b'Gel & Capillary | CE-IVD Assays TCRD Gene Clonality AssaysGel and CapillaryAssaysIdentiClone TCRD Gene Clonality AssaysAssay Description Performance Characteristics The IdentiClone TCRD Gene Clonality Assay is an in vitro diagnosticData from an independent, peer-reviewed study suggests the product 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 the lymphoproliferations and can be used to: IdentiClone tests, and there was a high level of precision. The clinico- histopathological diagnosis correlates well with PCR results in a higher Identify clonality in suspect lymphoproliferations number of patients when compared with Southern Blot (SB) results,Support a differential diagnosis between reactive lesions andas seen below: T-cell and some immature B-cell malignancies PCR/SB concordance: 1Determine lineage involvement in mature lymphoproliferativeTRD: 83% sensitivity / 95% specificity disordersMonitor and evaluate disease recurrence ReferenceSummary and Explanation of the Test1. JJM van Dongen et al., Leukemia 17:2257-2317 (2003).These test kits include two master mixes. The TCRD tube targets the framework regions within the variable region, the diversity region, and 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 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. 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-CT98-3936.76'