T-Cell Receptor β-Chain Gene Rearrangements

CPT: 81340
Updated on 7/17/2018
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Test Details

Synonyms

  • TCRB Gene Clonality Assay

Use

This assay can be used to detect clonal T-cell receptor β-chain gene rearrangements in blood, bone marrow, and tissue specimens. The presence of a monoclonal gene rearrangement usually, but not always, reflects the presence of a T-lymphocytic neoplasm, while polyclonal gene rearrangement patterns are found in benign reactive conditions. Thus, the results of these studies can assist in the diagnosis of lymphoproliferative disorders.

Limitations

This PCR assay is able to detect a clonal DNA population at the sensitivity of 5% in a background of polyclonal DNA.

This test was developed, and its performance characteristics determined, by LabCorp. It has not been cleared or approved by the US Food and Drug Administration (FDA). The FDA has determined that such clearance or approval is not necessary.

Methodology

Polymerase chain reaction (PCR)

Specimen Requirements

Specimen

Whole blood, bone marrow, formalin-fixed, paraffin-embedded (FFPE) tissue block or slides, fresh or frozen tissue

Volume

3 to 5 mL whole blood, 1 mL bone marrow, five unstained slides at 10 μM or formalin-fixed, paraffin-embedded tissue block, tissue in RPMI or frozen

Minimum Volume

0.5 mL whole blood, 0.5 mL bone marrow, two unstained slides at 10 μM

Container

Lavender-top (EDTA) tube, yellow-top (ACD) tube, or green-top (heparin) tube, FFPE tissue block or slides, or tissue in RPMI or frozen

Collection

Fresh tissue should be placed in RPMI medium or shipped frozen on dry ice. Small samples (eg, punch biopsies, fine-needle aspirate) will also be accepted. To avoid delays in turnaround time when requesting multiple tests on frozen samples, please submit separate specimens for each test requested.

Storage Instructions

Maintain blood, bone marrow or tissue in RPMI at 2°C to 8°C; FFPE specimens at room temperature; frozen tissue at -80°C.

Maintain blood, bone marrow or tissue in RPMI at 2°C to 8°C, FFPE specimens at room temperature, frozen tissue at -80°C

Maintain blood, bone marrow or tissue in RPMI at 2°C to 8°C; FFPE specimens at room temperature; frozen tissue at -80°C.

Causes for Rejection

Frozen whole blood/bone marrow; quantity not sufficient for analysis; tumor tissue; broken or stained slides

Clinical Information

Special Instructions

Please direct any questions regarding this test to customer service at 800-345-4363.

References

van Krieken JH, 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):201-206.17170732

LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
480985 TCRB Gene Clonality 480986 TCRB Gene Clonality Results: 21751-3
480985 TCRB Gene Clonality 480987 Clonal Size: N/A
480985 TCRB Gene Clonality 480989 Block Number: N/A
480985 TCRB Gene Clonality 480993 Director Review: 72486-4
480985 TCRB Gene Clonality 480984 Methodology: 49549-9
480985 TCRB Gene Clonality 480994 References: N/A

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CPT Statement/Profile Statement

The LOINC® codes are copyright © 1994-2018, Regenstrief Institute, Inc. and the Logical Observation Identifiers Names and Codes (LOINC) Committee. Permission is granted in perpetuity, without payment of license fees or royalties, to use, copy, or distribute the LOINC® codes for any commercial or non-commercial purpose, subject to the terms under the license agreement found at https://loinc.org/license/. Additional information regarding LOINC® codes can be found at LOINC.org, including the LOINC Manual, which can be downloaded at LOINC.org/downloads/files/LOINCManual.pdf