Wearable article with amniotic fluid marker detection test strip

Abstract

The invention provides a product capable of easily monitoring premature rupture of a fetal membrane. Provided is a wearable article having a test strip for detecting amniotic fluid-derived insulin-like growth factor binding protein 1 in vaginal secretions by immunochromatography, said test strip detecting 0.3 [mu] g / L to 25 [mu] g / L of insulin-like growth factor binding protein 1 as positive.

Description

TECHNICAL FIELD

[0001] The present application relates to a wearing article having an amniotic fluid marker test strip and an amniotic fluid marker test strip suitable for a wearing article. BACKGROUND

[0002] Monitoring to detect rupture of fetal membranes, particularly premature rupture of membranes, early is important for safe delivery.

[0003] As a conventional examination method, for example, a pH examination swab for confirming amniotic fluid at the time of premature rupture of membranes is known.

[0004] In addition, a kit based on an antigen-antibody reaction for detecting IGFBP-1 derived from amniotic fluid is also known. The kit uses a sterile swab to collect vaginal discharge. In this conventional examination kit, the detection range of IGFBP-1 is set to a relatively high concentration range. When made into an inner liner, IGFBP-1 is diluted by other compounds contained in mucus, but the dilution rate is unknown, so the sensitivity must be re-set.

[0005] In addition, a sanitary pad for detecting amniotic fluid leakage is also known, which functions by detecting a change in pH that is generally considered to indicate amniotic fluid outflow. SUMMARY

[0006] PROBLEMS TO BE SOLVED BY THE INVENTION

[0007] In the conventional method, in order to investigate whether the fetal membranes are ruptured prematurely, the inside of the vagina is wiped with a swab or the like, thereby collecting vaginal discharge as a detection object. This detection method is time-consuming and is not suitable for purposes such as continuous monitoring.

[0008] In addition, since the person himself / herself hardly perceives premature rupture of membranes, there can be no opportunity for monitoring.

[0009] An object of the present application is to provide a product that enables simple monitoring of premature rupture of membranes.

[0010] SOLUTION TO THE PROBLEM

[0011] The object of the present application is solved by the present application comprising the following means.

[0012] <Means 1>

[0013] A wearing article having a test strip using an immunochromatographic method,

[0014] the test strip for detecting insulin-like growth factor binding protein 1 derived from amniotic fluid in vaginal discharge,

[0015] The test strip detects insulin-like growth factor binding protein 1 in the range of 0.3 μg / L to 25 μg / L as positive.

[0016] <Mode 2>

[0017] The wearing article according to Mode 1 is a panty or an absorbent article.

[0018] <Mode 3>

[0019] The wearing article according to Mode 1 or 2, wherein the test strip has a width of 3 mm or less.

[0020] <Mode 4>

[0021] The wearing article according to any one of Modes 1 to 3, wherein the test strip has:

[0022] a first member that contacts vaginal fluid;

[0023] a second member that contains a labeled antibody that recognizes insulin-like growth factor binding protein 1 derived from amniotic fluid in the vaginal fluid; and

[0024] a third member that has a display portion containing a capture antibody,

[0025] the capture antibody is capable of capturing a complex formed by the labeled antibody and insulin-like growth factor binding protein 1,

[0026] the test strip is configured in such a manner that the insulin-like growth factor binding protein 1 derived from amniotic fluid in the vaginal fluid moves from the first member to the display portion of the third member via the second member, and

[0027] the display portion of the third member develops color by capturing the complex by the capture antibody.

[0028] <Mode 5>

[0029] The wearing article according to Mode 4, wherein the first member, the second member, and the third member at least partially overlap with each other in this order to be layered,

[0030] a total thickness of the first member, the second member, and the third member in the layering direction is 1.5 mm or less.

[0031] <Mode 6>

[0032] The wearing article according to Mode 4 or 5, wherein the labeled antibody has a coloring agent having a particle size of 250 nm to 500 nm.

