Human epidermal growth factor receptor Her-2/neu quantitative detection kit and preparation method and application thereof

Abstract

The invention provides a human epidermal growth factor receptor Her-2 / neu quantitative detection kit and a preparation method and application thereof. The kit is prepared through the magnetic particle chemiluminescent immunoassay, wherein a reconstructed Her-2 / neu antigen serves as a standard substance antigen and is diluted to a protein buffer component containing a non-ionic surfactant, the dispersity of the antigen is improved, autoagglutination is prevented, and the activity is maintained; besides, the Her-2 / neu protein antigen and magnetic particles are coupled, and the stability of a magnetic separation component is good by means of the optimized curing method and the blocking method; besides, by means of combined use of a multi-component immune complex and Roche active interference-eliminating proteins MAK33, the heterophil antibody interference in tumor marker sandwich method detection can be solved, and specificity of a finished product is improved. The kit is excellent in property, low in cost and long in validity period.

Description

technical field [0001] The invention belongs to the field of medical and biological immunological detection reagents, in particular to a human epidermal growth factor receptor Her-2 / neu quantitative detection kit and its preparation method and application, more specifically, to a magnetic particle separation Kit for quantitative detection of tumor marker human epidermal growth factor receptor Her-2 / neu by chemiluminescence method and preparation method thereof, and method for quantitative detection of tumor marker human epidermal growth factor receptor Her-2 / neu by using the kit . Background technique [0002] The human epidermal growth factor receptor Her-2 / neu gene is a proto-oncogene originally discovered in the DNA of chemically induced rat neuroblastoma and glioblastoma, also known as c-erB2, It consists of 922 adenines, 1,382 cytosines, 1,346 guanines and 880 thymines. It is located on human chromosome 17q21 and encodes a transmembrane glycoprotein (p185) with a relat...

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Problems solved by technology

HER2 gene overexpression occurs in about 30% of breast cancers and is associated with poorer prognosis

Breast cancer patients with HER2 overexpression have rapid disease progression, short chemotherapy remission period, poor endocrine therapy effect, low disease-free survival and overall survival

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