Absorbent article having test strip for leucorrhea, and test strip for leucorrhea used in absorbent article

Abstract

Provided is an absorbent article capable of predicting the ovulation day more easily than in the prior art. The present invention relates to an absorbent article comprising a test strip for detecting luteinizing hormone from leucorrhea using an immunochromatography method, said test strip detecting 0.05 mIU / mL to 2.5 mIU / mL of luteinizing hormone as positive.

Description

Technical Field

[0001] The present invention relates to an absorbent article having a test strip for leucorrhea. Further, the present invention relates to a test strip for leucorrhea to be used in an absorbent article. In addition, the present disclosure also includes Invention B. Invention B will be described later. Background Art

[0002] It is important for women who wish to become pregnant to know the ovulation day in advance. As a method for predicting the ovulation day, examination of luteinizing hormone (LH) in urine is widely used.

[0003] In addition, lateral flow assay for detecting the presence of an analyte in a liquid sample is known (Patent Document 1).

[0004] In addition, an absorbent article having a detection site based on immunochromatography is known (Patent Document 2). According to this absorbent article, it is possible to grasp the health condition by detecting the components of human excrement by means of an antigen-antibody reaction.

[0005] Prior art documents

[0006] Patent documents

[0007] Patent Document 1: Japanese Patent Application Laid-Open No. 2007-526443

[0008] Patent Document 2: International Publication No. 2021 / 132724 Summary of the Invention

[0009] Problems to be Solved by the Invention

[0010] Conventional ovulation day prediction methods that use urine as a detection target have problems in terms of simplicity, and there are also problems such that the detection operation and the acquisition of results require time and effort.

[0011] An object of the present invention is to provide an absorbent article capable of predicting the ovulation day more simply than in the past.

[0012] Means for Solving the Problems

[0013] The object of the present invention can be solved by the present invention including the following means:

[0014] <Means 1>

[0015] An absorbent article having a test strip using immunochromatography for detecting luteinizing hormone from leucorrhea, wherein

[0016] the test strip detects luteinizing hormone of 0.05 mIU / mL to 2.5 mIU / mL as positive.

[0017] <Solution 2>

[0018] According to the absorbent article described in Solution 1, wherein,

[0019] The test strip has a width of 5 mm or less.

[0020] <Solution 3>

[0021] According to the absorbent article described in Solution 1, wherein,

[0022] The test strip has a width of 3 mm or less.

[0023] <Solution 4>

[0024] According to the absorbent article described in any one of Solutions 1 to 3, wherein,

[0025] The test strip has:

[0026] A first member that contacts leucorrhea;

[0027] A second member that contains a labeled antibody that recognizes luteinizing hormone in leucorrhea; and

[0028] A third member that has a display portion containing a capture antibody,

[0029] The capture antibody can capture the complex formed by the binding of the labeled antibody and luteinizing hormone,

[0030] The absorbent article is configured such that luteinizing hormone in the leucorrhea moves from the first member through the second member to the display portion of the third member,

[0031] And is configured such that the complex is captured by the capture antibody, thereby causing the display portion of the third member to develop color.

[0032] <Solution 5>

[0033] According to the absorbent article described in Solution 4, wherein,

[0034] The first member, the second member, and the third member are at least partially overlapped and stacked in this order,

[0035] The total thickness of the first member, the second member, and the third member in the stacking direction is 1.5 mm or less.

[0036] <Solution 6>

[0037] According to the absorbent article described in Solution 4 or Solution 5, wherein,

[0038] The first member is formed of fibers having an average fiber diameter of 0.5 μm to 5 μm,

[0039] The second member is formed of fibers having an average fiber diameter of 10 μm to 40 μm,

[0040] and the average fiber diameter of the fibers of the first member is smaller than the average fiber diameter of the fibers of the second member.

[0041] <Solution 7>

[0042] The absorbent article according to any one of Solutions 4 to 6, wherein,

[0043] the average fiber diameter R1 of the fibers constituting the first member and the average fiber diameter R2 of the fibers constituting the second member satisfy the relationship of 5 ≤ (R2 / R1) ≤ 20.

[0044] <Solution 8>

[0045] The absorbent article according to any one of Solutions 4 to 7, wherein,

[0046] the absorbent article satisfies at least one of the following conditions:

[0047] (a) The second member has a basis weight of 100 gsm or more,

[0048] (b) The total thickness of the first member, the second member, and the third member is 1.5 mm or less, and the thickness of the second member accounts for 30% or more of the total thickness,

[0049] (b) The second member has a density of 0.05 g / m 3 to 0.80 g / m 3 of density.

[0050] <Solution 9>

[0051] The absorbent article according to any one of Solutions 4 to 8, wherein,

[0052] the labeled antibody has a coloring agent having a particle diameter of 10 nm to 500 nm.

[0053] <Solution 10>

[0054] The absorbent article according to any one of Solutions 4 to 8, wherein,

[0055] the labeled antibody has a coloring agent having a particle diameter of 250 nm to 500 nm.

[0056] <Solution 11>

[0057] The absorbent article according to any one of Aspects 1 to 10, wherein,

[0058] the absorbent article has a topsheet,

[0059] when using the absorbent article, the leucorrhea reaches the test strip via the topsheet.

[0060] <Aspect 12>

[0061] The absorbent article according to the description in Aspect 11, wherein,

[0062] the detection is performed by bringing at least a part of the topsheet into direct contact with the vulva.

[0063] <Aspect 13>

[0064] The absorbent article according to the description in Aspect 11 or Aspect 12, wherein,

[0065] the basis weight per unit area of the topsheet is 20 gsm or less.

[0066] <Aspect 14>

[0067] The absorbent article according to any one of Aspects 11 to 13, wherein the thickness of the topsheet is 1 mm or less.

[0068] <Aspect 15>

[0069] The absorbent article according to any one of Aspects 11 to 14, wherein the single fiber diameter of the fibers constituting the topsheet is 8.0 dtex or less.

[0070] <Aspect 16>

[0071] The absorbent article according to the description in Aspect 11, wherein,

[0072] the basis weight per unit area of the topsheet is 5 gsm or more,

[0073] the thickness of the topsheet is 0.1 mm or more,

[0074] and the single fiber diameter of the fibers constituting the topsheet is 1.0 dtex or more.

[0075] <Aspect 17>

[0076] The absorbent article according to any one of Aspects 11 to 16, wherein the topsheet has an embossed pattern at least partially,

[0077] the width of the test strip is larger than the size and / or interval of each pattern of the embossed pattern.

[0078] <Aspect 18>

[0079] The absorbent article according to any one of Aspects 11 to 17, wherein the topsheet partially has an embossed pattern,

[0080] The test strip can contact the leucorrhea through a portion of the topsheet that does not have the embossed pattern.

[0081] <Aspect 19>

[0082] The absorbent article according to any one of Aspects 11 to 18, wherein,

[0083] The topsheet does not contain TiO 2 .

[0084] <Aspect 20>

[0085] The absorbent article according to any one of Aspects 11 to 19, wherein,

[0086] The test strip has a first member that contacts the leucorrhea, and the first member is disposed at a position opposite to the vaginal part of the wearer during wearing.

[0087] The average fiber diameter of the fibers constituting the sample pad is the same as or smaller than the average fiber diameter of the fibers constituting the topsheet.

[0088] <Aspect 21>

[0089] A test strip for an absorbent article, which uses an immunochromatographic method for detecting luteinizing hormone in leucorrhea, wherein,

[0090] The test strip detects luteinizing hormone at 0.05 mIU / mL to 2.5 mIU / mL as positive.

[0091] Effects of the Invention

[0092] According to the present invention, an absorbent article capable of predicting the ovulation day more simply than before can be provided. BRIEF DESCRIPTION OF THE DRAWINGS

[0093] Figure 1 is a photograph showing the results of the sensitivity test of the test strip of the present invention.

[0094] Figure 2 is a photograph showing the results of the luminescence intensity test of the test strip of the present invention.

[0095] Figure 3-1 is a schematic plan view of the absorbent article of the embodiment as viewed from the skin side.

[0096] Figure 3-2It is a conceptual diagram related to the specific structure of the test strip of the present invention.

[0097] Figure 3-3 It is a schematic cross-sectional view of an absorbent article according to one embodiment of the present invention.

[0098] Figure 3-4 It is a schematic cross-sectional view of an absorbent article according to one embodiment of the present invention.

[0099] Figure 4 It is a graph obtained by separately plotting the LH concentration in urine and the LH concentration in leucorrhea with respect to the number of days with the LH surge in urine as the axis.

[0100] Figure 5 It is a graph obtained by separately plotting the LH concentration in urine and the LH concentration in leucorrhea with respect to the number of days with the LH surge in urine as the axis.

[0101] Figure 6 It is a graph showing the LH concentration near the day of the LH surge in leucorrhea.

[0102] Figure 7 It is a graph showing the result of the ROC analysis.

[0103] Figure 8-1 It is a graph showing the LH surge in leucorrhea.

[0104] Figure 8-2 It is a graph showing the LH surge in leucorrhea.

[0105] Figure 8-3 It is a graph showing the LH surge in leucorrhea.

[0106] Figure 9 It is a plan view of the topsheet 3 side of the sanitary napkin 1 according to the first embodiment of the present invention B.

[0107] Figure 10 It is a plan view of the backsheet 5 side of the sanitary napkin 1 according to the first embodiment of the present invention B.

[0108] Figure 11 It is in the present invention B Figure 1 End view at the III-III end face.

[0109] Figure 12 It is a plan view of the topsheet 3 side of the test strip 21 of the present invention B.

[0110] Figure 13 It is in the present invention B Figure 12 End view at the V-V end face. Detailed implementation mode

[0111] The detailed content of the present invention is described below.

[0112] <Scheme 1>

[0113] An absorbent article having a test strip using immunochromatography for detecting luteinizing hormone from leucorrhea, wherein,

[0114] The test strip detects luteinizing hormone at 0.05 mIU / mL to 2.5 mIU / mL as positive.

[0115] As described above, in the conventional ovulation day prediction methods, the method using urine as the detection target is a common method. In contrast, the inventor of the present case focused on leucorrhea as the detection target for predicting the ovulation day. Regarding luteinizing hormone (LH) in leucorrhea, there has been almost no opinion so far. However, according to the absorbent article having the test strip of the present case that detects luteinizing hormone at 0.05 mIU / mL to 2.5 mIU / mL as positive, luteinizing hormone in leucorrhea can be detected with high reliability.

[0116] In addition, according to the absorbent article of the present case, different from the conventional method for examining luteinizing hormone (LH) in urine, it can reduce the burden on the user in terms of not requiring intentional collection, etc., and at the same time can predict the ovulation day with high reliability.

[0117] Furthermore, the absorbent article of the present case is different from the conventional test kit for luteinizing hormone (LH) in urine and is an article for daily use. Therefore, the ovulation day can be predicted very simply, and in addition, it also has the effect of less psychological resistance.

[0118] Furthermore, in the conventional immunochromatography, operations such as making urine touch the test piece are required for detection, and there are cases where a relatively long time (for example, 10 minutes) is required. However, according to the absorbent article of the present case, since the detection reaction can be carried out only by wearing the absorbent article and discharging leucorrhea, the prediction of the ovulation day becomes simpler. For example, according to the absorbent article of the present case, there is no need to wait for 10 minutes to confirm the test result, and the test result can be confirmed together at the time of going to the bathroom, etc. at a time point more than 10 minutes after wearing the absorbent article. Therefore, it is simple.

[0119] In addition, different from the conventional case of using urine, the absorbent article of the present case also has the advantage that the detection can be carried out without worrying about getting hands dirty.

[0120] As described above, according to the invention of Scheme 1 of the present application, an absorbent article that can predict the ovulation day more simply than before can be provided.

[0121] In addition, although the LH concentration in urine sometimes varies significantly depending on water intake and the like, in the case of leucorrhea, the LH concentration is likely to be relatively stable. Therefore, by using leucorrhea as the detection target, it may also be possible to achieve effects that cannot be obtained when using urine as the detection target.

[0122] The test strip detects luteinizing hormone at a concentration of 0.05 mIU / mL to 5 mIU / mL as positive, more preferably detects luteinizing hormone at a concentration of 0.05 mIU / mL to 2.5 mIU / mL (Scheme 3 of the present invention) as positive, and particularly preferably detects luteinizing hormone at a concentration of 0.05 mIU / mL to 2.0 mIU / mL as positive.

[0123] It is easily understood by those skilled in the art that "detecting luteinizing hormone (LH) at a concentration of 0.05 mIU / mL to 2.5 mIU / mL as positive" means showing positive when the LH concentration is within this concentration range, rather than meaning "only" showing positive when the LH concentration is within this concentration range. That is, for example, a test strip that shows positive for LH in a concentration range of 0.05 mIU / mL to 10.0 mIU / mL shows positive for LH in a concentration range of 0.05 mIU / mL to 2.5 mIU / mL, and thus is included in the scope of the present invention.

[0124] The important point of the present invention is that, different from the conventional urine LH detection, the test strip is configured to detect LH at a relatively low concentration range of 0.05 mIU / mL to 2.5 mIU / mL as positive.

[0125] In addition, from the viewpoint of improving the reliability of detection, preferably, the present test strip does not detect as positive in a range less than 0.001 mIU / mL, and particularly preferably, the present test strip does not detect as positive in a range less than 0.005 mIU / mL, less than 0.01 mIU / mL, less than 0.02 mIU / mL, less than 0.03 mIU / mL, less than 0.04 mIU / mL, or further less than 0.05 mIU / mL.

[0126] The test strip of the above Scheme 1 can perform positive detection by color development, for example, when luteinizing hormone is within the above concentration range.

[0127] In addition, in the test strip of the above Scheme 1, for example, when luteinizing hormone is within the above concentration range (for example, 0.05 mIU / mL to 2.5 mIU / mL), it can develop color to a degree lower than the maximum color development degree. The degree of color development can be confirmed by visual inspection, for example.

[0128] A test strip capable of detecting LH within the above-mentioned concentration range as positive can be produced, for example, by adjusting the sensitivity of a substance (such as an antibody) that reacts with luteinizing hormone (such as a coloring agent), and in particular, by adjusting the size of the coloring agent attached to the antibody that recognizes luteinizing hormone, etc.

