b'Gel & Capillary | CE-IVD Assays TCRG Gene Clonality AssaysGel and CapillaryAssaysTCRG Gene Clonality AssaysAssay Description Tube B contains primers that target the V9 + V11 genes and J1.1, The IdentiClone TCRG Gene Clonality Assays are in vitro diagnosticJ1.3, J2.1, and J2.3 genes. The Specimen Control Size Ladder master products intended for PCR-based detection of clonal T-cell receptormix targets multiple genes and generates a series of ampliconsgamma chain gene rearrangements in patients with suspectof approximately 100, 200, 300, 400, and 600 base pairs to ensure lymphoproliferations. that the quality and quantity of input DNA is adequate to yielda valid result. A single thermal cycler program and similar detection Specifically, the IdentiClone TCRG Gene Clonality Assays can be methodologies are used with all of our gene clonality assays.used to: This improves consistency and facilitates cross-training.Identify clonality in suspect lymphoproliferations Performance Characteristics Support a differential diagnosis between reactive lesions andData from an independent, peer-reviewed study suggests theT-cell and some immature B-cell malignancies diagnostic accuracy of selected IdentiClone tests to be 96%. Determine lineage involvement in matureThere were no clear false-positive results generated using the IdentiClone 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 three master mixes targeting TRG (formerly known as TCRG) gene rearrangements. TCRG Tube A contains primers that target the V1-8 + V10 genes and J1.1, J1.3, J2.1, and J2.3 genes (also known as JP1, J1, JP2, and J2 respectively). TCRG Figure Legend: Simple representation of the organization of the T-cell receptor gamma chain gene on chromosome 7. Black arrows represent the relative positions of primers that target the variable (V) regions, and the downstream joining (J) gene segments. The amplicon products generated from each of these regions can be differentially detected when fluorescent primer sets are used with capillary electrophoresis instruments that employ differential fluorescence detection.This assay is based on the EuroClonality/BIOMED-2 Concerted Action BMH4-CT98-3936.72'