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B-Cell Gene Rearrangements Profile, IGH and IGK

Test Number 481222
Test number copied
CPT

81261; 81264
Synonyms
  • IGH Clonality Assay
  • IGH Gene Rearrangement Assay
  • IGK Clonality Assay
  • IGK Gene Rearrangement Assay

Test Details

Methodology

Polymerase chain reaction (PCR)

Result Turnaround Time

5 - 7 days

Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.

Related Information

Use

This profile can be used to detect clonal B-cell immunoglobulin heavy chain (IGH) and immunoglobulin k 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.
 

Special Instructions

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

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 Food and Drug Administration.

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):215-221.17170730
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

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, tan-top (K2-EDTA) tube and pink-top (K2-EDTA) tube, FFPE tissue block or slides, tissue in RPMI or frozen

Collection Instructions

Fresh tissue should be placed in RPMI medium or shipped frozen on dry ice. Small samples (e.g., 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

LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
481222 Gene Rearrangements, IGH IGK 104272-0 480717 B-Cell PCR Interpretation 21747-1
481222 Gene Rearrangements, IGH IGK 104272-0 480827 B Clonal Size N/A
481222 Gene Rearrangements, IGH IGK 104272-0 480778 Block Number: N/A
481222 Gene Rearrangements, IGH IGK 104272-0 489025 Director Review: 72486-4
481222 Gene Rearrangements, IGH IGK 104272-0 480720 Methodology: 49549-9
481222 Gene Rearrangements, IGH IGK 104272-0 481529 References: N/A
481222 Gene Rearrangements, IGH IGK 104272-0 480813 IgK PCR Interpretation 21748-9
481222 Gene Rearrangements, IGH IGK 104272-0 480828 K Clonal Size N/A
481222 Gene Rearrangements, IGH IGK 104272-0 480777 Block Number: N/A
481222 Gene Rearrangements, IGH IGK 104272-0 489028 Director Review 72486-4
481222 Gene Rearrangements, IGH IGK 104272-0 480831 Methodology: 49549-9
481222 Gene Rearrangements, IGH IGK 104272-0 480842 References: N/A
Order Code481222
Order Code NameGene Rearrangements, IGH IGK
Order Loinc104272-0
Result Code480717
Result Code NameB-Cell PCR Interpretation
UofM
Result LOINC21747-1
Order Code481222
Order Code NameGene Rearrangements, IGH IGK
Order Loinc104272-0
Result Code480827
Result Code NameB Clonal Size
UofM
Result LOINCN/A
Order Code481222
Order Code NameGene Rearrangements, IGH IGK
Order Loinc104272-0
Result Code480778
Result Code NameBlock Number:
UofM
Result LOINCN/A
Order Code481222
Order Code NameGene Rearrangements, IGH IGK
Order Loinc104272-0
Result Code489025
Result Code NameDirector Review:
UofM
Result LOINC72486-4
Order Code481222
Order Code NameGene Rearrangements, IGH IGK
Order Loinc104272-0
Result Code480720
Result Code NameMethodology:
UofM
Result LOINC49549-9
Order Code481222
Order Code NameGene Rearrangements, IGH IGK
Order Loinc104272-0
Result Code481529
Result Code NameReferences:
UofM
Result LOINCN/A
Order Code481222
Order Code NameGene Rearrangements, IGH IGK
Order Loinc104272-0
Result Code480813
Result Code NameIgK PCR Interpretation
UofM
Result LOINC21748-9
Order Code481222
Order Code NameGene Rearrangements, IGH IGK
Order Loinc104272-0
Result Code480828
Result Code NameK Clonal Size
UofM
Result LOINCN/A
Order Code481222
Order Code NameGene Rearrangements, IGH IGK
Order Loinc104272-0
Result Code480777
Result Code NameBlock Number:
UofM
Result LOINCN/A
Order Code481222
Order Code NameGene Rearrangements, IGH IGK
Order Loinc104272-0
Result Code489028
Result Code NameDirector Review
UofM
Result LOINC72486-4
Order Code481222
Order Code NameGene Rearrangements, IGH IGK
Order Loinc104272-0
Result Code480831
Result Code NameMethodology:
UofM
Result LOINC49549-9
Order Code481222
Order Code NameGene Rearrangements, IGH IGK
Order Loinc104272-0
Result Code480842
Result Code NameReferences:
UofM
Result LOINCN/A