A thrombosis elastic diagram instrument control product and its preparation methods and applications

A technology of thromboelastography and quality control products, which is applied in the direction of material inspection products and biological tests, can solve the problems of poor accuracy and stability, and achieve the effects of accurate value determination, high discrimination and good compatibility

Active Publication Date: 2019-09-20
SUZHOU INST OF BIOMEDICAL ENG & TECH CHINESE ACADEMY OF SCI
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] Therefore, the technical problem to be solved by the present invention is to overcome the defect of poor accuracy and stability of the quality control product of the elastography instrument in the prior art, and then provide a method that can quickly and effectively detect the accuracy, repeatability and stability of the elastography instrument. The quality control product is used to calibrate and debug the thrombelastograph, in order to obtain better detection results

Method used

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  • A thrombosis elastic diagram instrument control product and its preparation methods and applications
  • A thrombosis elastic diagram instrument control product and its preparation methods and applications
  • A thrombosis elastic diagram instrument control product and its preparation methods and applications

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Effect test

Embodiment 1

[0053] The invention provides a quality control product for a thromboelastography instrument, including a quality control product L1 and a quality control product L2;

[0054] Quality Control L1 includes raw materials in the following volume ratios:

[0055] Serum matrix solution 490, fibrinogen matrix solution 210, tissue factor 1.5, coagulation activator kaolin aqueous solution 10;

[0056] Quality Control L2 includes raw materials in the following volume ratios:

[0057] Serum matrix solution 650, fibrinogen matrix solution 50, tissue factor 1.5, coagulation activator kaolin aqueous solution 10;

[0058] Among them, the serum matrix solution is a mixed solution containing 8% of plasticizer mannitol and 5% of bovine serum albumin; solution; the mass concentration of kaolin aqueous solution is 1.0mg / mL; in the quality control product L1, the mass fraction of sodium citrate contained is 3.8‰, and the platelet content is 121×10 9 pc / L; in the quality control product L2, the ...

Embodiment 2

[0072] The invention provides a quality control product for a thromboelastography instrument, including a quality control product L1 and a quality control product L2;

[0073] Quality Control L1 includes raw materials in the following volume ratios:

[0074] Serum matrix solution 580, fibrinogen matrix solution 120, tissue factor 1.0, coagulation activator kaolin aqueous solution 6;

[0075] Quality Control L2 includes raw materials in the following volume ratios:

[0076] Serum matrix solution 620, fibrinogen matrix solution 80, tissue factor 2.0, coagulation activator kaolin aqueous solution 8;

[0077] Among them, the serum matrix solution is a mixed solution containing 8% plasticizer mannitol and 5% bovine serum albumin; the fibrinogen matrix solution is a mixed solution of fibrinogen and platelets; In the control product L1, the mass fraction of sodium citrate contained was 3.8‰, and the platelet content was 97×10 9 pc / L; in the quality control product L2, the mass fra...

Embodiment 3

[0091] The invention provides a quality control product for a thromboelastography instrument, including a quality control product L1 and a quality control product L2;

[0092] Quality Control L1 includes raw materials in the following volume ratios:

[0093] Serum matrix solution 400, fibrinogen matrix solution 300, tissue factor 2.0, coagulation activator kaolin aqueous solution 8;

[0094] Quality Control L2 includes raw materials in the following volume ratios:

[0095]Serum matrix solution 680, fibrinogen matrix solution 20, tissue factor 2.0, coagulation activator kaolin aqueous solution 6;

[0096] Wherein, the serum matrix solution is a mixed solution containing plasticizer glycine 5.6)% and sucrose 4.8%; the fibrinogen matrix solution is a fibrinogen saturated solution formed by dissolving fibrinogen and platelets in a Tris buffer at pH=7.6; The mass concentration of kaolin aqueous solution is 1.0 mg / mL; in the quality control product L1, the mass fraction of sodium ...

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Abstract

The invention belongs to the field of blood coagulation detection quality control and particularly relates to a thrombelastogram quality control product and a preparation method and application thereof. The quality control product comprises quality control products L1 and L2. Each one of the quality control products L1 and L2 is composed of a serum matrix fluid, a fibrinogen matrix fluid, a tissuefactor, an anticoagulant and a coagulation activator according to different ratios. Platelet content is controlled in a specific range, a shaping agent is used and a blood coagulation factor is not used so that the detection result is accurate and a calibrator function is obtained. The invention also provides a preparation method of the quality control product. The preparation method separates serum, fibrinogen and platelets in whole blood and accurately controls their contents so that the prepared quality control product has good accuracy and stability. The used serum and fibrinogen are derived from the unified blood system so that the product compatibility is good and the stability is further improved. The preparation method is simple, utilizes few additives and modulators and is easy to industrialize.

Description

technical field [0001] The invention belongs to the field of blood coagulation detection quality control, and in particular relates to a quality control product of a thromboelastography instrument and a preparation method and application thereof. Background technique [0002] Routine laboratory tests such as prothrombin time (PT), partial prothrombin time (PTT) or D-Dimer are only part of the isolated plasma and coagulation cascade reaction, that is, intrinsic or extrinsic coagulation bypass In the case of fibrinolysis or fibrinolysis, the whole process of blood coagulation is fragmented and partially traced, and the results are often affected by heparin substances. Thromboelastography (TEG) can completely monitor the whole process of blood samples from coagulation to clot formation and fibrinolysis, and realize the overall picture of coagulation in terms of coagulation factors, fibrinogen, platelet aggregation function and fibrinolysis. detection and evaluation. Because o...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N33/49
Inventor 刘元忠王弼陡梁伟国孙海旋杨语谌
Owner SUZHOU INST OF BIOMEDICAL ENG & TECH CHINESE ACADEMY OF SCI
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