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Detection method for protamine sulfate paracoagulation experiment

A technology of protamine sulfate and detection method, which is applied to the measurement of scattering characteristics, can solve the problems of low accuracy, expensive reagents, and high cost, and achieve the effect of low cost, good application prospect, and effective detection

Inactive Publication Date: 2017-05-10
WEST CHINA HOSPITAL SICHUAN UNIV
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] At the Seventh National Thrombosis and Hemostasis Academic Conference in October 1999, the classic plasma protein paracoagulation test was proposed for the diagnosis of disseminated intravascular coagulation (DIC). However, due to its purely manual operation and visual judgment results, the accuracy is not high, and the clinical acceptance is not too high. At present, it tends to be replaced by more sensitive and specific D-dimer and fibrin degradation products (FDP).
The cost of D-dimer and fibrin degradation products detection is too high
The occurrence of DIC is firstly the appearance of fibrin monomer (FM), and the reagents for measuring fibrin monomer (FM) at present are quite expensive and require special instruments

Method used

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  • Detection method for protamine sulfate paracoagulation experiment
  • Detection method for protamine sulfate paracoagulation experiment
  • Detection method for protamine sulfate paracoagulation experiment

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] Embodiment 1 Protamine sulfate paracoagulation experimental detection method of the present invention

[0022] 1. Testing instruments and reagents

[0023] Optical coagulation analyzer, SYSMEX company CA7000.

[0024] Protamine sulfate reagent, protamine sulfate injection (5ml: 50mg) produced by Beijing Yuekang Kaiyue Pharmaceutical Co., Ltd., wherein the concentration of protamine sulfate is 0.01g / ml.

[0025] 2. Detection method

[0026] Add 120uL of plasma to the reaction tube, pre-warm at 37°C for 3 minutes, add 30uL of the mixed solution of protamine sulfate solution and normal saline (the volume ratio of protamine sulfate injection: normal saline is 1:1), and detect the reaction after adding reagents The scattered light intensity of the system changes.

[0027] Judgment criteria: within 600s, the response curve of the scattered light intensity does not change, and it is judged as negative (such as figure 1 shown); on the contrary, if the response curve of scat...

experiment example 1

[0029] Experimental Example 1 Sensitivity and specificity of the inventive method

[0030] 1. Experimental method

[0031] Optical coagulation analyzer, SYSMEX company CA7000, according to image 3 After setting the detection scheme (reagent volume, sample volume, sample addition time, reaction detection time, etc.), reagent name and location, the method in Example 1 is used to detect sensitivity and specificity.

[0032] 2. Experimental results

[0033] The ROC curve was made with the rising height of the curve (H1.25 in the figure), plasma coagulation time (T1.25 in the figure) and its ratio (ratio 1.25) and the gold standard; the ROC curve is as follows Figure 4 As shown, it can be seen that the height of the curve rise (dH) is positively correlated with the gold standard, and the reaction solidification time (T) is negatively correlated with the gold standard. The CUT OFF value of the curve rising height (dH) of the method of the present invention is 5.5, the sensitivi...

experiment example 2

[0035] Experimental example 2 Comparison of the inventive method with the existing protamine sulfate paracoagulation test method

[0036] The improved protamine sulfate coagulation experiment reported in the existing literature, in which 36uL protamine sulfate solution is used for every 120uL plasma, the ROC curve is as follows Figure 5 As shown, the area under the curve is 0.857.

[0037] It can be seen that the area under the curve of the detection method of the present invention is significantly higher than the area under the curve of the existing protamine sulfate paracoagulation experiment detection method, indicating that the detection accuracy of the method of the present invention is significantly higher.

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Abstract

The invention discloses a detection method for a protamine sulfate paracoagulation experiment. The detection method comprises the following steps of taking to-be-detected blood plasma; adding a protamine sulfate solution with the concentration of 0.005 g / ml; and if a fibrin clot forms and the intensity of scattered light of a sample gradually increases in a reaction system, using an instrument to describe the optical change as a coagulation curve, and recording the coagulation time (T) and the curve lifting height (dH) at the same time after the sample is completely coagulated and the intensity of the scattered light is stabilized. The method has the advantages that disseminated intravascular coagulation can be accurately and effectively screened, the cost is very low, the method is suitable for clinical batch screening, and the application prospect is very good.

Description

technical field [0001] The invention relates to a protamine sulfate paracoagulation experimental detection method. Background technique [0002] Disseminated intravascular coagulation (DIC) is not an independent disease, but the final common path of coagulation dysfunction in the progress of many diseases, and it is a clinicopathological syndrome. Due to the disseminated activation of the coagulation mechanism in the blood, extensive fibrin deposition in small blood vessels is promoted, resulting in tissue and organ damage; on the other hand, the consumption of coagulation factors causes systemic bleeding tendency. The two contradictory manifestations coexist in the development of DIC and constitute a unique clinical manifestation. Inducing multiple organ dysfunction syndrome in patients in whom DIC has been initiated will be the leading cause of death. There is no report on the incidence in China. DIC fatality rate as high as 31% to 80%. Therefore, it is particularly im...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N21/47
CPCG01N21/47
Inventor 周静杨新春张崇唯
Owner WEST CHINA HOSPITAL SICHUAN UNIV
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