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Test ID BCGR Immunoglobulin Gene Rearrangement, Blood


Shipping Instructions


Specimen must arrive within 7 days of collection.



Specimen Required


Container/Tube:

Preferred: Lavender top (EDTA)

Acceptable: Yellow top (ACD)

Specimen Volume: 4 mL

Collection Instructions:

1. Invert several times to mix blood.

2. Send whole blood specimen in original tube. Do not aliquot.


Forms

1. Hematopathology Patient Information (T676)

2. If not ordering electronically, complete, print, and send a Hematopathology/Cytogenetics Test Request (T726) with the specimen.

Secondary ID

83123

Useful For

Determining whether a B-cell or plasma cell population is polyclonal or monoclonal using whole blood specimens

 

Identifying neoplastic cells as having B-cell or plasma cell differentiation

 

Monitoring for a persistent neoplasm by detecting an immunoglobulin gene rearrangement profile similar to one from a previous neoplastic specimen

Method Name

Polymerase Chain Reaction (PCR)

Reporting Name

Immunoglobulin Gene Rearrange, B

Specimen Type

Whole blood

Specimen Minimum Volume

1 mL

Specimen Stability Information

Specimen Type Temperature Time
Whole blood Ambient (preferred) 7 days
  Refrigerated  7 days

Clinical Information

The immunoglobulin 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 immunoglobulin gene rearrangement profile.

 

Reactive B-cell or plasma cell expansions are polyclonal, with each clone containing relatively few cells and no one 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 immunoglobulin gene rearrangement profile may be equated to the presence of a neoplastic B-cell or plasma cell clone.

Reference Values

An interpretive report will be provided.

Cautions

This test is neither 100% sensitive nor 100% specific.

 

False-negative results may occur if the immunoglobulin 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 immunoglobulin gene rearrangements)

-Whether a prominent clone is physiologic or neoplastic

Day(s) Performed

Monday through Friday

Report Available

5 to 7 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Test Classification

This test was developed using an analyte specific reagent. Its performance characteristics were determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the US Food and Drug Administration.

CPT Code Information

81261-IGH (Immunoglobulin heavy chain locus) (eg, leukemias and lymphomas B-cell), gene rearrangement analysis to detect abnormal clonal populations; amplified methodology (eg. polymerase chain reaction)

81264-IGK (Immunoglobulin kappa light chain locus) (eg, leukemia and lymphoma, B-cell) gene rearrangement analysis, evaluation to detect abnormal clonal populations

81479 (if appropriate for government payers)

NY State Approved

Yes