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Kit for measuring content of D-dimer through latex immunoturbidimetry

An immunoturbidimetric and dimer technology, applied in the field of biotechnology and medical testing, can solve the problems of measurement sensitivity, low precision, narrow linear range, unstable latex, etc., and achieve the effect of expanding the linear range and improving the sensitivity.

Inactive Publication Date: 2019-01-15
山东艾科达生物科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Aiming at the defects of latex instability, low sensitivity and precision, and narrow linear range in the existing D-dimer assay kits, the present invention provides a double-particle-diameter latex D-dimer assay kit with good stability , high sensitivity and precision, wide linear range

Method used

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  • Kit for measuring content of D-dimer through latex immunoturbidimetry
  • Kit for measuring content of D-dimer through latex immunoturbidimetry
  • Kit for measuring content of D-dimer through latex immunoturbidimetry

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] Example 1 Preparation of the kit.

[0031] Reagent preparation

[0032] The concentration of Tris buffer was 0.1mol / L, and the pH was adjusted to 7.4 with concentrated hydrochloric acid. Then add sodium chloride and ProClin 300 to make the final concentrations respectively: 0.5mol / L and 0.02%. Among them, Tris buffer plays the role of stabilizing the pH value of the reaction system, while sodium chloride provides an ionic environment for the reaction system, and ProClin 300 acts as a preservative in the reaction system.

[0033] Reagent preparation

[0034] (1) Measure 2L of purified water, weigh 27.218g of potassium dihydrogen phosphate and 58.44g of sodium chloride respectively, add them into 2L of purified water, and fully dissolve at room temperature to obtain phosphate buffer.

[0035] (2) Add 100mL of phosphate buffer to 40mL of polystyrene latex particles with a particle size of 300nm, and then add 10mL of polystyrene latex particles with a particle size of 60...

Embodiment 2

[0043] Example 2 Determination of D-dimer using a kit.

[0044] Determination was carried out by an automatic coagulation analyzer, and the detection conditions were as follows: detection temperature: 37°C; detection wavelength: 575nm; reaction time: R1 reagent: 30s, R2 reagent: 90s; reagent dosage: R1 reagent: 100µL, R2 reagent: 100µL; Sample volume: 30µL.

[0045] detection limit

[0046] The test kit prepared in Example 1 tests 5% bovine serum albumin solution, repeats the test 20 times, calculates the mean value of 20 times to be 0.05, and the standard deviation is 0.02, and the detection limit of the kit is calculated to reach 0.09 μg / mL FEU, The detection sensitivity is high.

[0047] Table 1 The detection limit of the kit in Example 1

[0048] .

[0049] repeatability

[0050] The normal quality control plasma and the abnormal quality control plasma were loaded on the detection and analysis system respectively, and the quality control plasma was tested under repe...

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Abstract

The invention provides a kit for measuring the content of D-dimer through latex immunoturbidimetry. The kit comprises anti-human D-dimer antibody latex. The latex is formed by polystyrene latex microspheres which are mixed according to the volume ratio of (4-8):1, wherein the average grain diameters of the polystyrene latex microspheres are 300 nm and 60 nm. The anti-human D-dimer antibody latex is formed by polystyrene latex and an anti-human D-dimer antibody which are subjected to chemical crosslinking. According to the kit provided by the invention, the detection limit of the kit is lower than that of an existing similar kit, the detected linearity range, relativity and sensitivity are all higher than those of the existing kit, the detection sensitivity of the D-dimer is improved remarkably, the measurement linearity range of the D-dimer is enlarged, and the problems that the existing kit for measuring the D-dimer is low in detection sensitivity and precision degree and narrow in linearity range are solved.

Description

technical field [0001] The invention belongs to the fields of biotechnology and medical inspection, and in particular relates to a kit for measuring D-dimer content. Background technique [0002] The fibrinolytic system is the most important anticoagulant system in the human body. When a fibrin clot is formed, in the presence of plasminogen activator, plasminogen is activated and converted into plasmin, and the process of fibrinolysis begins. Plasmin degrades fibrin clots to form various soluble fragments, among which D-dimer (D-Dimer) is a specific degradation product of cross-linked fibrin, and it is also the smallest fragment in the degradation products. An increase in the level of D-dimer in plasma indicates that there is a secondary fibrinolytic process, first thrombin is generated, and then the fibrinolytic system is activated, which also reflects that the local plasmin activity or concentration in thrombus formation exceeds plasma 2 ‰ Antiplasmin activity or concentr...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/559G01N33/86
CPCG01N33/559G01N33/86
Inventor 谭柏清孔静宋文娟
Owner 山东艾科达生物科技有限公司
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