JP2006266764A - Menopause stage determination implement - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a portable menopause stage determination implement capable of determining whether the situation is in menopause or not, or on which stage the situation is in the case of being in menopause, by using a humor such as urine or blood as a test sample. <P>SOLUTION: This menopause stage determination implement is equipped with a liquid absorbing piece capable of transferring the test sample by capillary phenomenon, and has characteristics wherein the liquid absorbing piece is equipped with (4a) a sample collection part for absorbing and collecting the test sample, (4b) an FSC reaction part carrying a labeled-anti-follicle stimulating hormone (FSC) antibody, and an LH reaction part carrying a labeled-anti-luteinizing hormone (LH) antibody, (4c-1) an FSC determination part equipped at an interval respectively with an FSH test result display part immobilizing an unlabeled-anti-FSH antibody and one or more FSH control display parts immobilizing an unlabeled-anti-'anti-FSH antibody' antibody, (4c-2) an LH determination part equipped at an interval respectively with an LH test result display part immobilizing an unlabeled-anti-LH antibody and one or more LH control display parts immobilizing an unlabeled-anti-'anti-LH antibody' antibody, and (4d) a liquid absorption part for absorbing residual liquid of the moved test sample. <P>COPYRIGHT: (C)2007,JPO&INPIT

Description

  The present invention relates to a menopause stage determination tool. More specifically, the present invention relates to a portable menopausal stage determination tool that can easily determine a woman's menopausal stage using body fluids such as urine and blood as test samples. According to the menopause stage determination tool, it is possible to easily determine whether or not a woman is in the menopause or at any stage of the menopause as needed without going to the hospital.

  The life of a woman's body depends on the amount of female hormones (estrogens = follicular hormones) secreted from the ovary, and is divided into five categories: “childhood”, “puberty”, “mature”, “menopause”, and “senile” Can be divided into periods. “Menopause” starts at around 40 years old when the endocrine function of the ovary gradually declines and the number of ovulations gradually decreases. Thereafter, menstruation gradually stops, and the function ages to “senile” Transition. In general, “menopause” is a period of several years to 10 years before and after menopause, and the age of menopause recognized internationally is 41 to 60 years.

  During menopause, the endocrine function of the ovaries declines and disappears, resulting in endocrine ataxia and autonomic disturbance, palpitations and hot flashes, headaches and nausea, hypersensitivity, depression and reduced energy, and irritation ( Indefinite complaint) occurs. Such disorders are called “menopausal disorders”, and in severe cases, treatment such as hormonal therapy is necessary, but some people can usually be overcome in daily life. For example, mental instability in menopause can be resolved by recognizing that indefinite complaints that occur during menopause are based on normal physiological functions in menopause and not disease. Therefore, if women in their late thirties are able to know whether they are menopause or at what stage of menopause, they can live in accordance with their hormone balance with the awareness that they are menopause. The rhythm and the like can be adjusted, and as a result, it becomes possible to spend a long period of menopause well and comfortably.

From these points, as a method / apparatus for easily inspecting whether or not it is menopause, a woman makes a self-judgment by observing the result that appears on the test paper by applying urine to the test paper (for example, Patent Document 1) In the United States, “Estroven (trademark) -Menopause Monitor-, Amerifit Nutorition, Inc.” is sold as a test kit that can be used at home (http://www.estrovenmonitor.com). However, there is no known method and instrument for determining each stage of menopause.
US patent application (US 2004/0063219 A1)

  The present invention is a portable menopause stage in which the subject himself / herself can know whether it is menopause and in which stage of menopause by using his / her body fluid such as urine and blood as a test sample. The purpose is to provide a judgment tool.

  In solving the above-mentioned problems, the present inventors have made various studies focusing on hormonal fluctuations during menopause. As a result, the follicle stimulating hormone secreted in the blood and urine (follicle stimulating hormone: It was also found that luteinizing hormone (also referred to as “LH” in the present invention) differs in each stage of menopause. Based on this finding, the present inventors have conceived that the above object can be achieved by a measuring instrument provided with a determination unit capable of determining and detecting and displaying fluctuations in the amount of secretion of these hormones. As a result of repeated studies, the following two types of menopausal stage determination tools have been completed.

One is an instrument for determining the menopause stage by detecting the amount of at least one of FSH and LH contained in the test sample, and at least two control display units in addition to the test result display unit in the determination unit A menopause stage determination tool (type 1). The other includes at least two reaction units for FSH and LH in the reaction unit, and at least two determination units for FSH and LH in the determination unit, and simultaneously detects two amounts of FSH and LH contained in the test sample. This is a menopause stage determination tool (type 2) for determining the menopause stage.
<Type 1>
The type 1 menopausal stage determination tool specifically has the following form:
1-1. A menopause stage determination tool comprising a liquid absorption piece made of a material capable of transferring a test sample by capillary action, wherein the liquid absorption piece is
(1a) a sample collection part for absorbing and collecting a test sample,
(1b) a label that specifically reacts with follicle stimulating hormone (FSH)-an FSH reaction part carrying an anti-FSH antibody,
(1c) an FSH determination unit provided with an FSH test result display unit and at least two FSH control display units with different amounts of antibody fixation, each of which is shown below,
(1) FSH test result display unit with an unlabeled anti-FSH antibody immobilized specifically reacting with follicle stimulating hormone (FSH),
(2) an FSH control display unit to which an unlabeled anti- “anti-FSH antibody” antibody that specifically reacts with an anti-FSH antibody is immobilized, and
(1d) A menopausal stage determination tool comprising a liquid absorption unit that absorbs a residual liquid of a test sample that has moved through the sample collection unit, the FSH reaction unit, and the FSH determination unit.

  As described above, according to a menopausal stage determination tool equipped with at least two FSH control display units, each of which has follicle stimulating hormone (FSH) as a test component and at which the non-labeled anti-anti- “anti-FSH antibody” antibody is immobilized at different concentrations. For example, it is possible to discriminate and detect at least three menopausal stages (A period, B to D period, and E period) for the subject. The definition of each stage of the menopause stage in the present invention will be described later.

1-2. A menopause stage determination tool comprising a liquid absorption piece made of a material capable of transferring a test sample by capillary action, wherein the liquid absorption piece is
(2a) a sample collection part for absorbing and collecting the test sample,
(2b) a label that specifically reacts with luteinizing hormone (LH)-an LH reaction part carrying an anti-LH antibody,
(2c) LH test result display section shown below, and an LH determination section provided with at least two LH control display sections with different antibody fixation amounts, each with an interval,
(1) LH test result display section with an unlabeled anti-LH antibody immobilized specifically reacting with luteinizing hormone (LH),
(2) a non-labeled anti- "anti-LH antibody" antibody that specifically reacts with the anti-LH antibody, and an LH control display unit, and
(2d) A menopausal stage determination tool comprising a liquid absorption unit that absorbs a residual liquid of a test sample that has moved through the sample collection unit, the LH reaction unit, and the LH determination unit.

  As described above, according to a menopausal stage determination tool equipped with at least two LH control display parts in which luteinizing hormone (LH) is used as a test component and non-labeled anti-anti- "anti-LH antibody" antibodies of different concentrations are fixed to the determination part. For example, at least three (A to B, C to D, and E) menopause stages can be determined and detected for the subject.

  The type 1 menopausal stage determination tool includes the following menopausal stage determination tool that can simultaneously detect both FSH and LH in the test sample (this is also the type 2 menopausal stage determination tool described later). I can say).

1-3. A menopause stage determination tool comprising a liquid absorption piece composed of a material capable of transferring a test sample by capillary action, the liquid absorption piece,
(3a) a sample collection part for absorbing and collecting the test sample,
(3b) Label reacting specifically with follicle stimulating hormone (FSH)-FSH reaction part carrying anti-FSH antibody and label reacting specifically with luteinizing hormone (LH)-LH reaction carrying anti-LH antibody Reaction part, including
(3c) Determination unit including the following FSH determination unit and LH determination unit:
(3c-1) FSH determination unit: The following FSH test result display unit and at least two FSH control display units with different amounts of antibody fixation are provided at intervals:
(i) an FSH test result display section in which an unlabeled anti-FSH antibody that specifically reacts with follicle stimulating hormone (FSH) is immobilized,
(ii) a non-labeled anti- “anti-FSH antibody” antibody immobilized FSH control display specifically reacting with the anti-FSH antibody, and
(3c-2) LH determination unit: The following LH test result display unit and at least two LH control display units with different antibody fixation amounts are provided at intervals:
(i) LH test result display with immobilized unlabeled anti-LH antibody that reacts specifically with luteinizing hormone (LH),
(ii) an unlabeled anti- "anti-LH antibody" antibody-fixed LH control display section that specifically reacts with the anti-LH antibody,
And
(3d) A menopausal stage determination tool comprising a liquid absorption unit that absorbs a residual liquid of a test sample that has moved through the sample collection unit, the reaction unit, and the determination unit.

