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.

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, green-top (heparin) tube, slides, blocks, tissue in RPMI, or frozen

Collection

Fresh tissue should be placed in RPMI medium or shipped frozen on dry ice. Also acceptable are small samples (eg, punch biopsies, fine-needle aspirate).

Storage Instructions

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

Causes for Rejection

Frozen whole blood/bone marrow; tumor block containing no tumor tissue; broken or stained slides; quantity not sufficient for analysis

Clinical Information

Special Instructions

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

References

Evans PA, Pott Ch, Groenen PJ, et al. Significantly improved PCR-based clonality testing in B-cell malignancies by use of multiple immunoglobulin gene targets. Report of the BIOMED-2 concerted action BHM4-CT98-3936. Leukemia. 2007 Feb; 21(2); 207-214. 17170731
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) 511824 Putaway 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
481222 B Cell Panel (IgH, IgK) 511824 Putaway N/A

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The LOINC® codes are copyright © 1994-2017, 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