Immunoglobulin Gene Rearrangement, V (BCGRV)

Test Code: BCGRVSO

Overview
Ordering
Specimen
Performing
Clinical/Interpretive
Contacts
Coding

Synonyms/Keywords

B-Cell Gene Rearrangement
B-Cell Immunoglobulin Gene Rearrangement
Immunoglobulin Gene Rearrange (PCR)
Lymphoma vs Benign Process
B-Cell Clonality by PCR
IGH
B Cell Gene Rearrangement

Useful For

Determining whether a B-cell or plasma cell population is polyclonal or monoclonal in specimens other than blood or bone marrow
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 that from a previous neoplastic specimen

Specimen Requirements

Specimen Type	Preferred Container/Tube	Specimen Volume	Specimen Minimum Volume (allows for 1 repeat)
Body Fluid	Sterile Container	5 mL	1 mL
Paraffin-embedded bone marrow aspirate clot	Paraffin block
Frozen Tissue	Plastic Container	100 mg	50 mg
Paraffin-embedded tissue	Paraffin block
Tissue	Unstained slides	10 slides
Spinal fluid	Sterile Vial	10 mL	1 mL
Extracted DNA from blood or bone marrow	1.5 to 2 mL tube with indication of volume and concentration of DNA	Entire Specimen	50 microliter at 20 ng/microliter

Collection Processing Instructions

Body fluid or spinal fluid specimens must arrive within 96 hours (4 days) of collection.

If sending body fluid:
1. If the volume is large, pellet cells prior to sending.

2. Send less volume at ambient temperature or as a frozen cell pellet.

Specimen Stability Information

Specimen Type	Temperature	Time
Body Fluid	Ambient	96 hours
	Refrigerate	96 hours
	Frozen	96 hours
Cell Pellet	Frozen	96 hours
Paraffin-embedded bone marrow aspirate clot	Ambient	Indefinitely
Frozen Tissue	Frozen	Indefinitely
Parrafin-embedded tissue	Ambient	Indefinitely
Parrafin-embedded tissue	Ambient	Indefinitely
Spinal Fluid	Ambient	96 hours
Spinal Fluid	Refrigerate	96 hours
Extracted DNA from blood or bone marrow	Ambient	Indefinitely
Extracted DNA from blood or bone marrow	Refrigerate	Indefinitely

Rejection Criteria

Bone marrow core biopsies
Paraffin shavings

Interference

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

False-negative results may occur if the immunoglobulin (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% to 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

Performing Laboratory Information

Performing Location	Day(s) Test Performed	Analytical Time	Methodology/Instrumentation
Mayo Clinic Laboratories	Monday through Friday	7-14 days	Polymerase Chain Reaction (PCR)

Reference Lab

Mayo Clinic Laboratories

Test Information

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 identical Ig gene rearrangement profiles.

Reactive B-cell or plasma cell expansions are polyclonal, with each clone containing relatively few cells and no single 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.

Reference Range Information

An interpretive report will be provided.

Interpretation

The interpretation of the presence or absence of a predominant immunoglobulin (Ig) gene rearrangement profile is sometimes subjective. These results must always be interpreted in the context of other clinicopathologic information to determine the significance of the result. The detection of a clonal Ig gene rearrangement by this test is not synonymous with the presence of a B-cell or plasma cell neoplasm.

Outreach CPTs

CPT	Modifier (if needed)	Quantity	Description	Comments
81261			IGH, gene rearrangement analysis, PCR
81264			IGK, gene rearrangement

Classification

Synonyms/Keywords

B-Cell Gene Rearrangement
B-Cell Immunoglobulin Gene Rearrangement
Immunoglobulin Gene Rearrange (PCR)
Lymphoma vs Benign Process
B-Cell Clonality by PCR
IGH
B Cell Gene Rearrangement

Ordering Applications

Ordering Application	Description
COM	Immunoglobulin Rearrang Varies

If the ordering application you are looking for is not listed, contact your local laboratory for assistance.