A dry chemical test paper and preparation process

Abstract

The embodiment of the present application provides a dry chemical test strip and a preparation process, which relates to the field of dry chemical detection. The dry chemical test strip includes an upper substrate, an intermediate layer and a lower substrate stacked in sequence along the longitudinal direction, and the upper substrate is provided with a plurality of sample addition holes arranged at intervals; the intermediate layer includes a plurality of detection areas and a barrier area, which is a porous material membrane and the pores of the barrier area are irreversibly closed-cell treated, the pores of the detection area can allow the liquid to penetrate from the sample addition holes and diffuse in the longitudinal and transverse directions, and each barrier area is correspondingly arranged around the periphery of the detection area and defines the lateral diffusion boundary of the liquid; the lower substrate is provided with a plurality of detection holes. The preparation process of the above-mentioned dry chemical test strip mainly involves stacking the layers together in sequence, performing a closed-cell treatment on the pores of the barrier area of ​​the intermediate layer, or performing a closed-cell treatment first and then stacking. The dry chemical test strip and the preparation process of the embodiment of the present application have a simple structure and process, and can realize independent detection of each detection area without interfering with each other.

Description

Technical Field

[0001] The present application relates to the field of dry chemical detection, and in particular, to a dry chemical detection test paper and a preparation process thereof. Background Art

[0002] Dry chemical test strips are widely used in the detection of biochemical projects because of their convenience, simple operation and rapid detection. According to the flow path of the liquid sample on the dry chemical test strip, the dry chemical test strip can be divided into many types, and the vertical test strip is one of them. The vertical test strip is a carrier with a detection reagent superimposed on each other, and the liquid sample flows from top to bottom through each detection reagent layer, and finally displays the test result. According to the number of samples that can be measured at one time and the type of measurement indicators, the dry chemical test strip can be divided into a single test strip and a multi-item test strip. The multi-item test strip generally integrates the test strips of each single test strip together, and each test item corresponds to a sample addition hole of a test strip, so that multiple biochemical indicators can be measured at the same time, which greatly improves the detection efficiency. However, since the detection reagents contained in each test strip may be different, it may also be that the amount of liquid sample added is too large to be absorbed. In order to achieve independent detection of each test strip, it is very important to prevent the mutual infiltration and interference between the test strips.

[0003] In order to solve the above problems, existing dry chemical test strips usually have barrier blocks or liquid locking components for blocking between each test strip block. For example: Patent document with announcement number CN 2247809Y records that the reagents or liquid samples between adjacent test strip blocks are blocked from infiltrating each other by embedding a fixed barrier block on the substrate between two adjacent test strip blocks; Patent document with announcement number CN 102128918B records a liquid locking component that can absorb excess liquid samples so that the excess samples will not flow out of the test strip range, thereby avoiding contamination of the environment and the detection instrument or touching the tester. Therefore, existing dry chemical test strips need to set up additional barrier components between each reagent block, resulting in a complex overall structure and a very complex production process. Summary of the invention

[0004] The purpose of the embodiments of the present application is to provide a dry chemical test strip and a preparation process, which has a simple structure and process and can achieve independent detection of each detection area without mutual interference.

[0005] In a first aspect, an embodiment of the present application provides a dry chemical test strip, which includes:

[0006] An upper substrate, wherein the upper substrate is provided with a plurality of sample addition holes arranged at intervals;

[0007] The middle layer includes a plurality of detection areas and barrier areas corresponding to the detection areas. The middle layer is a porous material membrane, and the pores of the barrier areas are irreversibly closed. The positions of the detection areas are arranged one by one corresponding to the positions of the sample addition holes. The pores of the detection areas enable liquid to penetrate from the sample addition holes and diffuse in the longitudinal and transverse directions. Each barrier area is correspondingly arranged outside the detection area and defines the transverse diffusion boundary of the liquid.

[0008] The lower substrate is provided with a plurality of detection holes corresponding to the detection areas one by one and used for photoelectric detection.

[0009] In the above implementation process, by utilizing the characteristics that the surface and internal pores of the porous material membrane are interconnected, the liquid can diffuse and flow along the horizontal and vertical directions of the membrane structure, and the middle layer (porous material membrane) is divided into a detection area and a barrier area by reprocessing. The pore structure of the detection area remains the same, and the liquid can freely diffuse and flow in the vertical and horizontal directions therein, realizing the vertical detection of the liquid sample in the vertical direction, and the detection area plays a role; the barrier area surrounds the periphery of the detection area, and its pores are treated with irreversible closed cells, so that the liquid cannot diffuse laterally between the pores in it and the detection area, playing a role of barrier, so that the detection reagent or liquid sample can diffuse and flow only in the limited area (detection area) of the porous material membrane. The dry chemical detection test paper of the present application has a simple structure, and utilizes its own membrane structure to form a barrier area. There is no need to add a barrier component, so that each detection area can be independently detected without interfering with each other.

[0010] In a possible implementation, the closed-cell treatment method is compression and / or heating and melting to close the pores; and / or, the closed-cell treatment method is filling the pores with ink or hot melt adhesive.

[0011] In the above implementation process, the pores in the barrier zone are closed by compression deformation (such as molding deformation) and / or heating and melting, and / or the pores in the barrier zone are filled with ink or hot melt adhesive to achieve closed-cell treatment, thereby achieving the function of the barrier zone in limiting the lateral diffusion boundary of the liquid, and the structure is simple.

