T-Cell Clonality Panel (TCRB, TCRG), PCR

Test Code

91445

CPT Codes
81340, 81342, 84999

Includes

Pathologist Interpretation

Preferred Specimen

5 mL whole blood or 3 mL bone marrow aspirate collected in an EDTA (lavender-top) tube • 8 unstained positively charged slides

Minimum Volume

3 mL whole blood • 1 mL bone marrow aspirate • 4 slides • 1 block

Other Acceptable Specimens

Whole blood or bone marrow aspirate collected in a sodium heparin (green-top) tube • Formalin-fixed, paraffin-embedded tissue • Fresh Tissue

Instructions

Do not reject specimens, send to laboratory for screening.

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 (eg. CytoLyt) are acceptable.

Transport Temperature

Fresh tissue: Frozen
All other specimens: Room temperature

Specimen Stability

Whole blood and bone marrow aspirate
Room temperature: 7 days
Refrigerated: 7 days
Frozen: Unacceptable

FFPE/Slides
Room temperature: 5 years
Refrigerated: 5 years
Frozen: Unacceptable

Unfixed tissue (acceptable)
Room temperature: See instructions
Refrigerated: See 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
14225 Newbrook Drive
Chantilly, VA 20153

The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.