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AML1/ETO t(8;21) Quantitative, Real-Time PCR
Test Code14995
CPT Codes
81401<br><br><br data-cke-filler="true">
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 10 ng/uL extracted RNA
Other Acceptable Specimens
Whole blood collected in EDTA (royal blue-top) tube, or sodium heparin (green-top) tube • Bone marrow collected in a sodium heparin (green-top) tube, or ACD solution B (yellow-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 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.
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
Whole blood and bone marrow: Room temperature
Extracted RNA: Refrigerated (cold packs)
Extracted RNA: Refrigerated (cold packs)
Specimen Stability
Whole blood and bone marrow
Room temperature: 5 days
Refrigerated: 5 days
Frozen: Unacceptable
Extracted RNA
Room temperature: Unacceptable
Refrigerated: Preferred
Frozen: Acceptable
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
Set up: Tues; Report available: 6 days
Reference Range
Negative
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.
