b'Gel & Capillary | CE-IVD Assays BCL1/JH Translocation AssayGel and CapillaryAssaysBCL1/JH Translocation AssayAssay Description Performance Characteristics The IdentiClone BCL1/J HTranslocation Assay is an in vitro diagnosticThe assay analytical performance was evaluated by testing spiked product intended for PCR-based detection of BCL1/J Ht(11;14)(q13;q32)Mantle Cell Lymphoma (MCL) IGH-CCND1 positive cell-line DNA into gene translocations in patients with suspect lymphoproliferations.tonsil DNA at six different dilutions. The Limit of Detection (LoD) was observed at 0.1% DNA dilution. To evaluate within-laboratory precision, Specifically, the BCL1/J HTranslocation Assay can be complete agreement of results was observed across four runs used to: executed by two operators over two days. dentify BCL1/J Hgene translocations highly suggestive of mantleTesting conducted across three laboratories using 25 samples Icell lymphoma (MCL) from cases of MCL with IGH-CCND1 translocations and 18 negative samples, showed 100% concordance of positive samples (25 of 25 Distinguish mantle cell lymphoma from other neoplastic or benignsamples) using fluorescence detection, and 88% (22 of 25 samples)B-cell proliferations using gel detection. For the negative samples, the concordance was Monitor and evaluate disease recurrence 100% using both gel detection (18 of 18 samples) and fluorescence detection (18 of 18 samples) formats. Specificity for both formats was 100% and sensitivity was determined to be between 10 -3and Summary and Explanation of the Test10 -4 . The sensitivity is sufficiently high for the detection of the IGH-The Invivoscribe CE-marked IdentiClone assays represent a uniqueCCND1 breakpoint in diagnostic material. However, only 40-50% of approach to PCR-based clonality testing. These standardizedthe t(11;14) breakpoints in MCL will be detected by PCR alone and assays were carefully optimized testing positive and negative controladditional detection method tools are recommended for diagnosis samples using multiplex master mixes. Assay development wasof breakpoints that do not fall within the major translocation cluster followed by extensive validation including the testing of more thanregion.400 clinical samples using Revised European/American Lymphoma (REAL) Classification. Testing was done at more than thirty prominentReferenceindependent testing centers throughout Europe in a collaborative study known as the BIOMED-2 Concerted Action. Results from this BIOMED-21. JJM van Dongen et al., Leukemia 17:2257-2317 (2003). study appear in Leukemia, a leading peer-reviewed journal. 1These test kits include includes two master mixes. The BCL1/J HTube targets the major translocation cluster (MTC) of the IGH-CCND1 locus and the joining region of the immunoglobulin heavy chain locus.The 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. A single thermal cycler program and similar detection methodologies are used with many of our assays. This improves consistency and facilitates cross-training.Figure Legend: Schematic diagram of the IGH-CCND1 t(11;14) translocation showing the cyclin D1 (CCND1) gene on the left and the Ig heavy chain (IGH) gene on the right. Shown are the relative positions and orientations for the BCL1/MTC primer and the JH primer, which are included in the BCL1/J HMaster Mix tube.This assay is based on the EuroClonality/BIOMED-2 Concerted Action BMH4-CT98-3936.76'