b'Gel & Capillary | CE-IVD Assays IGH + IGK B-Cell Clonality AssaysGel and CapillaryAssays IGH + IGK B-Cell Clonality AssaysGel and CapillaryAssaysIdentiClone IGH + IGK B-Cell Clonality AssaysReagentsControls Concentration Units in Assay Units in Assay MegaKitIVS-0030 Clonal Control DNA 200 g/mL 1 x 100 L tube 5 x 100 L tubesAssay Description Performance Characteristics IVS-0019 Clonal Control DNA 200 g/mL 1 x 100 L tube 5 x 100 L tubesThe IdentiClone IGH + IGK B-Cell Clonality Assay is an in vitro Data from two independent studies that tested more than 300IVS-0007 Clonal Control DNA 200 g/mL 1 x 100 L tube 5 x 100 L tubesdiagnostic product intended for PCR-based detection of clonalpatient samples of varying types suggests the diagnostic accuracy IVS-0000 Polyclonal Control DNA 200 g/mL 1 x 100 L tube 5 x 100 L tubesimmunoglobulin heavy chain and kappa light chain geneof selected IdentiClone tests to be 96%. In both peer-reviewed rearrangements in patients with suspect lymphoproliferations.studies, there were no clear false-positive results generated usingMaster Mixes Target Units in Assay Units in Assay MegaKitSpecifically, the IGH + IGK B-Cell Clonality Assay can be used to: the IdentiClone tests, and there was a high level of precision. 2IGH Tube A Framework 1 + J H 1 x 1500 L tube 10 x 1500 L tubesIdentify clonality in atypical lymphoproliferative disorders The clinico-histopathological diagnosis correlated well with PCR results in a higher number of patients when compared withIGH Tube B Framework 2 + J H 1 x 1500 L tube 10 x 1500 L tubesSupport a differential diagnosis between reactive lesions and Southern Blot (SB) results, as seen below: hematologic malignancies 4 1 IGH Tube C Framework 3 + J H 1 x 1500 L tube 10 x 1500 L tubes PCR/SB concordance:IGK Tube A V-J1 x 1500 L tube 10 x 1500 L tubesAssign presumptive lineage in mature monoclonalIGH:93% sensitivity / 92% specificitylymphoproliferative disorders IGK: 90% sensitivity / 90% specificityIGK Tube B V-Kde, Intron-Kde 1 x 1500 L tube 10 x 1500 L tubesIdentify tumor-specific markers (IGH and IGK gene Specimen Control Size Ladder Multiple Genes 1 x 1500 L tube 10 x 1500 L tubesrearrangements) for post-treatment monitoring PCR vs. SB analysis relative to histopathology and final diagnosis:Monitor and evaluate disease recurrence PCR/SB concordance: 2PCR sensitivity: SB sensitivity: IGH + IGK: 85% 98% 39%Summary and Explanation of the Test Ordering InformationReferencesThese kits include six master mixes to test for rearrangements of1. JJM van Dongen et al., Leukemia 17:2257-2317 (2003).Catalog # Products Quantityboth IGH and IGK. The IGH Tube A, B, and C master mixes target the2. Y Sandberg et al., J. Mol. Diag. 7(4):495-503 (2005).9-100-0010 IdentiCloneIGH + IGK B-Cell Clonality Assay - Gel Detection 33 reactionsframework 1, 2, 3 regions (respectively) within the variable (V H ) region, and the joining (J H ) region of the immunoglobulin heavy chain locus.3. Van Krieken, JHJM et al., Leukemia 21:201 - 206 (2007). 9-100-0031 IdentiClone IGH + IGK B-Cell Clonality Assay - ABI Fluorescence Detection 33 reactionsThe IGK Tube A master mix targets the variable (V) and the joining9-100-0041 IdentiClone IGH + IGK B-Cell Clonality Assay MegaKit - ABI Fluorescence Detection 330 reactions(J) region. IGK Tube B master mix targets kappa deleting element (K de ) rearrangements with the variable (V) region and the intragenic J-C region. The resulting V-K deand J-C intron-K derearrangementsThese are in vitro diagnostic products, and are not available for sale or use within North America.are a result of unsuccessful rearrangements retained by the B cell. For best sensitivity, it is recommended to test suspect B-cell malignancies for both IGH and IGK. 3The included 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: Simple representation of the organization of a rearranged immunoglobulin heavy chain (IGH) gene on chromosome 14q32.33 and the immunoglobulin kappa light chain gene on chromosome 2p11.2. Black arrows represent the relative positions of primers that target the conserved frameworkregions (FR1-3) and the downstream consensus J Hgene segments for IGH and the V, J, INTR and Kde primers which are included in the IGK master mix tubes.This assay is based on the EuroClonality/BIOMED-2 Concerted Action BMH4-CT98-3936.62Invivoscribe 2021|63'