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

Test Code

91445

CPT Codes
81342, 81340, 84999 (HCPCS: G0452)

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

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 formalin-fixed, paraffin-embedded 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.

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

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

A.M. Sets up 2 days a week.

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.

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.