b'Gel & Capillary | CE-IVD Assays IGK Gene Clonality AssaysGel and CapillaryAssays IGK Gene Clonality AssaysGel and CapillaryAssaysIdentiClone IGK Gene Clonality AssaysReagentsAssay Description Performance Characteristics The IdentiClone IGK 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 sample of varying types suggests the diagnostic accuracy IVS-0007 Clonal Control DNA 200 g/mL 1 x 100 L tube 5 x 100 L tubeskappa light chain gene rearrangements in patients with suspectof selected IdentiClone tests to be 96%. In both peer-reviewedIVS-0000 Polyclonal 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. 2Master Mixes Target Units in Assay Units in Assay MegaKitSpecifically, the IGK Gene Clonality Assay can be used to: The clinico-histopathological diagnosis correlated well with PCRIGK Tube A V - J1 x 1500 L tube 10 x 1500 L tubesIdentify clonality in atypical lymphoproliferative disorders results in a higher number of patients when compared withde de 1 x 1500 L tube 10 x 1500 L tubesSouthern Blot (SB) results, as seen below:IGK Tube B V -K , Intron-KSupport a differential diagnosis between reactive lesions andPCR/SB concordance: 1 Specimen Control Size Ladder Multiple Genes 1 x 1500 L tube 10 x 1500 L tubeshematologic malignanciesAssign presumptive lineage in mature monoclonal IGK: 90% sensitivity / 90% specificity lymphoproliferative disorders Ordering InformationIdentify tumor-specific markers (IGK and IGK-K derearrangements) PCR vs. SB analysis relative to histopathology and final diagnosis:for post-treatment monitoring Catalog # Products QuantityMonitor and evaluate disease recurrence PCR/SB concordance: 2PCR sensitivity: SB sensitivity:9-102-0020 IdentiClone IGK Gene Clonality Assay - Gel Detection 33 reactionsIGH + IGK: 85% 98% 39% 9-102-0030 IdentiClone IGK Gene Clonality Assay MegaKit - Gel Detection 330 reactionsSummary and Explanation of the Test9-102-0021 IdentiClone IGK Gene Clonality Assay - ABI Fluorescence Detection33 reactionsThese test kits include three master mixes. The IGK Tube A masterReferences 9-102-0031IdentiClone IGK Gene Clonality Assay MegaKit - ABI Fluorescence Detection330 reactionsmix targets the variable (V) and the joining (J) regions of the These are in vitro diagnostic products, and are not available for sale or use within North America.immunoglobulin kappa light chain locus, whereas the IGK Tube B1. JJM van Dongen et al., Leukemia 17:2257-2317 (2003). master mix targets kappa deleting element (K de ) rearrangements with2.Y Sandberg et al., J. Mol. Diag. 7(4):495-503 (2005).the V regions and the intragenic J-C regions. The V-K deand J-C intron-K derearrangements are a result of unsuccessful rearrangements retained by the B cell. The third master mix, the Specimen Control Size Ladder, 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: Schematic diagram of the immunoglobulin kappa light chain gene complex on chromosome 2p11.2. Shown are the relative positions and orientations for the V-J, and K deprimers, which are included in the IGK master mix tubes.This assay is based on the EuroClonality/BIOMED-2 Concerted Action BMH4-CT98-3936.66Invivoscribe 2021|67'