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| UWHC Lab Test Details | |
|---|---|
| Test Name | T Cell Clonality |
| Test Code(s) | HCTCELLC |
| CPT Code(s) | T-Cell Clonality: 81342(gamma) and 81340(Beta) |
| Methodology | Real-Time PCR by fluorescent capillary electrophoresis |
| Clinical Information | These Gene Rearrangement Assays are useful for the study of:
|
| Days Performed | Once a week. |
| In-Lab Turnaround Time | 10 days. |
| Collection Requirements | |||
|---|---|---|---|
| Specimen | Formalin-fixed, paraffin embedded tissue, whole blood or bone marrow aspirate | ||
| Collection Container |
| ||
| Collection Instructions | Batched runs begin Monday or first working day of each week and 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.
| ||
| Collection Volume | 1 mL | ||
| Pediatric Collection Volume | 0.6 mL | ||
| Specimen Processing Requirements | |||||||
|---|---|---|---|---|---|---|---|
| Stability |
| ||||||
| 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. In order to ensure that molecular testing is conducted on a representative sample and a direct correlation of molecular results with morphologic findings is possible, a pathologist selects the specimen(s) and, whenever possible, identifies the suspicious or neoplastic cells submitted for molecular testing | ||||||
| Outreach Specimen Processing | Transport with a cold pack. Avoid excessive heat. | ||||||
| Specimen Transport | Transport at room temperatureor with a cold pack. Avoid excessive heat. | ||||||
| Unacceptable Criteria | Specimens processed in alternative fixatives and or frozen | ||||||
| Interpretation | |
|---|---|
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 clonal T-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 repertoire, multiple (usually ≥3), T-Cell receptor gene rearrangement(s) are reproducibly detected in the presence of a polyclonal background. 3. Negative. A clonal T-Cell receptor gene rearrangement was not detected in a polyclonal background. 4. Indeterminate. T-Cell receptor gene specific amplification products (clonal and/or polyclonal) were not detected or their level of amplification was below acceptable levels.
| |
| Test Limitations | The lower limit of detection for clonal tumor DNA in a normal DNA beckground 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 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). |
