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CBFB/MYH11 inv(16), Quantitative, Real-Time PCR
MessageTest Code
CPT Codes
81401
Preferred Specimen
Minimum Volume
Other Acceptable Specimens
Instructions
Do not reject specimens, send to laboratory for screening.
Collect 5 mL of whole blood or 3 mL bone marrow in an EDTA (lavender-top) tube. Whole blood or bone marrow is shipped at room temperature or refrigerated (cold packs). Do not freeze whole blood or bone marrow.
After collection of the sample, draw date and time, as well as sample type, must be written on the tube and included as requested information.
If the stability of the sample cannot be determined, delay in result or cancelation of test may occur. Clotted specimens are unacceptable.
Only accept extracted RNA when extraction or isolation is performed in an appropriately qualified laboratory such as a CLIA-certified laboratory or a laboratory meeting equivalent requirements as determined by the CAP and/ or CMS.
Transport Temperature
Extracted RNA: Refrigerated (cold packs)
Specimen Stability
Room temperature: 5 days
Refrigerated: 5 days
Frozen: Unacceptable
Extracted RNA
Room temperature: Unacceptable
Refrigerated: Preferred
Frozen: Acceptable
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
Reference Range
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