b'Gel & Capillary | CE-IVD Assays TCRD Gene Clonality AssaysGel and CapillaryAssaysTCRD Gene Clonality AssaysAssay Description formerly known as TCRD). The Specimen Control Size Ladder master The IdentiClone TCRD Gene Clonality Assays are in vitro diagnosticmix targets multiple genes and generates a series of amplicons of products intended for PCR-based detection of clonal T-cellapproximately 100, 200, 300, 400, and 600 base pairs to ensure receptor delta chain gene rearrangements in patients with suspectthat the quality and quantity of input DNA is adequate to yield a lymphoproliferations. valid result. A single thermal cycler program and similar detection methodologies are used with all of our gene clonality assays. This Specifically, the IdentiClone TCRD Gene Clonality Assays can be improves consistency and facilitates cross-training.used to:Performance Characteristics Identify clonality in suspect lymphoproliferationsSupport a differential diagnosis between reactive lesions andData from an independent, peer-reviewed study suggests the diagnostic accuracy of selected IdentiClone tests to be 96%. T-cell and some immature B-cell malignancies There were no clear false-positive results generated using the Determine lineage involvement in matureIdentiClone tests, and there was a high level of precision. The clinico- lymphoproliferative disorders histopathological diagnosis correlates well with PCR results in a higher Monitor and evaluate disease recurrence number of patients when compared with Southern Blot (SB) results,as seen below:Summary and Explanation of the TestPCR/SB concordance: 1The Invivoscribe CE-marked IdentiClone Assays represent a uniqueIGH: 93% sensitivity / 92% specificity approach to PCR-based clonality testing. These standardizedIGK: 90% sensitivity / 90% specificity assays were carefully optimized testing positive and negative controlIGL: 86% sensitivity / 92% specificity samples using multiplex master mixes. Assay development wasTRB: 86% sensitivity / 98% specificity followed by extensive validation including the testing of more thanTRG: 89% sensitivity / 94% specificity 400 clinical samples using Revised European/American LymphomaTRD: 83% sensitivity / 95% specificity(REAL) Classification. Testing was done at more than thirty prominent independent testing centers throughout Europe in a collaborative study known as the BIOMED-2 Concerted Action. Results from this BIOMED-2 1 Referencestudy appear in Leukemia, a leading peer-reviewed journal.1. 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, 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-CT98-3936.74'