Method for manufacturing test strip for inspection

Abstract

A test kit and a manufacturing method of a test strip for the test kit, in which, as test regions for determining whether a test subject is positive or negative, a plurality of types of test regions in which a plurality of types of binding substances that specifically bind to different types of test substances, respectively, are immobilized, are provided, and a test strip-shaped carrier including at least a test strip in which a plurality of types of test items can be tested according to the number of different types of test regions is provided, in a case where a direction orthogonal to a length direction of the test strip-shaped carrier is set as a width direction, in the plurality of types of test regions, a length in the width direction of the test strip-shaped carrier is shorter than an entire width of each of the test strip-shaped carriers, and the plurality of types of test regions are arranged with positions in the width direction being staggered.

Description

Technical Field

[0001] This invention relates to a test kit and a method for manufacturing test strips. Background Technology

[0002] Japanese Patent Application Publication Nos. 2010-261961 and 2009-058507 disclose immunochromatographic kits for determining whether a sample is positive or negative, i.e., whether the sample contains a test substance, using immunochromatography. These immunochromatographic kits are referred to as testing kits, etc. The testing kits include test strips containing a strip-shaped carrier having a test area with a binding substance that specifically binds to the test substance. For example, if the sample containing the test substance is spread out in the test area, the color development state changes.

[0003] The testing kit includes a strip-shaped carrier for a test strip, which has multiple types of testing areas corresponding to various types of tests, such as influenza A and influenza B. When there are two types of tests, the strip-shaped carrier has a first testing area and a second testing area, each with a different test substance corresponding to a specific test. Because this testing kit has multiple types of testing areas on a single test strip carrier, multiple types of tests can be performed simultaneously on a single subject.

[0004] The arrangement patterns of the various types of test areas described in Japanese Patent Application Publication Nos. 2010-261961 and 2009-058507 are as follows. First, with the width direction orthogonal to the length direction of the test strip carrier defined as the width direction, the various types of test areas are each arranged as lines extending along the width direction of the test strip carrier. The length of these linear test areas covers the entire width direction of the test strip carrier; that is, the length of each test area is equivalent to the entire width of the test strip carrier. Thus, the various types of test areas, each with a length equal to the width of the test strip carrier, are arranged offset from the length direction of the test strip carrier. Summary of the Invention

[0005] The technical problem to be solved by the invention Regarding conventional test kits with various types of test area arrangements as described in Japanese Patent Application Publication Nos. 2010-261961 and 2009-058507, the following improvements are required. First, the binding material fixed to the test areas is relatively expensive, and the more test areas are set on the test strip carrier, the greater the increase in cost. Therefore, even when the number of tests is increased, there is a need to reduce the cost increase associated with the increase in the number of tests by suppressing the increase in the amount of binding material. Furthermore, even when the area of ​​the test areas is reduced to a smaller size than before to suppress the increase in cost, there is a need to ensure the identifiability of each test area.

[0006] The purpose of this invention is to provide a test kit and a method for manufacturing a test strip that ensures the recognizability of multiple types of test areas even when multiple types of test areas are provided on the test strip carrier of the test strip, and that can suppress cost increases compared to the past.

[0007] means for solving technical problems The test kit of the present invention is a test kit used in immunochromatographic assays. A test strip, used to determine whether a sample is positive or negative, comprises multiple types of test areas immobilized with various types of binding substances that specifically bind to different types of test substances, and a test strip-shaped carrier containing at least a number of test areas of different types, enabling the performance of multiple types of tests. When the direction orthogonal to the length direction of the test strip carrier is set as the width direction... In various types of testing areas, the length of the test strip carrier in the width direction is shorter than the entire width of the respective test strip carrier. Multiple types of inspection areas can be configured by offsetting their positions in the width direction.

[0008] In the test kit of the present invention, various types of test areas are preferably arranged in the width direction of the test strip carrier.

[0009] In the test kit of the present invention, each of the various types of test areas can be centrally located along the length of the test strip carrier and have the same width.

[0010] In the test kit of the present invention, adjacent test areas of different types in the width direction of the test strip carrier can be partially staggered in the length direction of the test strip carrier.

[0011] In the test kit of the present invention, various types of test areas can be configured in a manner that does not overlap along the length of the test strip carrier.

[0012] In the test kit of the present invention, the distance between the ends of various types of test areas along the length of the test strip carrier is preferably less than 2 mm.

[0013] The test strip manufacturing method of the test kit of the present invention includes: a coating step, wherein, in order to form multiple types of test areas on a sheet carrier having an area comprising multiple test strip-shaped carriers, multiple types of coating liquids comprising multiple types of binding substances are coated, and the multiple types of coating liquids are coated on the sheet carrier in a manner that the arrangement pattern of multiple types of test areas in a single test strip-shaped carrier is periodically repeated; and The cutting process involves cutting the sheet-like carrier along a direction orthogonal to the repeating direction of the pattern.

[0014] In the manufacturing method of the test strip for testing according to the present invention, it is preferable to coat various types of coating liquid in the coating process by arranging multiple patterns in a straight line along the repeating direction.

[0015] In the manufacturing method of the test strip for testing according to the present invention, in the coating process, gap regions where no one of the various types of coating liquid is coated can be provided between adjacent arrangement patterns in the repeating direction, and in the cutting process, sheet-like carriers are cut in the gap regions.

[0016] In the manufacturing method of the test strip of the present invention, various types of coating liquid can be applied in the coating process such that the positions of adjacent test areas between adjacent arrangement patterns in the repeating direction are staggered in a direction orthogonal to the repeating direction.

[0017] In the manufacturing method of the test strip of the present invention, a shielding member is used, which has a plurality of openings arranged in a straight line along a repeating direction with a period of 1 cycle for the width of a test strip-shaped carrier, and the length of the repeating direction of each opening is the length of the test area. The coating process may include: a first coating process in which a masking member is placed at a first position on a sheet-like carrier and a first coating liquid of one type of coating liquid is applied to a first portion exposed from an opening; and a second coating process in which the masking member is moved from the first position to a second position by offsetting it in a repeating direction within a period of one cycle, at the second position being exposed from an opening, and another coating liquid of one type of coating liquid, a second coating liquid, is applied to a second portion not coated with the first coating liquid.

[0018] In the manufacturing method of the test strip for testing according to the present invention, various types of coating liquids can be applied by inkjet printing.

[0019] The manufacturing method of the test strip for testing according to the present invention includes a marking step of setting a mark on a sheet-like carrier to indicate the position where a cutting process will be carried out in the cutting process, and the sheet-like carrier can be cut based on the mark in the cutting process.

[0020] Invention Effects According to the present invention, the test kit and test strip manufacturing method ensure the identification of multiple types of test areas even when multiple types of test areas are provided on the test strip carrier of the test strip, and can suppress the increase in cost compared with the past. Attached Figure Description

[0021] Figure 1 This is a perspective view of the test kit involved in the present invention.

[0022] Figure 2 This is an exploded perspective view of the test kit involved in the present invention.

[0023] Figure 3 These are top views (a) and side views (b) showing the structure of the test strip.

[0024] Figure 4 This is an illustrative diagram of immunochromatography.

[0025] Figure 5 This is a diagram used to illustrate a variation of the configuration of the inspection area.

[0026] Figure 6 This is an instruction manual for manufacturing test strips. Figure 1 .

[0027] Figure 7 This is an instruction manual for manufacturing test strips. Figure 2 .

[0028] Figure 8 This is an instruction manual for manufacturing test strips. Figure 3 .

[0029] Figure 9 This is an explanatory diagram illustrating a situation where the cutting position is misaligned during the manufacturing process of the test strip.

[0030] Figure 10 This is an explanatory diagram illustrating a variation of the manufacturing method of the test strip.

[0031] Figure 11 This is an explanatory diagram illustrating a variation of the manufacturing method of the test strip.

[0032] Figure 12 It was used Figure 11 This is an illustration of a situation where the cutting position is misaligned under certain manufacturing methods.

[0033] Figure 13 This is an explanatory diagram illustrating a variation of the manufacturing method of the test strip.

[0034] Figure 14 It was used Figure 13 This is an illustration of a manufacturing method where the cutting positions are staggered.

[0035] Figure 15 This is an illustration of the manufacturing method of test strips using the inkjet printing method. Detailed Implementation

[0036] Hereinafter, the test kit according to the embodiments of the present invention will be described with reference to the appendix. Figure 1 The description will proceed accordingly. In the various figures, the same symbols are used to denote the same constituent elements. However, unless otherwise stated in the specification, the constituent elements are not limited to one, and multiple elements may exist.

[0037] Furthermore, descriptions of structures and symbols repeated in the various figures are sometimes omitted. Additionally, the present invention is not limited to the following embodiments; it can be implemented through appropriate modifications, such as omitting structures or replacing them with different structures, within the scope of the invention's objectives.

[0038] The directions indicated by the arrows X and Y, as appropriately shown in each figure, are along the horizontal plane and are orthogonal to each other. The direction indicated by the arrow Z is along the vertical direction (up and down). In each figure, the directions indicated by the arrows X, Y, and Z are assumed to be consistent with each other.

[0039] <Overview of the test kit> Figure 1 This is an external image of a test kit 100 (hereinafter referred to as kit 100) according to one embodiment. Figure 2 This is an exploded 3D view of reagent kit 100. Figure 3 These are top views (a) and side views (b) of the test strips included in the kit 100. Additionally, Figure 4 This is an illustrative diagram of immunochromatography.

[0040] Kit 100 is a single-use kit, one for each subject (or specimen). Figure 2As shown, the kit 100 includes a test strip 1 containing an immunochromatographic carrier 2 in the shape of a test strip (hereinafter referred to as the test strip carrier 2). The test strip carrier 2 has a first test area A1 and a second test area A2. The first test area A1 and the second test area A2 are examples of multiple types of test areas where multiple types of binding substances, each specifically binding to different types of test substances, are immobilized. The test strip carrier 2 has different types of first test areas A1 and second test areas A2, and the number of these two test areas (two in this example) allows for the testing of various types of test items.

[0041] For example, the first examination area A1 is located on the subject 50 (reference). Figure 4 ) contains the first tested substance 41 (reference) Figure 4 In the case where the sample 50 is positive for the first test substance 41, the color development state changes. Similarly, the second examination area A2 changes when the sample 50 contains the second test substance 42 (see reference). Figure 4 In the case where the test sample 50 is positive for the second test substance 42, the color development status changes. The first test substance 41 and the second test substance 42 are different types of test substances. This kit 100 is designed to simultaneously determine whether the test sample 50 is positive or negative for each of the two different test substances, 41 and 42. For example, if the first test substance 41 is an influenza A antigen and the second test substance 42 is an influenza B antigen, it can simultaneously detect whether the patient has influenza A or B.

[0042] In addition, the “change in color development state” includes any one of the following: changing from a first color different from the color of the test strip carrier 2 to another second color (i.e., color change); changing the color of the test strip carrier 2 to another color by developing a color different from the color of the test strip carrier 2 (i.e., color development); and changing the color concentration (i.e., concentration change).

[0043] As for the test subject 50, any sample that may contain the test substance is acceptable; there are no particular limitations on the test subject 50. The test subject 50 can be, for example, a biological sample, especially bodily fluids such as blood, serum, plasma, cerebrospinal fluid, tears, sweat, urine, pus, nasal discharge, nasal swabs, pharyngeal swabs, nasal aspiration fluid, or sputum from animals (specifically humans), or excrement, organs, tissues, mucous membranes, and skin, or swabs containing them, or liquid samples containing the animal or plant itself or their dried bodies. Examples of test substances include antigens, antibodies, proteins, and low-molecular-weight compounds.

[0044] The kit 100 has a structure that allows the user to visually confirm whether the sample 50 is positive or negative. This kit 100 is also referred to as an immunochromatographic testing device or an immunochromatographic testing kit, etc.

[0045] like Figure 1 and Figure 2 As shown, for example, the kit 100 includes a housing 22 consisting of a housing body 20 and a cap member 21. The housing 22 is formed, for example, from a resin material. An opening is formed at the top of the housing body 20, and the test strip 1 is housed inside. The cap member 21 covers the opening of the housing body 20 by being installed in the opening portion of the housing body 20. The housing 22 is elongated in shape to accommodate the elongated shape of the test strip 1.

[0046] In this example, a dispensing port 26 and an observation window 28 are provided in the upper part of the outer casing 22, which is formed by the cover component 21. As an example, these components are integrally formed with the cover component 21. The dispensing port 26 is an opening for dispensing the test subject 50 into the interior of the outer casing 22.

[0047] The observation window 28 is an opening for observing the first inspection area A1 and the second inspection area A2 from the outside. In this example, the size of the observation window 28 is such that, in addition to observing the first inspection area A1 and the second inspection area A2, the size of the control area C (described later) can also be observed. A transparent component is embedded in the observation window 28. The user can observe the color display status of the first inspection area A1, the second inspection area A2, and the control area C through the observation window 28.

[0048] <Test strips> The test strip 1 comprises a test strip carrier 2, a marker holding pad 3, and an absorbent pad 6. The test strip carrier 2 is fixed and supported on a substrate 7 having an adhesive sheet on its surface. The marker holding pad 3 is disposed at one end of the carrier 2 along its length, and the absorbent pad 6 is disposed at the other end of the test strip carrier 2 along its length. The length direction of the test strip carrier 2 represents the length direction of the test strip 1 (Y direction in the figure). The direction perpendicular to the length direction of the test strip carrier 2 (X direction in the figure) is called the width direction of the test strip carrier 2. The width of the test strip carrier 2 has the same meaning as the width of the test strip 1.

[0049] The test strip carrier 2 is a porous, insoluble carrier used to unfold the test sample 50, and includes a first inspection area A1, a second inspection area A2, and a control area C. The first inspection area A1, the second inspection area A2, and the control area C are disposed on the test strip carrier 2, positioned between the marker holding pad 3 and the absorbent pad 6 along the length of the test strip 1. The control area C is located closer to the absorbent pad 6 than the first inspection area A1 and the second inspection area A2.

[0050] Also Figure 3 As shown, the first inspection area A1 and the second inspection area A2 are positioned offset from the width of the test strip carrier 2. As an example, in this case, the first inspection area A1 and the second inspection area A2 are arranged along the width of the test strip carrier 2. Furthermore, in this example, the center positions of the first inspection area A1 and the second inspection area A2 are aligned along the length of the test strip carrier 2, and their widths are identical. Here, "identical" means not only completely identical but also within a range of ±10%.

[0051] In other words, in this example, the first inspection area A1 and the second inspection area A2 together form a line extending along the width direction (X direction in the figure) of the test strip carrier 2, dividing the line into two areas in the width direction, namely the first inspection area A1 and the second inspection area A2.

[0052] Furthermore, the lengths L1 and L2 of the test strip carrier 2 in the width direction of the first inspection area A1 and the second inspection area A2 are both shorter than the entire width W of the test strip carrier 2. In this example, lengths L1 and L2 are the same, which are half the length W / 2 of the entire width W of the test strip carrier 2. That is, L1=L2=W / 2.

[0053] The control area C is a linear region extending along the width of the test strip carrier 2.

[0054] exist Figure 3 The text indicates that the first examination area A1, the second examination area A2, and the control area C are displayed as lines that can be visually recognized on the test strip carrier 2; however, they are not always displayed. Details will be explained later, when the subject 50 is unfolded (see reference). Figure 4 Before this stage, the colors of the first examination area A1, the second examination area A2, and the control area C are approximately the same as the color of the test strip carrier 2 (e.g., white). Therefore, at this stage, the first examination area A1, the second examination area A2, and the control area C cannot be clearly visually identified. The colorimetric concentration of the first examination area A1 increases when the test subject 50 is unfolded and the unfolded test subject 50 is positive for the first test substance 41, thus appearing as a line. Similarly, in the second examination area A2, the colorimetric concentration increases when the test subject 50 is unfolded and the unfolded test subject 50 is positive for the second test substance 42, thus appearing as a line.

[0055] Similarly, within control area C, if the sample 50 is expanded, the colorimetric concentration increases, thus appearing as a line. This allows for visual identification of control area C.

[0056] As the test strip carrier 2, a porous material such as a nitrocellulose membrane can be used, for example. Furthermore, in the substrate 7 that holds the test strip carrier 2, the surface on which the test strip carrier 2 is attached is the adhesive surface.

[0057] like Figure 4 As shown, a labeling substance 53 is fixed on the label holding pad 3. The labeling substance 53 is modified by a label binding substance 52 that specifically binds to the first test substance 41 and the second test substance 42 contained in the test subject 50. The label holding pad 3 is fixed on the test strip carrier 2 to the dispensing port 26 of the cap component 21 (see reference). Figure 2 The test subject 50 is dispensed from the dispensing port 26 onto the label holding pad 3. Therefore, the label holding pad 3 corresponds to the spot application area for the test subject 50.

[0058] The label holding pad 3 is fixed to one end of the test strip carrier 2 along its length via double-sided adhesive tape 4. As the labeling material 53, for example, gold colloidal particles (EM.GC50, manufactured by BBI Corporation) with a diameter of 50 nm can be used. Furthermore, the labeling material 53 is not limited to gold colloids; metal sulfides used in conventional chromatography, coloring particles used in immunoagglutination reactions, etc., can be used, with metal colloids being particularly preferred. Examples of metal colloids include gold colloids, silver colloids, platinum colloids, iron colloids, aluminum hydroxide colloids, and composite colloids thereof. In particular, within a suitable particle size, gold colloids are preferred for displaying red, silver colloids are preferred for displaying yellow, and gold colloids are most preferred.

[0059] like Figure 4As shown, the first inspection area A1 contains a first binding substance 56 that specifically binds to the first test substance 41, and captures the first test substance 41. In the first inspection area A1, if the first test substance 41 is captured by binding to it with the first binding substance 56, a labeling binding substance 52 and a labeling substance 53 bound to the first test substance 41 are also captured. When the test subject 50 contains the first test substance 41, by capturing the first test substance 41 and the labeling substance 53 in the first inspection area A1, the colorimetric concentration of the inspection area A1 rises above a predetermined reference. Thus, the first inspection area A1 is used to confirm the presence or absence of the first test substance 41 by the labeling signal from the labeling substance 53 captured by the first test substance 41. Similarly, the second inspection area A2 contains a second binding substance 57 that specifically binds to the second test substance 42, and captures the second test substance 42. In the second inspection area A2, if the second test substance 42 is captured by binding with the second binder 57, then the labeling binder 52 and the labeling substance 53 bound to the second test substance 42 are also captured. If the test subject 50 contains the second test substance 42, by capturing the second test substance 42 and the labeling substance 53 in the second inspection area A2, the colorimetric concentration of the second inspection area A2 rises above a predetermined reference. Thus, the second inspection area A2 is used to confirm the presence or absence of the second test substance 42 by the labeling signal from the labeling substance 53 captured via the second test substance 42.

[0060] Control area C contains confirmatory binder 58 that specifically binds to the labeling binder 52, and the labeling substance 53 is captured via the labeling binder 52. When the test subject 50 is applied to the label holding pad 3, the labeling substances 53 modified by the labeling binder 52 that do not bind to either the first test substance 41 or the second test substance 42 unfold together with the test subject 50 within the test strip carrier 2. The labeling substances 53 that do not bind to either the first test substance 41 or the second test substance 42 are not captured by either the first examination area A1 or the second examination area A2, but pass through the first examination area A1 and the second examination area A2. The labeling substances 53 that have passed through the first examination area A1 and the second examination area A2 bind to the confirmatory binder 58 via the labeling binder 52 and are captured in control area C via the labeling binder 52. Because the labeled substance 53 is captured in control region C, the colorimetric concentration in control region C rises above a preset reference level. Control region C is the area used to confirm the completion of the development of the subject 50 in the first examination region A1 and the second examination region A2 by means of the labeling signal from the labeled substance 53 captured by the labeling binding substance 52. Therefore, control region C is sometimes also referred to as the confirmation region.

[0061] (Combined substances) The labeling substance 53, and the labeling binding substance 52 that specifically binds to the first test substance 41 and the second test substance 42, refers to, for example, an antibody against the antigen when the test substance is an antigen, an antigen against the antibody when the test substance is an antibody, an aptamer against the protein or low molecular weight compound when the test substance is a protein or low molecular weight compound, etc., and is a substance that specifically binds to the test substance.

[0062] The first binding substance 56, which is fixed in the first inspection area A1 and specifically binds to the first test substance 41, refers to, for example, an antibody against the antigen when the first test substance 41 is an antigen, an antigen against the antibody when the test substance is an antibody, an aptamer against the protein or low molecular weight compound when the test substance is a protein or low molecular weight compound, etc., and is a substance that specifically binds to the test substance.

[0063] The second binding substance 57, which is fixed in the second inspection area A2 and specifically binds to the second test substance 42, refers to, for example, an antibody against the antigen when the second test substance 42 is an antigen, an antigen against the antibody when the test substance is an antibody, or an aptamer against the protein or low molecular weight compound when the test substance is a protein or low molecular weight compound, etc., and is a substance that specifically binds to the test substance.

[0064] The first binding substance 56 specifically binds to the first test substance 41, but not to the second test substance 42. Similarly, the second binding substance 57 specifically binds to the second test substance 42, but not to the first test substance 41. For example, if the first test substance 41 is influenza A virus and the second test substance 42 is influenza B virus, the first binding substance 56 is an antibody for influenza A virus that does not react with influenza B virus, and the second binding substance 57 is an antibody for influenza B virus that does not react with influenza A virus, etc.

[0065] The confirmatory binding substance 58 that specifically binds to the labeling binding substance 52 can be the first test substance 41 and the second test substance 42 themselves, or it can be a compound having the site to be identified by the labeling binding substance 52. For example, compounds that bind to proteins can be given as derivatives of the first test substance 41 or the second test substance 42.

[0066] (Absorbent pad) The absorbent pad 6 absorbs the sample 50 that has spread out in the test strip carrier 2. The absorbent pad 6 is located at the other end of the test strip carrier 2, which is downstream of the spreading direction of the sample applied to the marker holding pad 3 located at one end of the test strip carrier 2. The absorbent pad 6 absorbs the sample 50 that has passed through the first inspection area A1 or the second inspection area A2.

[0067] The absorbent pad 6 is formed of a porous material and absorbs the test subject 50 from the test strip carrier 2 through capillary force. By absorbing the test subject 50 at the end of the test strip carrier 2, the retention of the test subject 50 in the test strip carrier 2 can be prevented, allowing the test subject 50 to flow smoothly toward the absorbent pad 6.

[0068] <Immunochromatography> refer to Figure 4 The immunochromatographic method will be explained. Specifically, the explanation will be based on the premise that the test sample 50 contains both the first test substance 41 and the second test substance 42, that is, the test sample 50 is positive for both the first test substance 41 and the second test substance 42.

[0069] First, the test sample 50 is applied to the dot application area, i.e., the label holding pad 3 (step S1). The first test substance 41 and the second test substance 42 of the test sample 50 applied to the label holding pad 3 specifically bind to the label binding substance 52 of the labeling substance 53 contained in the label holding pad 3. The test sample 50 spreads from the label holding pad 3 toward the examination area A within the test strip carrier 2 through capillary action in the test strip carrier 2 (step S2).

[0070] The first test substance 41 in the sample 50 that arrives at the first inspection area A1 is captured by the first binding substance 56 in the first inspection area A1. That is, the first test substance 41 and the marker substance 53 bound by the marker binding substance 52 are captured in the first inspection area A1. Similarly, the second test substance 42 in the sample 50 that arrives at the second inspection area A2 is captured by the second binding substance 57 in the second inspection area A2. That is, the second test substance 42 and the marker substance 53 bound by the marker binding substance 52 are captured in the second inspection area A2. On the other hand, the marker substance 53 that is not bound to the first test substance 41 and the second test substance 42 is not captured and passes through the first inspection area A1 and the second inspection area A2, and is captured by the confirmation binding substance 58 in the control area C. As a result, the concentrations in the first inspection area A1, the second inspection area A2, and the control area C increase, and the lines in the first inspection area A1, the second inspection area A2, and the control area C become visible, thus becoming a definite state (process S3).

[0071] The immunochromatographic examination steps using the kit 100 in this example are as described above. According to the kit 100, as in the first examination area A1 and the second examination area A2, it has multiple examination areas of different types that capture different test substances, thus enabling simultaneous determination of positive or negative results for multiple test substances.

[0072] As described above, in the first test area A1 and the second test area A2 of the test strip 1 included in the kit 100, the lengths L1 and L2 in the width direction of the test strip carrier 2 are shorter than the entire width W of each test strip carrier 2. Furthermore, the first test area A1 and the second test area A2 are arranged in a staggered position in the width direction. Compared with conventional techniques where each length L1 and L2 is the same as the entire width W, by setting the lengths L1 and L2 in the width direction of the first test area A1 and the second test area A2 to be shorter than the entire width W of the test strip carrier 2, it is possible to suppress the increase in the amount of binding material used to form the first test area A1 and the second test area A2. Therefore, compared with the conventional method, even when the number of test items is increased, it is possible to suppress the increase in cost.

[0073] Furthermore, when the test area is formed as a line extending along the width direction, narrowing the line width can be a method to suppress the amount of binding substance. However, if the line width of the test area is too narrow, the recognizableness is significantly reduced, and the test accuracy may decrease. In contrast, in the kit 100 of this example, the length of the test area in the width direction of the test strip 1 is shortened instead of narrowing the line width, thus resulting in less reduction in detection accuracy.

[0074] Furthermore, the first inspection area A1 and the second inspection area A2 are staggered in the width direction, thus providing better identification compared to when they are aligned. This is because, for example, if multiple types of inspection areas A1 and A2 are close to each other or at least partially overlap along the length of the test strip 1, it would be difficult to identify each inspection area A1 and A2 if they were aligned in the width direction. In contrast, as long as the first inspection area A1 and the second inspection area A2 are staggered in the width direction, identification is much easier.

[0075] In this example, the width length L1 of the test strip 1 in the first test area A1 is the same as the width length L2 of the test strip 1 in the second test area A2, but they may not necessarily be the same. However, if one length is shorter than the other, the visibility of the positive or negative result for a test area is reduced. Therefore, it is preferable to set the width length of the test strip 1 in multiple test areas to be the same.

[0076] Furthermore, the first test area A1 and the second test area A2 are arranged along the width of the test strip carrier 2. This provides the following advantages: In conventional test kits, multiple types of test areas with the same length as the width of the test strip carrier are arranged offset along the length of the test strip carrier. When multiple types of test areas are arranged offset along the length of the test strip carrier, they are spaced at least 2 mm apart to avoid confusion in the test results. Therefore, compared to the case where there is only one test area, having multiple types of test areas results in a longer unfolding area of ​​the sample, leading to a longer liquid delivery time and consequently, a longer test time.

[0077] In contrast, in the test strip 1 of this embodiment, the first test area A1 and the second test area A2 are arranged in the width direction of the test strip 1. Therefore, the positions of the test strip 1 in the length direction of the first test area A1 and the second test area A2 are approximately the same. Since the test subject 50 is often unfolded along the length direction of the test strip 1, the unfolding time of the test subject 50 to each test area A1, A2 is approximately the same. Thus, even if there are multiple types of test items, the test can be performed in approximately the same time as if there were only one type of test item.

[0078] Furthermore, in the test strip 1 of this embodiment, the center positions of each of the first test area A1 and the second test area A2 are consistent along the length of the test strip 1, and their widths are the same. Therefore, the unfolding time of the subject 50 until it unfolds in the first test area A1 and the second test area A2 is approximately the same, so even when performing multiple types of tests, the test can be performed in the same amount of time as in the case of a single test item. Moreover, since the width and position of the different test areas are common, manufacturing is easy.

[0079] refer to Figure 5 This shows a variation of the configuration of the inspection area. Figure 5 A~ Figure 5 G is a schematic diagram showing the arrangement of the test areas A1 to A3 on the test strip carrier 2 of the test strip 1. Figure 5 The figures shown are enlarged representations. Figure 3 The diagram shows a partial area 5 of the test strip carrier 2 surrounded by double-dotted lines in the top view of the test strip 1. Figure 5 A represents the reference. Figures 2-4 The configuration of inspection areas A1 and A2 in the above-described embodiments is as follows: Figure 5B~ Figure 5 G represents a variant of the configuration of the inspection area.

[0080] In the test strip 1 mentioned above, such as Figure 5 As shown in Figure A, the test strip carrier 2 has two testing areas A1 and A2, but for example, as Figure 5 As shown in Figure B, the test strip 1 for testing according to the present invention may have three or more testing areas A1 to A3. Furthermore, the test strip 1 may also have four or more testing areas.

[0081] When there are three or more different types of test areas, the increase in the amount of binding material used to form the test areas can be suppressed by setting the length of each type of test area to be shorter than the entire width of the test strip, in the same manner as when there are two test areas. Therefore, even when adding test items, the cost can be reduced compared to the past. Furthermore, the different types of test areas are arranged in a staggered manner along the width direction, resulting in better recognition compared to the case where the positions are aligned along the width direction.

[0082] exist Figure 5 In the example shown in A, the first inspection area A1 and the second inspection area A2 are arranged such that their centers are aligned along the length of the test strip carrier 2. In this invention, in the "arrangement in the width direction," besides... Figure 5 In addition to the structure of A, it also includes, for example Figure 5 Like C, the inspection areas A1 and A2 are maintained in a state of at least partial overlap, and their center positions in the length direction are staggered.

[0083] Furthermore, at this time, along the length of the test strip 1, it is not limited to the case that the widths of each test area A1 and A2 are the same. Figure 5 Multiple inspection areas A1, A2 or D of D Figure 5 The widths of the multiple inspection areas A1 to A3 of E can also be different.

[0084] Multiple types of test areas A1 and A2, or A1 to A3, are arranged on a single test strip 1 along its width. Therefore, even if their centers are offset, as long as they partially overlap, the time it takes for the sample 50 to unfold into each test area A1 and A2, or A1 to A3, is approximately the same. Thus, even if there are multiple types of tests, the testing can be performed in approximately the same time as if there were only one type of test.

[0085] And, as Figure 5As shown in C, when adjacent different types of test areas in the width direction of the test strip 1 are partially staggered in the length direction of the test strip 1, the identification of adjacent test areas is sometimes good.

[0086] like Figure 5 F and Figure 5 As shown in G, the various types of inspection areas A1 and A2 can be further configured in a way that they do not overlap in the length direction of the test strip 1. The positions of the various types of inspection areas A1 and A2 are far apart in the length direction, which correspondingly improves their recognizability.

[0087] Furthermore, when multiple types of test areas A1 and A2 are arranged in a non-overlapping manner along the length of the test strip 1, it is preferable that the distance K between the ends of the multiple types of test areas A1 and A2 is less than 2 mm. Conventionally, when multiple test areas are formed as a line along the entire width of the test strip 1 along its length, they are arranged with a distance of 2 mm or more between them to avoid interference between adjacent test areas. As long as the distance K between the ends of the multiple types of test areas A1 and A2 is less than 2 mm, the testing time can be shortened compared to the conventional case where adjacent test areas are arranged with a distance of 2 mm or more.

[0088] exist Figure 5 A~ Figure 5 In G, the multiple test areas A1 to A3 contained in a test strip 1 are configured so that they do not overlap in the width direction of the test strip 1, but as... Figure 5 As with G, multiple inspection areas A1 and A2 can also be configured to partially overlap in the width direction of the test strip 1. In this case, the multiple inspection areas A1 and A2 have portions that do not overlap in the width direction of each other, thus improving the recognizability.

[0089] The aforementioned kit 100 is configured to determine whether the test subject 50 is positive or negative by applying the test subject 50. The kit of the present invention is not limited to this configuration; it can also be configured to hold a developing solution for promoting the development of the test subject 50, and to develop the developing solution after applying the test subject 50. Furthermore, the kit of the present invention can also be configured to hold an amplification solution for amplifying the label signals of the test and control regions, and to deliver the amplification solution after applying the test subject 50.

[0090] The test strip 1 described above has a test strip carrier 2, a label holding pad 3, and an absorption pad 6. However, depending on the kit, it may also have a delivery pad for delivering reagents such as developing solution or amplification solution.

[0091] <Manufacturing Method of Test Strips> like Figures 6-8 As shown, the manufacturing method of the test strip 1 includes: a coating step for forming various types of test areas A1 and A2 on a sheet-like carrier 12 having an area containing multiple test strips 1; and a cutting step for cutting the sheet-like carrier 12. The coating step involves coating the sheet-like carrier 12 with various types of coating liquids each containing various types of binding substances, and in the sheet-like carrier 12, the arrangement pattern P of the various types of test areas in one test strip 1 is periodically repeated while coating with the various types of coating liquids. The cutting step involves cutting the sheet-like carrier 12 along a direction orthogonal to the repeating direction of the arrangement pattern P of the various types of test areas.

[0092] The following is for reference. Figures 6-8 The specific manufacturing method of the test strip 1 for testing is explained.

[0093] like Figure 6 As shown, in manufacturing the test strip 1, firstly, as a sheet lamination process (S11), a sheet carrier 12 is attached to a sheet substrate 17 containing an area of ​​multiple test strips 1, and a sheet mark holding pad 13 and a sheet absorbent pad 16 are overlapped on the sheet carrier 12 to form a sheet laminate 11. The sheet carrier 12 has an area containing multiple test strip carriers 2. Similarly, the sheet mark holding pad 13 has an area containing multiple mark holding pads 3. The sheet mark holding pad 13 is attached to the sheet carrier 12 via sheet double-sided adhesive tape 14. A marking substance 53 modified by a marking bonding substance 52 (see reference) is pre-fixed in the sheet mark holding pad 13. Figure 4 ).

[0094] Next, as a control region formation step, a control region C is formed at a predetermined position on the absorbent pad 6 side of the sheet carrier 12 surface in the sheet-like laminate 11 (step S12). In the control region C, a confirmation binding agent 58 (see reference) is coated. Figure 4 It is formed by )

[0095] Next, the coating process described above, used to form various types of inspection areas (including inspection area A1 and inspection area A2), is performed. Figure 7 As shown, in this example, the coating process includes a first coating process (process S13) and a second coating process (process S14). A masking component 110 (see reference 110) is used in the coating process. Figure 7The masking member 110 includes a linear support member 111 and a plurality of mask portions 112 arranged in a comb-like pattern on the support member 111. In the mask portions 112, the width of the support member 111 in the longitudinal direction is equal to the width of the test strip carrier 2 of the first and second inspection areas A1 and A2 (see reference). Figure 3 The width of the masking member 110 is L (=L1=L2), and the width of the opening 113 between the masking parts 112 is also L. That is, the masking member 110 has a plurality of openings 113 arranged in a straight line along the repeating direction with a period of 1 cycle of the width W of a test strip carrier 2. The length of the repeating direction of each opening 113 is the length L of the first inspection area A1 and the second inspection area A2.

[0096] like Figure 7 As shown, in the first coating process, the mask portion 112 covers the area where the second inspection area A2 is formed, and the masking member 110 is placed on the sheet carrier 12 at the first position where the opening 113 is located at the area where the first inspection area A1 is formed, so that the masking member 110 contains the first binding material 56 (see reference). Figure 4 The coating head 115 of the first coating liquid is moved parallel to the length direction of the support member 111 (step S13). In this way, the first inspection area A1 is formed by applying the first coating liquid to the first portion a1 of the sheet carrier 12 exposed at the opening 113 of the masking member 110.

[0097] Next, the second coating process (process S14) is performed. For example... Figure 7 As shown, in the second coating process (process S14), the masking member 110 is offset by a length L in the longitudinal direction of the support member 111 on the sheet carrier 12, moving it from the first position to the second position where the opening 113 is located at the location forming the second inspection area A2. Thus, with the masking member 110 placed on the sheet carrier 12, the material containing the second binding substance 57 (see reference) is retained. Figure 4 The coating head 116 of the second coating liquid is moved parallel to the length direction of the support member 111. In this way, the second inspection area A2 is formed by applying the second coating liquid to the second portion a2 of the sheet carrier 12 exposed at the opening 113 of the masking member 110 where the first coating liquid is not applied.

[0098] As described above, coating is performed in a linear fashion along the repeating direction of the arrangement pattern P of the various types of inspection areas (including the first inspection area A1 and the second inspection area A2) in one inspection test strip 1, and the coating process is then completed (process S15). Thus, the following is obtained: Figure 3The arrangement pattern P of the first test area A1 and the second test area A2 in a test strip 1 shown is periodically repeated to form a linear sheet-like carrier 12 (reference). Figure 7 In this example, the repeating direction of the pattern P is consistent with the width direction of the sheet-like carrier 12, which corresponds to the width direction of the strip-like carrier 2.

[0099] Next, in Figure 8 In the cutting process shown (process S16), the cutting involves cutting a sheet-like laminate 11 that includes a sheet-like carrier 12 having a first inspection area A1 and a second inspection area A2. Figure 8 In the diagram, the areas to be cut (hereinafter referred to as cutting positions) are indicated by dashed lines. The first inspection area A1 and the second inspection area A2 are cut with the width of a test strip 1 containing an arrangement pattern P, one after another, to obtain multiple test strips 1. The cutting position is the boundary between the arrangement patterns P; in this example, it is the boundary between the first inspection area A1 and the second inspection area A2. The sheet-like laminate 11 is cut at cutting positions with a cycle equal to the width of a test strip-like carrier 2. After determining and cutting the first area, the sheet-like carrier 12 is offset by one cycle to become the next cutting position.

[0100] Complete the above steps to end use. Figures 1-4 The manufacturing process of the test strip 1 included in the test kit 100, which has been described, can produce the test strip 1 (process S17).

[0101] By using the masking member 110 to coat and form each inspection area A1 and A2, the formation area of ​​each inspection area A1 and A2 can be easily defined, and each inspection area A1 and A2 can be formed. In addition, the length in the width direction of the test strip carrier 2 of each inspection area A1 and A2 is shorter than the entire width of the test strip carrier 2.

[0102] In the above description, the case where two inspection areas A1 and A2 are formed by coating using a single masking member 110 and moving the masking member 110 has been explained. However, multiple masking members 110 can also be used to form coatings for each inspection area. In particular, when the coating length or coating width differs between various types of inspection areas, it is possible to efficiently form various types of inspection areas by using multiple masking members 110 with openings of sizes corresponding to each inspection area.

[0103] <Examples of variations in manufacturing methods> A variation of the above manufacturing method is used. Figures 9-15 Please provide an explanation. Additionally, in Figures 9-15 In the middle, to and Figures 1 to 8The same constituent elements shown are given the same symbols, and detailed descriptions are omitted.

[0104] like Figure 8 As shown, in the test strip 1 obtained by the above manufacturing method, a first inspection area A1 and a second inspection area A2 are arranged side-by-side in a straight line with the same length in the width direction of the test strip carrier 2. However, in reality, the areas coated with inspection areas A1 and A2 are not visible to the naked eye, so sometimes the cutting position is offset from the boundary between the first inspection area A1 and the second inspection area A2. Figure 9 As shown, if the cutting position is offset from the boundary between the first inspection area A1 and the second inspection area A2, for example, towards the first inspection area A1, then the cut is made midway through the first inspection area A1. Thus, when the cut is made at a position offset towards the first inspection area A1, as... Figure 9 As shown in the enlarged view, within the width direction of a test strip 1, there are first test areas A1 on both sides of the second test area A2. Thus, with first test areas A1 on both sides of the second test area A2, half of one side in the original width direction becomes the second test area A2. Therefore, even if only the first test area A1 is positive, it is possible to make a false positive judgment such as judging the second test area A2 as positive.

[0105] Here, the manufacturing method of the test strip 1 includes a marking step of setting a mark 18 indicating the position where a cut will be made in the cutting process on the sheet-like carrier 12, and preferably the sheet-like carrier 12 is cut based on the mark 18. Examples of marks 18 indicating the position where a cut will be made in the cutting process include... Figure 10 The notch is as shown in the diagram. The mark 18 is not limited to a notch; it can also be a symbol such as an arrow or a cross. Furthermore, here, "mark 18 is provided on the sheet-like carrier 12" means not only that it is provided on the sheet-like carrier 12 itself, but also that the mark 18 is provided on a component other than the sheet-like carrier 12 itself, in the same manner as when the mark 18 is provided on the sheet-like carrier 12 itself. In this example, the mark 18 is provided on the sheet-like substrate 17 to which the sheet-like carrier 12 is attached. The mark 18 is provided at a position related to the arrangement pattern P of the first inspection area A1 and the second inspection area A2, and at a position where a test strip 1 is cut in such a way that it includes one arrangement pattern P.

[0106] Markers 18 indicating the positions to be cut in the cutting process are set on the sheet carrier 12. The sheet carrier 12 is cut based on the marks 18, so that cutting can be performed with high precision at the cutting positions located at the boundary between the first inspection area A1 and the second inspection area A2 for cutting each test strip 1.

[0107] Marker 18 does not need to be set on every single cutting line; it only needs to be set at one point on the first cutting line to be cut. Marker 18 can be set on the starting position of the first cutting line among multiple cutting lines, such as... Figure 10 As shown, it can also be set at the starting point that indicates the start position of the cut. Figure 10 In the case where the width of the test strip 1 is 1 cycle, mark 18 is set at a position offset from the starting position of the cut by half a cycle.

[0108] The marking process is preferably performed before the coating process. In this case, mark 18 can be used as both the starting point for cutting and the starting point for coating. Figure 10 As shown, by determining the coating start position and the cutting start position simultaneously using the mark 18 as the starting point, the cutting position can be determined with high precision.

[0109] And, as Figure 11 As shown, in the coating process, it is preferable to provide a gap region 19, in which no one of the various types of coating liquid is coated, between adjacent arrangement patterns P in the repeating direction of the arrangement patterns P in the first inspection area A1 and the second inspection area A2. That is, as Figure 11 As shown, it is preferable that each cycle of the arrangement pattern P in the first inspection area A1 and the second inspection area A2 has a gap region 19. Moreover, in the cutting process, it is preferable to cut the sheet-like laminate 11 containing the sheet-like carrier 12 in the gap region 19.

[0110] Thus, as long as there is a gap region 19 in each cycle of the pattern P, misjudgment can be suppressed even when the cutting positions are misaligned. In the sheet carrier 12, one end of the second inspection region A2 is the gap region 19. Therefore, as... Figure 12As shown, even when the cutting position is offset from the gap region 19 towards the first inspection region A1, one end of the second inspection region A2 is adjacent to the gap region 19 in the width direction of the test strip carrier 2. Therefore, it contacts both sides of the second inspection region A2 without forming the first inspection region A1. Furthermore, since one end of the second inspection region A2 is adjacent to the gap region 19, even if the cutting position is offset within the first inspection region A1, it only slightly contacts the end of the test strip 1. Therefore, if only the first inspection region A1 is positive, it is possible to suppress false positives such as the second inspection region A2 being positive.

[0111] Furthermore, during the coating process, various types of coating liquids can be applied in a manner that staggers the positions of adjacent inspection areas between adjacent arrangement patterns P in a direction orthogonal to the repeating direction of the arrangement pattern P. For example, such as Figure 13 As shown, the first inspection area A1 and the second inspection area A2 are staggered along the length of the test strip 1 cut from the sheet-like laminate 11, thus offsetting the positions of adjacent inspection areas (wherein, the first inspection area A1 and the second inspection area A2) between adjacent arrangement patterns P. Figure 13 In the example shown, the repeating direction of the pattern P is the width direction of the test strip 1 cut from the sheet-like laminate 11, and the direction orthogonal to the repeating direction is the length direction of the test strip 1.

[0112] about Figure 13 The repeating pattern of the arrangement pattern P shown is obtained in the first coating step by offsetting the area coated with the first coating liquid from the area coated with the second coating liquid along the length direction of the test strip 1 cut from the sheet-like laminate 11. More specifically, after the first coating step (step S13), when moving to the second coating step (step S14), the masking member 110 is offset in the arrangement direction of the arrangement pattern and also offset along the length direction of the test strip 1. In this state, by applying the second coating liquid, the area offset along the length direction of the test strip 1 relative to the area coated with the coating liquid containing the first binding substance 56 in the first coating step can be coated with the coating liquid containing the second binding substance 57. Thus, a coating liquid containing the second binding substance 57 can be obtained. Figure 13 The pattern shown is a repeating pattern in which the arrangement pattern P, which is staggered along the length of the test strip carrier 2, is periodically repeated.

[0113] exist Figure 13In the sheet-like carrier 12 shown, adjacent inspection areas between the arrangement patterns P are staggered in a direction orthogonal to the repeating direction of the arrangement patterns P. Such repeating patterns of inspection areas... Figure 14 As shown, when the cutting position is offset from the boundary between the arrangement patterns P towards the first inspection area A1 of one arrangement pattern P, such as Figure 14 As shown in the enlarged view, the first inspection area A1 is formed at both ends of a test strip carrier 2 in the width direction. (See reference...) Figure 9 As explained, if the first inspection area A1 and the second inspection area A2 are aligned along the length of the test strip 1 and arranged side-by-side in a straight line, it is possible to confuse the results of the first inspection area A1 and the second inspection area A2, leading to a misjudgment. However, as Figure 14 As shown in the enlarged view, even though the first inspection area A1 is provided at both ends of the width direction on a test strip carrier 2, the first inspection area A1 and the second inspection area A2 are staggered in a direction orthogonal to the repeating direction of the arrangement pattern P. Therefore, the first inspection area A1 and the second inspection area A2 have high recognizability and can suppress the occurrence of false judgments.

[0114] Furthermore, the explanation focuses on the case where a single pattern has two inspection areas A1 and A2. However, when there are three or more inspection areas, it is sufficient that the areas formed at the ends of the test strip 1 in the width direction of the pattern are staggered in the length direction. This allows adjacent inspection areas of adjacent patterns to be staggered in the length direction. As long as adjacent inspection areas of adjacent patterns are staggered in the length direction, even if the cutting positions are misaligned, the boundaries between the patterns are clear, thus suppressing false judgments.

[0115] In the above-described method for manufacturing the test strip 1, a masking member 110 is used to define the coating area, thereby forming the first inspection area A1 and the second inspection area A2. However, the method for forming the inspection area is not limited to the coating method using the masking member 110. For example, various types of coating liquids can be applied by inkjet printing.

[0116] Figure 15 This diagram illustrates the first and second coating processes when using inkjet printing. Figures 6-8 In the manufacturing method of the test strip 1 described herein, the first coating step S13 and the second coating step S14 can be replaced with the first coating step S23 and the second coating step S24 using an inkjet method. The inkjet method is implemented using an inkjet coating apparatus.

[0117] like Figure 15As shown, in the first coating process S23, the first coating liquid is added to the first inspection area forming area to form the first inspection area A1. The first inspection area A1 is formed on a straight line parallel to the control area C at a period of one cycle corresponding to the arrangement pattern.

[0118] Subsequently, in the second coating process S24, the second coating liquid is dropped into the area between the first inspection areas A1 to form the second inspection area A2.

[0119] Thus, even when using inkjet printing, the test strip 1 for inspection can be manufactured in the same manner as when using the masking component 110. According to inkjet printing, the inspection area can be formed with high precision without the need for the masking component 110.

[0120] The entire contents of Japanese Patent Application No. 2021-120871, filed on July 21, 2021, are incorporated herein by reference.

[0121] All documents, patent applications and technical standards described herein are incorporated herein by reference to the same extent as those specifically and separately described herein.

Claims

1. A method for manufacturing a test strip, wherein, The test strips used for the examination are... As a testing area used to determine whether a sample is positive or negative, a test strip has multiple types of testing areas, each having immobilized with different types of binding substances that specifically bind to various types of test samples, and a test strip-shaped carrier comprising a test strip carrier that can perform various types of tests depending on the number of the different types of testing areas. When the direction orthogonal to the length direction of the test strip carrier is set as the width direction... In the various types of inspection areas, the length of the test strip carrier in the width direction is shorter than the entire width of the respective test strip carrier, and the various types of inspection areas are arranged to be staggered in the width direction. The method for manufacturing the test strip includes: In the coating process, to form the various types of test areas on a sheet carrier having an area comprising multiple test strip carriers, various types of coating liquids comprising the various types of binding substances are coated, and the various types of coating liquids are coated in the sheet carrier in a manner that the arrangement pattern of the various types of test areas in one test strip carrier is periodically repeated; and The cutting process involves cutting the sheet-like carrier along a direction orthogonal to the repeating direction of the arrangement pattern. In this manufacturing method, a shielding member is used, comprising a plurality of openings arranged in a straight line along the repeating direction with a period equal to the width of one of the test strip carriers, and the length of each opening in the repeating direction being equal to the length of the inspection area. The coating process includes: a first coating process in which the masking member is placed at a first position on the sheet-like carrier, and one of the various types of coating liquids, namely the first coating liquid, is applied to the first portion exposed from the opening; and a second coating process in which the masking member is moved from the first position to a second position by offsetting it in the repeating direction and within the range of the first cycle, at the second position being exposed from the opening, and another of the various types of coating liquids, namely the second coating liquid, is applied to the second portion that is not coated with the first coating liquid.

2. The method for manufacturing the test strip according to claim 1, wherein, In the coating process, the various types of coating liquid are applied in a manner in which multiple patterns are arranged in a straight line along the repeating direction.

3. The method for manufacturing the test strip according to claim 2, wherein, In the coating process, in the repeating direction, gap regions are provided between adjacent arrangement patterns where none of the various types of coating liquids are coated. In the cutting process, the sheet-like carrier is cut in the gap region.

4. The method for manufacturing the test strip according to claim 1, wherein, In the coating process, the various types of coating liquid are applied in such a way that the positions of adjacent inspection areas between adjacent arrangement patterns in the repeating direction are staggered in a direction orthogonal to the repeating direction.

5. The method for manufacturing the test strip according to claim 1, wherein, As the shielding component, a support member with a straight shape and a plurality of mask portions arranged in a comb-like shape relative to the support member are used, and the opening is formed by adjacent mask portions. By moving the coating head holding the coating liquid in a direction parallel to the length direction of the support member, the coating liquid is applied to the sheet-like carrier exposed at the opening.

6. A method for manufacturing a test strip according to any one of claims 1 to 5, comprising a marking step of setting a mark indicating the position where a cut is made in the cutting step on the sheet-like carrier. In the cutting process, the sheet-like carrier is cut based on the markings.

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