• Diagnose B-cell malignancies

• Determine leukemia and lymphoma lineage

• Detect minimal residual disease or recurrent disease

The evaluation of lymph nodes, bone marrow, and other tissues for the presence of lymphoma usually involves a multiparameter approach. The obligatory first step when evaluating a tissue for suspected lymphoma is to examine the tissue microscopically for morphology. In many cases, morphologic examination is sufficient to establish a diagnosis of malignant lymphoma. There is, however, a significant proportion of cases in which additional studies are needed in order to establish a definitive diagnosis. Those additional studies include immunoperoxidase staining of the tissue sections, flow cytometric evaluation of fresh cells from the specimen, and molecular analysis. Molecular analysis includes such modalities as cytogenetics (including FISH) and polymerase chain reaction (PCR). All of these special studies are intended to provide some evidence that can help to distinguish between benign lymphadenopathy and malignant lymphoma. In addition, the special tests can sometimes help to establish both the lineage and the presence of prognostically significant subtypes of malignant lymphoma.

14868X: B-Cell Gene Rearrangement, Qualitative PCR, Cell-Based

16119X: B-Cell Gene Rearrangement, Qualitative PCR, Plasma-Based, Leumeta™
Following extraction from cells (14868X) or plasma (16119X), DNA is amplified by PCR, utilizing 3 primer sets (FRII, FRIII, and FR3/CDR3) targeting the variable and joining regions of the immunoglobulin heavy chain gene. The amplification products are analyzed by capillary electrophoresis. Results are reported as negative or positive for the presence of a clonal B-cell expansion.

CPT codes*: 83890, 83898 x3, 83909, 83912

16005X: B-Cell Gene Rearrangement, Quantitative PCR, Cell-Based
16118X: B-Cell Gene Rearrangement, Quantitative PCR, Plasma-Based, Leumeta
Following extraction from cells (16005X) or plasma (16118X), DNA is amplified by PCR, utilizing a primer set (FR3/CDR3) targeting the variable and joining regions of the immunoglobulin heavy chain gene. The amplification products are analyzed by capillary electrophoresis. Results are reported as the ratio of the clonal peak area to that of the internal control (Ki-RAS). This test should be used to monitor patients being treated for B-cell malignancies. The analytical sensitivity is 1 monoclonal cell/10,000 normal cells when the initial pre-therapy sample is provided for comparison.

CPT codes*: 83890, 83898 x3, 83909, 83912

Positive results are highly suggestive of malignancy; however, a positive result should not be used as the sole criterion for diagnosis. Both positive and negative results should be interpreted in the context of all clinical and laboratory findings. Up to 20% of B-cell neoplasms can yield a false-negative result in these assays.

5 mL room temperature or refrigerated whole blood (EDTA, lavender-top tube); 1 mL minimum for cell-based tests and 3 mL minimum for plasma-based (Leumeta) tests.

Alternatively, for cell-based tests submit room-temperature or refrigerated bone marrow samples (EDTA, lavender-top tube); room-temperature formalin-fixed, paraffin-embedded tissue; or fresh frozen tissue.