B-Cell, IgH Gene Rearrangements

CPT: 81261
Updated on 10/8/2018
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Test Details

Use

This assay can be used to detect clonal immunoglobulin receptor heavy 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 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).

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.

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).

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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, 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, 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.

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.

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

Bruggemann 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):215-22117170730
Langerak AW, Groenen PJ, 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):2159-2171.22918122
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
Bruggemann 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):215-22117170730
Langerak AW, Groenen PJ, 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):2159-2171.22918122

LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
480716 B-Cell Gene Rearrangement, PCR 480717 B-Cell PCR Interpretation 21747-1
480716 B-Cell Gene Rearrangement, PCR 480827 B Clonal Size N/A
480716 B-Cell Gene Rearrangement, PCR 480778 Block Number: N/A
480716 B-Cell Gene Rearrangement, PCR 489025 Director Review: 72486-4
480716 B-Cell Gene Rearrangement, PCR 480720 Methodology: 49549-9
480716 B-Cell Gene Rearrangement, PCR 480821 References: N/A

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