[0129] In particular, for the above-mentioned test strip, it is more preferably to detect luteinizing hormone of 0.05 mIU / mL to 1.0 mIU / mL as positive, further preferably to detect luteinizing hormone of 0.05 mIU / mL to 0.5 mIU / mL as positive, and still further preferably to detect luteinizing hormone of 0.05 mIU / mL to 0.2 mIU / mL as positive.

[0130] The detection concentration of the test strip can be measured using a casein-blocking buffer solution of LH as a standard solution.

[0131] A casein-blocking buffer solution of LH can be prepared, for example, by the following method:

[0132] (a) Dissolve a casein blocking agent (1.0% casein, 100 mM borate, pH 8.5) in purified water to prepare a blocking buffer solution.

[0133] (b) Dilute a LH solution with a known concentration using the blocking buffer solution to prepare a standard solution of LH.

[0134] A casein blocking agent can be prepared, for example, as follows:

[0135] (1.0% casein, 100 mM borate, pH 8.5)

[0136] (a) Add 800 g of distilled water to a 1000 ml beaker.

[0137] (b) Add 2.0 ml of 20% NaOH.

[0138] (c) Stir for 10 minutes.

[0139] (d) Slowly add 10.0 g of casein powder.

[0140] (e) Stir for three hours.

[0141] (f) 6.18 g of boric acid (= add 100 mM).

[0142] (g) Stir for ten minutes.

[0143] (h) Add 2.5 ml of 20% NaOH.

[0144] (i) Dilute to 1000 ml with distilled water.

[0145] (j) Stir for ten minutes.

[0146] (k) Measure the pH.

[0147] (l) Filter using a filter unit (pore size 0.45 μm)

[0148] (m) Perform heat treatment at 30 °C for 24 hours.

[0149] (n) Aliquot into 15 ml or 50 ml containers for storage.

[0150] (o) Store at -80 °C.

[0151] In addition, the conventional LH detection method in urine assumes that a concentration range far higher than the 0.05 mIU / mL to 2.5 mIU / mL of the present invention is detected as positive. In addition, although blood can be collected and detected, it is accompanied by pain during blood collection or damage to the body during collection, so it is not as simple as an absorbent article.

[0152] For example, according to the existing literature (Bioeng. Transl. Med., 2017, 2(3): 238 - 246), the natural LH surge concentration in urine is 20 mIU / ml to 100 mIU / ml.

[0153] In addition, the conventional luteinizing hormone kit using urine test specimens uses a concentration range of luteinizing hormone in urine of 20 mIU / mL to 100 mIU / mL as the detection sensitivity range (Ministry of Health, Labour and Welfare, Pharmaceutical and Medical Devices Bureau Notice No. 0222, February 22, 2016).

[0154] In addition, the following literature relates to the study of the levels of reproductive hormones in urine during the menstrual cycle, and it is recorded that the median value of the total LH value on the day before ovulation is 38.3 (mIU / ml) (Table 2):

[0155] “Monitoring the menstrual cycle: comparison of urinary and serum reproductive hormones referenced true ovulation”, The European Journal of Contraception and Reproductive Health Care, 2015; Early Online: 1 - 13.

[0156] In addition, the following documents are related to hormones in urine and hormones in blood, and record the reference baseline range of LH during the ovulation period of women as 8 (mIU / mL) to 100 (mIU / mL):

[0157] "List of Endocrine Reference Values of Kansai Medical University"

[0158] Furthermore, the following documents are related to hormones in urine and hormones in blood, and record 6.69 (±5.22) (mIU / mg Cr) as the baseline LH value and 41.2 (±20.0) (mIU / mg Cr) as the LH peak value:

[0159] "Characteristics of the urinary luteinizing hormone surge in young ovulatory women" Fertil.Steril.2007 Sep;88(3);684-90

[0160] <Scheme 1-2>

[0161] The present disclosure also includes an absorbent article having a test strip using immunochromatography for detecting luteinizing hormone from leucorrhea, wherein

[0162] the test strip detects luteinizing hormone in the range of 0.05 mIU / mL to 10 mIU / mL as positive.

[0163] <Scheme 2>

[0164] In one scheme (Scheme 2) of the absorbent article of the present disclosure, the test strip has a width of 5 mm or less.

[0165] 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 be further 4 mm or less. In one embodiment of the present disclosure, the test strip has a width of 10 mm or less.

[0166] <Scheme 3>

[0167] In one scheme of the absorbent article of the present disclosure, the test strip has a width of 3 mm or less.

[0168] From the viewpoints of visual recognition and processability of the user, the width of the test strip is preferably 2 mm or more. Particularly preferably, the width of the test strip is 2 mm to 3 mm.

[0169] In the absorbent articles of Solution 2 and Solution 3, since the width of the test strip is reduced to less than 5 mm or further reduced to less than 3 mm, the amount of liquid to be retained for detection is relatively reduced. Therefore, according to the invention of Solution 2 or Solution 3, even when detecting leucorrhea with a small amount, high viscosity, and a small amount of LH as the detection target, the detection of LH can be performed well. In addition, when the width of the test strip is below the above upper limit, the risk of damage to the labia during the use of the absorbent article can be avoided.

[0170] In addition, since the width of the test strip is reduced, there is also an additional effect of reducing the discomfort when wearing the absorbent article.

[0171] <Solution 4>

[0172] In one aspect of the absorbent article of the present disclosure, the test strip has:

[0173] a first member that contacts the leucorrhea;

[0174] a second member that contains a labeled antibody that recognizes luteinizing hormone in the leucorrhea; and

[0175] a third member that has a display portion containing a capture antibody,

[0176] the capture antibody being capable of capturing the complex formed by the binding of the labeled antibody and luteinizing hormone,

[0177] the test strip is configured such that luteinizing hormone in the leucorrhea moves from the first member through the second member to the display portion of the third member,

[0178] and the test strip is configured such that the complex is captured by the capture antibody, thereby causing the display portion of the third member to develop color.

[0179] According to the absorbent article described in Solution 4, the detection of luteinizing hormone can be performed simply and quickly by means of a color reaction.

[0180] The measurement principle of the test strip is illustrated with a specific example. In the exemplified aspect, for example, the labeled antibody is a coloring agent-labeled anti-human luteinizing hormone mouse monoclonal antibody, and the capture antibody is an anti-human luteinizing hormone mouse monoclonal antibody. If human luteinizing hormone (hLH) is present in the specimen in contact with the first member, the labeled antibody reacts with hLH in the second member, and a complex based on the antigen-antibody reaction is formed. This complex moves to the display portion of the third member and is captured by the capture antibody fixedly bound thereto. As a result, the display portion develops color based on the coloring agent (pigment).

[0181] In addition, a second display unit (control unit) can be provided on the downstream side of the display unit in the moving direction of the antigen. A second capture antibody (for example, rabbit anti-mouse immunoglobulin polyclonal antibody) different from the above-mentioned capture antibody is fixedly bound to this control unit. This 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 unit but passes through the display unit and is captured by the control unit. As a result, the control unit develops color based on the coloring agent.

[0182] In this scheme, in the case of positive, both the display unit and the control unit develop color. In the case of negative, only the control unit develops color.

[0183] The detailed structure of the test strip will be described later.

[0184] <Scheme 4-2>

[0185] In an absorbent article according to an embodiment of the present disclosure:

[0186] The test strip has:

[0187] A second member containing a labeled antibody that recognizes luteinizing hormone in leucorrhea; and

[0188] A third member having a display unit containing a capture antibody,

[0189] The capture antibody can capture the complex formed by the binding of the labeled antibody and luteinizing hormone,

[0190] The test strip is configured such that luteinizing hormone in the leucorrhea moves from the second member to the display unit of the third member,

[0191] And it is configured such that the capture antibody captures the complex, thereby causing the display unit of the third member to develop color.

[0192] According to the absorbent article described in Scheme 4-2, luteinizing hormone can be detected simply and quickly by means of a color reaction.

[0193] The method of introducing leucorrhea (or leucorrhea components) into the test strip is not particularly limited. For example, it can be introduced by bringing leucorrhea into local contact with the test strip.

[0194] In one scheme of the absorbent article of the present disclosure, the test strip has a first member that comes into contact with leucorrhea. In this case, the test strip can be configured such that luteinizing hormone in leucorrhea moves from the first member via the second member to the display unit of the third member.

[0195] <Scheme 5>

[0196] In one embodiment of the absorbent article of the present disclosure, the first member, the second member, and the third member of the test strip are stacked at least partially overlapping each other in this order.

[0197] The total thickness of the first member, the second member, and the third member in the stacking direction is 1.5 mm or less.

[0198] As described above, leucorrhea has relatively high viscosity and low fluidity. In addition, the amount of leucorrhea is less than that of urine and the like. Therefore, especially in the detection using the immunochromatographic method, in the conventional method, it is difficult to detect LH in leucorrhea.

[0199] In addition, the inventors of the present case found that the amount of LH in leucorrhea is less than that in urine. In the conventional test strip, it is not easy to detect LH in leucorrhea.

[0200] In contrast, in the absorbent article of Scheme 5, since the thickness of the members constituting the test strip is reduced, the amount of liquid required to be held on the test strip for detection is relatively reduced. Therefore, according to the absorbent article of Scheme 5, even when leucorrhea with a small amount, high viscosity, and a small amount of LH is used as the detection target, LH can be detected well.

[0201] The suitable range of the thickness (film thickness) of each member is 90 μm to 230 μm, more preferably 100 μm to 220 μm. In particular, the suitable range of the thickness (film thickness) of each member is 160 μm to 230 μm, more preferably 180 μm to 220 μm.

[0202] <Scheme 6>

[0203] In one aspect of the absorbent article of the present disclosure,

[0204] The first member is formed of fibers having an average fiber diameter of 0.5 μm to 5 μm (or a fineness of 0.01 dtex to 0.1 dtex),

[0205] The second member is formed of fibers having an average fiber diameter of 10 μm to 40 μm (or a fineness of 2 dtex to 6 dtex),

[0206] The average fiber diameter of the fibers of the first member is smaller than the average fiber diameter of the fibers of the second member.

[0207] As described above, leucorrhea has relatively high viscosity and low fluidity. Therefore, especially in the detection using the immunochromatographic method, it is difficult to detect LH in leucorrhea. In addition, the inventors of the present case found that the amount of LH in leucorrhea is less than that in urine.

[0208] In contrast, in the test strip of Embodiment 6, since the average fiber diameter of the components constituting the test strip is optimized, even a small amount of highly viscous leucorrhea can be efficiently moved to the detection site (display part), enabling good detection.

[0209] The first component is preferably formed of fibers having an average fiber diameter of 1 μm to 4 μm, more preferably formed of fibers having an average fiber diameter of 1.5 μm to 3 μm.

[0210] The first component is preferably formed of fibers having a fineness of 0.02 dtex to 0.08 dtex, more preferably formed of fibers having a fineness of 0.03 dtex to 0.06 dtex.

[0211] The second component is preferably formed of fibers having an average fiber diameter of 15 μm to 30 μm, more preferably formed of fibers having a fiber diameter of 18 μm to 25 μm.

[0212] The second component is preferably formed of fibers having a fineness of 2.5 dtex to 5 dtex, more preferably formed of fibers having a fineness of 3 dtex to 5 dtex.

[0213] Preferably, the average fiber diameter of the fibers of the first component is smaller than the average fiber diameter of the fibers of the second component. In this case, especially for highly viscous leucorrhea, absorption in the first component can be further improved.

[0214] The average fiber diameters of the fibers constituting the first component and the second component can be measured using a scanning electron microscope, and the average value of the fiber diameters measured for N = 30 or more fibers can be used as the average fiber diameter. In addition, when measuring using a cross-section, there is a possibility of fiber shape change during cutting, so care should be taken. Also, when measuring in the planar direction, since there may be welding, avoid measuring at parts with shape changes such as welded parts.

[0215] <Mode 7>

[0216] In one embodiment of the absorbent article of the present disclosure, the average fiber diameter R1 of the fibers constituting the first component and the average fiber diameter R2 of the fibers constituting the second component satisfy the relationship of 5 ≤ (R2 / R1) ≤ 20.

[0217] According to this solution, since the correspondence relationship between the average fiber diameters of the first component and the second component constituting the test strip is optimized, as a result, even a small amount of highly viscous vaginal discharge can be efficiently moved to the detection site (display part), and detection can be performed well. That is, especially for highly viscous vaginal discharge, the absorbency in the first component is improved. In addition, in the second component, an effect of increasing the loading rate of the labeled antibody can also be obtained.

[0218] In a more preferred solution, it satisfies

[0219] 6 ≤ (R2 / R1) ≤ 18

[0220] 7 ≤ (R2 / R1) ≤ 16

[0221] 8 ≤ (R2 / R1) ≤ 14

[0222] 9 ≤ (R2 / R1) ≤ 12.

[0223] <Solution 7-2>

[0224] In one solution of the absorbent article of the present disclosure, the fineness D1 of the fibers constituting the first component and the fineness D2 of the fibers constituting the second component satisfy the relationship of 50 ≤ (D2 / D1) ≤ 200.

[0225] According to this solution, since the correspondence relationship between the finenesses of the first component and the second component constituting the test strip is optimized, as a result, even a small amount of highly viscous vaginal discharge can be efficiently moved to the detection site (display part), and detection can be performed well.

[0226] In a more preferred solution, it satisfies

[0227] 60 ≤ (D2 / D1) ≤ 190

[0228] 70 ≤ (D2 / D1) ≤ 180

[0229] 80 ≤ (D2 / D1) ≤ 170

[0230] 90 ≤ (D2 / D1) ≤ 160.

[0231] <Solution 8>

[0232] The absorbent article of one embodiment of the present disclosure satisfies at least one of the following conditions:

[0233] (a) The second component has a unit area weight of 100 gsm or more,

[0234] (b) The total thickness of the first member, the second member, and the third member is 1.5 mm or less, and the thickness of the second member accounts for 30% or more of the total thickness.

[0235] (c) The second member has a density of 0.05 g / m 3 ~0.80 g / m 3 .

