b'Gel & Capillary | CE-IVD Assays IGK Gene Clonality AssaysGel and CapillaryAssaysIGK Gene Clonality AssaysAssay Description Performance Characteristics The IdentiClone IGK Gene Clonality Assays are in vitro diagnosticData from two independent studies that tested more than 300 products intended for PCR-based detection of clonal immunoglobulinpatient sample of varying types suggests the diagnostic accuracykappa light chain gene rearrangements in patients with suspectof selected IdentiClone tests to be 96%. In both peer-reviewed lymphoproliferations. studies, there were no clear false-positive results generated using the IdentiClone tests, and there was a high level of precision. 2 Specifically, the IdentiClone IGK Gene Clonality Assays can be used to: The clinico-histopathological diagnosis correlated well with PCR results in a higher number of patients when compared withIdentify clonality in atypical lymphoproliferative disorders Southern Blot (SB) results, as seen below:PCR/SB concordance: 1Support a differential diagnosis between reactive lesions and hematologic malignancies IGH:93% sensitivity / 92% specificityAssign presumptive lineage in mature monoclonal IGK: 90% sensitivity / 90% specificity lymphoproliferative disorders IGL: 86% sensitivity / 92% specificity Identify tumor-specific markers (IGK and IGK-K derearrangements)TRB: 86% sensitivity / 98% specificity for post-treatment monitoring TRG: 89% sensitivity / 94% specificity Monitor and evaluate disease recurrence TRD: 83% sensitivity / 95% specificityPCR vs. SB analysis relative to histopathology and final diagnosis:Summary and Explanation of the Test2PCR/SB concordance:PCR sensitivity: SB sensitivity: The Invivoscribe CE-marked IdentiClone Assays represent a uniqueIGH + IGK: 85% 98% 39% approach to PCR-based clonality testing. These standardizedTRB: 85% 96% 35%assays were carefully optimized testing positive and negative control samples using multiplex master mixes. Assay development wasReferencefollowed by extensive validation including the testing of more than1. JJM van Dongen et al., Leukemia 17:2257-2317 (2003). 400 clinical samples using Revised European/American Lymphoma (REAL) Classification. Testing was done at more than thirty prominent2. Y Sandberg et al., J. Mol. Diag. 7(4):495-503 (2005).independent testing centers throughout Europe in a collaborative study known as the BIOMED-2 Concerted Action. Results from this BIOMED-2 study appear in Leukemia, a leading peer-reviewed journal. 1These test kits include three master mixes. The IGK Tube A master mix targets the variable (V) and the joining (J) regions of the immunoglobulin kappa light chain locus, whereas the IGK Tube B master mix targets kappa deleting element (K de ) rearrangements with 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. A single thermal cycler program and similar detection methodologies areFigure Legend: Schematic diagram of the immunoglobulin kappa light chain used with all of our gene clonality assays. This improves consistency andgene complex on chromosome 2p11.2. Shown are the relative positions and facilitates cross-training. 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-CT98-3936.62'