WO2013191361A1

WO2013191361A1 - Sensor strip

Info

Publication number: WO2013191361A1
Application number: PCT/KR2013/003067
Authority: WO
Inventors: 정소희
Original assignee: (주)미코바이오메드
Priority date: 2012-06-20
Filing date: 2013-04-12
Publication date: 2013-12-27
Also published as: KR20130142768A; KR101952957B1

Abstract

Provided is a sensor strip, which may include: a reticular layer for uniformly spreading a biological material; a reaction layer which is disposed below the reticular layer and to which a reagent is applied, said reagent reacting with the biological material so as to determine a disease using the biological material; and an absorption layer which is disposed below the reaction layer and which absorbs the biological material and the reagent from the reaction layer while the biological material and the reagent are reacting with each other so as to prevent the biological material and the reagent from being reabsorbed into the upper layer. Accordingly, the sensitivity of the sensor strip is improved and the presence or absence of a disease can be accurately determined.

Description

Sensor strip

The present invention relates to a sensor strip, and to a sensor strip for detecting a disease using a biological material.

The sensor strip is laminated with several layers including the reaction layer to which the reaction reagent is applied. The sensor strip detects a disease by using the color of the reaction layer that the supplied biological material reacts with the reaction reagent and changes through the reaction.

The biomaterial may be reversely absorbed into the upper layer of the reaction layer according to the difference in absorbance of each layer. Therefore, the biomaterial and the reaction reagent of the reaction layer do not sufficiently react, and the extent of the reaction layer is weakened. Therefore, it is difficult to accurately determine whether or not a disease using the color of the reaction layer, the reliability of the sensor strip may be lowered.

The present invention provides a sensor strip that can prevent back-absorption of biological material into the upper layer of the reaction layer.

The sensor strip according to the present invention is applied to the net layer to uniformly spread the biological material, and a reaction reagent which is disposed under the net layer, and reacts with the biological material to confirm the disease using the biological material. A reaction layer and a lower portion of the reaction layer to absorb the biomaterial and the reagent from the reaction layer while the biomaterial and the reagent react to prevent the biomaterial and the reagent from being absorbed back into the upper layer. It may include an absorbing layer.

According to one embodiment of the present invention, the sensor strip may be disposed between the net layer and the reaction layer, and may further include a separation layer for separating blood cells from the blood when the biological material is blood.

According to one embodiment of the invention, the separation layer may be a glass fiber bound to the polymer.

According to one embodiment of the present invention, the absorbing layer may be coated with a transparent film on the lower surface to prevent evaporation of the biological material and the reaction reagent absorbed in the absorbing layer into the atmosphere.

According to one embodiment of the invention, the sensor strip is disposed on the net layer, the upper case having a first opening for supplying the biological material to the net layer and is disposed below the absorber layer, The display device may further include a lower case having a second opening for measuring a reflectance of the absorbing layer and coupled to the upper case.

In the sensor strip according to the present invention, the hydrophilic absorbent layer is disposed under the reaction layer to absorb the biomaterial and the reaction reagent, thereby minimizing the reverse absorption of the biomaterial into the upper layer. Therefore, since the color development of the absorbent layer is improved, the disease can be accurately detected using the color of the absorbent layer.

In addition, since the sensor strip is transparently coated on the lower surface of the absorbent layer, the biomaterial and the reaction reagent of the absorbent layer may be prevented from evaporating downward.

1 is an exploded perspective view illustrating a sensor strip according to an embodiment of the present invention.

FIG. 2 is a side view illustrating the sensor strip shown in FIG. 1.

3 is a graph measuring the reflectance of the sensor strip including the absorbing layer according to the present invention.

4 is a graph measuring the reflectance of the sensor strip that does not include an absorbing layer.

Hereinafter, a sensor strip according to an exemplary embodiment of the present invention will be described in detail with reference to the accompanying drawings. As the inventive concept allows for various changes and numerous embodiments, particular embodiments will be illustrated in the drawings and described in detail in the text. However, this is not intended to limit the present invention to the specific disclosed form, it should be understood to include all modifications, equivalents, and substitutes included in the spirit and scope of the present invention. In describing the drawings, similar reference numerals are used for similar elements. In the accompanying drawings, the dimensions of the structures are shown in an enlarged scale than actual for clarity of the invention.