[0012] In a possible implementation, an ink printing layer is provided on the surface of the barrier region of the intermediate layer, and part of the ink of the ink printing layer is filled into the pores of the corresponding barrier region.

[0013] In the above implementation process, in order to ensure the formation of the barrier area and realize the barrier function, an ink printing layer can be set on the surface of the intermediate layer. The ink's own characteristics and gravity during printing can be used to penetrate into the originally through pores of the porous material membrane in the contacting barrier area. After the ink is solidified, the pores are blocked, preventing the liquid from freely diffusing in the pores of the porous material membrane in the barrier area, especially preventing the liquid in the detection area from diffusing into the barrier area.

[0014] In a possible implementation, a hot melt adhesive layer is provided between two adjacent layers, and a flow hole is provided in the hot melt adhesive layer corresponding to the detection area; optionally, part of the hot melt adhesive of the hot melt adhesive layer corresponding to the barrier area is filled into the pores of the corresponding barrier area.

[0015] In the above implementation process, two adjacent layers are bonded together by a hot melt adhesive layer to form an overall laminated structure, and the hot melt adhesive layer only completely covers the barrier area, while corresponding flow holes are provided in the detection area to ensure that the liquid in the detection area can flow vertically. Part of the hot melt adhesive of the hot melt adhesive layer is filled into the pores of the porous material membrane in the contacting barrier area, which not only plays a role of tight bonding, but also blocks the pores of the porous material membrane in the barrier area, and can even transform the originally hydrophilic porous material membrane into a hydrophobic one, surrounding the detection area to achieve the barrier function.

[0016] In a possible implementation, the upper substrate and / or the lower substrate is selected from polyethylene plastic sheet, polypropylene plastic sheet, polystyrene plastic sheet, polycarbonate plastic sheet, polyamide ester plastic sheet or polyester plastic sheet;

[0017] And / or, the middle layer includes at least one of a blood filtering layer, a reaction layer and other functional layers; optionally, the middle layer includes a blood filtering layer and a reaction layer stacked sequentially along the longitudinal direction, the blood filtering layer is selected from cellulose membrane, PES membrane, nylon membrane, non-woven fabric or glass fiber membrane; the reaction layer is selected from cellulose membrane, PES membrane, nylon membrane, glass fiber membrane, polyester membrane or non-woven fabric.

[0018] In the above implementation process, the upper substrate and the lower substrate play a supporting role, and it is convenient to process the sample addition hole and the detection hole. The middle layer usually includes a blood filter layer and a reaction layer, wherein the detection area of ​​the blood filter layer is used to filter blood cells, and the detection area of ​​the reaction layer is used to load the detection reagent and detect the biochemical indexes of the liquid sample. The above blood filter layer and the reaction layer have pores that are interconnected, and the pores are easily compressed and deformed to close. When a liquid sample is added to the sample addition hole, the liquid sample first diffuses to the corresponding detection area of ​​the blood filter layer to filter blood cells, and then diffuses to the corresponding detection area of ​​the reaction layer to react with the detection reagent. The reaction is checked through the corresponding detection hole and the detection result is judged.

[0019] In a second aspect, an embodiment of the present application provides a preparation process of the dry chemical test paper provided in the first aspect, which comprises the following steps:

[0020] The upper substrate, the middle layer and the lower substrate are stacked together in sequence along the longitudinal direction, and the pores in the barrier zone of the middle layer are irreversibly closed; or, the middle layer is irreversibly closed, and the upper substrate, the closed-pore middle layer and the lower substrate are stacked together in sequence along the longitudinal direction.

[0021] In the above-mentioned implementation process, the preparation method mainly utilizes the characteristics of the middle layer being a porous material membrane and reprocesses it. Specifically, the surface and internal pores of the porous material membrane in the barrier area are irreversibly closed so that it cannot penetrate the pores of the porous material membrane in the detection area, so that the liquid cannot diffuse laterally between the barrier area and the detection area, thereby realizing the barrier function.

[0022] In one possible implementation, the pores in the barrier zone are closed by at least one of molding, laser melting, and filling the pores with ink or hot melt adhesive; optionally, the molding method is heating molding or ultrasonic molding.

[0023] In the above-mentioned implementation process, it is very easy to close the pores in specific areas of the porous material membrane by molding, laser melting, or filling the pores with ink or hot melt adhesive. In particular, molding methods such as heat molding or ultrasonic molding can not only easily deform and close the pores of the porous material membrane in the barrier area, but also for the layer structure of specific materials, heat molding or ultrasonic molding can also make them compound (materials bond) together at the same time.

[0024] In a possible implementation, the method further includes printing ink on the surface of the barrier area of ​​the intermediate layer, allowing part of the ink to flow into the pores of the corresponding barrier area and solidify to form an ink printing layer; optionally, the ink is printed first and then molded.

[0025] In the above implementation process, the pores in the barrier area are closed by filling the pores with ink. Specifically, an ink pattern is printed on the surface of the porous material membrane to cover the barrier area. The ink will penetrate into the pores of the porous material membrane in the contacted barrier area under the action of gravity. After curing, the pores are blocked to prevent the free diffusion of liquid in the barrier area. In some embodiments of the present application, the printing ink and the molding method are combined to ensure the formation of the barrier area around the detection area; optionally, the ink is printed first and then molded, combined with the heating effect during molding, to ensure that the pores of the porous material membrane in the barrier area are fully blocked, which can enhance the blocking effect of the ink on the pores of the porous material membrane.

