Substrate for inspection device, inspection device, and method for manufacturing inspection device

Abstract

Provided is a substrate for an inspection device, which has an average thickness of 250 [mu] m or more and 350 [mu] m or less and a density of 0.25 * 106 g / m3 or more and 0.40 * 106 g / m3 or less.

Description

Technical Field

[0001] The present invention relates to a substrate for an inspection device, an inspection device, and a method for manufacturing the inspection device. Background Art

[0002] In recent years, measurement methods for the purpose of POCT (Point of Care Testing; real-time diagnosis at the clinical site) have rapidly become popular. As a representative example, a test device (hereinafter sometimes referred to as "test chip", "test device", etc.) using a measurement method called immunochromatography, which combines the principles of sandwich ELISA and chromatography, is used.

[0003] As such an inspection device, for example, a sheet-like inspection chip is proposed, which has a first layer on the surface side and a second layer on the back side, the first layer and the second layer are adjacent to each other, either the first layer or the second layer has a liquid receiving portion, the first layer has at least a detection confirmation portion, the second layer has at least a liquid flow portion adjacent to the detection confirmation portion, and a liquid flow path connected to the liquid flow portion (for example, refer to patent document 1).

[0004] In the inspection chip of patent document 1, when the above-mentioned first layer has a liquid receiving part, the above-mentioned liquid receiving part is isolated from the above-mentioned detection confirmation part. When the inspection liquid is dropped into the above-mentioned liquid receiving part, the inspection liquid flows through the above-mentioned liquid receiving part, the above-mentioned liquid flow path and the above-mentioned liquid circulation part in sequence until it reaches the above-mentioned detection confirmation part due to the capillary phenomenon.

[0005] Prior art literature

[0006] Patent Literature

[0007] Patent Document 1: Japanese Patent Application Publication No. 2021-175970 Summary of the invention

[0008] Problems to be solved by the invention

[0009] However, the inspection chip of the above-mentioned patent document 1 forms a flow path by thermally transferring a thermal transfer medium to a substrate, thereby maintaining a hydrophobic material (ink) containing a hydrophobic component as a thermal transfer medium, and the ink impregnation amount that can be impregnated in the substrate (such as filter paper) is limited. For example, in order to improve the impregnation of the ink, even if the ink impregnation amount is increased, penetration in the surface direction also occurs at the same time, which is related to the degradation of the flow path accuracy. In addition, the average thickness of the substrate that can form the flow path is also limited, and a thinner substrate is preferred for the flow path formation.

[0010] On the other hand, the substrate requires a certain degree of strength (paper strength) in its operation. In order to provide paper strength, it is preferred that the cellulose density is high. However, if the substrate becomes thinner and has a high density, the flowability of the inspection object decreases, and the inspection object with high viscosity or suspended inspection object becomes unsuitable. In particular, in fresh milk containing large milk fat particles, the milk fat particles are retained between the fibers constituting the substrate, which may block the flow path.

[0011] The present invention aims to solve the above-mentioned problems and achieve the following objectives. That is, the present invention aims to provide an inspection device substrate that can form a flow path and flow properties of a high-viscosity inspection object or a suspended inspection object, an inspection device using the inspection device substrate, and a method for manufacturing the inspection device.

[0012] Methods used to solve problems

[0013] The method for solving the above-mentioned problem is as follows.

[0014] <1> A substrate for an inspection device, having an average thickness of 250 μm or more and 350 μm or less and a density of 0.25×10 6 g / m 3 Above 0.40×10 6 g / m 3 the following.

[0015] <2> The substrate for inspection device according to <1> above, wherein the weight per unit area is 50 g / m 2 Above 100g / m 2 the following.

[0016] <3> The inspection device substrate according to <1> or <2>, comprising at least one selected from filter paper, woodfree paper, nonwoven fabric, and nitrocellulose.

[0017] <4> An inspection device for inspecting the presence or absence of a target substance in an inspection object, characterized in that

[0018] The inspection device substrate described in <1> or <2> is impregnated with a hydrophobic material.

