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Thromboelastography quality control material and preparation method thereof

A technology of thromboelastography and quality control products, which is applied in the preparation of test samples, material inspection products, biological testing, etc., can solve the problems of no commercial supply and high price, and achieve the convenience of industrial production and sufficient sources , low biohazard risk effect

Active Publication Date: 2016-06-08
ZHEJIANG SHENGYU MEDICAL TECH CO LTD
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

After consulting the website of the State Food and Drug Administration, there are only two units that have obtained the registration approval for quality control products of thromboelastography: one is imported, the supply is restricted in the market, and the price is high; the other is domestically produced, and there is no commercial supply

Method used

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  • Thromboelastography quality control material and preparation method thereof
  • Thromboelastography quality control material and preparation method thereof
  • Thromboelastography quality control material and preparation method thereof

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Embodiment Construction

[0047] The invention discloses a method for preparing a quality control product of a thromboelastography instrument by using pig plasma. Those skilled in the art can learn from the content of this article and appropriately improve the process parameters to realize the method. It should be pointed out that all similar substitutions and modifications are obvious to those skilled in the art, and they are all considered to be included in the present invention. The method and application of the present invention have been described through preferred embodiments, and relevant personnel can obviously implement and apply the method and application described herein by making changes or appropriate changes and combinations without departing from the content, spirit and scope of the present invention Fundamentally invented technology. The raw materials and reagents used in the method for preparing the quality control product of thromboelastography instrument using animal plasma provided ...

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Abstract

The invention relates to the field of quality control of blood coagulation detection of a clinical thromboelastography, in particular to a thromboelastography quality control material and a preparation method thereof. The preparation method of the thromboelastography quality control material comprises the following steps of step 1, collecting fresh pig whole blood and separating plasma; step 2, dividing the plasma into two parts, wherein the first part is used for extracting fibrinogen and a blood coagulation factor, and the second part is used for properly diluting to obtain diluted plasma; step 3, adding extracted fibrinogen and blood coagulation factor into the diluted plasma to obtain a mother solution, and adjusting an R value, a K value, an Angle value and an MA value to be within the ranges of L1 and L2; step 4, performing subpackage and freeze drying on the solution obtained in the step 3 to obtain a final product. The quality control material prepared by the preparation method disclosed by the invention has two specifications of L1 and L2 and is good in stability; the demand that quality control over normal and abnormal blood samples is simulated in a test room can be met.

Description

technical field [0001] The invention relates to the field of quality control of blood coagulation detection items of a clinical thromboelastography instrument, in particular to a quality control product of a thromboelastography instrument and a preparation method thereof. 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. [0003] 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...

Claims

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Application Information

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IPC IPC(8): G01N33/96G01N1/28
CPCG01N1/28G01N33/96
Inventor 赵蕾严静杨柄飞
Owner ZHEJIANG SHENGYU MEDICAL TECH CO LTD
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