[0236] According to the invention described in Embodiment 8, the unit area weight, thickness, and / or density of the second member (bonding pad) is optimized, thereby improving the diffusibility of the labeled antibody and the like. Therefore, even for leukorrhea with relatively high viscosity, detection can be performed well. In addition, within this range (especially the range of (c)), good liquid transferability and color development can be ensured.

[0237] <Embodiment 9>

[0238] In one embodiment of the absorbent article of the present disclosure, the labeled antibody has a coloring agent having a particle size of 10 nm to 500 nm.

[0239] When the coloring agent of the labeled antibody that binds to LH has a particle size of 10 nm to 500 nm, sufficient detectability can be ensured.

[0240] Examples of such coloring agents include gold colloids and cellulose nanoparticles. Gold colloids generally have a particle size of about 40 nm to 100 nm.

[0241] <Embodiment 10>

[0242] In the absorbent article according to one embodiment of the present disclosure, the labeled antibody has a coloring agent having a particle size of 250 nm to 500 nm (preferably 280 nm to 450 nm, more preferably 300 nm to 400 nm). Examples of such coloring agents include cellulose nanoparticles.

[0243] As described above, the inventors of the present case have found that the amount of LH in leukorrhea is less than that in urine. In this case, it is not easy to detect LH in leukorrhea with conventional test strips (especially those targeting LH in urine).

[0244] In contrast, in the test strip of Embodiment 10, since the labeled antibody that binds to LH has a coloring agent having a relatively large particle size, the visual recognition of detection is improved. Therefore, even when detecting leukorrhea with a small amount of LH, LH can be detected well.

[0245] <Embodiment 10-2>

[0246] In one embodiment of the absorbent article of the present disclosure, the test strip has a moving portion that connects the first member and the display portion, and has a first direction that is the moving direction of the leucorrhea component from the moving portion to the display portion, a second direction that is orthogonal to the first direction, and a thickness direction that is orthogonal to the first direction and the second direction.

[0247] The test strip has a central region located at the center in the second direction and side regions located at both ends in the second direction in a region obtained by dividing the test strip into five equal parts in the second direction.

[0248] The moving portion and the display portion are disposed at least in the central region and the side regions.

[0249] The maximum thickness of the central region is thicker than the maximum thickness of the side regions, and / or the average thickness of the central region is thicker than the average thickness of the side regions.

[0250] In the test strip of the absorbent article of this embodiment, the average thickness of the central region is thicker than the average thickness of the side regions, and a relatively large volume of the space for moving the excrement component can be ensured. As a result, in the central region, the leucorrhea component easily moves in the first direction, and at the display portion in the central region, a color development reaction is easily displayed. By displaying the color development reaction at the center in the second direction of the test strip, the wearer can easily visually recognize the color development reaction, and the visual recognition of the inspection result can be improved. In addition, in particular, the above-mentioned first direction and second direction can also be defined in the plane of the test strip. In this case, the second direction is orthogonal to the first direction in the plane of the test strip. The above-mentioned regions divided into five equal parts, particularly the central region and the side regions, can extend along the first direction.

[0251] <Solution 10-3>

[0252] In one embodiment of the absorbent article of the present disclosure, the display portion of the test strip can be visually recognized from the skin side of the absorbent article.

[0253] The test strip includes:

[0254] A transfer inhibition upper layer that inhibits the transfer of the wearer's excrement to the display portion of the test strip; and

[0255] A transfer inhibition lower layer that inhibits the transfer of the wearer's excrement to the display portion.

[0256] The transfer inhibition upper layer and the transfer inhibition lower layer abut against each other on the outside of the test strip in the width direction of the test strip.

[0257] In the absorbent article of this solution, the test strip has a transfer-inhibiting upper layer and a transfer-inhibiting lower layer, and these layers abut against the outside of the test strip in the width direction of the test strip. Therefore, it is possible to inhibit the accidental mixing of excrement (leukorrhea) from the width direction and / or the thickness direction of the test strip. In particular, it is possible to inhibit the excrement (especially leukorrhea) from directly transferring to the display part without passing through the sample pad and the conjugate pad of the test strip. As a result, this absorbent article can detect the antigen contained in leukorrhea in a state not easily affected by leukorrhea or the like.

[0258] The transfer-inhibiting upper layer and the transfer-inhibiting lower layer abut against the outside of the test strip in the width direction. More specifically, for example, it means that the two end portions in the width direction of the transfer-inhibiting upper layer and the transfer-inhibiting lower layer extend beyond the two end portions in the width direction of the test strip and abut against each other. That is, for example, when viewed from the skin side, the transfer-inhibiting upper layer and the transfer-inhibiting lower layer have a width wider than that of the test strip and abut against each other at the two end portions in the width direction.

[0259] The "transfer-inhibiting lower layer" can, for example, inhibit the transfer of excrement absorbed by the absorbent body to the display part when the test strip is disposed between the topsheet and the absorbent body.

[0260] In addition, in the absorbent article of Solution 10-3, since the test strip can be visually recognized from the skin side of the absorbent article, the position of the test strip of the absorbent article can be grasped during wearing, and the test strip can be disposed at an appropriate position. In addition, since the test strip can be visually recognized from the skin side, by visually recognizing the absorbent article from the skin side of the absorbent article, the inspection result can be grasped without peeling off the absorbent article from the wearing article or taking off the absorbent article from the wearing article.

[0261] The transfer-inhibiting upper layer and the transfer-inhibiting lower layer can each be a sheet, for example, a sheet formed of a hydrophobic material, especially a liquid-impermeable sheet. Compared with a sheet having an inter-fiber distance such as a non-woven fabric, the liquid-impermeable sheet has lower air permeability.

[0262] By sandwiching the test strip with two sheets as the transfer-inhibiting upper layer and the transfer-inhibiting lower layer, the object to be inspected can be held, and in addition, the drying of the test strip can be prevented. That is, an appropriate humidity can be maintained, and when leukorrhea and leukorrhea components are introduced, the leukorrhea components and the like can move smoothly, and the inspection can be appropriately performed.

[0263] The "transfer-inhibiting upper layer" and the "transfer-inhibiting lower layer" have a sealing part that seals their outer edges. In particular, the sealing part is formed at least along the two end portions in the width direction of the test strip, so that the transfer of excrement (especially leukorrhea) to the test strip can be inhibited.

[0264] The "transfer-inhibiting upper layer" and the "transfer-inhibiting lower layer" are preferably configured to not only inhibit the transfer of the wearer's excrement to the display portion of the test strip, but also inhibit the transfer of the wearer's excrement to the moving portion (e.g., Figure 1 66A in

[0265] <Solution 11>

[0266] In one embodiment of the absorbent article of the present disclosure, the absorbent article has a topsheet,

[0267] When using the absorbent article, the leucorrhea reaches the test strip via the topsheet.

[0268] According to the invention of Solution 11, the topsheet can be used to alleviate the discomfort during wearing caused by the test strip.

[0269] <Solution 11-2>

[0270] In one embodiment of the absorbent article of the present disclosure, the absorbent article has a front-back direction, a width direction orthogonal to the front-back direction, and a thickness direction orthogonal to the front-back direction and the width direction.

[0271] In the thickness direction, from the skin side of the wearer during use, there are further a topsheet and an absorbent body containing an absorbent material in sequence.

[0272] The test strip is disposed between the topsheet and the absorbent body.

[0273] According to this solution, since the test strip is disposed between the topsheet and the absorbent body (absorbent core), during the transfer of the excreted leucorrhea to the absorbent article, the leucorrhea can be efficiently transferred to the test strip (especially the first member of the test strip).

[0274] <Solution 11-3>

[0275] In one embodiment of the absorbent article of the present disclosure,

[0276] The test strip has:

[0277] A second member containing a labeled antibody that recognizes luteinizing hormone in leucorrhea; and

[0278] A third member having a display portion containing a capture antibody,

[0279] The capture antibody can capture the complex formed by the binding of the labeled antibody and luteinizing hormone,

[0280] The test strip is configured such that luteinizing hormone in vaginal discharge moves from the second member to the display portion of the third member.

[0281] And it is configured such that the complex is captured by the capture antibody, thereby causing the display portion of the third member to develop color.

[0282] The skin-side sheet having a coloring region is disposed at a position closer to the skin side than the test strip.

[0283] The labeled antibody in the second member of the test strip has a coloring agent.

[0284] When viewed from the skin side, the labeled antibody in the second member is covered by the coloring region of the skin-side sheet.

[0285] According to this aspect, when viewed from the skin side, the colored labeled antibody in the second member (e.g., conjugate pad) of the test strip is covered by the coloring region of the skin-side sheet. According to such an aspect, when the user visually recognizes the absorbent article before use from the skin side, it is difficult to visually recognize the colored labeled antibody, and misrecognition that the test member has already reacted can be suppressed before using the absorbent article.

[0286] In addition, since the labeled antibody in the second member (especially the reaction portion) of the test strip is colored, compared with the structure in which the labeled antibody is not colored, not only the labeled antibody is conspicuous relative to the surroundings, but also the complex is conspicuous relative to the surroundings. Therefore, during the inspection process, the regions other than the colored portion of the display portion are also colored, indicating that the inspection is in progress. Furthermore, after the inspection is completed, the complex and the display portion after the color development reaction using the complex can be made conspicuous. By making the display portion after the color development reaction conspicuous, the user can accurately and easily grasp the inspection result, and misrecognition by the user can be suppressed.

[0287] The method of introducing vaginal discharge (or vaginal discharge components) into the test strip is not particularly limited. For example, it can be introduced by bringing the vaginal discharge into local contact with the test strip. In one embodiment, the test strip has a first member that comes into contact with the vaginal discharge. In this case, the test strip can be configured such that luteinizing hormone in the vaginal discharge moves from the first member via the second member to the display portion of the third member.

[0288] In addition, for a more detailed specific aspect of the test strip of Aspect 11 - 3, reference can be made to the above description of the test strip.

[0289] <Aspect 12>

[0290] In one embodiment of the absorbent article of the present disclosure, the detection is performed by bringing at least a part of the topsheet into direct contact with the vulva.

[0291] According to the invention of Solution 12, since the leucorrhea adhering to the vulva can be recovered into the absorbent article, even a small amount of leucorrhea can be efficiently detected.

[0292] In particular, the absorbent article is configured such that, when worn, the portion of the test strip for adhering leucorrhea (especially the first member) is disposed in the excretory opening abutting region.

[0293] <Solution 13>

[0294] In one embodiment of the absorbent article of the present disclosure, the basis weight per unit area of the topsheet is 20 gsm or less.

[0295] According to the invention of Solution 13, since the basis weight per unit area of the topsheet is reduced, leucorrhea, which is a liquid substance having high viscosity, can relatively easily pass through the topsheet and contact the test strip. Thus, even when the discharge amount of leucorrhea is relatively small, for example, detection can be performed well.

[0296] In addition, according to the invention of Solution 13, since the basis weight per unit area of the topsheet is relatively reduced, the visual recognition of the test strip through the topsheet can be ensured.

[0297] In addition, according to the invention of Solution 13, by relatively reducing the basis weight per unit area of the topsheet, the topsheet becomes relatively soft. Therefore, the close contact with the wearer's body is improved. Thus, even when leucorrhea adheres to and remains on the wearer's body, the leucorrhea adhering to the body can be transferred to the topsheet by the wearer's movement or the like. Therefore, even when the discharge amount of leucorrhea is relatively small, it can be brought into contact with the test strip, and thus detection can be performed well.

[0298] <Solution 14>

[0299] In one embodiment of the absorbent article of the present disclosure, the thickness of the topsheet is 1 mm or less.

[0300] According to the invention of Solution 14, since the thickness of the topsheet is reduced, leucorrhea, which is a liquid substance having high viscosity, can relatively easily pass through the topsheet and reach the test strip. Thus, even when the discharge amount of leucorrhea is relatively small, detection can be performed well.

[0301] In addition, according to the invention of Solution 14, since the thickness of the topsheet is relatively reduced, the visual recognition of the test strip through the topsheet can be ensured.

[0302] In addition, according to the invention of Solution 14, by relatively reducing the thickness of the topsheet, the topsheet becomes relatively soft. Therefore, the close-fitting property to the wearer's body is improved. Thus, even when leucorrhea adheres to and remains on the wearer's body, the leucorrhea adhering to the body can be transferred to the topsheet by the wearer's movements or the like. Therefore, even a small amount of leucorrhea can be detected well.

[0303] <Solution 15>

[0304] In one embodiment of the absorbent article of the present disclosure, the single fiber diameter of the fibers constituting the topsheet is 8.0 dtex or less.

[0305] According to the invention of Solution 15, since the fiber diameter of the topsheet located between the wearer and the test strip is reduced, the gaps in the topsheet become relatively large. Therefore, leucorrhea, which is a liquid substance with high viscosity, can relatively easily pass through the topsheet and reach the test strip. Thus, even when the discharge amount of leucorrhea is relatively small, detection can be performed well.

[0306] In addition, according to the invention of Solution 15, by relatively reducing the fiber diameter of the topsheet, the topsheet becomes relatively soft. Therefore, the close-fitting property to the wearer's body is improved. Thus, even when leucorrhea adheres to and remains on the wearer's body, the leucorrhea adhering to the body can be transferred to the topsheet by the wearer's movements or the like. Therefore, even a small amount of leucorrhea can be detected well.

[0307] The single fiber diameter of the fibers constituting the topsheet is more preferably 5.0 dtex or less, and further preferably 3.0 dtex. If the single fiber diameter of the fibers constituting the topsheet is 3.0 dtex or less, particularly good skin feel can be obtained.

[0308] <Solution 16>

[0309] In one embodiment of the absorbent article of the present disclosure,

[0310] the basis weight per unit area of the topsheet is 5 gsm or more,

[0311] the thickness of the topsheet is 0.1 mm or more,

[0312] and the single fiber diameter of the fibers constituting the topsheet is 1.0 dtex or more.

[0313] When leucorrhea is brought into contact with the test strip via the topsheet, in order to make the leucorrhea with relatively high viscosity contact the test strip well, it is necessary to improve the permeability of the topsheet.