[0019] It comprises: a hydrophobic portion impregnated with the hydrophobic material, and an exposed portion which is not impregnated with the hydrophobic material and exposes the substrate for the inspection device.

[0020] <5> According to the inspection device described in <4> above, the exposed portion includes: a liquid receiving portion, a flow path portion communicating with the liquid receiving portion, and a detection portion communicating with the flow path portion.

[0021] <6> The inspection device according to <4> or <5>, wherein the hydrophobic portion and the exposed portion are provided on both surfaces of the inspection device substrate,

[0022] The inspection device substrate has flow paths of different designs formed on both surfaces thereof, and the flow paths are connected to each other in a three-dimensional manner.

[0023] <7> The inspection device according to any one of <4> to <6>, wherein the amount of the hydrophobic material impregnated into the inspection device substrate is 15 g / m 2 Above 20g / m 2 the following.

[0024] <8> The inspection device according to any one of <4> to <7>, which is for inspecting an emulsion containing droplets having a particle size of 1 μm or more.

[0025] <9> The inspection device according to any one of <4> to <8>, which is for inspecting homogenized untreated milk.

[0026] <10> A method for manufacturing an inspection device, characterized in that it includes the following steps: an impregnation step, in which a hydrophobic material is impregnated on both sides of the inspection device substrate described in any one of <1> to <9>, wherein the hydrophobic material is impregnated to form a hydrophobic portion, and an exposed portion in which the inspection device substrate is not impregnated with the hydrophobic material but is exposed.

[0027] Effects of the Invention

[0028] According to the present invention, the above-mentioned various problems in the past can be solved and the above-mentioned objectives can be achieved. A substrate for an inspection device that has both flow path forming properties and flow properties for a high-viscosity inspection object or a suspended inspection object, an inspection device using the above-mentioned substrate for an inspection device, and a method for manufacturing the inspection device can be provided. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] Figure 1 This is a schematic diagram showing an example of the inspection device of the present invention.

[0030] Figure 2 This is a schematic diagram showing an example of a thermal transfer medium.

[0031] Figure 3A This is a schematic diagram showing an example of a flow path pattern on the flow path side.

[0032] Figure 3B This is a schematic diagram showing an example of a flow path pattern on the detection unit side.

[0033] Figure 4AThis is a diagram showing a state in which no leakage of the inspection object to the flow path occurs and the barrier property is good in Example 1.

[0034] Figure 4B This is a diagram showing a state in which leakage occurs to the inspection object of the flow path in Comparative Example 2 and the barrier property is poor. DETAILED DESCRIPTION

[0035] (Substrate for inspection equipment)

[0036] The inspection device substrate of the present invention is a substrate for an inspection device used to inspect the presence or absence of a target substance in an inspection object. In the present invention, by optimizing the average thickness and density of the inspection device substrate and further optimizing the weight per unit area, it is possible to achieve both flow path formation and flowability of a high-viscosity inspection object or a suspended inspection object.

[0037] The average thickness of the inspection device substrate is 250 μm to 350 μm, preferably 250 μm to 300 μm. The average thickness can be measured, for example, according to JIS P8118:2014 "Paper and board - Test methods for thickness, density and specific volume".

[0038] The density of the substrate for the inspection device is 0.25×10 6 g / m 3 Above 0.40×10 6 g / m 3 Below, preferably 0.25×10 6 g / m 3 Above 0.35×10 6 g / m 3 The density can be calculated by dividing the weight per unit area of ​​the inspection device substrate by the average thickness of the inspection device substrate.

[0039] The weight per unit area of ​​the inspection device substrate is preferably 50 g / m 2 Above 100g / m 2 Below, more preferably 75g / m 2 Above 95g / m 2 The above-mentioned basis weight is a value measured in accordance with JIS P8124:2011 "Paper and board-Method for determination of basis weight".

[0040] The material of the substrate for the inspection device is not particularly limited and can be appropriately selected according to the purpose. Examples thereof include filter paper such as a film, ordinary paper, woodfree paper, watercolor paper, pastel paper, synthetic paper, synthetic resin film, special paper with a coating, nitrocellulose, cloth, fiber products, etc. These can be used alone or in combination of two or more. Among these, filter paper such as a film, woodfree paper, and cloth are preferred.

