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T-cell Clonality Panel (TCRB, TCRG), PCR
Test CodeTCELL CLONALITY
Quest Code
91445
Alias/See Also
T-Cell Clonality
T Cell Clonality
T Cell Clonality
CPT Codes
81342, 81340, 84999 (HCPCS: G0452) (Z-Code ZB0UO and modify CPT 81479)
Includes
Pathologist Interpretation
Preferred Specimen
5 mL whole blood or 3 mL bone marrow aspirate collected in an EDTA (lavender-top) tube or
8 unstained charged (+) slides
8 unstained charged (+) slides
Minimum Volume
3 mL whole blood • 1 mL bone marrow aspirate • 4 unstained charged (+) slides
Other Acceptable Specimens
Sodium heparin (green-top) tube • Formalin-fixed, paraffin-embedded tissue • Fresh tissue in sterile transport tube
Instructions
8 unstained sections on glass slides labeled with surgical case number (pathology report required, indicate if fixative is not formalin). Please include pathology report for frozen tissue and FFPE cases (partial/preliminary reports acceptable).
Needle washings (acceptable): In alcohol based fixative (e.g. CytoLyt®) are acceptable.
Do not reject specimens, send to laboratory for screening.
Needle washings (acceptable): In alcohol based fixative (e.g. CytoLyt®) are acceptable.
Do not reject specimens, send to laboratory for screening.
Transport Temperature
Room temperature
Specimen Stability
Whole blood and bone marrow aspirate
Room temperature: 7 days
Refrigerated: 7 days
Frozen: Unacceptable
FFPE tissue/slides
Room temperature: 5 years
Refrigerated: 5 years
Frozen: Unacceptable
Fresh tissue
Room temperature: See Collection Instructions
Refrigerated: See Collection Instructions
Frozen -20° C: See Collection Instructions
Frozen -70° C: 1 year
Room temperature: 7 days
Refrigerated: 7 days
Frozen: Unacceptable
FFPE tissue/slides
Room temperature: 5 years
Refrigerated: 5 years
Frozen: Unacceptable
Fresh tissue
Room temperature: See Collection Instructions
Refrigerated: See Collection Instructions
Frozen -20° C: See Collection Instructions
Frozen -70° C: 1 year
Methodology
Polymerase Chain Reaction (PCR) • Fragment Analysis
FDA Status
This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.
Setup Schedule
Set up: Daily; Report available: 5 days
Reference Range
See Laboratory Report
Clinical Significance
This test, which interrogates both the T-cell receptor beta (TCRB) locus and the T-cell receptor gamma (TCRG) locus by a PCR method based on the BIOMED-2 consensus, is useful in patients with suspected T-cell malignancies or to evaluate for residual disease after treatment. Several published studies have demonstrated that the combination of TCRB and TCRG PCR using the BIOMED-2 method can detect virtually all clonal T-cell populations.
Performing Laboratory
Quest Diagnostics Nichols Institute
33608 Ortega Highway
San Juan Capistrano, CA 92675-2042