T Cell Clonality [TCELLC]

T Cell Clonality [TCELLC]
WSLH Department: Cytogenetics
WSLH Test Code:840C54
CPT Code: 
Includes:Detection of T-cell receptor gene rearrangements. If T-cell Receptor gamma (TCRG) result is equivocal, negative or indeterminate the test will proceed to the analysis of T-Cell receptor beta (TCRB).
Methodology:**(CPT Codes: 81342, 81340)** 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 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.
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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