|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|
|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:|| |