[0314] In addition, when the leucorrhea contacts the test strip via the topsheet, it is necessary to ensure the visual recognition of the test strip and the wearability (tactile sensation) of the topsheet.

[0315] Furthermore, in order to efficiently collect a small amount of discharged leucorrhea and bring it into contact with the test strip, it is important to ensure the softness of the topsheet so that the leucorrhea attached to the body can be transferred to the topsheet (followability) by the wearer's movements, etc.

[0316] According to the invention described in Embodiment 16, an absorbent article can be obtained that satisfies all of the above requirements (i.e., "liquid permeability", "visual recognition", "wearability", "followability") important for detecting LH well from leucorrhea at a high level.

[0317] <Embodiment 17>

[0318] In one embodiment of the absorbent article of the present disclosure,

[0319] the topsheet has an embossed pattern at least partially,

[0320] and the width of the test strip is larger than the size and / or interval of each pattern of the embossed pattern.

[0321] When the topsheet is embossed, the fibers constituting the topsheet become thicker due to the embossing. As a result, the liquid permeability of the leucorrhea and / or the visual recognition through the topsheet decrease at the embossed pattern portion.

[0322] In contrast, according to the invention of Embodiment 17, since the width of the test strip is relatively large, it is possible to avoid a decrease in liquid permeability and / or visual recognition caused by the embossed pattern.

[0323] <Embodiment 18>

[0324] In one embodiment of the absorbent article of the present disclosure,

[0325] the topsheet has an embossed pattern partially,

[0326] and the test strip can contact the leucorrhea through a portion of the topsheet that does not have the embossed pattern.

[0327] When the topsheet is embossed, the fibers constituting the topsheet become thicker due to the embossing. As a result, the liquid permeability of the leucorrhea and / or the visual recognition through the topsheet decrease at the embossed pattern portion.

[0328] In contrast, according to the invention of Embodiment 18, since the width of the test strip is relatively large, it is possible to avoid a decrease in liquid permeability and / or visual recognition caused by the embossed pattern.

[0329] <Embodiment 19>

[0330] In one embodiment of the absorbent article of the present disclosure,

[0331] the topsheet does not contain TiO 2 .

[0332] According to the invention described in Scheme 19, since the visual recognition of the topsheet is further improved, the visual recognition performance of the test strip through the topsheet is further improved.

[0333] <Scheme 20>

[0334] According to the absorbent article described in any one of Schemes 11 to 19, wherein

[0335] the test strip has a sample pad as the first member in contact with leucorrhea, and the sample pad is disposed at a position opposite to the wearer's vaginal part during wearing,

[0336] the average fiber diameter of the fibers constituting the sample pad is the same as or smaller than the average fiber diameter of the fibers constituting the topsheet.

[0337] According to the invention described in Scheme 20, since the solid matter that cannot be filtered by the topsheet can be filtered by the sample pad, it is easier to detect LH in leucorrhea.

[0338] <Scheme 20-2>

[0339] In one embodiment, the test strip has a sample pad as the first member in contact with leucorrhea, and the sample pad is disposed at a position opposite to the wearer's vaginal part during wearing,

[0340] the topsheet and the sample pad are made of a sheet material having fibers,

[0341] the average fiber distance of the topsheet is longer than the average fiber distance of the sample pad.

[0342] According to this scheme, since the excrement (especially leucorrhea) in the topsheet is easily transferred to the first member (especially the sample pad) with a relatively narrow fiber distance, even a small amount of leucorrhea is easier to detect with the test strip.

[0343] <Scheme 21>

[0344] A test strip, which is a test strip for an absorbent article and uses an immunochromatographic method for detecting luteinizing hormone in leucorrhea, wherein

[0345] luteinizing hormone of 0.05 mIU / mL to 2.5 mIU / mL is detected as positive.

[0346] The test strip that detects luteinizing hormone (LH) at a positive level in the range of 0.05 mIU / mL to 2.5 mIU / mL can detect LH in leucorrhea with high reliability.

[0347] In addition, by using this test strip in an absorbent article, different from the conventional method for detecting LH in urine, it can reduce the burden on users in terms of not requiring intentional collection, etc., and can predict the ovulation day with high reliability.

[0348] Furthermore, by using this test strip in an absorbent article, different from the conventional LH test kit for urine, it can very simply predict the ovulation day, and also has the effect of causing less psychological resistance.

[0349] Moreover, in the immunochromatographic method, there are cases where a relatively long time (e.g., 10 minutes) is required for detection. However, by using this test strip in an absorbent article, the detection reaction can be carried out only by wearing the absorbent article, along with the discharge of leucorrhea, so the prediction of the ovulation day becomes simpler.

[0350] In addition, different from the conventional use of urine, by using this test strip in an absorbent article, it also has the advantage that the detection can be carried out without worrying about getting hands dirty.

[0351] As described above, according to the solution 21 of the present application, a test strip that can more simply predict the ovulation day than before can be provided.

[0352] In addition, for the detailed content of the test strip of solution 21, reference can be made to the description of the absorbent article regarding the above solutions 1 to 20 (especially the description related to the test strip).

[0353] <Schematic structure of the absorbent article>

[0354] The absorbent article 1 of the embodiment will be described with reference to the drawings. The absorbent article can be an absorbent article such as a sanitary pad. In the following embodiments, as an example of the absorbent article, a sanitary pad will be described. In addition, the drawings are not necessarily to scale and do not limit the present invention.

[0355] Figure 3-1 The absorbent article 1 can have an absorbent core 20, a topsheet 30, a backsheet, an adhesive portion, and a test strip (inspection member) 60. The absorbent core 20 contains an absorbent material for absorbing liquid. The absorbent material can be composed of at least one of pulp and a superabsorbent polymer, for example.

[0356] Figure 3-1The absorbent article 1 may have a longitudinal direction L, a width direction W, and a thickness direction T. The longitudinal direction L is the direction extending from the front side (ventral side) to the back side (dorsal side) of the user, or the direction extending from the back side to the front side of the user. The width direction W is the direction orthogonal to the longitudinal direction L. The thickness direction T is the direction extending from the skin-facing side to the non-skin-facing side of the user, or the direction extending from the non-skin-facing side to the skin-facing side of the user. Further, the thickness direction T is the direction orthogonal to the longitudinal direction L and the width direction W. The skin-facing side corresponds to the side facing the user's skin during use. The non-skin-facing side corresponds to the side opposite to the skin-facing side during use, i.e., the side facing away from the user's skin.

[0357] As Figure 3-1 shown, the absorbent article 1 may have a front side region S1, a back side region S2, and a central region S3. The front side region S1 is located at a position anterior to the central region S3, and the back side region S2 is located at a position posterior to the central region S3. The central region S3 includes a region that abuts against the user's excretory opening (e.g., vaginal opening). It may be that the front side region obtained by trisecting the absorbent article 1 in the longitudinal direction L is the front side region S1, the back side region is the back side region S2, and the central region between the front side region S1 and the back side region S2 is the central region S3. When the absorbent article 1 has wing portions, the central region S3 may be the region from the front edge to the back edge of the root of the wing portion. Further, the wing portion is a part that is folded back to the non-skin-facing side of the wearing article when using the absorbent article 1.

[0358] The absorbent article 1 may have an absorbent core (absorbent body) 20, a topsheet 30 (especially a surface sheet 31), a non-skin side sheet, an adhesive portion, and a test strip (inspection member) 60. The absorbent core 20 contains an absorbent material for absorbing liquid. The absorbent material may be composed of, for example, at least one of pulp and superabsorbent polymer.

[0359] The topsheet 30 is disposed at a position closer to the skin-facing side T1 than the absorbent body 20. The topsheet 30 may be the surface sheet 31 disposed at a position closer to the skin-facing side than the test strip 60. The surface sheet 31 faces the user's skin. The surface sheet 31 may also be composed of a plurality of sheets. In an embodiment, the topsheet 30 is composed of the surface sheet 31. The surface sheet 31 (topsheet 30) may be composed of, for example, spunlace nonwoven fabric, thermal bonded nonwoven fabric, spunbond nonwoven fabric, SMS nonwoven fabric, etc.

[0360] The visible light transmittance of the surface sheet 31 may be 60% or more. Preferably, the visible light transmittance of the surface sheet 31 may be 70% or more, and more preferably, the visible light transmittance of the surface sheet 31 may be 80% or more. The basis weight per unit area of the surface sheet 31 may be 90 gsm or less, may also be 30 gsm or less, and may further be 17 gsm or less. The thickness of the surface sheet 31 may be 5 mm or less.

[0361] The non-skin-side sheet 40 is disposed at a position closer to the non-skin surface side than the absorbent core 20. The non-skin-side sheet 40 may have a backsheet 41 facing the wearing article. The non-skin-side sheet 40 may be formed of, for example, a liquid-impermeable film. Further, the non-skin-side sheet 40 may be a sheet material having liquid impermeability and air permeability, such as a perforated plastic film.

[0362] An adhesive portion is provided on the non-skin surface of the non-skin-side sheet 40. The adhesive portion may be provided in a region overlapping the absorbent core 20 in the thickness direction T, or may be provided in a region not overlapping the absorbent core 20 in the thickness direction T. The adhesive portion may be provided on the wing. The absorbent article 1 is fixed to the wearing article by the adhesive portion.

[0363] Use Figure 3-1 The structure of the test strip will be further specifically described.

[0364] Figure 3-1 The test strip (inspection member) 60 has a display portion (62A, 62B) that can develop color based on excrement (leukorrhea). The test strip 60 has a contact portion (first member, such as a sample pad) 64 that comes into contact with leukorrhea. The test strip 60 may have a moving portion for the components contained in leukorrhea (hereinafter referred to as leukorrhea components) to move. In the moving portion, the leukorrhea components may move by capillary action. The moving portion may have a display moving portion 66A for the leukorrhea components to move from the contact portion 64 to the display portion (62A, 62B) and a terminal moving portion 66B for the leukorrhea components to move in a direction away from the display portion (62A, 62B). The terminal moving portion is a portion for the leukorrhea components and the like after passing through the display portion (62A, 62B) to move.

[0365] The contact portion (first member) 64 that comes into contact with leukorrhea may be formed of, for example, a pad (which may be referred to as a sample pad or a specimen pad). The leukorrhea components in the leukorrhea that come into contact with the contact portion 64 move in the pad, for example, and are transferred to the second member (such as a conjugate pad). The conjugate pad contains a labeled antibody that recognizes luteinizing hormone in leukorrhea. The conjugate pad (second member) is Figure 3-1Although not shown in the figure, it can be configured to overlap with the sample pad (the first member) in the thickness direction, for example. The white belt component, the complex formed by the antigen-antibody reaction with luteinizing hormone contained in the white belt component, and the labeled antibody can move in the moving part 66A by capillary action. The part for these substances to move can be composed of a membrane sheet, for example. The display part has a part 62A, and this part 62A contains a supplementary antibody that captures (binds) the formed complex. This part is colored when the complex is captured by the supplementary antibody. This part 62A of the display part can be called the test line.

[0366] The display part can have a part 62B, and this part 62B contains a capture antibody different from the part 62A that contains the capture antibody that captures the complex. The capture antibody of the part 62B can capture a complex different from the complex captured in the part 62A, or can capture the labeled antibody. The part 62B is colored by capturing the complex or the labeled antibody. The part 62B that captures the labeled antibody can be called the control line. The white belt component after passing through the display part 62 (that is, the component not supplemented by the capture antibody) moves in the terminal moving part 66B. The terminal moving part 66B can be composed of a membrane sheet. In addition, the terminal moving part 66B can have an adsorption pad that absorbs the white belt component after passing over the display part 62. Instead of the adsorption pad, the white belt component after passing over the display part 62 can be absorbed by the absorption core 20. In the case of using immunochromatography, the display part 62 and the contact part 64 are arranged at different positions. Therefore, in this case, the display part 62 and the contact part 64 are different.

[0367] The test strip (inspection member) 60 only needs to have a member that can hold or contain substances such as labeled antibodies and capture antibodies, and can be composed of any material such as paper, non-woven fabric, and fabric, for example.

[0368] The test strip (inspection member) 60 can be biased to one side in the front-rear direction L. As Figure 1As shown, the center CT of the front-back direction L of the inspection member 60 can be located at a position forward of the center CL of the front-back direction L of the absorbent article 1. In addition, the display units (62A, 62B) can be offset to one side in the front-back direction L. The display units (62A, 62B) can be located at a position forward of the center CL of the absorbent article 1, and the display units (62A, 62B) can be located at a position forward of the central region S3. The display unit 62 can be disposed in the front side region S1. Thus, since the display units (62A, 62B) are disposed at a position away from the excretory opening, it is possible to suppress the case where the color development of the display units (62A, 62B) is difficult to visually recognize due to leucorrhea. In particular, in the supine position, leucorrhea is not easily diffused to the front side region S1, so that it is possible to suppress the deterioration of the visual recognition of the color development caused by leucorrhea. In addition, in the inspection member 60 using the immunochromatography method, leucorrhea is not easily in direct contact with the display units (62A, 62B), so that the health state can be displayed with high precision.

[0369] In addition, the contact portion 64 can be offset to one side in the front-back direction L. The contact portion 64 can be located at a position forward of the center CL of the absorbent article 1. The contact portion 64 can be disposed in the crotch region (not shown). Since leucorrhea is easily in contact with the contact portion 64, the display unit is easily colored, and the user can easily confirm the health state. The contact portion 64 can be located at a position medial to the display units (62A, 62B) in the front-back direction L.

[0370] In the test strip 60, regarding the central region located at the center and the two side regions located at both ends when the region of the test strip is equally divided into five in the width direction W, the maximum thickness of the central region can be thicker than the maximum thickness of the side regions, and / or the average thickness of the central region can be thicker than the average thickness of the side regions.

[0371] The test strip (inspection member) is generally configured to have a plurality of members such as a moving portion and a display portion, and these plurality of members have their respective functions. If the respective constituent members are offset or curled, there is a risk of a decrease in inspection accuracy. When wearing the absorbent article, there is such a risk that an external force is applied to the inspection member due to the movement of the wearer or the like, causing deformation, and thus positional deviation and curling of the members constituting the inspection member occur.

