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Preparation method of d-dimer quality control substance

A technology of constitution and buffer solution, which is applied in the preparation of test samples, material inspection products, biological tests, etc., can solve problems such as interference with test results, test result errors, and impact on clinical results, and achieve simplified preparation processes, low cost, and The effect of simple and fast process

Inactive Publication Date: 2016-04-27
BLOOD TRASFUSION INST CHINESE ACAD OF MEDICAL SCI +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

The main raw material used in this technology is bovine plasma. Although the cost is saved, the obtained D-dimer substance is non-human and heterologous after all. The difference in the matrix may also interfere with the test results. To a certain extent, it cannot Represents the real situation inside the human body, and the test results obtained may have certain errors, which will affect the judgment of clinical results

Method used

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  • Preparation method of d-dimer quality control substance

Examples

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Embodiment 1

[0024] The preparation method of D-dimer quality control product, comprises the following steps:

[0025] (1) Preparation of enzyme complex solution: calcium chloride, thrombin, and urinary plasminogen activator are added to the buffer, so that their concentrations are respectively 0.03mol / L, 5U / ml, and 20mU / ml, and the obtained Incubate the enzyme complex solution at 37°C for 10-15 minutes;

[0026] (2) Preparation of fibrin clot: Incubate the mixed plasma of several people at 37°C for 5-10 minutes, mix it with the incubated enzyme complex solution, mix it upside down, and incubate at 37°C to form a fibrin clot piece;

[0027] (3) Preparation of D-dimer mother solution: wash the fibrin clot with buffer, squeeze out the plasma in the fibrin clot, then resuspend the fibrin clot with buffer, and incubate at 37°C for 1 hour , to dissolve the fibrin clot, add 2 μg / mL aprotinin, centrifuge at 10,000 g, 4°C for 15 minutes, collect the supernatant, and obtain the D-dimer mother sol...

Embodiment 2

[0032] The preparation method of D-dimer quality control product, comprises the following steps:

[0033] (1) Preparation of enzyme compound solution: calcium chloride, thrombin, and tissue plasminogen activator are added to the buffer solution so that their concentrations are respectively 0.01mol / L, 3U / ml, and 10mU / ml to obtain The enzyme complex solution was incubated at 37°C for 10-15 minutes;

[0034] (2) Preparation of fibrin clot: Incubate the mixed plasma of several people at 37°C for 5-10 minutes, mix with the incubated enzyme complex solution, invert and mix well, and incubate at 37°C to form a fibrin clot ;

[0035] (3) Preparation of D-dimer mother solution: wash the fibrin clot with buffer, squeeze out the plasma in the fibrin clot, then resuspend the fibrin clot with buffer, and incubate at 37°C for 0.5 hours , to dissolve the fibrin clot, add 10 μg / mL aprotinin, centrifuge at 10,000 g, 4°C for 15 minutes, collect the supernatant, and obtain the D-dimer mother s...

Embodiment 3

[0040] The preparation method of D-dimer quality control product, comprises the following steps:

[0041] (1) Preparation of enzyme complex solution: calcium chloride, thrombin, and streptokinase were added to the buffer to make their concentrations respectively 0.05mol / L, 1U / ml, and 5mU / ml, and the obtained enzyme complex solution was obtained at 37 Incubate at ℃ for 10-15 minutes;

[0042] (2) Preparation of fibrin clot: Incubate the mixed plasma of normal people at 37°C for 5-10 minutes, mix with the incubated enzyme complex solution, invert and mix well, and incubate at 37°C to form a fibrin clot ;

[0043] (3) Preparation of D-dimer mother solution: wash the fibrin clot with buffer, squeeze out the plasma in the fibrin clot, then resuspend the fibrin clot with buffer, and incubate at 37°C for 2 hours , to dissolve the fibrin clot, add 10 μg / mL aprotinin, centrifuge at 10,000 g, 4°C for 15 minutes, collect the supernatant, and obtain the D-dimer mother solution;

[0044] ...

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Abstract

The invention relates to a preparation method of a detection agent and specifically relates to a preparation method of D-dimer quality controls. The preparation method comprises the following steps: by taking the human plasma as a raw material, mixing the human plasma with an enzyme complex solution, incubating to form fibrin clots, washing the fibrin clots by use of a buffer solution, resuspending the fibrin clots by use of the buffer solution, dissolving the fibrin clots to form a D-dimer mother solution after incubation, adjusting the concentration of the D-dimer mother solution by use of the buffer solution, and adding the human normal mixed plasma to obtain the D-dimer quality controls different in concentration level. The preparation method of the D-dimer quality controls is simple and convenient in process, and low in cost. The human plasma is taken as the major raw material to directly prepare the fibrin; the fibrin dissolving process is as close to the natural fibrin dissolving process inside a human body as possible, and therefore, a product as similar to the human body inside product in properties and structure as possible can be obtained; the product is consistent with the D-dimer in the human body blood in state and properties under normal conditions or sick conditions.

Description

technical field [0001] The invention relates to a preparation method of a detection agent, in particular to a preparation method of a D-dimer quality control product. Background technique [0002] At present, thrombus formation is often found clinically through D-dimer or FDP detection, thereby helping the diagnosis of such diseases. D-dimer / FDP detection has the advantages of low detection cost, short result return time, high specificity, and high negative predictive value. [0003] In the detection of D-dimer, since the matrix of the test specimen is human plasma, if the matrix of the quality control product is the same or similar to that of human plasma, it will avoid the interference of the test results due to the different matrix, so as to better monitor the experiment accuracy and stability of the method. Usually, human plasma is directly used as a quality control product for the clinical detection of routine disease markers, but because the D-dimer content in normal...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N33/53
CPCG01N1/28G01N33/96
Inventor 苏娜林方昭谢兆林喻洪跃高翠华
Owner BLOOD TRASFUSION INST CHINESE ACAD OF MEDICAL SCI
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