JP3791640B2 - Inspection device - Google Patents

Description

[0001]
BACKGROUND OF THE INVENTION
The present invention detects the presence or quantitative ratio of a specific component contained in a biological liquid sample such as saliva, serum, plasma, urine, feces, amniotic fluid, or milk, or a liquid sample such as a diluted liquid thereof. , Devices for testing by measuring, and more particularly liquid samples by using a mobile label component that specifically binds to a specific component in the liquid sample, such as biological liquid samples or their dilutions The present invention relates to an inspection device used for detecting and measuring the presence or absence of a specific component and its quantitative ratio.
[0002]
[Prior art]
Analyzes of various liquid samples such as industrial and biological liquids because test tools in the form of columns, rod-shaped or sheet-like strips with solid particles or porous bodies can be used easily and quickly Used for diagnosis. Of these, the initial stage test tool is composed of a liquid-absorbing porous matrix, and the test liquid sample impregnated and absorbed at the end of the test tool is infiltrated using its capillary action, so that columns and strips can be obtained. By observing the response of a chromogenic indicator or the like previously placed in the middle of the test, the presence / absence or quantitative ratio of a specific component in the test liquid is detected and analyzed.
[0003]
Since then, test strips have been developed that cause several test reactions to occur in a predetermined order. For example, in the test strip described in U.S. Pat. No. 3,011,874, the test strip has a plurality of zones sequentially in the longitudinal direction. As an example of the strip, a first empty zone for immersion in a liquid sample is used. (BLANK BAND), then sequentially from reaction paper (REACTION BAND), outgassing band (GAS LIBERTION BAND), empty band (BLANK BAND), failure band (BARRIER BAND) and indicator band (INDICATOR BAND) It is configured.
[0004]
This point was further improved in Japanese Patent Laid-Open No. 53-47894. It consists of an elongated strip made of a material that allows the liquid sample to move longitudinally by capillarity and comprises a start zone, an intermediate zone and a termination zone to which the liquid to be tested is applied, and the intermediate zone A diagnostic device is described that includes a sheet-like strip made of a material that includes a sample-receiving area that is permanently fixed and arranged at a predetermined position of the substrate and that can transfer a developing solution (liquid sample) by capillary action. . As the material of the strip, furnace paper, various felts, cloths, gels, membranes or films made of natural or synthetic substances such as polymers are used.
[0005]
In the diagnostic device, a predetermined amount of a mobile label and a fixed form of a specific binding component are contained in each compartment at intervals in the strip. In use, the sample and the mobile label are mixed and carried as the developing solution travels longitudinally from its starting area through the strip, and comes into contact with the fixed binding hand component or partner component, The label and the ligand (specific component) in the sample compete to bind to the binding component. The portion of the mobile label that is successfully bound to the binding component is fixed in the compartment, and the presence or amount of the test substance is detected by the label.
[0006]
A so-called wick (a liquid absorber, a sponge, a wick, etc.) is appropriately provided in the starting end area to which the test liquid is applied in this type of diagnostic device in order to facilitate the absorption of the test liquid such as urine according to a conventional method. The strip is provided with a reinforcing support strip (backing member) as necessary. JP-A-61-145459 discloses that a plurality of sheets (at least three sheets are required when a sheet to which a sample is applied is included) are connected while being overlapped to form an active region. A solid diagnostic device used for detection and quantitative measurement of an analyte in a fluid is described. This solid diagnostic device is basically the same as that described in JP-A-53-47894, except that at least three or more connecting sheets are required, although the way of explanation is different. is there.
[0007]
JP-A-1-503174 discloses a sheet-like strip of the same type as described above, which is stored in a box-shaped hollow casing made of a moisture-impermeable solid material and stored in a dry state. An analytical test apparatus is described. In this analytical test apparatus, a cap is fitted to the exposed porous member for sample application before use, the cap is removed during use, a sample is applied to the porous member, and then the cap is re-fitted. The test results are observed. However, in such an analytical test apparatus, since it is a box-type hollow casing, not only is it stretched, but a cap is required separately, so a lot of materials are used and the cost is high, and it takes time and effort to remove the cap during the test, Furthermore, there is a problem that the amount of used waste increases.
