Test chip and manufacturing method thereof

Abstract

To provide an inspection chip capable of significantly suppressing coloring irregularities and easily attaining quantification without depending on the amount of introduction of a liquid to be inspected.SOLUTION: An inspection chip includes a first layer in one surface side and a second layer in the other surface side, at least one of the first layer and the second layer includes a liquid reception part A, the first layer at least includes a detection confirmation part B, the second layer at least includes a liquid circulation part D adjacent to the detection conformation part B and a liquid flow path E connected to the liquid circulation part D, a liquid to be inspected is circulated in predetermined order by capillarity when the liquid to be inspected is dropped to the liquid reception part A and arrives at the detection confirmation part B, and at least a surface of a material M other than the liquid reception part A from among the surface of the first layer and the surface of the second layer is sealed with a film.SELECTED DRAWING: Figure 5A

Description

[Technical field]

[0001] The present invention relates to a test chip and a method for manufacturing the same. [Background technology]

[0002] The idea that diagnosis can be performed in close proximity to patients (on-site diagnosis) is becoming more and more important in clinical settings. Based on this idea, test chips that enable practical analysis by providing micro-sized channels and reaction spots on a sheet-like substrate have been developed.

[0003] An example of the above-mentioned test chip has a mechanism in which, when a test liquid containing a target substance such as an antigen is introduced (dropped), the test liquid flows through a flow path, and a labeling medium such as an antibody that has been prepared in advance reacts with the target substance, thereby confirming the presence of the target substance by developing color (coloring). A typical example is a pregnancy test.

[0004] As an example of the above-mentioned test chip, a microfluidic device has already been reported in which a paper substrate is used to form channels and reaction spots on the paper using a wax printer or an inkjet printer (Non-Patent Document 1). Such devices are also called "μ-PADs (microfluidic paper-based analytical devices)" and have many advantages, such as (1) low cost, (2) pumpless, (3) no need for large-scale equipment, and (4) easy disposal. Research into improving such μ-PADs is being conducted worldwide.

[0005] For example, Patent Document 1 discloses that a test chip can be manufactured simply and at low cost by printing the outer edges of the above-mentioned flow paths and reaction spots on paper with ultraviolet-curable ink and curing the ink by irradiating ultraviolet light. Also, for example, Patent Document 2 discloses that a flow path with less unevenness on the side wall surface can be formed by thermally transferring a layer containing a thermoplastic material to a porous layer, thereby stabilizing the flow rate.

[0006] Here, in addition to confirming the presence or absence of a detection target substance, it is expected that the above-mentioned test chips such as μ-PADs can also realize quantification (i.e., quantitative analysis). It is also important that such quantification can be easily performed without depending on the amount of the test liquid introduced. However, Patent Documents 1 and 2 do not consider this point at all, so that a complicated task such as measuring the test liquid with a micropipette or the like is at least necessary for quantification.

[0007] As a clue to quantification, for example, Non-Patent Document 2 discloses a technique in which a bridge made of a soluble component is provided in advance in the middle of a flow path. In this technique, when a certain amount of test liquid flows, the bridge dissolves, and the flow of the liquid thereafter may be blocked. [Prior art documents] [Patent documents]

[0008] [Patent Document 1] International Publication No. 2012 / 160857 [Patent Document 2] JP 2015-007604 A [Non-patent literature]

[0009] [Non-Patent Document 1] Whiteside et al., Analytical Chemistry, Vol. 82, No. 1, January 1, 2010 [Non-Patent Document 2] Houghtaling et al., Analytical Chemistry, Vol. 85, 11201-11204, 2013 Summary of the Invention [Problem to be solved by the invention]

[0010] All of the conventional test chips described above are prone to uneven color development (color development), which can lead to variations in test results (insufficient reproducibility). As one example, there is a problem in that color development occurs near the edge of the detection area, making it difficult to visually observe. Such a problem can have a negative impact on the diagnosis of important diseases. Therefore, conventional test chips have room for improvement in terms of suppressing uneven color development. In particular, if the uneven color development (color development) described above can be suppressed, quantification will become more realistic by identifying the area and color information of the colored portion in the test chip and applying pixel analysis technology.

[0011] In addition, in the technique of Non-Patent Document 2, the test liquid comes into contact with soluble components before detection, which raises concerns about contamination and adverse effects on the reaction system. Therefore, there is a need to establish an alternative technique that can easily achieve quantification.

[0012] The present invention aims to solve the above-mentioned problems in the prior art and to achieve the following objectives. That is, the present invention aims to provide a test chip in which a target substance contained in a test liquid reacts with a labeling medium that has been previously added, and the presence of the target substance is confirmed by the color produced by the reaction, in which color unevenness is significantly suppressed and quantification can be easily achieved regardless of the amount of test liquid introduced. Another objective of the present invention is to provide a method for manufacturing the test chip, which can easily, highly accurately, and at low cost, manufacture the above-mentioned test chip. [Means for solving the problem]

[0013] In solving the above problem, the inventor first discovered that the problem with conventional test chips, that color development occurs near the edge of the detection area, is caused by the force and / or direction of the liquid flow reaching the detection area. After extensive research, the inventor then discovered that color development can be caused near the center of the detection area by optimizing the liquid flow path so that the liquid reaches the detection area from the thickness direction of the sheet.

[0014] In addition, the inventors have discovered that for a chip in which the liquid flow paths have been optimized as described above, the amount of liquid reaching the detection area can be controlled by sealing specific areas on both sides with a film.

[0015] The means for achieving the above object are as follows.

[0016] <1> A sheet-shaped test chip, A first layer on one surface side and a second layer on the other surface side, the first layer and the second layer are adjacent; Either the first layer or the second layer has a liquid receiving portion A, The first layer has at least a detection confirmation portion B, The second layer has at least a liquid flow section D adjacent to the detection confirmation section B and a liquid flow path E connected to the liquid flow section D, When the first layer has a liquid receiving portion A, the liquid receiving portion A is separated from the detection confirmation portion B, The first layer is formed on one surface of a sheet-like material, and the second layer is formed on the other surface of the sheet-like material, the liquid receiving portion A, the liquid flow path E, the liquid flow portion D, and the detection confirmation portion B are made of a material M that allows the flow of the test liquid to occur by capillary action; The portion other than the material M is made of a material that does not allow the passage of the test liquid, When a test liquid is dropped onto the liquid receiving section (A), the test liquid flows through the liquid receiving section (A), the liquid flow path (E) and the liquid flow section (D) in this order by capillary action, and reaches the detection confirmation section (B); A test chip characterized in that at least the surfaces of material M other than the liquid receiving section A, of the surfaces of the first layer and the second layer, are sealed with a film, thereby controlling the amount of the test liquid that reaches the detection confirmation section B.

[0017] <2> The first layer has the liquid receiving portion A separated from the detection confirmation portion B, the second layer has a liquid flow section C made of the material M, adjacent to the liquid receiving section A and connected to the liquid flow path E; When a test liquid is dropped onto the liquid receiving section A, the test liquid flows through the liquid receiving section A, the liquid flow section C, the liquid flow path E and the liquid flow section D in this order by capillary action, and reaches the detection confirmation section B. <1> The inspection chip according to claim 1.

[0018] <3> The material M is filter paper. <1> or <2> The inspection chip according to claim 1.

[0019] <4> the material through which the test liquid does not flow is a material M' obtained by impregnating the material M with a hydrophobic material; <1> ~ <3> 13. The test chip according to any one of claims 1 to 12.

[0020] <5> The airtightness of the material M' is 15 seconds or less. <4> The inspection chip according to claim 1.

[0021] <6> In the material M', the impregnation rate of the hydrophobic material into the material M is 70% or less. <4> or <5> The inspection chip according to claim 1.

