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