FISH, AML, CBFB/MYH11, Inversion 16

Test Code
10635


CPT Codes
88271 (x2), 88275

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


Minimum Volume
1 mL


Other Acceptable Specimens
Whole blood or bone marrow collected in: 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 information should be submitted with test order.

Specimen requirements: 3-5 mL whole blood or 1-3 mL bone marrow collected in a sodium heparin tube.

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

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


Transport Temperature
Room temperature


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


Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Received frozen


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 CBFB rearrangements such as inversion (16) and translocation t(16;16), by FISH (fluorescence in situ hybridization). This assay is useful for diagnosis of acute myeloid leukemia (AML) with inv(16) or t(16;16); CBFB-MYH11.


Performing Laboratory
Quest Diagnostics Nichols Institute
14225 Newbrook Dr
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.