[0008]
JP-A-5-87807 has a plurality of members of a urine collection part, a reagent part, a base part, and a determination part, and a fixing member that integrally fixes the plurality of members. There is described a pregnancy test tool including an outer cylindrical member that can be slidable, and the urine collection part or the determination part is exposed from the outer cylindrical member when the fixing member slides inside the outer cylindrical member. In this pregnancy test tool, the urine collection unit and the determination unit are stored in the outer cylindrical member in advance, and when collecting urine, the urine collection unit is exposed by sliding the fixing member in one direction, and further determination is made. In this case, the determination member is exposed by sliding the fixing member in the direction opposite to the direction. However, in such a pregnancy test tool, an outer cylindrical member is used, and a plurality of members such as a urine collection unit, a reagent unit, a base material unit, and a determination unit are used, and further, the side surfaces and bottom surfaces of the plurality of members are covered. Since the fixing member integrated by this is used, it is not only bulky but also uses a lot of materials, resulting in high costs. In addition, after the fixing member is slid to collect urine and the urine collection part is exposed from the outer cylindrical member, the determination part must be exposed by holding the fixing member and sliding in the opposite direction in order to make a determination. It is unsanitary and complicated to operate.
[0009]
In addition, Japanese Patent Laid-Open No. 8-94617 discloses a rod-shaped urine absorber having a base end portion inserted on one side of a holder, and is provided in the holder and connected to the base end portion of the urine absorber. A tray having a diagnostic piece for diagnosing the urine, and having a concave portion for housing the base end portion of the urine absorber and the diagnostic piece in the holder, and a flange portion provided at the periphery of the upper end portion of the concave portion And a portable diagnostic device having a transparent film portion bonded to the flange portion of the tray.
[0010]
In the above-described portable diagnostic device, since the entire holder is composed of a plastic molded product formed by injection molding or the like in a commercially available diagnostic device, and a transparent plastic part is also used for the transparent window, the plastic material of the product This is an improvement in that the amount of use of is not preferable in terms of waste disposal after use and the cost is increased. The urine absorber is provided with a chromogenic urine wetting checker to confirm whether urine is absorbed. However, in such a type of portable diagnostic device, since the length from the start end to the end is short, this actually hinders handling and is inconvenient as well as urine absorption. It is necessary to protect the entire device including the body with a hard packaging material.
[0011]
[Problems to be solved by the invention]
Therefore, in the present invention, one or two or more coupled pairs are provided which have a start area, an intermediate area, and an end area to which the test liquid is applied, and are permanently fixed and arranged at predetermined positions in the intermediate area. In an inspection device including a sheet-like strip made of a material containing a hand component and capable of transporting a test liquid by capillary action, a gripping body for gripping the sheet-like strip is provided separately, and before use, a sheet is provided. It is compact and hygienic, and solves the above-mentioned drawbacks at a stroke by making the sheet-shaped strip rotate and extendable when it is used. An object of the present invention is to provide an inspection device.
[0012]
[Means for Solving the Problems]
The present invention comprises a single piece or a plurality of connected sheet-like strips made of a material having a start zone, an intermediate zone and a termination zone and capable of transporting a test solution by capillary action. Includes a wick for impregnating and absorbing the test solution, includes a mobile marker component at the end of the start zone, and is permanently spaced at predetermined positions in the intermediate zone. A testing device comprising one or more binding hand components fixed and arranged, and the sheet-like strip including part or all of the sheet-like strip or wick is held by a holder The holding body holding the sheet-like strip including part or all of the sheet-like strip or wick is rotatably held by the sheet-like gripping body on the side facing the wick. Testing device To provide a scan.
[0013]
DETAILED DESCRIPTION OF THE INVENTION
The test device of the present invention is a single piece made of a material that can transfer a developing solution, that is, a test solution by capillary action or chromatographic action (herein referred to as “capillary phenomenon, capillary action, etc. as appropriate”). Sheet-like strips or a plurality of connected sheet-like strips and a support for supporting the strip-like strips. The sheet strip has a start area, an intermediate area, and an end area to which the test solution is applied, and is permanently fixed and arranged at one or more predetermined positions of the intermediate area. A solution absorber or wick for impregnating the test solution is brought into contact with the starting end region containing the anti-hand component and applying the test liquid. In the present specification, the start end area, the intermediate area, and the end area refer to the relative positional relationship in the sheet-like strip.
