IG Heavy Chain Gene Rearrangement with Reflex to IG Kappa Light Chain Gene Rearrangement (B-Cell Clonality Assay) by PCR : 1016806

Message

For tissue specimens, please provide most recent pathology report.

Test Code

MDFCPIGHREIGK or 1016806

CPT Codes
81261

Includes

If the IG Heavy Chain Rearrangeement is not definitively positive for clonal rearrangement, the IG Kappa Light Chain Gene Rearrangement will be performed at an additional charge (CPT code(s): 81264).

Instructions

Peripheral Blood in a lavender top tube (EDTA) or Bone Marrow in a lavender top tube (EDTA) or Tissue.

Transport Container

Submit 5 mL Blood (Min. 2 mL) or 2 mL Bone Marrow (Min. 0.5 mL): Do not centrifuge. Fresh Tissue: submit in RPMI media. Paraffin embedded Tissue: submit in sterile biohazard plastic bag. Slides: submit in slide holder. Do not submit decalcified tissue specimen.

Transport Temperature

Blood, Bone Marrow, or Fresh Tissue: Refrigerated; Paraffin embedded Tissue: Ambient or on ice pack in summer; Slides: Ambient.

Specimen Stability

Blood or Bone Marrow: Ambient: 24 hours; Refrigerated: 5 days; Frozen: Unacceptable

Paraffin embedded tissue: Ambient: Indefinitely; Refrigerated: Indefinitely; Frozen: Unacceptable

Fresh tissue: Refrigerated: 24 hours; Frozen: Unacceptable

Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)

Decalcified tissue specimen.

Methodology
Polymerase Chain Reaction (PCR)

Setup Schedule

Tuesday & Friday

Report Available

2-6 days
If reflex, 4-6 days after reflex added

Limitations

The kit used to perform this test is labeled for RESEARCH USE ONLY. Performance characteristics have been determined by med fusion. This test has not been cleared or approved by the U.S. Food and Drug Administration (FDA).

Reference Range

An interpretive report will be provided.

Clinical Significance

This assay identifies clonal rearrangements of the immunoglobulin heavy chain (IGH) gene and the immunoglobulin kappa light chain (IGK) gene associated with most B cell and some T cell malignancies. Somatic hypermutation can occur in certain B cell malignancies such as follicular lymphoma, diffuse large B cell lymphoma and multiple myeloma that would interfere with the detection of clonal B cell population.

Performing Laboratory
med fusion

The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.