b'Gel & Capillary | CE-IVD Assays IGL Gene Clonality AssaysGel and CapillaryAssaysIdentiClone IGL Gene Clonality AssaysAssay Description Performance Characteristics The IdentiClone IGL Gene Clonality Assay is an in vitro diagnosticData from two independent studies that tested more than 300 product intended for PCR-based detection of clonal immunoglobulinpatient samples of varying types suggests the diagnostic accuracylambda light chain gene rearrangements in patients with suspectof selected IdentiClone tests to be 96%. In both peer-reviewed lymphoproliferations and can be used to: studies, there were no clear false-positive results generated using the IdentiClone tests, and there was a high level of precision. 2Specifically, the IdentiClone IGL 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: Support a differential diagnosis between reactive lesions andPCR/SB concordance: 1hematologic malignancies IGL: 86% sensitivity / 92% specificity Assign presumptive lineage in mature monoclonallymphoproliferative disordersIdentify tumor-specific markers (IGL gene rearrangements) forpost-treatment monitoring ReferencesMonitor and evaluate disease recurrence 1. JJM van Dongen et al., Leukemia 17:2257-2317 (2003). 2. Y Sandberg et al., J. Mol. Diag. 7(4):495-503 (2005).Summary and Explanation of the Test These test kits include twomaster mixes. The IGL Tube master mix targets the variable (V )region and the joining (J )region of the immunoglobulin lambda light chain gene locus (IGL). 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 lambda light chain gene complex on chromosome 22q11.2. Shown are the relative positions and orientations for the V and J primers, which are included in the IGL master mix tube. The two V primers only target V1, 2, and 3 because these three V families cover approximately 70% of rearrangeable V gene segments, and approximately 90% of all IGL gene rearrangements involve these three families. Similarly, the single J primer only targets J1, 2, and 3 because these three J segments are involved in 98% of all IGL gene rearrangements.This assay is based on the EuroClonality/BIOMED-2 Concerted Action BMH4-CT98-3936.70'