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CBFB/MYH11 inv(16), Quantitative, Real-Time PCR
Test Code14992
CPT Codes
81401<br />
Preferred Specimen
5 mL whole blood or 3 mL bone marrow collected in an EDTA (lavender-top) tube
Minimum Volume
2 mL whole blood • 1 mL bone marrow • 20 uL extracted RNA
Other Acceptable Specimens
Whole blood or bone marrow collected in EDTA (royal blue-top), lithium heparin (green-top) or sodium heparin (green-top) tube • 50 uL of 10 ng/uL extracted RNA submitted in a microcentrifuge tube
Instructions
Do not reject specimens, send to laboratory for screening.
Collect 5 mL whole blood (preferred) or 3 mL bone marrow (acceptable) 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 cancellation of test may occur.
Please note: 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.
Collect 5 mL whole blood (preferred) or 3 mL bone marrow (acceptable) 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 cancellation of test may occur.
Please note: 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
Room temperature
Specimen Stability
Whole blood/Bone marrow
Room temperature: 5 days
Refrigerated: 5 days
Frozen: Unacceptable
Room temperature: 5 days
Refrigerated: 5 days
Frozen: Unacceptable
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Gross hemolysis • Clotted blood
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 FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.
Setup Schedule
A.M. Sets up 1 day a week.
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).