[0014]
A mobile label component or tracer (referred to as a mobile label component in the present specification as appropriate) is disposed on the side of the sheet-like strip opposite to the site where the wick of the starting end is in contact. In addition, the arrangement | positioning location of a mobile label | marker component may be the start end area side of an intermediate area. A mobile label component consists of a specific component in a liquid sample and a component that specifically binds by, for example, an antigen-antibody reaction. It is a solid at room temperature and is soluble in a solvent such as water or alcohol, or moves through a capillary tube using these solvents. Possible substances such as gold or silver or metal or inorganic particles such as selenium, fluorescent labels such as fluorescein or rhodamine, red blood cells, latex particles, dye labels such as colored or colored latex particles, β-galactosidase, peroxidase, Examples include those labeled with an enzyme label such as alkaline phosphatase, or a mixture thereof, and these may be modified by surface treatment. These mobile labeling components are moved along with the sample liquid when the sample solution is impregnated. In the intermediate zone, the specific component in the sample solution or one or more components that specifically bind to the mobile label component are permanently fixed and arranged at sequential intervals.
[0015]
When the test solution is impregnated into the wick, it penetrates by capillary action and specifically binds to one or two or more specific components in the test solution that are arranged on the way. The sample solution is (A) a mobile label component in which the test solution is specifically bound to one or more specific components (first specific component, second specific component, third specific component...). And (B) the first binding component in the middle section with the unbound mobile label component, and (A) the first specific component bound to the label component is the first binding partner. The label component is immobilized by binding with the component by, for example, antigen-antibody reaction (sandwich method, etc .: the antigen in this case indicates the first specific component, and the antibody indicates the first binding pair component) As a result, the presence / absence or quantitative ratio of the first specific component is detected.
[0016]
Next, the sample solution includes the remaining, that is, (A) a mobile label component specifically bound to a specific component other than the first specific component (second specific component, third specific component...) B) To the location of the second binding hand component in the middle zone with the unbound mobile label component. Here, (A) the presence of the second specific component by binding the second specific component bound to the label component to the second binding hand component by, for example, antigen-antibody reaction, fixing the label component, and accumulating And quantitative ratios are detected.
[0017]
Thereafter, the presence or absence of the third specific component, the fourth specific component,... Is detected in the same manner as described above. In this case, the unbound mobile label component is the final binding pair component and, for example, an antigen-antibody reaction (the antigen in this case indicates the mobile label component, and the antibody is the final bond component) In this case, it is confirmed that the above series of tests are completed by fixing and accumulating the label component. When the specific component to be inspected in the sample solution is one kind, the first binding hand component and the second binding hand component are arranged in the intermediate area, and the first binding hand component The presence / absence or quantitative ratio of the specific component is detected at the location of (2), and it is confirmed that the test has been completed and / or the test has been correctly performed at the location of the second binding pair component.
[0018]
As the sheet-like strip in the present invention, a material having a porous or capillary structure in which a solvent (water, alcohol, etc.) and a test component can permeate, a test solution can be developed, and a mobile label component can move Can be used, and it is composed of membranes or films of various materials. Examples thereof include sheets such as various furnace papers and chromatography papers, various felts, cloths such as woven fabrics and non-woven fabrics, and glass fibers. More preferably, organic porous materials are used. Examples include natural fibers such as cellulose, semi-synthetic fibers such as cellulose acetate, cellulose derivatives such as nitrocellulose, fiber aggregates formed of synthetic fibers such as polyethylene, polypropylene, nylon, and polyester, porous polypropylene, porous Examples thereof include porous synthetic resins such as porous polystyrene, porous polymethyl methacrylate, porous nylon, porous fluororesin, porous polysulfone, and polyvinylidene fluoride introduced with a hydrophilic group.
[0019]
Membranes or films made of these materials, i.e., sheet-like strips, are provided with a start area, an intermediate area and an end area to which the test solution is applied. A mobile label component is disposed in the start end region, and a first binding hand component, a second binding hand component, a third binding hand component,. Each is permanently fixed and arranged. And at each location where the first binding hand component, the second binding hand component, and the third binding hand component are arranged, the presence / absence or quantitative ratio of the specific component in the test solution is determined and inspected. It is confirmed that the inspection has been completed and / or that the test has been correctly performed at the place where the bond-hand component at the end is arranged.
[0020]
In the present invention, the sheet-like strip is held by the holding body. This holding body is made of various plastic sheets (plastic sheets), hard paper, sheets made of metal (including alloy) such as aluminum, and a multilayer sheet in which a plurality of these same or different sheets are bonded (bonded). [For example, a multi-layer paper in which a plurality of papers are pasted (laminated), a paper in which a plastic sheet and paper are pasted (laminated), etc.), a paper having a waterproof coating or the like, etc. The The holding of the sheet-like strip by the holding body is performed by sticking the upper surface of an appropriate portion of the sheet-like strip on the inner surface, for example, the appropriate portion of the terminal area (behind the position where the binding component at the final end is disposed). However, it can be performed by fixing. In the sheet-like strip, a mobile label component, a first binding hand component, a second binding hand component, a third binding hand component, etc. are sequentially arranged, and these binding hand components are arranged. It is confirmed that the presence / absence or quantitative ratio of the test component and the completion of the test and / or the test have been correctly performed at each location. Alternatively, two or more determination windows and confirmation windows are provided.
[0021]
Examples of test components that can be detected and measured by the device of the present invention include various liquid samples such as biological fluid samples such as saliva, serum, plasma, urine, feces, amniotic fluid, or milk, or liquid samples thereof. Ingredients. Examples thereof include dilantin, digoxin, morphine, digitoxin, barbiturates, catecholamines, glutethmine, cocaine, hemoglobin, transferrin, diphenylhydantoin, melbomamate, benzdiazocycloheptanes, phenothiazines, biotin, Vitamins B, vitamin A, vitamin D, vitamin E, vitamin K, folic acid, vitamins such as ascorbic acid, insulin, chorionic gonadotropin, luteinizing hormone, triiodothyronine, estriol, testosterone, androsterone, Hormones such as equilenin, progesterone, estrone, prognolenolone, cortisol, 17-hydroxydeoxycorticosterone, aldosterone, thyroxine, Binding proteins such as globulin, avidin, intrinsic factor and transcobalamin, bacteria, protozoa, fungi, viruses, various cells derived from higher animals, various insecticides, fungicides, nematode eradication agents, waste liquids or industrial fluids Various organic and inorganic components can be mentioned. Of these, for example, hemoglobin and transferrin are used as diagnostic devices for fecal occult blood tests, chorionic gonadotropins are used as diagnostic devices for pregnancy tests, and luteinizing hormones are used as ovulation tests. Used as a diagnostic device.
[0022]
【Example】
EXAMPLES Hereinafter, although this invention is demonstrated in more detail based on an Example, of course, this invention is not limited to these Examples. 1 to 8 are diagrams showing an embodiment of a testing device according to the present invention. FIG. 1 is a diagram showing a sheet-like strip (device main body) held by a holder, and FIG. 2 is a sheet-like strip. FIG. 3 is a view showing various embodiments of sheet-like strips (= membranes) held by the holding body, and FIG. 4 is a diagram showing the holding body formed by holding the sheet-like strips. FIG. 5 is a diagram showing the inspection device of the present invention in which the holding body (holding the sheet-like strip) is gripped with respect to the gripping body, and FIG. FIGS. 7 to 8 are views showing other modes of use of the inspection device of the present invention. In the following, the case where one determination window is provided is described, but the same applies to the case where two or more determination windows are provided.