[0033] <Mode 7>

[0034] A test strip for use with a wearable article using an immunochromatographic method,

[0035] The test strip is used to detect insulin-like growth factor binding protein 1 derived from amniotic fluid in vaginal discharge.

[0036] The test strip detects 0.3 μg / L to 25 μg / L of insulin-like growth factor binding protein 1 as positive.

[0037] Effects of the Invention

[0038] According to the present application, a product capable of easily monitoring premature rupture of fetal membranes can be provided. BRIEF DESCRIPTION OF DRAWINGS

[0039] Figure 1-1 is a schematic view of the specific configuration of the test strip of the present application.

[0040] Figure 1-2 is a schematic view of the specific configuration of the test strip of the present application.

[0041] Figure 2-1 is a view for explaining the reference example.

[0042] Figure 2-2 is a view for explaining the reference example.

[0043] Figure 2-3 is a view for explaining the reference example.

[0044] Figure 2-4 is a view for explaining the reference example.

[0045] Figure 2-5 is Figure 2-3 an enlarged view of the one chart.

[0046] Figure 2-6 is Figure 2-3 an enlarged view of the one chart.

[0047] Figure 2-7 is Figure 2-3 an enlarged view of the one chart.

[0048] Figure 2-8 is Figure 2-3 an enlarged view of the one chart.

[0049] Figure 3 is a view for explaining the reference example.

[0050] Figure 4 is a chart showing the results of sensitivity test of the test strips of Examples 1 and 2. DETAILED DESCRIPTION

[0051] The present application will be described in detail below.

[0052] <Mode 1>

[0053] A wearing article having a test strip using an immunochromatography method,

[0054] The test strip is used to detect insulin-like growth factor binding protein 1 derived from amniotic fluid in vaginal discharge.

[0055] The test strip detects insulin-like growth factor binding protein 1 in a range of 0.3 μg / L to 25 μg / L as positive.

[0056] As described above, in the conventional method, in order to investigate whether the fetal membrane is ruptured early, for example, the inside of the vagina is wiped with a cotton swab or the like, whereby the vaginal discharge is collected. However, since the person himself / herself hardly notices the rupture of the fetal membrane early, such a troublesome method can not be able to detect the rupture of the fetal membrane early.

[0057] In the technical solution of Mode 1 of the present application, since the test strip for detecting insulin-like growth factor binding protein 1 (IGFBP-1) contained in a large amount in amniotic fluid is applied to the wearing article, the rupture of the fetal membrane can be monitored only by wearing without special operation.

[0058] In addition, in the test strip of the wearing article of Mode 1 of the present application, the detection concentration range is optimized to 0.3 μg / L to 25 μg / L, and thus insulin-like growth factor binding protein 1 derived from amniotic fluid in vaginal discharge can be detected with high reliability.

[0059] The casein blocking buffer (1.0% casein, 100 mM borate, pH 8.5) of IGFBP1 can be used as a standard solution to determine the detection concentration of the test strip.

[0060] Without being limited, specifically, for example, the standard solution can be prepared by using human recombinant insulin-like growth factor binding protein 1 (IGFBP1) (25 μg) (Fuji Photo Film and Otsuka Pharmaceutical Co., Ltd.: product code 092-06201) as a positive sample powder, using a blocking buffer (1.0% casein, 100 mM borate, pH 8.5) as a dilution solution, dissolving and diluting the positive sample powder to a target concentration with the dilution solution.

[0061] The test strip of the present application:

[0062] More preferably, insulin-like growth factor binding protein 1 in a range of 0.4 μg / L to 20 μg / L is detected as positive,

[0063] Further preferably, 0.5 μg / L to 15 μg / L of insulin-like growth factor binding protein 1 is detected as positive,

[0064] Still further preferably, 0.5 μg / L to 10 μg / L of insulin-like growth factor binding protein 1 is detected as positive.

[0065] <Mode 2>

[0066] The wearing article according to Mode 1 is a panty or an absorbent article.

[0067] According to the technical solution of Mode 2, since the wearing article is a daily usable panty or absorbent article, the monitoring of premature rupture of fetal membranes can be performed relatively simply and continuously.

