b'Gel & Capillary | CE-IVD Assays BCL2/J HTranslocation AssayGel 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 three product 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 cases be 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 11 Distinguish lymphoma from benign lymphoid hyperplasia independent laboratories 1 . False-positive results (0.4%) were only Distinguish follicular lymphoma from other B-cell lymphomas that seen in 12 of 3036 analyses. may have a similar appearanceMonitor and evaluate disease recurrence This IdentiClone BCL2/J HTranslocation Assay was found to be more sensitive than Southern blot analysis. Sensitivity differed slightly between 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 andThese test kits include four master mixes. The BCL2/J HTranslocation1 positive cell in 10 3normal cells. master mixes (BCL2/J HTubes A, B, and C) target the joining (J)In conclusion, we have designed and evaluated the performance region 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 strategymajor 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 base pairs to ensure that the quality and quantity of input DNA is adequate to yield a valid result. Reference1. 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-CT98-3936.80'