  As described above, two components, follicle stimulating hormone (FSH) and luteinizing hormone (LH), are used as test components, and in addition to the FSH test result display unit, non-labeled anti-anti-anti In addition to the LH test result display part, at least two FSH control display parts to which the “FSH antibody” antibody was fixed were fixed, and in addition to the LH test result display part, a non-labeled anti- “anti-LH antibody” antibody having a different concentration was fixed. According to the menopausal stage determination tool provided with at least two LH control displays, it is possible to determine which menopausal stage is at least four (A period, B period, C to D period, and E period) for the subject. Can be detected.

<Type 2>
The type 2 menopausal stage determination tool specifically has the following form:
2-1. A menopause stage determination tool comprising a liquid absorption piece made of a material capable of transferring a test sample by capillary action, wherein the liquid absorption piece is
(4a) a sample collection part for absorbing and collecting the test sample,
(4b) Label reacting specifically with follicle stimulating hormone (FSH)-FSH reaction part carrying anti-FSH antibody, and label reacting specifically with luteinizing hormone (LH)-LH reaction carrying anti-LH antibody Part,
(4c-1) FSH determination unit provided with the following FSH test result display unit and FSH control display unit at intervals:
(1-1) FSH test result display unit with an unlabeled anti-FSH antibody immobilized specifically reacting with follicle stimulating hormone (FSH),
(1-2) a non-labeled anti- “anti-FSH antibody” antibody-fixed FSH control display specifically reacting with the anti-FSH antibody, and
(4c-2) LH determination unit with the following LH test result display unit and LH control display unit at intervals:
(2-1) LH test result display unit with an unlabeled anti-LH antibody that specifically reacts with luteinizing hormone (LH),
(2-2) an unlabeled anti- “anti-LH antibody” antibody-fixed LH control display unit that specifically reacts with anti-LH antibody, and
(4d) A menopausal stage determination tool comprising a liquid absorption unit that absorbs the residual liquid of the test sample that has moved through the sample collection unit, the FSH reaction unit, the LH reaction unit, the FSH determination unit, and the LH determination unit. .

  As described above, according to the menopausal stage determination tool designed to detect follicle stimulating hormone (FSH) and luteinizing hormone (LH) as test components and to detect both simultaneously, at least three (A Period, B period, and C to E period) can be determined and detected.

  In addition, as shown below, the type 2 menopausal stage determination tool has at least 2 non-labeled anti-anti- “anti-FSH antibody” antibodies of different concentrations fixed to the FSH determination section in addition to the FSH test result display section. Menopause stage with two FSH control display units, and at least two LH control display units fixed with non-labeled anti-anti- "anti-LH antibody" antibodies at different concentrations in addition to the LH test result display unit in the LH determination unit A determination tool is also included (this can also be said to be a type 1 menopausal stage determination tool described above).

2-2. A menopause stage determination tool comprising a liquid absorption piece made of a material capable of transferring a test sample by capillary action, wherein the liquid absorption piece is
(5a) a sample collection part for absorbing and collecting the test sample,
(5b) Label reacting specifically with follicle stimulating hormone (FSH)-FSH reaction part carrying anti-FSH antibody and label reacting specifically with luteinizing hormone (LH)-LH reaction carrying anti-LH antibody Part,
(5c-1) An FSH determination unit provided with an FSH test result display unit and at least two FSH control display units with different amounts of antibody fixation, each of which is shown below:
(1-1) FSH test result display unit with an unlabeled anti-FSH antibody immobilized specifically reacting with follicle stimulating hormone (FSH),
(1-2) a non-labeled anti- “anti-FSH antibody” antibody-fixed FSH control display specifically reacting with the anti-FSH antibody, and
(5c-2) An LH determination unit provided with an LH test result display unit and at least two LH control display units with different amounts of antibody fixed, each with an interval, as shown below:
(2-1) LH test result display unit with an unlabeled anti-LH antibody that specifically reacts with luteinizing hormone (LH),
(2-2) an unlabeled anti- “anti-LH antibody” antibody-fixed LH control display unit that specifically reacts with anti-LH antibody, and
(5d) A menopausal stage determination tool comprising a liquid absorption unit that absorbs the remaining liquid of the test sample that has moved through the sample collection unit, the FSH reaction unit, the LH reaction unit, the FSH determination unit, and the LH determination unit. .

  As described above, at least two of follicle stimulating hormone (FSH) and luteinizing hormone (LH) are used as test components, and different concentrations of unlabeled anti-anti- “anti-FSH antibody” antibodies are immobilized on each determination unit. According to the menopausal stage determination tool comprising an FSH control display and at least two LH control displays fixed with unlabeled anti- "anti-LH antibody" antibodies of different concentrations, at least four (A, B Period, C to D period, and E period) can be discriminated and detected.

  The “menopausal stage” in the present invention means a stage of perimenopause advocated by Prior JC, a Canadian endocrinologist (Prior JC, Endo Rev., 19, 397-428, ( 1998)). Prior JC described the perimenopause as “a period including pre-menopause and at least one year after menopause in which signs of endocrinological, biological, or clinical menopause are observed”. And is classified into five stages from A stage to E stage shown in Table 1 below.

  The “menopausal stage” of the present invention means five stages of menopause (A, B, C, D, and E) according to the definition proposed by Prior JC.

  In Japan Society of Obstetrics and Gynecology, “menopause” is “the transition period between the reproductive period (sexual maturity period) and the non-reproductive period (senile period), and the period until ovarian function begins to decline and disappears” In general, it means five years before and after menopause. Here, the period E (at least one year after menopause) in Prior JC is 5 years after menopause, but the two are not essentially different.

  The menopausal stage determination tool (types 1 and 2) of the present invention makes it possible for the subject himself / herself to contact which biological sample such as urine or blood, and which stage of the above menopause (A, B, C, D). It is configured so that it can be easily determined visually whether it is in the period or E period).

  The menopausal stage determination tool of the present invention includes a liquid-absorbing piece made of a material capable of transferring a test sample by capillary action or chromatography action (in the present invention, these are collectively referred to as “capillary phenomenon”). The liquid-absorbing piece can be a sheet-like strip (hereinafter referred to as “sheet-like strip”), and the sheet-like strip is formed by a single sheet or a plurality of sheets. Or they can be joined to form. Or a liquid absorption piece can be made into various forms which can be absorbed by liquid and can be transferred by capillary action, such as an elongated rod-like piece. In addition, the menopause stage determination tool of this invention may be further provided with the support body which supports said liquid absorption piece.

  The material for the liquid absorption piece includes a solvent (water, urine and other body fluids), a test component (follicle stimulating hormone (FSH), luteinizing hormone (LH)), and an antibody against the test component (for example, a label) Labeled anti-FSH antibody, labeled anti-LH antibody), and a complex containing a test component (eg, labeled anti-FSH antibody and FSH complex, labeled anti-LH antibody and LH complex) When a test sample containing a test component is applied (collected), the test sample contains the antibody or complex on the way, but in the porous structure or capillary structure. Any material can be used as long as it can move (deploy). For example, various furnace papers, sheets such as chromatography papers, various felts, cloths such as woven fabrics and non-woven fabrics, and glass fibers can be used. Of these, organic porous materials are more preferable. Examples of organic porous materials include fiber aggregates formed of natural fibers such as cellulose, semi-synthetic fibers such as cellulose acetate, cellulose derivatives such as nitrocellulose, synthetic fibers such as polyethylene, polypropylene, nylon, and polyester. Body, porous polypropylene, porous polystyrene, porous polymethyl methacrylate, porous nylon, porous polysulfone, porous fluororesin, porous synthetic resin such as polyvinylidene fluoride introduced with hydrophilic groups, etc. Can be mentioned. Preferred are natural fibers such as cellulose, semi-synthetic fibers such as cellulose acetate, and cellulose derivatives such as nitrocellulose.

  The size of the liquid-absorbing piece is not particularly limited, but from the viewpoint of portability, the width (short side length) is about 2 to 30 mm, preferably about 5 to 15 mm, and the length (long side It is preferable that the length is 5 to 200 mm, preferably 10 to 150 mm.

  Hereinafter, menopausal stage determination tools according to embodiments of the present invention will be described by type (types 1 and 2) with reference to the accompanying drawings.