[0068] In this mode, for example, the test strip can be attached to the inner side surface of the panty, or alternatively, the test strip can be arranged between sheet members constituting the absorbent article. The method of applying the test strip to the wearing article such as the absorbent article is not particularly limited, and can be performed according to a known method.

[0069] <Mode 3>

[0070] The wearing article according to Mode 1 or 2, wherein the test strip has a width of 3 mm or less.

[0071] In the case of premature rupture of fetal membranes, the amount of liquid is sometimes small. In addition, in the case of premature rupture of fetal membranes, amniotic fluid can be discharged together with secretions and the like, in which case the viscosity of the amniotic fluid-containing vaginal secretion in contact with the test strip can become relatively high.

[0072] In the technical solution of Mode 3, however, the width of the test strip is reduced to 3 mm or less, and thus the amount of liquid required to be held in the test strip for detection is relatively reduced. Therefore, according to the technical solution of Mode 3, even in the case where the amniotic fluid-containing vaginal secretion having a small amount and a high viscosity is used as the detection object, the detection can be performed favorably.

[0073] Note that the width of the test strip can be 1 mm to 10 mm, but is preferably 5 mm or less. The upper limit of the width of the test strip can further be 4 mm or less. Particularly preferably, the width of the test strip is 1 mm or more and less than 5 mm, 1.5 mm to 4.5 mm, or further 2 mm to 4 mm, particularly 2 mm to 3 mm. When the width of the test strip is within these ranges, the visual recognition of the color development reaction and the like can be particularly favorable.

[0074] From the viewpoint of visual recognition by the user and processability, the width of the test strip is preferably 2 mm or more.

[0075] <Mode 4>

[0076] The wearable article according to any one of Modes 1 to 3, wherein the test strip has:

[0077] a first member that contacts the vaginal discharge;

[0078] a second member that contains a labeled antibody that recognizes insulin-like growth factor binding protein 1 derived from amniotic fluid in the vaginal discharge; and

[0079] a third member that has a display portion containing a capture antibody,

[0080] the capture antibody being capable of capturing a complex formed by the labeled antibody and insulin-like growth factor binding protein 1,

[0081] the test strip being configured in such a manner that the insulin-like growth factor binding protein 1 derived from amniotic fluid in the vaginal discharge moves from the first member to the display portion of the third member via the second member, and

[0082] the display portion of the third member develops color by capturing the complex by the capture antibody.

[0083] The wearable article according to Mode 4 allows simple and rapid detection of insulin-like growth factor binding protein 1 through a color development reaction.

[0084] When the wearable article is an undergarment, for example, color development can be confirmed by visually recognizing the test strip adhered to the inner surface of the undergarment. When the wearable article is an absorbent article (e.g., a sanitary pad), for example, color development on the test strip disposed between sheet members constituting the absorbent article can be confirmed by a sheet member having visible light transmittance.

[0085] The principle of measurement of the test strip of Mode 4 will be described using specific examples. In an exemplary mode, for example, the labeled antibody is a mouse anti-human insulin-like growth factor binding protein type 1 monoclonal antibody labeled with a coloring agent, and the capture antibody is a mouse anti-human insulin-like growth factor binding protein type 1 monoclonal antibody. When IGFBP-1 is present in the test body that contacts the first member, the labeled antibody reacts with IGFBP-1 in the second member to form a complex based on an antigen-antibody reaction. This complex moves to the display portion of the third member and is captured by the capture antibody fixedly bound thereto, as a result of which the display portion develops color based on the coloring agent.

[0086] Note that a second display portion (control portion) can be provided on the downstream side of the display portion in the direction of movement of the antigen. A second capture antibody (e.g., rabbit anti-mouse immunoglobulin polyclonal antibody) different from the above-described capture antibody is fixedly bound to the control portion. The second capture antibody can recognize the labeled antibody. The labeled antibody that has not formed a complex with the antigen is not captured by the display portion but passes through the display portion and is captured at the control portion, as a result of which the control portion develops color based on the coloring agent.

