b'Gel & Capillary | CE-IVD Assays BCL1/J HTranslocation AssayGel and CapillaryAssays BCL1/J HTranslocation Assay Gel and CapillaryAssaysIdentiClone BCL1/JTranslocation AssayHReagentsAssay Description Performance CharacteristicsControls Concentration Units in Assay Units in Assay MegaKitThe IdentiClone BCL1/J HTranslocation Assay is an in vitro diagnosticThe assay analytical performance was evaluated by testing spikedIVS-0010 Clonal Control DNA 200 g/mL 1 x 100 L tube 5 x 100 L tubesproduct intended for PCR-based detection of BCL1/J Ht(11;14)(q13;q32)Mantle Cell Lymphoma (MCL) IGH-CCND1 positive cell-line DNA intoIVS-0000 Polyclonal Control DNA 200 g/mL 1 x 100 L tube 5 x 100 L tubesgene 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,Master Mixes Target Units in Assay Units in Assay MegaKitIdentify BCL1/J Hgene translocations highly suggestive of mantle complete agreement of results was observed across four runsBCL1/ J HTube - Unlabeled MTC of BCL1 + IGH J H 1 x 1500 L tube 10 x 1500 L tubescell lymphoma executed by two operators over two days.Specimen Control Size Ladder - Unlabeled Multiple Genes 1 x 1500 L tube 10 x 1500 L tubesDistinguish 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)Ordering Informationusing gel detection. For the negative samples, the concordance was Summary and Explanation of the Test100% using both gel detection (18 of 18 samples) and fluorescenceCatalog # Products Quantitydetection (18 of 18 samples) formats. Specificity for both formatsThese test kits include includes two master mixes. The BCL1/J HTubewas 100% and sensitivity was determined to be between 10 -3and9-308-0010 IdentiCloneBCL1/J H Translocation Assay - Gel Detection 33 reactionstargets the major translocation cluster (MTC) of the IGH-CCND1 locus10 -4 . The sensitivity is sufficiently high for the detection of the IGH- 9-308-0020 IdentiClone BCL1/J HTranslocation Assay MegaKit - Gel Detection 330 reactionsand 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 andThese are in vitro diagnostic products, and are not available for sale or use within North America.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-CT98-3936.76Invivoscribe 2021|77'