(1) Type 1: Menopausal stage determination tool FIG. 1 shows an aspect of a type 1 menopausal stage determination tool. FIG. 1 is a diagram of a type 1 menopausal stage determination tool (hereinafter, also simply referred to as “menopausal stage determination tool 1 ”) viewed obliquely from above. Hereinafter, the menopause stage determination tool 1 will be described with reference to FIG.

In the climacteric stage determination tool 1 , the liquid absorption piece moves through the sample collection unit (A), the reaction unit (B), the determination unit (C), and the sample collection unit, reaction unit, and determination unit. And a liquid absorption part (D) for absorbing the remaining liquid of the test sample. In this example, the liquid absorbing piece is a sheet-like strip formed by a plurality of sheets, but the sheet-like strip may be a single sheet made of the same material, A single sheet may be formed as a whole from a plurality of sheets made of the same or different materials. In addition, the whole sheet | seat may consist of a several sheet | seat, and may have a part partially formed from a several sheet | seat.

In the illustrated example, the sheet-like strip 20 is bonded onto the support 10 . This sheet-like strip 20 includes, in order from one end side to the other end side in the longitudinal direction, a sheet 21 that forms a sample collection part (A), a sheet 22 that forms a determination part (C), and a liquid absorption part (D). A sheet 23 to be formed is provided, and the end portions of the sheets 21 and 23 overlap with the end portions of the sheet 22 , thereby allowing the liquid to move. In addition, a sheet 24 that forms the reaction part (B) is bonded under the portion of the sheet 21 close to the sheet 22.

  The sample collection part (A) is a part (test sample supply part) for absorbing and collecting a test sample to be measured. The test sample is not particularly limited as long as it is a body fluid containing a test component (follicle stimulating hormone (FSH) or luteinizing hormone (LH), preferably both), which is a measurement target of the present invention. Examples include blood (serum, plasma), sweat, saliva and the like. From the viewpoint of easy acquisition, urine is preferable. The sample collection part (A) is basically located at the end (starting end) of the sheet-like strip as illustrated in FIG. For this reason, it is also possible to collect the test sample by immersing the end of the sheet-like strip where the sample collection unit is located in the test sample placed in the container. Alternatively, when the test sample is urine, urine can be collected by directly contacting the sample collection unit during urination.

  The sample collection part (A) is preferably composed of a hydrophilic and water-absorbing material so that the test sample (body fluid such as urine) can be quickly absorbed among the materials employed for the sheet-like strip. Such materials include filter paper, various fibers [natural fibers such as cotton, pulp, hemp, silk, wool, and flax; regenerated fibers such as rayon, polynosic, cupra, and lyocell; semisynthetic fibers such as acetate; polyamide ( Nylon), vinylon (polyvinyl alcohol), polyester, acrylic (polyacrylonitrile, etc.), polyolefin (polyethylene, polypropylene, etc.), and synthetic fibers such as polyurethane (glass fibers), sponges, felts, non-woven fabrics, woven fabrics, papers, etc. Can be illustrated. Preferred examples include polyester, polypropylene, rayon, sponge made of glass fiber, non-woven fabric, woven fabric, and paper.

The reaction part (B) is formed in the sheet | seat 24 which overlapped with the said sample collection part (A) in the terminal part of the sample collection part (A) as mentioned above. The reaction part (B) contains an antibody that specifically reacts and binds to a test component (FSH, LH) to be measured in a detachable state.

Specifically, the menopausal stage determination tool 1 (hereinafter simply referred to as “menopausal stage determination tool 1 (FSH)”) using follicle stimulating hormone (FSH) as a test component (detection target) is provided on the sheet 24 . And anti-FSH antibody that specifically binds to FSH by antigen-antibody reaction in a detachable state. Further, the menopausal stage determination tool 1 (hereinafter simply referred to as “menopausal stage determination tool 1 (LH)”) using luteinizing hormone (LH) as a test component (detection target) is provided on the sheet 24 with LH and antigen. -An anti-LH antibody that specifically binds by an antibody reaction is included in a removable state.

  Here, it is desirable that the anti-FSH antibody specifically binds to FSH and has no cross-reactivity with other proteins. Such an anti-FSH antibody is commercially available from, for example, Biogenesis LTD. As an anti-human follicle stimulating hormone antibody (mouse). It is desirable that the anti-LH antibody also specifically binds to LH and does not cross-react with other proteins. Such an anti-LH antibody is also commercially available as an anti-human luteinizing hormone antibody (mouse), for example, from Biogenesis LTD.

  These antibodies (anti-FSH antibody, anti-LH antibody) are used in a state labeled with any labeling agent. The labeling agent used here is a metal or inorganic particle such as gold, silver, or selenium; a fluorescent labeling agent such as fluorescein or rhodamine; a dye labeling agent such as red blood cells, latex particles, colored or colored latex particles An enzyme labeling agent such as β-galactosidase, alkaline phosphatase, peroxidase; or a mixture thereof. Inorganic particles made of gold are preferable. The labeling method with a labeling agent is well known, and can be performed according to a standard method depending on the type of the labeling agent to be used.

  The reaction part (B) contains the label-anti-FSH antibody or the label-anti-LH antibody in a detachable state among the materials adopted for the sheet-like strip, and the test moved from the sample collection part (A) Test antigen-antibody complex (complex of FSH and label-anti-FSH antibody, complex of LH and label-anti-LH antibody) formed by reaction with the test component (FSH or LH) in the sample It is preferable that the sample is made of a hydrophilic and water-absorbing material having such a property that it can be moved in the direction indicated by an arrow p in the drawing as the sample moves to the determination unit (C).

  Such materials include filter paper, various fibers [natural fibers such as cotton, pulp, hemp, silk, wool, and flax; regenerated fibers such as rayon, polynosic, cupra, and lyocell; semisynthetic fibers such as acetate; polyamide ( Nylon), vinylon (polyvinyl alcohol), polyester, acrylic (polyacrylonitrile, etc.), polyolefin (polyethylene, polypropylene, etc.), and synthetic fibers such as polyurethane (glass fibers), sponges, felts, non-woven fabrics, woven fabrics, papers, etc. Can be illustrated. Preferred examples include polyester, polypropylene, rayon, sponge made of glass fiber, non-woven fabric, woven fabric, and paper.

  In addition, the method of loading the label-anti-FSH antibody or the label-anti-LH antibody in a detachable state in the reaction part (B) is not limited, but includes the label-anti-FSH antibody or the label-anti-LH antibody. A method of impregnating or adhering the solution to the reaction part (B) can be exemplified. In addition, the reaction part (B) carries the above-mentioned label-anti-FSH antibody or label-anti-LH antibody in excess to bind the test component (FSH or LH) contained in the test sample to the antibody without omission. It is preferable to keep it.

  The determination unit (C) is a part that further transfers the test sample that has moved from the sample collection unit (A) through the reaction unit (B) to the liquid absorption unit (D), and on the transfer region, It includes a portion [test result display section (C0)] that captures specific components contained in the transferred test sample and displays the capture results. Based on the results shown in the test result display section (C0), the menopausal stage can be determined, and the region including the display section (C0) is referred to as “determination section (C)”.

The menopausal stage determination tool 1 of the present invention includes at least two control display units (C1) and (C2) having different antibody fixing amounts in addition to the test result display unit (C0) in the determination unit (C). It is characterized by. The test result display unit (C0) and the at least two control display units (C1) and (C2) are sequentially arranged at intervals.

The test result display section (C0) includes an unlabeled antibody that specifically reacts with the test component (FSH, LH) [menopausal stage determination tool 1 (FSH): unlabeled anti-FSH antibody, menopausal stage determination tool 1 ( LH): unlabeled anti-LH antibody] is fixed in an excessive amount. Therefore, the test component bound to the label-antibody by the antigen-antibody reaction in the reaction part (B) is captured by the test result display part (C0), and the labeling agent has a strength corresponding to the captured amount. It develops color caused by. Specifically, for the menopausal stage determination tool 1 (FSH), FSH (labeled anti-FSH antibody and FSH complex combined with labeled anti-FSH antibody by antigen-antibody reaction in the reaction part (B)) ) Is captured by the test result display section (C0) to which the non-labeled anti-FSH antibody is immobilized, and exhibits a color caused by the labeling agent with an intensity corresponding to the captured amount. For menopausal stage determination tool 1 (LH), LH (complex of labeled-anti-LH antibody and LH) bound to labeled-anti-LH antibody by the antigen-antibody reaction in the reaction part is unlabeled-anti-antibody. It is captured by the test result display section (C0) to which the LH antibody is immobilized, and develops color caused by the labeling agent with the intensity according to the captured amount.

