Lymphocyte Clonality Panel, PCR

Test Code

91634

CPT Codes
81261, 81264, 81340, 81342, 84999

Includes

B-cell Gene Rearrangement (IGH, IGK)
T-cell Gene Rearrangement (TCRG, TCRB)
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 • Tissues in formalin fixative or RPMI

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/Bone marrow aspirate
Room temperature: 7 days
Refrigerated: 7 days
Frozen: Unacceptable

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

Fresh, 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 assay interrogates simultaneously the immunoglobulin kappa (IGK), the immunoglobulin heavy chain (IGH), the T-cell receptor beta (TCRB) and the T-cell receptor gamma (TCRG) genes by PCR methods based on the BIOMED-2 consensus. This combination assay will be most useful in diagnosing mixed B-cell and T-cell atypical infiltrates and for lineage identification in poorly differentiated or immature lymphoid malignancies.

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.