[0372] On the contrary, in the case where the maximum thickness and / or the average thickness of the side regions are thinner than the maximum thickness and / or the average thickness of the central region, there is such a situation that the edge of the inspection member is not easily caught, and curling at the edge of the inspection member can be suppressed, thereby maintaining the inspection accuracy.

[0373] In addition, by suppressing the curling and twisting of the edge of the test strip, it is possible to suppress local variations in the thickness and density of each constituent member. If the thickness and density vary locally, there is a risk that the movement of excretory components will stagnate or the color development reaction will be difficult to perform at the varying portions. By suppressing local variations in the thickness and density of each constituent member, it is thus possible to suppress a decline in inspection accuracy.

[0374] A conceptual diagram of the test strip is shown in the appendix Figure 3-2 Regarding other structures of the test strip, for example, reference can be made to the description in WO2021 / 132724A1.

[0375] Figure 3-3 is a cross-sectional schematic view of an absorbent article according to one embodiment of the present invention. The test strip (inspection member) is disposed between the topsheet and the absorbent core (absorbent body). In the illustrated embodiment, a second sheet is disposed between the absorbent core and the test strip (inspection member).

[0376] Figure 3-4 is a cross-sectional schematic view of an absorbent article according to one embodiment of the present invention. The test strip has a sample pad, a conjugate pad, and a membrane (including a display portion). When observing the absorbent article from the skin side, the colored region carried on the first skin-side sheet covers the conjugate pad (second member). Further, in the illustrated embodiment, the pad located on the downstream side of the membrane having the display portion is also covered by the colored region.

[0377] <Method for Detecting Luteinizing Hormone from Leukorrhea>

[0378] The present disclosure includes a method for detecting luteinizing hormone from leukorrhea using an absorbent article having a test strip employing immunochromatography, the method including a step of attaching leukorrhea to the test strip of the absorbent article, in which luteinizing hormone at a concentration of 0.05 mIU / mL to 2.5 mIU / mL is detected as positive in the test strip.

[0379] Regarding the detailed content of each constituent element such as the absorbent article and the test strip in this method, reference can be made to the above description related to the test strip and the absorbent article.

[0380] Regarding the method of attaching leukorrhea to the test strip of the absorbent article, there is no particular limitation, and reference can be made to the above description related to the absorbent article and the test strip. For example, the present wearing article can be configured such that leukorrhea excreted from a wearer wearing the present absorbent article attaches to the test strip (particularly the first member of the test strip) during wearing. Additionally, for example, the absorbent article has a topsheet, and during use of the absorbent article, leukorrhea reaches the test strip via the topsheet, whereby leukorrhea can be attached to the test strip of the absorbent article. Preferably, at least a part of the topsheet is in direct contact with the vulva.

[0381] In one embodiment of the above method, luteinizing hormone at a level of 0.05 mIU / mL to 1.0 mIU / mL, or 0.05 mIU / mL to 0.5 mIU / mL, or further 0.05 mIU / mL to 0.2 mIU / mL is detected as positive.

[0382] <Absorbent article for inferring ovulation date>

[0383] The present disclosure includes the following absorbent article (“Solution X1”):

[0384] An absorbent article having a test strip using immunochromatography for detecting luteinizing hormone (LH) from leucorrhea, wherein

[0385] the test strip is configured to infer that the wearer of the absorbent article is in the period from 5 days before the ovulation date to the ovulation date.

[0386] The absorbent article according to Solution X1 can provide an absorbent article capable of grasping the period suitable for pregnancy activities at an earlier timing than before. In particular, according to this solution, an absorbent article capable of grasping the period suitable for pregnancy activities at an earlier timing and with relatively high accuracy can be provided.

[0387] In addition, according to Solution X1, an absorbent article capable of predicting the ovulation date more simply than before can be provided.

[0388] In conventional ovulation date prediction methods, particularly those using LH in urine, there are cases where the predicted ovulation date approaches and the timing of pregnancy activities is inappropriate, resulting in missed opportunities. In addition, in the prediction of the ovulation date based on the menstrual cycle, there are cases where the accuracy of determining the ovulation date is low and the results of pregnancy activities cannot be fully obtained. In addition, regarding the present disclosure, “pregnancy activities” refers to the situation of having sexual intercourse for the purpose of having a baby.

[0389] Furthermore, conventional ovulation date prediction methods using urine as the detection target have problems in terms of simplicity, and there are also problems such as the detection operation and obtaining the results taking time and effort. That is, in conventional ovulation date prediction methods, there are cases where pregnancy activities cannot be carried out appropriately.

[0390] Specifically, for example, the surge of LH in urine peaks locally within two days including the ovulation date. By using the LH value in urine, two days including the ovulation date can be determined. However, there are cases where even if the user grasps two days including the ovulation date through the examination of LH in urine, the ovulation date is approaching and pregnancy activities cannot be planned, and even if the ovulation date is grasped, pregnancy activities cannot be carried out.

[0391] In addition, to facilitate the planning of pregnancy activities, the ovulation day is predicted based on the menstrual cycle. However, in the prediction of the ovulation day based on the menstrual cycle, the accuracy of determining the ovulation day is low, and the results of pregnancy activities cannot be fully obtained. Generally speaking, menstruation occurs around 14 days after the ovulation day, but there are cases where it varies depending on changes in physical condition, etc., and it only gives a rough indication of the ovulation day.

[0392] In contrast, the absorbent article of the above-mentioned Solution X1 has a test strip using immunochromatography for detecting luteinizing hormone (LH) from vaginal discharge, and the test strip is configured to infer that the wearer of the absorbent article is in the pregnancy activity period from 5 days before the ovulation day to the ovulation day itself. More specifically, the absorbent article of the above-mentioned Solution X1 detects LH in the vaginal discharge excreted during the pregnancy activity period from 5 days before the ovulation day to the ovulation day itself, for example, by color development, etc., and thus can determine with relatively high accuracy that the wearer is in the pregnancy activity period from 5 days before the ovulation day to the ovulation day itself.

[0393] The invention of this Solution X1 is based on such a new insight: by paying attention to LH in vaginal discharge, the ovulation scheduled day can be predicted earlier than before. That is, the inventors of this case found that by using LH in vaginal discharge as the detection object, it is possible to determine with a relatively high probability that the wearer of the absorbent article is in the period from 5 days before the ovulation day to the ovulation day itself (the period suitable for pregnancy activities).

[0394] According to this Solution X1, compared with the case where the LH surge in urine is used as an indicator, the ovulation day can be grasped from an earlier period, so the possibility of ensuring more opportunities for pregnancy activities increases, and pregnancy activities can be planned and carried out. In addition, compared with the conventional method of being able to grasp on the ovulation day or the day before, it is possible to reduce the burden of having to plan pregnancy activities on that day or the day before or two days before, and / or to suppress the situation where pregnancy activities cannot be carried out due to inability to plan in advance. As a result, it is possible to improve the execution of pregnancy activities while reducing the mental burden.

[0395] Furthermore, since the absorbent article of Solution X1 has a test strip using immunochromatography for detecting luteinizing hormone from vaginal discharge, compared with the prior art such as using the menstrual cycle as an indicator, the pregnancy activity period can be grasped with relatively high accuracy.

[0396] Furthermore, the absorbent article for absorbing vaginal discharge is an article commonly used. Therefore, for the absorbent article of Solution X1 of the present invention, the user can perform the inspection by wearing this absorbent article in the same way as the absorbent article usually worn.

[0397] Furthermore, since the inspection result of leucorrhea is awaited while in a worn state, there is no need for the time for awaiting the inspection result as in the case of an inspection member using urine, and the mental burden and time burden of the inspection can be reduced.

[0398] Appendix Figures 8-1 to 8-3 These are graphs showing the LH surge in leucorrhea. These graphs show that the LH surge in leucorrhea can be detected at an earlier stage than the LH surge in urine. From this result, it is also clear that by using the LH value in leucorrhea as an index, the period suitable for pregnancy activities (for example, the period from 5 days before ovulation day to ovulation day) can be grasped. Figures 8-1 to 8-3 The horizontal axis represents the number of days when the LH peak in urine is set to day 0.

[0399] The pregnancy activity period to which the test strip of Plan X1 can respond can be further limited. For example, it can also be the pregnancy activity period from 5 days before ovulation day to the day before ovulation day, the pregnancy activity period from 5 days before ovulation day to 2 days before ovulation day, the pregnancy activity period from 5 days before ovulation day to 3 days before ovulation day, or further the pregnancy activity period from 5 days before ovulation day to 4 days before ovulation day.

[0400] When the LH in leucorrhea is the detection target, it is not necessarily possible to detect only the above-mentioned specific pregnancy activity period. However, when the LH in leucorrhea is the detection target, the ovulation day can be predicted at a relatively earlier stage than before, and thus it is possible to determine with a higher probability than before that the wearer is in the above-mentioned pregnancy activity period.

[0401] The detailed structure of the absorbent article of the above Plan X1, that is, the absorbent article having a test strip configured to infer that the wearer of the absorbent article is in the period from 5 days before ovulation day to ovulation day, is not particularly limited. For example, it can be achieved by using the test strip of the following Plan X2.

[0402] This disclosure also includes the following absorbent article ("Plan X2"):

[0403] According to the absorbent article of the above Plan X1, the absorbent article has a test strip using immunochromatography for detecting luteinizing hormone from leucorrhea, wherein

[0404] the test strip detects luteinizing hormone of 0.05 mIU / mL to 10 mIU / mL as positive.

[0405] According to this Plan X2, it is possible to provide a test strip for an absorbent article that can grasp the period suitable for pregnancy activities at an earlier timing than before. In particular, according to this plan, it is possible to provide a test strip for an absorbent article that can grasp the period suitable for pregnancy activities at an earlier timing and with relatively high accuracy than before.

[0406] In addition, according to the above-described Solution X2, a test strip for an absorbent article that can predict the ovulation day more simply than before can be provided.

[0407] Although there is no intention to limit by theory, in conventional urine test strips, since the amount of luteinizing hormone (LH) to be detected is relatively large, the detection sensitivity is set relatively low accordingly. In contrast, in the invention of the above-described Solution X2 of the present invention, in order to detect luteinizing hormone in vaginal discharge in a relatively small amount, the detection sensitivity is set relatively high compared with conventional urine test strips. Therefore, according to the absorbent article of the above-described Solution X2 of the present invention, it is also possible to detect an increase in luteinizing hormone at an earlier stage that could not be detected before, and as a result, it is considered that an earlier stage before the ovulation day can be grasped.

[0408] <Test strip for inferring ovulation day>

[0409] In addition, the present disclosure includes the following test strip (“Solution Y1”):

[0410] A test strip, which is a test strip for an absorbent article and uses an immunochromatographic method for detecting luteinizing hormone in vaginal discharge, wherein

[0411] the test strip is configured to infer that the wearer of the absorbent article is in the period from 5 days before the ovulation day to the ovulation day.

[0412] Similar to the content described above regarding Solution X1, according to the test strip of Solution Y1, compared with, for example, the case where the LH surge in urine is used as an index, the ovulation day can be grasped at an earlier stage. Therefore, it is possible to increase the possibility of ensuring more opportunities for pregnancy activities and to plan pregnancy activities. In addition, compared with the conventional method of being able to grasp the ovulation day on the day of or the day before the ovulation day, it is possible to reduce the burden of having to plan pregnancy activities on that day or the day before or two days before, and / or to suppress the situation where pregnancy activities cannot be carried out due to inability to plan in advance. As a result, it is possible to improve the execution of pregnancy activities while reducing the mental burden.

[0413] Furthermore, since the test strip of Solution Y1 uses an immunochromatographic method for detecting luteinizing hormone from vaginal discharge, it is possible to accurately grasp the pregnancy activity period compared with existing technologies such as using the menstrual cycle as an index.

[0414] The following shows solutions related to the above-described Solution X1, Solution X2, and Solution Y1. For the detailed content of these solutions, reference can be made to the above description related to Solutions 1 to 21 of the present invention:

[0415] <Solution X1>

[0416] An absorbent article having a test strip using immunochromatography for detecting luteinizing hormone (LH) from vaginal discharge, wherein,

[0417] the test strip is configured to infer that the wearer of the absorbent article is in the period from 5 days before the ovulation day to the ovulation day.

[0418] <Scheme X2>

[0419] According to the absorbent article described in Scheme X1, having a test strip using immunochromatography for detecting luteinizing hormone from vaginal discharge, wherein,

[0420] the test strip detects luteinizing hormone in the range of 0.05 mIU / mL to 10 mIU / mL as positive.

[0421] <Scheme X3>

[0422] An absorbent article having a test strip using immunochromatography for detecting luteinizing hormone from vaginal discharge, wherein,

[0423] the test strip detects luteinizing hormone in the range of 0.05 mIU / mL to 2.5 mIU / mL as positive.

[0424] <Scheme X4>

[0425] According to the absorbent article described in any one of Schemes X1 to X3, wherein,

[0426] the test strip has a width of 10 mm or less.

[0427] <Scheme X5>

[0428] According to the absorbent article described in any one of Schemes X1 to X4, wherein,

[0429] the test strip has:

[0430] a second member containing a labeled antibody that recognizes luteinizing hormone in vaginal discharge; and

[0431] a third member having a display portion containing a capture antibody,

[0432] the capture antibody is capable of capturing the complex formed by the binding of the labeled antibody and luteinizing hormone,

[0433] the test strip is configured such that luteinizing hormone in the vaginal discharge moves from the second member to the display portion of the third member,

[0434] And it is configured to capture the complex by the capture antibody, thereby causing the display portion of the third member to develop color.

[0435] <Solution X6>

[0436] According to the absorbent article described in Solution X5, wherein,

[0437] The labeled antibody has a coloring agent having a particle size of 250 nm to 500 nm.

[0438] <Solution X7>

[0439] According to the absorbent article described in Solution X5 or Solution X6, wherein,

[0440] The test strip has a moving portion connecting the second member and the display portion, and has a first direction as the moving direction in which the leucorrhea component moves from the moving portion to the display portion, a second direction orthogonal to the first direction, and a thickness direction orthogonal to the first direction and the second direction.