  The amount of antibody immobilized on the test result display unit (C0) is not limited. For example, in the case of the “menopausal stage determination tool (1) (FSH)” using blood as a test sample, the amount of antibody immobilized on the test result display unit is not limited. Examples of the amount of the labeled anti-FSH antibody include an amount capable of binding to 200 mIU / mL or more of FSH present in blood. In the case of the “menopausal stage determination tool (1) (LH)” using blood as a test sample, the amount of unlabeled anti-LH antibody immobilized on the test result display section is, for example, 200 mIU / Mention may be made of the amount capable of binding to mL of LH or more. When urine is used as a test sample, about 2 to 10% of each of the above values can be set as an eye.

In the control display parts (C1) and (C2), a predetermined amount of unlabeled-antibody (second antibody) that specifically reacts with the labeled-antibody contained in the reaction part (B) is fixed. The menopause stage determination tool 1 of the present invention has the above-described control display sections at least at two positions in the determination section (C) region. More specifically, the test result display unit (C0) is spaced in the direction of movement of the test sample (direction p in the figure), the first control display unit (C1), and then the same interval. Are arranged in the order of the second control display section (C2),... And the nth control display section (Cn). In each control display section, unlabeled-antibody (second antibody) that reacts specifically with the labeled-antibody contained in the test sample is fixed in different amounts. Although it is not limited, a low concentration of the second antibody is immobilized on the first control display section (C1), and the second antibody of the high concentration becomes the second,..., And nth. It is preferably immobilized.

  In each of the control display parts, the label-antibody released from the reaction part and released in the test sample is captured and labeled with the intensity according to the amount of the second antibody immobilized on each control display part. It develops color due to the antibody labeling agent.

Specifically, each control display section of the menopausal stage determination tool 1 (FSH) contains a predetermined amount of an unlabeled anti- “anti-FSH antibody” antibody (second antibody) that specifically reacts with the labeled anti-FSH antibody. A fixed amount of unlabeled anti- “anti-LH antibody” antibody (second antibody) that reacts specifically with the labeled anti-LH antibody is present in each control display part of the menopausal stage determination tool 1 (LH). It is fixed.

  Here, the anti- “anti-FSH antibody” antibody desirably binds specifically to the anti-FSH antibody and does not cross-react with other proteins. Such an anti- “anti-FSH antibody” antibody can be prepared according to a conventional method using, for example, an anti-FSH antibody (for example, obtained from Biogenesis LTD.) As a material. It is also desirable that the anti- “anti-LH antibody” antibody be one that specifically binds to the anti-LH antibody and does not cross-react with other proteins. Such an anti- “anti-LH antibody” antibody can be prepared according to a conventional method using, for example, an anti-LH antibody (for example, obtained from Biogenesis LTD.) As a material.

  For example, in the case of “menopausal stage determination tool 1 (FSH)” using blood as a test sample, the concentration in the test sample is 0 mIU / mL to 50 mIU / mL, preferably 15 mIU / mL as the control display section (C1). A control display (C1) with an anti- “anti-FSH antibody” antibody (second antibody) immobilized so that an amount of anti-FSH antibody that binds to FSH in the range of ˜30 mIU / mL can be quantitatively detected, and a test Anti-FSH antibodies that bind to FSH at concentrations in the sample ranging from 25 mIU / mL to 200 mIU / mL, and preferably in the range of 40 mIU / mL to 100 mIU / mL, can be detected so that they can be quantitatively detected. It is preferable to include at least a control display part (C2) to which an “anti-FSH antibody” antibody (second antibody) is immobilized.

  Also, for example, in the case of “menopausal stage determination tool 1 (LH)” using blood as a test sample, the concentration in the test sample is 0 mIU / mL to 30 mIU / mL, preferably 5 mIU / mL as the control display section (C1). a control display (C1) with an anti- "anti-LH antibody" antibody (second antibody) immobilized so that an amount of anti-LH antibody that binds to LH in the range of mL to 20 mIU / mL can be quantitatively detected; The anti-LH antibody in an amount that binds to LH with a concentration in the test sample in the range of 15 mIU / mL to 200 mIU / mL, preferably 20 mIU / mL to 100 mIU / mL, can be detected quantitatively. It is preferable to include at least a control display part (C2) to which an “anti-LH antibody” antibody (second antibody) is immobilized.

  The determination of the menopause stage is made by determining the color intensity (darkness) in the at least two control display parts (C1) and (C2) in the determination part (C) and the color intensity in the test result display part (C0). This can be done by comparing the thickness (darkness).

  The determination unit (C) can move a test sample containing various components to the liquid absorption unit (D) by capillarity among the materials adopted for the sheet-like strip, and the test result display unit (C0 ) With the above-mentioned non-labeled antibody, and the control display part (C1) and (C2) with the above-mentioned non-labeled-second antibody. It is preferred that

  Such materials include filter paper, various fibers [natural fibers such as cotton, pulp, hemp, silk, wool, and flax; regenerated fibers such as rayon, polynosic, cupra, and lyocell; semisynthetic fibers such as acetate; polyamide ( Nylon), vinylon (polyvinyl alcohol), polyester, acrylic (polyacrylonitrile, etc.), polyolefin (polyethylene, polypropylene, etc.), and synthetic fibers such as polyurethane (glass fibers), sponges, felts, non-woven fabrics, woven fabrics, papers, etc. Can be illustrated. Preferred examples include sponges, nonwoven fabrics, woven fabrics, and papers made of cellulose and nitrocellulose.

  The liquid absorption part (D) passes from the sampling part (A) through the reaction part (B) and the judgment part (C) (test result display part (C0), control display part (C1) and (C2)). This is the part that absorbs the residual liquid of the test sample that has moved in the direction of the arrow p.

  The liquid absorbing part (D) is preferably a material having the property of not allowing water to be absorbed from the absorbed liquid, although it is preferable that it is excellent in hydrophilicity and absorbability among the materials adopted for the sheet-like strip. Alternatively, it is desirable to be made of an elastic material. Specific examples of such a material include absorbent cotton and hydrophilic fiber nonwoven fabric, and a laminate of absorbent cotton and nonwoven fabric can also be used.

As described above, menopausal stage determination tool 1 using either follicle-stimulating hormone (FSH) or luteinizing hormone (LH) as a test component to be measured [Menopausal stage determination tool 1 (FSH), menopause stage determination tool 1 (LH) ] Was explained.

However, the menopausal stage determination tool 1 may use both follicle stimulating hormone (FSH) and luteinizing hormone (LH) as test components to be measured (hereinafter referred to as “menopausal stage determination tool 1 ( FSH / LH) ”). Such menopausal stage determination tool 1 (FSH / LH) is a “reaction part (B)” located between the sample collection part (A) and the liquid absorption part (D), and specifically with follicle stimulating hormone (FSH). Reacting label-FSH reaction part (b) carrying anti-FSH antibody and LH reaction part (b ') carrying label-anti-LH antibody reacting specifically with luteinizing hormone (LH) As `` determination part (C) '' located after the reaction part,
(i) an FSH determination unit (c) provided with an FSH test result display unit and at least two FSH control display units with different amounts of antibody fixation, each of which is shown below,
(1) FSH test result display section (c0), in which an unlabeled anti-FSH antibody that specifically reacts with FSH is immobilized,
(2) FSH control display section (c1) and (c2) to which an unlabeled anti- “anti-FSH antibody” antibody that specifically reacts with anti-FSH antibody is immobilized, and
(ii) an LH determination unit (c ′) having an LH test result display unit and at least two LH control display units with different antibody fixation amounts, each having an interval, as shown below,
(1) LH test result display section (c0 ′), to which an unlabeled anti-LH antibody that specifically reacts with LH is immobilized,
(2) LH control display sections (c1 ′) and (c2 ′) to which an unlabeled anti- “anti-LH antibody” antibody that specifically reacts with the anti-LH antibody is immobilized.

  Regarding the positional relationship between the FSH reaction part (b) and the LH reaction part (b ′) on the sheet-like slice, and the positional relationship between the FSH determination part (c) and the LH determination part (c ′), the FSH in the test sample As long as the amount of LH can be measured and the object of the present invention can be achieved, there is no particular limitation. For example, as an example, as shown in FIG. 2, a mode in which the determination unit (C) is provided in a state where the FSH determination unit (c) and the LH determination unit (c ′) are separated by a gap (slit) or the like. Can do.

The menopause stage determination tool 1 of the present invention is basically composed of a sheet-shaped strip having the above-described configuration, but can further include a support 10 in addition to the sheet-shaped strip. The support 10 is not particularly limited as long as it has a material and form capable of holding the sheet-like strip. For example, it may be a sheet-like support used by being laminated on the back surface (lower layer surface) of the sheet-like strip, or may be a housing-type support that accommodates the sheet-like strip.