[0026] In a possible implementation, the ink is a high-viscosity resin; optionally, the ink is a high-viscosity resin that is photocurable or electron-ray-curable; optionally, the ink further contains at least one of hot melt adhesive powder and paraffin powder.

[0027] In the above implementation process, the printing ink uses a high-viscosity resin, which will penetrate into the pores of the porous material membrane due to its own characteristics and gravity, and the high-viscosity resin will seal the pores after curing. The use of light-cured or electron-beam-cured resin, combined with the corresponding curing method only for the barrier area, can prevent excessive diffusion of the resin from affecting the precise boundary between the barrier area and the detection area. In order to enhance the sealing effect of the ink on the pores of the porous material membrane, hot melt adhesive powder, paraffin powder and other ingredients can be added to the ink, combined with the heating effect during molding, to ensure that the pores of the porous material membrane in the barrier area are fully blocked.

[0028] In a possible implementation, the method further includes providing a hot melt adhesive layer between two adjacent layers, and providing a flow hole in the hot melt adhesive layer corresponding to the detection area, and bonding the two adjacent layers together by heat pressing; optionally, the hot pressing causes part of the hot melt adhesive to flow into the pores of the corresponding barrier area.

[0029] In the above implementation process, the two adjacent layers are bonded together by the hot melt adhesive layer to form an overall laminated structure, and flow holes are pre-drilled in the area of ​​the hot melt adhesive layer corresponding to the detection area by die-cutting, so that the hot melt adhesive layer only completely covers the barrier area, and hot pressing is used to bond the two adjacent layers together, and the liquid in the detection area maintains a vertical flow function. When hot pressing causes part of the hot melt adhesive of the hot melt adhesive layer to fill the pores of the porous material membrane in the contacting barrier area, it not only plays a role of tight bonding, but also uses the hot melt adhesive to fill and seal the pores of the porous material membrane in the barrier area, and can even transform the originally hydrophilic porous material membrane into a hydrophobic one, surrounding the detection area, so that the reagent barrier effect can be achieved without adding additional blocking blocks or liquid locking components. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings required for use in the embodiments of the present application will be briefly introduced below. It should be understood that the following drawings only show certain embodiments of the present application and therefore should not be regarded as limiting the scope. For ordinary technicians in this field, other related drawings can be obtained based on these drawings without paying creative work.

[0031] Figure 1 A schematic diagram of the exploded structure of a dry chemical test strip provided in the first embodiment of the present application;

[0032] Figure 2 A schematic diagram of the exploded structure of a dry chemical test strip provided in the second embodiment of the present application;

[0033] Figure 3 A schematic diagram of the exploded structure of a dry chemical test strip provided in the third embodiment of the present application;

[0034] Figure 4This is a schematic diagram of the layer structure of forming an ink printing layer on a reaction layer according to an embodiment of the present application;

[0035] Figure 5 This is a schematic diagram of the layer structure after the reaction layer is molded according to an embodiment of the present application.

[0036] Icon: 100-test paper; 110-upper substrate; 111-sample loading hole; 120-blood filter layer; 130-reaction layer; 140-lower substrate; 141-detection hole; 150-ink printing layer; 160-hot melt adhesive layer; 161-circulation hole; 200-test paper; 300-test paper. DETAILED DESCRIPTION

[0037] The technical solutions in the embodiments of the present application will be described below in conjunction with the drawings in the embodiments of the present application.

[0038] In order to make the purpose, technical solution and advantages of the embodiments of the present application clearer, the technical solution in the embodiments of the present application will be clearly and completely described below in conjunction with the drawings in the embodiments of the present application. Obviously, the described embodiments are part of the embodiments of the present application, rather than all the embodiments. The components of the embodiments of the present application described and shown in the drawings here can be arranged and designed in various different configurations.

[0039] Therefore, the following detailed description of the embodiments of the present application provided in the accompanying drawings is not intended to limit the scope of the present application for which protection is sought, but merely represents selected embodiments of the present application. Based on the embodiments in the present application, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present application.

[0040] It should be noted that similar reference numerals and letters denote similar items in the following drawings, and therefore, once an item is defined in one drawing, further definition and explanation thereof is not required in subsequent drawings.

[0041] In the description of the present application, it should be noted that the terms "upper", "lower", "vertical", "horizontal", "inside", "outside", etc. indicate orientations or positional relationships based on the orientations or positional relationships shown in the accompanying drawings, or are the orientations or positional relationships in which the product of the application is usually placed when in use. They are only for the convenience of describing the present application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be understood as a limitation on the present application.

[0042] In the description of this application, it is also necessary to explain that, unless otherwise clearly specified and limited, the terms "disposed" and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection, or it can be an indirect connection through an intermediate medium, or it can be the internal communication of two elements. For ordinary technicians in this field, the specific meanings of the above terms in this application can be understood according to specific circumstances.