[0041] Examples of the cloth include artificial fibers such as rayon, lining, acetate, nylon, polyester, and vinylon, natural fibers such as cotton and silk, blended fibers thereof, and nonwoven fabrics thereof.

[0042] The shape of the inspection device substrate is not particularly limited and can be appropriately selected depending on the intended purpose. Examples thereof include a sheet shape and a strip shape.

[0043] The structure of the inspection device substrate is not particularly limited and can be appropriately selected depending on the intended purpose.

[0044] The inspection device substrate of the present invention can achieve both flow path formability and flowability of a highly viscous inspection object or a suspended inspection object, and is suitable for use as a substrate of the inspection device of the present invention as described below.

[0045] (Inspection device)

[0046] The inspection device of the present invention is an inspection device for inspecting the presence or absence of a target substance in an inspection object. A hydrophobic material is impregnated in a substrate for the inspection device of the present invention, and the substrate comprises: a hydrophobic portion impregnated with the hydrophobic material, and an exposed portion that is not impregnated with the hydrophobic material and exposes the substrate for the inspection device.

[0047] <Inspection object>

[0048] The test object is not particularly limited as long as it is a liquid and can be appropriately selected according to the purpose, and examples thereof include blood (serum, plasma), lymph, urine, spinal fluid, nasal fluid, saliva, or specimen extract, etc. The test object includes all animals including humans.

[0049] <Target substances>

[0050] The target substance is not particularly limited and can be appropriately selected depending on the purpose. Examples thereof include cells, nucleic acids, proteins, amino acids, sugars, lipids, tumor markers, inflammatory markers, enzymes, hormones, and signal transduction substances.

[0051] Examples of the cells include circulating tumor cells (CTCs), red blood cells, and white blood cells in the blood.

[0052] Examples of the nucleic acid include circulating normal DNA, circulating tumor DNA, and non-coding RNA (miRNA, transfer RNA, ribosomal RNA, etc.).

[0053] Examples of the protein include albumin, hemoglobin, γ-globulin, fibrinogen, antithrombin III, transferrin, ceruloplasmin, cytokines including growth factors, and chemokines.

[0054] Examples of the sugar include glucose and 1.5AG (1.5 anhydroglucitol).

[0055] Examples of the lipids include neutral fat, HDL cholesterol, and LDL cholesterol.

[0056] The above-mentioned tumor markers are not particularly limited and can be appropriately selected according to the purpose. For example, α-fetoprotein (AFP), carcinoma fetal antigen (CEA), CA19-9 (Cereal Lewis A carbohydrate), prostate specific antigen (PSA), CA125 (glycoprotein), SSC (squamous cell carcinoma-associated antigen), etc. can be mentioned.

[0057] The inflammatory marker is not particularly limited and can be appropriately selected depending on the intended purpose. Examples thereof include C-reactive protein (CRP) and the like.

[0058] Examples of the enzyme include γ-GTP, AST (aspartate aminotransferase), ALT (alanine aminotransferase), and amylase.

[0059] Examples of the hormone include adrenocorticoids, luteinizing hormone, follicle stimulating hormone, prolactin, thyroid hormone, parathyroid hormone, aldosterone, insulin, estrogen, progesterone, and growth hormone.

[0060] The inspection device of the present invention includes a hydrophobic portion and an exposed portion, and further includes other members as necessary.

[0061] <Hydrophobic part>

[0062] The hydrophobic portion is a portion impregnated with a hydrophobic material. The hydrophobic portion has hydrophobicity due to the impregnation with the hydrophobic material, and the flow of the inspection object due to the capillary phenomenon is not observed.

[0063] <Exposed area>

[0064] The exposed portion is a portion where the hydrophobic material is not impregnated and the substrate for the inspection device is exposed. The exposed portion preferably includes a liquid receiving portion, a flow path portion connected to the liquid receiving portion, and a detection portion connected to the flow path portion. The liquid given to the liquid receiving portion is the inspection object.

[0065] The liquid receiving portion is a portion where the inspection object is dropped.