[0022] <7> A color reaction caused by the detection target substance occurs in the detection confirmation section B. <1> ~ <6> 13. The test chip according to any one of claims 1 to 12.

[0023] <8> the above <1> ~ <7> A method for producing the test chip according to any one of the above, a film forming step of forming a first hydrophobic film on a first substrate and a second hydrophobic film on a second substrate using a hydrophobic material; a first printing step of printing a first sacrificial substrate with a first hydrophobic film on the first substrate in a reverse design of a first layer of the test chip; a second printing step of printing a second sacrificial substrate with a second hydrophobic film on the second substrate in a reverse design of a second layer of the test chip; a first transfer step of transferring the first hydrophobic film after the first printing step onto one surface of a sheet-like material and impregnating the sheet-like material to form a first layer; a second transfer step of transferring the second hydrophobic film after the second printing step to the other surface of the one sheet-like material and impregnating the sheet-like material to form a second layer; a sealing step of sealing at least the non-impregnated surfaces of the first layer and the second layer other than the liquid receiving portion A with a film; A method for manufacturing an inspection chip, comprising: Effect of the Invention

[0024] According to the present invention, in a test chip for confirming the presence of a target substance by the color development caused by a reaction between a target substance contained in a test liquid and a labeling medium previously prepared, it is possible to provide a test chip in which color development unevenness is significantly suppressed and quantification can be easily achieved regardless of the amount of test liquid introduced. Also, according to the present invention, it is possible to provide a method for manufacturing the test chip, which is capable of manufacturing the above-mentioned test chip simply, highly accurately, and at low cost. [Brief description of the drawings]

[0025] [Figure 1A] FIG. 1 is a schematic perspective view of a test chip according to an example of the present invention (film is not shown). [Figure 1B] FIG. 1B is a schematic perspective view of the test chip of FIG. 1A (the film is not shown). [Diagram 2] 1B is a schematic plan view of the checking surface and the back surface of the test chip of FIG. 1A. [Diagram 3] FIG. 1B is a schematic cross-sectional view of the test chip of FIG. 1A. [Figure 4] FIG. 2 is a schematic exploded view of the test chip according to one embodiment of the present invention. [Figure 5A] FIG. 1B is a schematic perspective view of the test chip of FIG. 1A (film shown). [Figure 5B] FIG. 1B is a schematic perspective view of the test chip of FIG. 1A (film shown). [Figure 6] 1 is a schematic plan view of a confirmation surface and a back surface of an example of a test chip of the present invention. [Figure 7]FIG. 7 is a schematic cross-sectional view of the test chip of FIG. [Figure 8] 1 is a schematic plan view of a confirmation surface and a back surface of an example of a test chip of the present invention. [Figure 9] FIG. 9 is a schematic cross-sectional view of the test chip of FIG. [Figure 10] 1 is a schematic plan view of a confirmation surface and a back surface of an example of a test chip of the present invention. [Figure 11] 1 is a schematic plan view of a confirmation surface and a back surface of an example of a test chip of the present invention. [Figure 12] 1A and 1B are schematic plan views of a confirmation surface and a back surface of a test chip of a comparative example. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0026] Hereinafter, the present invention will be described in detail based on embodiments.

[0027] (Test chip) The test chip of the present invention is a sheet-shaped test chip, A first layer on one surface side and a second layer on the other surface side, the first layer and the second layer are adjacent; Either the first layer or the second layer has a liquid receiving portion A, The first layer has at least a detection confirmation portion B, The second layer has at least a liquid flow section D adjacent to the detection confirmation section B and a liquid flow path E connected to the liquid flow section D, When the first layer has a liquid receiving portion A, the liquid receiving portion A is separated from the detection confirmation portion B, The first layer is formed on one surface of a sheet-like material, and the second layer is formed on the other surface of the sheet-like material, the liquid receiving portion A, the liquid flow path E, the liquid flow portion D, and the detection confirmation portion B are made of a material M that allows the flow of the test liquid to occur by capillary action; The portion other than the material M is made of a material that does not allow the passage of the test liquid, One feature of this device is that when the test liquid is dropped into the liquid receiving section A, the test liquid flows through the liquid receiving section A, the liquid flow path E and the liquid flow section D in that order due to capillary action, and reaches the detection confirmation section B (first feature).

[0028] The test chip of the present invention is also characterized in that, of the surfaces of the first layer and the second layer, at least the surfaces of material M other than the liquid receiving section A are sealed with a film (second feature). Due to this feature, the test chip of the present invention controls the amount of the test liquid that reaches the detection confirmation section B. In this specification, the term "sealing" refers to restricting or blocking the inflow or outflow of gas or liquid by covering or the like.

[0029] In the test chip of the present invention, the liquid receiving section A is a section where the test liquid is dropped. Also, in the test chip of the present invention, the detection confirmation section B is a section where the presence or absence of a target substance such as an antigen in the test liquid dropped into the liquid receiving section A is confirmed by the presence or absence of color development. Therefore, the test chip of the present invention can be provided with a medium that reacts with the target substance and / or a labeling medium that causes a color development reaction due to the target substance, in an appropriate position. Also, preferably, in the test chip of this embodiment, a color development reaction due to the target substance occurs in the detection confirmation section B.

[0030] The test chip may have multiple sets of combinations of the detection confirmation unit B, the liquid flow unit D, and the liquid flow path E. In this case, the presence or absence of multiple detection targets can be confirmed simultaneously in one test.

[0031] As described above, the test chip of the present invention has a first layer and a second layer formed on both sides of a single sheet-like material (i.e., material M), and therefore has a different configuration from, for example, a chip formed by stacking two or more sheets of sheet-like material or a chip formed by folding a single sheet-like material. Such a test chip of the present invention has various advantages, such as (1) it is possible to avoid the labor and cost of stacking (or folding), (2) the flow of the test liquid by capillary action is ensured between the first and second layers, and (3) it is easy to dispose of because no tool or the like is required to hold the stacked (or folded) sheet-like material. The test chip of the present invention can be manufactured, for example, by the method for manufacturing a test chip described below.

[0032] The thickness of the test chip of the present invention is not particularly limited, but can be, for example, 100 to 300 μm.

[0033] (Test chip of the first embodiment) 1A and 1B are schematic perspective views of the test chip 1 of the first embodiment (illustration of the film is omitted. The same applies to Figs. 2 to 4, 6 to 11 below). The test chip 1 includes a first layer 10 on one surface (surface on which the test result is confirmed during use) and a second layer 20 on the other surface (rear surface). Fig. 1A is a perspective view of the test chip 1 with the confirmation surface facing up, and Fig. 1B is a perspective view of the test chip 1 with the rear surface facing up. As shown in Figs. 1A and 1B, the test chip 1 is sheet-shaped. In addition, the first layer 10 and the second layer 20 in the test chip 1 are adjacent to each other without any intervening layer. The shape of the test chip 1 in a plan view is not particularly limited and can be appropriately selected depending on the purpose. For example, it may be rectangular as shown in Figs. 1A and 1B, or may be circular, elliptical, or the like.

[0034] Fig. 2 is a schematic plan view of the confirmation surface and back surface of the above-mentioned test chip 1, and its structure corresponds to the test chip 1 shown in Fig. 1A and Fig. 1B. As shown in Fig. 2, the test chip 1 has a liquid receiving section A and a detection confirmation section B provided in a first layer 10 arranged on the confirmation surface side. The liquid receiving section A and the detection confirmation section B are spaced apart in the first layer 10 of the test chip 1.

[0035] Furthermore, the first layer 10 of the test chip 1 is provided with a liquid non-flowing portion X as a portion other than the liquid receiving portion A and the detection confirmation portion B. The liquid receiving portion A and the detection confirmation portion B are made of a material M that allows the flow of the test liquid by capillary action. The liquid non-flowing portion X is made of a material that does not allow the flow of the test liquid, in particular, a material M' obtained by impregnating the material M with a hydrophobic material.

