Method for manufacturing inspection strips

Abstract

Provided are: a test cartridge comprising a test strip which includes at least a strip-shaped carrier that has, as a test area for determining whether a sample is positive or negative, a plurality of types of test areas in which a plurality of types of binding substances that specifically bind to each of a plurality of different types of test substances are immobilized, and that enables tests on a plurality of types of test items according to the number of different types of test areas, wherein, when a direction orthogonal to the longitudinal direction of the strip-shaped carrier is the width direction, the plurality of types of test areas have respective lengths in the width direction of the strip-shaped carrier which are shorter than the overall width of the strip-shaped carrier, and the plurality of types of test areas are disposed such that the positions thereof in the width direction are displaced; and a method for manufacturing the test strip.

Description

Technical Field

[0001] The present disclosure relates to a method for manufacturing a test cartridge and a test strip.

Background Art

[0002] Japanese Patent Application Laid-Open No. 2010-261961 and Japanese Patent Application Laid-Open No. 2009-058507 describe an immunochromatography kit for performing a test to determine whether a specimen is positive or negative, that is, whether the specimen contains a target substance, using the immunochromatography method. This immunochromatography kit is called a test cartridge or the like. The test cartridge includes a test strip including a strip-shaped carrier having a test region on which a binding substance that specifically binds to a target substance is fixed. In the test region, for example, when the specimen developed in the test region contains the target substance, the color development state changes.

[0003] Among test cartridges, there is a test cartridge having a strip-shaped carrier of one test strip with a plurality of test regions corresponding to a plurality of types of test items such as influenza A and influenza B. When there are two types of test items, the strip-shaped carrier is provided with a first test region and a second test region on which different target substances corresponding to the test items are respectively fixed. According to such a test cartridge, since a plurality of types of test regions are provided on the strip-shaped carrier of one test strip, a plurality of types of tests with different test items can be performed on one specimen at a time.

[0004] The arrangement patterns of the multiple types of inspection areas described in Japanese Patent Publication No. 2010-261961 and Japanese Patent Publication No. 2009-058507 are as follows. First, when the direction perpendicular to the longitudinal direction of the strip-shaped carrier is defined as the width direction, each of the multiple types of inspection areas is in the shape of a line extending along the width direction of the strip-shaped carrier. The length of the multiple types of line-shaped inspection areas is formed over the entire width direction of the strip-shaped carrier; that is, the length of each inspection area is equivalent to the total width of the strip-shaped carrier. The multiple types of inspection areas, each having the same length as the width of the strip-shaped carrier, are arranged with their positions in the longitudinal direction of the strip-shaped carrier offset. [Overview of the Initiative] [Problems that the invention aims to solve]

[0005] Conventional inspection cartridges having multiple types of inspection area arrangement patterns, as described in Japanese Patent Publication No. 2010-261961 and Japanese Patent Publication No. 2009-058507, have received the following requests for improvement. First, the binding material used to fix the inspection areas is relatively expensive, and the cost increases significantly as the number of inspection areas on the strip-shaped carrier increases. Therefore, even when the number of inspection items is increased, there is a desire to reduce the cost increase associated with the increase in inspection items by suppressing the increase in the amount of binding material. Furthermore, there is a desire to ensure the identifiability of each inspection area even when the area of ​​the inspection area is made smaller than conventionally to suppress the increase in cost.

[0006] The present disclosure aims to provide a method for manufacturing an inspection cartridge and an inspection strip that can suppress cost increases compared to conventional methods, while ensuring the identifiability of multiple types of inspection areas even when multiple types of inspection areas are provided on the strip-shaped carrier of the inspection strip. [Means for solving the problem]

[0007] The test cartridge of this disclosure is a test cartridge used in immunochromatographic testing, The test strip comprises at least one strip-shaped carrier, each having multiple types of test areas, each immobilized with multiple types of binding substances that specifically bind to each of several different types of test substances, and capable of testing multiple types of test items depending on the number of different types of test areas. When the width direction is defined as the direction perpendicular to the longitudinal direction of the strip-shaped carrier, In the various types of inspection areas, the length in the width direction of the strip-shaped carrier is shorter than the total width of the strip-shaped carrier. Multiple types of inspection areas are arranged with their positions offset in the width direction.

[0008] In the inspection cartridge of this disclosure, it is preferable that multiple types of inspection areas are arranged side by side in the width direction of the strip-shaped carrier.

[0009] In the inspection cartridge of this disclosure, each of the multiple types of inspection areas may have the same center position in the longitudinal direction of the strip-shaped carrier and the same width.

[0010] In the inspection cartridge of this disclosure, different types of inspection areas adjacent to each other in the width direction of the strip-shaped carrier may be partially offset in the longitudinal direction of the strip-shaped carrier.

[0011] In the inspection cartridge of this disclosure, multiple types of inspection areas may be arranged in a manner that they do not overlap in the longitudinal direction of the strip-shaped carrier.

[0012] In the inspection cartridge of this disclosure, it is preferable that the distance between the ends of multiple types of inspection areas in the longitudinal direction of the strip-shaped carrier is less than 2 mm.

[0013] A method for manufacturing an inspection strip for an inspection cartridge of the present disclosure is a coating step of applying multiple types of coating solutions, each containing multiple types of binding substances, to a sheet-like carrier having an area including multiple strip-shaped carriers, in order to form multiple types of inspection areas, wherein the coating step of applying multiple types of coating solutions to the sheet-like carrier is such that the arrangement pattern of multiple types of inspection areas on one strip-shaped carrier is periodically repeated. The process includes a cutting step of cutting a sheet-like carrier along a direction perpendicular to the repeating direction of the array pattern.

[0014] In the method for manufacturing inspection strips according to the present disclosure, it is preferable to apply multiple types of coating liquids in the coating step such that multiple arrangement patterns are linearly aligned along the repeating direction.

[0015] In the method for manufacturing inspection strips according to the present disclosure, in the coating step, gap regions may be provided between adjacent arrangement patterns in the repeating direction, where none of the multiple types of coating liquids are applied, and in the cutting step, the sheet-like carrier may be cut in the gap regions.

[0016] In the method for manufacturing inspection strips according to the present disclosure, multiple types of coating solutions may be applied in the coating step such that the positions of adjacent inspection areas between adjacent array patterns in the repeating direction are shifted in a direction perpendicular to the repeating direction.

[0017] The present disclosure provides a method for manufacturing an inspection strip, using a masking member having a plurality of openings arranged linearly along a repeating direction with a period of one cycle equal to the width of one strip-shaped carrier, wherein the length of each opening in the repeating direction is the length of the inspection area. The coating process may include a first coating step of placing a masking member at a first position on a sheet-like carrier and applying a first coating liquid, which is one of a plurality of types of coating liquids, to a first portion exposed from the opening, and a second coating step of moving the masking member from the first position to a second position by shifting it within a range of one cycle in the repeating direction and applying a second coating liquid, which is another one of the plurality of types of coating liquids, to a second portion exposed from the opening at the second position and not coated with the first coating liquid.

[0018] In the method for manufacturing the test strip of the present disclosure, the plurality of types of coating liquids may be applied by an inkjet method.

[0019] The method for manufacturing the test strip of the present disclosure may include a marking step of providing a mark indicating a cutting position in the cutting step on the sheet-like carrier, and in the cutting step, cutting the sheet-like carrier based on the mark.

Advantages of the Invention

[0020] According to the method for manufacturing the test cartridge and the test strip of the present disclosure, even when a plurality of types of test regions are provided on the strip-like carrier of the test strip, it is possible to suppress an increase in cost compared to the conventional method while ensuring the distinguishability of the plurality of types of test regions.

Brief Description of the Drawings

[0021] [Figure 1] It is a perspective view of a test cartridge according to the present disclosure. [Figure 2] It is an exploded perspective view of a test cartridge according to the present disclosure. [Figure 3] It is a plan view (a) and a side view (b) showing the configuration of a test strip. [Figure 4] It is an explanatory diagram of an immunochromatography method. [Figure 5] It is a diagram for explaining a modification of the arrangement of test regions. [Figure 6] It is an explanatory diagram 1 of a method for manufacturing a test strip. [Figure 7]It is explanatory drawing 2 of the manufacturing method of the test strip. [Figure 8] It is explanatory drawing 3 of the manufacturing method of the test strip. [Figure 9] It is an explanatory drawing in the case where the cutting position is deviated in the manufacturing method of the test strip. [Figure 10] It is an explanatory drawing of a modification example of the manufacturing method of the test strip. [Figure 11] It is an explanatory drawing of a modification example of the manufacturing method of the test strip. [Figure 12] It is an explanatory drawing in the case where the cutting position is deviated when the manufacturing method of FIG. 11 is used. [Figure 13] It is an explanatory drawing of a modification example of the manufacturing method of the test strip. [Figure 14] It is an explanatory drawing in the case where the cutting position is deviated when the manufacturing method of FIG. 13 is used. [Figure 15] It is an explanatory drawing of the manufacturing method of the test strip using the inkjet method.

Embodiments for Carrying Out the Invention

[0022] Hereinafter, the test cartridge according to the embodiment of the present disclosure will be described with reference to the drawings. Components shown with the same reference numerals in each drawing mean the same components. However, unless otherwise specified in the specification, each component is not limited to one, and a plurality of them may exist.

[0023] In addition, descriptions of overlapping configurations and reference numerals in each drawing may be omitted. Note that the present disclosure is not limited to the following embodiments, and appropriate changes such as omitting configurations or replacing them with different configurations can be made and implemented within the scope of the object of the present disclosure.

[0024] The directions indicated by the arrows X and Y appropriately shown in each figure are directions along the horizontal plane and are orthogonal to each other. The direction indicated by the arrow Z is a direction along the vertical direction (up and down direction). In each figure, the directions indicated by the arrows X, Y, and Z are assumed to be the same as each other.

[0025] <Overview of the Inspection Cartridge> Figure 1 is an external view of an inspection cartridge 100 (hereinafter referred to as cartridge 100) according to one embodiment, and Figure 2 is an exploded perspective view of cartridge 100. Figure 3 is a plan view (a) and a side view (b) of an inspection strip provided inside cartridge 100. Figure 4 is an explanatory diagram of the immunochromatography method.

[0026] Cartridge 100 is a single-use type, with one cartridge used for each sample to be tested. Inside cartridge 100, as shown in Figure 2, is a test strip 1 containing a strip-shaped immunochromatographic carrier 2 (hereinafter referred to as strip-shaped carrier 2). The strip-shaped 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, each immobilized with multiple types of binding substances that specifically bind to multiple different types of test substances. The strip-shaped carrier 2 has different types of first test areas A1 and second test areas A2, and it is possible to test multiple types of test items depending on the number of test areas (two in this example) of the two test areas, the first test area A1 and the second test area A2.

[0027] For example, the first test area A1 changes color when the sample 50 (see Figure 4) contains the first test substance 41 (see Figure 4), that is, when the sample 50 is positive for the first test substance 41. Similarly, the second test area A2 changes color when the sample contains the second test substance 42 (see Figure 4), that is, when the sample 50 is positive for the second test substance 42. The first test substance 41 and the second test substance 42 are different types of test substances, and this cartridge 100 is a cartridge that simultaneously determines whether the sample 50 is positive or negative for each of these two different test substances, the first test substance 41 and the second test substance 42. For example, if the first test substance 41 is the antigen for influenza A and the second test substance 42 is the antigen for influenza B, then the presence or absence of influenza A and B can be tested simultaneously.

[0028] Furthermore, "change in color development state" includes any of the following: a change from a first color different from the color of the strip-shaped carrier 2 to a different second color (i.e., discoloration); a change in the color of the strip-shaped carrier 2 due to the development of a different color from the strip-shaped carrier 2 (i.e., color development); or a change in the density of the color (i.e., density change).

[0029] Sample 50 can be any sample that may contain the test substance, and the sample is not particularly limited. Sample 50 may be, for example, a biological sample, particularly bodily fluids such as blood, serum, plasma, cerebrospinal fluid, tears, sweat, urine, pus, nasal secretions, nasal swabs, pharyngeal swabs, nasal aspirates, or sputum from animals (especially humans), or excretions, organs, tissues, mucous membranes and skin or swabs containing them, or liquid samples containing plants and animals themselves or their dried forms. Examples of test substances include antigens, antibodies, proteins and low molecular weight compounds.

[0030] Cartridge 100 has a configuration that allows the user to visually confirm whether sample 50 is positive or negative. Such a cartridge 100 is also called an immunochromatographic testing device or an immunochromatographic testing kit.

[0031] As shown in Figures 1 and 2, the cartridge 100 includes, for example, a case 22 composed of a case body 20 and a cover member 21. The case 22 is made of, for example, a resin material. The case body 20 has an opening at the top and houses the inspection strip 1 inside. The cover member 21 covers the opening of the case body 20 by being attached to the opening. The case 22 has an overall elongated shape to match the elongated shape of the inspection strip 1.

[0032] In this example, the upper part of the case 22, which is formed by the cover member 21, is provided with a dropper port 26 and an observation window 28. These parts are integrally molded with the cover member 21 as an example. The dropper port 26 is an opening for dropping the sample 50 into the inside of the case 22.

[0033] 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 the control area C, described later, can also be observed in addition to the first inspection area A1 and the second inspection area A2. A transparent member is fitted into the observation window 28. The user can observe the color development state of the first inspection area A1, the second inspection area A2, and the control area C through the observation window 28.

[0034] <Inspection strips> The inspection strip 1 comprises a strip-shaped carrier 2, a label-holding pad 3, and an absorbent pad 6. The strip-shaped carrier 2 is fixed and supported on a base material 7 having an adhesive sheet on its surface. The label-holding pad 3 is positioned at one end of the carrier 2 in the longitudinal direction, and the absorbent pad 6 is provided at the other end of the strip-shaped carrier 2 in the longitudinal direction. The longitudinal direction of the strip-shaped carrier 2 refers to the longitudinal direction of the inspection strip 1 (direction Y in the figure). The direction perpendicular to the longitudinal direction of the strip-shaped carrier 2 (direction X in the figure) is called the width direction of the strip-shaped carrier 2. The width of the strip-shaped carrier 2 is synonymous with the width of the inspection strip 1.

[0035] The strip-shaped carrier 2 is a porous, insoluble carrier for spreading the sample 50, and comprises 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 provided on the strip-shaped carrier 2 and are positioned between the label holding pad 3 and the absorbent pad 6 in the longitudinal direction of the inspection 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.

[0036] As shown in Figure 3, the first inspection area A1 and the second inspection area A2 are positioned with a staggered position in the width direction of the strip-shaped carrier 2. As an example, in this example, the first inspection area A1 and the second inspection area A2 are positioned side by side in the width direction of the strip-shaped carrier 2. Furthermore, in this example, the first inspection area A1 and the second inspection area A2 have the same center position in the longitudinal direction of the strip-shaped carrier 2, and their widths are identical. Here, "identical" includes not only perfectly identical but also a range of ±10%.

[0037] In other words, the first inspection area A1 and the second inspection area A2 in this example form a single line extending in the width direction (X direction in the figure) of the strip-shaped carrier 2, and the first inspection area A1 and the second inspection area A2 are the regions obtained by dividing this line in the width direction.

[0038] Furthermore, the widthwise lengths L1 and L2 of the strip-shaped carrier 2 in the first inspection area A1 and the second inspection area A2 are both shorter than the total width W of the strip-shaped carrier 2. In this example, lengths L1 and L2 are the same, and each is half the total width W of the strip-shaped carrier 2, W / 2. That is, L1 = L2 = W / 2.

[0039] The control region C is a line-shaped region extending in the width direction of the strip-shaped carrier 2.

[0040] In Figure 3, the first test area A1, the second test area A2, and the control area C are shown as visible lines on the strip carrier 2, but they are not always visible. As will be explained in detail later, before the sample 50 (see Figure 4) is unfolded, the colors of the first test area A1, the second test area A2, and the control area C are almost the same as the color of the strip carrier 2 (e.g., white), so at this stage, the first test area A1, the second test area A2, and the control area C cannot be clearly seen. The first test area A1 appears as a line when the sample 50 is unfolded and the unfolded sample 50 is positive for the first test substance 41, as the color intensity increases. Similarly, the second test area A2 appears as a line when the sample 50 is unfolded and the unfolded sample 50 is positive for the second test substance 42, as the color intensity increases.

[0041] When sample 50 is unfolded, the color intensity of control region C increases, causing it to appear as a line. This makes control region C visible.

[0042] As the strip-shaped carrier 2, for example, a porous material such as a nitrocellulose membrane can be used. Furthermore, the substrate 7 to which the strip-shaped carrier 2 is fixed has an adhesive surface on the side to which the strip-shaped carrier 2 is attached.

[0043] As shown in Figure 4, a labeling substance 53 is fixed to the labeling pad 3. The labeling substance 53 is modified with a labeling binder 52 that specifically binds to the first test substance 41 and the second test substance 42 contained in the sample 50. This labeling pad 3 is fixed on the strip-shaped carrier 2 at a position opposite the dropper port 26 (see Figure 2) of the cover member 21. Therefore, the sample 50 is dropped onto the labeling pad 3 from the dropper port 26. Thus, the labeling pad 3 corresponds to the application area where the sample 50 is applied.

[0044] The label-holding pad 3 is fixed to one end of the strip-shaped carrier 2 in the longitudinal direction via double-sided tape 4. As the labeling substance 53, for example, gold colloid particles with a diameter of 50 nm (EM.GC50, manufactured by BBI) can be used. Note that the labeling substance 53 is not limited to gold colloid, but can also be metal sulfides that can be used in ordinary chromatography methods, colored particles used in immunoaggregation reactions, etc., and metal colloids are particularly preferred. Examples of metal colloids include gold colloid, silver colloid, platinum colloid, iron colloid, aluminum hydroxide colloid, and composite colloids thereof. Gold colloid is particularly preferred because, at an appropriate particle size, it exhibits a red color and silver colloid exhibits a yellow color, and among these, gold colloid is the most preferred.

[0045] As shown in Figure 4, the first test area A1 contains a first binding substance 56 that specifically binds to the first test substance 41, and captures the first test substance 41. When the first test substance 41 is captured in the first test area A1 by the binding of the first binding substance 56 to the first test substance 41, the labeling binding substance 52 and labeling substance 53 bound to the first test substance 41 are also captured. If the sample 50 contains the first test substance 41, the color intensity of the first test area A1 rises above a preset standard as the first test substance 41 and labeling substance 53 are captured in the first test area A1. Thus, the first test area A1 is a region for confirming the presence or absence of the first test substance 41 by the labeling signal from the labeling substance 53 captured via the first test substance 41. Similarly, the second test 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 testing area A2, when the second binding substance 57 binds to the second test substance 42 and captures the second test substance 42, the labeling binding substance 52 and labeling substance 53 bound to the second test substance 42 are also captured. If the sample 50 contains the second test substance 42, the capture of the second test substance 42 and labeling substance 53 in the second testing area A2 causes the color intensity of the second testing area A2 to rise above a predetermined standard. In this way, the second testing 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. It is a domain.

[0046] Control region C contains a confirmation binding substance 58 that specifically binds to the labeling binding substance 52, and captures the labeling substance 53 via the labeling binding substance 52. When the sample 50 is applied to the label-holding pad 3, the labeling substance 53 modified with the labeling binding substance 52 that is not bound to either the first test substance 41 or the second test substance 42 unfolds within the strip-shaped carrier 2 together with the sample 50. The labeling substance 53 that is not bound to either the first test substance 41 or the second test substance 42 passes through the first and second test regions A1 and A2 without being captured in either of them. After passing through the first and second test regions A1 and A2, the labeling substance 53 is captured in control region C via the labeling binding substance 52, as the labeling binding substance 52 binds to the confirmation binding substance 58. When the labeling substance 53 is captured in control region C, the color intensity in control region C rises to a preset standard or higher. Control area C is a region used to confirm that the sample 50 has completed its deployment to the first test area A1 and the second test area A2, based on the labeling signal from the labeling substance 53 captured via the labeling binding substance 52. For this reason, control area C is sometimes called the confirmation area.

[0047] (binding substance) The labeling conjugate 52, which modifies the labeling substance 53 and specifically binds to the first test substance 41 and the second test substance 42, is a substance that specifically binds to the test substance, such as an antibody against the antigen if the test substance is an antigen, an antigen against the antibody if the test substance is an antibody, or an aptamer for proteins and low molecular weight compounds if the test substance is a protein and low molecular weight compound.

[0048] The first binding substance 56, which is fixed in the first test area A1 and specifically binds to the first test substance 41, is a substance that specifically binds to the test substance, such as an antibody against the antigen if the first test substance is an antigen, an antigen against the antibody if the test substance is an antibody, or an aptamer against proteins and low molecular weight compounds if the test substance is a protein and low molecular weight compound.

[0049] The second binding substance 57, which is fixed in the second test area A2 and specifically binds to the second test substance 42, is, for example, an antibody against the antigen if the second test substance 42 is an antigen, an antigen against the antibody if the test substance is an antibody, or an aptamer against proteins and low molecular weight compounds if the test substance is a protein and low molecular weight compound, etc., and is a substance that specifically binds to the test substance.

[0050] The first binding substance 56 specifically binds to the first test substance 41, but does not specifically bind to the second test substance 42. Similarly, the second binding substance 57 specifically binds to the second test substance 42, but does not specifically bind 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, then 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, and so on.

[0051] The confirmation binding substance 58 that specifically binds to the labeling binding substance 52 may be the first test substance 41 and the second test substance 42 themselves, or it may be a compound that has a site recognized by the labeling binding substance 52. Examples include compounds obtained by binding a derivative of the first test substance 41 or the second test substance 42 to a protein.

[0052] (Absorbent pad) The absorbent pad 6 absorbs the sample 50 that is spread onto the strip-shaped carrier 2. The absorbent pad 6 is located at the other end of the strip-shaped carrier 2, downstream in the direction of spread of the sample that is dropped onto the label-holding pad 3, which is provided at one end of the strip-shaped carrier 2. The absorbent pad 6 absorbs the sample 50 that has passed through the first test area A1 or the second test area A2.

[0053] The absorbent pad 6 is made of a porous material and absorbs the sample 50 from within the strip-shaped carrier 2 by capillary action. By absorbing the sample 50 at the end of the strip-shaped carrier 2, the accumulation of the sample 50 within the strip-shaped carrier 2 is suppressed, and the sample 50 can flow smoothly toward the absorbent pad 6.

[0054] <Immunochromatography> The immunochromatographic method will be explained with reference to Figure 4. Here, the explanation assumes that sample 50 contains both the first test substance 41 and the second test substance 42, that is, that sample 50 is positive for both the first test substance 41 and the second test substance 42.

[0055] First, the sample 50 is spot-applied onto the label-holding pad 3, which is the spot-applied area (step S1). The first test substance 41 and the second test substance 42 in the sample 50 spot-applied onto the label-holding pad 3 specifically bind to the label-binding substance 52 that modifies the label substance 53 contained in the label-holding pad 3. The sample 50 is then unfolded within the strip-shaped carrier 2 by capillary action, moving from the label-holding pad 3 toward the test area A (step S2).

[0056] The first test substance 41 in the sample 50 that reaches the first test area A1 is captured by the first binding substance 56 in the first test area A1. That is, the labeled substance 53 that is bound to the first test substance 41 via the labeling binding substance 52 is captured in the first test area A1. Similarly, the second test substance 42 in the sample 50 that reaches the second test area A2 is captured by the second binding substance 57 in the second test area A2. That is, the labeled substance 53 that is bound to the second test substance 42 via the labeling binding substance 52 is captured in the second test area A2. On the other hand, the labeled substance 53 that is not bound to the first test substance 41 and the second test substance 42 passes through the first test area A1 and the second test area A2 without being captured and is captured by the confirmation binding substance 58 in the control area C. As a result, the concentrations in the first test area A1, the second test area A2, and the control area C increase, causing the lines in the first test area A1, the second test area A2, and the control area C2 to appear, making it possible to determine the result (step S3).

[0057] The immunochromatographic testing procedure using cartridge 100 in this example is as described above. Cartridge 100 has multiple different types of testing areas, such as the first testing area A1 and the second testing area A2, which capture different test substances, so it is possible to simultaneously determine positive or negative results for multiple test substances.

[0058] As previously described, the first inspection area A1 and the second inspection area A2 of the inspection strip 1 provided in the cartridge 100 have widthwise lengths L1 and L2 of the strip-shaped carrier 2, respectively, which are shorter than the total width W of the strip-shaped carrier 2. Furthermore, the first inspection area A1 and the second inspection area A2 are positioned offset from each other in the widthwise direction. By making the widthwise lengths L1 and L2 of the first inspection area A1 and the second inspection area A2 shorter than the total width W of the strip-shaped carrier 2, the increase in the amount of each binding substance required to form the first inspection area A1 and the second inspection area A2 can be suppressed compared to the conventional method where each length L1 and L2 is the same as the total width W. Therefore, even when the number of inspection items is increased, the increase in cost can be suppressed compared to the conventional method.

[0059] Furthermore, when the inspection area is formed in the shape of a line extending in the width direction, one method to suppress the amount of binding substance is to narrow the line width. However, if the line width of the inspection area is too narrow, there is a concern that the discriminability will be significantly reduced and the inspection accuracy will decrease. In contrast, in the cartridge 100 of this example, the line width of the inspection area is not narrowed, and the length of the inspection area in the width direction of the inspection strip 1 is shortened, so it is thought that the decrease in detection accuracy is minimal.

[0060] Furthermore, because the first inspection area A1 and the second inspection area A2 are positioned offset from each other in the width direction, their identifiability is better compared to when their positions coincide. For example, if multiple types of inspection areas A1 and A2 are close together or at least partially overlap in the longitudinal direction of the inspection strip 1, it becomes difficult to distinguish each inspection area A1 and A2 if their positions coincide in the width direction. In contrast, if the positions of the first inspection area A1 and the second inspection area A2 are offset in the width direction, they are easier to distinguish.

[0061] In this example, the widthwise length L1 of the test strip 1 in the first test area A1 and the widthwise length L2 of the test strip 1 in the second test area A2 are the same, but they do not necessarily have to be the same. However, if one length is shorter than the other, the visibility of the positive / negative determination for one test area will decrease, so it is preferable that the widthwise lengths of the test strip 1 in multiple test areas are approximately the same.

[0062] Furthermore, the first testing area A1 and the second testing area A2 are arranged side by side in the width direction of the strip-shaped carrier 2. This has the following effect. In other words, in conventional testing cartridges, multiple types of testing areas, each having the same length as the width of the strip-shaped carrier, are arranged with their positions offset in the longitudinal direction of the strip-shaped carrier. When multiple types of testing areas are arranged with their positions offset in the longitudinal direction of the strip-shaped carrier, they are spaced at least 2 mm apart in the longitudinal direction of the strip-shaped carrier so as not to interfere with each other, in order to prevent confusion of the test results of the test items. As a result, when there are multiple types of testing areas compared to when there is only one testing area, the area for sample development becomes longer, and consequently, the liquid delivery time increases, leading to a longer testing time.

[0063] In contrast, in the inspection strip 1 of this embodiment, the first inspection area A1 and the second inspection area A2 are arranged side by side in the width direction of the inspection strip 1. Therefore, the positions of the first inspection area A1 and the second inspection area A2 in the longitudinal direction of the inspection strip 1 are approximately the same. Since the sample 50 is often unfolded along the longitudinal direction of the inspection strip 1, the unfolding time of the sample 50 into each inspection area A1 and A2 is approximately the same. As a result, even if there are multiple types of test items, the test can be performed in approximately the same amount of time as when there is only one type of test item.

[0064] Furthermore, in the inspection strip 1 of this embodiment, the first inspection area A1 and the second inspection area A2 each have the same center position in the longitudinal direction of the inspection strip 1, and their widths are identical. Therefore, the unfolding time until the sample 50 unfolds into the first inspection area A1 and the second inspection area A2 is approximately the same, so even when inspecting multiple types of inspection items, the inspection can be performed in the same amount of time as when there is only one inspection item. In addition, since the width and position of the different inspection areas are the same, manufacturing is also easier.

[0065] <Variations in the arrangement of the inspection area> Refer to Figure 5 to see modified examples of the arrangement of the inspection areas. Figures 5A to 5G are schematic diagrams showing the arrangement of inspection areas A1 to A3 on the strip-shaped carrier 2 of the inspection strip 1. Each figure in Figure 5 is an enlarged view of a part of the strip-shaped carrier 2 enclosed by the dashed line in the plan view of the inspection strip 1 in Figure 3. Figure 5A shows the arrangement of inspection areas A1 and A2 in the above embodiment described with reference to Figures 2 to 4, and Figures 5B to 5G show modified examples of the arrangement of the inspection areas.

[0066] In the inspection strip 1 described above, as shown in Figure 5A, the strip-shaped carrier 2 has two inspection areas A1 and A2. However, for example, as shown in Figure 5B, the inspection strip 1 of this disclosure may have three or more inspection areas A1 to A3. Furthermore, the inspection strip 1 may have four or more inspection areas.

[0067] Even when there are three or more types of inspection areas, similar to the case with two inspection areas, the increase in the amount of binding material required to form the inspection areas can be suppressed by making the length of each of the multiple types of inspection areas shorter than the total width of the inspection strip. Therefore, even when the number of inspection items is increased, the increase in cost can be suppressed compared to conventional methods. In addition, since the multiple types of inspection areas are arranged with their positions offset in the width direction, their identifiability is better compared to when their positions in the width direction coincide.

[0068] In the example shown in Figure 5A, the first inspection area A1 and the second inspection area A2 are arranged in the longitudinal direction of the strip-shaped carrier 2 with their respective centers aligned. In this disclosure, "arranged side by side in the width direction" includes, in addition to the configuration in Figure 5A, a state in which at least a portion of each inspection area A1 and A2 overlaps while their longitudinal centers are offset, as shown in Figure 5C.

[0069] Furthermore, in this case, the widths of each inspection area A1 and A2 in the longitudinal direction of the inspection strip 1 may not be the same, but the widths of the multiple inspection areas A1 and A2 in Figure 5D or the multiple inspection areas A1 to A3 in Figure 5E may be different.

[0070] Since multiple types of test areas A1 and A2, or A1 to A3, are arranged side by side in the width direction of the test strip 1, even if the center positions are offset, as long as there is some overlap, the time it takes to unfold the sample 50 into each test area A1 and A2, or A1 to A3, will be approximately the same. As a result, even if there are multiple types of test items, the test can be performed in approximately the same amount of time as when there is only one type of test item.

[0071] Furthermore, as shown in Figure 5C, it may be better in terms of distinguishing adjacent inspection areas if different types of inspection areas adjacent in the width direction of the inspection strip 1 are slightly offset in the longitudinal direction of the inspection strip 1.

[0072] Furthermore, as shown in Figures 5F and 5G, multiple types of inspection areas A1 and A2 may be arranged in a manner that they do not overlap in the longitudinal direction of the inspection strip 1. The greater the distance between the positions of the multiple types of inspection areas A1 and A2 in the longitudinal direction, the improved identifiability.

[0073] Furthermore, when multiple types of inspection areas A1 and A2 are arranged in a manner that they do not overlap along the longitudinal direction of the inspection strip 1, it is preferable that the distance K between the ends of the multiple types of inspection areas A1 and A2 is less than 2 mm. Conventionally, when multiple inspection areas were formed in a line shape along the entire width of the inspection strip 1 along the longitudinal direction, adjacent inspection areas were arranged with a distance of 2 mm or more to prevent interference. If the distance K between the ends of the multiple types of inspection areas A1 and A2 is less than 2 mm, the inspection time can be shortened compared to the conventional case where adjacent inspection areas were arranged with a distance of 2 mm or more.

[0074] In Figures 5A to 5G, the multiple inspection areas A1 to A3 contained within a single inspection strip 1 are arranged so as not to overlap in the width direction of the inspection strip 1. However, as shown in Figure 5G, it is acceptable for the multiple inspection areas A1 and A2 to partially overlap in the width direction of the inspection strip 1. In this case as well, since the multiple inspection areas A1 and A2 have portions that do not overlap with each other in the width direction, an improvement in identifiability can be obtained.

[0075] The cartridge 100 described above is designed to determine whether the sample 50 is positive or negative by applying the sample 50 to it. The specifications of the cartridge in this disclosure are not limited to this, and it may also hold a developing solution to accelerate the development of the sample 50, and be configured to allow the developing solution to be released after the sample 50 has been applied. Furthermore, the cartridge in this disclosure may also hold an amplification solution to amplify the labeling signals of the test area and the control area, and be configured to allow the amplification solution to be delivered after the sample 50 has been applied.

[0076] The above-described test strip 1 comprises a strip-shaped carrier 2, a label-holding pad 3, and an absorption pad 6. Depending on the specifications of the cartridge, it may also be equipped with a liquid delivery pad for delivering reagents such as developing solution and amplification solution.

[0077] <Method for manufacturing inspection strips> The manufacturing method for the inspection strip 1 described above includes, as shown in Figures 6 to 8, a coating step for forming multiple types of inspection areas A1 and A2 on a sheet-like carrier 12 having an area that includes multiple inspection strips 1, and a cutting step for cutting the sheet-like carrier 12. The coating step is a step of applying multiple types of coating liquids, each containing multiple types of binding substances, to the sheet-like carrier 12, and is a step of applying multiple types of coating liquids to the sheet-like carrier 12 in such a manner that the arrangement pattern P of the multiple types of inspection areas on one inspection strip 1 is periodically repeated. The cutting step is a step of cutting the sheet-like carrier 12 along a direction perpendicular to the repeating direction of the arrangement pattern P of the multiple types of inspection areas.

[0078] The specific manufacturing method of inspection strip 1 will be explained below with reference to Figures 6 to 8.

[0079] When manufacturing the inspection strip 1, as shown in Figure 6, first, in a sheet lamination process (S11), a sheet carrier 12 is attached to a sheet-like substrate 17 having an area that includes multiple inspection strips 1, and a sheet-like label holding pad 13 and a sheet-like absorbent pad 16 are stacked on top of the sheet-like carrier 12 to create a sheet-like laminate 11. The sheet-like carrier 12 has an area that includes multiple strip-like carriers 2. Similarly, the sheet-like label holding pad 13 has an area that includes multiple label holding pads 3. The sheet-like label holding pad 13 is attached to the sheet-like carrier 12 via a sheet-like double-sided tape 14. The sheet-like label holding pad 13 has a labeling substance 53 (see Figure 4) modified with a labeling binder 52 fixed to it beforehand.

[0080] Next, as a control region formation step, a control region C is formed at a predetermined position on the absorption pad 6 side of the surface of the sheet-like carrier 12 in the sheet-like laminate 11 (step S12). The control region C is formed by applying a confirmation binding substance 58 (see Figure 4).

[0081] Next, a coating process is carried out to form the multiple types of inspection areas described above (in this case, the first inspection area A1 and the second inspection area A2). As shown in Figure 7, in this example, the coating process includes a first coating process (process S13) and a second coating process (process S14). A masking member 110 is used in the coating process (see Figure 7A). The masking member 110 comprises a linear support member 111 and a plurality of mask portions 112 arranged in a comb-like manner relative to the support member 111. The width of the mask portion 112 in the longitudinal direction of the support member 111 is the length L (=L1=L2) in the width direction of the strip-shaped carrier 2 (see Figure 3) of the first and second inspection areas A1 and A2, and the width of the opening 113 between the mask portions 112 is also L. That is, the masking member 110 has a plurality of openings 113 arranged linearly along the repeating direction with a period of one cycle equal to the width W of one strip-shaped carrier 2. The length of each opening 113 in the repeating direction is the length L of the first inspection area A1 and the second inspection area A2.

[0082] As shown in Figure 7, in the first coating step, the masking member 110 is placed on the sheet-like carrier 12 at a first position where the mask portion 112 covers the area to be formed in the second inspection area A2 and the opening 113 is located in the area to be formed in the first inspection area A1. The coating head 115, which holds the first coating liquid containing the first binding substance 56 (see Figure 4), is moved parallel to the longitudinal direction of the support member 111 (step S13). In this way, the first coating liquid is applied to the first portion a1 of the sheet-like carrier 12 that is exposed to the opening 113 of the masking member 110 by the coating head 115, thereby forming the first inspection area A1.

[0083] Next, the second coating process (process S14) is performed. As shown in Figure 7, in the second coating process (process S14), the masking member 110 is moved on the sheet-like carrier 12 by a length L in the longitudinal direction of the support member 111, from the first position to the second position where the opening 113 is located in the area that will form the second inspection area A2. With the masking member 110 placed on the sheet-like carrier 12 in this manner, the coating head 116 holding the second coating liquid containing the second binding substance 57 (see Figure 4) is moved parallel to the longitudinal direction of the support member 111. In this way, the coating head 116 applies the second coating liquid to the second portion a2 of the sheet-like carrier 12 that is exposed to the opening 113 of the masking member 110 and has not been coated with the first coating liquid, thereby forming the second inspection area A2.

[0084] As described above, the coating process is completed (step S15) by coating the strip 1 in such a manner that multiple array patterns P are arranged linearly along the repeating direction of the array patterns P of multiple types of inspection areas (in this case, the first inspection area A1 and the second inspection area A2). This results in a sheet-like carrier 12 formed in which the array patterns P of the first inspection area A1 and the second inspection area A2 on the strip 1 shown in Figure 3 are periodically repeated linearly (see Figure 7). In this example, the repeating direction of the array patterns P coincides with the width direction of the sheet-like carrier 12, which corresponds to the width direction of the strip-like carrier 2.

[0085] Next, in the cutting process (process S16) shown in Figure 8, the sheet-like laminate 11, which includes the sheet-like carrier 12 on which the first inspection area A1 and the second inspection area A2 are formed, is cut. In Figure 8, the locations to be cut (hereinafter referred to as cutting positions) are indicated by dashed lines. Multiple inspection strips 1 are obtained by cutting to the width of one inspection strip 1 containing one array pattern P that includes one first inspection area A1 and one second inspection area A2. The cutting positions are the boundaries between the array patterns P, and in this example, they are the boundaries between the first inspection area A1 and the second inspection area A2. The sheet-like laminate 11 is cut at cutting positions in a cycle where the width of one strip-like carrier 2 constitutes one cycle. After determining the first cutting position and cutting, the next cutting position is the position where the sheet-like carrier 12 is shifted by one cycle.

[0086] By following the above procedure, the manufacturing process for the inspection strip 1 provided in the inspection cartridge 100, as described in Figures 1 to 4, is completed, and the inspection strip 1 can be obtained (step S17).

[0087] Since the masking member 110 is used to coat and form each inspection area A1 and A2, the formation areas of each inspection area A1 and A2 can be easily defined and formed. Note that the length in the width direction of each inspection area A1 and A2 of the strip-shaped carrier 2 is shorter than the total width of the strip-shaped carrier 2.

[0088] In the above description, a case was explained in which two inspection areas A1 and A2 are coated by using a single masking member 110 and moving the masking member 110. However, multiple masking members 110 may be used to coat each inspection area. In particular, when the coating length or coating width differs between multiple types of inspection areas, multiple masking members 110 having openings of a size appropriate to each inspection area can be used to efficiently coat multiple types of inspection areas.

[0089] <Examples of manufacturing methods> Modified examples of the above manufacturing method will be explained using Figures 9 to 15. In Figures 9 to 15, components identical to those shown in Figures 1 to 8 are denoted by the same reference numerals, and detailed explanations are omitted.

[0090] As shown in Figure 8, the inspection strip 1 obtained by the manufacturing method described above has a first inspection area A1 and a second inspection area A2 of the same length arranged in parallel in the width direction of the strip-shaped carrier 2. However, since the areas to which inspection areas A1 and A2 are coated are not actually visible, the cutting position may be offset from the boundary between the first inspection area A1 and the second inspection area A2. As shown in Figure 9, 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 side, the strip will be cut in the middle of the first inspection area A1. In this case, as shown in the enlarged view in Figure 9, the inspection strip 1 will have the first inspection area A1 on both sides of the second inspection area A2 in the width direction. Thus, when the first test area A1 is provided on both sides of the second test area A2, there is a concern that misdiagnosis may occur, such as the second test area A2 being judged as positive even if only the first test area A1 is positive, because the second test area A2 is originally half of the width.

[0091] Therefore, the manufacturing method of the inspection strip 1 preferably includes a marking step of providing a mark 18 on the sheet-like carrier 12 to indicate the cutting position in the cutting step, and cutting the sheet-like carrier 12 based on the mark 18. An example of a mark 18 indicating the cutting position in the cutting step is a notch as shown in Figure 10. The mark 18 is not limited to a notch, but may also be a symbol such as an arrow or a cross mark. Here, "providing a mark 18 on the sheet-like carrier 12" includes not only providing it on the sheet-like carrier 12 itself, but also providing the mark 18 on a member of the sheet-like laminate 11 other than the sheet-like carrier 12 that will indicate the cutting location of the sheet-like carrier 12, similar to the case where the mark 18 is provided on the sheet-like carrier 12 itself. In this example, the mark 18 is provided on the sheet-like base material 17 to which the sheet-like carrier 12 is attached. Mark 18 is located at a position associated with the sequence patterns P in the first inspection area A1 and the second inspection area A2, where one inspection strip 1 is cut to include one sequence pattern P.

[0092] In the cutting process, marks 18 are provided on the sheet-like carrier 12 to indicate the cutting position, and the sheet-like carrier 12 is cut based on the marks 18. This makes it possible to cut each inspection strip 1 with high precision at a cutting position located at the boundary between the first inspection area A1 and the second inspection area A2, which are used for cutting.

[0093] Mark 18 does not need to be placed on each of the multiple cutting lines; it is sufficient to place it at one location indicating the first cutting line among the multiple cutting lines. Mark 18 may be placed at the cutting start position of the first cutting line among the multiple cutting lines, or it may be placed at the starting point indicating the cutting start position, as shown in Figure 10. In the case of Figure 10, Mark 18 is placed at a position shifted by half a cycle from the cutting start position, when the width of the inspection strip 1 is considered as one cycle.

[0094] The marking process is preferably performed before the coating process. In this case, the mark 18 can be used as the starting point for both the cutting start position and the coating start position. As shown in Figure 10, by determining the coating start position and the cutting start position using the mark 18 as the starting point, the cutting position can be determined with high precision.

[0095] Furthermore, as shown in Figure 11, in the coating process, it is preferable to provide gap regions 19 between adjacent arrangement patterns P in the repeating direction of the arrangement patterns P of the first inspection area A1 and the second inspection area A2, where none of the multiple types of coating liquids are applied. That is, as shown in Figure 11, it is preferable to provide a gap region 19 for each cycle of the arrangement pattern P of the first inspection area A1 and the second inspection area A2. Then, 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.

[0096] In this way, by providing a gap region 19 for each period of the sequence pattern P, the occurrence of misjudgments can be suppressed even if the cutting position is shifted. In the sheet-like carrier 12, one end of the second inspection region A2 is a gap region 19. Therefore, as shown in Figure 12, even if the cutting position is shifted 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 one strip-like carrier 2, so the first inspection region A1 is not formed adjacent to both sides of the second inspection region A2. Furthermore, since one end of the second inspection region A2 is adjacent to the gap region 19, even if the cutting position is shifted into the first inspection region A1, it only slightly overlaps the end of the inspection strip 1, thus suppressing the occurrence of misjudgments such as the second inspection region A2 being judged as positive when only the first inspection region A1 is positive.

[0097] Furthermore, in the coating process, multiple types of coating liquids may be applied in such a manner that the positions of adjacent inspection areas between adjacent array patterns P are shifted in a direction perpendicular to the repeating direction of the array pattern P. For example, as shown in Figure 13, the first inspection area A1 and the second inspection area A2 are positioned offset in the longitudinal direction of the inspection strip 1 cut from the sheet-like laminate 11, thereby causing the positions of adjacent inspection areas between adjacent array patterns P (in this case, the first inspection area A1 and the second inspection area A2) to be shifted. In the example shown in Figure 13, the repeating direction of the array pattern P is the width direction of the inspection strip 1 cut from the sheet-like laminate 11, and the direction perpendicular to the repeating direction is the longitudinal direction of the inspection strip 1.

[0098] The repeating pattern of the array pattern P shown in Figure 13 is obtained by shifting the areas to which the first coating solution is applied and the areas to which the second coating solution is applied in the longitudinal direction of the inspection strip 1 cut from the sheet-like laminate 11 during the first coating step. More specifically, when moving from the first coating step (step S13) to the second coating step (step S14), the masking member 110 is shifted in the direction of the array pattern and also shifted in the longitudinal direction of the inspection strip 1 before being placed on it. By applying the second coating solution in this state, the coating solution containing the second binding substance 57 can be applied to the area of ​​the inspection strip 1 that is shifted in the longitudinal direction, relative to the area to which the coating solution containing the first binding substance 56 was applied in the first coating step. As a result, the repeating pattern shown in Figure 13 is obtained, in which the array pattern P, in which the first inspection area A1 and the second inspection area A2 are shifted in the longitudinal direction of the strip-like carrier 2, is periodically repeated.

[0099] In the sheet-like carrier 12 shown in Figure 13, adjacent inspection areas between array patterns P are offset from each other in directions perpendicular to the repeating direction of the array patterns P. As shown in Figure 14, which has such a repeating pattern of inspection areas, if the cutting position is shifted from the boundary between array patterns P towards the first inspection area A1 of one of the array patterns P, then, as shown in the enlarged view in Figure 14, the first inspection area A1 will be provided at both ends in the width direction of one strip-like carrier 2. As explained with reference to Figure 9, if the first inspection area A1 and the second inspection area A2 are arranged in parallel in a straight line, coinciding with the longitudinal direction of the inspection strip 1, there is a concern that the results of the first inspection area A1 and the second inspection area A2 may be confused and misjudged. However, as shown in the enlarged view in Figure 14, even if the first inspection area A1 is provided at both ends in the width direction of a single strip-shaped carrier 2, the first inspection area A1 and the second inspection area A2 are offset from each other in a direction perpendicular to the repeating direction of the arrangement pattern P. This allows for high identifiability between the first inspection area A1 and the second inspection area A2, and suppresses the occurrence of misjudgments.

[0100] Here, we have described the case where one sequence pattern has two inspection areas A1 and A2. However, if there are three or more inspection areas, it is sufficient that the areas formed at the widthwise ends of the inspection strip 1 of the sequence pattern are offset in the longitudinal direction. This allows adjacent inspection areas of adjacent sequence patterns to be positioned offset in the longitudinal direction. If adjacent inspection areas of adjacent sequence patterns are positioned offset in the longitudinal direction, even if the cutting position is off, the boundaries between the sequence patterns will be clear, thus suppressing misjudgment.

[0101] In the manufacturing method of the inspection strip 1 described above, the first inspection area A1 and the second inspection area A2 are formed by coating the strip by defining the coating area using a masking member 110. However, the method for forming the inspection area is not limited to the coating method using the masking member 110. For example, multiple types of coating liquids may be applied by an inkjet method.

[0102] Figure 15 shows the first and second coating steps when using the inkjet method. In the manufacturing method of the inspection strip 1 described using Figures 6 to 8, the first coating step S13 and the second coating step S14 may be replaced with the first coating step S23 and the second coating step S24 using the inkjet method. The inkjet method is carried out using an inkjet coating apparatus.

[0103] As shown in Figure 15, in the first coating step S23, the first coating solution is dropped onto the first inspection area formation 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, with a period corresponding to one cycle of the arrangement pattern. Subsequently, in the second coating step S24, the second coating solution is dropped into the area between the first inspection areas A1 to form the second inspection area A2.

[0104] Thus, the inspection strip 1 can be manufactured using the inkjet method in the same way as when the masking member 110 is used. The inkjet method allows for the formation of an inspection area with high accuracy without the use of the masking member 110.

[0105] The disclosure of Japanese Patent Application No. 2021-120871, filed on 21 July 2021, is incorporated herein by reference in its entirety. All documents, patent applications, and technical standards described herein are incorporated by reference to the same extent as if each individual document, patent application, and technical standard were specifically and individually noted to be incorporated by reference.

Claims

1. A test strip comprising a strip-shaped carrier having multiple types of test areas, each having multiple types of binding substances immobilized on it, which specifically bind to each of multiple different types of test substances, and capable of testing multiple types of test items depending on the number of different types of test areas, for determining whether a sample is positive or negative, In a method for manufacturing an inspection strip, where the width direction is defined as the direction perpendicular to the longitudinal direction of the strip-shaped carrier, the length of each of the multiple types of inspection areas in the width direction of the strip-shaped carrier is shorter than the total width of the strip-shaped carrier, and the multiple types of inspection areas are arranged with their positions offset in the width direction, A coating step of applying multiple types of coating solutions, each containing the multiple types of binding substances, to a sheet-like carrier having an area including multiple strip-shaped carriers, in order to form the multiple types of inspection areas on the sheet-like carrier, wherein the coating step of applying the multiple types of coating solutions is such that the arrangement pattern of the multiple types of inspection areas on one strip-shaped carrier is periodically repeated on the sheet-like carrier, The process includes a cutting step of cutting the sheet-like carrier along a direction perpendicular to the repeating direction of the arrangement pattern, A masking member having a plurality of openings arranged linearly along the repeating direction in a period of which the width of one strip-shaped carrier constitutes one period, wherein the length of each opening in the repeating direction is the length of the inspection area, A method for manufacturing an inspection strip, comprising: a first coating step of placing the masking member on a first position on the sheet-like carrier and applying a first coating liquid, which is one of the plurality of types of coating liquids, to a first portion exposed from the opening; and a second coating step of moving the masking member from the first position to a second position by shifting it within the range of one cycle in the repeating direction, and applying a second coating liquid, which is another of the plurality of types of coating liquids, to a second portion exposed from the opening at the second position that has not been coated with the first coating liquid.

2. The method for manufacturing an inspection strip according to claim 1, wherein in the coating step, the plurality of the arrangement patterns are applied in a manner such that the plurality of coating liquids are arranged linearly along the repeating direction.

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

4. The method for manufacturing an inspection strip according to claim 1, wherein in the coating step, the plurality of coating liquids are applied in such a manner that the positions of adjacent inspection areas between adjacent array patterns in the repeating direction are shifted in a direction perpendicular to the repeating direction.

5. The masking member comprises a linear support member and a plurality of mask portions arranged in a comb-like manner relative to the support member, and the opening is formed by the masking member formed by adjacent mask portions. The coating head that holds the coating liquid is moved parallel to the longitudinal direction of the support member, thereby applying the coating liquid to the sheet-like carrier exposed in the opening. A method for manufacturing an inspection strip according to claim 1.

6. The cutting process includes a marking step of providing marks on the sheet-like carrier to indicate the cutting positions, A method for manufacturing an inspection strip according to any one of claims 1 to 5, wherein in the cutting step, the sheet-like carrier is cut based on the mark.

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