[0066] The detection section is a part that confirms whether or not the target substance is present in the inspection object dropped into the liquid receiving section.

[0067] The liquid receiving portion, the flow path portion, and the detection portion as the exposed portion allow the object to be inspected to flow by capillary action.

[0068] The inspection device substrate preferably has the hydrophobic portion and the exposed portion on both surfaces thereof, thereby forming a three-dimensional flow path in the substrate.

[0069] It is preferable that flow paths having different designs are formed on both surfaces of the inspection device substrate, and that the flow paths are connected to each other in a three-dimensional manner.

[0070] The hydrophobic material is preferably impregnated in an amount of 15 g / m 2 Above 20g / m 2 Below, more preferably 15g / m 2 Above 18g / m 2 If the impregnation amount of the above hydrophobic material is 15g / m 2 Above 20g / m 2 If the impregnation amount of the hydrophobic material exceeds 20 g / m 2 , the hydrophobic material may penetrate not only in the thickness direction of the flow path but also in the surface direction and block the flow path.

[0071] The impregnation of the inspection device substrate with the hydrophobic material is preferably performed by, for example, bringing a transfer layer of the hydrophobic material containing a thermal transfer medium into contact with the inspection device substrate and performing thermal transfer.

[0072] <Other components>

[0073] The other member is not particularly limited and can be appropriately selected depending on the purpose, and examples thereof include a protective member.

[0074] The protective member is a member for preventing contamination when the hand touches the inspection device. The protective member is not particularly limited and can be appropriately selected according to the purpose, for example, a housing covering the entire inspection device, a protective film provided on an exposed portion of a flow path, etc.

[0075] The material of the protective film is not particularly limited as long as it can be easily peeled off from the inspection device, and can be appropriately selected depending on the purpose. Examples thereof include silicone paper, polyolefin sheets such as polypropylene, and polytetrafluoroethylene sheets.

[0076] here, Figure 1 This is a schematic diagram showing an example of the inspection device of the present invention. Figure 1 This is a diagram schematically showing an exploded view of the inspection device. Figure 1 As shown on the left side of , the inspection device 10 has an inspection device substrate 1, a first layer 2 formed of a hydrophobic material, and a second layer 3 formed of a hydrophobic material. In addition, the inspection device 10 has a structure in which the first layer 1 and the second layer 3 are impregnated from both sides of the inspection device substrate 1.

[0077] The inspection device 10 includes a liquid receiving portion 4, a flow path portion 6 connected to the liquid receiving portion, and a detection portion 5 connected to the flow path portion. If an inspection object is dropped into the liquid receiving portion 4, the inspection object flows through the liquid receiving portion 4, the flow path portion 6, and the detection portion 5 in this order through a capillary phenomenon.

[0078] The shape of the liquid receiving part 4 in a plan view is not particularly limited and can be appropriately selected depending on the purpose. For example, it may be circular, elliptical, rectangular, or the like.

[0079] The shape of the detection portion 5 in a plan view is not particularly limited and can be appropriately selected depending on the purpose, and may be circular, elliptical, rectangular, or the like.

[0080] (Manufacturing method of inspection device)

[0081] The method for producing an inspection device of the present invention includes an impregnation step and further includes other steps as necessary.

[0082] <Impregnation process>

[0083] The above-mentioned impregnation process is: impregnating the hydrophobic material from both sides of the inspection device substrate of the present invention to form a hydrophobic part impregnated with the above-mentioned hydrophobic material, and an exposed part that is not impregnated with the above-mentioned hydrophobic material and exposes the above-mentioned inspection device substrate.

[0084] The impregnation process is performed by using a thermal transfer medium and a heat laminating material. For example, a thermal transfer medium with a pattern on the flow path side can be fixed on both sides of the inspection device substrate and a thermal transfer medium with a pattern on the detection unit side can be fixed on the opposite side. The hydrophobic material contained in the transfer layer on the thermal transfer medium with different shapes on the front and back sides is impregnated into the substrate by the heat laminating material set at a predetermined temperature, thereby forming a flow path of a three-dimensional shape in the substrate.