Terms such as first and second may be used to describe various components, but the components should not be limited by the terms. The terms are used only for the purpose of distinguishing one component from another. For example, without departing from the scope of the present invention, the first component may be referred to as the second component, and similarly, the second component may also be referred to as the first component.

The terminology used herein is for the purpose of describing particular example embodiments only and is not intended to be limiting of the invention. Singular expressions include plural expressions unless the context clearly indicates otherwise. In this application, the terms "comprise" or "have" are intended to indicate that there is a feature, number, step, action, component, part, or combination thereof described on the specification, and one or more other features. It is to be understood that the present invention does not exclude the possibility of the presence or the addition of numbers, steps, operations, components, parts or combinations thereof.

Unless defined otherwise, all terms used herein, including technical or scientific terms, have the same meaning as commonly understood by one of ordinary skill in the art. Terms such as those defined in the commonly used dictionaries should be construed as having meanings consistent with the meanings in the context of the related art and shall not be construed in ideal or excessively formal meanings unless expressly defined in this application. Do not.

1 is an exploded perspective view illustrating a sensor strip according to an exemplary embodiment of the present invention, and FIG. 2 is a side view illustrating the sensor strip illustrated in FIG. 1.

1 and 2, the sensor strip 100 detects a disease using a biomaterial. The biological material may constitute any human body or any substance capable of detecting the disease as a secretion of the human body, and examples thereof include blood and urine.

The sensor strip 100 includes a net layer 110, a separation layer 120, a reaction layer 130, an absorption layer 140, an upper case 150, and a lower case 160.

The net layer 110 has a net structure and allows the injected biomaterial to be uniformly spread. When the pore size of the net layer 110 is less than about 100 μm, the net layer 110 is too dense so that some of the components of the biological material having a large size are hooked to the net layer 110 so that the biomaterial is formed in the net layer ( It is absorbed into the lower layer of 110 and acts as a blocking element. For example, when the biological material is blood, blood cells among the components of the blood may be caught in the net layer 110. Therefore, the time required for the biomaterial to be absorbed into the lower layer can be increased. When the pore size of the net layer 110 exceeds about 500 μm, the net layer 110 is sparse and may be absorbed into the lower layer before the biological material is uniformly spread. Therefore, the effect of spreading the biological material uniformly by the net layer 110 can be reduced.

Therefore, the pore size of the net layer 110 is preferably about 100 to 500㎛.

The separation layer 120 is disposed under the net layer 110, and may separate specific components from the biological material. The specific component may be a component having a relatively large size in the biological material. For example, when the biological material is blood, the separation layer 120 may separate blood cells from the blood. The separation layer 120 is made of glass fiber, and a polymer is bound to the glass fiber for separation of the specific component.

When the thickness of the separation layer 120 is less than about 300 μm, the separation layer 120 is thin so that the specific component is not properly separated. When the thickness of the separation layer 120 exceeds about 1000 μm, the separation layer 120 is so thick that it takes a very long time for the specific components to separate.

Therefore, the thickness of the separation layer 120 may be about 300 to 1000㎛.

When the sensor strip 100 is used for liver disease measurement and cholesterol level measurement, the sensor strip 100 may include a separation layer 120 because a process of separating specific components, for example, blood cells, from the biological material is required. Can be.

However, when the sensor strip 100 is used for measuring anemia, the sensor strip 100 may not include the separation layer 120 because separation of the specific component from the biological material is not necessary. In addition, even when the sensor strip 100 is used for liver disease measurement and cholesterol level measurement, when the biological material is supplied with the specific component separated in advance, the separation of the specific component from the biological material is unnecessary. 100 may not include a separation layer 120.

The reaction layer 130 is disposed below the separation layer 120 and contains a reaction reagent. The reaction reagent reacts with the biological material. For example, when measuring liver disease and cholesterol level, the reaction reagent may chemically react with plasma from which blood cells are separated from blood, which is the biological substance. The type of reaction reagent included in the reaction layer 130 may vary depending on the type of disease to be measured and the type of the biological material. The separation layer 120 is colored according to the reaction between the reaction reagent and the biological material.