[0087] According to this method, in the case of positive, the display portion and the control portion develop color, and in the case of negative, only the control portion develops color.

[0088] The constitution of the test strip will be described later in detail.

[0089] <Mode 5>

[0090] The wearable article according to Mode 4, wherein the first member, the second member, and the third member at least partially overlap each other in this order so as to be layered,

[0091] The total thickness of the first member, the second member, and the third member in the layering direction is 1.5 mm or less.

[0092] As described above, in the case of premature rupture of the fetal membranes, amniotic fluid is sometimes discharged together with secretions and the like, and in this case, the viscosity of the amniotic fluid-containing vaginal secretion that comes into contact with the test strip sometimes becomes high. Therefore, the detection method of the related art using the immunochromatography method sometimes does not easily detect insulin-like growth factor binding protein 1 derived from amniotic fluid in the vaginal secretion.

[0093] On the other hand, in the test strip of Mode 5, the thickness of the members constituting the test strip is reduced, and the amount of liquid that needs to be held in the test strip to perform detection is relatively reduced. Therefore, according to the test strip of Mode 5, even in the case where amniotic fluid-containing vaginal secretion having a small amount and high viscosity is used as the detection target, insulin-like growth factor binding protein 1 can be favorably detected.

[0094] The suitable range of the film thickness is 160 to 230 μm, and more preferably 180 to 220 μm.

[0095] <Mode 6>

[0096] The wearable article according to Mode 4 or 5, wherein the labeled antibody has a coloring agent, and the coloring agent has a particle diameter of 250 nm to 500 nm (preferably 280 to 450 nm, and more preferably 300 nm to 400 nm).

[0097] As described above, in the case of premature rupture of the fetal membranes, amniotic fluid is sometimes discharged together with the secretion and the like. In this case, the viscosity of the amniotic fluid-containing vaginal secretion in contact with the test strip sometimes becomes high. When the viscosity of the amniotic fluid-containing vaginal secretion is high, the flowability of the specimen in the test strip decreases, and the absolute amount of the antigen for detection sometimes becomes relatively small. In addition, the amount of the amniotic fluid contained in the vaginal secretion is sometimes small.

[0098] On the other hand, in the wearing article of Mode 6, since the labeled antibody that binds to insulin-like growth factor binding protein 1 has a coloring agent with a large particle diameter, the visual recognition of the detection is improved. Therefore, according to the wearing article of Mode 6, even in the case where the viscosity and / or the amount of the amniotic fluid-containing vaginal secretion causes a relative decrease in the amount of the antigen, good detection can be performed.

[0099] <Mode 7>

[0100] A test strip for use in a wearing article, which employs an immunochromatographic method,

[0101] The test strip is for detecting insulin-like growth factor binding protein 1 derived from amniotic fluid in vaginal secretion.

[0102] The test strip detects 0.3 μg / L to 25 μg / L of insulin-like growth factor binding protein 1 as positive.

[0103] As described above, in the conventional method, in order to investigate whether the fetal membranes are ruptured prematurely, for example, the inside of the vagina is wiped with a cotton swab or the like, and thereby the vaginal secretion is collected. However, since the person himself / herself hardly notices the premature rupture of the fetal membranes, such a troublesome method can not be able to detect the premature rupture of the fetal membranes early.

[0104] On the other hand, in the technical solution of Mode 7, a test strip for detecting insulin-like growth factor binding protein 1 (IGFBP-1) contained in a large amount in amniotic fluid is applied to a wearing article, and thus the monitoring of the rupture of the fetal membranes (particularly, the premature rupture of the fetal membranes) can be performed only by wearing without special operation.

[0105] In addition, according to the test strip, the detection concentration range is optimized to 0.3 μg / L to 25 μg / L, and thus insulin-like growth factor binding protein 1 derived from amniotic fluid in vaginal secretion can be detected with high reliability.