[0085] -Thermal transfer media-

[0086] The thermal transfer medium has a support, a transfer layer containing a hydrophobic material on the support, and further has other members as necessary.

[0087] --Support--

[0088] The shape, structure, size, material and the like of the support are not particularly limited and can be appropriately selected depending on the purpose.

[0089] Examples of the shape of the support include a belt shape and a film shape.

[0090] The support may have a single-layer structure or a laminated structure.

[0091] The size of the support can be appropriately selected according to the size of the inspection apparatus and the like.

[0092] As the material of the above-mentioned support, there is no particular limitation, and it can be appropriately selected according to the purpose, and for example, polyesters such as polyethylene terephthalate (PET) and polyethylene naphthalate (PEN), polycarbonate, polyimide resin (PI), polyamide, polyethylene, polypropylene, polyvinyl chloride, polyvinylidene chloride, polystyrene, styrene-acrylonitrile copolymer, cellulose acetate, etc. can be mentioned. They can be used alone or in combination of two or more. Among these, polyethylene terephthalate (PET) and polyethylene naphthalate (PEN) are particularly preferred.

[0093] The support is not particularly limited, and may be a suitably synthesized one, or a commercially available one may be used.

[0094] The average thickness of the support is not particularly limited and can be appropriately selected depending on the intended purpose, but is preferably 3 μm to 100 μm, and more preferably 5 μm to 50 μm.

[0095] --Transfer layer--

[0096] The transfer layer contains a hydrophobic material and is formed by applying the hydrophobic material to the support. The hydrophobic material is not particularly limited as long as it can be impregnated into the inspection device substrate and inhibit the capillary phenomenon in the inspection device substrate, and contains a hydrophobic component, preferably a binder resin, and further contains other components as needed.

[0097] ---Hydrophobic ingredients---

[0098] Examples of the hydrophobic component include wax and the like.

[0099] The wax is not particularly limited and can be appropriately selected according to the purpose, and examples thereof include natural waxes such as beeswax, carnauba wax, spermaceti wax, wood wax, candelilla wax, rice bran wax, and montan wax; synthetic waxes such as paraffin wax, microcrystalline wax, oxidized wax, ozokerite, ceresin, ester wax, polyethylene wax, and oxidized polyethylene wax; higher fatty acids such as margaric acid, lauric acid, myristic acid, palmitic acid, stearic acid, furoic acid, and behenic acid; higher alcohols such as stearyl alcohol and behenyl alcohol; esters such as fatty acid esters of sorbitan; amides such as stearamide and oleamide, etc. These can be used alone or in combination of two or more.

[0100] ---Binder Resin---

[0101] The binder resin is not particularly limited and can be appropriately selected according to the purpose, and examples thereof include ethylene-vinyl acetate copolymers, partially saponified ethylene-vinyl acetate copolymers, ethylene-vinyl alcohol copolymers, ethylene-sodium methacrylate copolymers, polyamides, polyesters, polyurethanes, polyvinyl alcohols, methylcellulose, carboxymethylcellulose, starch, polyacrylic acid, isobutylene-maleic acid copolymers, styrene-maleic acid copolymers, polyacrylamide, polyvinyl acetal, polyvinyl chloride, polyvinylidene chloride, isoprene rubber, styrene-butadiene copolymers, ethylene-propylene copolymers, butyl rubber, acrylonitrile-butadiene copolymers, etc. These may be used alone or in combination of two or more.

[0102] ---Other ingredients---

[0103] Examples of the other components include a colorant, a viscosity modifier, a dispersant, a dispersing aid, and a filler.

[0104] The method for forming the transfer layer is not particularly limited and can be appropriately selected depending on the purpose. Examples thereof include a hot melt coating method and a method of applying a coating liquid prepared by dispersing the wax and the binder resin in a solvent.

[0105] In addition, the hydrophobic material is preferably heated and melted when forming the transfer layer.

