FISH, APL, PML/RARA, Translocation 15, 17

Test Code
14617


CPT Codes
88275, 88271 (x2)

Includes
If results are not possible from the submitted specimen, the test order will be canceled and replaced with a Cytogenetics Communication.


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


Minimum Volume
1 mL bone marrow • 3 mL whole blood


Other Acceptable Specimens
Whole blood collected in: Sodium heparin (royal blue-top) tube or sodium heparin lead-free (tan-top) tube • Bone marrow collected in: Bone marrow transport tube (available upon request), sodium heparin (royal blue-top) tube, or sodium heparin lead-free (tan-top) tube


Instructions
Clinical history and reason for referral are required with test order. Prior therapy/transplant history should be submitted with test order.
⁠⁠⁠⁠⁠⁠⁠
Specimen viability decreases during transit. Send specimen to testing laboratory for viability determination. Do not freeze. Do not reject.


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: 5 days


Reference Range
See Laboratory Report


Clinical Significance
This test is performed to detect the PML-RARA fusion, t(15;17), by FISH (fluorescence in situ hybridization). This assay is useful for diagnosis and monitoring of acute promyelocytic leukemia.


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.