b'Gel & Capillary | CE-IVD Assays BCL1/J HTranslocation AssayGel and CapillaryAssaysIdentiClone BCL1/JTranslocation AssayHAssay 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 andtonsil DNA at six different dilutions. The Limit of Detection (LoD) was can be used to: observed at 0.1% DNA dilution. To evaluate within-laboratory precision, Identify BCL1/J Hgene translocations highly suggestive of mantle complete agreement of results was observed across four runs cell lymphoma executed by two operators over two days.Distinguish mantle cell lymphoma from other neoplastic or benign Testing conducted across three laboratories using 25 samples B-cell proliferations from cases of MCL with IGH-CCND1 translocations and 18 negative Monitor and evaluate disease recurrence samples, showed 100% concordance of positive samples (25 of 25 samples) using fluorescence detection, and 88% (22 of 25 samples) using gel detection. For the negative samples, the concordance was Summary and Explanation of the Test100% using both gel detection (18 of 18 samples) and fluorescence detection (18 of 18 samples) formats. Specificity for both formats These test kits include includes two master mixes. The BCL1/J HTubewas 100% and sensitivity was determined to be between 10 -3and targets the major translocation cluster (MTC) of the IGH-CCND1 locus10 -4 . The sensitivity is sufficiently high for the detection of the IGH-and the joining region of the immunoglobulin heavy chain locus. CCND1 breakpoint in diagnostic material. However, only 40-50% of The Specimen Control Size Ladder master mix targets multiple genesthe t(11;14) breakpoints in MCL will be detected by PCR alone and and generates a series of amplicons of approximately 100, 200, 300,additional detection method tools are recommended for diagnosis 400, and 600 base pairs to ensure that the quality and quantity ofof breakpoints that do not fall within the major translocation cluster input DNA is adequate to yield a valid result.region. Reference1. JJM van Dongen et al., Leukemia 17:2257-2317 (2003).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-CT98-3936.78'