[0106] There is no particular limitation on the formation (printing) of the flow path pattern of the transfer layer on the support, and for example, a thermal transfer printer can be used. In addition, in the first printing step, the first transfer layer on the first support is used to print the first transfer layer on the first support in a manner that becomes the reverse design of the first layer of the inspection device. In addition, in the second printing step, the second transfer layer on the second support is used to print the second transfer layer on the second support in a manner that becomes the reverse design of the second layer of the inspection device.

[0107] In addition, the design of printing can be prepared in advance by, for example, a personal computer, etc., and the data can be taken into the printing device. In addition, the printing on the front and back sides of the substrate for the inspection device can be performed separately or simultaneously.

[0108] The thermal transfer printer is not particularly limited and can be appropriately selected depending on the purpose. Examples thereof include thermal printers having a tandem thermal head, a line thermal head, and the like.

[0109] <Other Process>

[0110] The other steps are not particularly limited and can be appropriately selected depending on the purpose, and examples thereof include a drying step and a transport step.

[0111] The inspection device of the present invention is preferably used for inspecting an emulsion containing droplets having a particle size of 1 μm or more. Examples of the droplets having a particle size of 1 μm or more include milk fat particles.

[0112] Furthermore, the inspection device of the present invention is preferably used for inspecting homogenized untreated milk, specifically, fresh milk of cows that has not been homogenized.

[0113] The inspection device of the present invention using the inspection device substrate of the present invention can have both flow path forming properties and fluidity of high-viscosity inspection objects or suspended inspection objects, can inspect fresh cow milk that has not been homogenized without blocking it, and can also detect hormone components such as progesterone contained in milk fat particles. It can be suitable for use in pregnancy test drugs, etc.

[0114] Example

[0115] Hereinafter, examples of the present invention will be described, but the present invention is not limited to these examples.

[0116] (Examples 1 to 4 and Comparative Examples 1 to 5)

[0117] <Manufacturing of inspection equipment>

[0118] -Preparation of hydrophobic materials-

[0119] 72 parts by mass of paraffin wax (Praffin Wax-135 manufactured by Nippon Seira Co., Ltd.) as a hydrophobic component, 18 parts by mass of synthetic wax ("Diakarna (registered trademark) 30" manufactured by Mitsubishi Chemical Corporation) as a hydrophobic component, 11.25 parts by mass of ethylene-vinyl acetate copolymer resin ("Ultrasen 722" manufactured by Tosoh Corporation) and 1.8 parts by mass of carbon black ("MA-100" manufactured by Mitsubishi Chemical Corporation) as a colorant were melt-mixed at 100°C. At this time, a sand mill was used to disperse the components. The hydrophobic material was prepared as above.

[0120] The viscosity of the obtained hydrophobic material was measured at 140° C. and 3,000 / s using a rheometer AR-G2 manufactured by TA Instruments, and the result was 23 mPa·s.

[0121] -Production of thermal transfer media-

[0122] Next, a support (Lumirror 6CF531, PET film, 6 μm thick, manufactured by Toray Industries, Ltd.) was placed on a hot plate maintained at 120°C. Next, the hydrophobic material maintained in a molten state at 120°C was applied to the support through a wire rod (manufactured by Mitsui Electric Seiki Co., Ltd.) in such a manner that the average thickness was 5 μm to 12 μm, thereby forming a transfer layer. Figure 2 The thermal transfer medium 20 is constructed as shown. Figure 2 11 is a support, and 12 is a transfer layer.

[0123] -Flow path formation (printing)-

[0124] Next, using a thermal transfer printer (Lesprit R412v-ex, manufactured by Sato Holdings Co., Ltd.), the flow path (surface) side of the substrate shown in Table 1 was Figure 3A The circles shown have a diameter of 4 mm and are arranged at intervals of 6 mm from the center. These circles are connected by a flow path with a width of 2.5 mm, and the detection part (inside) is Figure 3B The patterns in which the uppermost and lowermost circular parts of the flow path shown are penetrated with the same diameter are respectively printed on the substrate shown in Table 1 by the above-mentioned thermal transfer printer, thereby forming a flow path pattern of the hydrophobic material leading out of the printing part on the thermal transfer medium.