The reaction layer 130 has an asymmetric structure for separation of specific components of the biological material. Specifically, the reaction layer 130 has fine pores penetrating up and down, and the pores have a structure in which the cross-sectional area becomes narrower from the upper surface of the reaction layer 130 to the lower surface. Therefore, when the biomaterial passes through the pores, a relatively large component of the biomaterial is caught by the micropores so that the reaction layer 130 may separate the specific component from the biomaterial. For example, when the biological material is blood, the specific component may be blood cells.

The thickness of the reaction layer 130 is related to the absorption of the reaction layer 130. When the thickness of the reaction layer 130 is less than about 100 μm, there are relatively few reaction reagents included in the reaction layer 130. Therefore, since the biological material and the reaction reagent are not sufficiently reacted, the degree of generation of the reaction layer 130 is low, so that the sensitivity of the reaction layer 130 is lowered and an accurate measurement value of the biological material cannot be derived. In addition, when the thickness of the reaction layer 130 is about 500 μm or more, the reagent included in the reaction layer 130 is more than necessary, and the reaction reagent may be abused. Therefore, since the reaction reagent is excessively used, unnecessary cost loss may occur.

The absorber layer 140 is disposed below the reaction layer 130 and is made of a hydrophilic material. Examples of the hydrophilic material include nitrocellulose, cotton, fiberglass, and the like.

Since the absorbing layer 140 is made of the hydrophilic material, the biomaterial and the reaction reagent are absorbed from the reaction layer 130 while the biomaterial and the reaction reagent are reacted in the reaction layer 130. In addition, the absorber layer 140 absorbs the biological material and the reagent of the reaction layer 130, so that the biological material and the reagent of the reaction layer 130 can be prevented from being reversely absorbed into the upper layer, that is, the separation layer 120. Can be. Therefore, the absorption layer 140 can prevent the reaction sensitivity of the reaction layer 130 from being lowered.

In addition, since the absorbing layer 140 absorbs the biological material and the reaction reagent, the absorbing layer 140 may be colored similarly to the reaction layer 130.

The absorption layer 140 needs an appropriate thickness to absorb the reaction reagent of the reaction layer 130. When the thickness of the absorber layer 140 is less than about 50 μm, the thickness of the absorber layer 140 is relatively thin, so that the absorbent layer 140 may not fully absorb the reaction reagent absorbed from the reaction layer 130, and the reaction reagent may overflow. . When the thickness of the absorber layer 140 exceeds about 150 μm, the thickness of the absorber layer 140 is relatively thick, and the reaction reagent of the reaction layer 130 may not be sufficiently absorbed into the absorber layer 140. Therefore, the color of the absorber layer 140 is not normal.

Therefore, the thickness of the absorber layer 140 is preferably about 50 to 150㎛.

On the other hand, the absorber layer 140 is coated with a transparent film on the lower surface. The transparent film may prevent the biological material and the reaction reagent absorbed in the absorbing layer 140 from being evaporated through the lower surface. In addition, since the transparent film is transparent, the color of the absorbing layer 140 can be displayed as it is.

The upper case 150 is disposed on the net layer 110 and has a substantially rectangular flat plate shape. The upper case 150 has first openings 152. The first openings 152 are arranged in a line along the longitudinal direction of the upper case 150 and penetrate the upper and lower portions of the upper case 150. The first openings 152 expose the mesh layer 110, and the biomaterial may be injected through the first openings 152.

The lower case 160 is disposed under the absorber layer 140 and has a substantially rectangular flat plate shape. The lower case 160 has second openings 162. The second openings 162 are arranged in a line along the length direction of the lower case 160 and penetrate the upper and lower sides of the lower case 160. The number of second openings 162 is the same as the number of first openings 152, and the second openings 162 and the first openings 152 are disposed to correspond to each other. The second openings 162 expose the absorbing layer 140, and the color of the absorbing layer 140 may be measured through the second openings 162. The color measurement of the absorber layer 140 may be performed by measuring the reflectance of the absorber layer 140.

The upper case 150 and the lower case 160 may be coupled to each other. For example, the fastening holes 154 of the upper case 150 and the fastening pins 164 of the lower case 160 may be fastened.

On the other hand, the upper case 150 and the lower case 160 may be hinged by one side is coupled to each other by being provided with grooves and protrusions on the other side opposite to the one side, respectively.

