B-cell Clonality Panel (IGH, IGK), PCR

Test Code

91635

CPT Codes
81261, 81264, 84999 (HCPCS: G0452)

Includes

Test includes pathologist interpretation

Preferred Specimen

5 mL whole blood collected in an EDTA (lavender-top) tube 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

Whole blood or bone marrow aspirate collected in a sodium heparin (green-top) tube • Formalin-fixed, paraffin-embedded tissue, fresh tissue, or tissues in formalin fixative or RPMI

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.

Transport Temperature

All other specimens: Room temperature
Fresh tissue: Frozen

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

Set up: Daily; Report Available: 5 days

Clinical Significance

This assay, which interrogates the immunoglobulin kappa light chain gene (IGK) and the immunoglobulin heavy chain (IGH), by a PCR method based on the BIOMED-2 consensus, is useful for establishing clonality of B-cell lymphoid neoplasms. It can be used also for identification of minimal residual disease or early recurrence in patients with a previous diagnosis of a B-cell neoplasm. Testing for both IGH and IGK gene rearrangements is reported to detect up to 99% of B-cell malignancies, compared to 80-90% for IGH and 85-90% for IGK alone.

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.