[0125] -Formation of flow paths in substrates-

[0126] A thermal transfer medium with a pattern on the lead-out flow path side is fixed on one side of a substrate, and a thermal transfer medium with a pattern on the lead-out detection portion side is fixed on the opposite side of the substrate. The hydrophobic material of the thermal transfer medium with different shapes is impregnated into the substrate from the inside and outside through the heat lamination material under the following conditions, thereby forming a three-dimensional flow path in the substrate.

[0127] -Hot Lamination Conditions-

[0128] As a heat laminating material, GL535ML manufactured by GBC Corporation was used for heat lamination.

[0129] (1) Transfer of hydrophobic material to substrate: thermal lamination is performed at a temperature of 85° C. to 120° C. and a line speed of 10 mm / sec.

[0130] (2) Impregnation of the substrate with a hydrophobic material: thermal lamination was performed at a temperature of 85° C. to 120° C. and a line speed of 5 mm / sec.

[0131] -Formation of flow paths with different impregnation amounts of hydrophobic material on substrates-

[0132] As shown in Table 1, flow paths with adjusted impregnation amounts of hydrophobic material are formed by combining the weight (thickness) of the hydrophobic material of the thermal transfer medium used to form the flow path side pattern and the weight (thickness) of the hydrophobic material of the thermal transfer medium used to form the detection portion side pattern.

[0133] As described above, the inspection devices of Examples 1 to 4 and Comparative Examples 1 to 5 were produced.

[0134] Next, each of the inspection devices produced was operated as follows to evaluate each performance. The results are shown in Table 2.

[0135] <Barrier>

[0136] In each inspection device produced, a solution of aqueous fluorescent ink extracted from a fluorescent marker manufactured by ASKUL Co., Ltd. dissolved in distilled water (inspection object) was added dropwise to the liquid receiving part using a pipette at a volume of 16 μL. The leakage of the solution from the flow path was visually observed using a UV lamp (manufactured by contec Co., Ltd., BL-LED3435-UV) and judged based on the following criteria.

[0137] [Evaluation criteria]

[0138] ○: No leakage from the flow path, good barrier properties

[0139] △: Leakage from the flow path occurs slightly, but is not a problem in practical use

[0140] ×: Leakage from the flow path, poor barrier properties

[0141] If the impregnation of the filter paper with the hydrophobic material is insufficient, the object to be inspected may leak out of the flow path. The extent of leakage of the object to be inspected out of the flow path is observed. Figure 4A This shows a good state in which no leakage of the inspection object in the flow path of Example 1 occurs and the barrier property is good. Figure 4B The figure shows a state in which leakage of the inspection object occurs in the flow path of Comparative Example 2 and the barrier property is poor.

[0142] <Liquid flowability>

[0143] For each inspection device, unhomogenized cow's milk and the solution of the above-mentioned aqueous fluorescent ink dissolved in distilled water were dripped into the liquid receiving part using a pipette, and the time until it reached the detection part was measured using a stopwatch. If it did not reach the detection part until 3 minutes (180 seconds), it was considered "occluded". In addition, the evaluation number was n = 3, the circulation time was the average value of n = 3, and "occlusion" was determined when even one of n = 3 was confirmed.

[0144] <Paper Power>

[0145] Whether each of the manufactured inspection devices can be cut into a predetermined shape using a cutter (Hyper AL model, manufactured by Olfa Corporation) was evaluated based on the following criteria.

[0146] [Evaluation criteria]

[0147] 0:Can be easily cut with a knife

[0148] 〇△: Cutting with a knife is possible

[0149] △: Difficult to cut with a knife

[0150] ×: Cannot be cut with a knife (fiber cohesion is weak and breaks)

[0151] [Table 1]

[0152]

[0153] [Table 2]

[0154]

[0155] -Base Material-

[0156] Samples 1 to 4: filter papers prepared to have the average thickness, basis weight, and density shown in Table 1

[0157] Whatman #40, #41, #42: Commercially available quantitative filter paper, manufactured by Merck

[0158] Advantec No.60: Commercially available filter paper for viscous liquids, manufactured by Advantech Toyo Co., Ltd.