The laminated structure including the net layer 110, the separation layer 120, the reaction layer 130, and the absorber layer 140 may include the number of first openings 152 between the upper case 150 and the lower case 160. Number of second openings 162) and spaced apart from each other. That is, the stacked structures are respectively disposed between the first opening 152 and the second opening 162 facing each other. Since the stacked structures are spaced apart from each other, the biomaterial supplied through the first openings 152 may be prevented from moving to the other stacked structures. Thus, different measurements can be made at each laminate structure.

Since the fastening holes 154 of the upper case 150 and the fastening pins 164 of the lower case 160 may be disposed between measurement structures spaced apart from each other, the upper case 150 and the lower case 160. Can be fixed at a constant and strong pressure.

Figure 3 is a graph measuring the reflectance of the sensor strip containing the absorbing layer according to the present invention, Figure 4 is a graph measuring the reflectance of the sensor strip not containing the absorbing layer.

Referring to FIG. 3, when the absorbing layer is included in the sensor strip, the reflectance at 300 seconds was about 72% at ALT 9.5U / L, about 59% at ALT 50U / L, and about 44% at ALT 265.7U / L.

Referring to FIG. 4, the reflectance at 300 seconds when the absorbing layer is not included in the sensor strip is about 78% at ALT 9.5U / L, about 71% at ALT 50U / L, and about 54% at ALT 265.7U / L. appear.

The difference in reflectance between the ALT low concentrations of ALT 9.5U / L and ALT 50U / L in the sensor strip with absorbing layer is about 13%, and the ALT low concentrations of ALT 9.5U / L and ALT 50U / L in the sensor strip without absorbing layer The difference in reflectance is about 7%. The inclusion of the absorbing layer reveals that the difference in reflectance between ALT 9.5U / L and 50U / L in the sensor strip is nearly doubled from about 7% to about 13%.

At both low concentrations of ALT 9.5U / L and ALT 50U / L and high concentrations of ALT 265.7U / L, the reflectance of the sensor strip with absorbing layer was measured to be lower than that of the sensor strip without absorbing layer. Specifically, even at a high concentration of 265U / L, the reflectance of the sensor strip including the absorbing layer was about 44%, and was measured to be about 10% lower than the reflectance of about 44% of the sensor strip without the absorbing layer.

Therefore, it can be seen that the absorption layer included in the sensor strip prevents reverse absorption and evaporation of the biomaterial and the reaction reagent, thereby improving the degree of color development of the sensor strip even at the same concentration of the biomaterial.

As described above, the sensor strip according to the present invention may have an absorbent layer coated on a lower surface thereof to prevent reverse absorption and evaporation of the biological material and the reaction reagent. Therefore, the sensitivity of the sensor strip can be improved to accurately measure the presence or absence of a disease using the biomaterial and the reliability of the sensor strip can be improved.

While the foregoing has been described with reference to preferred embodiments of the present invention, those skilled in the art will be able to variously modify and change the present invention without departing from the spirit and scope of the invention as set forth in the claims below. It will be appreciated.

Claims

A net layer for uniformly spreading the biological material;

A reaction layer disposed below the net layer and coated with a reaction reagent reacting with the biological material to identify a disease using the biological material; And

A lower absorbing layer disposed under the reaction layer, the absorbing layer absorbing the biomaterial and reagent from the reaction layer during the reaction of the biomaterial and the reagent to prevent the biomaterial and the reagent from being reversely absorbed into the upper layer; Sensor strip, characterized in that.
The sensor strip of claim 1, further comprising a separation layer disposed between the net layer and the reaction layer and separating a blood cell from the blood when the biological material is blood.
The sensor strip of claim 2, wherein the separation layer is a glass fiber bound to a polymer.
The sensor strip of claim 1, wherein the absorbent layer is coated with a transparent film on a lower surface of the absorbent layer to prevent evaporation of the biological material and the reaction reagent into the atmosphere.
2. The apparatus of claim 1, further comprising: an upper case disposed on the mesh layer, the upper case having a first opening for supplying the biological material to the mesh layer; And

And a lower case disposed under the absorbent layer, the lower case having a second opening for measuring the reflectance of the absorbent layer and coupled to the upper case.