[0036] As shown in FIG. 2, the second layer 20 of the test chip 1 is provided with a liquid circulating section C, a liquid circulating section D, and a liquid flow path E on the back side. The liquid flow path E is connected to the liquid circulating section D and is also connected to the liquid circulating section C. Furthermore, the second layer 20 of the test chip 1 is provided with a liquid non-circulating section Y as a portion other than the liquid circulating section C, the liquid flow path E, and the liquid circulating section D. The liquid circulating section C, the liquid flow path E, and the liquid circulating section D are made of a material M that allows the flow of the test liquid to occur due to capillary action, similar to the above-mentioned liquid receiving section A and detection confirmation section B. The liquid non-circulating section Y is made of a material that does not allow the flow of the test liquid to occur, particularly a material M' obtained by impregnating the material M with a hydrophobic material, similar to the above-mentioned liquid non-circulating section X.

[0037] 3 shows a schematic cross-sectional view of the test chip 1 of FIG. 2 cut along line a-a'. As shown in FIG. 3, in the test chip 1 of the first embodiment, the liquid receiving section A of the first layer 10 and the liquid flow section C of the second layer 20 are adjacent to each other, and the detection confirmation section B of the first layer 10 and the liquid flow section D of the second layer 20 are adjacent to each other. That is, in the test chip 1 of the first embodiment, the liquid receiving section A, the liquid flow section C, the liquid flow path E, the liquid flow section D, and the detection confirmation section B are adjacent to each other or connected in this order. In other words, the test chip 1 of the first embodiment is configured such that when the test liquid is dropped into the liquid receiving section A, the test liquid flows through the liquid receiving section A, the liquid flow section C, the liquid flow path E, and the liquid flow section D in this order by capillary action, and finally reaches the detection confirmation section B.

[0038] Here, in conventional test chips, the liquid receiving section and the detection confirmation section (detection area) are simply connected by a flow path on the substrate, so that when the test liquid is dropped into the liquid receiving section, the force of the liquid flow that advances in the surface direction of the substrate and reaches the detection area causes the color to be unevenly distributed near the end of the detection area (especially near the end farther from the liquid receiving section). On the other hand, in the above test chip 1, since it has the above-mentioned configuration, the test liquid dropped into the liquid receiving section A can finally reach the detection confirmation section B in the thickness direction of the test chip 1 (the direction from the liquid flow section D toward the detection confirmation section B). Therefore, the coloring point can be kept near the center of the detection confirmation section B, so that the coloring unevenness can be significantly suppressed.

[0039] In the test chip 1, the interface between the first layer 10 and the second layer 20 does not need to be substantially planar, as long as the first layer 10 has a predetermined portion such as the detection confirmation portion B, and the second layer 20 has a predetermined portion such as the liquid flow portion D. The dotted line as the boundary between the first layer 10 and the second layer 20 shown in Figures 1A, 1B, 3, etc. is schematic, and the first layer 10 and the second layer 20 are usually integrated.

[0040] FIG. 4 shows a schematic exploded view of the test chip 1 of FIG. 1A and FIG. 1B. As shown on the left side of FIG. 4, the test chip 1 (before film sealing) is typically composed of the above-mentioned material M, a pre-first layer 10' made of a hydrophobic material 50 having the design of the first layer 10, and a pre-second layer 20' made of a hydrophobic material 50 having the design of the second layer 20. As shown on the left side of FIG. 4, the test chip 1 has a configuration in which the pre-first layer 10' and the pre-second layer 20' are impregnated from both sides of the material M. As shown on the right side of FIG. 4, the test chip 1 is composed of, for example, a material M and a material M' obtained by impregnating the material M with a hydrophobic material 50. Due to this configuration, there is no significant difference between the thickness of the material M shown on the left side of FIG. 4 and the thickness of the test chip 1 shown on the right side of FIG. 4.

[0041] The material M is not particularly limited as long as it generates capillary action, and examples thereof include paper such as filter paper, nonwoven fabric, nitrocellulose, polypropylene, etc. Among these, from the viewpoint of more conveniently and inexpensively producing the test chip, the material M is preferably filter paper. The thickness and basis weight (density) of the material M can be appropriately selected in consideration of the viscosity of the test liquid, etc.

[0042] The hydrophobic material is not particularly limited as long as it can be impregnated into the material M and inhibits the capillary phenomenon in the material M, and examples of the hydrophobic material include wax and a composition containing the wax. From the viewpoint of ease of production, the hydrophobic material preferably has a melting point of 90° C. or lower.

[0043] In the above test chip, the material of the liquid non-flowing portion X on the confirmation surface side is preferably colored so that the person conducting the test can easily visually recognize the liquid receiving portion A and the detection confirmation portion B on the confirmation surface side. On the other hand, the material M' of the liquid non-flowing portion Y on the back surface side of the above test chip may be colored, or may be white or transparent, or may not be colored.

[0044] The coloring of the material M' can be achieved, for example, by impregnating the material M with a colorant in addition to the hydrophobic material. Such a colorant is preferably hydrophobic, and examples of such a colorant include pigments such as carbon black (black pigment). In addition, it is preferable to select a colorant that does not adversely affect the reagent used in the test chip.

[0045] The shape of the liquid receiving portion A in a plan view is not particularly limited and can be appropriately selected depending on the purpose. For example, it may be circular as shown in FIG. 2, or it may be elliptical, rectangular, or the like.

[0046] The shape of the detection confirmation portion B in a plan view is not particularly limited and can be appropriately selected depending on the purpose. It may be circular as shown in FIG. 2, or may be elliptical, rectangular, or the like.

[0047] The shape of the liquid flow section C in a plan view is not particularly limited and can be appropriately selected depending on the purpose, but it is preferably the same shape as the liquid receiving section A. In addition, it is preferable that the liquid flow section C has a shape that substantially coincides with the liquid receiving section A in a plan view of the test chip.

[0048] The shape of the liquid flow section D in a plan view is not particularly limited and can be appropriately selected depending on the purpose, but it is preferably the same shape as the detection confirmation section B. In addition, it is preferable that the liquid flow section D has a shape that substantially coincides with the detection confirmation section B in a plan view of the test chip.

[0049] Furthermore, in the test chip of the present invention, at least the surfaces of the material M other than the liquid receiving portion A of the surfaces of the first layer and the second layer are sealed with a film (second feature). Figs. 5A and 5B are diagrams of the test chip in Figs. 1A and 1B to which a film is added. As shown in Fig. 5A, in the test chip 1 of the first embodiment, all surfaces of the surface of the first layer 10 other than the liquid receiving portion A are covered and sealed with a film 61. Also, as shown in Fig. 5B, in the test chip 1 of the first embodiment, all surfaces of the second layer 20 are covered and sealed with a film 62. Note that in Figs. 5A and 5B, the dotted lines in the films 61 and 62 represent the outlines of the portions of the lower layer (the first layer 10 or the second layer 20) made of the material M.

[0050] In the test chip 1 of the first embodiment, as described above, when the test liquid is dropped into the liquid receiving section A, the test liquid flows through the parts made of the material M, specifically, the liquid receiving section A, the liquid flow section C, the liquid flow path E, and the liquid flow section D in this order, and finally reaches the detection confirmation section B. Here, in order for the test liquid to finally reach the detection confirmation section B, the gas present in the space through which the test liquid flows needs to be discharged outside the system. In addition, when the liquid flows, it is considered that most of the gas is discharged outside the system from the part where the material M is exposed on the surface. Therefore, in the present invention, as a second feature, the surface of the material M other than the liquid receiving section A among the surface of the first layer 10 and the surface of the second layer 20 of the test chip 1 is sealed with a film. As a result, the part where the gas is discharged outside the system is limited, and as a result, the amount of liquid that reaches the detection area of ​​the test chip 1, i.e., the detection confirmation section B, can be controlled (constant) regardless of the amount of the test liquid introduced.

