B-Cell, IgK Gene Rearrangements

CPT: 81264
Updated on 7/17/2018
Print Share

Test Details

Synonyms

  • IGK Gene Clonality Assay

Use

This assay can be used to detect clonal immunoglobulin receptor kappa-chain gene rearrangements in blood, bone marrow, and tissue specimens with combined B-cell clonality detection rate of 94% to 99%. 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 uM or formalin-fixed, paraffin-embedded tissue block, tissue in RPMI or frozen

Minimum Volume

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

Container

Lavender-top (EDTA) tube, yellow-top (ACD) tube, 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 aspirates) will also be accepted. To avoid delays in turnaround time when requesting multiple test on frozen samples, please submit separate specimens for each test requested.

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

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

Storage Instructions

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

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

Maintain whole 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 block containing no 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
480812 IgK Gene Rearrangement, PCR 480813 IgK PCR Interpretation 21748-9
480812 IgK Gene Rearrangement, PCR 480828 K Clonal Size N/A
480812 IgK Gene Rearrangement, PCR 480777 Block Number: N/A
480812 IgK Gene Rearrangement, PCR 489028 Director Review 72486-4
480812 IgK Gene Rearrangement, PCR 480831 Methodology: 49549-9
480812 IgK Gene Rearrangement, PCR 480821 References: N/A

For Providers

Please login to order a test.

 

© 2018  Laboratory Corporation of America® Holdings and Lexi-Comp Inc. All Rights Reserved.

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