  As the sheet-like support, for example, various plastic sheets (plastic sheets), hard paper, sheets made of metal (including alloys) such as aluminum, for example, a plurality of different or homogeneous papers are laminated (bonded). Multi-layer paper, laminated plastic sheet and paper, laminated paper and metal sheet (laminated), laminated plastic sheet, paper and metal sheet (laminated), paper And the like coated with a waterproof coating or the like. Preferably, it has a waterproof function.

  The support in the form of a housing is preferably made of a moisture-impermeable material such as polyvinyl chloride, polypropylene, polyethylene, polystyrene, or acrylic acid polymer. The housing corresponds to at least the `` liquid collection window '' corresponding to the sample collection part (A) of the above-mentioned sheet-like piece housed inside, and corresponding to the test result display part (C0) of the judgment part (C). It is desirable that a “control display window” is formed corresponding to the “determination display window” and the control display section [at least the control display sections (C1) and (C2)]. The “determination display window” and the “control display window” may be formed individually, but may be formed as one window.

When the menopausal stage determination tool 1 of the present invention having the above-mentioned sheet-like strip is used, the sample collection part (A) is first impregnated with the test sample. Then, the test sample absorbed in the sample collection part (A) penetrates into the sheet-like strip by capillary action, and first label-antibody [menopausal stage determination tool 1 (FSH): label-anti-FSH antibody, menopausal stage determination] The tool 1 (LH): label-anti-LH antibody] reaches the reaction part (B) which is supported so as to be removable. Here, the test component (FSH, LH) in the test sample specifically binds by the above-mentioned label-antibody and antigen-antibody reaction [for climacteric stage determination tool 1 (FSH), FSH and label-anti-FSH antibody and Binds, and for menopausal stage determination tool 1 (LH), LH binds to the labeled anti-LH antibody. ]. Next, the test sample is “label-antibody specifically bound to the test component” (menopause stage determination tool 1 (FSH): complex of FSH and label-anti-FSH antibody, menopause stage determination tool 1 (LH): LH and label-anti-LH antibody complex) and "excess label-antibody that did not bind to the test component" (menopausal stage determination tool 1 (FSH): label-anti-FSH antibody, menopause stage determination tool 1 ( (LH): label-anti-LH antibody), and the test result display part (C0) of the judgment part (C) is reached. The test result display section (C0) has an unlabeled antibody that specifically binds to the test component (menopausal stage determination tool 1 (FSH): unlabeled-anti-FSH antibody, menopausal stage determination tool 1 (LH): unlabeled- Since the anti-LH antibody is stably immobilized, the “label-antibody specifically bound to the test component” in the test sample is captured and accumulated therein. As a result, the test result display section (C0) develops a color with an intensity corresponding to the amount of the test component in the test sample based on the captured label-antibody labeling agent. Thereby, the presence or absence and quantitative ratio of the test component in the test sample can be detected.

Next, the test sample reaches the control display units (C1) and (C2) of the determination unit (C) with “excess label-antibody not bound to the test component”. The control display sections (C1) and (C2) include a second antibody that specifically binds to the label-antibody [menopausal stage determination tool 1 (FSH): unlabeled-anti- “anti-FSH antibody” antibody, menopause stage determination tool 1 (LH): Unlabeled-anti- “anti-LH antibody” antibody] is stably immobilized in a certain amount, and thus the above excess labeled-antibody in the test sample is captured and accumulated therein. As a result, the control display parts (C1) and (C2) are able to detect the amount of the second antibody immobilized on the control display parts (C1) and (C2), respectively (or the amount of the labeled antibody bound to the second antibody). ) The color develops at an intensity corresponding to Here, if the amount of the second antibody to be immobilized is determined in advance, the relationship between the amount of labeled-antibody to be captured and the intensity (darkness) of color development can be known. This relationship is further clarified by fixing different amounts of the second antibody to the control display sections (C1) and (C2). In addition, the menopause stage judgment tool 1 (FSH / LH) shown in FIG.
Has two control display portions as one embodiment of the present invention, but is not limited thereto, and three or more control display portions can be provided. That is, by comparing the color development intensity (darkness) presented on at least two control display sections with the color development intensity (darkness) presented on the test result display section, the test included in the test sample It is possible to know in which range the amount of the component is.

  This relationship is shown in Table 2 as an example when blood is used as the test sample. “<” Shown in the table indicates the degree of darkness (order) of each line [test result display part (C0), control display part (C1) and (C2)] of the display part (C) of the determination tool.

  For example, the follicle stimulating hormone (FSH) concentration in the blood is 15 mIU / mL or less in the A phase of the menopause stage, 15-30 mIU / mL in the B phase, 15-30 mIU / mL in the C phase, and 15-30 mIU / mL in the D phase. It is known that it is 30 mIU / mL or more in mL and E phase. Therefore, an anti- “anti-FSH antibody” antibody (second antibody) is immobilized on the control display section (C1) so that, for example, an amount of anti-FSH antibody that binds to 25 mIU / mL of FSH can be quantitatively detected. A determination part (C) comprising an anti- “anti-FSH antibody” antibody (second antibody) immobilized on the part (C2) so that, for example, an amount of anti-FSH antibody that binds to 50 mIU / mL of FSH can be quantitatively detected. According to the menopausal stage determination tool 1 (FSH) (test sample: blood) having the above, it is possible to determine which menopausal stage (A period, B to D period, E period) the subject is in.

  The luteinizing hormone (LH) concentration in the blood is 25 mIU / mL or less in the A phase of the menopause stage, 25 mIU / mL or less in the B phase, 25 to 50 mIU / mL in the C phase, and 25 to 50 mIU / mL in the D phase. It is known that it is 50 mIU / mL or more in the E phase. Therefore, an anti- "anti-LH antibody" antibody (second antibody) is fixed to the control display section (C1) so that, for example, an amount of anti-LH antibody that binds to 15 mIU / mL of LH can be quantitatively detected. The determination part (C) formed by fixing an anti- "anti-LH antibody" antibody (second antibody) to the part (C2) so that the amount of anti-LH antibody that binds to 30 mIU / mL of LH can be quantitatively detected. According to the menopausal stage determination tool 1 (LH) (test sample: blood), it is possible to determine which menopausal stage (A to B period, C to D period, E period) the subject is in.

Furthermore, for example, a control display part (c1) to which an anti- “anti-FSH antibody” antibody (second antibody) is immobilized so that an amount of anti-FSH antibody that binds to 25 mIU / mL of FSH can be quantitatively detected, and 15 mIU / mL Binds to the control display (c1 ') with anti- "anti-LH antibody" antibody (second antibody) immobilized so that the amount of anti-LH antibody that binds to LH can be quantitatively detected, and to 50mIU / mL of FSH A control display (c2) with an anti- “anti-FSH antibody” antibody (second antibody) immobilized so that the amount of anti-FSH antibody can be detected quantitatively, and an amount of anti-LH antibody that binds to 30 mIU / mL LH Menopausal stage determination tool 1 (FSH / LH) having a determination part (C) equipped with a control display part (c2 ′) to which an anti- “anti-LH antibody” antibody (second antibody) is immobilized for quantitative detection ( According to the test sample (blood), it is possible to determine which menopausal stage (A period, B period, C to D period, E period) the subject is in. .

  When urine is used as a test sample, about 2 to 10% of each of the above values can be set as a target (New Physiological Sciences (Vol. 14) Neuroendocrinology (1989), page 122, ( (Published by Medical School).

(2) Type 2: Menopause stage determination tool FIG. 2 shows an embodiment of a type 2 menopause stage determination tool.

The illustrated menopausal stage determination tool 2 is designed so that two components, follicle stimulating hormone (FSH) and luteinizing hormone (LH), can be detected simultaneously. The menopausal stage determination tool 2 includes a sampling unit (A), a reaction unit (B), a determination unit (C) including a test result display unit (C0) and a control display unit (Cn: n is a positive number), and liquid absorption A sheet-like strip 30 having a portion (D) is provided. Similarly to the menopause stage determination tool 1 , the menopause stage determination tool 2 also includes a support 10 for supporting the sheet-like strip.

The sheet-shaped strip 30 is the same as the sheet-shaped strip of the menopausal stage determination tool 1 described above as an overall configuration. However, the sheet-like strip of the menopause stage determination tool 2 includes two sheets 32 and 33 arranged in parallel to each other so as to form a gap 34 therebetween, and these sheets have two reaction sections (B) and A determination unit (C) is formed. Further, the sheet-like strips are formed in order from one end side to the other end side in the longitudinal direction, the sheet 31 forming the sample collection part (A), the sheets 32 and 33 forming the determination part (C), and the liquid absorption part (D ) has a seat 35 for forming the end portion of the sheet 31 and 35, allowing the movement of the liquid by overlapping the ends of each of the sheets 32 and 33. A reaction part (B) is formed in a portion near the sheet 31 in the sheets 32 and 33 .

