Test Catalog

Test Id : BCGR

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Immunoglobulin Gene Rearrangement, Blood

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Overview

Test Catalog

Useful For
Suggests clinical disorders or settings where the test may be helpful

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
A short description of the method used to perform the test

Polymerase Chain Reaction (PCR)

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

Immunoglobulin Gene Rearrange, B

Aliases
Lists additional common names for a test, as an aid in searching

B-Cell Gene Rearrangement

B-Cell Immunoglobulin Gene Rearrangement

Immunoglobulin Gene Rearrange (PCR)

Lymphoma vs Benign Process

IGH

B Cell Gene Rearrangement

B-Cell Clonality by PCR

Specimen Type
Describes the specimen type validated for testing

Whole blood

Shipping Instructions

Specimen must arrive within 7 days of collection.

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

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.

Special Instructions
Library of PDFs including pertinent information and forms related to the test

Forms

1. Hematopathology Patient Information (T676)

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

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the testing laboratory. The minimum volume is sufficient for one attempt at testing.

1 mL

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

Gross hemolysis Reject
Moderately to severely clotted Reject

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

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

Useful For
Suggests clinical disorders or settings where the test may be helpful

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

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

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
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

An interpretive report will be provided.

Interpretation
Provides information to assist in interpretation of the test results

An interpretive report will be provided.

 

The interpretation of the presence or absence of a predominant immunoglobulin 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 immunoglobulin gene rearrangement by this test is not synonymous with the presence of a B-cell or plasma cell neoplasm.

Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

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

Clinical Reference
Recommendations for in-depth reading of a clinical nature

1. van Dongen JJ, Wolvers-Tettero IL: Analysis of immunoglobulin and T-cell receptor genes. Part II: Possibilities and limitations in the diagnosis and management of lymphoproliferative diseases and related disorders. Clin Chim Acta. 1991 April;198(1-2):93-174

2. Coad JE, Olson DJ, Lander TA, McGlennen RC: Molecular assessment of clonality in lymphoproliferative disorders: I. Immunoglobulin gene rearrangements. Mol Diagn. 1996 Dec;1(4):335-355

3. Kokovic I, Novakovic BJ, Novakovic S: Diagnostic value of immunoglobulin k light chain gene rearrangement analysis in B-cell lymphomas. Int J Oncol. 2015 Mar;46(3):953-962

Method Description
Describes how the test is performed and provides a method-specific reference

Genomic DNA is extracted from all specimens.

 

In the polymerase chain reaction (PCR) assay, a total of 34 upstream and 5 downstream primers are used (Invivoscribe IGH and IGK gene clonality reagents). The primers are designed to amplify fragments from all theoretical rearrangements of the immunoglobulin heavy and kappa light chain genes. Each unique rearrangement should produce PCR fragments of unique sizes. The primers cannot amplify anything if the immunoglobulin genes are not rearranged because the distance is too great. The primers are labeled with a fluorescent tag so that the PCR product can be detected. The PCR fragments are analyzed by capillary gel electrophoresis using a genetic analyzer for fragment size and amount.(Unpublished Mayo method)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Monday through Friday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

5 to 7 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

Whole blood: 2 weeks; Extracted DNA: 3 months

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

Fees :
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their account representative. For assistance, contact Customer Service.

Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

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
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

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

LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

Test Id Test Order Name Order LOINC Value
BCGR Immunoglobulin Gene Rearrange, B 61113-7
Result Id Test Result Name Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
18229 Final Diagnosis: 34574-4
608948 Signing Pathologist 19139-5

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports