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Test Code BCL2IGH Gene BCL2-IGH Gene Rearrangement,PCR

Performing Laboratory

Quest Diagnostics Nichols Insitute, Chantilly, VA

Methodology

Polymerase Chain Reaction (PCR) • Fragment Analysis

Reference Values

See Report

Test Classification and CPT Coding

81261

84999

Physician Office Specimen Requirements

Container/Tube: Lavender-top (EDTA) tube, or Soudium Heparin (Dark green), or tissue in lymph node transport bottle or Fine neddle aspirates

Specimen: Whole blood, bone marrow, fresh or frozen tissue, fixed-cell pellet 7 mL whole blood, 2 mL bone marrow,or 0.5 g tissue ( 3 mL whole blood min)

Transport Temperature: Room Temperature

Stability:

Whole blood/Bone marrow
Room temperature: 7 days
Refrigerated: 7 days
Frozen: Unacceptable

Formalin-fixed Paraffin-embedded tissue block (acceptable)
Room temperature: Indefinitely
Refrigerated: Indefinitely
Frozen: Unacceptable

Fresh, unfixed tissue (acceptable)
Room temperature: See instructions
Refrigerated: See instructions
Frozen -70°C: 1 year

Collection Instructions

 

Whole blood/bone marrow:
Collect whole blood or bone marrow in an EDTA (lavender-top) tube and ship refrigerated or room temperature. Stability of whole blood and bone marrow samples at room and refrigerated temperature is 7 days.

Fixed tissues (acceptable):
1 paraffin block (preferred) or 12 unstained sections on glass slides labeled with surgical case number (pathology report required, indicate if fixative is not formalin). Paraffin blocks are to be shipped at room temperature. Stability for paraffin blocks is indefinite. Do not freeze.

Fresh/unfixed tissue samples (acceptable):

Ship frozen on dry ice in tube labeled with specimen source and surgical case number; include preliminary pathology report. Frozen tissue is stable for approximately 1 year at -70°C. For tissue samples, fresh frozen tissue is preferred and to be shipped frozen. Frozen tissue is stable for approximately 1 year at -70°C. Tissues in formalin fixative or RPMI are to be shipped at room temperature or refrigerated.

Needle washings (acceptable):
In alcohol based fixative (eg. CytoLyt) are acceptable. Please include pathology report for all fresh FNA, frozen tissue and FFPE cases (partial/preliminary reports acceptable).

 

Used For

This assay, which interrogates the immunoglobulin heavy chain gene (IGH) by a PCR method based on the BIOMED-2 consensus, is useful for establishing clonality of B-cell lymphoid neoplasms and in the identification of minimal residual disease or early recurrence in patients with a previous diagnosis of a B-cell neoplasm. It can be used in association with the immunoglobulin kappa light chain (IGK test code 90363, or IGH/IGK combo test code 91635), since false-negative results can occur in up to 10-20% of B-cell malignancies when testing for IGH only. The highest rates of non-detectable IGH clonal rearrangements are in IGVH-mutated B-cell neoplasms such as follicular lymphoma and plasma cell neoplasms and in B-lymphoblastic leukemia/lymphoma due to absent or incomplete B-cell receptor

 

Computer Interface Code

PDM #  1859733