[0023]
First, FIG. 1A is a plan view of a sheet-like strip formed by holding the sheet-like strip by a holding body, and FIGS. 1B to 1C are taken along line AA in FIG. FIG. 1D is a transverse cross-sectional view, and shows the back side of a sheet-like strip held by a holding body. 1A to 1C, 1 is a device body, 2 is a wick, and 3 is a holding body. The sheet-shaped strip 1 is composed of a single sheet-shaped strip [as described above, various furnace papers, cloths such as woven fabrics and nonwoven fabrics, films, membranes, and the like (hereinafter also referred to as membranes as appropriate). The holding body 3 is a sheet made of a sheet made of plastic, hard paper, aluminum or other metal (including alloy), or a laminate of one or more of these. Configured as
[0024]
The width of the membrane 1 is not particularly limited, but is about 2 to 20 mm, preferably about 3 to 10 mm. The length of the membrane 1 is 50 including the portion of the wick 2 extended from the membrane 1. About 200 mm, preferably about 80 to 150 mm. The holding body 3 for holding the membrane 1 has a relatively large width compared to the width of the membrane 1 such as 10 to 40 mm, and holds the membrane 1 in the longitudinal direction on the back surface. To do.
[0025]
By making the width of the holder 3 relatively large as compared with the width of the membrane 1, the handling operation when using the device can be easily performed. In this case, in the illustrated embodiment, the membrane 1 is fixed and held by the holding member 3 with the fixing member 4. As the material of the fixing member 4, a material that can achieve its fixing purpose, for example, plastic, paper, hard rubber, etc., is used, but if it is made of a porous material, for example, a hard or semi-hard sponge, it becomes a wick. A suction action of the test solution to be applied and impregnated can also be provided.
[0026]
The membrane 1 has a mobile label component (specifically binds to a specific component in the test solution) 5 in sequence, a first bond component permanently fixed (the test solution specifically bound to the label component) (Specifically binds to a specific component in the inside) 6, and a permanently fixed second bond component (specifically binds to a mobile label component accompanying the test solution) 7 is arranged Yes. As shown in the drawing, the holding body 3 is provided with a determination window 8 and an end confirmation window 9 in order corresponding to the positions of the first bond component 6 and the second bond component 7, respectively. In the illustrated example, two fixed bond components are arranged at intervals, but three or more bond components are arranged according to the number of specific components in the test solution to be examined. A plurality of components to be detected can be detected and analyzed simultaneously. In this case, in addition to the confirmation window, a determination window is provided for each fixed position of each bond component.
[0027]
The wick 2 is made of, for example, filter paper, sponge made of various materials, porous cellulose, or other aqueous solution-absorbing substances. The wick 2 abuts and is fixed to the device main body, that is, the starting end portion of the membrane 1, and can be fixed at a location indicated by reference numeral 10 in FIG. In addition, the back surface and both side surfaces of the membrane 1 (only the back surface may be used if necessary) are sealed with a liquid-impermeable thin film to protect the membrane 1 itself, and the liquid to be tested is sprinkled when the device is used. Can be avoided. In FIGS. 1B to 1C, reference numeral 11 denotes the seal thin film.
[0028]
The membrane 1 is provided with supporting strips for reinforcement, that is, backing members, as necessary. In FIG. 1C, reference numeral 12 indicates the backing member. When the back surface of the membrane 1 is sealed as described above, the backing member 12 can be applied by, for example, sticking to the sealing surface. Further, the backing member 12 is applied up to the position corresponding to the tip of the wick 2 in FIG. 1C, but it may be applied by the length of the holding body 3.
[0029]
The holding body 3 can take various aspects in addition to the above-described aspects. For example, both ends or one end thereof may be open (both ends may be sealed) in a flat bag shape, and the membrane 1 may be inserted and fixed therein. FIG. 2 shows an example of the embodiment, FIG. 2 (a) is a plan view thereof, FIG. 2 (b) is a sectional view taken along line AA in FIG. 2 (a), and FIG. FIG. 2 (d) is a cross-sectional view taken along line BB in FIG. 2 (a). Among these, FIG.2 (d) is expanding relatively compared with FIG.2 (a)-(c). In addition, the same reference numerals are used for portions common to those in FIG. 1, and the same applies to the following points.