[0051] In the test chip of the present invention, the surface sealed with the film preferably includes all surfaces of material M other than the liquid receiving portion A, and more preferably substantially all surfaces other than the liquid receiving portion A as shown in Figures 5A and 5B. When all surfaces other than the liquid receiving portion A are sealed with the film, it is considered that gas accompanying the flow of liquid is discharged mainly from the end face of the test chip.

[0052] The material of the film is not particularly limited as long as it exhibits sealing performance, and various resins, polymers, etc. can be used. In addition, an adhesive film can be used as the film. In addition, the film is preferably transparent so that the presence or absence of color development in the detection confirmation part B can be easily confirmed.

[0053] When the above-mentioned test chip 1 is made of a material M (a material in which the flow of the test liquid is manifested by capillary action) and a material M' (a material in which the flow of the test liquid is not manifested, which is obtained by impregnating the material M with a hydrophobic material), the airtightness of the material M' is preferably 15 seconds or less, and more preferably 3 seconds or more. By manufacturing the test chip so that the airtightness is 3 seconds or more, it is possible to sufficiently avoid liquid leakage from the flow path (ensuring barrier properties), and more reliably obtain a test chip having a desired flow path structure. Furthermore, by manufacturing the test chip so that the airtightness is 15 seconds or less, it is possible to sufficiently avoid problems such as blockage when impregnating the material M with a hydrophobic material, and also to sufficiently smoothly discharge gas accompanying the flow of the liquid, and more reliably and quickly achieve a constant amount of liquid reaching the detection confirmation part B. In addition, when measuring the airtightness of the material M', a material M' having a size of 40 mm x 40 mm and covered on both sides with film (one of the films has an opening) is used as a measurement sample. The sample is then subjected to a pressure of 1 kg / cm 2 The sample is pressed against a glass plate at a pressure of 100 mmHg, and suction is applied from the opening of the sample. The time from when the pressure difference reaches 370 mmHg until 10 cc of gas leaks is defined as the airtightness. More specifically, the airtightness of the material M' can be obtained by the method described in the Examples. The airtightness can be adjusted by, for example, adjusting the amount of hydrophobic material to be impregnated (impregnation rate described below), components, viscosity, etc., and by appropriately selecting the material M.

[0054] When the above-mentioned test chip 1 is made of a material M (a material in which the flow of the test liquid is realized by capillary action) and a material M' (a material in which the flow of the test liquid is not realized, which is obtained by impregnating the material M with a hydrophobic material), the impregnation rate of the hydrophobic material in the material M' is preferably 70% or less, and more preferably 14% or more. By manufacturing the test chip so that the impregnation rate is 70% or less, problems such as blockages occurring when the material M is impregnated with the hydrophobic material can be sufficiently avoided, and a test chip having a desired flow path structure can be more reliably obtained. Furthermore, by manufacturing the test chip so that the impregnation rate is 14% or more, liquid leakage from the flow path can be sufficiently avoided (ensuring barrier properties), and a test chip having a desired flow path structure can be more reliably obtained.

[0055] The above impregnation rate refers to the impregnation rate of the material M' in a region of the test chip 1 that is made of the material M' over the entire thickness direction. The above-mentioned impregnation rate can be considered to be 100% for a material M' obtained by immersing the material M in a hydrophobic material that has been heated to a sufficiently low viscosity (for example, heated to 120°C) and leaving it for a sufficient time (for example, 3 minutes) while maintaining the temperature. More specifically, the above-mentioned impregnation rate can be obtained by the method described in the examples. The impregnation rate can be adjusted, for example, by adjusting the amount of hydrophobic material to be impregnated (such as the thickness of the hydrophobic film).

[0056] (Test chip according to second embodiment) Fig. 6 is a schematic plan view of the confirmation surface and back surface of the test chip 1 of the second embodiment (film is omitted). As shown in Fig. 6, the test chip 1 has a liquid receiving section A and a detection confirmation section B provided in a first layer 10 arranged on the confirmation surface side. The liquid receiving section A and the detection confirmation section B are spaced apart in the first layer 10 of the test chip 1. The test chip 1 also has a liquid flow path F connected to the liquid receiving section A in the first layer 10 arranged on the confirmation surface side.

[0057] Furthermore, the first layer 10 of the test chip 1 is provided with a liquid non-flowing portion X as a portion other than the liquid receiving portion A, the detection confirmation portion B, and the liquid flow path F. The liquid receiving portion A, the detection confirmation portion B, and the liquid flow path F are made of a material M that allows the flow of the test liquid by capillary action. The liquid non-flowing portion X is made of, for example, a material that does not allow the flow of the test liquid, in particular, a material M' obtained by impregnating the material M with a hydrophobic material.

[0058] As shown in FIG. 6, the second layer 20 of the test chip 1 is provided with a liquid flow section D and a liquid flow path E on the back side. The liquid flow path E is connected to the liquid flow section D. Furthermore, the second layer 20 of the test chip 1 is provided with a liquid non-flow section Y as a portion other than the liquid flow path E and the liquid flow section D. The liquid flow path E and the liquid flow section D are made of a material M that allows the flow of the test liquid to occur due to capillary action, similar to the above-mentioned liquid receiving section A, detection confirmation section B, and liquid flow path F. The liquid non-flow section Y is made of a material that does not allow the flow of the test liquid to occur, particularly a material M' obtained by impregnating a hydrophobic material into the material M, similar to the above-mentioned liquid non-flow section X.

[0059] FIG. 7 shows a schematic cross-sectional view of the test chip 1 of FIG. 6 cut along the line b-b'. As shown in FIG. 7, in the test chip 1 of the second embodiment, the detection confirmation section B of the first layer 10 and the liquid flow section D of the second layer 20 are adjacent to each other, and the liquid flow path F of the first layer 10 and the liquid flow path E of the second layer 20 are connected to each other. That is, in the test chip 1 of the second embodiment, the liquid receiving section A, the liquid flow path F, the liquid flow path E, the liquid flow section D, and the detection confirmation section B are adjacent to each other or connected in this order. In other words, the test chip 1 of the second embodiment is configured such that when the test liquid is dropped into the liquid receiving section A, the test liquid flows through the liquid receiving section A, the liquid flow path F, the liquid flow path E, and the liquid flow section D in this order by capillary action, and finally reaches the detection confirmation section B. Therefore, in the test chip 1 of the second embodiment, as in the first embodiment, the test liquid dropped into the liquid receiving section A can ultimately reach the detection confirmation section B in the thickness direction of the test chip 1 (the direction from the liquid flow section D toward the detection confirmation section B).

[0060] In the above test chip, the material of the liquid non-flowing portion X on the confirmation surface side is preferably colored so that the person conducting the test can easily visually recognize the liquid receiving portion A and the detection confirmation portion B on the confirmation surface side. On the other hand, the material of the liquid non-flowing portion Y on the back surface side of the above test chip may be colored, or may be white or transparent, or may not be colored.

[0061] Other than the above, description of matters common to the first embodiment will be omitted.

[0062] (Test chip according to the third embodiment) Fig. 8 is a schematic plan view of the confirmation surface and back surface of the test chip 1 having the third embodiment (film is omitted). As shown in Fig. 8, the test chip 1 has a detection confirmation section B provided on the first layer 10 arranged on the confirmation surface side, and does not have a liquid receiving section A provided thereon.

[0063] Furthermore, the first layer 10 of the test chip 1 is provided with a liquid non-flowing portion X as a portion other than the detection confirmation portion B. The detection confirmation portion B is made of a material M that allows the flow of the test liquid by capillary action. The liquid non-flowing portion X is made of a material that does not allow the flow of the test liquid, in particular, a material M' obtained by impregnating the material M with a hydrophobic material.

