b'Gel & Capillary | CE-IVD Assays IGH Gene Clonality AssaysGel and CapillaryAssays IGH Gene Clonality AssaysGel and CapillaryAssaysIdentiClone IGH Gene Clonality AssaysReagentsAssay Description Performance Characteristics The IdentiClone IGH Gene Clonality Assay is an in vitro diagnosticData from two independent studies that tested more than 300Controls Concentration Units in Assay Units in Assay MegaKitproduct intended for PCR-based detection of clonal immunoglobulinpatient samples of varying types suggests the diagnostic accuracy IVS-0030 Clonal Control DNA 200 g/mL 1 x 100 L tube 5 x 100 L tubesheavy chain gene rearrangements in patients with suspectof selected IdentiClone tests to be 96%. In both peer-reviewedIVS-0019 Clonal Control DNA 200 g/mL 1 x 100 L tube 5 x 100 L tubeslymphoproliferations. studies, there were no clear false-positive results generated using the IdentiClone tests, and there was a high level of precision. 2 IVS-0024 Clonal Control DNA 200 g/mL 1 x 100 L tube 5 x 100 L tubesSpecifically, the IGH Gene Clonality Assay can be used to: The clinico-histopathological diagnosis correlated well with PCRIVS-0008 Clonal Control DNA 200 g/mL 1 x 100 L tube 5 x 100 L tubesresults in a higher number of patients when compared with IVS-0000 Polyclonal Control DNA 200 g/mL 1 x 100 L tube 5 x 100 L tubesIdentify clonality in atypical lymphoproliferative disorders Southern Blot (SB) results, as seen below: Support a differential diagnosis between reactive lesions andMaster Mixes Target Units in Assay Units in Assay MegaKit4PCR/SB concordance: 1hematologic malignancies IGH:93% sensitivity / 92% specificity IGH Tube A Framework 1 + J H 1 x 1500 L tube 10 x 1500 L tubesAssign presumptive lineage in mature monoclonal IGH Tube B Framework 2 + J H 1 x 1500 L tube 10 x 1500 L tubeslymphoproliferative disordersIdentify tumor-specific markers (IGH gene rearrangements) for PCR vs. SB analysis relative to histopathology and final diagnosis: IGH Tube C Framework 3 + J H 1 x 1500 L tube 10 x 1500 L tubespost-treatment monitoring PCR/SB concordance: 2PCR sensitivity: SB sensitivity:IGH Tube D D H 1-6 + J H 1 x 1500 L tube 10 x 1500 L tubesMonitor and evaluate disease recurrence IGH + IGK: 85% 98% 39%IGH Tube E D H 7 + J H 1 x 1500 L tube 10 x 1500 L tubesSummary and Explanation of the TestReferences Specimen Control Size Ladder Multiple Genes 1 x 1500 L tube 10 x 1500 L tubes1. JJM van Dongen et al., Leukemia 17:2257-2317 (2003). These test kits include six master mixes. The IGH Tube A, B, and C master mixes target the framework 1, 2, and 3 regions (respectively)2. Y Sandberg et al., J. Mol. Diag. 7(4):495-503 (2005). Ordering Informationwithin the variable (V H ) region and the joining (J H ) region of theCatalog # Products Quantityimmunoglobulin heavy chain locus. The IGH Tube D and E master mixes target the diversity and joining regions. The Specimen Control9-101-0020 IdentiClone IGH Gene Clonality Assay - Gel Detection 33 reactionsSize Ladder master mix targets multiple genes and generates a series9-101-0040 IdentiClone IGH Gene Clonality Assay MegaKit - Gel Detection 330 reactionsof amplicons of approximately 100, 200, 300, 400, and 600 base pairs to ensure that the quality and quantity of input DNA is adequate to9-101-0061 IdentiClone IGH Gene Clonality Assay - ABI Fluorescence Detection 33 reactionsyield a valid result.9-101-0081 IdentiClone IGH Gene Clonality Assay MegaKit - ABI Fluorescence Detection 330 reactionsThese are in vitro diagnostic products, and are not available for sale or use within North America.Figure Legend: Simple representation of the organization of a rearranged immunoglobulin heavy chain gene on chromosome 14q32.33. Black arrows represent the relative positions of primers that target the conserved framework (FR1-3) and diversity (D H 1-7) regions, and the downstream consensus J Hgene 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-CT98-3936.64Invivoscribe 2021|65'