[0043] First embodiment

[0044] See also Figure 1 The present embodiment provides a dry chemical test strip 100, which includes: an upper substrate 110, an intermediate layer and a lower substrate 140 which are sequentially stacked together in the longitudinal direction, and the upper substrate 110 is provided with a plurality of sample loading holes 111 which are arranged at intervals. Generally, the intermediate layer includes one functional layer or two or more functional layers which are sequentially stacked together in the longitudinal direction. In the present embodiment, the intermediate layer includes a blood filter layer 120 for filtering blood cells and a reaction layer 130 for loading detection reagents which are sequentially stacked together in the longitudinal direction. In some other embodiments, the intermediate layer is only the reaction layer 130, or according to actual needs, the intermediate layer may also include other functional layers. Each functional layer of the intermediate layer is a porous material membrane, and the pores of the barrier zone are irreversibly closed. Each functional layer of the intermediate layer includes a plurality of detection zones and a barrier zone corresponding to the detection zone. The position of the detection zone is set one-to-one with the position of the sample loading hole 111. The pores of the porous material membrane in each detection zone are connected, so that the liquid penetrates from the sample loading hole and diffuses in the longitudinal and transverse directions. The pores of the porous material membrane in the barrier zone are compressed and deformed to be closed, and each barrier zone is correspondingly arranged around the periphery of the detection zone, so that it cannot penetrate the pores of the porous material membrane in the detection zone, that is, the lateral diffusion boundary of the liquid is limited; the lower substrate 140 is provided with a plurality of detection holes 141 for photoelectric detection, which correspond one-to-one to the detection zone and are independent of each other.

[0045] It should be noted that the closed pores in the present application refer to at least part of the pores of the porous material membrane in the barrier area being compressed and deformed and / or filled with other substances to the point that they cannot penetrate the pores of the porous material membrane in the detection area, that is, the liquid cannot flow and diffuse laterally between the barrier area and the detection area. As an embodiment, the closed pore treatment method is compression and / or heating and melting to close the pores; and / or, the closed pore treatment method is filling the pores with ink or hot melt adhesive.

[0046] In the embodiments of the present application, a porous material membrane generally refers to a material having pores that are interconnected on its surface and inside, similar to a sponge. This porous structure not only realizes the longitudinal flow (i.e., stacking direction / thickness direction) of the liquid sample, but also realizes the lateral flow and diffusion of the liquid sample. The blood filtering layer 120 and the reaction layer 130 are both porous material membranes and are stacked together. In order to achieve specific functions, such as filtering blood cells, the pore sizes of some functional layers must have a gradient change. The middle layer is divided into a detection zone and a barrier zone in the horizontal direction. The pores of the porous material membrane in the detection zone remain original and functional, while the pores of the porous material membrane in the barrier zone are closed to the point where they cannot be connected with the pores of the porous material membrane in the detection zone, so that the flow and diffusion of the liquid sample cannot be carried out. In this way, each sample addition hole 111 and its corresponding detection area and detection hole 141 are arranged from top to bottom to form a reaction unit of a test paper block for measuring a biochemical indicator, and the barrier area surrounding the detection area ensures that the detection reagent and / or liquid sample diffuses and flows only in the limited area (i.e., the reaction area) of the porous material membrane.

[0047] In order to achieve the vertical flow of liquid samples, the sample loading holes 111, the detection area and the detection holes 141 need to correspond one to one and be arranged from top to bottom. The corresponding sample loading holes 111, the detection area and the detection holes 141 can completely overlap in the vertical direction, or they can partially overlap, as long as they can achieve the vertical flow. In some embodiments of the present application, the corresponding sample loading holes 111 and the detection holes 141 have the same shape and size, such as both are circular, and completely overlap in the vertical direction. This arrangement is not only easy to process, but also reduces the waste of detection reagents and reduces production costs; the detection area between the sample loading holes 111 and the detection holes 141 can be circular or square. In this embodiment, the detection area is a circular area with the same shape and size as the sample loading holes 111 and the detection holes 141. Correspondingly, the barrier area is the area surrounding the detection area.

[0048] The reaction layer 130 of the present application is loaded with detection reagents, and the type of detection reagents determines the detection items of the corresponding reagent block. Usually, the detection reagents contain a variety of specific enzymes and reagents and are specifically matched to achieve the purpose of fast and accurate detection. By loading different detection reagents, the dry chemical test paper 100 of the present application can be used for the detection of a series of biochemical indicators such as glucose, cholesterol, triglycerides, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, uric acid, bilirubin, total protein, hemoglobin, ketone bodies, creatinine, urea, etc.

[0049] In some embodiments of the present application, the upper substrate 110 and the lower substrate 140 are respectively selected from polyethylene plastic sheets, polypropylene plastic sheets, polystyrene plastic sheets, polycarbonate plastic sheets, polyamide ester plastic sheets or polyester plastic sheets, and the thickness is generally 0.1mm to 0.3mm; the blood filter layer 120 is selected from cellulose membrane, PES membrane, nylon membrane, non-woven fabric or glass fiber membrane, and the thickness is generally 200-500μm, and the thickness is 300μm in this embodiment; the reaction layer 130 is selected from cellulose membrane, PES membrane, nylon membrane, glass fiber membrane, polyester membrane or non-woven fabric, and the thickness is generally 100-200μm, and the thickness is 100μm in this embodiment. In this embodiment, the upper substrate 110 and the lower substrate 140 are respectively perforated polypropylene plastic sheets; the blood filter layer 120 is a cellulose membrane; and the reaction layer 130 is a PES membrane.

