b'Gel & Capillary | CE-IVD Assays TCRB Gene Clonality AssaysGel and CapillaryAssaysIdentiClone TCRB Gene Clonality AssaysAssay Description ReferencesThe IdentiClone TCRB Gene Clonality Assay is an in vitro diagnostic1. JJM van Dongen et al., Leukemia 17:2257-2317 (2003).product intended for PCR-based detection of clonal T-cell2. Y Sandberg et al., J. Mol. Diag. 7(4):495-503 (2005).receptor beta chain gene rearrangements in patients with suspect lymphoproliferations.Specifically, the TCRB Gene Clonality Assay can be used to:Identify clonality in suspect lymphoproliferationsSupport a differential diagnosis between reactive lesions andT-cell and some immature B-cell malignanciesDetermine lineage involvement in mature lymphoproliferativedisordersMonitor and evaluate disease recurrenceSummary and Explanation of the Test These kits include four master mixes. TCRB Tubes A and B targetFigure Legend: Simplified diagram of a representative framework regions within the variable region, and the joining regionrearranged T-cell receptor beta gene showing the (V) of the TCR beta chain locus. TCRB Tube C targets the diversityapproximate placement of the upstream and downstream and joining (J) regions of the TCR beta chain locus. The SpecimenDNA primers. The numbers of primers and their specificity Control Size Ladder master mix included targets multiple genes andare listed for Master Mix Tubes A, B, and C.generates a series of amplicons of approximately 100, 200, 300, 400, and 600 base pairs to ensure that the quality and quantity of input DNA is adequate to yield a valid result. Performance Characteristics Data from two independent studies that tested more than 300 patient samples of varying types suggests the diagnostic accuracyof selected IdentiClone tests to be 96%. In both peer-reviewed studies, there were no clear false-positive results generated using the IdentiClone tests, and there was a high level of precision. 2 The clinico-histopathological diagnosis correlated well with PCR results in a higher number of patients when compared withSouthern Blot (SB) results, as seen below:PCR/SB concordance: 1TRB: 86% sensitivity / 98% specificityPCR vs. SB analysis relative to histopathology and final diagnosis:PCR/SB concordance: 2PCR sensitivity: SB sensitivity: TRB: 85% 96% 35%This assay is based on the EuroClonality/BIOMED-2 Concerted Action BMH4-CT98-3936.72'