That is, in order to detect FSH and LH simultaneously as test components, the menopausal stage determination tool 2 has, as a reaction part (B), an FSH reaction part (b) carrying an anti-FSH antibody, and a label- An LH reaction part (b ′) carrying an anti-LH antibody is provided. In addition, as the determination part (C), the FSH test result display part (c0) in which the non-labeled anti-FSH antibody is immobilized, and the FSH control display part (c1) in which the non-labeled anti-anti- “anti-FSH antibody” antibody of different concentration is immobilized And (c2), an FSH determination unit (c) having an interval, and an LH test result display unit (c0 ′) to which an unlabeled-anti-LH antibody is immobilized, and unlabeled-anti-anti An LH control display section (c1 ′) and (c2 ′) to which an “LH antibody” antibody is immobilized is provided with an LH determination section (c ′) provided with an interval.

Thus, in FIG. 2, the menopausal stage determination in which the FSH reaction part (b) and the LH reaction part (b ′), and the FSH determination part (c) and the LH determination part (c ′) are separated by the gap (slit). The tool 2 is illustrated. However, the arrangement of the FSH reaction unit (b), the LH reaction unit (b ′), the FSH determination unit (c), and the LH determination unit (c ′) is not limited to this.

The menopausal stage determination tool 2 can also know the amount of the test component (FSH, LH) in the test sample based on the same principle as the menopause stage determination tool 1 , thereby determining which menopausal stage the subject is in. be able to. In FIG. 2, the control display unit has two locations for determining each test component (FSH, LH) [FSH control display units (c1) and (c2), LH control display units (c1 ′) and (c2 ′ )] to illustrate the menopausal stage determination device 2 thus provided, the menopausal stage determination device 2 controls the display unit each test component (FSH, may have one each for the determination of the LH). These determination principles and how to provide the control display unit are as described above.

  For example, the follicle stimulating hormone (FSH) concentration in the blood is 15 mIU / mL or less in the A period of the climacteric stage, 15-30 mIU / mL in the B period, 15-30 mIU / mL in the C period, and D period, as described above. 15-30 mIU / mL in the E phase, 30 mIU / mL or more in the E phase, and the luteinizing hormone (LH) concentration in the blood is 25 mIU / mL or less (FSH) in the A phase of the menopause stage and 25 mIU in the B phase, respectively. / mL or less, 25 to 50 mIU / mL in the C phase, 25 to 50 mIU / mL in the D phase, and 50 mIU / mL or more in the E phase.

Therefore, in the case of the menopausal stage determination tool 2 having one control display unit for each determination unit, the FSH control display unit (c1) of the FSH determination unit (c) has an amount of resistance that can be combined with, for example, 25 mIU / mL FSH. An anti- “anti-FSH antibody” antibody (second antibody) is immobilized so that the FSH antibody can be detected quantitatively, and the LH control display part (c1 ′) of the LH determination part (c ′) has, for example, 15 mIU / mL LH According to the menopausal stage determination tool 2 (test sample: blood) in which an anti- “anti-LH antibody” antibody (second antibody) is immobilized so that the amount of anti-LH antibody bound to can be quantitatively detected, It is possible to determine which menopause stage (A period, B period, C to E period). In addition, the FSH control display part (c1) of the FSH determination part (c) can detect, for example, an anti- “anti-FSH antibody” antibody (secondary) so that an amount of anti-FSH antibody that binds to 50 mIU / mL of FSH can be quantitatively detected. Antibody) is fixed, and an anti-anti-LH antibody can be quantitatively detected in the LH control display part (c1 ′) of the LH determination part (c ′) so that, for example, an amount of anti-LH antibody that binds to 15 mIU / mL of LH can be quantitatively detected. According to the menopausal stage determination tool 2 (test sample: blood) to which the “antibody” antibody (second antibody) is fixed, which menopausal stage (A to B, C to D, E) the subject is in Can be determined. Further, the FSH control display part (c1) of the FSH determination part (c) can detect, for example, an anti- “anti-FSH antibody” antibody (the first anti-FSH antibody) so that an amount of anti-FSH antibody that binds to 25 mIU / mL of FSH can be quantitatively detected. The anti-anti-HH antibody can be quantitatively detected in the LH control display part (c1 ′) of the LH determination part (c ′) so that, for example, an amount of anti-LH antibody that binds to 30 mIU / mL of LH can be quantitatively detected. According to the menopausal stage determination tool 2 (test sample: blood) to which the “LH antibody” antibody (second antibody) is fixed, which menopausal stage (A stage, B to D stage, E stage) the subject is in Can be determined. Furthermore, the FSH control display part (c1) of the FSH determination part (c) can detect an anti- “FSH antibody” antibody (second antibody) so that, for example, an anti-FSH antibody that binds to 50 mIU / mL of FSH can be quantitatively detected. ) Is fixed, and the anti-LH antibody is quantitatively detected in the LH control display part (c1 ′) of the LH determination part (c ′) so that, for example, an amount of anti-LH antibody that binds to 30 mIU / mL of LH can be quantitatively detected. According to the menopausal stage determination tool 2 (test sample: blood) to which the antibody (second antibody) is fixed, it is possible to determine which menopausal stage (AD period, E period) the subject is in. .

As described above, the menopausal stage determination tool 2 has at least two control display units [FSH control display units] in each determination unit [FSH determination unit (c), LH determination unit (c ′)], as in Type 1. (c1) and (c2)), and LH control display sections (c1 ′) and (c2 ′)]. In the case of such menopausal stage determination tool 2 (test sample: blood), the anti- “anti-FSH” can be used as the FSH control indicator (c) so that, for example, an amount of anti-FSH antibody that binds to 25 mIU / mL of FSH can be quantitatively detected. FSH control display (c1) to which the “antibody” antibody (second antibody) is immobilized, and the anti- “anti-FSH antibody” antibody (the first antibody) so that the amount of anti-FSH antibody that binds to 50 mIU / mL of FSH can be quantitatively detected. The FSH control display part (c2) and the LH control display part (c ′) to which two antibodies are fixed are used so that, for example, an anti-LH antibody in an amount that binds to 15 mIU / mL of LH can be quantitatively detected. LH antibody "(second antibody) immobilized LH control display (c1 ') and anti-" anti-LH antibody "antibody to detect quantitatively the amount of anti-LH antibody that binds to 30mIU / mL LH LH control display unit fixing the (second antibody) (c2 ') the equipped with menopause stage determination device 2 (test samples: blood According to, it is possible to determine the subject what menopausal stage (A phase, B phase, C-D stage, E stage) or in.

The menopausal stage determination tool 2 has two reaction parts [(b) and (b ′)] and a determination part [(c) so that both follicle stimulating hormone (FSH) and luteinizing hormone (LH) can be detected simultaneously. And (c ′)]. Such menopausal stage determination tool 2 includes the following types of determination tools.

FIG. 3 shows the menopausal stage determination tool 2 in which sheet-like strips 40 composed of two sheets 41 and 42 having different widths are bonded onto the support 10 (in the figure, these are in an exploded state). Show).

The sheet strip 40 is approximately on the seat 41 of the same width as support 10 is obtained by bonding overlapping sheets 42 of substantially half the width of the sheet 41. In the sheets 41 and 42 , a sample collection part (A), a reaction part (B), a determination part (C), and a liquid absorption part (D) are formed from one end side to the other end side. , Indicated by an arrow p).

In this example, on a wide sheet 41 , an FSH reaction part (b) carrying a labeled-anti-FSH antibody, an FSH test result display part (c0) to which an unlabeled-anti-FSH antibody is immobilized, and an unlabeled-anti-anti FSH control display portions (c1) and (c2) to which the “FSH antibody” antibody is immobilized are formed. Then, on a narrow sheet 42 , an LH reaction part (b ′) carrying a labeled-anti-LH antibody, an LH test result display part (c0 ′) on which an unlabeled-anti-LH antibody is immobilized, an unlabeled-anti-anti LH control display portions (c1 ′) and (c2 ′) to which the “LH antibody” antibody is immobilized are formed. Instead of the above, the LH reaction part (b ′), the LH test result display part (c0 ′), the LH control display parts (c1 ′) and (c2 ′) are added to the wide sheet 41. In 42 , an FSH reaction part (b), an FSH test result display part (c0), and FSH control display parts (c1) and (c2) may be formed. The sample collection part (A) and the liquid absorption part (D) are formed by one end and the other end of the sheets 41 and 42 in the longitudinal direction.

