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发明公开
CN108504742A 一种基于数字PCR技术检测HER-2基因拷贝数变异的试剂盒及方法 有权

一种基于数字PCR技术检测HER-2基因拷贝数变异的试剂盒及方法
摘要：
本发明提供了一种基于数字PCR技术检测HER-2基因拷贝数变异的试剂盒及方法。试剂盒包括：用于检测HER-2基因的两组引物对和检测探针以及三个内参基因CEP17、EIF2C1和EFTUD2的引物对和检测探针、数字PCR预混液、荧光素酶、ddH2O和校准文件。除此之外，本发明还提供了一种基于数字PCR技术检测HER-2基因拷贝数变异的方法，可排除第17号染色体多体、非整倍体以及着丝粒扩增的现象，用于准确判定HER-2基因扩增为阳性或者阴性的情况。
摘要（英）：

The invention provides a kit for detecting the copy number variation of an HER-2 gene by virtue of a digital PCR technique and a method. The kit comprises two groups of primer pairs and detection probes, a primer pair, a detection probe, a digital PCR premixed solution, luciferase, ddH2O and a calibration file, wherein the primer pairs and the detection probes are used for detecting the HER-2 gene, and the primer pair and the detection probe are used for detecting three reference genes CEP17, EIF2C1 and EFTUD2. Besides, the invention further provides a method for detecting the copy number variation of the HER-2 gene by virtue of the digital PCR technique. According to the method, phenomena of 17# chromosome multimer, aneuploid and centromere amplification can be eliminated, and the methodcan be used for accurately detecting whether the HER-2 gene is amplified to be positive or negative.

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