BCL2::IGH translocation major breakpoint (MBR) by real-time PCR

CPT Code(s)

81401, G0452

Synonym(s)

Hematopathology, MBR, , follicular lymphoma, diffuse large B-cell lymphoma, BCL2::IGH, BCL2::IGH, BCL2/JH, t(14;18)

Performed

Molecular Diagnostics Laboratory

Clinical Indication and Relevance

The assay can confirm the initial diagnosis of major-breakpoint (MBR) BCL2::IGH translocation-positive follicular lymphoma or diffuse large B-cell lymphoma. It can also be used to monitor minimal residual disease in MBR-positive patients.

Methodology

DNA is isolated and amplified with specific primers targeting the BCL2/JH major breakpoint (MBR) using real-time PCR. PCR product is then sized by capillary gel electrophoresis. Results are reported as positive or negative for BCL2 MBR. The assay’s analytic detection limit is 1 tumor cell in 1000 normal cells.

Minimum Specimen Requirements

Collect

  • Peripheral blood (PB): 3-5 mL, in purple top (sodium EDTA) tube.
  • Bone marrow (BM): 1-3 mL, drawn into a syringe containing anticoagulant and then delivered in purple top tube.
  • Fresh or frozen tissue: fresh tissue should be obtained in a sterile manner, and a minimum 3 mm3 of tissue is required. Fresh tissue should be placed in culture medium for transport or snap frozen (see transport section below).
  • Formalin-fixed, paraffin-embedded (FFPE) tissue blocks: send tissue block to the lab, or contact lab for instructions regarding cutting paraffin sections for molecular studies.

Transport

  • PB or BM sample, deliver immediately at 2-8°C (wet ice or cold packs). Do not freeze.
  • Tissue samples should be delivered at room temperature in RPMI culture medium to the lab within 3 hours of collection, or snap frozen in liquid nitrogen at -70°C and packed in dry ice for delivery. Please do not allow frozen tissues to thaw.
  • Formalin-fixed paraffin-embedded tissue blocks can be delivered at room temperature.

Stability PB or BM samples: ambient – 1 hour; refrigerated – 48 hours. Unacceptable Samples

  • Serum or plasma; frozen PB or BM; clotted blood; severely hemolyzed samples
  • Paraffin tissue fixed in Zenker’s, B5, or Bouin’s fixatives
  • Bone marrow biopsy decalcified in formic acid

Turnaround time

Five to seven working days

View Requisition Sheet