[0030]
As shown in FIG. 2, the holding body 3 is formed in a flat bag shape, and the membrane 1 (including the above-described seal and / or backing member when included) is fixed and held therein. In the case of this embodiment, as clearly shown in FIG. 2D, the thicknesses of the membrane 1 (including this when sealing), the backing member 12 and the thickness of the wick 2 are determined. The combined thickness (the distance between the upper and lower surfaces can be more than the total thickness), and the membrane 1 including the wick 2 is inserted and fixed therebetween. In addition, the holder 3 can be partially or entirely sealed with a moisture-impermeable thin film in any of the above embodiments. In addition, the shape of the both-ends part of the holding body 3 is comprised not only the shape shown as the code | symbol K in FIG.2 (d) but in an appropriate shape, such as tapering or giving roundness.
[0031]
When the test device is used, when the wick 2 is impregnated with the test solution, the test solution penetrates the membrane 1 by capillary action, and first reaches the position where the mobile label component 5 is disposed. Here, the specific component in the test solution specifically binds to the mobile label component 5 by, for example, an antigen-antibody reaction. Next, the test solution was fixed and arranged permanently with (A) the mobile label component specifically bound to the specific component and (B) the remaining mobile label component 5 not bound to the specific component. It reaches the position of one bond component 6. Here, (A) the specific component bonded to the mobile label component specifically binds to the first bond component and the labeled particles 5 are fixed and gathered, and a change in color tone due to the collected label component is determined. By observing through the window 8, the presence or the quantitative ratio of the specific component is detected.
[0032]
The test solution further reaches the position 7 of the second bond component, where (B) the remaining mobile label component 5 that does not bind to the specific component specifically binds to the second bond component and becomes labeled particles. 5 are fixed and gathered, and it is confirmed that the inspection has been completed and / or that the test has been correctly performed by observing the color tone change and the like by the accumulated label component with the confirmation window 9. On the other hand, in the above, when the specific component is not present in the test solution, the test solution includes (B) the position of the first binding component 6 with only the mobile label component 5 that does not bind to the specific component. It passes through to the point 7 of the second bond component. At this point 7, (B) the mobile label component 5 specifically binds to the second bond component and the label particles 5 are fixed and gathered, and the test is completed and / or the test is correctly performed. [In this case, as a result of the test, it is confirmed that there is no specific component in the test solution (or even if there is a specific component, the quantitative ratio is small)].
[0033]
FIG. 3 shows various embodiments of the device main body (sheet-like strip = membrane) held by the holding body 3. In the example of FIG. 3 (a), the membrane 1 has the same length or almost the same length as the holding body 3, and in the case of FIG. 3 (b), the rear part of the membrane 1 is shortened and the fixing to the holding body 3 is performed by the confirmation window 9. This is performed by the fixing member 4 in the vicinity. In the example of FIG. 3C, the tip of the membrane 1 is configured to be the same as or substantially the same as the tip of the holding body 3, and the rear thereof is configured to be as short as in the case of FIG. . In any of these aspects, as in the case of FIGS. 1B to 1C described above, the membrane 1 can be sealed as necessary, and a backing member can be applied.
[0034]
FIGS. 3D to 3F are embodiments in the case where the wick 2 is disposed upside down with respect to the membrane 1. 3D to 3F, the determination window 8 and the confirmation window 9 are provided on the holding body 3 corresponding to the first bond component and the second bond component disposed in the membrane 1. Although there is no change in the arrangement, there is no need for an interval corresponding to the thickness of the wick 2 between the upper surface of the membrane 1 and the holding body 3 (upper surface), so that the changes seen through these two windows are easier to see. There are advantages. On the other hand, since a space corresponding to the thickness of the wick 2 is generated in the lower part of the membrane 1, it is more preferable to use the holding body of the embodiment shown in FIG. In any of these embodiments, the membrane 1 can be sealed as necessary, and a backing member can be applied in the same manner as described above.
[0035]
As described above, the “holding body holding the membrane” (hereinafter referred to as a device body as appropriate) is gripped so as to be rotatable with respect to the gripping body. FIG. 4 is a plan view showing the sheet-like gripping body 13 for the device body. FIG. 4 (a) shows the front surface and FIG. 4 (b) shows the back surface. As shown in the drawing, a hole 14 is formed in the sheet-like gripping body 13, and the membrane 1 is gripped by the hole 14 through the holding body 3 so as to be rotatable. The sheet-like grip 13 is made of a material such as plastic, hard paper, or metal sheet. Further, a part or all of the sheet-like gripper can be sealed with a moisture-impermeable thin film, and in this respect, the sheet-like gripper of any aspect used in the present invention including the case described below. Is the same.
