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3-level thrombelastogram quality control product and application thereof

A technology of thromboelasticity and quality control products, which is applied in the field of quality control of coagulation testing items, to achieve the effects of cost reduction, good stability and repeatability, and rapid detection

Inactive Publication Date: 2015-11-25
北京乐普诊断科技股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] However, there is currently no report on the preparation of 3-level thromboelastometry quality control products using porcine plasma from a single animal plasma. Therefore, the present invention discloses for the first time the preparation of 3-level thromboelastometry by adding different concentrations of citrate anticoagulants to pig blood. Methods and Applications of Figure Quality Controls

Method used

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  • 3-level thrombelastogram quality control product and application thereof
  • 3-level thrombelastogram quality control product and application thereof
  • 3-level thrombelastogram quality control product and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] 1. Preparation of porcine plasma

[0035] Weigh 2.0g, 3.0g, and 4.0g of sodium citrate (AR) with an electronic balance, and distribute them in three 1000mL beakers. Add 100mL of distilled water each, dissolve and shake well. That is, 2%, 3% and 4% sodium citrate solutions of 3 different concentrations were obtained. Take 2700mL of fresh uncoagulated pig blood, and the color of pig blood should be dark red (dark red is the color of fresh pig blood, mainly to prevent the use of rotten pig blood). Divide into 3 equal parts, 900mL each, and mix them with sodium citrate solutions of different concentrations in 1000mL beakers to obtain 3 different anticoagulant concentrations of porcine plasma A1, A2, A3. Centrifuge at low speed, 4000r / min, centrifuge for 5 minutes, and take the supernatant plasma. The yield of pig plasma after centrifugation is shown in Table 1.

[0036] Table 1 Yield after centrifugation of pig plasma

[0037]

[0038] 2. Tissue factor purity test ...

Embodiment 2

[0043] 1. Thromboelastography test of quality control product Ⅰ

[0044] Take a bottle of quality control product I, accurately add 1mL of distilled water to redissolve, and place it at room temperature for more than 30min to keep the reagent at room temperature. Turn on the thrombelastograph and the connection terminal, and on the corresponding software interface, enter the quality control type, quality control batch number, and test type and select "L1" in the drop-down box. Load a set of sample cups on the channel of the thromboelastometer and pipette 20 μL of CaCl with a 20 μL pipette 2 into the sample cup. After adding the reagents, pipette 340 μL of the reconstituted quality control I into the sample cup. Quickly push the cup to the test position, turn the test rod to the "test" position, click "Start" or "Start" to start the test, and perform 3 parallel experiments. Table 2 shows the target value of quality control product I.

[0045] Table 2 Target value of quality ...

Embodiment 3

[0059] Test 10 quality control materials Ⅰ, Ⅱ and Ⅲ of the same batch with reagents, and test each item (R, K, Angel, MA) once, and calculate R (coagulation time), K ( Coagulation rate), Angel (angle between tangent and horizontal), MA (maximum amplitude) values ​​( ) and standard deviation (S 1 ); in the same way, any bottle in the 10 quality control products to be tested is continuously detected 2 times, and the mean value of the calculation results ( ) and standard deviation (S 2 ). Calculate the coefficient of variation (CV) according to formula (1), and the obtained result CV should be less than 10%.

[0060]

[0061]

[0062] When S 1 2 , let CV=0

[0063] Table 53 Horizontal thromboelastography quality control product bottle difference data

[0064]

[0065]

[0066]

[0067] The experimental results show that the CV values ​​of the thrombelastography quality control Ⅰ, quality control Ⅱ and quality control Ⅲ are all within 10%, and the stability ...

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Abstract

The invention relates to the field of quality control of blood coagulation testing items and provides a 3-level thrombelastogram quality control product. The quality control product is prepared by the following steps: respectively mixing pig blood with 3 different concentrations of sodium citrate, centrifuging, taking blood plasma, respectively adding a coagulation activator and a tissue factor and lyophilizing to prepare a powdery quality control product I, adding a coagulation activator and lyophilizing to prepare a powdery quality control product II, and adding a coagulation activator and human lyophilized platelets and lyophilizing to prepare a powdery quality control product III. The 3-level thrombelastogram quality control product provided by the invention is shaped as a lyophilized powder, can be used to monitor R and MA values simultaneously, is better used for quality control of an thromboelastography instrument and a thrombelastogram detection kit, is fast to detect, has accurate results and is simple to operate.

Description

technical field [0001] The invention relates to the field of quality control of blood coagulation test items, in particular to a 3-level thrombelastography quality control product used in a thromboelastography instrument or a thromboelastography detection kit and an application thereof. Background technique [0002] Blood product transfusion during operation is one of the important methods to ensure the safety of surgical patients during the perioperative period. With the development of my country's medical industry, the number of operations continues to increase, and the demand for blood products in the perioperative period also continues to increase, and the problem of scarcity of blood product resources has become increasingly prominent. At present, there are more objective standards for the indications of red blood cell transfusion in the world, but the indications for the transfusion of blood products related to the correction of coagulation function, such as fresh froz...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/96
CPCG01N33/96
Inventor 陈勇魏明明邱笑违
Owner 北京乐普诊断科技股份有限公司
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