[0106] Note that the details of the test strip of Mode 7 can be referred to the description of the wearing articles of Modes 1 to 6 described above (particularly, the description of the test strip).

[0107] <Specific Example of Test Strip>

[0108] A schematic view of the test strip is shown in the accompanying Figure 1-1For other configurations of the test strip, reference can be made to the description of WO 2021 / 132724 A1. Further, for an absorbent article having a test strip, reference can be made to the description of WO 2021 / 132724.

[0109] A test strip employing an immunochromatography method is described in detail with reference to the drawings. Note that the drawings are not necessarily drawn to scale, and do not limit the present application.

[0110] Figure 1-2 The test strip (examination member) 60 has display portions (62A and 62B) that can develop color based on excrement (vaginal secretion). The test strip 60 has a contact portion (1st member, such as a sample pad) 64 that contacts the vaginal secretion. The test strip 60 can have a movement portion for movement of components contained in the vaginal secretion (hereinafter also referred to as "vaginal secretion components"). In the movement portion, the vaginal secretion components can move using the capillary phenomenon. The movement portion can have a display movement portion 66A in which the vaginal secretion components move from the contact portion 64 to the display portions (62A, 62B), and a terminal movement portion 66B in which the vaginal secretion components move in a direction away from the display portions (62A, 62B). The terminal movement portion is a portion in which the vaginal secretion components and the like that have passed through the display portions (62A and 62B) move.

[0111] The contact portion (1st member) 64 that contacts the vaginal secretion can be configured by, for example, a pad (which can be referred to as a sample pad or a specimen pad). The vaginal secretion components in the vaginal secretion that contacts the contact portion 64 move in the pad, for example, and move to the 2nd member (such as a conjugate pad). The conjugate pad contains a labeled antibody that recognizes the insulin-like growth factor binding protein 1 derived from amniotic fluid in the vaginal secretion. The conjugate pad (2nd member) can be configured to overlap the sample pad (1st member) in the thickness direction, although not shown in Fig. 1-1. The vaginal secretion components, a complex formed by the antigen-antibody reaction with the insulin-like growth factor binding protein 1 derived from amniotic fluid contained in the vaginal secretion components, and the labeled antibody can move in the movement portion 66A using the capillary phenomenon. The portion in which these substances move can be configured by a membrane, for example. The display portion has a position 62A that contains a capture antibody that captures the complex formed. This position develops color by the complex being captured by the capture antibody. This position 62A of the display portion can be referred to as a test line. Figure 3 -1, but can be configured to overlap the sample pad (1st member) in the thickness direction, for example. The vaginal secretion components, a complex formed by the antigen-antibody reaction with the insulin-like growth factor binding protein 1 derived from amniotic fluid contained in the vaginal secretion components, and the labeled antibody can move in the movement portion 66A using the capillary phenomenon. The portion in which these substances move can be configured by a membrane, for example. The display portion has a position 62A that contains a capture antibody that captures the complex formed. This position develops color by the complex being captured by the capture antibody. This position 62A of the display portion can be referred to as a test line.

[0112] The display portion can have a position 62B that contains a capture antibody different from the capture antibody of the capture complex in the position 62A. The capture antibody of the position 62B can capture a complex different from the complex captured by the position 62A, or can capture a labeled antibody. The position 62B is colored by the capture complex or the labeled antibody. The position 62B that captures the labeled antibody can be referred to as a control line. The vaginal secretion component that has passed through the display portion 62 (i.e., the component that is not captured by the capture antibody) moves in the terminal movement portion 66B. The terminal movement portion 66B can be composed of a membrane. In addition, the terminal movement portion 66B can have an adsorption pad that absorbs the vaginal secretion component that has passed through the display portion 62. The vaginal secretion component that has passed through the display portion 62 can also be absorbed by an absorbent wick instead of the adsorption pad. When the immunochromatography method is employed, the display portion 62 and the contact portion 64 are disposed at different positions. Therefore, in this case, the display portion 62 is different from the contact portion 64.

