AML1/ETO gene fusion detection probe (AML1/ETO)

AML1/ETO [RUNX1/RUNX1T1 t(8; 21)] Gene Fusion Probe Detection Kit - 100µL/10 Tests

RUNX1 is a transcription factor that forms a complex with the cofactor CBFB. This complex provides stability to the RUNX1 protein which is involved in the generation of hematopoietic stem cells and for their differentiation into myeloid and lymphoid lines. Loss of RUNX1 function has been shown to impair differentiation between myeloid and lymphoid lines often resulting in the development of leukemia.

RUNX1T1 (RUNX1 Partner Transcriptional Co-Repressor 1) is a Protein Coding gene. Diseases associated with RUNX1T1 include Acute Myeloid Leukemia With T(8;21)(Q22;Q22) Translocation and Myeloid Leukemia. Among its related pathways are NF-kappaB Signaling. Gene Ontology (GO) annotations related to this gene include DNA-binding transcription factor activity and identical protein binding. 

Product Main Components

The kit consists of AML1/ETO dual-color probes

Intended use

This product is suitable for qualitative detection of AML1 / ETO fusion gene in bone marrow samples of leukemia patients. It is only used for the auxiliary diagnosis of molecular typing of treated patients. Leukemia is a kind of malignant clonal disease of hematopoietic stem cells. Clonal leukemia cells proliferate and accumulate in bone marrow and other hematopoietic tissues, infiltrate other non-hematopoietic tissues and organs, and inhibit normal hematopoietic function.

AML1 / ETO fusion gene is a common cytogenetic abnormality in patients with acute myeloid leukemia (AML). About 12% ~ 20% of AML patients have AML1 / ETO fusion gene, while the positive rate in AML-M2 leukemia is 20% ~ 40%, of which the positive rate in M2b subtype is as high as 90%, which is rare in other subtypes. Patients with simple AML1 / ETO fusion gene positive have better prognosis and high complete remission rate. This kit is only applicable to the detection of AML1 / ETO fusion gene status. The test results are only for clinical reference and should not be used as the only basis for patient diagnosis and treatment. Clinicians should comprehensively judge the test results in combination with other clinical test indicators and other factors.

Detection principle

Fluorescence in situ hybridization is a technique for directly observing specific nucleic acids in cells in vitro. According to the principle of base complementary pairing, the specific probe is complementary to the target sequence in the cell. Due to the fluorescence of the probe, the gene state of the hybrid probe and the target sequence can be clearly observed under the fluorescence microscope under the appropriate excitation light. The kit uses orange fluorescein to label ETO probe and green fluorescein to label AML1 probe. The two probes can be combined with the target detection site by in situ hybridization. Under normal conditions (AML1 / ETO gene does not fuse), it is displayed as two orange signals and two green signals under fluorescence microscope. When there is a fusion gene, the green and orange signals form a yellow fusion signal due to recombination.

Applicable Instruments

1. Fluorescence microscopy imaging system includes fluorescence microscope and filter sets. The kit is labeled with orange fluorescein, and the filter set compatible with the fluorescent labeled dye should be selected.

Orange fluorescence: The maximum excitation wavelength is 552nm and the maximum emission wavelength is 576nm.

Green fluorescence: The maximum excitation wavelength is 496nm and the maximum emission wavelength is 520nm.

Fluorescence microscopy imaging system should use a microscope with orange and green channels. For monochromatic channel microscope, image synthesis analysis results should be used.

2. Automatic hybridization instrument: Strict temperature uniformity is required, and the temperature difference should be ≤1o C.