b'Gel & Capillary | CE-IVD Assays T-Cell Receptor Gamma GeneGel and CapillaryAssays Rearrangement Assay 2.0T-Cell Receptor Gamma GeneRearrangement Assay 2.0Assay Description Performance Characteristics The IdentiClone T-Cell Receptor Gamma Gene Rearrangement AssayTo assess the performance of the TCRG 2.0 Assay, testing was 2.0 is an in vitro diagnostic product intended for PCR-based detectionperformed on cell lines with known clonal rearrangements followed of clonal T-cell receptor gamma chain gene rearrangements inby testing on previously sequenced clinical samples. patients with suspect lymphoproliferations.Specifically, the T-Cell Receptor Gamma Gene Rearrangement AssayWhen used in combination with the provided TCRG Algorithm 2.0 can be used to identify clonality in suspected lymphoproliferations. worksheet, the assay was capable of detecting DNA from 6 control cell lines (200 ng/L) diluted into polyclonal tonsil DNA (200 ng/L) at 5% (v/v).Summary and Explanation of the TestFurthermore, the performance of the TCRG 2.0 Assay was evaluated Rearrangements of the antigen receptor genes occur during ontogenyon clinical samples for which the T-cell receptor gamma gene in B- and T-lymphocytes. These gene rearrangements generaterearrangement status had been identified by Roche 454 sequencing. products that are unique in length and sequence. Polymerase chainFor the 7 samples that had been identified as clonal by sequencing, reaction (PCR) assays can be used to identify lymphocyte populationsthe TCRG 2.0 assay had 100% concordance. For the 12 samples derived from a single cell by detecting the unique V-J genethat were either negative for a clonal event or were oligoclonal, rearrangements present within these antigen receptor loci 1 . concordance of the TCRG 2.0 assay was 75%. Sample types included peripheral blood, bone marrow, and formalin-fixed, paraffin The Invivoscribe designed CE-marked IdentiClone Assaysembedded (FFPE) tissue. represents an improved approach to PCR-based clonality testingAlways interpret the results of molecular clonality tests in the contextof lymphoproliferative disorders, as it can detect the vast majorityof clinical, histological and immunophenotypic data.of T-cell receptor gamma (TRG, formerly known as TCRG) gene rearrangements with a single multiplex master mix.This assay allows for amplification of the TRG region with fluorescentReferencelabeled primers, yielding products that can be grouped under a1. Miller JE, Wilson SS, Jaye DJ, and Kronenberg M. Mol. Diag. 1999, single Gaussian distribution when separated by size using capillary electrophoresis. In addition, the product size facilitates increased4(2):101-117. success when testing FFPE samples. The included analysis algorithm2. Armand, Marine et al. HemaSphere, 2019;3:3.aids in the interpretation of data and identification of significant clonal peaks. Presence or absence of molecular clonality can support the differential diagnosis of reactive lesions and certain B- and T-cell malignancies, provided that the results are interpreted in the context of all available clinical, histological, and immunophenotypic data.This assay was developed by Invivoscribe.The performance of this assay was reviewed and validated by the EuroClonality/BIOMED-2 Group. 2Figure Legend: Simple representation of the organization of the T-cell receptor gamma gene on chromosome 7p14. Black arrows represent the relative positions of primers that target the variable region genes and the downstream joining region gene segments that are involved in rearrangements in T-cell lymphomas. The downstream primers are fluorescently labeled through the incorporation of a 6FAM fluorophore. The amplicon products generated from these rearrangements are detected by capillary electrophoresis.70'