The IdentiClone™ T Cell Receptor Gamma Gene Rearrangement Assay 2.0 is an in vitro diagnostic product intended for PCR-based detection of Clonal T-cell receptor gamma chain gene rearrangement in patients with suspect lymphoproliferations.
Specifically, the T Cell Receptor Gamma Gene Rearrangement Assay 2.0 can be used to identify clonality in patients with lymphoproliferations.
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. 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 T-cell populations. This test amplifies the DNA between primers that target conserved regions within the variable (V) and the joining (J) regions that flank the unique hypervariable antigen-binding region 3 (CDR3). Click to read more
This assay tests genomic DNA extracted and purified from peripheral blood, bone marrow aspirates or paraffin embedded tissue.