The AML1-ETO t(8;21)(q22;q22) is an in vitro diagnostic test for the identification and quantification of the AML1-ETO gene fusion transcripts resulting from t(8;21)(q22;q22) , by one-step Real-Time PCR.
The AML1-ETO t(8;21)(q22;q22) assay 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).
The device is intended for detecting the presence of gene fusion resulting from the t(8;21)(q22;q22), the most frequently observed chromosomal aberration associated with Acute Myeloid Leukemia (AML), and for determining disease status.
Acute myeloid leukemia (AML) with the t(8;21) (q22;q22) creating the AML1-ETO fusion gene is a distinct type of AML generally associated with a favorable prognosis.
The translocation t(8;21)(q22;q22) generates a fusion gene located on the derivative chromosome 8, composed of the ETO gene on chromosome 8 and the AML1 gene (also known as RUNX1) on chromosome 21. The AML1-ETO fusion gene and its transcripts can be detected by reverse transcriptase–polymerase chain reaction (RT-PCR). The detection of the AML1-ETO fusion gene allows patients to be assigned to the appropriate risk group for management.
- AML1-ETO fusion transcript
- Internal Control (IC): ABL gene
Standard for quantification:
Synthetic Nucleic Acids corresponding to gene fusion region AML1-ETO/ABL (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.