D-dimer detection kit and use method thereof

A detection kit and dimer technology, applied in the direction of measurement device, analysis by chemical reaction of materials, instruments, etc., can solve the problems of cumbersome operation and narrow detection range, simplify the operation steps, meet the requirements of rapid diagnosis, The effect of improving the detection speed

Active Publication Date: 2018-04-20
NANTONG EGENS BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0005] Therefore, the technical problem to be solved by the present invention is that the existing D-dimer detection kit uses plasma or serum as a sample, which has the defects of cumbersome operation and narrow detection range, thereby providing a method that can directly use whole blood as a sample and detect A wide range of D-dimer detection kits; further, the present invention also provides a method for using the detection kit

Method used

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  • D-dimer detection kit and use method thereof

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Embodiment 1

[0054] The preparation of embodiment 1 enzyme conjugate

[0055] 1. Weigh 3mg of Traut's reagent, and prepare a solution with a concentration of 1.376mg / mL with 100mmol / L triethanolamine buffer (pH=8.5±0.05); weigh 0.5mg of D-dimer labeled antibody, and use 100mmol / L triethanolamine buffer solution (pH=8.5 ± 0.05) was prepared into a solution with a concentration of 2mg / mL, and to it was added a concentration of 1.376mg / mL of Traut's solution, D-dimer labeled antibody and Traut The molar ratio of 's reagent is 1:15, mix immediately, and react at room temperature for 15 minutes. Add the glycine solution of 1mmol / L, the amount of substance of glycine is 10 of the amount of 4-(N-maleimidomethyl) cyclohexane-1-carboxylic acid sulfosuccinimide ester sodium salt substance times, mix immediately, and react at room temperature for 10 minutes. Desalted and replaced with 100 mmol / L triethanolamine cross-linking buffer (pH=7.3±0.05).

[0056] 2. Weigh 3 mg of 4-(N-maleimidomethyl) cyc...

Embodiment 2

[0060] The preparation of embodiment 2 enzyme conjugates

[0061] 1. Weigh 3mg of Traut's reagent, and prepare a solution with a concentration of 1.3mg / mL with 100mmol / L triethanolamine buffer solution (pH=8.5±0.05); weigh 0.5mg of D-dimer labeled antibody, and use 100mmol / L triethanolamine buffer solution (pH=8.5 ± 0.05) was prepared into a solution with a concentration of 5mg / mL, and to it was added a concentration of 1.3mg / mL Traut's solution, D-dimer labeled antibody and Traut The molar ratio of 's reagent is 1:10, mix immediately, and react at room temperature for 12 minutes. Add the glycine solution of 1mmol / L, the amount of substance of glycine is 20% of the amount of 4-(N-maleimidomethyl) cyclohexane-1-carboxylic acid sulfosuccinimide ester sodium salt substance times, mix immediately, and react at room temperature for 12 minutes. Desalted and replaced with 100 mmol / L triethanolamine cross-linking buffer (pH=7.3±0.05).

[0062] 2. Weigh 3 mg of 4-(N-maleimidomethyl)...

Embodiment 3

[0066] The preparation of embodiment 3 enzyme conjugates

[0067]1. Weigh 3mg of Traut's reagent, and prepare a solution with a concentration of 1.5mg / mL with 100mmol / L triethanolamine buffer solution (pH=8.5±0.05); weigh 0.5mg of D-dimer labeled antibody, and use 100mmol / L triethanolamine buffer solution (pH=8.5±0.05) was prepared into a solution with a concentration of 2.5mg / mL, and to which was added a concentration of 1.5mg / mL Traut's solution, D-dimer labeled antibody and The molar ratio of Traut's reagent was 1:15, mixed immediately, and reacted at room temperature for 18 minutes. Add the glycine solution of 1mmol / L, the amount of substance of glycine is 15% of the amount of 4-(N-maleimidomethyl) cyclohexane-1-carboxylic acid sulfosuccinimide ester sodium salt substance times, mix immediately, and react at room temperature for 10 minutes. Desalted and replaced with 100 mmol / L triethanolamine cross-linking buffer (pH=7.3±0.05).

[0068] 2. Weigh 3 mg of 4-(N-maleimidom...

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Abstract

The invention belongs to the field of in vitro diagnosis kits, and concretely relates to a D-dimer detection kit and a use method thereof. The D-dimer detection kit comprises a calibration product, areagent R1, an enzyme conjugate working solution R2, a magnetic bead conjugate working solution M, a cleaning solution and a chemiluminescent substrate, and the reagent R1 contains an imidazole component, so blood cells in the whole blood can be quickly eliminated to effectively avoid the possibility of blood cells swallowing magnetic beads. The kit can directly use fingertip whole blood or anticoagulant venous whole blood as a sample to be tested, and can directly detect the whole blood sample without preprocessing the whole blood sample, so the detection speed is greatly improved, the operation steps are simplified, the application range of the kit is enlarged, and large-scale promotion and application are easy.

Description

technical field [0001] The invention belongs to the field of in vitro diagnostic kits, and in particular relates to a D-dimer detection kit and a use method thereof. Background technique [0002] The fibrinolytic system is the most important anticoagulant system in the human body. It plays an important role in maintaining the normal permeability of the blood vessel wall, maintaining blood flow and tissue repair. The system consists of 4 main parts: plasminogen , plasminogen activator, plasmin and plasmin inhibitor. When a fibrin clot is formed, in the presence of plasminogen activators, plasminogen is activated and converted into plasmin, the process of fibrinolysis begins, and plasmin degrades the fibrin clot to form various soluble fragments, Fibrin degradation products (FDP) are formed. Among them, D-dimer is the smallest fragment in the degradation products, which is a specific degradation product of cross-linked fibrin, with a molecular weight of about 62ku and a half...

Claims

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Application Information

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IPC IPC(8): G01N33/543G01N33/535G01N33/531G01N21/76
CPCG01N21/76G01N33/531G01N33/535G01N33/54326
Inventor 王保君汤双双欧卫军徐艳褚晖
Owner NANTONG EGENS BIOTECH
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