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AML1/ETO t(8;21) Quantitative, Real-Time PCR
Test Code14995X
CPT Codes
81401<br />
Preferred Specimen
3 mL whole blood or bone marrow collected in an EDTA (lavender-top) tube
Minimum Volume
1 mL whole blood or bone marrow
20 uL extracted RNA
20 uL extracted RNA
Other Acceptable Specimens
Whole blood or bone marrow collected in a Sodium heparin (green-top) or ACD-B (yellow-top) tube
50 uL of 10 ng/uL extracted RNA submitted in a microcentrifuge tube
Instructions:
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.
Instructions
Collect 3 mL of whole blood or bone marrow in a lavender-top (EDTA) tube, green-top (Heparin) or yellow-top (ACD) tube. Whole blood or bone marrow are shipped at room temperature or 4°C. Do not freeze whole blood or bone marrow. Record the draw time and date on the tube. Information regarding draw time and date is required to ensure stability of the sample is maintained.
Transport Temperature
Room temperature
Specimen Stability
Whole blood & bone marrow:
Room temperature: 5 days
Refrigerated: 5 days
Frozen: Unacceptable
Extracted RNA:
Room temperature: Unacceptable
Refrigerated: Preferred
Frozen: Acceptable
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Gross hemolysis • Clotted blood or bone marrow • Frozen samples
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.
Report Available
Reports in 5 days.
Clinical Significance
To detect AML1-ETO t (8;21) fusion transcript that is common in acute myeloid leukemia (AML) M2 subtype. Besides initial diagnosis and prognosis evaluation, this assay is intended to monitor the clinical course and effectiveness of therapy of Minimal Residual Disease (MRD). It may be valuable to monitor the disease trend in the same patient and predict the approaching relapse.