[0050] This embodiment also provides a preparation process of the above-mentioned dry chemical detection test paper 100, which includes the following steps:

[0051] The upper substrate 110, the blood filter layer 120, the reaction layer 130 and the lower substrate 140 are stacked together in sequence along the longitudinal direction, and the pores of the porous material membrane in the barrier area of ​​the blood filter layer 120 and the reaction layer 130 are subjected to irreversible pore closing treatment; or, the pores of the porous material membrane in the barrier area of ​​the blood filter layer 120 and the reaction layer 130 are subjected to irreversible pore closing treatment, and the upper substrate 110, the intermediate layer subjected to pore closing treatment and the lower substrate 140 are stacked together in sequence along the longitudinal direction. Generally, the pores in the barrier area can be closed by at least one of molding, laser melting and filling the pores with ink or hot melt adhesive until they cannot be connected with the pores in the detection area. The molding method is generally heating molding or ultrasonic molding. Molding can also melt and bond the barrier areas of the blood filter layer 120 and the reaction layer 130 together. Since the upper substrate 110 and the lower substrate 140 of this embodiment are plastic sheets, they cannot be melted and bonded with other layers only by molding. Therefore, the barrier area of ​​the blood filter layer 120 and the corresponding upper substrate 110, and the barrier area of ​​the reaction layer 130 and the corresponding lower substrate 140 of this embodiment are bonded together by hot melt adhesive (not shown), so as to achieve the composite between the layers. In order to ensure the molding and bonding effect, in this embodiment, the reaction layer 130 can be bonded to the lower substrate 140 by hot melt adhesive, heated and molded, and then the blood filter layer 120 is set, heated and molded, and then the upper substrate 110 is bonded by hot melt adhesive and heated and molded.

[0052] In the above process, it also includes the steps of positioning spraying of the detection reagent and optionally cutting the test strip according to the actual situation. Among them, the positioning spraying of the detection reagent is carried out after the reaction layer 130 is set, but before other layers that will completely cover the detection area of ​​the reaction layer 130 are set. The structure of the test paper 100 of the present application, and the processing method of first spraying the test paper 100 and then cutting, have the advantage of being able to operate on a large scale during the process of dripping the detection reagent (enzyme solution), and each detection unit realizes independent liquid dosing, the accuracy and precision of the liquid dosing are guaranteed, the preparation process is simple and efficient, and the existing technology of cutting first and then spraying must rely on manual operation, which reduces the efficiency and the uncertainty caused by manual operation.

[0053] Second embodiment

[0054] See also Figure 2 The present embodiment provides a dry chemical test strip 200, which includes: an upper substrate 110, an ink printing layer 150, a blood filter layer 120, an ink printing layer 150, a reaction layer 130, an ink printing layer 150 (can be omitted), and a lower substrate 140 stacked in sequence along the longitudinal direction. The upper substrate 110 is provided with a plurality of sample loading holes 111 arranged at intervals; the blood filter layer 120 and the reaction layer 130 are both porous material membranes, and are divided into a plurality of detection areas corresponding to the sample loading holes 111, and a barrier area surrounding each detection area. The ink printing layer 150 is only arranged on the barrier area surface of the blood filter layer 120 or the reaction layer 130, and is usually formed by printing ink on the barrier area surface of the blood filter layer 120 or the reaction layer 130 in advance. Therefore, the ink printing layer 150 has through holes corresponding to the reaction area, and part of the ink of the ink printing layer 150 is filled into the pores of the porous material membrane of the adjacent barrier area. The thickness of the ink printing layer 150 (excluding the portion immersed in the pores) is generally 10 to 30 μm. Figure 2 It shows the stacking order between the layers of the dry chemical test strip 200. In the actual product, the ink printing layer 150 is compounded on the surface of the contacting blood filter layer 120 or the reaction layer 130. The pores of the porous material membrane in each detection area are connected along the stacking direction, and the pores of the porous material membrane in the barrier area are compressed and deformed to be closed, and cannot be connected with the pores of the porous material membrane in the detection area; the lower substrate 140 is provided with a plurality of detection holes 141 for photoelectric detection, which correspond to the detection areas one by one and are independent of each other.

[0055] This embodiment also provides a preparation process of the above-mentioned dry chemical detection test paper 200, which includes the following steps:

[0056] First, ink is printed on the upper and lower surfaces of the barrier areas of the blood filtering layer 120 and the reaction layer 130 respectively, so that part of the ink flows into the pores of the porous material membrane in the adjacent barrier areas and solidifies to form an ink printing layer 150. The ink is generally a high-viscosity resin; optionally, the ink is a high-viscosity resin that is photocurable or electron-beam-curable; optionally, the ink also contains at least one of hot-melt adhesive powder and paraffin powder, for example, the content of polyurethane acrylate in the ink is 50%, and hot-melt adhesive powder is added with a content of 25% and a particle size of 200 mesh.

[0057] Then, the upper substrate 110, the blood filtering layer 120 with the ink printing layer 150, the reaction layer 130 with the ink printing layer 150 and the lower substrate 140 are stacked together in sequence, and the pores of the porous material membranes in the barrier areas of the blood filtering layer 120 and the reaction layer 130 are compressed and deformed by molding until they cannot penetrate the pores of the porous material membranes in the detection area. The blood filtering layer 120 with the ink printing layer 150 and the reaction layer 130 with the ink printing layer 150 can also be melted and bonded together by molding, and the barrier area of ​​the blood filtering layer 120 and the corresponding upper substrate 110, and the barrier area of ​​the reaction layer 130 and the corresponding lower substrate 140 are bonded together by hot melt adhesive (not shown), thereby achieving compounding between the layers.

