CPT Codes

81261
81264

Synonyms

  • B-Cell IGH Heavy Chain Gene Clonality
  • B-Cell IGK Kappa Light chain Gene Clonality,
  • B-Lymphocyte Immunoglobulin
  • Heavy Chain Gene Rearrangement

Test Includes

Detection of monoclonal B-cell populations in B-lymphoproliferative disorders

Performing Laboratory / Facility

UCLA Medical Center Clinical Laboratory (CHS)

Performing Section

Molecular Pathology

Availability

Monday through Friday, 0700-1700

Turnaround Time

14 days from receipt of specimen in performing lab

Methodology

Polymerase Chain Reaction (PCR) The IgH Gene Clonality Assay amplifies the DNA between primers that target the conserved framework (FR 1,2 and 3) and joining (J) region, and the diversity (D) and joining regions

Use

Heavy chain gene rearrangement is a useful marker of the clonality of B-lymphoproliferative disorders.

Limitations

Rearrangement will not be detected if the submitted tissue is not from the involved tumor. Some rearrangements may not be detectable due to the nature of the breakpoints. Some T-cell malignancies will show immunoglobulin gene rearrangements.

Additional Information

IgK will be performed if IgH is negative

Specimen Type

Whole Blood
Bone Marrow
Fresh Frozen Tissue
FFPE Slides

Container

Whole Blood and Bone Marrow - Lavender/EDTA
Tissue - Sterile Container or Sterile Container with RPMI

Collection Instructions

Tissue must be carefully cut from the surgically removed tumor and contain a representative sampling of at least 5% to 10% of tumor cells from the involved area.

Volume

Whole Blood - 4 mL
Bone Marrow - 4 mL
Fresh Frozen Tissue - 5mm3
FFPE Slides - 10 Unstained Slides + 1 H&E Slide

Minimum Volume

Whole Blood - 1 mL
Bone Marrow - 1 mL

Storage Temperature

Fresh frozen tissue can be stored in a -70°C freeze

Special Instructions

When IGH is tested negative will proceed to test IGK

Shipping and Handling Instructions

Blood and bone marrow transport at room temperature. Fresh frozen tissue transport on dry ice.

Causes for Rejection

Tumor block containing insufficient tumor tissue, tumor tissue fixed in a heavy metal fixative (e.g. B-5 and Zenker's fixatives), Broken and stained slides.

Reference Range

No clonality observed
Test Information

CPT Codes

81261
81264

Synonyms

  • B-Cell IGH Heavy Chain Gene Clonality
  • B-Cell IGK Kappa Light chain Gene Clonality,
  • B-Lymphocyte Immunoglobulin
  • Heavy Chain Gene Rearrangement

Test Includes

Detection of monoclonal B-cell populations in B-lymphoproliferative disorders

Performing Laboratory / Facility

UCLA Medical Center Clinical Laboratory (CHS)

Performing Section

Molecular Pathology

Availability

Monday through Friday, 0700-1700

Turnaround Time

14 days from receipt of specimen in performing lab

Methodology

Polymerase Chain Reaction (PCR) The IgH Gene Clonality Assay amplifies the DNA between primers that target the conserved framework (FR 1,2 and 3) and joining (J) region, and the diversity (D) and joining regions

Use

Heavy chain gene rearrangement is a useful marker of the clonality of B-lymphoproliferative disorders.

Limitations

Rearrangement will not be detected if the submitted tissue is not from the involved tumor. Some rearrangements may not be detectable due to the nature of the breakpoints. Some T-cell malignancies will show immunoglobulin gene rearrangements.

Additional Information

IgK will be performed if IgH is negative
Specimen Collection and Handling

Specimen Type

Whole Blood
Bone Marrow
Fresh Frozen Tissue
FFPE Slides

Container

Whole Blood and Bone Marrow - Lavender/EDTA
Tissue - Sterile Container or Sterile Container with RPMI

Collection Instructions

Tissue must be carefully cut from the surgically removed tumor and contain a representative sampling of at least 5% to 10% of tumor cells from the involved area.

Volume

Whole Blood - 4 mL
Bone Marrow - 4 mL
Fresh Frozen Tissue - 5mm3
FFPE Slides - 10 Unstained Slides + 1 H&E Slide

Minimum Volume

Whole Blood - 1 mL
Bone Marrow - 1 mL

Storage Temperature

Fresh frozen tissue can be stored in a -70°C freeze

Special Instructions

When IGH is tested negative will proceed to test IGK

Shipping and Handling Instructions

Blood and bone marrow transport at room temperature. Fresh frozen tissue transport on dry ice.

Causes for Rejection

Tumor block containing insufficient tumor tissue, tumor tissue fixed in a heavy metal fixative (e.g. B-5 and Zenker's fixatives), Broken and stained slides.
Result Interpretation

Reference Range

No clonality observed