Kit as well as preparation method and application thereof

A kit and reagent technology, applied in the field of drug detection, can solve the problems of poor sensitivity and repeatability, narrow linear range, and complicated operation of enzyme-linked immunosorbent assay.

Pending Publication Date: 2021-04-27
深圳天辰医疗科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Both colloidal gold test paper detection method and fluorescence immunochromatography method are chromatography methods. Both have the characteristics of convenience, quickness, and stable reagents. However, colloidal gold test paper detection method cannot currently achieve quantitative testing. Fluorescence immunochromatography The ratio of the test line or the ratio of the test line to the control line is used to determine the amount of the detected substance, but b

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  • Kit as well as preparation method and application thereof
  • Kit as well as preparation method and application thereof
  • Kit as well as preparation method and application thereof

Examples

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preparation example Construction

[0052] The present invention further proposes a preparation method of the kit as described above, comprising the following steps:

[0053] S10, adding the magnetic beads coated with streptavidin into the first buffer and mixing evenly to obtain the R1 reagent.

specific Embodiment approach

[0055] Mix 50mM Tris, 0.1% Tween-20, 0.1% Proclin300, 0.9% NaCl, and 1.2% BSA to obtain the first buffer solution with a pH value of 7.4, and dilute streptavidin magnetic beads with the first buffer solution to obtain 0.05%-0.1% magnetic bead solution coated with streptavidin is the R1 reagent.

[0056] S20. Mix the activated β-human chorionic gonadotropin monoclonal antibody with the enzyme solution to prepare enzyme-labeled β-human chorionic gonadotropin monoclonal antibody, and prepare the enzyme-labeled β-human chorionic gonadotropin monoclonal antibody The antibody was added to the second buffer and mixed evenly to obtain the R2 reagent.

[0057] Specifically, in the embodiment of the present invention, the preparation method of the enzyme-labeled β-human chorionic gonadotropin monoclonal antibody is as follows:

[0058] Add PBS buffer and EDC aqueous solution to β-human chorionic gonadotropin monoclonal antibody in turn, add enzyme solution after activation and mix well...

Embodiment 1

[0079] Example 1 Kit

[0080] R1 reagent: magnetic beads coated with streptavidin, the first buffer [50mM Tris, 0.1% Tween-20 (v / v), 0.1% Proclin300 (v / v), 0.9% NaCl (w / v) and 1.2% BSA (w / v)], wherein the pH value of the first buffer solution is 7.4, and the concentration of the magnetic beads coated with streptavidin is 0.05% mg / ml;

[0081] R2 reagent: enzyme-labeled β-human chorionic gonadotropin monoclonal antibody, second buffer [50mM MES, 0.1% Tween-20 (v / v), 0.1% Proclin300 (v / v), 0.9% NaCl ( w / v) and 1.2% BSA (w / v)], wherein the pH value of the second buffer solution is 6.5, and the mass ratio of beta human chorionic gonadotropin monoclonal antibody to enzyme is 5:6;

[0082] R3 reagent: biotin-labeled β-human chorionic gonadotropin monoclonal antibody, the third buffer [50mM Tris, 1% B-cyclodextrin (w / v), 1% BSA (w / v), 0.1% Temperature-20 (v / v), 0.9% NaCl (w / v) and 0.05% Proclin300 (v / v)], wherein, the pH value of the third buffer solution is 7.4, β human chorionic...

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Abstract

The invention discloses a kit as well as a preparation method and application thereof, and belongs to the technical field of drug detection. The kit is used for detecting the content of beta human chorionic gonadotropin. The kit comprises an R1 reagent, an R2 reagent and an R3 reagent; the R1 reagent comprises streptavidin-coated magnetic beads and a first buffer solution with a pH value of 7.2-7.6; the R2 reagent comprises an enzyme labeled beta human chorionic gonadotropin monoclonal antibody and a second buffer solution with the pH value of 6.3-6.7; and the R3 reagent comprises a biotin labeled beta human chorionic gonadotropin monoclonal antibody and a third buffer solution with the pH value of 7.2-7.6. When the kit provided by the invention is used for detecting the content of beta human chorionic gonadotropin, the sensitivity is high, and the stability and the repeatability are good.

Description

technical field [0001] The invention relates to the technical field of drug detection, in particular to a kit and its preparation method and application. Background technique [0002] Human chorionic gonadotropin (HCG) is a glycoprotein hormone secreted by placental syncytiotrophoblast cells. HCG enters the ovary from the placental trophoblast through the blood circulation, stimulates the corpus luteum to secrete progesterone to maintain the corpus luteum function, and keeps the endometrium suitable for embryo implantation. state of bed development. Serum β-HCG can be detected 6-7 days after fertilization. It is one of the earliest hormones secreted by female pregnancy hormones. The serum β-HCG of normal pregnant women increases with the increase of gestational age. Reliable indicators, but also an important indicator to determine whether the pregnancy is normal. There are differences in serum β-HCG levels among different pregnant individuals, and the main influencing fact...

Claims

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Application Information

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IPC IPC(8): G01N33/76
CPCG01N33/76
Inventor 黄美玲黄金浪唐灿
Owner 深圳天辰医疗科技有限公司
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