External diagnostic reagent kit used for measuring blood plasma fibrinogen FIB content

A technology for fibrinogen and in vitro diagnosis, which is applied in the direction of biological testing, microbial measurement/inspection, material inspection products, etc. It can solve the problems of loss of reliability of test results, reduce medical costs, save time, and have good consistency Effect

Active Publication Date: 2008-07-16
SHANGHAI SUNBIO TECH
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0004] The PT-Der method is calculated during the detection of PT. When the plasma fibrinogen content is within the normal range, the PT-Der method has no significant difference with the classic Clauss method or is slightly higher than the Clauss method; but when the fibrinogen decreases or increased, the PT-Der method is often too high, making the test results unreliable

Method used

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  • External diagnostic reagent kit used for measuring blood plasma fibrinogen FIB content
  • External diagnostic reagent kit used for measuring blood plasma fibrinogen FIB content
  • External diagnostic reagent kit used for measuring blood plasma fibrinogen FIB content

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] Embodiment 1 Application of kit of the present invention

[0025] 1. Detection principle:

[0026] Adding thrombin to the plasma to be tested converts fibrinogen into insoluble fibrin, resulting in coagulation. When there is a sufficient amount of thrombin, it interacts with different contents of fibrinogen, and the coagulation time is negatively correlated with the content of fibrinogen, so the content of fibrinogen can be calculated.

[0027] 2. Detection steps (Pacific TS400C hemagglutination analyzer):

[0028] Dissolve FIB thrombin with a certain volume of distilled water by shaking gently. The FIB-rated plasma was reconstituted with 1.0ml of distilled water, and then diluted with buffer solution at 1:5, 1:10, 1:15, 1:20, and 1:30. Select the FIB item in the main menu of the coagulation analyzer for detection: take 100 μl of fixed-value plasma at different dilutions, pre-warm the pre-warmed well at 37°C for 3 minutes, transfer it into the measurement well and ac...

Embodiment 2

[0031] Embodiment 2 compares with commercially available FIB reagent stability

[0032] FIB thrombin was dissolved by shaking with a certain volume of distilled water, and then the reconstituted reagent was stored at 37°C. The same normal quality control plasma (FIB value: 200-400 mg / dL) was measured on a Pacific TS400C coagulation analyzer, and commercially available reagents were measured simultaneously. (See Table 2 for the results)

[0033] Table 2 shows that the FIB reagent of the present invention is relatively stable in the eight days after reconstitution, and it begins to change on the ninth day, while the commercially available reagents begin to change on the second day. This result is very important for clinical laboratories. Very important as it reduces waste and thus costs.

[0034] Table 2

[0035]

Embodiment 3

[0036] Embodiment 3 is compared with commercially available FIB reagent repeatability

[0037] The FIB assay reagent of the present invention and the commercially available reagent were used to simultaneously measure the same sample on the Pacific TS400C coagulation analyzer according to the method described in Example 1. (See Table 3 for the results)

[0038] Table 3 shows that compared with commercially available reagents, the FIB reagent of the present invention has a smaller coefficient of variation (CV) and better repeatability.

[0039] table 3

[0040]

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PUM

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Abstract

The invention relates to an in vitro diagnostic kit which uses a Clauss method to test the content of plasma fibrinogen (FIB). The invention consists of a FIB thrombin, a FIB buffer solution and FIB accurate value plasma, and the invention is used for the determination of the content of fibrinogen in the plasma. The invention has the advantages of long stability time and good repeatability of the thrombin reagent after the re-dissolution, at the same time, the invention has better consistency of the measurement results of a blood coagulation analyzer by using an optical method and a magnetic bead method, therefore, the invention is applicable to large, medium and small hospitals, and the test results of different hospitals have comparability, so the invention has important meaning for implementing the one general report of the test reports and provides reliable experimental data for the clinical diagnosis and the treatment of thrombosis and hemostasis diseases.

Description

Technical field: [0001] The invention belongs to the field of biotechnology, in particular to an in vitro diagnostic kit for measuring plasma fibrinogen (FIB) content by a Clauss method. Background technique: [0002] Plasma fibrinogen (Fibrinogen, FIB) is a coagulation protein with the highest content among all coagulation factors. Rheology, the change of its level is closely related to coagulation disorder, bleeding disease, disseminated intravascular coagulation (DIC) and inflammatory response. In recent years, it has been found that FIB is one of the important risk factors for cardiovascular diseases. During the development of cardiovascular diseases, plasma FIB is mainly involved in the formation of intravascular obstructive thrombus, and plays an enhanced role in the final stage of arterial thrombosis. It has been reported that most patients with myocardial infarction, sudden myocardial ischemic death and unstable angina have obstructive thrombosis in the coronary art...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/68G01N33/86C12Q1/56
Inventor 谢永华朱美萍
Owner SHANGHAI SUNBIO TECH
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