[0159] From the results in Table 1 and Table 2, it can be seen that Examples 1 to 3 satisfy the requirement that the average thickness of the substrate is 250 μm or more and 350 μm or less, and the density is 0.25×10 6 g / m 3 Above 0.40×10 6 g / m 3 Below, liquid flowability, barrier properties and paper strength are all good.

[0160] It can be seen that Example 4 does not meet the requirement that the impregnation amount of the hydrophobic material is 15 g / m 2 Above 20g / m 2 Therefore, the barrier properties and water flowability are slightly lowered compared with Examples 1 to 3.

[0161] On the other hand, since the average thickness of the substrate of Comparative Example 1 was thin, the flow path was blocked when using fresh cow milk that had not been homogenized.

[0162] It is understood that the substrate of Comparative Example 2 has a large average thickness and a low density, and therefore has low barrier properties and water permeability.

[0163] It is understood that the substrate of Comparative Example 3 has a thin average thickness and a low density, and therefore when using water and unhomogenized cow's milk, the flow path is blocked and the paper strength is low.

[0164] The substrates of Comparative Examples 4 and 5 had a thin average thickness and a high density, so the flow time was significantly delayed, and the flow path was blocked when using fresh cow milk that had not been homogenized.

[0165] Industrial Availability

[0166] The inspection device of the present invention using the inspection device substrate of the present invention can have both flow path forming properties and fluidity of high-viscosity inspection objects or suspended inspection objects, so it can inspect fresh cow milk that has not been homogenized without blocking it, and the detection of hormone components such as progesterone contained in milk fat particles becomes possible, which can be applied to pregnancy test drugs, etc.

[0167] This application claims priority based on Japanese Patent Application No. 2022-100746 filed with the Japan Patent Office on June 23, 2022, and cites all the contents described in the above application.

[0168] Explanation of symbols

[0169] 1 Inspection device substrate

[0170] 2 Layer 1

[0171] 3 Layer 2

[0172] 4 Liquid receiving part

[0173] 5. Inspection Department

[0174] 6 Flow path section

[0175] 10 Inspection device

[0176] 11 Support

[0177] 12 Transfer layer

[0178] 20 Thermal transfer media

Claims

1. A substrate for an inspection device, having an average thickness of 250 μm or more and 350 μm or less and a density of 0.25×10 6 g / m 3 Above 0.40×10 6 g / m 3 the following.

2. The substrate for inspection device according to claim 1, wherein the weight per unit area is 50 g / m 2 Above 100g / m 2 the following. 3 . The substrate for an inspection device according to claim 1 , comprising at least one selected from the group consisting of filter paper, woodfree paper, nonwoven fabric and nitrocellulose.

4. An inspection device, characterized in that: An inspection device for inspecting the presence or absence of a target substance in an inspection object. The inspection device substrate according to any one of claims 1 to 2 is impregnated with a hydrophobic material, and comprises a hydrophobic portion impregnated with the hydrophobic material and an exposed portion where the inspection device substrate is not impregnated with the hydrophobic material and is exposed.

5. The inspection device according to claim 4, The exposed portion includes a liquid receiving portion, a flow path portion communicating with the liquid receiving portion, and a detection portion communicating with the flow path portion.

6. The inspection device according to claim 4, The inspection device substrate has the hydrophobic portion and the exposed portion on both sides thereof, The inspection device substrate has flow paths of different designs formed on both surfaces thereof, and the flow paths are connected to each other in a three-dimensional manner.

7. The inspection device according to claim 4, The impregnation amount of the hydrophobic material with respect to the inspection device substrate is 15 g / m 2 Above 20g / m 2 the following.

8. The inspection device according to claim 4, It is used to inspect emulsions containing droplets with a particle size of 1 μm or more.

9. The inspection device according to claim 4, It is used for homogenized untreated milk examination.

10. A method for manufacturing an inspection device, characterized in that: It includes the following steps: The impregnation step is to impregnate the inspection device substrate according to claim 1 or 2 with a hydrophobic material from both sides to form a hydrophobic portion impregnated with the hydrophobic material and an exposed portion where the inspection device substrate is exposed without being impregnated with the hydrophobic material.

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