b'Gel & Capillary | CE-IVD Assays TCRD Gene Clonality AssaysGel and CapillaryAssays TCRD Gene Clonality Assays Gel and CapillaryAssaysIdentiClone TCRD Gene Clonality AssaysReagentsAssay Description Performance Characteristics Controls Concentration Units in Assay Units in Assay MegaKitThe IdentiClone TCRD Gene Clonality Assay is an in vitro diagnosticData from an independent, peer-reviewed study suggests theIVS-0021 Clonal Control DNA 200 g/mL 1 x 100 L tube 5 x 100 L tubesproduct intended for PCR-based detection of clonal T-celldiagnostic accuracy of selected IdentiClone tests to be 96%. receptor delta chain gene rearrangements in patients with suspectThere were no clear false-positive results generated using theIVS-0000 Polyclonal Control DNA 200 g/mL 1 x 100 L tube 5 x 100 L tubeslymphoproliferations and can be used to: IdentiClone tests, and there was a high level of precision. The clinico-Master Mixes Target Units in Assay Units in Assay MegaKithistopathological diagnosis correlates well with PCR results in a higher Identify clonality in suspect lymphoproliferations number of patients when compared with Southern Blot (SB) results, TCRD Tube Multiple V + D +J1 x 1500 L tube 10 x 1500 L tubesSupport a differential diagnosis between reactive lesions andas seen below: Specimen Control Size Ladder Multiple Genes 1 x 1500 L tube 10 x 1500 L tubes T-cell and some immature B-cell malignancies PCR/SB concordance: 1Determine lineage involvement in mature lymphoproliferativeTRD: 83% sensitivity / 95% specificity disorders Ordering InformationMonitor and evaluate disease recurrence Reference Catalog # Products QuantitySummary and Explanation of the Test1. JJM van Dongen et al., Leukemia 17:2257-2317 (2003).9-206-0010 IdentiClone TCRD Gene Clonality Assay - Gel Detection 33 reactions These test kits include two master mixes. The TCRD tube targets the9-206-0011 IdentiClone TCRD Gene Clonality Assay - ABI Fluorescence Detection33 reactionsframework regions within the variable region, the diversity region,9-206-0021 IdentiClone TCRD Gene Clonality Assay MegaKit - ABI Fluorescence Detection 330 reactionsand the joining region of the T-cell receptor delta chain locus (TRD, formerly known as TCRD). The Specimen Control Size Ladder master mix targets multiple genes and generates a series of amplicons ofThese are in vitro diagnostic products, and are not available for sale or use within North America.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. Figure Legend: Simplified diagram of a representative rearranged T-cell receptor delta gene showing the approximate placement of the upstream and downstream DNA primers. The numbers of primers and their specificity are listed for the TRD Tube Master Mix tube.This assay is based on the EuroClonality/BIOMED-2 Concerted Action BMH4-CT98-3936.74Invivoscribe 2021|75'