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Specimen must arrive within 168 hours (7 days) of draw.
Send specimen in orginial tube. Do not aliquot.
This test is neither 100% sensitive nor 100% specific.
False-negative results may occur if the Ig gene has numerous point alterations introduced during expansion in a follicle center (somatic hypermutation) such that none of the polymerase chain reaction (PCR) primers will bind. False-negative results will also occur if the clonal cells have not rearranged the Ig genes being evaluated or are present below the sensitivity level of the assay (sensitivity is quite variable but the assay requires that at least 1%-5% of the nucleated cells present be clonal). False-positive results are rare but may occur if a predominant clone (or small number of clones) is produced or sampled from a polyclonal expansion.
The test does not provide information regarding:
-The differentiation of the clonal cell population (neoplastic cells other than B cells or plasma cells may occasionally have Ig gene rearrangements)
-Whether a prominent clone is physiologic or neoplastic
The immunoglobulin (Ig) genes (heavy, kappa, and lambda) are comprised of numerous, discontinuous coding segments. As B cells develop, the segments are rearranged such that each mature B cell and plasma cell has a unique rearrangement profile. Other cell types usually retain the unrearranged gene structures. Clonal expansion of any B cell or plasma cell will result in a population of cells that all contain an identical Ig gene rearrangement profile.
Reactive B-cell or plasma cell expansions are polyclonal, with each clone containing relatively few cells and no 1 clone predominating. Conversely, neoplastic clones are generally large such that the clonal cells are the predominant B cells or plasma cells present.
In the appropriate clinical and pathologic setting, detection of a prominent Ig gene rearrangement profile may be equated to the presence of a neoplastic B-cell or plasma cell clone.
An interpretive report will be provided.