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D-Dimer measuring kit (latex immunonephelometry method)

A technology of latex immunity and dimer, which is applied in the field of medical immunology in vitro diagnosis, can solve the problems of low overall sensitivity of dimer detection kits, restrictions on the routine development of detection items, and expensive imported kits, so as to achieve accurate detection data Reliable, low detection cost, less disturbing effect

Active Publication Date: 2010-09-01
SHANGHAI SUNBIO TECH
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AI Technical Summary

Problems solved by technology

[0005] The latex agglutination method is simple and fast, and is suitable for emergency detection, but it can only be used for qualitative or semi-quantitative determination, often used as a screening; enzyme-linked immunosorbent assay (ELISA) method is accurate, quantitative, and has high sensitivity. However, the operation requirements are strict and time-consuming, and it is not suitable for the timely diagnosis and treatment of emergency and clinical patients; the fluorescent antibody detection method is based on ELISA combined with fluorescence detection, which has high sensitivity and has a good consistency with the ELISA method. However, the instrument is expensive and difficult to popularize in small and medium-sized hospitals; the immunogold standard method has the characteristics of simple and fast operation of the latex agglutination method, and has the characteristics of accuracy and quantification of the ELISA method, but the determination of rheumatoid factor, heparin and blood lipids has certain limitations. Interference; Latex immunoturbidimetry has the advantages of simple operation, rapidity, accurate quantification, high sensitivity, and specificity, and can meet the needs of outpatient and emergency departments, and is more and more widely used in clinical research
However, the existing commercially available commercial D-dimer assay kits prepared by this method have low overall sensitivity and poor stability after opening the bottle; while imported kits are expensive and the detection cost is high, which limits the detection. Routine development of the project

Method used

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  • D-Dimer measuring kit (latex immunonephelometry method)
  • D-Dimer measuring kit (latex immunonephelometry method)
  • D-Dimer measuring kit (latex immunonephelometry method)

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0050] 1. Preparation of detection kit:

[0051] 1. D-dimer R 1 Reagent preparation: the concentration of DIPSO is 50mmol / L, and the pH value is 7.4 after adjusting with sodium hydroxide. Then add sodium chloride, PEG-8000, and sodium azide, and the final concentrations are: 0.85% sodium chloride, PEG-80005%, and 0.1% sodium azide.

[0052] 2. D-dimer R 2 Reagent preparation:

[0053] (1) Preparation of carboxylated modified polystyrene latex solution

[0054] a. Add 150 mL of deionized water, 0.2 g of emulsifier sodium dodecyl sulfate (SDS), nonylphenol polyoxyethylene ether (OP -10) 1.0 g, purged with argon for 0.5 hours. Heat in a water bath to 50-60°C, stir, and when the emulsifier is completely dissolved, add 20 g of styrene core monomer to emulsify the monomer for 30-40 minutes. The solution was heated up to 80°C, and stirred at this temperature for 10 minutes to equilibrate, 10 mL of initiator solution (0.2 g of potassium persulfate dissolved in 10 mL of deionized...

Embodiment 2

[0102] 1. The composition and preparation method of the detection kit

[0103] 1. D-dimer R 1 Reagent preparation: the concentration of HEPES is 50mmol / L, and the pH value is 7.5 after adjusting with sodium hydroxide. Potassium chloride, PEG8000, and Proclin300 (purchased from SUPELCO, active ingredients are MCI and CMCI) were added, and the final concentrations were: potassium chloride 0.8%, PEG80002%, and Proclin3000.05%.

[0104] 2. D-dimer R 2 Reagent preparation:

[0105] Add 0.5 ml of deionized distilled water to the lyophilized product containing 250 μg of mouse anti-human D-dimer monoclonal antibody (purchased from American Diagnostica Inc., product number ADI No. 300, clone number DD-3B6 / 22). Take 100 μl of the solution, dilute it with 5ml of 0.12M phosphate buffer (pH 7.4), add the carboxylated modified polystyrene latex solution prepared in Example 1, then add 2mg of EDC, stir and react at 4°C for 6 hours, add 0.2ml 0.1mol / L glycine buffer solution (pH 8.2) was ...

Embodiment 3

[0121] 1. The composition and preparation method of the detection kit

[0122] 1. D-dimer R 1 Reagent preparation: the concentration of Tris is 50mmol / L, and the pH value is 8.5 after adjusting with hydrochloric acid. Then add sodium sulfate, PEG6000, and thimerosal, the final concentrations of which are respectively: 0.7% sodium sulfate, PEG60004%, and 0.01% thimerosal.

[0123] 2. D-dimer R 2 The reagent is a latex reagent:

[0124] Add 0.5 ml of deionized distilled water to the lyophilized product containing 250 μg of mouse anti-human D-dimer monoclonal antibody (purchased from American Diagnostica Inc., product number ADI No. 300, clone number DD-3B6 / 22). Take 100 μl of the solution, dilute it with 5ml 0.12M PBS buffer (pH 7.4), add the carboxylated modified polystyrene latex solution prepared in Example 1, then add 2mg EDC, stir and react at 4°C for 6 hours, add 0.2 mL of 0.1mol / L glycine buffer solution (pH 8.2) was stirred for 30 minutes to stop the reaction, centri...

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Abstract

The invention relates to a kit for measuring the D-Dimer content by adopting a latex immunonephelometry method. The kit comprises a D-Dimer reagent R1, a D-Dimer reagent R2, a D-Dimer diluent and a D-Dimer calibration product, wherein the D-Dimer reagent R1 comprises a buffering solution, a stabilizing agent (1), coagulant and preservative; the D-Dimer reagent R2 comprises mouse anti-human D-Dimer monoclonal antibody latex enhanced particles, a buffering solution, a stabilizing agent (2) and preservative; the D-Dimer diluent comprises a buffering solution and preservative; and the D-Dimer calibration product is prepared by subpacking and freeze-drying a solution comprising a fibrin degradation product D-Dimer, a buffering solution, a stabilizing agent (3), excipient and preservative. The kit has the advantages of simple and rapid operation, accurate quantification, high sensitivity, strong specificity, low detection cost and strong instrument compatibility and is suitable for being popularized and used in various big-scale and small-scale hospitals.

Description

technical field [0001] The invention relates to a kit for measuring the content of D-dimer (D-Dimer) in a sample, in particular to a kit for measuring the content of D-dimer (D-Dimer) by latex immunoturbidimetric method, which belongs to medicine Immunodiagnostic field. Background technique [0002] The fibrinolysis system (fibrinolysis system) is the most important anticoagulant system in the human body. It plays an important role in maintaining the normal permeability of blood vessel walls, maintaining blood flow and tissue repair. The system consists of 4 main parts: Plasminogen, plasminogen activator (such as t-PA, u-PA), plasmin (plasmin), plasmin inhibitor (plasmin inhibitor, such as PAI-1, PAI -2, α2-AP). When a fibrin clot forms, in the presence of t-PA, plasminogen is activated and converted to plasmin, the fibrinolytic process begins, plasmin degrades fibrinogen and cross-links fibrin to form Various soluble fragments, collectively referred to as fibrin (ogen) d...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/543G01N33/577
Inventor 谢永华朱美萍许付
Owner SHANGHAI SUNBIO TECH
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