b'Gel & Capillary | CE-IVD Assays BCL2/J HTranslocation AssayGel and CapillaryAssays BCL2/JH Translocation Assay Gel and CapillaryAssaysIdentiClone BCL2/JTranslocation AssayHAssay Description Performance Characteristics The IdentiClone BCL2/J HTranslocation Assay is an in vitro diagnosticThe initial evaluation of this assay was performed in threeReagentsproduct intended for PCR-based detection of BCL2/J Ht(14;18) genelaboratories on DNA derived from 124 cases of follicular cell translocations in patients with suspect lymphoproliferations and canlymphoma (FCL) known to carry the t(14;18) translocation. 109 casesControls Concentration Units in Assay Units in Assay MegaKitbe used to: were identified with the IGH-BCL2 fusion gene (88%) using this PCR assay. The final testing and evaluation was done on samples in 11IVS-0030 Clonal Control DNA 100 L @ 200 g/mL 1 x 100 L tube 5 x 100 L tubesDistinguish lymphoma from benign lymphoid hyperplasia independent laboratories 1 . False-positive results (0.4%) were onlyIVS-P002 Clonal Control DNA 100 L @ 1600 pg/mL 1 x 100 L tube 5 x 100 L tubesDistinguish follicular lymphoma from other B-cell lymphomas that seen in 12 of 3036 analyses. may have a similar appearance IVS-0031 Clonal Control DNA 100 L @ 200 g/mL 1 x 100 L tube 5 x 100 L tubesMonitor and evaluate disease recurrence This IdentiClone BCL2/J HTranslocation Assay was found to be moreIVS-0000 Polyclonal Control DNA 100 L @ 200 g/mL 1 x 100 L tube 5 x 100 L tubessensitive than Southern blot analysis. Sensitivity differed slightlyMaster Mixes Target Units in Assay Units in Assay MegaKitbetween the master mixes. However, overall sensitivity for the assay Summary and Explanation of the Testwas determined to be between 1 positive cell in 10 2normal cells and BCL2/J HTube A - Unlabeled BCL2 MBR + IGH J H 1 x 1500 L tube 10 x 1500 L tubesThese test kits include four master mixes. The BCL2/J HTranslocation1 positive cell in 10 3normal cells.BCL2/J HTube B - Unlabeled BCL2 3 MBR + IGH J H 1 x 1500 L tube 10 x 1500 L tubesmaster mixes (BCL2/J HTubes A, B, and C) target the joining (J)In conclusion, we have designed and evaluated the performanceBCL2/J HTube C - Unlabeled BCL2 mcr + IGH J H 1 x 1500 L tube 10 x 1500 L tubesregion of the immunoglobulin heavy chain (IGH) gene and distinctcharacteristics of a robust three tube multiplex PCR assay in orderregions of the BCL2 gene. These master mixes are used to detectto maximize the detection of the t(14;18) breakpoint. This strategy Specimen Control Size Ladder - Unlabeled Multiple Genes 1 x 1500 L tube 10 x 1500 L tubesmajor breakpoint region (MBR) and minor cluster region (mcr) of theis capable of amplifying across the breakpoint region in theIGH-BCL2 t(14;18)(q32;q21) translocations. The Specimen Control Sizemajority of cases of follicular lymphoma with a cytogeneticallyLadder master mix targets multiple genes and generates a series defined translocation.of amplicons of approximately 100, 200, 300, 400, and 600 baseOrdering Informationpairs to ensure that the quality and quantity of input DNA is adequate to yield a valid result. Reference Catalog # Products Quantity1. JJM van Dongen et al., Leukemia 17:2257 - 2317 (2003). 9-309-0020 IdentiClone BCL2/J HTranslocation Assay - Gel Detection 33 reactions 9-309-0040 IdentiClone BCL2/J HTranslocation Assay MegaKit - Gel Detection 330 reactionsThese are in vitro diagnostic products, and are not available for sale or use within North America. 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-CT98-3936.78Invivoscribe 2021|79'