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25626 Immunoglobulin Gene Rearrangement, V (BCGRV)

Immunoglobulin Gene Rearrangement, V (BCGRV)
Test Code: BCGRVSO
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
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 Acceptable Container/Tube Specimen Volume Specimen Minimum Volume
(allows for 1 repeat)		 Pediatric Minimum Volume
(no 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 ​ ​ ​ ​
​Spinal fluid ​Sterile Vial ​ ​10 mL ​5 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 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.

Include Hematopathology Patient Information Sheet.
(http://www.mayomedicallaboratories.com/it-mmfiles/hematopathology-request-form.pdf)
Specimen Stability Information
Specimen Type Temperature Time
​Body Fluid ​ ​ ​Room Temperature ​96 hours
​Refrigerate ​96 hours
​Frozen ​96 hours
​Cell Pellet ​Frozen ​96 hours
​Paraffin-embedded bone marrow aspirate clot ​ ​Room Temperature ​Indefinitely
​Refrigerate ​​Indefinitely
​Frozen Tissue ​Frozen ​​Indefinitely
​Parrafin-embedded tissue ​ ​ ​Room Temperature ​​Indefinitely
​Refrigerate ​​Indefinitely
​Frozen ​​Indefinitely
​Spinal Fluid ​ ​Room Temperature ​96 hours
​Refrigerate ​96 hours
​Extracted DNA from blood or bone marrow ​ ​Room Temperature ​​Indefinitely
​Refrigerate ​​Indefinitely
Rejection Criteria
Bone marrow biopsies, slides or paraffin shavings
Performing Laboratory Information
Performing Location Day(s) Test Performed Analytical Time Methodology/Instrumentation
​Mayo Medical Laboratories ​Monday through Friday ​7-14 days ​Genomic DNA Extracted followed by Polymerase Chain Reaction (PCR)
Reference Lab
Mayo Clinic Laboratories
Test Information

This test was developed and its performance characteristics determined by Marshfield Labs.  It has not been cleared or approved by the U.S. Food and Drug Administration.  The FDA has determined that such clearance or approval is not necessary.  This test is for clinical purposes.  It should not be regarded as investigational or for research.  This laboratory is certified under the Clinical Laboratory Improvement Amendments (CLIA) as qualified to perform high complexity clinical testing.

​
Interpretation
An interpretive report will be provided. 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

This test was developed and its performance characteristics determined by Marshfield Labs.  It has not been cleared or approved by the U.S. Food and Drug Administration.  The FDA has determined that such clearance or approval is not necessary.  This test is for clinical purposes.  It should not be regarded as investigational or for research.  This laboratory is certified under the Clinical Laboratory Improvement Amendments (CLIA) as qualified to perform high complexity clinical testing.

​
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.
Specimen Requirements
Specimen Type Preferred Container/Tube Acceptable Container/Tube Specimen Volume Specimen Minimum Volume
(allows for 1 repeat)		 Pediatric Minimum Volume
(no 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 ​ ​ ​ ​
​Spinal fluid ​Sterile Vial ​ ​10 mL ​5 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
​Body fluid or spinal fluid specimens must arrive within 96 hours 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.

Include Hematopathology Patient Information Sheet.
(http://www.mayomedicallaboratories.com/it-mmfiles/hematopathology-request-form.pdf)
Specimen Stability Information
Specimen Type Temperature Time
​Body Fluid ​ ​ ​Room Temperature ​96 hours
​Refrigerate ​96 hours
​Frozen ​96 hours
​Cell Pellet ​Frozen ​96 hours
​Paraffin-embedded bone marrow aspirate clot ​ ​Room Temperature ​Indefinitely
​Refrigerate ​​Indefinitely
​Frozen Tissue ​Frozen ​​Indefinitely
​Parrafin-embedded tissue ​ ​ ​Room Temperature ​​Indefinitely
​Refrigerate ​​Indefinitely
​Frozen ​​Indefinitely
​Spinal Fluid ​ ​Room Temperature ​96 hours
​Refrigerate ​96 hours
​Extracted DNA from blood or bone marrow ​ ​Room Temperature ​​Indefinitely
​Refrigerate ​​Indefinitely
Rejection Criteria
Bone marrow biopsies, slides or paraffin shavings
Useful For
Determining whether a B-cell or plasma cell population is polyclonal or monoclonal
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
Interpretation
An interpretive report will be provided. 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.
For more information visit:
Performing Laboratory Information
Performing Location Day(s) Test Performed Analytical Time Methodology/Instrumentation
​Mayo Medical Laboratories ​Monday through Friday ​7-14 days ​Genomic DNA Extracted followed by Polymerase Chain Reaction (PCR)
Reference Lab
Mayo Clinic Laboratories
For billing questions, see Contacts
Outreach CPTs
CPT Modifier
(if needed)		 Quantity Description Comments
​81261 ​ ​ ​IGH, gene rearrangement analysis, PCR ​
​81264 ​ ​ ​​IGK, gene rearrangement ​
Classification

This test was developed and its performance characteristics determined by Marshfield Labs.  It has not been cleared or approved by the U.S. Food and Drug Administration.  The FDA has determined that such clearance or approval is not necessary.  This test is for clinical purposes.  It should not be regarded as investigational or for research.  This laboratory is certified under the Clinical Laboratory Improvement Amendments (CLIA) as qualified to perform high complexity clinical testing.

​
For most current information refer to the Marshfield Laboratory online reference manual.