FISH, B-Cell Chronic Lymphocytic Leukemia Panel

Test Code

16864

CPT Codes
88271 (x6), 88275 (x3)

Preferred Specimen

3 mL bone marrow or 5 mL whole blood collected a sodium heparin (green-top) tube

Minimum Volume

1 mL bone marrow • 3 mL whole blood

Other Acceptable Specimens

Bone marrow or whole blood collected in: Sodium heparin (royal blue-top) tube or sodium heparin lead-free (tan-top) tube • 5x5 tumor tissue collected in a transport media

Instructions

Bone marrow: 1-3 mL bone marrow in sodium heparin (green-top), (royal-blue-top) or lead-free (tan-top) tube. Ship room temperature. Do not freeze.
Whole blood: 3-5 mL whole blood collected in a sodium heparin (green-top), (royal-blue-top) or lead-free (tan-top) tube. Ship room temperature. Do not freeze.
Lymph node tissue: 5x5 mm in culture transport media. Ship room temperature.

Transport Temperature

Room temperature

Specimen Stability

Specimen viability decreases during transit. Send specimen to testing lab for viability determination. Do not freeze. Do not reject.

Methodology
Fluorescence in situ Hybridization (FISH)

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: 5-7 days

Clinical Significance

⁠⁠⁠⁠⁠⁠⁠This test is performed to detect the rearrangements of 6q21 (SEC63), 6q23 (MYB), ATM (11q22.3), centromere 12 (D12Z3), 13q14.3 (DLEU), 13q34 (LAMP1) and TP53 (17p13.1) regions, by FISH (fluorescence in situ hybridization). This assay is useful for prognostic assessment for chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).

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.