Test Id : TCGRV
T-Cell Receptor Gene Rearrangement, PCR, Varies
    
        Useful For
            
                
                
                    
                    Suggests clinical disorders or settings where the test may be helpful
                
            
    
    Determining whether a T-cell population is polyclonal or monoclonal using body fluid or tissue specimens
    
        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
                
            
    
    Lymphoma vs Benign Process
Reactive Lymphocytic Process
TCGRV
T Cell Gene Rearrangement
T Cell Clonality
Gene Rearrangement
T-Cell Receptor Gene Rearrangement
    
        Specimen Type
            
                
                
                    
                    Describes the specimen type validated for testing
                
            
    
        Varies
    
        Shipping Instructions
    
    Body fluid or spinal fluid specimens must arrive within 4 days of collection.
    
        ORDER QUESTIONS AND ANSWERS
    
    | Question ID | Description | Answers | 
|---|---|---|
| MP016 | 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
Container/Tube: Unstained tissue slides
Specimen Volume: 10 slides
Specimen Stability: 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 with indication of volume and concentration of DNA
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 fluid or Spinal fluid: 1 mL
Tissue: 50 mg
Extracted DNA: 50 microliters 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 T-cell population is polyclonal or monoclonal using body fluid or tissue specimens
    
        Clinical Information
            
                
                
                    
                    Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
                
            
    
    The T-cell receptor (TCR) genes (alpha, beta, delta, and gamma) are comprised of numerous, discontinuous coding segments that somatically rearrange to produce heterodimeric cell surface TCR, either alpha/beta (90%-95% of T cells) or gamma/delta (5%-10% of T cells). With rare exceptions (eg, some neoplastic B-lymphoid proliferations), other cell types retain the germline configuration of the TCR genes without rearrangement.
The marked diversity of somatic TCR-gene rearrangements is important for normal immune functions but also serves as a valuable marker to distinguish abnormal T-cell proliferations from reactive processes. A monoclonal expansion of a T-cell population will result in the predominance of a single TCR-gene rearrangement pattern. In contrast, reactive T-cell expansions are polyclonal (or multiclonal), with no single clonotypic population predominating in the population of T cells. These distributive differences in both TCR sequence and genomic rearrangement fragment sizes can be detected by molecular techniques (ie, polymerase chain reaction) and used to determine if a population of T cells shows monoclonal or polyclonal features.
    
        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.
Positive, negative, or indeterminate for a clonal T-cell population
    
        Interpretation
            
                
                
                    
                    Provides information to assist in interpretation of the test results
                
            
    
    An interpretive report will be provided.
Results will be characterized as positive, negative, or indeterminate for a clonal T-cell population.
In the appropriate clinicopathologic setting, a monoclonal result is associated with a neoplastic proliferation of T cells (see Cautions).
    
        Cautions
            
                
                
                    
                    Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
                
            
    
    To determine the significance of the result, it must always be interpreted in the context of other clinicopathologic information.
The interpretation of the presence or absence of a predominant T-cell receptor (TCR)-gene rearrangement profile is sometimes subjective.
The detection of a clonal TCR-gene rearrangement by this test is not necessarily synonymous with the presence of a T-cell neoplasm. False-positive results can occur because of the sensitivity of polymerase chain reaction (PCR) technique and the problem of nonuniform (skewed) amplification of target T-cell gene rearrangements. The latter problem can occur when the total T-cell number in a sample is limited, or because of physiologic skewing of the T-cell repertoire as seen with aging, posttransplantation, or T-cell reactions in autoimmune or (nonlymphoid) malignancies. False-negative results can occur for many reasons, including tissue sampling, poor amplification, or failure to detect a small minority of T-cell gene segment rearrangements with the use of consensus PCR primers. In some cases, an indeterminate or equivocal result will occur because the pattern of gene rearrangements is abnormal (compared to typical polyclonal T-cell processes), but not definitive, for a monoclonal T-cell population. In these situations, distinction of a small monoclonal subpopulation from an over-represented, but reactive, population may not be possible.
    
        Clinical Reference
            
                
                
                    
                    Recommendations for in-depth reading of a clinical nature
                
            
    
    1. Liu H, Bench AJ, Bacon CM, et al: A practical strategy for the routine use of BIOMED-2 PCR assays for detection of B- and T-cell clonality in diagnostic haematopathology. Br J Haematol. 2007 Jul;138(1):31-43
2. van Krieken JHJM, Langerak AW, Macintyre EA, et al: Improved reliability of lymphoma diagnostics via PCR-based clonality testing: report of the BIOMED-2 Concerted Action BHM4-CT98-3936. Leukemia. 2007 Feb;21(2):201-206
3. Bruggermann M, White H, Gaulard P, et al: Powerful strategy for polymerase chain reaction-based clonality assessment in T-cell malignancies Report of the BIOMED-2 Concerted Action BHM4 CT98-3936. Leukemia. 2007 Feb;21(2):215-221
4. Langerak AW, Groenen PJTA, Bruggemann M, et al: EuroClonality/BIOMED-2 guidelines for interpretation and reporting of Ig/TCR clonality testing in suspected lymphoproliferations. Leukemia. 2012 Oct;26(10):2159-2171. doi: 10.1038/leu.2012.246
5. Davies K, Staniforth J, Haowei Xie, W, et al: Advances in the assessment of T-cell clonality. Diagn Histopathol. 2020 Sept;26(9):388-397
    
        Method Description
            
                
                
                    
                    Describes how the test is performed and provides a method-specific reference
                
            
    
    Genomic DNA is extracted from the tissue source. T-cell receptor beta (TCRB) and T-cell receptor gamma (TCRG) loci (official designations TRB and TRG, respectfully) are amplified by polymerase chain reaction (PCR) using a multiplex primer method based on the BIOMED-2 strategy. Specific primers are labeled with fluorochrome dyes, permitting precise fragment sizing of PCR products by capillary gel electrophoresis using a genetic analyzer. Each amplified locus is assessed for gene rearrangement patterns and an overall interpretation of the assay is made with regards to the presence or absence of a monoclonal population.(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.
                
            
    
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- 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.
81340-TCB (T cell antigen receptor, beta) (eg, leukemia and lymphoma), gene rearrangement analysis to detect abnormal clonal population(s), using amplification methodology (eg, PCR)
81342-TCG (T cell receptor, gamma) (eg, leukemia and lymphoma), gene rearrangement analysis, evaluation to detect abnormal clonal population(s)
    
        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 | 
|---|---|---|
| TCGRV | T Cell Receptor Gene Rearrange, V | In Process | 
| 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.
                                     | 
|---|---|---|
| MP016 | Specimen: | 31208-2 | 
| 19936 | Final Diagnosis: | 22637-3 | 
| 608953 | Signing Pathologist | 19139-5 |