Human chorionic gonadotropin detection kit, preparation method and application method thereof

A chorionic gonadotropin and detection kit technology, which is applied in the direction of biological testing, measuring devices, material inspection products, etc., can solve the problems of unfavorable automatic detection, low technical sensitivity, unfavorable popularization, etc., and achieve favorable signal detection, The effect of high signal sensitivity and long platform stability period

Inactive Publication Date: 2018-12-21
TAIZHOU ZECEN BIOTECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] In China, human chorionic gonadotropin (Total-βhCG) is mainly detected clinically by latex set inhibition test and hemagglutination inhibition test; radioimmunoassay (RIA); enzyme-linked immunosorbent assay (ELISA); monoclonal antibody colloidal gold The test application is mainly used, and the price of imported reagents is very expensive, which brings a great economic burden to patients. automatic detection

Method used

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  • Human chorionic gonadotropin detection kit, preparation method and application method thereof
  • Human chorionic gonadotropin detection kit, preparation method and application method thereof
  • Human chorionic gonadotropin detection kit, preparation method and application method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0048] The coating antibody described in the present invention is a monoclonal antibody that can specifically bind to the human chorionic gonadotropin (Total-βhCG) antigen in the human body, and the labeled antibody is a monoclonal antibody that can specifically bind to the human chorionic gonadotropin (Total-βhCG) antigen. βhCG) antigen-specific binding monoclonal antibody. In addition to being capable of specifically binding to the human chorionic gonadotropin (Total-βhCG) antigen, the coating antibody and the labeled antibody can form a "sandwich" sandwich structure with the antigen when paired.

[0049] The human chorionic gonadotropin (Total-βhCG) antigen used in the present invention can adopt but not limited to the human chorionic gonadotropin (Total-βhCG) antigen of Fitzgerald company; The human chorionic gonadotropin (Total-βhCG) antigen used in the present invention ( Total-βhCG) coating antibody and labeled antibody can be used but not limited to human chorionic gon...

Embodiment 2

[0077] A human chorionic gonadotropin detection kit, the detection kit includes the following reagent components:

[0078] Calibrators, quality controls, anti-reagent A, anti-reagent B, magnetic particle reagents and luminescent substrates;

[0079] The calibrators and quality controls are prepared by dissolving the Total-βhCG antigen in a calibrator buffer solution to a constant volume of 0.3 mg / mL, and diluting it with a calibrator buffer solution after 20 min; the calibrator buffer solution includes the following components: bovine serum, tetracycline accounting for 0.01% by mass of the newborn bovine serum and neomycin sulfate accounting for 0.1% by mass of the newborn bovine serum, obtained by filtering through a 0.22 μm filter membrane;

[0080] Calibrators and quality controls were calibrated to different concentrations with calibrator buffer (see the table below for specific concentrations):

[0081] Reagent name

Target Concentration (mIU / mL)

Calib...

Embodiment 3

[0104] A human chorionic gonadotropin detection kit, the detection kit includes the following reagent components:

[0105] Calibrators, quality controls, anti-reagent A, anti-reagent B, magnetic particle reagents and luminescent substrates;

[0106] The calibrators and quality controls are prepared by dissolving the Total-βhCG antigen in a calibrator buffer to a volume of 0.8 mg / mL, and diluting it with a calibrator buffer after 40 min; the calibrator buffer includes the following components: bovine serum, tetracycline accounting for 0.05% by mass of the newborn bovine serum and neomycin sulfate accounting for 0.5% by mass of the newborn bovine serum, obtained by filtering through a 0.22 μm filter membrane;

[0107] The anti-reagent A is prepared by adding fluorescein isothiocyanate-labeled Total-βhCG coating antibody to Tris salt buffer; the Tris salt buffer includes the following components: Tris salt 0.5mM, accounting for the Tris Tetracycline at 0.05% by volume of the sal...

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Abstract

The invention discloses a human chorionic gonadotropin detection kit, a preparation and an application method thereof. The kit comprises a calibrator, a quality control serum, an anti-reagent A, an anti-reagent B, a magnetic particle reagent and a luminescent substrate. The calibrator and the quality control serum are prepared by first dissolving a Total-[beta]hCG antigen with a protein-containingbuffer solution, and then diluting the protein-containing buffer solution to a fresh bovine serum-containing buffer solution; the anti-reagent A is a Total-[beta]hCG coating antibody labeled by a fluorescein isothiocyanate, and the anti-reagent B is a Total-[beta]hCG labeled antibody labeled by a alkaline phosphatase; the magnetic particle reagent is prepared by coupling the fluorescein isothiocyanate antibody with magnetic particles. The invention also relates to a preparation method of the kit and a method for quantitatively detecting the content of human chorionic gonadotropin (Total-[beta]hCG) in human serum by using the kit. According to the human chorionic gonadotropin detection kit, the preparation and the application method thereof, the kit is reliable in performance, high in sensitivity, wide in linear range, and can be used in conjunction with semi-automatic and full-automatic instruments.

Description

technical field [0001] The invention relates to the technical field of in vitro detection, in particular to a human chorionic gonadotropin detection kit and a preparation method and use method thereof. Background technique [0002] Human Chorionic Gonadotropin (Total-βhCG) is a glycoprotein secreted by trophoblast cells of the placenta, which is composed of α- and β-dimer glycoproteins. Human chorionic gonadotropin has the functions of FSH and LH, maintains the life of the menstrual corpus luteum, and increases the menstrual corpus luteum to become the pregnancy corpus luteum. Promotes the aromatization of androgens into estrogens while stimulating the formation of progesterone. Inhibit the stimulating effect of phytohemagglutinin on lymphocytes, human chorionic gonadotropin can be adsorbed on the surface of trophoblasts, so as to prevent embryonic trophoblast cells from being attacked by maternal lymphocytes. LH-like function, before the fetal pituitary gland secretes LH,...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/76G01N33/68G01N33/58G01N33/558G01N33/543G01N33/533
CPCG01N33/76G01N33/533G01N33/54326G01N33/558G01N33/582G01N33/68
Inventor 刘振鹏刘振世刘振国汪丹薛黎侯军霞
Owner TAIZHOU ZECEN BIOTECH CO LTD
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