withMonitor and evaluate disease recurrence Southern Blot (SB) results, as seen below:PCR/SB concordance: 1Summary and Explanation of the TestIGH:93% sensitivity / 92% specificityThe Invivoscribe CE-marked IdentiClone Assays represent a uniqueIGK: 90% sensitivity / 90% specificity approach to PCR-based clonality testing. These standardizedIGL: 86% sensitivity / 92% specificity assays were carefully optimized testing positive and negative controlTRB: 86% sensitivity / 98% specificitysamples using multiplex master mixes. Assay development wasTRG: 89% sensitivity / 94% specificity followed by extensive validation including the testing of more thanTRD: 83% sensitivity / 95% specificity400 clinical samples using Revised European/American LymphomaPCR vs. SB analysis relative to histopathology and final diagnosis:(REAL) Classification. Testing was done at more than thirty prominent independent testing centers throughout Europe in a collaborative studyPCR/SB concordance: 2PCR sensitivity: SB sensitivity: known as the BIOMED-2 Concerted Action. Results from this BIOMED-2IGH + IGK: 85% 98% 39% study appear in Leukemia, a leading peer-reviewed journal. TRB: 85% 96% 35%These kits include four master mixes. TCRB Tubes A and B target framework regions within the variable region, and the joining region Reference(V) of the TCR beta chain locus.TCRB Tube C targets the diversity and joining (J) regions of the TCR beta chain locus. The Specimen1. JJM van Dongen et al., Leukemia 17:2257-2317 (2003).Control Size Ladder master mix included targets multiple genes and generates a series of amplicons of approximately 100, 200, 300,2. Y Sandberg et al., J. Mol. Diag. 7(4):495-503 (2005).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.This assay is based on the EuroClonality/BIOMED-2 Concerted Action BMH4-CT98-3936.68'