FISH, B-Cell Chronic Lymphocytic Leukemia Panel, Technical Component

Test Code
37885


CPT Codes
88271 (x5), 88275 (x5)<br /> Client Restricted - Tech Only Code

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


Minimum Volume
1 mL bone marrow • 3 mL whole blood • 5x5mm tissue


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 mm tumor tissue collected in transport media


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.


Transport Temperature
Room temperature


Specimen Stability
Room temperature: See instructions
Refrigerated: See instructions
Frozen: See instructions


Methodology
Fluorescence in situ Hybridization

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.