Preparation method of D-dimer quality controls

A technology of dimer matrix and physique, applied in the preparation of test samples, material inspection products, biological testing, etc., can solve the problems of interference test results, clinical results, test result errors, etc., to simplify the preparation process, process Simple, quick and low-cost effect
CN104459103AInactive Publication Date: 2015-03-25BLOOD TRASFUSION INST CHINESE ACAD OF MEDICAL SCI +1
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Patent Information

Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
BLOOD TRASFUSION INST CHINESE ACAD OF MEDICAL SCI
Publication Date
2015-03-25
Estimated Expiration
Not applicable · inactive patent

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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.
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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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