The PML-RARA t(15;17)(q22;q21) is an in vitro diagnostic test for the detection and identification of the PML-RARA gene fusions resulting from the t(15;17)(q22;q21) , by multiplex one-step Real-Time PCR.
The PML-RARA t(15;17)(q22;q21) allows also the detection and quantification of ABL as a endogenous control gene. Standard curves of known amounts of both the endogenous control and the gene fusion cDNA allow the calculation of the ratio of specific fusion transcript signal to endogenous control gene signal in each sample, allowing the identification of the minimal residual disease (MRD).
Promyelocytic leukemia/retinoic acid receptor alpha or PML-RARA refers to an abnormal fusion gene sequence. It is a specific rearrangement of genetic material from two separate chromosomes (chromosomal translocation) and is associated with a specific type of leukemia. This test detects and measures PML-RARA in the blood or bone marrow to determine if an individual has acute promyelocytic leukemia (APL), a subtype of acute myeloid leukemia (AML).
Targets (all in one Mix):
- PML-RARA BCR1 fusion transcript
- PML-RARA BCR2 fusion transcript
- PML-RARA BCR3 fusion transcript
- Internal Control (IC): ABL gene
Standard for quantification:
Synthetic Nucleic Acids corresponding to gene fusion region derived from PML-RARA and ABL as control gene (100.000 cps/µL - 100 cps/µL)
- Mononuclear cells isolated from whole blood collected in EDTA or Bone Marrow collected in EDTA
Real-Time PCR instruments:
- Applied Biosystems 7500 Fast (ThermoFisher SCIENTIFIC)
- Rotor-Gene Q MDx (RG-Q MDx - QIAGEN)
- CFX96 Real-Time PCR Detection System (Bio-Rad)
Manual Extraction with:
- RNeasy Mini Kit (QIAGEN)
Automatic Extraction with:
- CloNext 12 or CloNext 24 (ref. OP01018/OP01019). Robotic Workstation for the automatic purification of the nucleic acids.