Real-time RT-PCR for quantitative detection of the t(8;21) RUNX1-RUNX1T1 fusion transcript (formerly called AML1-ETO). Analytical sensitivity is 1 tumor cell in 100,000 normal cells. Positive results are reported as a ratio between quantities of (8;21) transcript and a normal control gene.
The (8;21) translocation occurs in approximately 5% of AML. These cases are usually considered core-binding factor AML (CBF-AML). The translocation is usually associated with a high rate of complete remission and longer overall survival in AML subtype M2. This assay is recommended for diagnostic confirmation of and for monitoring minimal residual disease (MRD). c-KIT mutation testing may be considered for t(8;21)-positive AML patients as c-KIT mutations are considered an adverse risk factor in these patients.
- Peripheral blood: 5 mL in EDTA tube.
- Bone marrow: 2 mL in EDTA tube.
Note: Test is RNA-based. Please select Extract & Hold – RNA if specimen hold service is desired.
Use cold pack for transport, making sure cold pack is not in direct contact with specimen. Ship same day as drawn whenever possible; specimens <72 hours old preferred.
7 days