Test Id : BCGRV
Immunoglobulin Gene Rearrangement, PCR, Varies
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 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
Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.
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.
Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test
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
B-Cell Clonality by PCR
IGH
B Cell Gene Rearrangement
Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.
Specimen Type
Describes the specimen type validated for testing
Varies
Shipping Instructions
Body fluid or spinal fluid must arrive within 4 days of collection.
ORDER QUESTIONS AND ANSWERS
| Question ID | Description | Answers |
|---|---|---|
| MP017 | Specimen: |
Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing
Submit only 1 of the following specimens:
Specimen Type: Body fluid
Container/Tube: Sterile container
Specimen Volume: At least 5 mL
Collection Instructions:
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:
Body fluid: Ambient 4 days/Refrigerated/Frozen
Cell pellet: Frozen
Specimen Type: Paraffin-embedded bone marrow aspirate clot
Container/Tube: Paraffin block
Specimen Stability Information: Ambient
Specimen Type: Frozen tissue
Container/Tube: Plastic container
Specimen Volume: 100 mg
Collection Instructions: Freeze tissue within 1 hour of collection.
Specimen Stability Information: Frozen
Specimen Type: Paraffin-embedded tissue
Container/Tube: Paraffin block
Specimen Stability Information: Ambient
Specimen Type: Tissue
Slides: Unstained slides
Specimen Volume: 10 Slides
Specimen Stability Information: Ambient
Specimen Type: Spinal fluid
Container/Tube: Sterile vial
Specimen Volume: 5 to 10 mL
Specimen Stability Information: Ambient 4 days/Refrigerated
Specimen Type: Extracted DNA
Container/Tube: 1.5- to 2-mL tube
Specimen Volume: Entire specimen
Collection Instructions:
1. Label specimen as extracted DNA and source of specimen
2. Indicate volume and concentration of DNA on label
Specimen Stability Information: Refrigerated/Ambient
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.
Body and spinal fluid: 1 mL
Tissue: 50 mg
Extracted DNA: 50 microliters (mcL) at 20 ng/mcL
Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected
| Bone marrow core biopsies Paraffin shavings | 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 |
|---|---|---|---|
| Varies | Varies | ||
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 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
Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.
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 identical immunoglobulin 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 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 immunoglobulin 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 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 Apr;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. doi: 10.3892/ijo.2014.2790
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
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.
Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
Performing Laboratory Location
Indicates the location of the laboratory that performs the test
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.
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 |
|---|---|---|
| BCGRV | Immunoglobulin Gene Rearrange, V | 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.
|
|---|---|---|
| MP017 | Specimen: | 31208-2 |
| 19915 | Final Diagnosis: | 34574-4 |
| 608950 | Signing Pathologist | 19139-5 |