[0113] The test strip (examination member) 60 can be composed of any material such as paper, nonwoven fabric, cloth, or the like as long as it has a member that can hold or contain substances such as a labeled antibody and a capture antibody.

[0114] Method for detecting insulin-like growth factor binding protein 1 derived from amniotic fluid from vaginal secretion

[0115] The present application includes a method for detecting insulin-like growth factor binding protein 1 derived from amniotic fluid from vaginal secretion using a wearing article having a test strip that employs an immunochromatography method, the method comprising:

[0116] a step of attaching vaginal secretion to the test strip,

[0117] The test strip detects insulin-like growth factor binding protein 1 at 0.3 μg / L to 25 μg / L as positive.

[0118] Detailed descriptions of each component such as the wearing article and the test strip in the method can be found in the above descriptions of the wearing article and the test strip.

[0119] The method for attaching vaginal secretion to the test strip is not particularly limited and can be found in the above descriptions of the wearing article and the test strip. For example, the present wearing article can be configured such that the vaginal secretion discharged from the wearer wearing the present wearing article is attached to the test strip (particularly, the first member of the test strip). In addition, for example, the test strip of the above-described mode 4 can be configured such that the vaginal secretion is directly attached to the first member (particularly, the sample pad), thereby attaching the vaginal secretion to the test strip. It is preferable that the test strip be configured to be in direct contact with the vagina (vulva).

[0120] In one embodiment of the above method, 0.4 μg / L to 20 μg / L or 0.5 μg / L to 15 μg / L of insulin-like growth factor binding protein 1 is detected as positive, or, further, 0.5 μg / L to 10 μg / L of insulin-like growth factor binding protein 1 is detected as positive.

[0121] <Reference Example>

[0122] For reference, the attached Figures 2-1 to 2-8 and Figure 3 Experimental results on detection of a substance (LH) in vaginal discharge are described.

[0123] <<Examples 1 to 2>>

[0124] In Examples 1 and 2, a test strip for detecting insulin-like growth factor binding protein 1 derived from amniotic fluid in vaginal discharge using an immunochromatography method was prepared, and a sensitivity test was performed. In addition, the test strip was applied to a wearing article and a wearing test was performed.

[0125] (Example 1)

[0126] The test strip of Example 1 has:

[0127] a first member that contacts vaginal discharge;

[0128] a second member that contains a labeled antibody (manufactured by Medix biochemica) that recognizes insulin-like growth factor binding protein 1 (IGFBP-1) derived from amniotic fluid in vaginal discharge; and

[0129] a third member that has a display portion containing a capture antibody,

[0130] The capture antibody of the test strip of Example 1 is capable of capturing a complex formed by the labeled antibody and insulin-like growth factor binding protein 1,

[0131] The test strip is configured in such a manner that insulin-like growth factor binding protein 1 derived from amniotic fluid in vaginal discharge moves from the first member to the display portion of the third member via the second member, and,

[0132] The display portion of the third member develops color by capturing the complex by the capture antibody.

[0133] The test strip of Example 1 has a length of 12 mm and a width of 3 mm. The sample pad as the first member has a thickness of 0.1 mm, the conjugate pad as the second member has a thickness of 0.55 mm, and the membrane as the third member has a thickness of 0.1 mm, and the total thickness of the first to third members is 0.75 mm.

[0134] The labeled antibody in the conjugate pad of Example 1 has blue nano-beads (product name: NanoAct, manufactured by Asahi Kasei Corporation) with a particle diameter of 350 nm as a coloring agent.

[0135] (Example 2)

[0136] The overall configuration and size of the test strip of Example 2 and the size of the first to third members are the same as those of Example 1 described above.

[0137] The labeled antibody in the conjugate pad of Example 2 has blue nano-beads (product name: NanoAct, manufactured by Asahi Kasei Corporation) with a particle diameter of 350 nm as a coloring agent.

