b'Gel & Capillary | CE-IVD Assays TCRB Gene Clonality AssaysGel and CapillaryAssays TCRB Gene Clonality Assays Gel and CapillaryAssaysIdentiClone TCRB Gene Clonality AssaysAssay Description References ReagentsThe IdentiClone TCRB Gene Clonality Assay is an in vitro diagnostic1. JJM van Dongen et al., Leukemia 17:2257-2317 (2003).Controls Concentration Units in Assay Units in Assay MegaKit product intended for PCR-based detection of clonal T-cell2. Y Sandberg et al., J. Mol. Diag. 7(4):495-503 (2005). IVS-0009 Clonal Control DNA 200 g/mL 1 x 100 L tube 5 x 100 L tubesreceptor beta chain gene rearrangements in patients with suspect lymphoproliferations. IVS-0004 Clonal Control DNA 200 g/mL 1 x 100 L tube 5 x 100 L tubesSpecifically, the TCRB Gene Clonality Assay can be used to: IVS-0000 Polyclonal Control DNA 200 g/mL 1 x 100 L tube 5 x 100 L tubesIVS-0021 Clonal Control DNA 200 g/mL 1 x 100 L tube 5 x 100 L tubes Identify clonality in suspect lymphoproliferations Master Mixes Target Units in Assay Units in Assay MegaKitSupport a differential diagnosis between reactive lesions and TCRB Tube A Multiple V + J1/2 1 x 1500 L tube 10 x 1500 L tubesT-cell and some immature B-cell malignanciesDetermine lineage involvement in mature lymphoproliferativeTCRB Tube B Multiple V + J2 1 x 1500 L tube 10 x 1500 L tubes disorders TCRB Tube C Multiple D + J1/2 1 x 1500 L tube 10 x 1500 L tubesMonitor and evaluate disease recurrence Specimen Control Size Ladder Multiple Genes 1 x 1500 L tube 10 x 1500 L tubesSummary and Explanation of the Test These kits include four master mixes. TCRB Tubes A and B targetFigure Legend: Simplified diagram of a representativeOrdering Informationframework 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 downstreamCatalog # Products Quantityand joining (J) regions of the TCR beta chain locus. The SpecimenDNA primers. The numbers of primers and their specificityControl Size Ladder master mix included targets multiple genes andare listed for Master Mix Tubes A, B, and C. 9-205-0010 IdentiCloneTCRBClonality Assay - Gel Detection 33 reactionsgenerates a series of amplicons of approximately 100, 200, 300, 400,9-205-0020 IdentiClone TCRBClonality Assay MegaKit - Gel Detection 330 reactionsand 600 base pairs to ensure that the quality and quantity of input9-205-0011IdentiClone TCRBClonality Assay - ABI Fluorescence Detection 33 reactionsDNA is adequate to yield a valid result. 9-205-0021 IdentiClone TCRBClonality Assay MegaKit - ABI Fluorescence Detection 330 reactionsPerformance CharacteristicsThese are in vitro diagnostic products, and are not available for sale or use within North America.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-CT98-3936.70Invivoscribe 2021|71'