[0441] The test strip has a central region located at the center in the second direction and side regions located at both ends in the second direction in a region obtained by dividing the test strip into five equal parts in the second direction.

[0442] The moving portion and the display portion are disposed at least in the central region and the side regions.

[0443] The maximum thickness of the central region is thicker than the maximum thickness of the side regions, and / or the average thickness of the central region is thicker than the average thickness of the side regions.

[0444] <Solution X8>

[0445] According to the absorbent article described in any one of Solutions X5 to X7, wherein,

[0446] The display portion of the test strip can be visually recognized from the skin side of the absorbent article.

[0447] The test strip includes:

[0448] A transfer-inhibiting upper layer that inhibits the excrement of the wearer from transferring to the display portion of the test strip; and

[0449] A transfer-inhibiting lower layer that inhibits the excrement of the wearer from transferring to the display portion.

[0450] The transfer-inhibiting upper layer and the transfer-inhibiting lower layer abut against each other on the outside of the test strip in the width direction of the test strip.

[0451] <Solution X9>

[0452] The absorbent article according to any one of Aspects X1 to X8, wherein,

[0453] the absorbent article has a topsheet,

[0454] when using the absorbent article, leukorrhea reaches the test strip via the topsheet.

[0455] <Aspect X10>

[0456] The absorbent article according to the description in Aspect X9, wherein,

[0457] the absorbent article has a front-back direction, a width direction orthogonal to the front-back direction, and a thickness direction orthogonal to the front-back direction and the width direction,

[0458] in the thickness direction, from the side of the wearer's skin during use, there are further provided the topsheet and an absorbent body containing an absorbent material in this order,

[0459] the test strip is disposed between the topsheet and the absorbent body.

[0460] <Aspect X11>

[0461] The absorbent article according to the description in Aspect X9 or Aspect X10, wherein,

[0462] the test strip has: a second member containing a labeled antibody that recognizes luteinizing hormone in leukorrhea; and a third member having a display portion containing a capture antibody,

[0463] the capture antibody can capture a complex formed by the binding of the labeled antibody and luteinizing hormone,

[0464] the test strip is configured such that luteinizing hormone in the leukorrhea moves from the second member to the display portion of the third member,

[0465] and is configured such that the capture antibody captures the complex, thereby causing the display portion of the third member to develop color,

[0466] a skin-side sheet having a colored region is disposed at a position closer to the skin side than the test strip,

[0467] the labeled antibody in the second member of the test strip has a coloring agent,

[0468] and when observed from the skin side, the labeled antibody in the second member is covered by the colored region of the skin-side sheet.

[0469] <Aspect X12>

[0470] An absorbent article according to any one of Aspects X9 to X11, wherein,

[0471] The detection is performed by bringing at least a part of the topsheet into direct contact with the vagina.

[0472] <Aspect X13>

[0473] An absorbent article according to any one of Aspects X9 to X12, wherein,

[0474] The test strip has a sample pad as a first member that comes into contact with vaginal discharge, and the sample pad is disposed at a position opposite to the vaginal part of the wearer during wearing.

[0475] The fiber diameter of the fibers constituting the sample pad is the same as or smaller than the fiber diameter of the fibers constituting the topsheet.

[0476] <Aspect X14>

[0477] An absorbent article according to any one of Aspects X9 to X13, wherein,

[0478] The test strip has a sample pad as a first member that comes into contact with vaginal discharge, and the sample pad is disposed at a position opposite to the vaginal part of the wearer during wearing.

[0479] The topsheet and the sample pad are made of a sheet material having fibers.

[0480] The average inter-fiber distance of the topsheet is longer than the average inter-fiber distance of the sample pad.

[0481] <Aspect Y1>

[0482] A test strip for an absorbent article, which uses an immunochromatographic method for detecting luteinizing hormone in vaginal discharge, wherein,

[0483] The test strip is configured to infer that the wearer of the absorbent article is in the period from 5 days before the ovulation day to the ovulation day.

[0484] <Aspect Y2>

[0485] A test strip for an absorbent article, which uses an immunochromatographic method for detecting luteinizing hormone in vaginal discharge, wherein,

[0486] Luteinizing hormone of 0.05 mIU / mL to 2.5 mIU / mL is detected as positive.

[0487] Examples

[0488] Hereinafter, the present invention will be specifically described with reference to embodiments. The present invention is not limited by these embodiments.

[0489] <Experimental Example>

[0490] <<Possibility of Luteinizing Hormone (LH) in Leukorrhea as a Biomarker for Predicting Ovulation Day>>

[0491] Tests related to using luteinizing hormone (LH) in leukorrhea as a biomarker for predicting ovulation day were conducted.

[0492] It is important for women who wish to become pregnant (pregnancy-active women) to know the ovulation day in advance. From the viewpoints of convenience, etc., the most widely used at present is the test kit for luteinizing hormone (LH) in urine. The measurement of LH in urine is a relatively simple measurement that is completed about 15 minutes after spraying urine on the test kit. However, daily measurement is a great burden on users, and the utilization rate of the LH test kit in the urine of pregnancy-active women is definitely not high. Therefore, in order to establish a new method for predicting the ovulation day, leukorrhea was focused on as a measurement specimen. Leukorrhea is a specimen that can achieve "the measurement is already completed when noticed", with extremely little burden on the user, in that it can be collected non-invasively and does not require intentional collection. On the other hand, there are few research examples of leukorrhea as a measurement specimen, and there is no report on the measurement of ovulation prediction biomarkers represented by LH. Therefore, the determination of LH in leukorrhea was carried out to verify the possibility as a biomarker.

[0493] The following shows the test methods, results, research, and conclusions.

[0494] <Test Methods (Methods)>

[0495] ● Recruitment of testers

[0496] Women aged 20 or above and less than 40 years old without menstrual-related diseases, with no restrictions on nulliparity or parity.

[0497] ● Collection of testers' specimens

[0498] A urine specimen collection kit and a fragrance-free sanitary pad were distributed to the testers, and urine and sanitary pads from the 10th day after menstruation to the 19th day after menstruation were collected. To prevent the evaporation of liquid from the sanitary pad, the sanitary pad was immediately bundled with a non-permeable film after being unpacked, and on this basis, stored at -18°C or below, and then transported and collected at -15°C or below.

[0499] ● Extraction of leukorrhea components from sanitary pads

[0500] The central part of the collected sanitary pad was cut into 2 cm 2, and immersed in 500 μl of PBS, and then the extract was recovered by centrifugation at 3600 rpm to obtain the measurement specimen.

[0501] ● Measurement of Specimen

[0502] LH in urine and LH in leucorrhea were measured by Enzyme-Linked Immunosorbent Assay (ELISA method: enzyme-linked immunosorbent assay). In addition, to exclude external factors of the specimen concentration, urine was measured using creatinine in urine (ELISA method), and leucorrhea was measured using the total protein amount (BCA assay) and corrected.

[0503] ● Definition of Leucorrhea Surge

[0504] The surge of LH in leucorrhea was defined as follows.

[0505] □ When compared with the previous day, it was confirmed that the concentration increased by more than twice and LH / total protein in leucorrhea exceeded 0.05 mlU / mg.

[0506] □ In the case of multiple peaks, assuming the actual LH test in leucorrhea, it is not the peak but the peak closest to the present.

[0507] ● Exclusion Criteria

[0508] Specimens that met any of the following conditions were excluded as measurement specimens.

[0509] □ Specimens in which LH surge in urine did not occur during the recovery period

[0510] □ Specimens in which, although an increase in concentration considered to be LH surge in urine was observed during the recovery period, the concentration did not decrease during the period

[0511] □ Specimens in which the recovery of leucorrhea could not be performed and the start date of LH surge in leucorrhea was not determined

[0512] ● Number of Specimens Used for Analysis

[0513] □ 16 individuals

[0514] □ 29 specimens

[0515] Results

[0516] (1) Figure 4 and Figure 5It is a graph obtained by separately plotting the LH concentration in urine and the LH concentration in leucorrhea with respect to the number of days centered around the LH surge in urine. It is known that the LH surge in urine occurs several hours later than the LH surge in blood, but there is no definite relationship between the LH in leucorrhea and the LH in urine. In addition to the pattern where surges are observed on the same day, there is also a pattern where surges are observed with a time lag before and after.

[0517] (2) Table 1 shows the ratio of the number of specimens observed for the ovulation day assumed based on the LH surge in urine and the LH surge in leucorrhea. The conception window uses the criteria determined based on the reports by Dunson (※2) et al. When the ovulation day is determined based on the LH surge in urine, the proportion of specimens with an LH surge in leucorrhea within the conception window is 86%.

[0518] (*2) D.B. Dunson et al. Day-specific probabilityes of clinical pregnancy based on two studies with imperfect measures of ovulation, Human Reproduction, 1999; 14(7): 1835 - 1839

[0519] [Table 1]

[0520] Table 1 Ratio of the number of days since the ovulation day predicted based on the LH surge in urine and the number of specimens observed for the LH surge in leucorrhea

[0521]

[0522] As observed in Figures 4 to 7 , the LH surge in leucorrhea appears within the conception window at a proportion of 86%. Therefore, it can be known that the absorbent article of the present invention can fully function as a biomarker for predicting the ovulation day.

[0523] (3) The surge day and the day before it were compared, and the intensity of the surge was measured. As a result, the sensitivity of LH in leucorrhea at the threshold of 0.15 mIU / mg was 85%, and the specificity was 77%. In addition, the result of the ROC analysis was that the AUC was 0.79. Figure 6 It is a graph showing the LH concentration near the LH surge day in leucorrhea. Figure 7 It is a graph showing the result of the ROC analysis.

[0524] Research and Conclusion (Disucussion&Conclusion)

[0525] Since the LH surge in vaginal discharge occurs in 86% of the fertile window, it can function sufficiently as a biomarker. In addition, the LH surge in vaginal discharge is significantly stronger, and by constructing an appropriate measurement system, it has the performance of discrimination with a sensitivity of 85% and a specificity of 77%.

[0526] This study shows the biological possibility among the possibilities of a wearable LH measurement system in vaginal discharge, and believes that the possibility of enabling pregnant women to conceive more easily by developing inspection devices is increased.

[0527] <Summary of Results>

[0528] Predicting the ovulation day in advance is important for women who wish to conceive. There are various methods for predicting the ovulation day at present, such as direct observation using ultrasound, basal body temperature, and observation of fern-like crystals. However, from the perspective of convenience, etc., the examination of luteinizing hormone (LH) in urine is the most widely used. The measurement of LH in urine is a relatively simple measurement that is completed about 15 minutes after spraying urine on the test kit. Nevertheless, daily measurement is also a great burden for users, and the utilization rate of LH test kits in the urine of pregnant women is definitely not high. Therefore, the research team focused on vaginal discharge as a specimen. Vaginal discharge has the advantage that the burden on users is extremely small in that it can be collected non-invasively and does not require intentional collection. However, the research on LH in vaginal discharge has not been sufficient, and it is not clear how much LH is contained in vaginal discharge and whether its behavior is sufficient for predicting the ovulation day. In this experiment, as described above, for 29 testers, urine and vaginal discharge were collected for 10 days from 10 days to 19 days after the start of menstruation, and the LH in the urine and vaginal discharge of the testers was measured by ELISA method and compared. As a result, a surge similar to that in urine was also observed in the LH in vaginal discharge. When the LH surge in the urine of the LH test kit in urine is assumed to be one day before the ovulation day, the proportion of the LH surge in vaginal discharge appears in "5 days before ovulation to 0 days before ovulation" with a higher pregnancy probability is 86% (Table 1 above). It was also found that the amount of LH in vaginal discharge is less than that in urine, and a detection system with higher sensitivity than commercially available LH test kits in urine is required for detection. According to the results of this experiment, although it cannot be said that LH in urine and LH in vaginal discharge show the same behavior in various aspects such as concentration and surge day, it can be considered that the ovulation day can be predicted sufficiently by measuring LH in vaginal discharge.

[0529] <Examples>

[0530] As the test strips of the present invention, "Example 1" and "Example 2" were produced, and their performance was investigated.

[0531] (Standard Solution)

[0532] The LH standard solution uses a casein blocking buffer solution of LH. Specifically, as the positive specimen solution, "LUMIPULSE Presto LH LH Calibrator (250 mIU)" (Fujirebio Inc.: Product No. 291573) is used, and as the dilution solution, 1% casein, 100 mM borate, pH 8.5 is used. The positive specimen solution is diluted to an arbitrary concentration with the dilution solution to obtain the standard solution.

[0533] (Example 1 (Sample 1))

[0534] The test strip of Example 1 has:

[0535] A first member that contacts vaginal discharge;

[0536] A second member that contains a labeled antibody that recognizes luteinizing hormone in vaginal discharge; and

[0537] A third member that has a display portion containing a capture antibody,

[0538] The capture antibody can capture the complex formed by the binding of the labeled antibody and luteinizing hormone,

[0539] The test strip is configured such that luteinizing hormone in vaginal discharge moves from the first member through the second member to the display portion of the third member,

[0540] And it is configured such that the complex is captured by the capture antibody, thereby causing the display portion of the third member to develop color.

[0541] The length of the test strip of Example 1 is 12 mm and the width is 3 mm. The thickness of the sample pad as the first member is 0.1 mm, the thickness of the conjugate pad as the second member is 0.55 mm, and the thickness of the membrane as the third member is 0.1 mm. The total thickness of the first member to the third member is 0.75 mm. The average fiber diameter of the fibers constituting the first member is about 2 μm, and the average fiber diameter of the second member is about 20 μm. The labeled antibody in the conjugate pad has a red nanobead with a particle diameter of 335 nm (Product name: NanoAct, manufactured by Asahi Kasei Corporation) as the coloring agent.

[0542] The average fiber diameters of the fibers constituting the first member and the second member are obtained as follows: Samples cut to a predetermined size are placed on a scanning electron microscope (FlexSEM 1000 manufactured by Hitachi High-Technologies Corporation), the fiber diameters are measured, and the measured values of the fiber diameters of N = 30 or more are averaged.