[0058] Third embodiment

[0059] See also Figure 3 The present embodiment provides a dry chemical test strip 300, which includes the following components which are laminated and compounded from top to bottom: an upper substrate 110, a hot melt adhesive layer 160, an ink printing layer 150, a blood filter layer 120, a hot melt adhesive layer 160, an ink printing layer 150, a reaction layer 130, a hot melt adhesive layer 160 and a lower substrate 140. The upper substrate 110 is provided with a plurality of sample loading holes 111 arranged at intervals; the blood filter layer 120 and the reaction layer 130 are both porous material membranes, which are divided into a plurality of detection areas corresponding to the sample loading holes 111 one by one, and a barrier area surrounding each detection area; the ink printing layer 150 is only provided on the surface of the barrier area of ​​the adjacent blood filter layer 120 or the reaction layer 130, and part of the ink of the ink printing layer 150 is filled into the pores of the porous material membrane of the adjacent barrier area; the hot melt adhesive layer 160 is provided with a flow hole in the area corresponding to the detection area. The through hole 161 is only arranged on the surface of the barrier area of ​​the adjacent blood filtering layer 120 or the reaction layer 130, and part of the melt of the hot melt adhesive layer 160 corresponding to the barrier area is filled into the pores of the porous material membrane in the adjacent barrier area; the pores of the porous material membrane in each detection area are connected along the stacking direction, and the pores of the porous material membrane in the barrier area are compressed and deformed to be closed, and cannot be connected with the pores of the porous material membrane in the detection area; the lower substrate 140 is provided with a plurality of detection holes 141 for photoelectric detection, which correspond to the detection areas one by one and are independent of each other.

[0060] In this embodiment, different dry chemical test strips 300 are provided according to the different detection reagents loaded on the reaction layer 130. The structures of the dry chemical test strips 300 are roughly the same, but the specific preparation processes are different. The specific embodiments are as follows:

[0061] Example 3.1

[0062] This embodiment provides a total cholesterol test strip 300, the preparation process of which includes the following steps:

[0063] Step 1: A hot melt adhesive layer 160 (polyurethane, TPU) is attached or coated with hot melt adhesive on a lower substrate 140 made of PET material with a certain hardness and a thickness of 0.2 mm to form a hot melt adhesive layer 160 , and a through hole is punched for use. The through hole on the lower substrate 140 is the detection hole 141 , and the through hole on the hot melt adhesive layer 160 is the flow hole 161 .

[0064] Step 2: Heat and compound the porous membrane material (polyethersulfone, PES) as the reaction layer 130 on the hot melt adhesive layer 160 of the lower substrate 140. The thermal compounding temperature is 70°C and the speed is 0.3 m / min. The reaction layer 130 needs to completely cover the hot melt adhesive layer 160 and the flow holes 161 thereon. Hot pressing is used to make part of the molten adhesive flow into the pores of the porous material membrane adjacent to the barrier area.

[0065] Step 3, screen printing ink on the reaction layer 130, the ink contains 80% polyurethane acrylate, 17.8% trimethylolpropane triacrylate (TMPTA), 0.1% defoamer, 0.1% leveling agent, 1% photocuring initiator, and 1% other additives by mass percentage; the printing mesh number is 200 mesh, and the printing film thickness is 20 μm; after printing, the printed film is left horizontally for 5 minutes, and irradiated with ultraviolet light or visible light to cure the ink to form the ink printing layer 150. In this embodiment, the layer structure of the ink printing layer 150 formed by printing ink on the reaction layer 130 is as follows Figure 4 As shown, from Figure 4 It can be seen that the ink printing layer 150 only covers the surface of the barrier area of ​​the reaction layer 130, while the detection area of ​​the reaction layer 130 is exposed. After the ink is printed, part of the ink corresponding to the barrier area of ​​the reaction layer 130 flows into the pores of the barrier area of ​​the reaction layer 130 and fills the gap, presenting a visual effect that the ink printing layer 150 and the reaction layer 130 are combined into one.

[0066] Step 4: Cover the ink printing layer 150 of the reaction layer 130 with the hot melt adhesive layer 160 having the flow holes 161, and heat and pressurize the area of ​​the above layer structure corresponding to the barrier area using a mold to melt or soften the hot melt adhesive, and at the same time compress and deform the layer structure to form a molding effect. In this embodiment, the layer structure after the hot melt adhesive layer 160 is covered on the reaction layer 130 and molded is as follows: Figure 5 As shown, from Figure 5It can be seen that the hot melt adhesive layer 160 covers the surface of the reaction layer 130, the area of ​​the reaction layer 130 corresponding to the flow hole 161 is exposed and visible, and the area outside the reaction layer 130 corresponding to the flow hole 161 is compressed and thinned, presenting a visual effect that the area of ​​the reaction layer 130 corresponding to the flow hole 161 is relatively protruding.

