b'ClonalityIGK Clonality AssayTestsClinical Information Test Name sequencing of the PCR products is used to identifyDuring development of lymphoid cells, antigen receptorIGK molecules are assembled from multiple polymorphicIGK Clonality AssayDNA sequences specific to clonal gene rearrangements. genes undergo somatic gene rearrangements. 1 gene segments that undergo rearrangements generatingBioinformatics tools facilitate the characterization of gene receptors unique in both length and sequence. sequences present at greater than 5% of the population. The human immunoglobulin kappa (IGK) locus onAssay Type These sequences can be used to track specific clonal Since leukemias and lymphomas originate from thepopulations.chromosome 2 (2p11.2) includes 7 variable (V) region genemalignant transformation of individual lymphoid cells,Next-Generation Sequencing (NGS)segments and 5 joining (J) gene segments upstream ofwhich means that all leukemias and lymphomas generally the constante (C) region. The kappa deleting element (K de ),share one or more cell-specific or clonal antigen receptorThis test is performed by using the LymphoTrack orIndications for Testingapproximately 24 kb downstream of the J-C region, cangene rearrangements. Therefore, tests that detect IGKLymphoTrack Dx Assay from Invivoscribe. Identify clonality in atypical lymphoproliferative also rearrange with V gene segments and the isolatedclonal rearrangements can be useful in the study of B-recombination signal sequence in the J-C intronic region. 2and T-cell malignancies. disordersMethod Description Support a differential diagnosis between reactive Specifically during B-cell development, genes encodingFor detection of the vast majority of IGK genelesions and hematologic malignanciesrearrangements, a multiplex master mix targeting theAssign presumptive lineage in mature monoclonalconserved V, J, C ,and kappa deleting element (K de )lymphoproliferative disordersregions is used for PCR amplification. Next-generationMonitor and evaluate disease recurrenceInterpretation TurnaroundSpecimenShippingSpecimen Time Requirements Conditions StabilityAn interpretive report will be5 to 10 1-3 mL of peripheralAmbient or2-8 C up issued indicating whetherbusiness daysblood in Heparin,Cool; do notto 7 days prior evidence of clonality wasEDTA or ACD freeze (peripheralto testingdetected. The report furtherblood or bone provides a summary of the0.25-1 mL of bonemarrow) top 5 merged sequences,marrow in Heparin, including the % total reads, theEDTA or ACD Ambient or 500 ng of previouslyfrozen on dry ice rearrangement class and the sequence. isolated DNA(isolated DNA)References1.Tonegawa S (1983) Somatic Generation of Antibody Diversity. Nature 302:575-581. 2.JE Miller et al., Molecular Genetic Pathology (2013, 2nd ed.) Springer Science & Business Media 302.2.7.13 and 30.2.7.18.28 LabPMM Services Catalog 2021|29'