Kit for detecting CBFbeta-MYH11 fusion genes

Abstract

The invention relates to a kit for detecting CBFbeta-MYH11 fusion genes. The kit comprises a CBFbeta-MYH11 fusion gene amplification detection reagent group, which comprises a primer group and a detection probe used for amplifying the CBFbeta-MYH11 fusion gene. The kit can be used for detecting samples with the ultralow fusion proportion, so that the positive leakage inspection rate of the kit islower; the detection accuracy and sensitivity are higher. In addition, the kit has the advantages that the operation is simple, convenient and fast; the automatic degree is high; the cost is low; thefinal result judgment and reading are simple and objective; the detection sensitivity and accuracy are high, so that the result can be directly issued for the samples with positive and negative results detected by a digital PCR method. Generally, the kit has the advantages that the detection effect is good; the popularization is easy; good application prospects are realized.

Description

technical field [0001] The present invention relates to the detection field of CBFβ-MYH11 fusion, more particularly, relates to a kit for detecting CBFβ-MYH11 fusion. Background technique [0002] Clinically, acute myeloid leukemia (AML) can be divided into 8 subtypes according to the detection results of blood picture, bone marrow picture, cytochemical staining, and immunological staining, which are named M0-M7 respectively, and M4Eo is M4 subtype. A special type of acute myeloid leukemia, accounting for about 10% of acute myeloid leukemia. Myeloid and monocytic blasts in the patient's bone marrow were simultaneously malignantly proliferated, and eosinophils accounted for 5%-30%. Inv(16)(p13;q22) is found in more than 90% of AML-M4Eo patients, which is a non-random chromosomal abnormality, specifically the CBFβ gene on the long arm of chromosome 16 and the smooth muscle myosin heavy chain gene on the short arm (MYH11) fusion, forming two fusion genes, CBFβ-MYH11 and MYH11...

AI Technical Summary

Problems solved by technology

Although the results of fluorescence in situ hybridization (FISH) method are relatively intuitive, the test process is cumbersome, involving a wide variety of reagents, time-consuming and labor-intensive, and the results need to be interpreted by experienced professionals, and the result interpretation is relatively subjective

The simple RT-PCR method is for endpoint quantification, and cannot accurately estimate the amount of starting template

Currently the most widely used fluorescent PCR technology in the market has the advantages of high sensitivity of PCR, specificity of DNA hybridization and accurate quantification of spectral technology. The results are intuitive and can directly monitor changes in the PCR process. Compared with ordinary PCR, its The results can be observed in real time, the product does not need to be detected by gel electrophoresis, and the operation is completely closed, which effectively reduces the risk of PCR product contamination, but qPCR needs to prepare a standard curve every time, which greatly increases the cost, and the quantitative accuracy of PCR inhibitors, etc. The sensitivity of qPCR is relatively difficult to detect small residues, and the missed detection rate of positive samples with a very low fusion ratio is very high

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