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T-cell Receptor (TCR) Beta Gene Rearrangement, PCR
Test CodeTCELL BETA
Quest Code
91446
CPT Codes
81340, 84999 (HCPCS: G0452) (ZB0UP)
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
Whole blood or bone marrow aspirate collected in: Sodium heparin (green-top) tube • Formalin-fixed, paraffin-embedded tissue or fresh tissue
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
Fresh tissue: Frozen
All other specimens: Room temperature
All other specimens: 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 locus (TCRB) by a PCR method based on the BIOMED-2 consensus, is useful for establishing clonality of T-cell lymphoid neoplasms and identification of minimal residual disease or early recurrence in patients with a previous diagnosis of a T-cell neoplasm. It can be used in association with T-cell receptor (TCR) gamma PCR assay (Test code 90509), since false-negative results can occur in up to 5-10% of T-cell malignancies with TCRB PCR alone.
Performing Laboratory
Quest Diagnostics Nichols Institute
33608 Ortega Highway
San Juan Capistrano, CA 92675-2042