[0138] <Sensitivity Check>

[0139] The test strips of Examples 1 to 2 were subjected to a sensitivity check. Specifically, solutions of IGFBP-1 at concentrations of 2.5 ng / ml, 10 ng / ml, 25 ng / ml, and 50 ng / ml were prepared, and the sensitivity of each after applying the solutions to the test strips was measured using an absorbance meter (manufactured by Hamamatsu Photonics K.K., product name: Immunochromato Reader (C10066-10)). The results are shown in the graph of Figure 4

[0140] As shown in the graph of Figure 4 According to the test strips of Examples 1 to 2, it was possible to detect IGFBP-1 at a lower concentration (for example, 0.5 to 10 μg / L) with very high sensitivity. According to these test strips, it was possible to reliably detect a small amount of amniotic fluid mixed in.

[0141] In addition, a test was also performed in which the test strips of Examples 1 and 2 were attached to a wearing article and actually worn by a pregnant woman. As a result, no false positives occurred, and good detection was possible.

[0142] <<Examples 3 to 4>>

[0143] In Examples 3 to 4, the relationship between the width of the test strip and the visual recognition of the color development was investigated. The test strip of Example 3 had a width of 5 mm, and the test strip of Example 4 had a width of 3 mm. Note that the width of the test strip refers to the length in the direction perpendicular to the length direction of the test strip (in particular, the direction of travel of the vaginal secretion components) in the overall plane of the test strip.

[0144] The vaginal secretions of three subjects collected over 10 to 12 days were attached to the sample pad of the test strip of Example 3 or 4 having the same configuration as Example 1 described above, and the color development on the display portion was observed. For the total number of checks performed, Example 3 was n = 25, and Example 4 was n = 28. ​

[0145] For color development on the display part, the proportion of cases in which the control line was clearly visually recognized (O) and the proportion of cases in which the control line was visually recognized but the visual recognition was slightly poor (Δ) were calculated. The results are shown in Table 1 below.

[0146] Table 1

[0147]

[0148] As can be seen from Table 1, the test strip of Example 4 having a width of 3 mm showed more excellent visual recognition than the test strip of Example 3 having a width of 5 mm.

[0149] Without being limited by theory, it is believed that the flowability of the sample is improved by the narrower width of the test strip. That is, it is believed that in the test strip of Example 4, the components of the vaginal discharge (and components thereof) reaching the display part as the color development site are relatively increased, and as a result, the visual recognition is improved.

Claims

1. A wearable article comprising a test strip using an immunochromatographic method, The test strip is used to detect insulin-like growth factor binding protein 1 derived from amniotic fluid in vaginal secretions. The test strip detects 0.3 μg / L to 25 μg / L of insulin-like growth factor binding protein 1 as positive.

2. The wearing article according to claim 1, which is underwear or an absorbent article.

3. The wearing article according to claim 1 or 2, wherein The test strip has a width of 3 mm or less.

4. The wearing article according to claim 1 or 2, wherein The test strip has: The first component that comes into contact with vaginal secretions; a second component comprising a labeled antibody that recognizes amniotic fluid-derived insulin-like growth factor binding protein 1 in vaginal secretions; as well as a third member having a display portion, wherein the display portion contains a capture antibody, The capture antibody is capable of capturing a complex formed by the binding of the labeled antibody and insulin-like growth factor binding protein 1. The test strip is configured such that the insulin-like growth factor binding protein 1 derived from amniotic fluid in the vaginal secretions moves from the first member to the display portion of the third member via the second member, and The complex is captured by the capture antibody, and the display portion of the third member develops color.

5. The wearing article according to claim 4, wherein The first member, the second member, and the third member are stacked in this order by at least partially overlapping each other. The total thickness of the first member, the second member, and the third member in the stacking direction is 1.5 mm or less.

6. The wearing article according to claim 4, wherein The labeled antibody has a colorant, and the colorant has a particle size of 250 nm to 500 nm.

7. A test strip using immunochromatography, suitable for use on wearable articles, The test strip is used to detect insulin-like growth factor binding protein 1 derived from amniotic fluid in vaginal secretions. The test strip detects 0.3 μg / L to 25 μg / L of insulin-like growth factor binding protein 1 as positive.

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