[0067] Step 5: Prepare the detection reagent: The detection reagent includes 6-8.5 KU / L cholesterol esterase, 3-5 KU / L cholesterol oxidase, 15-20 KU / L horseradish peroxidase, 3-5 KU / L ascorbic acid oxidase, 0.20-0.35 g / L 4-aminoantipyrine, 0.20-0.30 g / L color developing substance and 0.15-0.25 mmol / L Tris-HCl buffer with a pH of 5.5-6.5; it also includes 0.80-1.0 g / L sea salt. Algae sugar, 0.1-0.3 g / L bovine serum albumin, 0.15-0.25 g / L [(3-cholamidopropyl) dimethylammonium] -1-propanesulfonate; the coloring substance is selected from one or more of N-ethyl-N-(2-hydroxy-3-sulfopropyl)-3-methylaniline sodium salt, N,N-bis(4-sulfobutyl)-3-methylaniline disodium salt, N-ethyl-N-(2-hydroxy-3-sulfopropyl)-3'5-dimethoxyaniline sodium salt, phenols, and 3,3',5,5'-tetramethylbenzidine.

[0068] The prepared detection reagent is dripped into the detection area (corresponding to the through hole) of the reaction layer 130 using a dispensing machine, with a dripping amount of 1ul per hole. The membrane plate after dripping is placed in a drying oven for drying at a drying temperature of 37°C and a drying time of 20min to obtain a reaction layer 130 loaded with the detection reagent.

[0069] Step 6: A hot melt adhesive layer 160 with flow holes 161 is attached to the reaction layer 130, and then the blood filter layer 120 is attached. The surface of the blood filter layer 120 away from the reaction layer 130 has been screen-printed to form an ink printing layer 150. The ink printing layer 150 is formed in the same manner as the ink printing layer 150 described above. After being attached and fixed, a hot mold press is used for pressing at a temperature of 70°C and a pressure of 50kg / cm 2 , time 2s.

[0070] Step 7: The hot melt adhesive layer 160 with the flow hole 161 and the upper substrate 110 made of PET material with a certain hardness, a thickness of 0.2 mm and a sample addition hole 111 are sequentially attached to the above layer structure and fixed by hot pressing.

[0071] Step 8: Cut the test paper according to the required width.

[0072] Example 3.2

[0073] This embodiment provides a hemoglobin test strip 300, and its preparation process includes the following steps:

[0074] Steps 1 to 4 are the same as the corresponding steps in Example 3.1.

[0075] Step 5: Prepare the detection reagent: The detection reagent includes 0.48 g / L sodium deoxycholate and 4.2 g / L sodium nitrite, 0.12 mmol / L PBS buffer (pH=7.5) and 0.09 g / L Triton X-300.

[0076] The prepared detection reagent is dripped into the detection area (corresponding to the through hole) of the reaction layer 130 using a dispensing machine, with a dripping amount of 1ul per hole. The membrane plate after dripping is placed in a drying oven for drying at a drying temperature of 37°C and a drying time of 20min, thereby obtaining a reaction layer 130 loaded with the detection reagent.

[0077] Step 6: The hot melt adhesive layer 160 with the flow hole 161 and the upper substrate 110 made of 0.2 mm thick PET material with a certain hardness and the sample addition hole 111 are sequentially attached to the above layer structure and fixed by hot pressing.

[0078] Step 7: Cut the test paper according to the required width.

[0079] Example 3.3

[0080] This embodiment provides a dry chemical test paper for quantitatively measuring the urea content in human blood, and its preparation process comprises the following steps:

[0081] Steps 1 to 4 are the same as the corresponding steps in Example 3.1.

[0082] Step 5. Prepare the detection reagent: The detection reagent includes 50 KU / L urease, 1.0 g / L trehalose, 20 g / L color developing substance, 0.15 g / L BSA, and 0.1 g / L sodium chloride.

[0083] The prepared detection reagent is dripped into the detection area (corresponding to the through hole) of the reaction layer 130 using a dispensing machine, with a dripping amount of 1ul per hole. The membrane plate after dripping is placed in a drying oven for drying at a drying temperature of 37°C and a drying time of 20min, thereby obtaining a reaction layer 130 loaded with the detection reagent.

[0084] Steps 6 to 8 are the same as the corresponding steps in Example 3.1.

[0085] Example 3.4

[0086] This embodiment provides a triglyceride detection test strip 300, and its preparation process includes the following steps:

[0087] Steps 1 to 4 are the same as the corresponding steps in Example 3.1.

[0088] Step 5. Prepare the detection reagent: The detection reagent contains LPL: 0.16 kU / mL, GK: 0.28 kU / mL, GPO: 0.10 kU / mL, HRP: 0.12 kU / mL, ATP: 6.0 mM, 4-AAP: 12.0 mM, DAOS: 7.0 mM, Mg 2+ :0.3mM, Trton X-300: 0.2%.

[0089] The prepared detection reagent is dripped into the detection area (corresponding to the through hole) of the reaction layer 130 using a dispensing machine, with a dripping amount of 1ul per hole. The membrane plate after dripping is placed in a drying oven for drying at a drying temperature of 37°C and a drying time of 20min, thereby obtaining a reaction layer 130 loaded with the detection reagent.

[0090] Steps 6 to 8 are the same as the corresponding steps in Example 3.1.

[0091] Example 3.5

[0092] This embodiment provides a β-hydroxybutyric acid detection reagent and a β-hydroxybutyric acid detection test paper 300, and the preparation process thereof includes the following steps:

[0093] Steps 1 to 4 are the same as the corresponding steps in Example 3.1.

