The IdentiClone™ IGK Gene Clonality Assay is an in vitro diagnostic product intended for PCR-based detection of clonal immunoglobulin kappa light chain gene rearrangements in patients with suspect lymphoproliferations.
Specifically, the IGK Gene Clonality Assay can be used to:
- Identify clonality in atypical lymphoproliferative disorders
- Support a differential diagnosis between reactive lesions and hematologic malignancies
- Assign presumptive lineage in mature monoclonal lymphoproliferative disorders
- Identify tumor-specific markers (IGK and IGK-Kde rearrangements) for post-treatment monitoring
- Monitor and evaluate disease recurrence
IdentiClone™ assay kits are in vitro
diagnostic products. These standardized PCR-based tests come with a Standard Operating Procedure (SOP), an interpretative guide, master mixes, and controls. Master mixes are composed of a buffered magnesium solution, deoxynucleotides, and multiple primers that target the gene segments of interest. Multiple primers are used to ensure a more comprehensive testing approach necessary to reliably identify clonal rearrangements. These assay kits are complete with the exception of Taq DNA polymerase, which is not provided. A single thermocycler program and similar detection methods are used within each series of kits to improve consistency, reduce human error, and facilitate cross training. Click to read more
Rearrangements of the antigen receptor genes occur during ontogeny in B and T lymphocytes. These gene rearrangements generate products that are unique in length and sequence for each cell. Therefore, polymerase chain reaction (PCR) assays can be used to identify lymphocyte populations derived from a single cell by detecting the unique V-J gene rearrangements present within these antigen receptor loci. Click to read more
Polymerase Chain Reaction (PCR)
PCR assays are routinely used for the identification of clonal B-cell populations. These tests amplify the DNA between primers that target the variable (V) and joining (J) regions (IGK Tube A), or the variable, Jκ-Cκ intron, and Kde regions (IGK Tube B). The conserved V and J regions lie on either side of the hypervariable, complementarity-determining region 3 (CDR3) where programmed genetic rearrangements occur during maturation of all B and T lymphocytes. Click to read more
This product tests genomic DNA. DNA can be extracted from the following specimens:
- 5cc of peripheral blood, bone marrow biopsy, or bone marrow aspirate anti-coagulated with heparin or EDTA; OR,
- Minimum 5mm cube of tissue shipped frozen, at room temperature, or on ice in RPMI 1640; OR,
- Formalin-fixed paraffin embedded tissue or slides.