Blood coagulation test kit

Abstract

The invention relates to a test kit used in performing the blood coagulation test known as INR measurement, which enables the user to perform the said test in a practical way at home.

Description

[0001] DESCRIPTION

[0002] Blood Coagulation test kit

[0003] Field of the Invention

[0004] The invention is generally related to devices that allow blood tests to be performed.

[0005] The invention is specifically related to a blood clotting test kit, which is known as INR measurement, that enables to perform by user at home environment, in a practical way.

[0006] State of the Art

[0007] The patients on blood coagulation regulators should perform blood clotting test (INR measurement) on daily periods. The result of the performed test reveals that the patient should go to the hospital or not at that time.

[0008] The present blood clotting test technique carries out by an advanced analysis technique with equipment at hospital environment. This technique, is a technique which requires blood collection from patients by going to hospital. Besides this, there are digital devices aiming the use by patients at home environment. These devices can be assumed as relatively expensive for the most of the patients requiring expensive consumables (strip). Therefore, most of the patients have to visit the hospital.

[0009] In the research conducted on the current state of the technology, several documents related to the topic can be found. The document with the number of TR2015 / 11116 is related to a method for blood clotting time measurement and a device for the application. The mentioned device aims the measurement of blood clotting time by whole blood. Yet, aforementioned device and method is both expensive and complicated for home use by a complicated structure.

[0010] The document with the number of EP2201365B1 is related to a microfluidic device and method to determine fluid coagulation time. The device mentioned in this document contains microfluidic channels with extra parts like sensors, valves etc. Therefore, this structuring would be a high-cost product due to having relatively high technology. Besides, aforementioned device and method gives results in numeric and this resultshould be understood and interpret by the user. For this reason, it is a relatively more complicated product for the last user.

[0011] Consequently, the devices used for blood tests w§ll bw upgraded, for this reason new construes to eliminate these disadvantages and provide new solutions are needed.

[0012] Aim of the Invention

[0013] Current invention is related to a test kit which meets the aforementioned needs, eliminates the disadvantages and brings up new advantages.

[0014] The main target of the invention is to ensure blood coagulation test performed.

[0015] A target of invention is to ensure performing the blood coagulation test at home environment without going to hospital.

[0016] Another target of the invention is to present a product to perform blood coagulation test with lower cost and convenience.

[0017] The current invention is a test kit to perform blood coagulation test by accomplishing all of the advantages implied from aforementioned and the following expression:

[0018] In order to realize all the advantages mentioned above and understood from the detailed explanation below, the present invention is a test kit used in performing the blood coagulation test;

[0019] • outer cassette with a viewing window that allows monitoring of blood flow,

[0020] • sample pad positioned inside the outer cassette, allowing the blood sample to be taken,

[0021] • The membrane located in the outer cassette, which provides lateral blood flow,

[0022] • A structure containing an absorption pad positioned within the outer cassette, on which the blood is collected after flowing over the membrane, has been obtained.The structural and characteristic features of the invention and all its advantages will be understood more clearly thanks to the figures given below and the detailed explanation written by making references to these figures. Therefore, the evaluation should be made by taking these figures and detailed explanation into consideration.

[0023] Figures Clarifying the Invention

[0024] In order to best understand the structure of the present invention and its advantages together with the additional elements, it should be evaluated together with the figures explained below.

[0025] Figure 1 : The subject of the invention is a general view of the test kit.

[0026] Figure 2: The subject of the invention is a detailed view of the internal structure of the test kit.

[0027] Elements Helping to Understand Figures

[0028] 1. Outer cassette

[0029] 1.1. viewing window

[0030] 2. Sample pad

[0031] 3. Membrane

[0032] 4. Absorption pad

[0033] Detailed Description of the Invention

[0034] In this detailed description, the preferred embodiments of the test kit which is the subject of the invention are explained only for the purpose of a better understanding of the subject and in a way that does not create any limiting effect.

[0035] The invention is a test kit used to perform a blood coagulation test;outer cassette (1) with a viewing window (1.1) that allows monitoring of blood flow,

[0036] • sample pad (2) positioned inside the outer cassette (1), which allows the blood sample to be taken,

[0037] • the membrane (3) positioned within the outer cassette (1), which provides lateral blood flow,

[0038] • Absorption pad (4) positioned inside the outer cassette (1), on which the blood is collected after flowing over the membrane (3)

[0039] Are comprised.

[0040] Figure 1 provides a general view of the test kit, which is the subject of the invention. In the said test kit, the outer cassette (1) forms the main body of the test kit. There is a viewing window (1.1) on the mentioned outer cassette (1) that allows the blood to be monitored. Blood can be monitored with a mark such as a line or a dot next to the viewing window (1.1) on the outer cassette (1) or on the viewing window (1.1).

[0041] Figure 2 shows the part of the outer cassette (1) where the blood flows. The mentioned part consists of a sample pad (2) that allows the blood sample to be taken, a membrane (3) that provides the lateral flow of the blood coming from the sample pad (2) and an absorption pad (4) that collects the blood after the flow. The membrane (3) that allows the blood to be monitored with lateral flow and the test result to be understood is used for the paper-based separation process, and its general use is to provide the western blot.

[0042] In the test kit of the invention, the lateral flow rate of blood on the membrane (3) is evaluated depending on the coagulation properties of the blood. What is important here is the selection of the right membrane (3), its dimensions and the optimization of the applications that determine the movement of the blood applied to this membrane (3). In our invention, the duration and distance were optimized using the experimental design method to obtain the optimumconditions. For this purpose, the Taguchi design was used, and the statistical decision-making criterion (TOPSIS) was applied to optimize both responses at the same time, and the kits were produced with the obtained results and the clinical study was carried out. As a result of the studies, nitrocellulose membrane (3) was used as the membrane (3) material, the optimum sodium dodecyl sulfate (SDS) solution concentration was applied as 3% and the membrane (3) dimensions were produced as 4cm x 2mm. The membranes (3) coated with SDS were dried at 37°C.

[0043] With our invention, a simple, fast and cheap solution has been presented that the patient can easily apply at home with a few drops of blood and interpret the results easily by himself. It has a simple use with the paper-based lateral flow method. In addition to the test, with the help of a suitable lancet provided in the kit, it will be possible to understand whether the blood coagulation (INR) value is appropriate with the blood taken from the patient's finger within a maximum of 5 minutes. In patients using warfarin, the expected INR value is between 2-3, and in this invention, if the blood passes the line on the outer cassette (1), the person's INR value may be greater than 3 and they should apply to the nearest health institution; if the blood does not advance to the mentioned line, the INR value is less than 3 and can be considered normal.

Claims

CLAIMSa test kit used in blood coagulation testing and its features are;• outer cassette (1) with a viewing window (1.1) that allows blood flow to be monitored,• sample pad (2) positioned inside the outer cassette (1) that allows blood sample to be taken,• membrane (3) positioned inside the outer cassette (1) that allows lateral blood flow,• absorption pad (4) positioned inside the outer cassette (1) that collects blood after it flows over the membrane (3).

Images