CBFB/MYH11 inv(16), Quantitative Real-Time PCR

Message
For Specimen Integrity during Extreme Weather see the “Lockbox Usage in Extreme Weather” document at the top of this page.


Test Code
CBFBMY


CPT Codes
81401

Preferred Specimen
5 mL whole blood collected in an EDTA (lavender-top) tube, EDTA (royal blue-top) tube, or lithium heparin or sodium heparin (green-top) tube


Minimum Volume
2 mL whole blood • 1 mL bone marrow


Other Acceptable Specimens
3 mL bone marrow collected in an EDTA (lavender-top) tube, EDTA (royal blue-top) tube, or lithium heparin or sodium heparin (green-top) tube


Instructions
Stability Limitations: Sample must arrive in Chantilly Friday through Monday a.m. within 24 hours of collection.


Transport Temperature
Room temperature


Specimen Stability
Room temperature: 72 hours
Refrigerated: 72 hours
Frozen: Unacceptable


Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Clotted blood • Gross hemolysis


Methodology
Real-Time Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)

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
Tuesday Morning Report available: 6 Days


Reference Range
Negative


Clinical Significance

This Real-Time Quantitative (Reverse Transcription Polymerase Chain Reaction) for the amplification of CBFB/MYH11 fusion transcript can be used to detect the chromosome aberration of inv (16) or t (16;16). It can be used to detect Minimal Residual Disease (MRD) and assess the risk for disease relapse in inv (16) or t (16;16) Acute Myeloid Leukemia (AML).



Performing Laboratory
Quest Diagnostics Nichols Institute-San Juan Capistrano, CA
33608 Ortega Highway
San Juan Capistrano, CA 92675-2042



Last Updated: November 29, 2021


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.