[0064] As shown in FIG. 8, the second layer 20 of the test chip 1 is provided with a liquid receiving section A, a liquid flow section D, and a liquid flow path E on the back side. The liquid flow path E is connected to the liquid flow section D and is also connected to the liquid receiving section A. Furthermore, the second layer 20 of the test chip 1 is provided with a liquid non-flow section Y as a portion other than the liquid receiving section A, the liquid flow path E, and the liquid flow section D. The liquid receiving section A, the liquid flow path E, and the liquid flow section D are made of a material M that allows the flow of the test liquid to occur due to capillary action, similar to the above-mentioned detection confirmation section B. The liquid non-flow section Y is made of a material that does not allow the flow of the test liquid to occur, particularly a material M' obtained by impregnating a hydrophobic material into the material M, similar to the above-mentioned liquid non-flow section X.

[0065] FIG. 9 shows a schematic cross-sectional view of the test chip 1 of FIG. 8 cut along the c-c' line. As shown in FIG. 9, in the test chip 1 of the third embodiment, the detection confirmation section B of the first layer 10 and the liquid flow section D of the second layer 20 are adjacent to each other. That is, in the test chip 1 of the third embodiment, the liquid receiving section A, the liquid flow path E, the liquid flow section D, and the detection confirmation section B are adjacent to each other or connected in this order. In other words, the test chip 1 of the third embodiment is configured such that, when the test liquid is dropped into the liquid receiving section A, the test liquid flows through the liquid receiving section A, the liquid flow path E, and the liquid flow section D in this order by capillary action, and finally reaches the detection confirmation section B. Therefore, in the test chip 1 of the third embodiment, the test liquid dropped into the liquid receiving section A can finally reach the detection confirmation section B in the thickness direction of the test chip 1 (the direction from the liquid flow section D toward the detection confirmation section B), as in the first embodiment.

[0066] In the above test chip, it is preferable that the material M' of the liquid non-circulating portion X on the confirmation surface side and the liquid non-circulating portion Y on the back surface side be colored so that the person conducting the test can easily visually identify the liquid receiving portion A and the detection confirmation portion B on the confirmation surface side.

[0067] The test chip of the third embodiment is particularly useful, for example, in cases where it is desired to arrange the liquid receiving portion A and the detection confirmation portion B on different surfaces from the viewpoint of fail-safe.

[0068] Other than the above, description of matters common to the first embodiment will be omitted.

[0069] Furthermore, the test chip of this embodiment may have the following characteristics as appropriate. The following description will be based on the first embodiment, but all of the characteristics are applicable to the second and third embodiments.

[0070] Fig. 10 is a schematic plan view of the confirmation surface and the back surface of the test chip 1 of one embodiment. The test chip 1 shown in Fig. 10 is similar to that shown in Fig. 2, except that the liquid flow section D provided in the second layer 20 arranged on the back surface side has a ring structure and a liquid non-flow section D' is formed on the inside. In this test chip 1, due to the presence of the liquid non-flow section D', when the test liquid advances from the liquid flow section D toward the detection confirmation section B, a liquid flow can be formed in the detection confirmation section B from the outside toward the center. Therefore, the coloring area can be further confined near the center of the detection confirmation section B, and color unevenness can be further significantly suppressed.

[0071] In the test chip 1 as described above, the liquid flow section D, which is an annular structure, can have any contour shape, such as a circle, an ellipse, a rectangle, etc., but preferably has a contour shape that substantially matches that of the detection confirmation section B in a planar view of the test chip. Also, it is preferable that the liquid non-flow section D' has a shape that is a scaled-down version of the contour shape of the liquid flow section D in a planar view of the test chip. Furthermore, it is preferable that the liquid non-flow section D' is white or transparent, or is not colored, so as not to impede confirmation of color development in the detection confirmation section B.

[0072] Fig. 11 is a schematic plan view of the confirmation surface and back surface of a test chip 1 of another embodiment. The test chip 1 shown in Fig. 11 is similar to that of Fig. 2, except that the second layer 20 arranged on the back surface side has a plurality of liquid flow paths E (two paths, E1 and E2, in Fig. 11). In this test chip 1, the presence of a plurality of liquid flow paths E allows the momentum of the liquid flow from each liquid flow path E to be offset when the test liquid advances from the liquid flow section D toward the detection and confirmation section B, thereby promoting the liquid flow in the thickness direction of the test chip 1. Therefore, the coloring area can be further confined near the center of the detection and confirmation section B, and color unevenness can be further significantly suppressed.

[0073] Regarding the above-mentioned features, in the case of the testing chip of the second embodiment, a plurality of liquid flow paths F can be provided in the same number as the number of liquid flow paths E, and the plurality of liquid flow paths F in the first layer 10 can be connected to the plurality of liquid flow paths E in the second layer 20, respectively.

[0074] (Method of manufacturing the test chip) A method for producing a test chip according to an embodiment of the present invention is a method for producing the test chip described above, a film forming step of forming a first hydrophobic film on a first substrate and a second hydrophobic film on a second substrate using a hydrophobic material; a first printing step of printing a first sacrificial substrate with a first hydrophobic film on the first substrate in a reverse design of the first layer of the test chip; a second printing step of printing a second sacrificial substrate with a second hydrophobic film on the second substrate in a reverse design of the second layer of the test chip; a first transfer step of transferring the first hydrophobic film after the first printing step onto one surface of a sheet-like material and impregnating the sheet-like material to form a first layer; a second transfer step of transferring the second hydrophobic film after the second printing step to the other surface of the one sheet-like material and impregnating the sheet-like material to form a second layer; a sealing step of sealing at least the non-impregnated surfaces of the first layer and the second layer other than the liquid receiving portion A with a film; The present invention is characterized by comprising: According to this manufacturing method, the above-mentioned test chip can be manufactured easily, highly accurately, and at low cost.

[0075] <Film formation process> In the film formation step, a first hydrophobic film is formed on a first substrate using a hydrophobic material, and a second hydrophobic film is formed on a second substrate.

[0076] A colorant can be blended into the hydrophobic material. A viscosity adjusting component (e.g., resin, etc.), a dispersion aid, a filler, etc. can be appropriately blended into the hydrophobic material. The hydrophobic material and the colorant are as described above with respect to the test chip.

[0077] The composition of the hydrophobic material used to form the first hydrophobic film and the composition of the hydrophobic material used to form the second hydrophobic film may be the same or different.

[0078] The above-mentioned hydrophobic material is preferably heated and melted before forming the film. The heating temperature can be appropriately set in consideration of the melting points of the hydrophobic material and the viscosity adjusting component. In addition, the viscosity of the hydrophobic material when melted can be appropriately selected in consideration of the thickness and basis weight (density) of the sheet-like material to be used later, so that the sheet-like material can be impregnated with the hydrophobic material as desired.

[0079] The viscosity of the hydrophobic material is not particularly limited, but from the viewpoint of sufficiently avoiding problems such as blockage during impregnation, the viscosity is set to 140° C. and a shear rate of 3000 s -1 is preferably 100 mPa·s or less, more preferably 50 mPa·s or less, and even more preferably 30 mPa·s or less.

[0080] The first and second substrates are not components of the final test chip, but are one of the components used for manufacturing the test chip. For the first and second substrates, for example, polyesters such as polyethylene terephthalate (PET) and polyethylene naphthalate (PEN), polyphenylene sulfide (PPS), and films made of cellophane can be used. The first and second substrates may have any shape, such as a ribbon shape or a film shape. The first and second substrates may be the same substrate.

