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Serum-free quality control material for thromboelastography and its use

A thromboelastography, serum-free technology, applied in the serum-free quality control material, thromboelastography instrument serum-free quality control material field, can solve the problems of high price, high energy consumption, strict storage and transportation conditions, etc. The production process is simple, the test data is guaranteed, and the stability is good.

Active Publication Date: 2019-12-31
重庆鼎润医疗器械有限责任公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Imported products are expensive, about 100 RMB each, and not easy to buy (including users who buy their instruments)
Although domestic products are easier to obtain than imported products, the price is still not cheap. If users are required to check their instruments with quality control products every day, it will be a big burden for users
For the manufacturer, the production process is relatively long, the energy consumption is high, and it is easy to deteriorate and fail. The storage and transportation conditions are relatively strict, and it needs to be stored at a low temperature of 2-8 degrees.
Moreover, it cannot meet the calibration and inspection of instruments in the three states of low coagulation, hypercoagulation and normal coagulation.

Method used

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  • Serum-free quality control material for thromboelastography and its use
  • Serum-free quality control material for thromboelastography and its use
  • Serum-free quality control material for thromboelastography and its use

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] Embodiment 1, the simulated detection of blood coagulation parameter in normal state

[0021] The final result of the blood coagulation process is the formation of a blood clot, and the physical properties (speed, firmness, stability) of the blood clot will determine whether the patient has normal coagulation function, will bleed or form a thrombus. Thromboelastography monitors, measures, and analyzes the coagulation process of blood samples, and makes quantitative and qualitative predictions of the coagulation status of patients. As the clot forms, retracts, and / or dissolves, a computer-controlled thromboelastometer automatically records dynamic changes and draws a thromboelastogram (TEG). Thromboelastography is a dynamic, complete, continuous and true representation of the whole process of blood coagulation.

[0022] The R value represents the reaction time of coagulation factors, reflecting the comprehensive effect and overall activity of coagulation factors partici...

Embodiment 2

[0025] Embodiment 2, simulation detection of coagulation parameters in hypercoagulable state

[0026] The final result of the blood coagulation process is the formation of a blood clot, and the physical properties (speed, firmness, stability) of the blood clot will determine whether the patient has normal coagulation function, will bleed or form a thrombus. Thrombelastography (TEG) monitors, measures, and analyzes the coagulation process of blood samples to make quantitative and qualitative predictions of the coagulation status of patients. As the clot forms, retracts, and / or dissolves, a computer-controlled thromboelastometer automatically records dynamic changes and draws a thromboelastogram (TEG). Thromboelastography is a dynamic, complete, continuous and true representation of the whole process of blood coagulation.

[0027] The R value represents the reaction time of coagulation factors, reflecting the comprehensive effect and overall activity of coagulation factors part...

Embodiment 3

[0030] Embodiment 3, simulated detection of blood coagulation parameters in hypocoagulable state

[0031] Thromboelastography is a dynamic, complete, continuous and true representation of the whole process of blood coagulation. The R value represents the reaction time of coagulation factors, reflecting the comprehensive effect and overall activity of coagulation factors participating in the coagulation initiation process. Under normal conditions, the R value of human blood coagulation is between 4.0-8.0, and the present invention obtains an R value of 8.0 by adjusting the concentration of ABS (6.5%-7.5%) and PES (3%-7%) The simulated value between -9.1, its TEG pattern and parameters are very close to the value of human blood sample under low coagulation state, which proves that this serum-free quality control product can be used as a substitute for human low coagulation blood sample to carry out instrument calibration and inspection ( image 3 ).

[0032] The specific opera...

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Abstract

The invention relates to a serum-free quality control material for a thromboelastography (TEG) and use of the serum-free quality control material. The serum-free quality control material is prepared from the following components by weight percent: 3.5-25% of acrylamide and methylene diacrylamide mother liquor (24 to 1), 0.1-1% of tetramethyl ethylenediamine (TEMED), 1-15% of persulfate and 0.01% of stabilizer; water is used as a solvent, and inorganic polymers with definite chemical compositions are used; the serum-free quality control is simple in production process and low in cost, can be stored at the room temperature, and is good in stability; by controlling the concentration and amount of a catalyst, the kinetic parameters of the blood can be well simulated in three states of hypocoagulability, hypercoagulability and normal blood coagulation; a user can use very low cost to achieve the test or correction of operating states of the instrument in the three states of hypocoagulability, hypercoagulability and normal blood coagulation every day, thus guaranteeing the stability and reliability of test data.

Description

technical field [0001] The invention belongs to the field of quality control of blood coagulation test items, relates to a serum-free quality control product for a thrombelastography (TEG), and also relates to the application of the serum-free quality control product. Background technique [0002] Thromboelastography is used to monitor the coagulation state of blood samples to assist clinical evaluation of patients. Thromboelastography is widely used in the monitoring of postoperative bleeding and (or) thrombus formation during or after cardiac surgery, organ transplantation, tumor and radiotherapy. The instrument adopts the coagulation method to simulate the physiological blood coagulation conditions, and some reagent is added to start the blood coagulation reaction, so that the fibrinogen in the sample is converted into cross-linked fibrin, so that the sample coagulates. The motor inside the instrument drives the sample cup carrying the blood sample to rotate at a certain...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N33/96G01N33/86
CPCG01N33/86G01N33/96
Inventor 马永平邹忠良
Owner 重庆鼎润医疗器械有限责任公司
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