B Cell Clonality [BCELLC]

B Cell Clonality [BCELLC]
WSLH Department: Cytogenetics
WSLH Test Code:840C53
Includes:Detection of B-Cell Receptor Gene Rearrangement for Immunoglobulins IGH (Heavy Chain) and IGK (Kappa Chain).
Methodology:**(CPT Codes: 81261, 81264)** Real-Time PCR by fluorescent capillary electrophoresis
Availability:Once a week.
Turn-around Time:10 Days
Recommended Uses:Formalin-fixed, paraffin embedded tissue, whole blood or bone marrow aspirate
Contraindications: 
Specimen Requirements:1 mL Whole blood or Bone Marrow in EDTA (Lavender Top)
Collection Kit/Container: 
Patient Preparation: 
Collection Instructions:Batched runs begin on Monday or first working day of each week.
Specimen Handling and Transport:Three slides each containing 5 microns (uM) of FFPE tissue should be sent. Second slide should be H&E stained with the tumor circled. Please indicate percent tumor on Intra-Lab Send-Out Form. Blood/Bone Marrow Aspirate - Whole Blood. Do not centrifuge. Transport at room temperature. Outreach: Transport with a cold pack. Avoid excessive heat. Provider must contact patient's insurance about coverage for this molecular test and then counsel the patient on out-of-pocket costs.
Unacceptable Conditions:Blood/Bone Marrow Aspirate - Whole Blood. Do not centrifuge or freeze.
Requisition Form:Cytogenetics Lab Neoplasia Diagnosis Form #132
Required Information: 
Results include:A written interpretative report will be provided. Results will be reported as: *1. Positive. Consist with either mono- or bi-allelic rearrangement(s), one or two major clonal B-cell receptor gene rearrangement(s) were reproducibly detected in either the relative absence or presence of a polyclonal background. *2. Equivocal (oligoclonal). Consistent with a restricted cell receptor repretoire, multiple (usually ≥ 3), B-Cell receptor gene rearrangement(s) are reproducibly detected in the presence of a polyclonal background. *3. Negative. A clonal B-cell receptor gene rearrangement was not detected in a polyclonal background. *4. Indeterminate. B-Cell receptor gene specific amplification products (clonal and/or polyclonal) were not detected or their level of amplification was below acceptable levels. This would be most consistant with: a) few B-cells being present in the sample b) The quality of the DNA being poor; and c) a clonal signal was not detected due to somatic hypermutation in malignant B-cells.
Limitations:This method is qualitative. The lower limit of detection for clonal tumor DNA in a normal DNA background is approximately 5-10%. This test should not be used as the only criterion to form a clinical conclusion; instead, results should be correlated with other test results, patient symptoms and clinical presentation.
Additional Tests Recommended: 
Additional Comments:The performance characteristics of this test were validated by UWHC Clinical Laboratories. The U.S. Food and Drug Administration (FDA) has not approved or cleared this test; however, FDA approval or clearance is currently not required for clinical use of this test. The UWHC Clinical Laboratories is authorized under Clinical Laboratory Improvement Amendments (CLIA) to perform high-complexity testing.
Additional Tests Performed: 

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