[0081] In the film formation step, the hydrophobic film can be formed on the first substrate and the second substrate by applying the above-mentioned hydrophobic material. It is preferable to heat and hold the first substrate and the second substrate before applying the hydrophobic material. The thickness of the first hydrophobic film and the second hydrophobic film to be formed can be appropriately selected in consideration of the thickness of the sheet-like material to be used later, the impregnation rate, etc.

[0082] <First printing process and second printing process> In a first printing step, the first hydrophobic film formed on the first substrate is used to print a first sacrificial substrate, and in a second printing step, the second hydrophobic film formed on the second substrate is used to print a second sacrificial substrate.

[0083] The first sacrificial substrate and the second sacrificial substrate are not components of the final test chip, but are one of the components used for manufacturing the test chip. The first sacrificial substrate and the second sacrificial substrate are preferably versatile and can be printed with high precision, such as fine paper, coated paper, synthetic paper, etc. The first sacrificial substrate and the second sacrificial substrate may be the same substrate.

[0084] Printing on the first sacrificial substrate and printing on the second sacrificial substrate are not particularly limited, but for example, a label writer commonly used as an office product can be suitably used. In the first printing step, the first hydrophobic film on the first substrate is used to print on the first sacrificial substrate so as to form an inverted design of the first layer of the test chip. In the second printing step, the second hydrophobic film on the second substrate is used to print on the second sacrificial substrate so as to form an inverted design of the second layer of the test chip. In this regard, taking the manufacture of the test chip shown in FIG. 2 as an example, the design printed on the first sacrificial substrate is a design having a printed film corresponding to the liquid receiving portion A and the detection confirmation portion B. In addition, the design printed on the second sacrificial substrate is a design having a printed film corresponding to the liquid flow portion C, the liquid flow portion D, and the liquid flow path E.

[0085] The design to be printed may be created in advance using a personal computer or the like, and the data may be input to the printing device. The first printing step and the second printing step may be performed simultaneously.

[0086] <First transfer step and second transfer step> In the first transfer step, the first hydrophobic film after the first printing step is transferred to one side of one sheet-like material and the sheet-like material is impregnated with the first hydrophobic film to form a first layer, and in the second transfer step, the second hydrophobic film after the second printing step is transferred to the other side of the sheet-like material and the sheet-like material is impregnated with the second hydrophobic film to form a second layer.

[0087] In this case, the areas through which the test liquid flows (the liquid receiving area A in either the first layer or the second layer, the detection confirmation area B in the first layer, and the liquid flow area D and liquid flow path E in the second layer) correspond to non-impregnated areas.

[0088] A transfer device such as a laminator may be used for transferring the hydrophobic film. In addition, when transferring the first hydrophobic film onto the first substrate and the second hydrophobic film onto the second substrate, it is preferable to appropriately adjust the transfer positions of each film according to the design of the desired test chip.

[0089] The sheet-like material is as described above with respect to the material M.

[0090] The impregnation of the sheet-like material with the hydrophobic film can be achieved, for example, by heating. In this regard, for example, by using a transfer device such as a heatable laminator, both the transfer and the impregnation of the hydrophobic film can be performed.

[0091] Here, in the first transfer step and the second transfer step, the first hydrophobic film transferred from the first substrate and the second hydrophobic film transferred from the second substrate are at least partially in contact with each other in the material M by the above-mentioned impregnation. In other words, in a portion of the sheet-like material where the hydrophobic film is transferred to both sides in the thickness direction, the hydrophobic film is impregnated throughout the entire thickness direction. On the other hand, in a portion of the sheet-like material where the hydrophobic film is transferred only to one surface in the thickness direction, the hydrophobic film is not impregnated to the other surface. Such adjustment can be performed, for example, by appropriately adjusting the viscosity of the hydrophobic material, the thickness of the sheet-like material, the thickness of the hydrophobic film, etc.

[0092] In the first and second transfer steps, the transferred hydrophobic film can be entirely impregnated into the sheet-like material. In this case, the thickness of the sheet-like material hardly changes before and after the first and second transfer steps (however, there is a possibility that the thickness may decrease due to the effect of compression by a laminator, etc.).

[0093] The first transfer step may be performed before the second transfer step or after the second transfer step. Alternatively, the first transfer step and the second transfer step may be performed simultaneously. In that case, the sheet-like material can be sandwiched between the first substrate and the second substrate so that the hydrophobic film is in contact with the sheet-like material.

[0094] After the first and second transfer steps, the first and second substrates can be peeled off as appropriate. Also, a substance that causes a color-developing reaction (such as an enzyme) can be placed in an appropriate location in the non-impregnated area.

[0095] <Sealing process> In the sealing step, at least the non-impregnated surfaces of the first layer formed in the first transfer step and the second layer formed in the second transfer step other than the liquid receiving portion A are sealed with a film. In this way, the test chip of this embodiment can finally be obtained. The film is as described above with respect to the test chip.

[0096] In the sealing step, it is preferable to previously cut or hollow out the film so that at least the surface of the liquid receiving portion A is exposed when the film is placed.

[0097] In the manufacturing method of the test chip of this embodiment, the specified printing and transfer processes described above are performed, so that even if a sheet-like material with a relatively rough surface, such as commercially available filter paper, is used, there is little transfer failure or void occurrence, and the test chip can be manufactured with higher precision.

[0098] Furthermore, in the method for producing the test chip of this embodiment, the first and second layers having a desired design can be formed without using a mold or the like, making on-demand production possible.

[0099] Furthermore, in the manufacturing method of the test chip of this embodiment, the test chip can be manufactured by forming a first layer and a second layer on both sides of a single sheet-like material, respectively. Therefore, compared to, for example, a manufacturing method using two sheets of sheet-like material (or a manufacturing method by folding a single sheet-like material), this method has various advantages, such as: (1) the effort and cost of stacking (or folding) can be avoided; (2) the flow of the test liquid by capillary action is ensured between the first and second layers of the obtained test chip; and (3) since no tool or the like for maintaining the stacking (or folding) is required, the obtained test chip can be easily disposed of. EXAMPLES

[0100] Next, the present invention will be described more specifically with reference to examples and comparative examples, but the present invention is not limited to the following examples.

[0101] (Experiment 1) First, we investigated the effect of the design (channel structure) of the first and second layers on color unevenness for a test chip without film sealing.

[0102] 48 parts by mass of paraffin wax (manufactured by Nippon Seiro Co., Ltd., "Paraffin Wax -155"), 48 parts by mass of synthetic wax (manufactured by Mitsubishi Chemical Corporation, "Diacarna (registered trademark) 80"), 2 parts by mass of ethylene-vinyl acetate copolymer resin (manufactured by Tosoh Corporation, "Ultrathene (registered trademark) 681"), and 2 parts by mass of carbon black (manufactured by Mitsubishi Chemical Corporation, "MA-100") as a colorant were blended and melt-mixed at 100°C. At that time, each component was dispersed using a sand mill. In this manner, a hydrophobic material was prepared.

[0103] A substrate (Toray Industries, Inc.'s "Lumirror (registered trademark) #5A-F531", polyester film, one side heat-resistant treated) was placed with the side that had not been heat-resistant facing up on a hot plate maintained at 120° C. Next, the above-mentioned hydrophobic material maintained in a molten state at 120° C. was applied to the substrate with a thickness of about 6 to 12 μm using a Mayer bar to form a ribbon-shaped hydrophobic film (first hydrophobic film and second hydrophobic film).

[0104] Next, using a label writer (King Jim Co., Ltd., "Tepra SR750"), the above-mentioned hydrophobic film was printed on the fine paper as the first sacrificial substrate so as to have the desired design created in advance on a personal computer. Similarly, the above-mentioned hydrophobic film was printed on the fine paper as the second sacrificial substrate so as to have the desired design created in advance on a personal computer. The above-mentioned two designs printed on the fine paper correspond to the inverted designs of the confirmation surface (first layer) and back surface (second layer) of the final test chip, respectively. The fine paper after printing is not particularly used in the subsequent process.

