||Immunoglobulin heavy chain (IgH) gene rearrangements occur early in B-cell ontogeny and are unique to each B-cell. Hence, they can be used as a marker of a common origin, or clonality, among a B-cell population. This test is useful for determining whether a clonal population of B cells is present in a specimen. The B-cell clonality assay by PCR establishes whether a population of B cells is clonal by immunoglobulin gene rearrangement studies. The test amplifies DNA using Invivoscribe primers for IgH variable gene framework regions 1-3, diversity and joining regions. For samples that are negative or equivocal at the IgH locus, the immunoglobulin Kappa region is tested for evidence of clonal rearrangement.
Clonality studies should be interpreted in light of available clinical and pathologic information. It is important to note that identification of a clonal cell population is not by itself diagnostic of malignancy. This test is useful for diagnosis and monitoring of B-cell malignancies.