The sheets 41 and 42 can be made of the above-described exemplified materials, and both can be made of the same material or different materials. Adhesives or pressure-sensitive adhesives for adhering these sheets include alkyl acrylate copolymers, ethylene / vinyl acetate copolymers, alkyl acrylate / vinyl acetate copolymers, styrene / isoprene / styrene block copolymers, and styrene.・ Ethylene propylene / styrene block copolymer, styrene / butadiene / styrene block copolymer, styrene / ethylene butylene / styrene block copolymer, amorphous polypropylene resin, amorphous propylene / ethylene copolymer, amorphous Examples thereof include propylene / ethylene / butene copolymers and amorphous propylene / butene copolymers.

Since the sheet-like strip 40 is composed of two sheets 41 and 42 , the test sample collected by the sample collection unit (a) mainly moves along each sheet. The amount of the test component (FSH) bound to the antibody and the test component (LH) bound to the label-anti- "LH" antibody is small between the two sheets, and there is no judgment problem. In particular, the adhesive layer between the two sheets is less likely to cause such mixing problems.

FIG. 4 shows the menopausal stage determination tool 2 in which a sheet-like strip 50 composed of a single sheet 51 having a slit formed in the center is bonded onto the support 10 (in the figure, these are disassembled). Indicated by state).

This sheet 51 has substantially the same width as the support 10 and a slit 54 extending in the longitudinal direction of the sheet is formed at the center. In the sheet 51 , a sample collection part (A), a reaction part (B), a determination part (C), and a liquid absorption part (D) are formed from one end side to the other end side. (indicated by p).

In this example, one side piece 52 of the sheet 51 separated by the slit 54 has an FSH reaction part (b) carrying a labeled-anti-FSH antibody, and an FSH test result display part (non-labeled-anti-FSH antibody fixed) ( c0), and FSH control display portions (c1) and (c2) to which an unlabeled anti- “anti-FSH antibody” antibody is immobilized are formed. Then, on the other side piece 53 , an LH reaction part (b ') carrying a labeled-anti-LH antibody, an LH test result display part (c0') on which an unlabeled-anti-LH antibody is immobilized, an unlabeled-anti-anti-anti LH control display portions (c1 ′) and (c2 ′) to which the “LH antibody” antibody is immobilized are formed. The sample collection part (A) and the liquid absorption part (D) are formed by one end part 55 and the other end part 56 in the longitudinal direction, in which the slits 54 in the sheet 51 are not formed.

The sheet 51 can be composed of the previously exemplified materials. The sheet-like strip 50 has a simple configuration in which a slit 54 is provided in one sheet, so that a test sample collected by the sample collection unit (A) is labeled antibody (label-anti- “FSH” antibody, labeled -An advantage is that it can avoid mixing after binding with anti- "LH" antibody) or other antibodies.

FIG. 5 shows a type 1 menopausal stage determination tool as an example. In the menopausal stage determination tool 1 , a sheet-like strip 60 is bonded on a support 10 . In the same manner as in the above-described example, the sheet-shaped strip 60 includes a sample collection unit (A), a reaction unit (B), a determination unit (C), and a liquid absorption unit in order from one end side to the other end side in the longitudinal direction. (D) is provided. In this example, as shown in FIG. 5 (a), the sampling part (A) is wider in the width direction than the other parts, and before use, as shown in FIG. The part is folded from both sides to the center. The sheet of the sheet-like strip 60 can be composed of the materials exemplified above.

The menopausal stage determination tool 1 shown in FIG. 5 is convenient to carry and carry because the sample collection part (A) is folded and compact as a whole before use. In use, the sample collection part (A) is expanded in the width direction, so that the sample can be easily and reliably received over a wide area. Particularly when urine is used as a test sample, it is advantageous for sample collection during urination. It is. In addition, this wide sampling part (A) is applicable also to the type 2 menopausal stage determination tool (for example, the example of FIGS. 2-4).

FIG. 6 shows an example of a type 1 menopausal stage determination tool in which the sheet-like strip 20 is housed in a case. The climacteric stage determination device 1 is accommodated in an elongated casing 70 of sheet-like strip 20 shown in FIG. 1, it is obtained by freely out the tip. The case 70 includes a main body 71 having an opening at one end in the longitudinal direction, and a lid 72 hinged to the opening. A groove 76 extending in the longitudinal direction is formed at the other end of the case, and a button 77 that slides in the groove is fitted therein. The inner end portion of the button 77 is fixed to the end portion of the sheet-like strip 20 . Therefore, if the button 77 is moved closer to the end of the case, the sheet-like strip 20 is drawn into the case 70 , and if moved to the opposite side, the tip of the sheet-like strip 20 is moved to the case 70 as shown. Can be exposed from. The case 70 has windows 73 , 74 , and 75 at positions corresponding to the test result display section (C 0) and the control display sections (C 1) and (C 2) when the front end of the sheet-like strip 20 is pushed out. Is provided. Desirably, these windows are covered with a transparent plastic plate or the like.

This menopause stage determination tool 1 is carried or transported by pulling the sheet-like strip 20 into the case 70 and binding the lid 72 before use, and in use, the lid 72 is opened and the button 77 is slid to slide the sheet-like strip. The tip of 20 (sample collection part (A)) is exposed. In this state, the sample may be brought into contact with the tip. After use, the sheet-like strip 20 is pulled in and the lid 72 is closed. As described above, the menopausal stage determination tool 1 is easy to operate, and can keep the sheet-like strip clean before and after sampling when being carried or transported.

FIG. 7 shows an example of a type 2 menopausal stage determination tool in which sheet-like strips are housed in a case. The climacteric stage determination device is to have paid a sheet strip 30 shown in FIG. 2 in an elongated casing 80. The case 80 includes a case body 81 having an opening at one end in the longitudinal direction, and a cap 82 detachably fitted in the opening. When the cap 82 is removed, the tip of the sheet-like strip 30 can be exposed from the case main body 81 as shown. The case body 81 is provided with windows 83 , 84 and 85 at positions corresponding to the FSH test result display part (c0) and the FSH control display parts (c1) and (c2) for the test component FSH. Windows 83 ′ , 84 ′, and 85 ′ are provided at positions corresponding to the LH test result display section (c0 ′) and the control display sections (c1 ′) and (c2 ′). Desirably, these windows are covered with a transparent plastic plate or the like. Further, at least one part of the plurality of windows may be connected in the longitudinal direction or the width direction of the case main body 81 . When only one control display unit is provided for each test component, only windows corresponding thereto are provided as shown in FIG.

This menopause stage determination tool 2 is carried or transported with the sheet-shaped strip 30 placed in the case body 81 and the cap 82 closed before use, and when used, the cap 82 is removed and the tip of the sheet-shaped strip 30 is removed. Part (sample collection part (A)) is exposed. And what is necessary is just to make a sample contact a front-end | tip part in this state. After use, the cap 82 is put on the case body 81 to cover the sheet-like strip 30 . Thus, this menopausal stage determination tool 2 is also easy to operate, and when carrying or carrying, the sheet-like strip can be kept clean before and after sampling.

The menopausal stage determination tools 1 and 2 can be used in various forms instead of the sheet-like strips described above as the liquid-absorbing pieces. 8-10 has shown the example which used the rod-shaped object as a liquid absorption piece.

FIG. 8 shows the menopausal stage determination tool 1 provided with a cylindrical rod-shaped piece 90 as a liquid-absorbing piece. In this menopause stage determination tool, the sample collection part (A), the reaction part (B), the determination part (C), and the liquid absorption part (D) are sequentially arranged from one end side to the other end side in the longitudinal direction of the rod-shaped strip 90. It has.

FIG. 9 shows the menopausal stage determination tool 1 in which sheet-like portions 101 and 103 are arranged at both ends of a cylindrical rod-like portion 102 as a liquid absorbing piece. These parts can be joined by an adhesive, heat fusion, a thread, a wire, or the like, and the liquid transferability between the parts is maintained. This menopausal stage determination tool 1 includes a sheet-like portion 101 as a sampling portion (A), a rod-like portion 102 as a reaction portion (B) and a determination portion (C), and a sheet-like portion 103 as a liquid absorption portion (D). Yes. And the liquid absorption piece which consists of these is fixed to the support body 10 by adhesion | attachment etc.

