Real-time RT-PCR for quantitative detection of the t(15;17) PML-RARA fusion transcript using cell-free plasma DNA/RNA. Both long and short isoforms of the fusion transcript are detected.
The (15;17) translocation occurs in nearly all cases of acute promyelocytic leukemia (APL, or AML subtype M3). The translocation is associated with a high rate of complete remission due to sensitivity of leukemic cells to all trans-retinoic acid (ATRA). This assay is recommended for diagnostic confirmation and initiation of ATRA therapy, for monitoring minimal residual disease, and for detection of relapse. In addition, this test can be used for screening and determining if a bone marrow biopsy is an absolute necessity. It can also be used for performing molecular studies when a bone marrow sample is inadequate (dry tap, insufficient quantity, or not viable), or not available.
- Peripheral blood: 2 x 6 mL EDTA tubes (total 12 mL) or 10 mL in EDTA tube.
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.