B-Cell Gene Rearrangements Profile, IgH and IgK

CPT: 81261; 81264
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Test Details

Synonyms

  • IgH Clonality Assay
  • IgH Gene Rearrangement Assay
  • IgK Clonality Assay
  • IgK Gene Rearrangement Assay

Use

This profile can be used to detect clonal B-cell immunoglobulin heavy chain (IgH) and immunoglobulin κ light chain (IgK) gene rearrangements in blood, bone marrow, and tissue specimens with combined B-cell clonality detection rate of 99%. The presence of a monoclonal gene rearrangement usually, but not always, reflects the presence of a B-lymphocytic neoplasm, while polyclonal gene rearrangement patterns are found in benign reactive condition. 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, 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 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; 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
481222 B Cell Panel (IgH, IgK) 480717 B-Cell PCR Interpretation 21747-1
481222 B Cell Panel (IgH, IgK) 480827 B Clonal Size N/A
481222 B Cell Panel (IgH, IgK) 480778 Block Number: N/A
481222 B Cell Panel (IgH, IgK) 489025 Director Review: 72486-4
481222 B Cell Panel (IgH, IgK) 480720 Methodology: 49549-9
481222 B Cell Panel (IgH, IgK) 480821 References: N/A
481222 B Cell Panel (IgH, IgK) 480813 IgK PCR Interpretation 21748-9
481222 B Cell Panel (IgH, IgK) 480828 K Clonal Size N/A
481222 B Cell Panel (IgH, IgK) 480777 Block Number: N/A
481222 B Cell Panel (IgH, IgK) 489028 Director Review 72486-4
481222 B Cell Panel (IgH, IgK) 480831 Methodology: 49549-9
481222 B Cell Panel (IgH, IgK) 480821 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