b'Next-Generation Sequencing (NGS) | CE-IVD AssaysTRB Assay Next-Generation Sequencing (NGS) | CE-IVD Assays TRB Assay Next-Generation Sequencing (NGS) | CE-IVD AssaysLymphoTrack Dx TRB Assay Reagents - MiSeq DetectionKit A Components Panel Components(includes all master mixes from Kit A plus the items below)Assay Description testing for TRG gene rearrangements only. As a result, combiningMaster Mix Name Index # Master Mix Name Index # Master Mix Name Index #The LymphoTrack Dx TRB Assay for the Illumina MiSeq is an inthe analysis of TRB and TRG loci increases the sensitivity of clonalityTRB MiSeq 01 A001 TRB MiSeq 09 A009 TRB MiSeq 18 A018vitro diagnostic product intended for next-generation sequencingdetection.TRB MiSeq 02 A002 TRB MiSeq 10 A010 TRB MiSeq 19 A019(NGS) based determination of the frequency distribution of TRB geneThe human T-cell receptor beta (TRB) gene locus on chromosome rearrangements in patients suspected of having lymphoproliferative7 (7q34) includes 65 V (variable) gene segments, followed by twoTRB MiSeq 03 A003 TRB MiSeq 11 A011 TRB MiSeq 20 A020disease. This assay aids in the identification of lymphoproliferativeseparate clusters of genes each containing a D (diversity) gene,TRB MiSeq 04 A004 TRB MiSeq 12 A012 TRB MiSeq 21 A021disorders. several J (joining) genes, and a C (constant) region spread overTRB MiSeq 05 A005 TRB MiSeq 13 A013 TRB MiSeq 22 A022685 kilobases. The 2 C genes, TRBC1 and TRBC2, encode highlyTRB MiSeq 06 A006 TRB MiSeq 14 A014 TRB MiSeq 23 A023Summary and Explanation of the Test homologous products with no functional difference. TRB MiSeq 07 A007 TRB MiSeq 15 A015 TRB MiSeq 25 A025During lymphoid cell development, antigen receptor genes undergo This assay utilizes a single multiplex master mix to target conservedsomatic gene rearrangements. 1Specifically, during T-cell developmentTRB MiSeq 08 A008 TRB MiSeq 16 A016 TRB MiSeq 27 A027V and J regions of the human TRB gene locus described in lymphoidgenes encoding TRB molecules are assembled from multipleControls Controlsmalignancies, thereby reducing sample DNA requirements andpolymorphic gene segments that generate V - D - J combinationsTRB POS (+) Qty. 1 NGS NEG (-) Qty. 1 TRB POS (+) Qty. 3 NGS NEG (-) Qty. 3simplifying the testing workflow. The LymphoTrack Dx TRB masterunique in both length and sequence. 2mix primers are designed with Illumina adapters and 8 (Kit A) or 24 (Panel) different indices. This allows amplicons generated fromSince leukemias and lymphomas originate from the malignant different indexed TRB master mixes to be pooled into a single librarytransformation of individual lymphoid cells, all leukemias and for loading onto one MiSeq flow cell. lymphomas generally share one or more cell-specific or clonal The associated LymphoTrack Dx Software is capable of sortingantigen receptor gene rearrangements. Therefore, tests that detect complex NGS data by gene target, offering a second layer ofTRB clonal rearrangements can be useful in the study of B- and V-J Sequence Frequencies. The LymphoTrack Dx bioinformatics software provides T-cell malignancies.a stacked bar graph depicting the relative frequencies for the 200 most prevalent multiplexing. This provides users the ability to reduce per sampleLymphoTrack Dx TRB Assay - V -J Sequence Frequencies rearrangements sequenced and identified in the sample. To learn more about testing costs by sequencing amplicons from any LymphoTrack DxNote: For a more thorough explanation of the locus and the targetedthe LymphoTrack Dx software, please refer to the LymphoTrack Dx Bioinformatics MiSeq Assay (e.g. TRB, TRG, IGH, IGK) at the same time. In addition,deep sequencing strategy, please refer to Principle of ImmunoglobulinSoftware section.the LymphoTrack Dx Software provides an easy and streamlinedand T-Cell Receptor Gene Rearrangement. 2method for visualization of data. Guidelines to interpret samples for evidence or no evidence of clonality are included in the instructionsfor use provided with each kit. Specimen RequirementPositive clonal and negative polyclonal DNA controls are included in kits. 50 ng of high-quality genomic DNA.Background ReferencesThe LymphoTrack Dx TRB Assays represent a significant improvement1. Tonegawa, S. (1983). Nature 302, 575-581. over fragment analysis methods for clonality testing by providing two2. Miller JE. (2013) Molecular Genetic Pathologyimportant and complementary uses:(2nd Edition.,sections 30.2.7.13 and 30.2.7.18).1.Detection of initial clonal populations. Ordering Information3. JE Miller et al., Molecular Genetic Pathology (2nd ed.). Springer Science & Business Media. 2013: 30.2.7.13.2. Identification of sequence information required to track clonalCatalog # Products Quantity Components rearrangements in subsequent samples. 9-225-0009 LymphoTrack Dx TRB Assay Kit A - MiSeq8 indices - 5 sequencing reactions eachAnalysis of the rearranged TRB locus increases the probability of9-225-0019 LymphoTrack Dx TRB Assay Panel - MiSeq24 indices - 5 sequencing reactions eachidentifying T cell receptor gene rearrangements, as compared to9-500-0009 LymphoTrack Dx Software - MiSeq1 CD complimentary with purchaseSimplified Representation of the TRB GeneV D1 J1 C1 D2 J2 C2Depicted are the variable (V), diversity (D), and joining (J) gene regions involved in TRB gene rearrangements, in addition to the downstream consensus (C) gene regions.These products are CE-IVD assays for in vitro diagnostic use.34Invivoscribe 2021|35'