[0094] Step 5. Prepare the detection reagent: The detection reagent includes 3 KU / L diaphorase, 9 KU / L β-hydroxybutyrate dehydrogenase, 1.2 KU / L NAD and 0.6 KU / L NBT, 0.08 mmol / L (pH 8.0) Tris-HCl buffer, and 1.0 g / L trehalose.

[0095] The prepared detection reagent is dripped into the detection area (corresponding to the through hole) of the reaction layer 130 using a dispensing machine, with a dripping amount of 1ul per hole. The membrane plate after dripping is placed in a drying oven for drying at a drying temperature of 37°C and a drying time of 20min, thereby obtaining a reaction layer 130 loaded with the detection reagent.

[0096] Steps 6 to 8 are the same as the corresponding steps in Example 3.1.

[0097] In summary, the dry chemical test strip and preparation process of the embodiment of the present application have simple structure and process, and can realize independent detection of each detection area without mutual interference.

[0098] The above description is only an embodiment of the present application and is not intended to limit the protection scope of the present application. For those skilled in the art, the present application may have various modifications and variations. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present application shall be included in the protection scope of the present application.

Claims

1. A dry chemical test paper, characterized in that: It includes the following stacked in sequence along the longitudinal direction: An upper substrate, wherein the upper substrate is provided with a plurality of sample addition holes arranged at intervals; An intermediate layer, the intermediate layer comprising a plurality of detection zones and barrier zones corresponding to the detection zones, the intermediate layer being a porous material membrane, and the pores of the barrier zones being irreversibly closed, the positions of the detection zones being arranged in one-to-one correspondence with the positions of the sample loading holes, the pores of the detection zones enabling liquid to penetrate from the sample loading holes and diffuse in the longitudinal and transverse directions, and each barrier zone being arranged correspondingly around the periphery of the detection zone and defining the transverse diffusion boundary of the liquid; A lower substrate, the lower substrate being provided with a plurality of detection holes corresponding one-to-one to the detection areas and used for photoelectric detection; The method of the pore closing treatment is compression and / or heating and melting to close the pores; And / or, the closed-cell treatment is performed by filling the pores with ink or hot-melt adhesive; The upper substrate and / or the lower substrate are selected from polyethylene plastic sheets, polypropylene plastic sheets, polystyrene plastic sheets, polycarbonate plastic sheets, polyamide ester plastic sheets or polyester plastic sheets; And / or, the intermediate layer includes at least one of a blood filtering layer and a reaction layer.

2. The dry chemical test paper according to claim 1, characterized in that: An ink printing layer is arranged on the surface of the barrier area of ​​the intermediate layer, and part of the ink of the ink printing layer is filled into the pores of the corresponding barrier area.

3. The dry chemical test paper according to claim 1, characterized in that: A hot melt adhesive layer is also arranged between two adjacent layers, and a flow hole is opened in the hot melt adhesive layer corresponding to the detection area.

4. The dry chemical test paper according to claim 3, characterized in that: Part of the hot melt adhesive of the hot melt adhesive layer corresponding to the barrier area is filled into the pores of the corresponding barrier area.

5. The dry chemical test paper according to claim 1, characterized in that: The middle layer comprises a blood filtering layer and a reaction layer stacked in sequence along the longitudinal direction, wherein the blood filtering layer is selected from cellulose membrane, PES membrane, nylon membrane, non-woven fabric or glass fiber membrane; and the reaction layer is selected from cellulose membrane, PES membrane, nylon membrane, glass fiber membrane, polyester membrane or non-woven fabric.

6. A process for preparing a dry chemical test paper as claimed in claim 1, characterized in that: It includes the following steps: The upper substrate, the middle layer and the lower substrate are stacked together in sequence along the longitudinal direction, and the pores in the barrier zone of the middle layer are irreversibly closed; or, the middle layer is irreversibly closed, and the upper substrate, the closed-pore middle layer and the lower substrate are stacked together in sequence along the longitudinal direction.

7. The preparation process of the dry chemical test paper according to claim 6, characterized in that: The pores in the barrier zone are irreversibly closed by at least one of molding, laser melting, and filling the pores with ink or hot melt adhesive.

8. The preparation process of the dry chemical test paper according to claim 7, characterized in that: The molding method is heating molding or ultrasonic molding.

9. The process for preparing the dry chemical test paper according to any one of claims 6 to 8, characterized in that: The step also includes printing ink on the surface of the barrier area of ​​the intermediate layer, allowing part of the ink to flow into the pores of the corresponding barrier area and solidify to form an ink printing layer.

10. The process for preparing the dry chemical test paper according to claim 9, characterized in that: First print the ink, then mold it.

11. The process for preparing the dry chemical test paper according to claim 9, characterized in that: The ink is a high-viscosity resin.

12. The process for preparing the dry chemical test paper according to claim 11, characterized in that: The ink is a high-viscosity resin that is photocurable or electron-ray curable.

13. The preparation process of the dry chemical test paper according to claim 11, characterized in that: The ink also contains at least one of hot melt adhesive powder and paraffin powder.

14. The process for preparing the dry chemical test paper according to claim 6, characterized in that: The method also includes the steps of arranging a hot melt adhesive layer between two adjacent layers, wherein a flow hole is opened in an area of ​​the hot melt adhesive layer corresponding to the detection area, and bonding the two adjacent layers together by heat pressing.

15. The process for preparing the dry chemical test paper according to claim 14, characterized in that: The heat pressing causes part of the hot melt adhesive to flow into the pores of the corresponding barrier area.

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