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Beta-human chorionic gonadotropin determination kit and preparation method thereof

A chorionic gonadotropin and kit technology is applied in membrane chromatography technology, labeling immunoassay technology, β-human chorionic gonadotropin assay kit, protein cross-linking technology field, and can solve the problem of high intensity and strong interference, etc. problems, to achieve the effect of rapid response, high sensitivity, and clear clinical significance

Inactive Publication Date: 2017-04-26
WEIHAI NEOPROBIO
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In the usual fluorescence measurement, because the test sample contains a variety of fluorescent components, the background fluorescence (scattered light caused by colloidal particles and solvent molecules in the

Method used

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  • Beta-human chorionic gonadotropin determination kit and preparation method thereof
  • Beta-human chorionic gonadotropin determination kit and preparation method thereof
  • Beta-human chorionic gonadotropin determination kit and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0044] The components of the test paper card in the β-human chorionic gonadotropin assay kit can be prepared by the following measures:

[0045] 1. Preparation of sample pad 2:

[0046] Soak the glass fiber membrane in the treatment solution containing 1.0% Triton X-100, 2.5% BSA, 0.15M Tris buffer, pH7.5, soak at 4°C for 4 hours, then place it in an oven and dry it at 37°C 2 hours.

[0047] 2. Preparation of binding pad 3 for absorbing fluorescent microsphere-labeled antibody:

[0048] Soak the glass fiber membrane in 150mM Tris-HCL treatment solution (containing 1.0% Triton X-100, 2.5% BSA, pH7.4), soak for 2 hours at 4°C, then take it out of the oven at 37°C and dry it for 4 hours, and set aside. The glass fiber membrane was placed on the Bio-DotXYZ3050 three-dimensional spraying platform, and the rare earth Eu 3+ The conjugated complex of anti-β-human chorionic gonadotropin monoclonal antibody labeled with fluorescent microspheres is sprayed onto the glass fiber membran...

Embodiment 2

[0057] Embodiment 2: accuracy test

[0058] Select the above test paper card and fluorescence immunochromatography analyzer (model: NEO-007),

[0059] Setting of the parameters of the fluorescence immunoassay analyzer: After setting the process parameters of the test paper card on the fluorescence immunoassay analyzer, take the above assembled test paper card and use 5, 500, 1000, 5000, 10000, 20000, 40000mIU / mL respectively The β-human chorionic gonadotropin calibrator is measured with a test paper card to obtain the fluorescence intensity value of each calibrator, and the result is input into the parameters of the analyzer to complete the parameter setting of the analyzer.

[0060] Main testing materials: clinical samples obtained from relevant hospitals, a total of 300 latex-enhanced immunoturbidimetric value samples, including 100 serum samples, 100 plasma samples, 100 whole blood samples, content distribution of β-human chorionic gonadotropin The interval is between 5-40...

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Abstract

The invention relates to the technical field of fluorescence immunochromatography in medical immunology, and in particular, relates to a beta-human chorionic gonadotropin determination kit and a preparation method thereof. The kit is provided with a test paper card and is characterized in that the test paper card is successively provided with a PVC plate, a sample pad, a combination pad, a cellulose nitrate membrane and a water absorbent pad from bottom to top, wherein the combination pad is adsorbed with rare earth Eu<3+> fluorescent microsphere-labeled beta-human chorionic gonadotropin monoclonal antibody, and rare earth fluorescent microspheres have the diameter of 150 nm, contain a rare earth lanthanide element Eu<3+>, are stable under a ground state and emit fluorescence with the wavelength of 615 nm under the action of a 337 nm excitation light source; the monoclonal antibody is a monoclonal antibody obtained by mixing after purification and is derived from monoclonal antibody cell lines for 2-6 different beta-human chorionic gonadotropin antigen epitopes; the kit has the advantages of simple operation, quick response, high sensitivity, high specificity and the like.

Description

[0001] Technical field: [0002] The invention relates to the technical field of fluorescence immunochromatography in medical immunology, including protein cross-linking technology, membrane chromatography technology, marker immunoassay technology and the like. Specifically, it is a beta-human chorionic gonadotropin assay kit and a production method that can quickly and accurately perform quantitative analysis of beta-human chorionic gonadotropin in samples such as serum, plasma, and whole blood. [0003] Background technique: [0004] Human chorionic gonadotropin (Human Chorionic Gonadotropin, HCG) is a kind of glycoprotein hormone secreted by placental trophoblast cells. It consists of two subunits, α and β, with a sugar content of about 30%. The α-subunit is composed of 92 amino acid residues and has a molecular weight of 14.5KD. It is similar in structure to the α-subunits of FSH, LH and TSH. The β-subunit is a specific chain composed of 145 amino acids and has a molecular ...

Claims

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Application Information

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IPC IPC(8): G01N33/76G01N33/577G01N33/558
CPCG01N33/76G01N33/558G01N33/577
Inventor 王有志王文亮刘衍亮陈萍萍宋璐琳李红江
Owner WEIHAI NEOPROBIO