b'Next-Generation Sequencing (NGS) | CE-IVD AssaysTRG Assay Next-Generation Sequencing (NGS) | CE-IVD Assays TRG Assay Next-Generation Sequencing (NGS) | CE-IVD AssaysLymphoTrack Dx TRG Assay Reagents - MiSeq DetectionKit A Components Panel Components(includes all master mixes from Kit A plus the items below)Master Mix Name Index # Master Mix Name Index # Master Mix Name Index #Assay Description The TRG gene locus on chromosome 7 (7q14) includes 14 V (variableTRG MiSeq 01 A001 TRG MiSeq 09 A009 TRG MiSeq 18 A018region) genes (Group I, II, III, and IV), 5 J (joining region) geneTRG MiSeq 02 A002 TRG MiSeq 10 A010 TRG MiSeq 19 A019The LymphoTrack Dx TRG Assays for the IlluminaMiSeq,Thermosegments, and 2 C (constant region) genes spread over 200 kilobases. TRG MiSeq 03 A003 TRG MiSeq 11 A011 TRG MiSeq 20 A020Fisher Scientific Ion PGM or Ion S5 instruments are in vitro diagnostic products intended for next-generation sequencing (NGS) basedDuring development of lymphoid cells, antigen receptor genesTRG MiSeq04 A004 TRG MiSeq 12 A012 TRG MiSeq 21 A021determination of the frequency distribution of TRG gene rearrangementsundergo somatic gene rearrangements. 1Specifically during T-cellTRG MiSeq 05 A005 TRG MiSeq 13 A013 TRG MiSeq 22 A022in patients suspected with having lymphoproliferative disease. Thesedevelopment, genes encoding TRG molecules are assembled fromTRG MiSeq 06 A006 TRG MiSeq 14 A014 TRG MiSeq 23 A023assays aid in the identification of lymphoproliferative disorders. multiple polymorphic gene segments that undergo rearrangement generating V-J combinations unique in both length and sequence. 2 TRG MiSeq 07 A007 TRG MiSeq 15 A015 TRG MiSeq 25 A025Since leukemias and lymphomas originate from the malignantTRG MiSeq 08 A008 TRG MiSeq 16 A016 TRG MiSeq 27 A027Summary and Explanation of the Test transformation of individual lymphoid cells, all leukemias and lymphomas generally share one or more cell-specific or clonalControls ControlsThis assay utilizes a single multiplex master mix to target conservedantigen receptor gene rearrangement. Therefore, tests that detectTRG POS (+) Qty. 1 NGS NEG (-) Qty. 1 TRG POS (+)Qty. 3 NGS NEG (-) Qty. 3V and J regions of the human TRB gene locus described in lymphoidTRG clonal rearrangements can be useful in the study of B- andmalignancies, thereby reducing sample DNA requirements andT-cell malignancies. simplifying the testing workflow. Primers are designed with Illumina Reagents - Ion S5/PGM Detectionor Thermo Fisher Scientific adapters and up to 24 different indices;Note: For a more thorough explanation of the locus and the targeted thereby allowing amplicons generated from different TRG masterdeep sequencing strategy, please refer to Principle of ImmunoglobulinAssay componentsmixes to be pooled together for sequencing on a single MiSeqflow2cell, or Ion PGM or Ion S5 chip. and T-Cell Receptor Gene Rearrangement. Master Mix Name Index # Master Mix Name Index # Master Mix Name Index #TRG S5/PGM 01 IonXpress_001 TRG S5/PGM 07 IonXpress_007 TRG S5/PGM 11 IonXpress_011The associated LymphoTrack Dx Software sorts complex NGS data by gene target, providing users the ability to reduce per sample testingSpecimen Requirement TRG S5/PGM 02 IonXpress_002 TRG S5/PGM 08 IonXpress_008 TRG S5/PGM 12 IonXpress_012costs by sequencing amplicons generated with any LymphoTrack Dx50 ng of high-quality genomic DNA. TRG S5/PGM 03 IonXpress_003 TRG S5/PGM 09 IonXpress_009 TRG S5/PGM 13 IonXpress_013Assay (e.g. IGH, IGK, TRB, TRG) at the same time. In addition, theTRG S5/PGM 04 IonXpress_004 TRG S5/PGM 10 IonXpress_010 TRG S5/PGM 14 IonXpress_014LymphoTrack Dx Software provides an easy and streamlined methodControlsfor data visualization and guidelines provided in the instructions for useReferencesallow samples to be interpreted for evidence or no evidence of clonality. 1. Tonegawa, S. (1983). Nature 302, 575-581.TRG POS (+) Qty. 2 NGS NEG (-) Qty. 2Positive clonal and negative polyclonal DNA controls are included in kits. 2. Miller JE. (2013) Molecular Genetic Pathology LymphoTrack Dx TRG Assay - V -J Sequence Frequencies V-J Sequence Frequencies. The LymphoTrack Dx bioinformatics software provides (2nd Edition.,sections 30.2.7.13 and 30.2.7.18). PDF reports which include Top 10 Merged Read Summary as well as a stacked bar graph depicting the relative frequencies of the V-J rearrangements identified in the sample. To learn more about the LymphoTrack Dx software, please refer to the Background LymphoTrack Dx Bioinformatics Software section.The LymphoTrack Dx TRG Assays represent a significant improvement over existing fragment analysis clonality assays by providing two important and complementary uses:1.Detection of initial clonal populations.2.dentification of sequence information required to track clonal Irearrangements in subsequent samples.Ordering InformationCatalog # Products Quantity ComponentsSimplified Representation of the TRG Gene 9-227-0019 LymphoTrack Dx TRG Assay Kit A - MiSeq 8 indices - 5 sequencing reactions each9-227-0009 LymphoTrackDx TRG Assay Panel - MiSeq 24 indices - 5 sequencing reactions each9-500-0009 LymphoTrackDx Software - MiSeq 1 CD complimentary with purchase9-227-0007 LymphoTrackDx TRG Assay - S5/PGM12 indices - 5 sequencing reactions eachDepicted are the variable region (V) genes and downstream consensus joining region genes (J) that are involved in TRG gene rearrangements. 9-500-0007 LymphoTrackDx Software - S5/PGM1 CD complimentary with purchaseThese products are CE-IVD assays for in vitro diagnostic use.32Invivoscribe 2021|33'