FIG. 10 shows a menopause stage determination tool 2 in which a prismatic rod-like portion 112 is used as the liquid absorption piece, and sheet-like portions 111 and 113 are arranged at both ends. These parts can also be joined by an adhesive, heat fusion, a thread, a wire, or the like, and is performed so as to maintain liquid transportability between the parts. This menopausal stage determination tool 2 includes a sheet-like portion 111 for sampling part (A), one of the two rod-like parts 112 for FSH reaction part (b) and judgment part (c) [FSH test result display Part (c0) and FSH control display part (c1) and (c2)], the other is the reaction part (B) and judgment part (c ') for LH [LH test result display part (c0') and LH control display Parts (c1 ′) and (c2 ′)] and a sheet-like part 113 are provided as the liquid absorbing part (D). And the liquid absorption piece which consists of these is carried out to the support body 10 by adhesion | attachment etc. If a liquid-absorbing piece using these rod-shaped materials is used, a compact menopausal stage determination tool having a small width can be obtained. This is particularly advantageous for a type 2 menopausal stage determination tool. These menopause stage determination tools 2 can also take the form accommodated in the case as shown in FIG.6 and FIG.7. Further, in order to facilitate the visual recognition of the color of the determination unit, the window provided in the case can be formed in a convex lens shape.

The above-described menopausal stage determination tool 1 and 2 of the present invention can also be accompanied by a display means document (specification) explaining the method of using the menopause stage determination tool and the method of determining the menopause stage. Provides a menopause stage determination kit in which the menopause stage determination tool 1 or 2 and specifications are set. In the manual on how to judge the menopause stage, in what kind of menopause stage (A to E) the color development intensity (darkness) presented in the test result display part and the control part will be A specific example of what can be determined to be present can be exemplified. The display means may be a document in the form of a specification, or may be represented on the case surface shown in FIGS.

  In addition to these, various modifications can be made to both menopausal stage determination tools of type 1 and type 2 without departing from the scope of the present invention.

It is a perspective view which shows one Embodiment of the menopausal stage determination tool of the type 1 which concerns on this invention. It is a perspective view which shows one Embodiment of the menopausal stage determination tool of the type 2 which concerns on this invention. It is a perspective view which shows other embodiment of the menopausal stage determination tool of the type 2 which concerns on this invention. It is a perspective view which shows other embodiment of the menopausal stage determination tool of the type 2 which concerns on this invention. It is a perspective view which shows other embodiment of the menopausal stage determination tool of the type 1 which concerns on this invention. It is a perspective view which shows other embodiment of the menopausal stage determination tool of the type 1 which concerns on this invention. It is a perspective view which shows other embodiment of the menopausal stage determination tool of the type 2 which concerns on this invention. It is a perspective view which shows other embodiment of the menopausal stage determination tool of the type 1 which concerns on this invention. It is a perspective view which shows other embodiment of the menopausal stage determination tool of the type 1 which concerns on this invention. It is a perspective view which shows other embodiment of the menopausal stage determination tool of the type 2 which concerns on this invention.

Explanation of symbols

1: Type 1 menopausal stage determination tool 2: Type 2 menopausal stage determination tool 10: Support 20, 30, 40, 50, 60: Liquid absorbing piece (sheet-like strip)
90, 102: Liquid absorbing piece (bar-shaped)
112: Liquid absorption piece (prism shape)
A: Sampling part
B: Reaction part
C: Judgment part
D: Liquid absorption part b: FSH reaction part b ': LH reaction part
c0: FSH test result display
c0 ': LH test result display area
c1, c2: FSH control display
c1 ', c2': LH control display

Claims (7)

A menopause stage determination tool comprising a liquid absorption piece made of a material capable of transferring a test sample by capillary action, wherein the liquid absorption piece is
(1a) a sample collection part for absorbing and collecting a test sample,
(1b) a label that specifically reacts with follicle stimulating hormone (FSH)-an FSH reaction part carrying an anti-FSH antibody,
(1c) an FSH determination unit provided with an FSH test result display unit and at least two FSH control display units with different amounts of antibody fixation, each of which is shown below,
(1) FSH test result display section with unlabeled anti-FSH antibody immobilized specifically reacting with FSH,
(2) an FSH control display unit to which an unlabeled anti- “anti-FSH antibody” antibody that specifically reacts with an anti-FSH antibody is immobilized, and
(1d) A menopausal stage determination tool comprising a liquid absorption unit that absorbs a residual liquid of a test sample that has moved through the sample collection unit, the FSH reaction unit, and the FSH determination unit. A menopause stage determination tool comprising a liquid absorption piece made of a material capable of transferring a test sample by capillary action, wherein the liquid absorption piece is
(2a) a sample collection part for absorbing and collecting the test sample,
(2b) a label that specifically reacts with luteinizing hormone (LH)-an LH reaction part carrying an anti-LH antibody,
(2c) LH test result display section shown below, and an LH determination section provided with at least two LH control display sections with different antibody fixation amounts, each with an interval,
(1) LH test result display section on which an unlabeled anti-LH antibody that specifically reacts with LH is immobilized,
(2) a non-labeled anti- "anti-LH antibody" antibody that specifically reacts with the anti-LH antibody, and an LH control display unit, and
(2d) A menopausal stage determination tool comprising a liquid absorption unit that absorbs a residual liquid of a test sample that has moved through the sample collection unit, the LH reaction unit, and the LH determination unit. A menopause stage determination tool comprising a liquid absorption piece composed of a material capable of transferring a test sample by capillary action, the liquid absorption piece,
(3a) a sample collection part for absorbing and collecting the test sample,
(3b) Label reacting specifically with follicle stimulating hormone (FSH)-FSH reaction part carrying anti-FSH antibody and label reacting specifically with luteinizing hormone (LH)-LH reaction carrying anti-LH antibody Reaction part, including
(3c) Determination unit including the following FSH determination unit and LH determination unit:
(3c-1) FSH determination unit: The following FSH test result display unit and at least two FSH control display units with different amounts of antibody fixation are provided at intervals:
(i) an unlabeled anti-FSH antibody that specifically reacts with FSH, and an FSH test result display section,
(ii) a non-labeled anti- “anti-FSH antibody” antibody immobilized FSH control display specifically reacting with the anti-FSH antibody, and
(3c-2) LH determination unit: The following LH test result display unit and at least two LH control display units with different antibody fixation amounts are provided at intervals:
(i) LH test result display section with an unlabeled anti-LH antibody immobilized specifically reacting with LH,
(ii) an unlabeled anti- "anti-LH antibody" antibody-fixed LH control display section that specifically reacts with the anti-LH antibody,
And
(3d) A menopausal stage determination tool comprising a liquid absorption unit that absorbs a residual liquid of a test sample that has moved through the sample collection unit, the reaction unit, and the determination unit. A menopause stage determination tool comprising a liquid absorption piece made of a material capable of transferring a test sample by capillary action, wherein the liquid absorption piece is
(4a) a sample collection part for absorbing and collecting the test sample,
(4b) Label that reacts specifically with follicle-stimulating hormone (FSH)-FSH reaction part carrying anti-FSH antibody (b) and label that reacts specifically with luteinizing hormone (LH)-carrying anti-LH antibody LH reaction part,
(4c-1) FSH determination unit provided with the following FSH test result display unit and FSH control display unit at intervals:
(1-1) FSH test result display section with an unlabeled anti-FSH antibody immobilized specifically reacting with FSH,
(1-2) a non-labeled anti- “anti-FSH antibody” antibody-fixed FSH control display specifically reacting with the anti-FSH antibody, and
(4c-2) LH determination unit with the following LH test result display unit and LH control display unit at intervals:
(2-1) LH test result display section with an unlabeled anti-LH antibody immobilized specifically reacting with LH,
(2-2) an unlabeled anti- “anti-LH antibody” antibody-fixed LH control display unit that specifically reacts with anti-LH antibody, and
(4d) Menopausal stage determination characterized by comprising a liquid absorption part that absorbs the remaining liquid of the test sample that has moved through the sample collection part, FSH reaction part, LH reaction part, FSH determination part, and LH determination part Ingredients.   The FSH determination unit includes an FSH test result display unit and at least two FSH control display units having different concentrations of immobilized non-labeled anti- “anti-FSH antibody” antibody, and the LH determination unit includes an LH determination unit. The menopausal stage determination tool according to claim 4, comprising a test result display section and at least two LH control display sections having different concentrations of immobilized non-labeled anti- "anti-LH antibody" antibody.   The menopausal stage determination tool according to any one of claims 1 to 5, wherein the test sample is female urine.   A menopause stage determination kit comprising the menopause stage determination tool according to any one of claims 1 to 6, and display means for explaining a method for using the menopause stage determination tool and a method for determining the menopause stage.

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