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Activated coagulation detection reagent and application thereof

A detection reagent and coagulation technology, applied in the field of activated coagulation detection reagent, to achieve the effects of good effect, low cost and stable properties

Active Publication Date: 2017-01-04
重庆鼎润医疗器械有限责任公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, lyophilized phospholipids will cause physical stability problems, and the steps of reconstitution are added during use, which also introduces additional variation factors that affect the test results. Therefore, it is more preferable to store phospholipids in an aqueous dispersion solution. Good choice

Method used

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  • Activated coagulation detection reagent and application thereof
  • Activated coagulation detection reagent and application thereof
  • Activated coagulation detection reagent and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] The preparation of embodiment 1 reagent

[0026] A kind of preparation of activated blood coagulation detection reagent is as follows:

[0027] Each component of described reagent is composed as follows:

[0028] Kaolin: 0.0024%

[0029] Mixed phospholipids: 20μg / mL

[0030] PVP40: 0.1%

[0031] Sodium azide: 0.02%

[0032] Betaine: 5mM

[0033] Phenol: 0.36%

[0034]The percentages are mass volume percentages, and the unit is g / ml.

[0035] Calculate according to the total volume of 1L and accurately weigh or measure the corresponding above-mentioned components, disperse evenly with distilled water, and set the volume to 1L. Stir evenly and dispense into sample tubes, 40 μL each.

[0036] The preparation of mixed phospholipids is widely reported in professional literature (for example, Clin Chem.1997; 43(7):1215-1222.), and is not limited to specific and single specific conditions.

Embodiment 2

[0037] Embodiment 2 Detection effect verification of reagents

[0038] Detection of the effect of activated coagulation detection reagent

[0039] The activated coagulation detection reagent prepared in Example 1 and the imported activated coagulation reagent were tested on the TEG5000 analyzer with the same blood sample, and the parameters of the test were explained as follows: R represents the period between the detection and the formation of the first fibrin clot A period of time; Angle is used to evaluate the efficiency of blood clot formation; MA directly reflects the strongest dynamic characteristics of the interaction between fibrin and platelets through GPIIb / IIIa, representing the maximum strength of fibrin clot.

[0040] The detection data of embodiment 1 gained reagent and import reagent are as shown in table 1:

[0041] Table 1 Test results of various parameters

[0042]

[0043] As can be seen from Table 1, the reagents of the present invention are equivalent...

Embodiment 3

[0044] Embodiment 3 The stability research of reagent

[0045] The accelerated stability of each group is detected respectively according to the test groups described in Table 2:

[0046] Table 2 Classification of experimental groups

[0047]

[0048] Note: The percentages in the above table are mass volume percentages, and the unit is g / ml.

[0049] According to the preparation method described in Example 1, the three groups of reagents were formulated into reagent samples, and then each group of samples were stored at 60°C for accelerated destruction. The test was carried out on the first day, and the test results are shown in Table 3:

[0050] Table 3 represents the stability detection result of each group of reagents

[0051]

[0052] From the test data shown in Table 3, it can be seen that the test results of the three groups of reagents on the day of preparation are equivalent, and there is no significant difference in the test averages of R value, Angle value, ...

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Abstract

The invention discloses an activated coagulation detection reagent and an application thereof. The reagent is prepared from the following components: an activating agent, mixed phospholipid and composite stabilizer, wherein the activating agent comprises one or more of kaolin, porcellanite, diatomite, ellagic acid, silicon dioxide and a tissue factor, and the composite stabilizer comprises a polymer, an anticorrosive agent and a water soluble antioxidant. The detection reagent does not use a buffer solution adopted in the prior art and does not use normal saline. By combining the activating agent, the mixed phospholipid and the composite stabilizer, the composite stabilizer is used as a solution environment, so that the stability of the detection reagent can be guaranteed. The detection reagent can effectively avoid the adverse influence of the buffer solution used in the prior art for promoting the hydrolysis of the phospholipid; and moreover, the activated coagulation detection reagent is low in cost, good in effect and stable in properties.

Description

technical field [0001] The invention belongs to the field of hemostasis and blood coagulation detection, in particular to an activated blood coagulation detection reagent and application thereof. Background technique [0002] The evaluation experiment of blood coagulation function is of great significance to the diagnosis, treatment and prognosis of various diseases. It can not only be used for screening and auxiliary diagnosis of bleeding diseases, but also for prediction or risk assessment of thrombotic diseases; it can also be used for diagnosis, medication guidance and prognosis judgment of coagulation factor deficiency and von Willebrand's disease. Coagulation detection is also used to screen for various coagulation abnormalities in the perioperative period, and to guide blood transfusion and medication of components with coagulation disorders. [0003] The blood coagulation function under physiological state is jointly completed by blood vessels, platelets, coagulatio...

Claims

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Application Information

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IPC IPC(8): G01N33/86
CPCG01N33/86
Inventor 严俊刘涛蒋友红尹忠宝卿小红
Owner 重庆鼎润医疗器械有限责任公司
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