Test Overview
Test Methodology

Real-Time Polymerase Chain Reaction (PCR)

Test Usage

This test qualitatively detects IGH/BCL2, t(14;18) translocations involving the mbr, mcr, and icr breakpoint regions in peripheral blood, bone marrow, and fresh, frozen, or paraffin-embedded tissues. The t(14;18) translocation is the most frequent recurrent cytogenetic abnormality in follicular lymphoma, occurring in up to 90% of cases. The t(14;18) may also be identified in up to 30% of cases of de novo diffuse large B-cell lymphoma. The translocation joins the immunoglobulin heavy chain (IGH) locus on chromosome 14 and the BCL2 proto-oncogene on chromosome 18. The chromosome 14 breakpoints occur within the joining region (JH) of IGH, while the chromosome 18 breakpoints cluster within several distinct regions. These include the major (mbr), minor (mcr), and intermediate (icr) breakpoint cluster regions, which collectively account for approximately 70-80% of t(14;18) associated lymphomas.

Reference Range *

Interpretive report provided.

* Reference ranges may change over time. Please refer to the original patient report when evaluating results.

Test Limitations

This assay will only detect rearrangements involving the major breakpoint region (mbr), minor cluster region (mcr) or intermediate cluster region. Together these breakpoint regions account for approximately 70-80% of t(14;18) associated lymphomas. In addition, this assay will not detect BCL2 rearrangements involving translocation partners other than IGH. The limit of detection of this assay is approximately 1 in 10,000 translocation-bearing cells. Translocations may not be detected in samples with a neoplastic burden below this level. In addition, IGH-BCL2 fusions have described in peripheral blood and reactive lymph nodes from individuals without other evidence of a neoplasm using sensitive methods like PCR.

Test Details
Days Set Up
Monday - Friday
Analytic Time

3 - 10 days

Soft Order Code
BCL2
MiChart Code
IGH/BCL2 t(14;18) Translocation by PCR
Synonyms
  • BCL2S
  • t(14;18) Translocation
  • IGH/BCL2 TRANSLOCATION ASSAY
  • BCL2
  • IGH/BCL2, t(14;18) Shadow
  • MLABEL
Laboratory
Molecular Diagnostics
Section
Molecular Diagnostics
Specimen Requirements
Collection Instructions

Collect blood or bone marrow in a lavender top tube. Refrigerate and send intact blood or bone marrow specimen within 48 hours of collection. Fresh tissue (preferably 0.5cm3, sent in RPMI) and fresh aspirates or body fluids are acceptable. Refrigerate and send, preferably within 24 hours. Frozen tissue specimens – preferably frozen with 1 hour of collection – may also be sent frozen on dry ice. Fresh cell suspensions in RPMI should be refrigerated and sent, preferably within 48 hours. Frozen cell suspensions – preferably frozen with 1 hour of collection – may also be sent frozen on dry ice. For formalin-fixed, paraffin-embedded tissue, a tissue block is preferred. Unstained, UNBAKED slides (5-8, 10-micron slides; 10-15 if few neoplastic cells are present) with associated H&E stained slide are also acceptable. Decalcified tissue or other fixatives will be accepted and the assay attempted, however these may result in failed testing due to degraded nucleic acid. Both blocks and slides should be stored at room temperature.

Alternate Specimen
The preferred specimen is whole blood or bone marrow collected in EDTA (lavender top). However, ACD (yellow top) and heparin (green top) may also be accepted. Previously extracted DNA may also be accepted.
Lavender Top Tube
Normal Volume
5 mL EDTA (lavender) whole blood; 3 mL EDTA (lavender) bone marrow; Fresh/frozen tissue and fresh aspirates or body fluids; Fresh/frozen cells in RPMI; Formalin-fixed, paraffin-embedded tissue. Extracted DNA is also acceptable if extracted in a CLIA certified laboratory.
Additional Information

By ordering this test the clinician acknowledges that informed consent has been obtained from the patient as required by applicable state or federal laws and the ordering clinician has authorization from the patient permitting MLabs to report the test results to the ordering clinician. Test includes pathologist interpretation of results billed as a separate additional charge. This test is not available without interpretation.

Billing
CPT Code
81278
Fee Code
NA113
Pro Fee CPT
G0452-26
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