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D-dimer immunofluorescent quantitative test strip and preparation method thereof

An immunofluorescence and dimer technology, applied in the field of immunological detection, can solve the problems of poor accuracy of results, complex reagents, and inaccurate results, and achieve the effects of good precision, good storage stability and high accuracy.

Active Publication Date: 2017-02-15
ZHONGSHAN CHUANGYI BIOCHEM ENG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Latex agglutination method can only detect qualitatively, but cannot measure the change of D-dimer content in plasma; the operation of ELISA is easily affected by the change of enzyme activity, and the result is not very accurate; Influenced by blood lipids, the accuracy of the results is poor; the reaction specificity of latex turbidimetry is not good, and the reagents required are relatively complicated

Method used

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  • D-dimer immunofluorescent quantitative test strip and preparation method thereof
  • D-dimer immunofluorescent quantitative test strip and preparation method thereof
  • D-dimer immunofluorescent quantitative test strip and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] The preparation process of the D-dimer immunofluorescence quantitative test strip is as follows:

[0026] (1) The preparation of preferred stock solution: the mass concentration of PB is 20mM, the percentage concentration of BSA is 1.8%, the percentage concentration of Tween-80 is 0.5%, the percentage concentration of glucose is 0.5%, the percentage concentration of glycine The percentage concentration of PEG4000 is 1%, the percentage concentration of PEG20000 is 1.5%, and the percentage concentration of Proclin300 is 0.03%. After mixing according to the above formula, filter and sterilize to prepare the storage solution;

[0027] (2) Preparation of the sample pad: soak the glass fiber membrane with the sample pad treatment solution for 10 minutes, place in a drying room at 37°C and 30% humidity, and dry for 3 hours to prepare the sample pad for use;

[0028] (3) Preparation of the bonding pad: Soak the glass cellulose membrane with the bonding pad treatment solution fo...

Embodiment 2

[0042] The D-dimer immunofluorescence quantitative test strip prepared in Example 1 is used to establish a standard curve and detect it, and the implementation method is as follows:

[0043](1) Establish a standard curve: use Sysmex D dimer concentration as the high and low value calibrator and mix and dilute to 200ng / mL, 500ng / mL, 900ng / mL, 1800ng / mL, 3600ng / mL, 6000ng / mL, 8000ng / mL seven concentrations. Add 80 μL of prepared test strips to immunofluorescence analysis for detection, and repeat 3 times for each concentration to obtain the average value. Take the ratio of the T peak area from the detection line to the C peak area from the quality control line as the ordinate, and the theoretical value of the standard as the abscissa.

[0044] standard curve as figure 1 Shown; y=0.0023x-0.2779, R 2 =0.9966, this equation can be used to calculate the D-dimer content in the sample, to achieve quantification, and the correlation is good.

[0045] (2) Sample detection: D-dimer ...

Embodiment 3

[0048] Prepare the control storage solution, the specific formula is: the mass concentration of PB is 50mM, the percentage concentration of BSA is 1%, the percentage concentration of Tween-80 is 1%, the percentage concentration of glucose is 1%, and the percentage concentration of glycine 0.5%, the percentage concentration of PEG4000 is 2%, and the percentage concentration of Proclin300 is 0.3%.

[0049] The preferred storage solution prepared in Example 1 (hereinafter referred to as storage solution 2) is compared with the reference storage solution (hereinafter referred to as storage solution 1) for stabilizing performance and precision, and the implementation method and results are as follows:

[0050] Use storage solution 1 and storage solution 2 to spray and dry the D-dimer (D-Dimer) primary antibody-fluorescent microspheres labeled by the same process, assemble them into 40 test strips, put them in aluminum foil bags, and seal them with desiccant . One bag was stored in...

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Abstract

The invention discloses a D-dimer immunofluorescent quantitative test strip and a preparation method thereof. Compared with a test strip prepared from a common stock solution, the D-dimer immunofluorescent quantitative test strip prepared in the invention has better storage stability and higher precision, and in peak appearance of a detected sample, a higher signal, a flat baseline and high accuracy are realized.

Description

technical field [0001] The invention relates to the field of immunological detection, in particular to a D-dimer immunofluorescence quantitative test strip and a preparation method thereof. Background technique [0002] D-dimer is a polymer formed by coagulation of fibrinogen in blood by the action of thrombin, etc., and is a specific degradation product of cross-linked fibrin. Under normal physiological conditions, the body maintains a dynamic balance between coagulation and fibrinolysis to ensure the timely formation and removal of fibrin. When this balance is disrupted, intravascular coagulation tendency is enhanced, fibrin aggregates, fibrin degradation products increase, and D-dimer content increases. Therefore, the increase of D-dimer level reflects the dual activation of coagulation and fibrinolysis system in vivo, which can be used as one of the molecular markers of hypercoagulability and hyperfibrinolysis in vivo, and can be used to detect the course of many diseas...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/558G01N33/543G01N33/533
CPCG01N33/533G01N33/54393G01N33/558
Inventor 何平梁德智陈润文
Owner ZHONGSHAN CHUANGYI BIOCHEM ENG
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