[0105] Here, in Comparative Example 1, the design of the confirmation surface (first layer) and the design of the back surface (second layer) were as shown in Fig. 12. That is, in Comparative Example 1, the liquid receiving section A and the detection confirmation section B are connected by a liquid flow path on the confirmation surface, and the designs of the confirmation surface and the back surface are substantially the same. Also, in Reference Examples 1-1 and 1-2, the designs of the confirmation surface (first layer) and the back surface (second layer) were as shown in Figs. 2 and 10, respectively.

[0106] Next, using the printed substrate, filter paper (Whatman grade 41) as sheet-like material M was sandwiched while appropriately adjusting the position so that the hydrophobic film was in contact with the filter paper. Then, using a laminator maintained at 90 ° C, the hydrophobic film was transferred to both sides of the filter paper at once. Each hydrophobic film was almost completely impregnated into the filter paper from both sides, and the filter paper portion directly below was hydrophobized. As a result, a first layer having a predetermined design was formed on the confirmation surface side of the filter paper, and a second layer having a predetermined design was formed on the back side of the filter paper. In addition, in the part of the filter paper where the hydrophobic film was transferred to both sides in the thickness direction, the hydrophobic film was impregnated throughout the entire thickness direction, and in the part where the hydrophobic film was transferred to only one surface in the thickness direction, the impregnation was not allowed to reach the other surface. Thereafter, the substrates on both sides were peeled off to finally obtain a test chip (without film sealing).

[0107] <Evaluation of color unevenness> Each of the obtained test chips was placed with the confirmation surface (first layer) facing up, and a mark was made with a water-based red highlighter pen in the center of the detection confirmation part B. Then, three drops of distilled water were dropped into the liquid receiving part A with a dropper, and the change in the red mark due to the flow of water was observed.

[0108] As a result, in Comparative Example 1 (FIG. 12), the red mark that was in the center of the detection confirmation part B moved to the periphery of the detection confirmation part B (especially the side farther from the liquid receiving part A), making it difficult to visually confirm the red color. Therefore, it is recognized that the test chip of Comparative Example 1 has uneven color development.

[0109] In contrast, in Reference Example 1-1 (FIG. 2) and Reference Example 1-2 (FIG. 10), the highlighter mark at the center of detection confirmation section B remained inside the outer periphery of detection confirmation section B. In particular, in Reference Example 1-2 (FIG. 10), the highlighter mark at the center of detection confirmation section B remained closer to the center of detection confirmation section B. This is thought to be because, compared to Comparative Example 1, the liquid flow path has been optimized to allow water to flow three-dimensionally within the filter paper. Therefore, it is recognized that the test chips of Reference Examples 1-1 and 1-2 have significantly suppressed color unevenness.

[0110] (Experiment 2) Next, we investigated the effect of film sealing on the behavior of the liquid reaching the detection area.

[0111] A hydrophobic material (ink 1) was prepared by blending 72.0 parts by mass of paraffin wax (manufactured by Nippon Seiro Co., Ltd., "Paraffin Wax -135"), 18.0 parts by mass of synthetic wax (manufactured by Mitsubishi Chemical Corporation, "Diacarna (registered trademark) 30"), 1.8 parts by mass of carbon black (manufactured by Mitsubishi Chemical Corporation, "MA-100") as a colorant, and 11.25 parts by mass of resin (manufactured by Tosoh Corporation, "Ultrathene (registered trademark) 722") of ink 1 at 140°C and a shear rate of 3000 s -1 The viscosity at is 23 mPa s and the density is 0.85 g / cm 3 It was.

[0112] Next, a test chip (without film sealing) was obtained in a manner generally similar to that of Experiment 1, except that Ink 1 was used as the hydrophobic material. In this case, the thickness of each of the ribbon-shaped hydrophobic films (the first hydrophobic film and the second hydrophobic film) was 10.8 μm, the design of the first layer and the second layer was generally as shown in Figure 2, and the liquid receiving portion A was φ5 mm.

[0113] Furthermore, in Example 2, the entire surface of the second layer of the test chip was covered (sealed) with a film ("660PF" manufactured by Nichiban Co., Ltd.), and the surface of the first layer was covered (sealed) with the above film having a hole of φ6 mm so that the surface of the liquid receiving part A was exposed, to obtain a test chip. On the other hand, in Comparative Example 2, such film sealing was not performed.

[0114] The test chips of Example 2 (with film sealing) and Comparative Example 2 (without film sealing) were arranged so that the surface of the first layer was facing upward. Then, a predetermined amount of a colored aqueous solution in which food coloring was dissolved was weighed and dropped into the liquid receiving part A, and in each case, the detection confirmation part B was photographed with a digital camera 5 minutes after the start of dropping, and the Lab value was obtained using the image analysis application "ImageJ". In each of Example 2 and Comparative Example 2, the amount of the colored aqueous solution dropped was appropriately changed to 5 μL, 8 μL, 12 μL, and 16 μL, and the above test was performed. Then, the Lab value when the amount of the colored aqueous solution dropped was 5 μL was set as the standard (zero), and the change in the Lab value when the amount of the colored aqueous solution dropped was increased was calculated as the color difference ΔE. The results are shown in Table 1.

[0115] [Table 1]

[0116] As can be seen from Table 1, in Example 2, the change in ΔE when the amount of dripping was increased was smaller than in Comparative Example 2. This shows that by sealing the specified surface of the test chip with a film, the amount of liquid reaching the detection confirmation part B can be made constant even if the amount of dripping into the liquid receiving part A becomes excessive.

[0117] Next, for the test chips of Example 2 and Comparative Example 2, 16 μL of colored aqueous solution, which is considered to be an excessive amount, was weighed and dropped into the liquid receiving part A. Then, the detection confirmation part B was photographed with a digital camera at 3 minutes, 5 minutes, 7 minutes, 9 minutes, and 12 minutes after the start of dropping, and the Lab value was calculated in the same manner as above. In each of Example 2 and Comparative Example 2, the Lab value 3 minutes after the start of dropping was set as the reference (zero), and the change in the Lab value thereafter was calculated as the color difference ΔE. The results are shown in Table 2.

[0118] [Table 2]

[0119] From Table 2, in Example 2, the ΔE value is generally smaller after 5 minutes from the drop compared to Comparative Example 2. This shows that the amount of liquid reaching the detection confirmation part B itself can be reduced by sealing the specified surface of the test chip with a film. Furthermore, from Table 2, in Comparative Example 2, the ΔE value continues to increase even after 7 minutes from the drop, whereas in Example 2, the increase in the ΔE value has mostly subsided 5 minutes from the drop. In other words, by sealing the specified surface of the test chip with a film, the amount of liquid reaching the detection confirmation part B is saturated early, so that a reduction in the test time can also be expected.

[0120] (Experiment 3) Next, various characteristics of the test chip that can ensure good liquid flow and flow channel barrier properties were examined.

[0121] The same filter paper (Whatman grade 41) used in experiment 2 was cut to a size of 5 cm x 2 cm, dried at 120°C for 3 minutes, and the dry mass M0 (g) was measured. The filter paper was then immersed in the same hydrophobic material (ink 1) used in experiment 2 and left at 120°C for 3 minutes. After immersion, the filter paper was sandwiched between the same type of filter paper and a slide glass and left at 120°C for 1 minute under a load of 100 gf to remove excess hydrophobic material. The mass M1 (g) of the filter paper was then measured. The maximum impregnation amount per unit area P was calculated from (M1-M0) x 1000. maxWhen we calculated, P max =68.3g / m 2 It was.

