Method and detection kit for detecting ERBB2 gene amplification based on digital PCR technology

A gene amplification and technical detection technology, applied in the method and its detection kit, is based on the digital PCR technology to detect the ERBB2 gene amplification field, which can solve the real-time and dynamic monitoring of the ERBB2 gene state of tumor cells, which is disadvantageous to wide application, To solve the problem of high patient charges, to achieve convenient auxiliary diagnosis and clinical treatment guidance, improve the success rate, and achieve good results in data amplification
CN112553337APending Publication Date: 2021-03-26杭州求臻医学检验实验室有限公司
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Patent Information

Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
杭州求臻医学检验实验室有限公司
Publication Date
2021-03-26

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Abstract

The invention belongs to the technical field of molecular diagnosis, and particularly relates to a method and detection kit for detecting ERBB2 gene amplification based on a digital PCR technology. The kit comprises primer and probe premix liquid, wherein the premix liquid comprises upstream and downstream primers for detecting an ERBB2 gene, a fluorescent probe for detecting the ERBB2 gene, upstream and downstream primers for detecting a human ATCB reference gene, and a fluorescent probe for detecting the human ATCB reference gene. The method comprises the following steps of S1, providing a detection sample of a testee, wherein the detection sample is a plasma sample; S2, extracting ctDNA of a to-be-detected sample from the plasma sample in the step S1; S3, performing an amplification reaction on the sample extracted in the step S2 by using a digital PCR platform; and S4, analyzing and interpreting an amplification result. The ERBB2 gene amplification detection method provided by theinvention is based on a micro-droplet digital PCR detection system, reduces the interference of manual operation, has the advantages of stable result, high accuracy and good data amplification effect,and can be more conveniently used for auxiliary diagnosis and clinical treatment guidance.
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Description

technical field

[0001] The invention belongs to the technical field of molecular diagnosis, in particular to a method for detecting ERBB2 gene amplification based on digital PCR technology and a detection kit thereof. Background technique

[0002] The tyrosine kinase receptor ERBB2 (also known as ERBB2 / NEU) gene encodes a 185kDa transmembrane glycoprotein with tyrosine kinase activity and is a member of the EGFR family. Amplification or overexpression of the ERBB2 gene can lead to excessive proliferation of cells and the formation of tumors. Studies have shown that about 25% to 30% of invasive breast cancer and 80% of gastric cancer patients have ERBB2 gene amplification or protein overexpression.

[0003] ERBB2 amplification may be used to predict the body's sensitivity to ERBB2-targeted therapeutic drugs, such drugs include lapatinib, trastuzumab, pertuzumab, T-DM1, etc. Taking the earliest and most successful trastuzumab (Herceptin) as an example, clinical studies have ...

Claims

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