[0543] (Example 2 (Sample 2))

[0544] The overall structure and dimensions of the test strip of Example 2, as well as the dimensions of the first to third members, are the same as those of Example 1 above. The labeled antibody in the conjugate pad of Example 2 has a blue nanobead with a particle diameter of 320 nm (product name: NanoAct, manufactured by Asahi Kasei Corporation) as a coloring agent.

[0545] Furthermore, the labeled antibodies used in Example 1 and Example 2 differ in the way of recognizing LH. LH is a glycoprotein composed of two subunits, α and β, and these subunits separate when the LH surge exceeds. The antibody used in Example 1 binds only to the substance (α-β) formed by the binding of the α subunit and the β subunit. In contrast, the antibody used in Example 2 can bind to the substance (α-β) formed by the binding of the α subunit and the β subunit, and can also bind to the β subunit.

[0546] In addition, in Example 2, compared with Example 1, the color of the coloring agent was changed to blue, which is easier to observe even when lighter, and the amount of the labeled antibody was doubled.

[0547] (Sensitivity test)

[0548] A standard solution containing various concentrations of LH was dropped twice, 24 μL each time, onto the sample pads of the test strips of Example 1 and Example 2 above, and the color development of the display portion was confirmed. As a difference between Example 2 and Example 1, the detection accuracy was also improved, and since the visual recognition was also improved, the probability that the wearer could make a judgment by himself was increased.

[0549] The results are shown in Figure 1 .

[0550] As can be seen from Figure 1 In Example 1, when the LH concentration was 0.5 mIU / mL or 1.0 mIU / mL or more, the color development of the display portion could be confirmed.

[0551] Regarding Example 1, at least in the concentration range of 0.5 mIU / mL to 1 mIU / mL, a proportional relationship could be confirmed between the LH concentration and the color development intensity.

[0552] In addition, as can be seen from Figure 1 In Example 2, when the LH concentration was 0.05 mIU / mL or 0.1 mIU / mL or more, the color development of the display portion could be confirmed.

[0553] Regarding Example 2, at least in the concentration range of 0.05 mIU / mL to 1.0 mIU / mL, a proportional relationship could be confirmed between the LH concentration and the color development intensity.

[0554] <Comparison>

[0555] The color development intensities of the test strips of Example 1 and Example 2 were compared.

[0556] The results are shown in Figure 2 . As can be seen from Figure 2 , the test strips of the present invention show good color development intensity over a relatively wide LH concentration range. The test strip of Example 2 shows better color development intensity than the test strip of Example 1.

[0557] <Leukorrhea test>

[0558] A test for detecting LH in leukorrhea discharged from the vagina of a wearer was carried out using a sanitary napkin with the test strips of Example 1 and Example 22 above.

[0559] The test results for Example 1 are shown in Table 2 below.

[0560] [Table 2]

[0561] Table 2

[0562] Number of subjects 30 LH surge can be confirmed 26 Vaginal discharge adheres to LN 25 Vaginal discharge adheres to the test piece 25 Control line appears for two days 21 Test line appears 15 Identify the test line 5

[0563] As can be seen from Table 2, when using the test strip of Example 1, LH can be detected with relatively high accuracy. Specifically, among 25 users with leukorrhea attached to the test piece, 15 users (60%) had a test line appear, and among them, 5 users (20%) could identify the test line.

[0564] The test results for Example 2 are shown in Table 3 below.

[0565] [Table 3]

[0566] Table 3

[0567] Number of subjects 28 LH surge can be confirmed 26 LH surge can be confirmed and vaginal discharge adheres to LN 23 LH surge can be confirmed and vaginal discharge adheres to the test piece 23 Control line appears for two days 22 Test line appears (confirmed by the researcher) 22 Subject identifies the test line 16

[0568] As can be seen from Table 3, when using the test strip of Example 2, LH can also be detected with relatively high accuracy. In particular, the detection accuracy of Example 2 is higher than that of Example 1. Specifically, among 23 users with leukorrhea attached to the test piece, 22 users (94%) had a test line appear, and among them, 16 users (72%) could identify the test line.

[0569] <<Example 3 and Comparative Example 1>>

[0570] In Example 3 and Comparative Example 1, the test strips of the present invention were applied to absorbent articles, and the performance was evaluated.

[0571] <Example 3>

[0572] (Manufacture of Absorbent Articles with Test Strips)

[0573] Prepare a test strip that detects LH at 0.05 mIU / mL to 10.0 mIU / mL as positive. This test strip has the same structure as the test strip used in Example 2 above.

[0574] Apply this test strip to a sanitary napkin as an absorbent article (Product name: Sofy Kiyora fragrance-free, manufactured by Unicharm Corporation) to produce the absorbent article of Example 3. Specifically, configure the test strip such that the sample pad portion of the test strip is disposed at the vaginal discharge port abutting portion of the topsheet constituting the sanitary napkin. The test strip is fixed to the topsheet using an upper cover tape.

[0575] (Wearing Test)

[0576] A wearing test was conducted using the absorbent article of Example 3. Specifically, in the case of wearing this absorbent article in a general manner and having leucorrhea, the attachment of leucorrhea to the test strip, the reaction of the test line (presence or absence of positive), and the number of days relative to the ovulation day were confirmed.

[0577] The wearing test was repeated, and the reaction of the test line for various days relative to the ovulation day was confirmed.

[0578] The reaction of the test line (presence or absence of positive) was judged based on the presence or absence of color development, and it was set as positive when color development was visually confirmed.

[0579] The number of days relative to the ovulation day was determined based on the ovulation day predicted according to the LH surge in urine (0 day). Creatinine in urine was measured from the urine collected from the tester (ELISA method) to determine the LH surge in urine.

[0580] The results are shown in Table 4 below.

[0581] <Comparative Example 1>

[0582] In Comparative Example 1, in the absorbent article manufactured in the same manner as in Example 3 above, regarding the case of the test strip to which urine was attached to the absorbent article, the reaction of the test line (presence or absence of positive) and the number of days relative to the ovulation day were confirmed.

[0583] The attachment of urine to the test strip was carried out by appropriately dropping the urine collected from the tester onto the test strip using a dropper.

[0584] The confirmation of the reaction of the test line and the determination of the number of days relative to the ovulation day were carried out in the same manner as in Example 3.

[0585] The results are shown in Table 4 below.

[0586] [Table 4]

[0587] Table 4

[0588]

[0589] As seen in Table 4 above, when discharge of leucorrhea excreted during the period from the ovulation day (day 0) to 5 days before the ovulation day (-5 days) adheres to the test strip of the present disclosure while wearing an absorbent article (sanitary pad), a positive test line is confirmed.

[0590] In contrast, when discharge of leucorrhea excreted 1 day after the ovulation day (+1 day) or 6 days before the ovulation day (-6 days) adheres to the test strip, a positive test line is not confirmed.

[0591] This result indicates that by using the test strip of the present invention, the ovulation day of the tester can be predicted. By applying the test strip to an absorbent article, the ovulation day can be simply predicted. That is, the tester does not need to perform special operations, and as long as the tester wears an absorbent article as usual and there is discharge of leucorrhea, the reaction (such as the presence or absence of color development) of the test line in the test strip can be confirmed.

[0592] Comparative Example 1 shows the results of the case of dropping urine onto the test strip of the present invention. As seen in Table 4, in Comparative Example 1, when urine collected at the timing of -8 days, -1 day, 3 days, and 5 days from the ovulation day adheres to the test strip, regardless of the number of days from the ovulation day, a positive test line is confirmed in any case.

[0593] Although there is no intention to limit by theory, this result indicates that the test strip of the present invention is optimized for LH detection in leucorrhea. That is, the test strip of the present invention has relatively high detection sensitivity for detecting LH in leucorrhea. Therefore, it is considered that when urine is applied to the test strip of the present invention, since the LH concentration in urine is relatively high, a positive reaction will occur regardless of the LH surge in urine.

[0594] In addition, when wearing a sanitary pad, although there is a risk that urine adheres to the test strip due to urine leakage or the like, in the normal wearing state and normal use, the risk that urine adheres to the test strip is low.

[0595] <<Invention B>>

[0596] The present disclosure also includes the following invention (“the present invention B” or “Invention B”).

[0597] Invention B relates to an absorbent article.

[0598] <Background Art of Invention B>

[0599] Antigens are detected using body fluids such as urine and saliva for pregnancy tests, diagnosis of viral infections, diagnosis of bacterial infections, etc.

[0600] For example, a pregnancy test device is disclosed in a patent document (Japanese Patent Laid-Open No. 5-87807). The pregnancy test device is characterized in that it consists of a test device main body and a bag for storing the test device main body. The test device main body includes: a urine collection part that contacts and absorbs urine; a reagent part that is arranged in contact with the urine collection part; a base material part through which the urine collected by the urine collection part passes through the reagent part; a determination part that determines whether a person is pregnant based on whether the urine that has moved through the base material part causes color development; and a fixing member that integrally fixes the above-mentioned urine collection part, reagent part, base material part, and determination part. The bag has a component that can be opened in such a way that only the urine collection part and the determination part of the test device main body are sequentially exposed.

[0601] <Problems to be Solved by Invention B>

[0602] In general pregnancy test drugs including the pregnancy test device disclosed in the patent document (Japanese Patent Laid-Open No. 5-87807), in order to measure whether a person is pregnant, human chorionic gonadotropin (hCG), which is an antigen contained in urine, is measured. By using urine, the amount of antigen can be easily measured.

[0603] However, generally, it is known that the more the amount of water obtained, the lower the concentration of the components in urine. Due to less water obtained or more sweating, the concentration of the components in urine decreases, and the concentration of the antigen in urine also easily changes. Therefore, in the case of a pregnancy test drug using urine, it is recommended to measure in the morning when the concentration of hCCG in urine is high.

[0604] In vaginal discharge, it is generally considered that the change in the amount of antigen caused by factors such as the amount of water obtained is less compared to urine. Therefore, if the antigen in vaginal discharge can be easily detected, it is considered that the detection accuracy of the antigen is improved. In addition, if the antigen in vaginal discharge can be easily detected, the options for detecting the antigen increase, so it is considered meaningful. Furthermore, when the antigen contained in vaginal discharge is also contained in urine, it is expected to improve the detection accuracy of the antigen by detecting both the antigen in vaginal discharge and the antigen in urine.

[0605] On the other hand, since vaginal discharge generally cannot be controlled by the will of the excretor, there is a tendency that it takes time to detect the antigen contained in vaginal discharge.

[0606] In addition, since the vaginal orifice and the urinary orifice are located in close proximity, there is a tendency for the detection of antigens contained in vaginal excreta to be easily affected by urine.

[0607] Therefore, an object of the present disclosure is to provide an absorbent article capable of detecting antigens contained in vaginal excreta in a state not easily affected by urine.

[0608] <Means for Solving the Problems of Invention B>

[0609] The inventors of the present disclosure have found the following Invention B (Solutions B1 to B14):

[0610] <Solution B1>

[0611] An absorbent article having a test strip for detecting antigens contained in vaginal excreta and having a thickness direction, characterized in that

[0612] the absorbent article sequentially includes a liquid-permeable topsheet, the test strip, an absorber, and a liquid-impermeable backsheet in the thickness direction,

[0613] the test strip sequentially includes a sample pad, a conjugate pad, and a developing membrane in the thickness direction, the sample pad preventing the mucin contained in the vaginal excreta from inhibiting the antigen-antibody reaction, the conjugate pad including a labeled antibody, and the developing membrane including an immobilized antibody,

[0614] the sample pad or the conjugate pad is in direct contact with the absorber or is in indirect contact with the absorber via a liquid-permeable sheet.

[0615] <Solution B2>

[0616] The absorbent article according to Solution 1, wherein

[0617] the antigens contained in the vaginal excreta are also contained in urine.

[0618] <Solution B3>

[0619] The absorbent article according to Solution B1 or Solution B2, wherein

[0620] a transfer-inhibition lower layer for inhibiting the transfer of excreta of the wearer absorbed by the absorber to the developing layer is further provided between the developing layer and the absorber.

[0621] <Solution B4>

[0622] The absorbent article according to any one of Solutions B1 to B3, wherein

[0623] The test strip further includes a transfer-inhibition upper layer between the unfolding layer and the top sheet for inhibiting the transfer of the wearer's excrement to the unfolding layer.

[0624] <Scheme B5>

[0625] The absorbent article according to any one of Schemes B1 to B4, wherein

[0626] The test strip further includes a transfer-inhibition upper layer between the unfolding layer and the top sheet for inhibiting the transfer of the wearer's excrement to the unfolding layer, and a transfer-inhibition lower layer between the unfolding layer and the absorbent body for inhibiting the transfer of the excrement absorbed by the absorbent body to the unfolding layer.

[0627] The test strip includes a sealing portion for sealing the outer edges of the transfer-inhibition upper layer and the transfer-inhibition lower layer.

[0628] <Scheme B6>

[0629] The absorbent article according to any one of Schemes B1 to B5, wherein

[0630] The fiber density of the sample pad is higher than that of the top sheet.

[0631] <Scheme B7>

[0632] The absorbent article according to any one of Schemes B1 to B6, wherein

[0633] The hydrophilicity of the sample pad is higher than that of the top sheet.

[0634] <Scheme B8>

[0635] The absorbent article according to any one of Schemes B1 to B7, wherein

[0636] The sample pad is in contact with the absorbent body, and the fiber density of the absorbent body is higher than that of the sample pad.

[0637] <Scheme B9>

[0638] The absorbent article according to any one of Schemes B1 to B8, wherein

[0639] The sample pad is in contact with the absorbent body, and the hydrophilicity of the absorbent body is higher than that of the sample pad.

[0640] <Scheme B10>

[0641] The absorbent article according to any one of Schemes B1 to B9, wherein

[0642] The fiber density of the bonding pad is higher than that of the sample pad.

[0643] <Scheme B11>

[0644] The absorbent article according to any one of Schemes B1 to B10, wherein

[0645] The hydrophilicity of the bonding pad is higher than that of the sample pad.

[0646] <Scheme B12>

[0647] The absorbent article according to any one of Schemes B1 to B11, wherein

[0648] The expansion layer is not in direct contact with the absorbent body.