[0122] Next, a test chip (without film sealing) having a design of the first layer and the second layer generally as shown in Figure 2 was obtained in a manner generally similar to that of Experiment 2, except that the thicknesses of the first hydrophobic film used to form the first layer and the second hydrophobic film used to form the second layer were appropriately changed as shown in Table 3. The liquid receiving portion A was φ5 mm in both cases.

[0123] Next, similarly to Example 2 of Experiment 2, the entire surface of the second layer of the test chip was covered (sealed) with a film ("660PF" manufactured by Nichiban Co., Ltd.), and the surface of the first layer was covered (sealed) with the above film having a hole of φ6 mm so that the surface of the liquid receiving portion A was exposed, thereby obtaining the test chips (with film sealing) of Examples 3-1 to 3-4. Note that the conditions of Example 3-2 correspond to those of Example 2 of Experiment 2.

[0124] (Hydrophobic material impregnation rate) For each example, the density of Ink 1 is used to calculate the actual wettability per unit area P (g / m 2 ) and calculate (P / P max The impregnation rate (%) of the hydrophobic material into the filter paper was calculated from the formula: (1) x 100. The calculated impregnation rates are shown in Table 3.

[0125] (Airtightness of impregnated part (material M')) The filter paper used in each example, i.e., Whatman grade 41, was cut to a size of 40 mm x 40 mm. A hydrophobic film having the same composition and thickness as the first hydrophobic film in each example was transferred to the entire surface of one side of the filter paper, and at the same time, a hydrophobic film having the same composition and thickness as the second hydrophobic film in each example was transferred to the entire other surface of the filter paper. In this way, the entire filter paper with a size of 40 mm x 40 mm was impregnated with a hydrophobic material to obtain a material M'. Next, one entire surface of the impregnated filter paper was covered (sealed) with the film used in each example, i.e., "660PF" manufactured by Nichiban Co., Ltd., and the other surface was covered (sealed) with a similar film with a φ6 mm opening to prepare a sample for measurement. Then, using a Beck smoothness meter, the above sample was placed on a glass plate with the opening facing the suction part, with a pressure of 1 kg / cm. 2 The time (seconds) until 10 cc of gas leaked after the pressure difference reached 370 mmHg was measured as the airtightness of material M'. The measurement results are shown in Table 3. The leak at this time was led from the end cross section of the sample in the planar direction to the suction part.

[0126] <Evaluation of liquid flowability> Each of the obtained test chips (with film sealing) was placed so that the surface on the first layer side faced upward. Next, about 0.3 mL of a liquid prepared by dissolving water-based fluorescent ink in distilled water was dropped with a dropper into the liquid receiving part A, and the time (flow time) from the start of the drop to the time when the liquid reached the detection confirmation part B was measured. The measurement results are shown in Table 3. The shorter the flow time, the better the liquid flow property.

[0127] <Evaluation of flow path barrier properties> Each of the obtained test chips (with film sealing) was placed so that the surface on the first layer side faced upward. Next, a liquid prepared by dissolving water-based fluorescent ink in distilled water was dropped into the liquid receiving part A. At this time, the presence or absence of liquid leakage from the flow path was visually confirmed using a UV lamp. If no liquid leakage was confirmed, the flow path barrier property was evaluated as good. The results are shown in Table 3.

[0128] [Table 3]

[0129] From Table 3, it can be said that all of Examples 3-1 to 3-4 have good liquid flow and flow path barrier properties. From this, it can be considered that if the airtightness of the material M' is about 15 seconds or less, good liquid flow and flow path barrier properties can be more reliably ensured. Similarly, it can be considered that if the impregnation rate of the hydrophobic material is about 70% or less, good liquid flow and flow path barrier properties can be more reliably ensured. [Industrial Applicability]

[0130] According to the present invention, in a test chip for confirming the presence of a target substance by the color development caused by a reaction between a target substance contained in a test liquid and a labeling medium previously prepared, it is possible to provide a test chip in which color development unevenness is significantly suppressed and quantification can be easily achieved regardless of the amount of test liquid introduced. Also, according to the present invention, it is possible to provide a method for manufacturing the test chip, which is capable of manufacturing the above-mentioned test chip simply, highly accurately, and at low cost. [Explanation of symbols]

[0131] 1. Test chip 10 1st layer 10' Pre 1st layer 20 2nd layer 20' Pre 2nd layer 50 Hydrophobic Materials 61 Film (for 1st layer) 62 Film (for second layer) A Liquid receiving part B Detection confirmation section C, D liquid flow section D' Liquid non-flow area E, E1, E2 liquid flow path F Liquid flow path M: Material in which the flow of the test liquid is expressed M' Material that does not allow the test liquid to flow X, Y liquid non-flow area

Claims

1. A sheet-shaped test chip, A first layer on one surface side and a second layer on the other surface side, the first layer and the second layer are adjacent; Either the first layer or the second layer has a liquid receiving portion A, The first layer has at least a detection confirmation portion B, The second layer has at least a liquid flow section D adjacent to the detection confirmation section B and a liquid flow path E connected to the liquid flow section D, When the first layer has a liquid receiving portion A, the liquid receiving portion A is separated from the detection confirmation portion B, The first layer is formed on one surface of a sheet-like material, and the second layer is formed on the other surface of the sheet-like material, The liquid receiving portion A, the liquid flow path E, the liquid flow portion D, and the detection confirmation portion B are made of a material M that allows the flow of the test liquid to occur by capillary action, The portion other than the material M is made of a material that does not allow the passage of the test liquid, When a test liquid is dropped onto the liquid receiving section A, the test liquid flows through the liquid receiving section A, the liquid flow path E, and the liquid flow section D in this order by capillary action, and reaches the detection confirmation section B, A test chip characterized in that at least the surfaces of material M other than the liquid receiving portion A of the first layer and the second layer are sealed with a film, thereby controlling the amount of the test liquid that reaches the detection confirmation portion B.

2. The first layer has the liquid receiving portion A spaced apart from the detection confirmation portion B, the second layer has a liquid flow section C made of the material M, adjacent to the liquid receiving section A and connected to the liquid flow path E; The test chip according to claim 1, wherein when a test liquid is dropped into the liquid receiving section A, the test liquid flows through the liquid receiving section A, the liquid flow section C, the liquid flow path E and the liquid flow section D in this order by capillary action, and reaches the detection confirmation section B.

3. The test chip according to claim 1 or 2, wherein the material M is filter paper.

4. 4. The test chip according to claim 1, wherein the material through which the test liquid does not flow is a material M' obtained by impregnating the material M with a hydrophobic material.

5. 5. The test chip according to claim 4, wherein the material M' has an airtightness of 15 seconds or less.

6. 6. The test chip according to claim 4, wherein an impregnation rate of said hydrophobic material into said material M' is 70% or less.

7. The test chip according to any one of claims 1 to 6, wherein a color reaction caused by a substance to be detected occurs in said detection confirmation part B.

8. A method for producing the test chip according to any one of claims 1 to 7, comprising the steps of: a film forming step of forming a first hydrophobic film on a first substrate and a second hydrophobic film on a second substrate using a hydrophobic material; a first printing step of printing a first sacrificial substrate with a first hydrophobic film on the first substrate in a reverse design of a first layer of the test chip; a second printing step of printing a second sacrificial substrate with a second hydrophobic film on the second substrate in a reverse design of a second layer of the test chip; a first transfer step of transferring the first hydrophobic film after the first printing step onto one surface of a sheet-like material and impregnating the sheet-like material to form a first layer; a second transfer step of transferring the second hydrophobic film after the second printing step to the other surface of the one sheet-like material and impregnating the sheet-like material to form a second layer; a sealing step of sealing at least the non-impregnated surfaces of the first layer and the second layer other than the liquid receiving portion A with a film; A method for manufacturing an inspection chip, comprising:

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