b'Gel & Capillary | CE-IVD Assays BCL2/JH Translocation AssayGel and CapillaryAssaysBCL2/JH Translocation AssayAssay Description Ladder master mix targets multiple genes and generates a seriesThe IdentiClone BCL2/J HTranslocation Assay is an in vitro diagnosticof amplicons of approximately 100, 200, 300, 400, and 600 base product intended for PCR-based detection of IGH-BCL2 t(14;18) genepairs to ensure that the quality and quantity of input DNA is translocations in patients with suspect lymphoproliferations. adequate to yield a valid result. A single thermal cycler programand similar detection methodologies are used with many of our Specifically, the BCL2/J HTranslocation Assay can be assays. This improves consistency and facilitates cross-training.used to:Performance Characteristics Distinguish lymphoma from benign lymphoid hyperplasiaDistinguish follicular lymphoma (FL) from other B-cell lymphomasThe initial evaluation of this assay was performed in three laboratories on DNA derived from 124 cases of follicular cell that may have a similar appearance lymphoma (FCL) known to carry the t(14;18) translocation. 109 cases Monitor and evaluate disease recurrence were identified with the IGH-BCL2 fusion gene (88%) using this PCR assay. The final testing and evaluation was done on samples in 11 Summary and Explanation of the Testindependent laboratories 1 . False-positive results (0.4%) were only seen in 12 of 3036 analyses. The Invivoscribe CE-marked IdentiClone Assays represent a unique approach to PCR-based clonality testing. These standardizedThis IdentiClone BCL2/J HTranslocation Assay was found to be more assays were carefully optimized testing positive and negative controlsensitive than Southern blot analysis. Sensitivity differed slightly samples using multiplex master mixes. Assay development wasbetween the master mixes. However, overall sensitivity for the assay followed by extensive validation including the testing of more thanwas determined to be between 1 positive cell in 10 2normal cells and400 clinical samples using Revised European/American Lymphoma1 positive cell in 10 3normal cells. (REAL) Classification. Testing was done at more than thirty prominent independent testing centers throughout Europe in a collaborative studyIn conclusion, we have designed and evaluated the performance known as the BIOMED-2 Concerted Action. Results from this BIOMED-2characteristics of a robust three tube multiplex PCR assay in orderstudy appear in Leukemia, a leading peer-reviewed journal. 1 to maximize the detection of the t(14;18) breakpoint. This strategyis capable of amplifying across the breakpoint region in theThese test kits include four master mixes. The BCL2/J HTranslocationmajority of cases of follicular lymphoma with a cytogeneticallymaster mixes (BCL2/J HTubes A, B, and C) target the joining (J)defined translocation.region of the immunoglobulin heavy chain (IGH) gene and distinct regions of the BCL2 gene. These master mixes are used to detect major breakpoint region (MBR) and minor cluster region (mcr) of theReferenceIGH-BCL2 t(14;18)(q32;q21) translocations. The Specimen Control Size1. JJM van Dongen et al., Leukemia 17:2257 - 2317 (2003). Figure Legend: Schematic diagram of the IGH-BCL2 t(14;18) translocation showing the BCL2 gene on the left and the Ig heavy chain (IGH) gene on the right. Shown are the relative positions and orientations for the major breakpoint region (MBR) primers, the minor cluster region (mcr) primers, and the J Hprimer, which are included in the 3 BCL2/J Hmaster mix tubes.This assay is based on the EuroClonality/BIOMED-2 Concerted Action BMH4-CT98-3936.78'