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Reference material for assaying d-dimer

A standard substance and dimer technology, applied in the field of clinical examination, can solve the problems of stable supply, insufficient, low concentration, etc., and achieve the effect of improving diagnostic sensitivity and specificity

Active Publication Date: 2006-08-30
SYSMEX CORP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

Such a standard substance is preferable in terms of the same reactivity, but the concentration of D-dimer is not stable, or its concentration is low, and it is not enough to obtain a desired standard curve.
In addition, human-derived raw materials are also problematic in terms of stable supply

Method used

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  • Reference material for assaying d-dimer
  • Reference material for assaying d-dimer
  • Reference material for assaying d-dimer

Examples

Experimental program
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Effect test

Embodiment 1

[0054] (1) Preparation of fibrin

[0055] Starting from human fibrinogen as a starting material, fibrin blocks were prepared in the following procedure. Purified fibrinogen raw material (manufactured by Enzyme Research Laboratories) was dissolved in 50 mM TBS (Tris 50 mM, NaCl 0.15 mM, pH 7.4) to a concentration of 5 mg / mL, and calcium chloride (final concentration 25 mM, manufactured by Kishida Chemical Co., Ltd.), After factor XIII (final concentration 10 μg / ml, Fibrogammin preparation), human thrombin (final concentration 2 U / ml, manufactured by Mitsubishi Wool Pharma Co., Ltd.) was added. The mixture was incubated at 37°C for 18 hours to obtain fibrin in the form of a gel. The resulting gel was washed with 50 mM TBS (pH 7.4) for 1 hour to remove water, then transferred to a glass eggplant-shaped bottle, freeze-dried and pulverized with a PE2049 freeze-drying device (manufactured by Memoto Vacuum Technology Co., Ltd.) to obtain fibrin powder.

[0056] (2) Decomposition st...

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Abstract

The present invention relates to a reference material for assaying D-dimer, comprising a fibrin degradation product, wherein no less than 70 % of a total peak area has the molecular weight of no less than 500,000 in a molecular weight distribution of the fibrin degradation product, measured by gel filtration chromatography.

Description

technical field [0001] The present invention relates to the field of clinical inspection, in particular to a standard substance for D-dimer measurement which can be used in D-dimer measurement. Background technique [0002] Methods for measuring D-dimer are known in clinical examinations, especially in the field of blood coagulation-fibrinolysis examinations. D-dimer is one of the molecular markers of blood coagulation. Through its determination, it is useful for the diagnosis of blood coagulation, hyperfibrinolytic system, various embolisms or DIC (Diffuse Intravascular Coagulation Syndrome), and the diagnosis of the above diseases. Indexes for grasping pathological conditions and judging therapeutic effects are important. [0003] The so-called D-dimer (D-dimer) is a polymer formed by the coagulation of fibrinogen in the blood by the action of thrombin, etc. - the fibrin obtained by decomposing stabilized fibrin by enzymes such as plasmin Degradants are a general term fo...

Claims

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Application Information

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IPC IPC(8): G01N33/68
CPCC07K16/18Y10T436/105831
Inventor 奥田昌宏竹下浩生
Owner SYSMEX CORP
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