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25627 Immunoglobulin Gene Rearrangement, Bld (BCGR)

Immunoglobulin Gene Rearrangement, Bld (BCGR)
Test Code: BCGRSO
Synonyms/Keywords
B-Cell Gene Rearrangement
B-Cell Immunoglobulin Gene Rearrangement
Immunoglobulin Gene Rearrange (PCR)
Lymphoma vs Benign Process
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 one 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)
​Whole Blood ​EDTA Lavender Top Tube (LTT) ​ACD Yellow Top Tube (YTT) ​4 mL ​1 mL ​
Collection Processing Instructions
​Specimen must arrive within 168 hours of draw.
 
Specimen Stability Information
Specimen Type Temperature Time
​Whole Blood ​ ​Room Temperature (preferred) ​7 days
​Refrigerate ​7 days
Rejection Criteria
Gross Hemolysis
Performing Laboratory Information
Performing Location Day(s) Test Performed Analytical Time Methodology/Instrumentation
​Mayo Medical Laboratories ​Monday through Friday ​5 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.

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Reference Range Information
Performing Location Reference Range
​Mayo Medical Laboratories ​​Positive, negative, or indeterminate for a clonal T-cell population
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 analysis, PCR ​
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
IGH
B Cell Gene Rearrangement
Ordering Applications
Ordering Application Description
​COM ​Immunoglobulin Rearrangement B
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)
​Whole Blood ​EDTA Lavender Top Tube (LTT) ​ACD Yellow Top Tube (YTT) ​4 mL ​1 mL ​
Collection Processing
​Specimen must arrive within 168 hours of draw.
 
Specimen Stability Information
Specimen Type Temperature Time
​Whole Blood ​ ​Room Temperature (preferred) ​7 days
​Refrigerate ​7 days
Rejection Criteria
Gross Hemolysis
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 one from a previous neoplastic specimen
Reference Range Information
Performing Location Reference Range
​Mayo Medical Laboratories ​​Positive, negative, or indeterminate for a clonal T-cell population
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 ​5 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 analysis, PCR ​
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.

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