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 • 5x5mm lymph node tissue collected in Culture Transport Medium

Instructions

Clinical history and reason for referral are required with test order. Prior therapy and transplant history should be provided with test order.

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

Note: If results are not possible, the test order may be canceled and replaced with a Cytogenetics Communication.

Transport Temperature

Room temperature

Specimen Stability

Room temperature: See Collection Instructions
Refrigerated: See Collection Instructions
Frozen: See Collection Instructions

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 the U.S. Food and Drug Administration. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

Setup Schedule

Set up: Daily; Report available: 8 days

Reference Range

See Laboratory Report

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.