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B Cell Gene Rearrangement By PCR

Gene Rearrangement, Immunoglobulin Gene Rearrangement, IGH Gene Rearrangement, B-cell Clonality, B-cell PCR, Immunoglobulin Heavy Chain (IGH) Gene Rearrangement By PCR, Lymphocyte Gene Rearrangement, Gene Tests

Test Codes

EPIC: LAB5128, SOFT LAB: MBCLG, SOFT GENE: MBCEL, SOFTPATH: MBCLG

Department

Molecular Pathology

Specimen Collection Criteria

Collect: One of the following specimen types, as described below:

1. Blood: 5.0 mL whole blood in Lavender-top EDTA tubes. Invert several times to mix blood. (Minimum: 3.0 mL)
2. Bone Marrow: 2.0 mL bone marrow in a Lavender-top EDTA tube. Invert several times to mix bone marrow.
3. Spinal Fluid: 10 mL spinal fluid in the original sterile collection container. An attempt will be made to extract sufficient DNA from any volume submitted. (Minimum: 5.0 mL)
4. Solid Tissue:
   • Paraffin-Embedded Tissue: A paraffin block must be submitted. (Slides or paraffin shavings are not acceptable.) Submit a 10% formalin-fixed, paraffin-embedded block with corresponding H&E slide. Average tissue size: 5.0 mm².

• All specimen types should be sent to the Laboratory immediately for processing.
• DNA will be assessed for quality. If it is deemed unacceptable, testing will be cancelled with client notification.
• The specimen must be accompanied by a completed requisition and must contain the patient name, hospital and visit number, date of birth, collection date, ordering physician, and source of specimen.

Physician Office/Draw Specimen Preparation

Maintain whole blood, bone marrow, and spinal fluid at room temperature (20-26°C or 68-78.8°F) or refrigerated (2-8°C or 36-46°F) prior to transport. Maintain paraffin-embedded tissue at room temperature (20-26°C or 68-78.8°F).

Preparation for Courier Transport

Transport: Paraffin-embedded tissue at room temperature (20-26°C or 68-78.8°F), blood, bone marrow, or spinal fluid, refrigerated (2-8°C or 36-46°F).

Rejection Criteria

• Anticoagulants other than EDTA or heparin.
• Clotted peripheral blood or bone marrow.
• Fresh or frozen tissue specimens.
• Decalcified tissue.
• Fixatives other than 10% neutral buffered formalin (e.g. zinc formalin)
• Improper labeling or inadequate information. 
• Less than 10 percent tumor cellularity, at discretion of medical director.
• Poor quality and/or quantity of extracted genomic DNA.

Inpatient Specimen Preparation

Specimens at Royal Oak may be sent to the Surgical Pathology tube station, #201. In-house specimens are also picked up by a Surgical Pathology assistant every hour on the hour.

In-Lab Processing

Maintain whole blood, bone marrow, and spinal fluid refrigerated (2-8°C or 36-46°F), or paraffin-embedded tissue at room temperature (20-26°C or 68-78.8°F) until testing.

Storage

Specimen Stability for Testing:

Blood, Bone Marrow, and Spinal Fluid
Room Temperature (20-26°C or 68-78.8°F): 72 hours
Refrigerated (2-8°C or 36-46°F): 72 hours
Frozen (-20°C/-4°F or below): Unacceptable

Paraffin-Embedded Tissue
Room Temperature (20-26°C or 68-78.8°F): Indefinitely
Refrigerated (2-8°C or 36-46°F): Unacceptable
Frozen (-20°C/-4°F or below): Unacceptable

Specimen Storage in Department Prior to Disposal:

Refrigerated (2-8°C or 36-46°F): 7 days

Laboratory

Royal Oak Clinical Molecular Pathology Laboratory

Performed

Monday – Friday.
Results available in 10 business days.

Reference Range

An interpretive report will be provided.

Test Methodology

RNA extraction and analysis for BCR-ABL fusion transcript from whole blood or bone marrow using the reverse transcriptase and the polymerase chain reaction (RT-PCR) followed by high resolution capillary electrophoresis. 

Interpretation

An interpretive report will be provided.

Clinical Utility

Detection of a prominent IGH gene rearrangement is supportive of a neoplastic B-cell process. However, the results must always be interpreted in the context of other clinicopathologic information as non-neoplastic conditions (e.g., infectious and autoimmune processes) may yield a monoclonal IGH gene rearrangement.

Limitations:

1. This test is neither 100% sensitive nor 100% specific.
2. False-positive results are not uncommon encountered with Polymerase Chain Reaction (PCR)-based assays. This is usually because the kinetics of end-point, competitive PCR are such that the true proportions of rearrangements present may not be maintained during amplification.
3. False-negative PCR results may occur if there is failure of primer binding or if the rearrangement involves a segment that is not bound by the primers used in the assay. False-negative results will also occur if the clonal cells have not rearranged the TCR-gamma genes being evaluated or are present below the sensitivity of the assay (approximately 1-5% of abnormal nucleated cells).
4. This assay cannot determine whether a clonal rearrangement is physiologic or neoplastic.
5. This assay cannot be utilized to definitively assign lineage (i.e., B-cell vs. T-cell) to a neoplastic process.

Reference

1. Coad JE, et al. Molecular Assessment of Clonality in Lymphoproliferative Disorders: I. Immunoglobulin Gene Rearrangements. Mol Diagnosis 1996 Mar;1(4):335-55.

CPT Codes

81261

Contacts

Last Updated

3/22/2021