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UWHC Lab Test Details | |
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Test Name | B Cell Clonality |
Test Code(s) | BCELLC |
CPT Code(s) | B-Cell Clonality: 81261(IGH) and 81264(IGK) |
Methodology | Real-Time PCR by fluorescent capillary electrophoresis |
Clinical Information | These Gene Rearrangement Assays are useful for the study of:
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Days Performed | Once a week. |
In-Lab Turnaround Time | 10 days. |
Collection Requirements | |||
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Specimen | Formalin-fixed, paraffin embedded tissue, whole blood or bone marrow aspirate | ||
Collection Container |
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Collection Instructions | Batched runs begin Monday or first working day of each week andon Wednesday of each week. FFPE tissue - The percentage of tumor in the specimen should be ≥20%. specimens with <20% tumor will be evaluated on a case by case basis to determine whether macro-dissection is possible based on the dispersal of cells.
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Collection Volume | 1 mL | ||
Pediatric Collection Volume | 0.6 mL |
Specimen Processing Requirements | |||||||
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Stability |
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Sample Analyzed | Tissue, whole blood, or bone marrow | ||||||
Testing Volume | 1 mL | ||||||
Pediatric Testing Volume | 0.6 mL | ||||||
Specimen Processing | 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 the H&E. | ||||||
Outreach Specimen Processing | Transport with a cold pack. Avoid excessive heat. | ||||||
Specimen Transport | Transport at room temperature or with a cold pack. Avoid excessive heat. | ||||||
Unacceptable Criteria | Specimens processed in alternative fixatives and or frozen |
Interpretation | |
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A written interpretative report will be provided by the laboratory.
This method is qualitative.
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. | |
Test Limitations | The lower limit of detection for clonal tumor DNA in a normal DNA background is approximately 5-10%.
Inadequate specimen collection, processing and storage may invalidate test results.
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 Information | 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.
A professional fee is associated with this test (CPT Code G0452). |