FISH, AML, CBFB/MYH11, Inversion 16, Technical Component

Test Code

37881

CPT Codes
88271 (x2), 88275<br>Restricted Client Code - Tech Only Code

Preferred Specimen

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

Minimum Volume

3 mL whole blood • 1 mL bone marrow

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

Methodology: FISH (fluorescence in situ hybridization) is performed to detect CBFB rearrangements. 200 interphase nuclei are scored for the probe set and are provided to the client for the purpose of determining rearrangements, gains, and/ or losses of the probe region.

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

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: 5 days

Reference Range

See Laboratory Report

Clinical Significance

This assay for CBFB-MYH11 rearrangements such as inv(16) and t(16:16) is useful for diagnosis of acute myeloid leukemia (AML) (M4) and less frequently in myelodysplastic syndromes (MDS).

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.