[0649] <Scheme B13>

[0650] An absorbent article, which has a test strip for detecting an antigen contained in vaginal excrement and has a thickness direction, and is characterized in that

[0651] The absorbent article sequentially includes a liquid-permeable topsheet, the test strip, an absorbent body, and a liquid-impermeable backsheet in the thickness direction.

[0652] The test strip further includes a transfer inhibition lower layer between the test strip and the absorbent body to inhibit the transfer of the wearer's excrement absorbed by the absorbent body to the test strip.

[0653] <Scheme B14>

[0654] The absorbent article according to Scheme B13, wherein

[0655] The test strip further includes a transfer inhibition upper layer between the test strip and the topsheet to inhibit the transfer of the wearer's excrement other than the vaginal excrement to the test strip.

[0656] <Effects of Invention B>

[0657] The absorbent article of Invention B can detect the antigen contained in vaginal excrement in a state not easily affected by urine.

[0658] <Modes for Implementing Invention B>

[0659] Specifically, Invention B of the present disclosure relates to the following schemes.

[0660] [Scheme B1]

[0661] An absorbent article, which has a test strip for detecting an antigen contained in vaginal excrement and has a thickness direction, and is characterized in that

[0662] The absorbent article described above successively includes a liquid-permeable topsheet, the test strip, an absorbent body, and a liquid-impermeable backsheet in the above-mentioned thickness direction.

[0663] The test strip successively includes a sample pad, a conjugate pad, and a developing membrane in the above-mentioned thickness direction. The sample pad prevents the mucin contained in the vaginal excretions from inhibiting the antigen-antibody reaction. The conjugate pad includes a labeled antibody, and the developing membrane includes an immobilized antibody.

[0664] The sample pad or the conjugate pad is in direct contact with the absorbent body or is in indirect contact with the absorbent body through a liquid-permeable sheet.

[0665] In the absorbent article described above, vaginal excretions (such as leucorrhea or menstrual blood) pass through the liquid-permeable sheet after reaching the liquid-permeable sheet and reach the sample pad of the test strip. In the sample pad, the vaginal excretions are treated to prevent the mucin contained in the vaginal excretions from inhibiting the antigen-antibody reaction, and the vaginal excretions are transferred to the conjugate pad. In the conjugate pad, the antigen contained in the vaginal excretions binds to the labeled antibody in the conjugate pad to form an immune complex, and the immune complex (vaginal excretions?) is transferred to the developing membrane. In the developing membrane, the antigen is detected by binding the immune complex to the immobilized antibody and causing color development.

[0666] On the other hand, since the vaginal orifice and the urinary orifice are located close to each other, the absorbent article sometimes absorbs the urine of the wearer, and there is a case where the urine absorbed by the absorbent article reaches the test strip and has an adverse effect on the detection of the antigen.

[0667] In the absorbent article described above, since the sample pad or the conjugate pad is in direct contact with the absorbent body or is in indirect contact with the absorbent body through a liquid-permeable sheet, the urine that reaches the sample pad of the test strip can be transferred to the absorbent body. Therefore, the absorbent article can detect the antigen contained in the vaginal excretions in a state not easily affected by urine.

[0668] [Solution B2]

[0669] According to the absorbent article described in Solution B1, wherein,

[0670] The antigen contained in the vaginal excretions is also contained in urine.

[0671] In the absorbent article described above, since the antigen contained in the vaginal excretions as the detection target is also contained in urine, urine tends to easily affect the detection of the antigen contained in the vaginal excretions.

[0672] In the above absorbent article, since the sample pad or the binding pad is in direct contact with the absorbent body or is in indirect contact with the absorbent body through a liquid-permeable sheet, urine that has reached the sample pad of the test strip can be transferred to the absorbent body. Therefore, the above absorbent article can detect an antigen contained in vaginal excretions in a state that is not easily affected by urine.

[0673] [Solution B3]

[0674] The absorbent article according to Solution B1 or Solution B2, wherein

[0675] The above test strip further has a transfer inhibition lower layer between the above development layer and the above absorbent body to inhibit the transfer of the wearer's excretions absorbed by the above absorbent body to the above development layer.

[0676] Since the above absorbent article has a predetermined transfer inhibition lower layer, it can inhibit the transfer of the wearer's excretions absorbed by the absorbent body, such as vaginal excretions, urine, feces, etc., to the development layer. As a result, the above absorbent article can detect an antigen contained in vaginal excretions in a state that is not easily affected by urine.

[0677] [Solution B4]

[0678] The absorbent article according to any one of Solutions B1 to B3, wherein

[0679] The above test strip further has a transfer inhibition upper layer between the above development layer and the above topsheet to inhibit the transfer of the wearer's excretions to the above development layer.

[0680] Since the above absorbent article has a predetermined transfer inhibition upper layer, it can inhibit the direct transfer of the wearer's excretions, such as vaginal excretions, urine, feces, etc., to the development layer without passing through the sample pad and the binding pad. As a result, the above absorbent article can detect an antigen contained in vaginal excretions in a state that is not easily affected by excretions.

[0681] [Solution B5]

[0682] The absorbent article according to any one of Solutions B1 to B4, wherein

[0683] The above test strip further has a transfer inhibition upper layer between the above development layer and the above topsheet to inhibit the transfer of the wearer's excretions to the above development layer, and the above test strip further has a transfer inhibition lower layer between the above development layer and the above absorbent body to inhibit the transfer of the excretions absorbed by the above absorbent body to the above development layer.

[0684] The above test strip has a sealing portion for sealing the outer edges of the above transfer inhibition upper layer and the above transfer inhibition lower layer.

[0685] In the above absorbent article, since the test strip has a transfer-inhibiting upper layer, a transfer-inhibiting lower layer, and a sealing portion that seals their outer edges, it is possible to inhibit the direct transfer of excreta of the wearer, such as vaginal excreta, urine, feces, etc., to the development layer without passing through the sample pad and the conjugate pad. As a result, the above absorbent article can detect an antigen contained in vaginal excreta in a state not easily affected by excreta.

[0686] [Solution B6]

[0687] According to the absorbent article described in any one of Solutions B1 to B5, wherein,

[0688] The fiber density of the above sample pad is higher than that of the above topsheet.

[0689] The above absorbent article facilitates the transfer of vaginal excreta from the topsheet to the sample pad.

[0690] [Solution B7]

[0691] According to the absorbent article described in any one of Solutions B1 to B6, wherein,

[0692] The hydrophilicity of the above sample pad is higher than that of the above topsheet.

[0693] The above absorbent article facilitates the transfer of vaginal excreta from the topsheet to the sample pad.

[0694] [Solution B8]

[0695] According to the absorbent article described in any one of Solutions B1 to B7, wherein,

[0696] The above sample pad is in contact with the above absorbent body, and the fiber density of the above absorbent body is higher than that of the above sample pad.

[0697] The above absorbent article facilitates the penetration of urine from the sample pad into the absorbent body.

[0698] [Solution B9]

[0699] According to the absorbent article described in any one of Solutions B1 to B8, wherein,

[0700] The above sample pad is in contact with the above absorbent body, and the hydrophilicity of the above absorbent body is higher than that of the above sample pad.

[0701] The above absorbent article facilitates the penetration of urine from the sample pad into the absorbent body.

[0702] [Solution B10]

[0703] According to the absorbent article described in any one of Solutions B1 to B9, wherein,

[0704] The fiber density of the above-mentioned binding pad is higher than that of the above-mentioned sample pad.

[0705] The above absorbent article facilitates the penetration of urine from the binding pad into the absorbent body.

[0706] [Scheme B11]

[0707] An absorbent article according to any one of Schemes B1 to B10, wherein

[0708] The hydrophilicity of the above-mentioned binding pad is higher than that of the above-mentioned sample pad.

[0709] The above absorbent article facilitates the penetration of urine from the binding pad into the absorbent body.

[0710] [Scheme B12]

[0711] An absorbent article according to any one of Schemes B1 to B11, wherein

[0712] The above-mentioned unfolding layer does not directly contact the above-mentioned absorbent body.

[0713] The test strip of the above absorbent article is not easily affected by excrement.

[0714] [Scheme B13]

[0715] An absorbent article, which has a test strip for detecting an antigen contained in vaginal excrement and has a thickness direction, and is characterized in that

[0716] The above absorbent article sequentially includes a liquid-permeable topsheet, the above test strip, an absorbent body, and a liquid-impermeable backsheet in the above thickness direction.

[0717] The above test strip further includes a transfer inhibition lower layer between the test strip and the absorbent body to inhibit the transfer of the wearer's excrement absorbed by the absorbent body to the test strip.

[0718] Since the above absorbent article has a predetermined transfer inhibition lower layer, it can inhibit the transfer of the wearer's excrement such as vaginal excrement, urine, feces, etc. absorbed by the absorbent body to the test strip. As a result, the above absorbent article can detect the antigen contained in vaginal excrement in a state not easily affected by urine.

[0719] [Scheme B14]

[0720] An absorbent article according to Scheme B13, wherein

[0721] The above test strip further includes a transfer inhibition upper layer between the test strip and the topsheet to inhibit the transfer of the wearer's excrement other than the above vaginal excrement to the test strip.

[0722] Since the absorbent article has a predetermined transfer-inhibiting upper layer, it can inhibit the transfer of excreta other than vaginal excreta from the wearer to the test strip. As a result, the absorbent article can detect the antigen contained in the vaginal excreta in a state not easily affected by excreta.

[0723] Description of Reference Numerals

[0724] 1. Absorbent article (sanitary napkin); 3, 20. Topsheet; 5. Backsheet; 7, 20. Absorbent body; 9. Second sheet; 21, 60. Test strip; 23, 64. Sample pad (first member); 25. Conjugate pad; 66A. Moving portion (display moving portion); 66B. Moving portion (terminal moving portion); 27. Release film; 31. Transfer-inhibiting upper layer; 33. Transfer-inhibiting lower layer; 35. Cover tape; 101. Fixing portion; L. Front-back direction; W. Width direction; CL. Center CT in the front-back direction L of the absorbent article; CT. Center CT in the front-back direction L of the test strip; SR. ; S1. Front region of the absorbent article; S2. Rear region of the absorbent article; S3. Central region of the absorbent article.

Claims

1. An absorbent article having a test strip using an immunochromatographic method for detecting luteinizing hormone from vaginal discharge, wherein, the test strip detects luteinizing hormone at a concentration of 0.05 mIU / mL to 2.5 mIU / mL as positive.

2. The absorbent article according to claim 1, wherein, the test strip has a width of 5 mm or less.

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

4. The absorbent article according to claim 1 or 2, wherein, the test strip has: a first member that comes into contact with vaginal discharge; a second member that contains a labeled antibody that recognizes luteinizing hormone in vaginal discharge; and a third member that has a display portion containing a capture antibody, the capture antibody being capable of capturing a complex formed by the binding of the labeled antibody and luteinizing hormone, the absorbent article being configured such that luteinizing hormone in the vaginal discharge moves from the first member via the second member to the display portion of the third member, and being configured such that the capture antibody captures the complex, thereby causing the display portion of the third member to develop color.

5. The absorbent article according to claim 4, wherein, the first member, the second member, and the third member are at least partially overlapped and laminated in this order, and the total thickness of the first member, the second member, and the third member in the lamination direction is 1.5 mm or less.

6. The absorbent article according to claim 4, wherein, the first member is formed of fibers having an average fiber diameter of 0.5 μm to 5 μm, the second member is formed of fibers having an average fiber diameter of 10 μm to 40 μm, and the average fiber diameter of the fibers of the first member is smaller than the average fiber diameter of the fibers of the second member.

7. The absorbent article according to claim 4, wherein, the average fiber diameter R1 of the fibers constituting the first member and the average fiber diameter R2 of the fibers constituting the second member satisfy the relationship of 5 ≤ (R2 / R1) ≤ 20.

8. The absorbent article according to claim 4, wherein, the absorbent article satisfies at least one of the following conditions: (a) The second member has a basis weight of 100 gsm or more, (b) The total thickness of the first member, the second member, and the third member is 1.5 mm or less, and the thickness of the second member accounts for 30% or more of the total thickness. (b) The second component has a density of 0.05 g / m 3 to 0.80 g / m 3 .

9. The absorbent article according to claim 4, wherein, the labeled antibody has a coloring agent having a particle diameter of 10 nm to 500 nm.

10. The absorbent article according to claim 4, wherein, the labeled antibody has a coloring agent having a particle diameter of 250 nm to 500 nm.

11. The absorbent article according to claim 1 or 2, wherein, the absorbent article has a topsheet, and when using the absorbent article, the vaginal discharge reaches the test strip via the topsheet.

12. The absorbent article according to claim 11, wherein, the detection is performed by bringing at least a part of the topsheet into direct contact with the vulva.

13. The absorbent article according to claim 11, wherein, the basis weight of the topsheet is 20 gsm or less per unit area.

14. The absorbent article according to claim 11, wherein, the thickness of the topsheet is 1 mm or less.

15. The absorbent article according to claim 11, wherein, the single fiber diameter of the fibers constituting the topsheet is 8.0 dtex or less.

16. The absorbent article according to claim 11, wherein, the basis weight of the topsheet is 5 gsm or more, the thickness of the topsheet is 0.1 mm or more, and the single fiber diameter of the fibers constituting the topsheet is 1.0 dtex or more.

17. The absorbent article according to claim 11, wherein, the topsheet has an embossed pattern at least partially, and the width of the test strip is larger than the size and / or interval of each pattern of the embossed pattern.

18. The absorbent article according to claim 11, wherein, the topsheet has an embossed pattern partially, and the test strip can contact the leukorrhea through a portion of the topsheet that does not have the embossed pattern.

19. The absorbent article according to claim 11, wherein, The topsheet does not contain TiO 2 .

20. The absorbent article according to claim 11, wherein, the test strip has a first member that contacts the leukorrhea, and the first member is disposed at a position opposite to the vaginal part of the wearer during wearing, the average fiber diameter of the fibers constituting the sample pad is the same as or smaller than the average fiber diameter of the fibers constituting the topsheet.

21. A test strip for an absorbent article, which uses an immunochromatographic method for detecting luteinizing hormone in leukorrhea, wherein, the test strip detects luteinizing hormone of 0.05 mIU / mL to 2.5 mIU / mL as positive.

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