b'Next-Generation Sequencing (NGS) | CE-IVD AssaysIGK Assay Next-Generation Sequencing (NGS) | CE-IVD Assays IGK Assay Next-Generation Sequencing (NGS) | CE-IVD AssaysLymphoTrack Dx IGK Assay Reagents - MiSeq DetectionKit A Components Panel Components(includes all master mixes from Kit A plus the items below)Assay Description Background Master Mix Name Index # Master Mix Name Index # Master Mix Name Index #The LymphoTrack Dx IGK Assays for the IlluminaMiSeq, or ThermoThe LymphoTrack Dx IGK Assays represent a significant improvementIGK MiSeq 01 A001 IGK MiSeq 09 A009 IGK MiSeq 18 A018Fisher Scientific Ion PGM and Ion S5 instruments are in vitroover existing fragment analysis clonality assays by providing twoIGK MiSeq 02 A002 IGK MiSeq 10 A010 IGK MiSeq 19 A019diagnostic products intended for next-generation sequencing (NGS)important and complementary uses: IGK MiSeq 03 A003 IGK MiSeq 11 A011 IGK MiSeq 20 A020based determination of the frequency distribution of IGK gene rearrangements in patients suspected of having lymphoproliferative1. Detection of clonal populations. IGK MiSeq 04 A004 IGK MiSeq 12 A012 IGK MiSeq 21 A021disease. These assays aid in the identificationIGK MiSeq 05 A005 IGK MiSeq 13 A013 IGK MiSeq 22 A022of lymphoproliferative disorders. 2. Identification of sequence information and gene segment utilization.IGK MiSeq 06 A006 IGK MiSeq 14 A014 IGK MiSeq 23 A0233. Ability to track sequences in subsequent samples with the use of the IGK MiSeq 07 A007 IGK MiSeq 15 A015 IGK MiSeq 25 A025Summary and Explanation of the Test Invivoscribe LymphoTrack MRD Software. IGK MiSeq 08 A008 IGK MiSeq 16 A016 IGK MiSeq 27 A027In contrast to the IdentiClone fragment analysis assays for clonalityThe human immunoglobulin kappa (IGK) gene locus on chromosomeControls Controlsthat utilize two master mixes, these NGS assays contain a single2 (2p11.2) includes 76 V (variable) region genes spanning 7 subgroups multiplex master mix to target conserved regions of the IGK gene locusand 5 J (joining) region gene segments upstream of the (C )region. IGK POS (+) Qty. 1 NGS NEG (-) Qty. 1 IGK POS (+) Qty. 3 NGS NEG (-) Qty. 3described in lymphoid malignancies, thereby, reducing sample DNA requirements and simplifying the testing workflow. The LymphoTrackDuring lymphoid cell development, antigen receptor genesReagents - Ion S5/PGM DetectionDx IGK master mix primers are also designed with Illumina or Thermoundergo somatic gene rearrangements. 1Specifically, during B-cell Fisher Scientific adapters and up to 24 different indices. This allowsdevelopment, genes encoding IGK molecules are assembled fromAssay Componentsamplicons generated from different indexed IGK master mixes to bemultiple polymorphic gene segments that generate V-J combinations pooled into a single library for loading onto one MiSeq flow cell,unique in both length and sequence. 2 Master Mix Name Index # Master Mix Name Index #Ion PGM or Ion S5 chips. In addition, the kappa deleting element (K de ), approximately 24 kbIGK S5/PGM 01 IonXpress_001 IGK S5/PGM 11 IonXpress_011The associated LymphoTrack Dx Software is capable of sortingdownstream of the J-C region can also rearrange with V geneIGK S5/PGM 02 IonXpress_002 IGK S5/PGM 12 IonXpress_012complex NGS data by gene target, providing users the ability tosegments and the isolated recombination signal sequence in the IGK S5/PGM 04 IonXpress_004 IGK S5/PGM 13 IonXpress_013reduce per sample testing costs by sequencing amplicons from anyJ-C intron (J-C INTR).LymphoTrack Dx Assay (e.g. IGH, IGK, TRB, TRG) at the same time.IGK S5/PGM 08 IonXpress_008 IGK S5/PGM 14 IonXpress_014In addition, the LymphoTrack Dx Software provides an easy andSince leukemias and lymphomas originate from the malignantIGK S5/PGM 09 IonXpress_009 IGK S5/PGM 16 IonXpress_016streamlined method for visualization of data and guidelines providedtransformation of individual lymphoid cells, all leukemias andIGK S5/PGM 010 IonXpress_010 IGK S5/PGM 17 IonXpress_017in the instructions for use allow samples to be interpreted for evidencelymphomas generally share one or more cell-specific or clonal or no evidence of clonality. antigen receptor gene rearrangements. Therefore, tests that detectControlsIGK clonal rearrangements can be useful in the study of B- cellIGK POS (+) Qty. 2 NGS NEG (-) Qty. 2Positive clonal and negative polyclonal DNA controls are included in kits. malignancies and complement IGH testing, as the IGK receptor is less susceptible to somatic mutations. V-J Sequence Frequencies. The LymphoTrack Dx Software provides a stacked bar LymphoTrack Dx IGK Assay - V -J Sequence Frequencies graph depicting the relative frequencies for the most prevalent rearrangements Specimen Requirementidentified in a sample. To learn more about the LymphoTrack Dx software, please refer to the LymphoTrack Dx Bioinformatics Software section.50 ng of high-quality genomic DNA. References1.Tonegawa, S. (1983). Nature 302, 575-581.2. Miller JE. (2013) Molecular Genetic Pathology(2nd Edition.,sections 30.2.7.13 and 30.2.7.18).Ordering InformationCatalog # Products Quantity ComponentsSimplified Representation of the IGK Gene 9-122-0009 LymphoTrackDx IGK Assay Kit A - MiSeq 8 indices - 5 sequencing reactions eachDepicted are the variable region (V) or variable9-122-0019 LymphoTrackDx IGK Assay Panel - MiSeq 24 indices - 5 sequencing reactions eachintragenic J-C intron (J-C INTR) genes involved9-500-0009 LymphoTrackDx Software - MiSeq 1 CD complimentary with purchaseKdein IGK gene rearrangements in addition to the9-122-0007 LymphoTrackDx IGK Assay - S5/PGM12 indices - 5 sequencing reactions eachdownstream consensus joining region genes (J) or9-500-0007 LymphoTrackDx Software - S5/PGM1 CD complimentary with purchaseKdekappa deleting element (K de ).These products are CE-IVD assays for in vitro diagnostic use.30Invivoscribe 2021|31'