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Liquid thrombin time detection reagent

A technology of thrombin time and detection reagents, which is applied in the direction of biological testing, measuring devices, material inspection products, etc., can solve the problems of unstable test results, unstable product quality, and difficult comparison of results, and achieve convenient thrombin time detection. It is convenient for clinical application and verifies the effect of high accuracy

Inactive Publication Date: 2019-01-18
DIRUI MEDICAL TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The TT time detection and determination process is affected by many factors, among which the quality of the detection reagent is the key factor. Due to the problems of unstable product quality and poor sensitivity of the current domestic coagulation reagents, the detection results are unstable. Different clinical tests It is difficult to compare the results measured between them. Although WHO standard reference materials are used, it is still difficult to reduce the error to an acceptable level.

Method used

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  • Liquid thrombin time detection reagent

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0065] 1. The principle of liquid thrombin time detection reagent:

[0066] When an appropriate amount of thrombin solution is added to the plasma to be tested, the fibrinogen is transformed into insoluble fibrin, and the time required for coagulation is measured, which is the thrombin time.

[0067] 2. Preparation of liquid thrombin time detection reagents with different ratios

[0068] Prepare buffer solution and preservative reagent according to the ratio shown in Table 1:

[0069] Table 1 Preparation of different proportioning reagents

[0070]

[0071]

[0072] 3. Preparation of liquid thrombin time detection reagent:

[0073] Bovine thrombin freeze-dried powder (1000 / mL, 1 mL / bottle) was rewarmed at room temperature for 30 minutes, diluted with the above reagents in different proportions according to the expected dilution ratio to a final concentration of 3.5 U / mL, and stored at 4 °C spare.

Embodiment 2

[0074] Example 2: Test procedure for liquid thrombin time detection reagents with different ratios:

[0075]Test procedure: Take 100 μL of plasma to be tested, pre-warm at 37°C for 3 minutes, and then add 100 μL of liquid thrombin time detection reagents prepared in Example 1 with different ratios; test instrument: SYSMEX CA7000 coagulation analyzer; test sample: quality control Plasma (target value: 10-16s); see specific examples for specific comparison verification results.

Embodiment 3

[0076] Example 3: Comparison of the high temperature stability between the liquid thrombin time detection reagent of the present invention and the commercially available thrombin time detection reagent

[0077] The liquid-type thrombin time detection reagent prepared in Example 1 with different ratios was placed in a 37°C incubator. According to the test procedure, the test was carried out on the SYSMEX CA7000 coagulation analyzer to verify the high-temperature stability of the reagent. The test sample was a quality control product. Plasma (target value: 10-16s), and a commercially available reagent (the commercially available reagent is Shanghai Sun Biotechnology Co., Ltd. TT reagent) was used for simultaneous comparative test verification. The results are shown in Table 2.

[0078] Table 2 compares with commercially available TT reagent high temperature stability test results

[0079]

[0080]

[0081] Precautions:

[0082] 1. The test sample should be free of air bub...

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Abstract

The invention relates to a liquid thrombin time detection reagent and belongs to the field of medical in vitro diagnosis. The liquid thrombin time detection reagent disclosed by the invention consistsof the following components: 2 to 4U / mL of bovine thrombin; 10 to 66mM of Tris; 0.1 to 3% of gelatin, 0.1 to 2% of PEG 6000; 0.1 to 5% of BSA; 0.1 to 1.5% of sodium chloride, 2mM to 12mM of benzamidine hydrochloride; 0.05 to 0.3% of preservative ProClin300; and the balance of water. The invention provides the liquid thrombin time detection reagent by researching a blood coagulation reaction mechanism; the detection reagent adopts a unique buffer system to stabilize the activity of thrombin, so that the thrombin time detection reagent is higher in stability and repeatability verification accuracy and convenient for clinical application, reduces medical cost, is mutually beneficial for medical treatment and diseases and avoids resource waste. The liquid thrombin time detection reagent disclosed by the invention is applied to existance of an anticoagulant material or fibrinogen dissolving system abnormality and blood coagulation abnormality monitoring treatment, and finally, the thrombinliquid reagent is widely applied to clinical detection, so that thrombin time detection is more convenient, accurate and standardized.

Description

technical field [0001] The invention belongs to the field of medical in vitro diagnosis, in particular to a liquid thrombin time detection reagent. Background technique [0002] Thrombin is a protein that acts on the coagulation process. It combines with free fibrinogen in the plasma and converts it into insoluble fibrin, thereby causing blood to coagulate. Thrombin time (TT) refers to the blood coagulation time when an appropriate amount of thrombin is added to the plasma. The normal coagulation time is between 12.0s and 18.0s, and the difference of more than 3 seconds from the normal value is abnormal. The test of thrombin time is convenient and easy to operate. It is a screening test to check the ability of subjects to convert plasma fibrinogen into fibrin, and it is also a simple test for clinical detection of coagulation, anticoagulation and fibrinogen dissolution system functions. [0003] Clinically, TT prolongation is often seen in the presence of increased heparin...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/86C12Q1/56
CPCC12Q1/56G01N33/86G01N2333/96433
Inventor 张立媛姜佳曲欣楠高威孙成艳何浩会
Owner DIRUI MEDICAL TECH CO LTD
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