[0036]
FIG. 5 is a view showing a mode in which the sheet-like strip held by the holding body 3, that is, the membrane 1 is gripped so as to be rotatable with respect to the sheet-like holding body 13. FIG. 5A shows a sheet-like gripping body 13 having a hole 14 formed therein. FIG. 5B shows a device main body (holding body holding a sheet-like strip) gripped by the sheet-like gripping body 13, corresponding to the hole 14 of the sheet-like gripping body 13 on the side facing the wick 2. A hole 15 is formed at a location. After superposing the holding body 3 holding the sheet-like strips on the sheet-like holding body 13, rivets or the like are inserted into the holes 14 and 15 to fix both of them rotatably. FIG. 5C shows the fixed state.
[0037]
FIGS. 6A to 6B are diagrams showing how the inspection device of this aspect is used. 6A shows a state before use of the device [same as the state of FIG. 5C], and FIG. 6B shows a state in use. 6 (a), which is the state before use, is rotated by 180.degree., For example, by 180.degree. State. In FIG. 6A, an arc-shaped arrow (→) indicates the relative movement direction of both.
[0038]
The test device is used by holding the gripping body 13 and impregnating urine or other test solution over the wick 2 after the state shown in FIG. In addition, the test solution may be stored in a suitable container, and may be used by an appropriate method such as impregnation by dipping the portion of the wick 2 in the stored test solution. In addition, although the state of FIG.6 (b) is the state which the preparation for use as a device was complete | finished, it has described as including the state at the time of use as mentioned above, About this point also about the following example The same.
[0039]
The length of the inspection device of the present invention is about 80 to 400 mm, preferably about 100 to 300 mm, and more preferably about 120 to 230 mm when the state shown in FIG. As described above, the length of the membrane 1 is about 50 to 200 mm, preferably about 80 to 150 mm including the portion of the wick 2 extended from the membrane 1. Then, handling at the time of device use becomes much easier, and the inspection by this can be performed very hygienically. Further, as described above, the width of the holding body 3 that holds the membrane 1 is relatively larger than the width of the membrane 1 and is, for example, about 10 to 40 mm, but the width of the gripping body is at least more than that. And These dimensions are the same for the other embodiments of the present invention.
[0040]
The test device is used while holding the gripping body 13 in the state shown in FIG. 6B, but when the wick 2 is impregnated with the test solution, the test solution penetrates the membrane 1 by capillary action. First, it reaches the position where the mobile label component 5 is arranged. Here, the specific component in the test solution specifically binds to the mobile label component 5 by, for example, an antigen-antibody reaction. Next, the test solution reaches the location of the first binding hand component 6 that is permanently fixed and arranged, with the mobile label component 5 (including the mobile label component specifically bound to the specific component). . Here, the specific component bound to the mobile label component is specifically bound to the binding hand component by the sandwich method or the like, and the label particles 5 are fixed and gathered. By doing this, the presence or the quantitative ratio of the specific component is detected.
[0041]
In the inspection device of the present invention, the holding body holding the sheet-like strip is rotatably held by the sheet-like holding body with the side facing the wick as a fulcrum. Various modes can be adopted as long as the structure is provided. In the example of FIG. 7, the sheet-like gripping body is shaped like a flat sheath, and the holding body is gripped so as to be rotatable therebetween. As shown in FIGS. 7A to 7B, an opening is provided on one side between the upper and lower sheets (16, 17), and the holder is freely put in and out. In this case, both sheets (16, 17) can also be formed by bending one sheet. Moreover, FIG.7 (b) is a cross-sectional view at the time of cut | disconnecting along the BB line in Fig.7 (a).
[0042]
In FIG. 7, 18 is a hole for pivotally supporting the holding body, and 19 is a hole provided in the holding body correspondingly. After the gripping body and the holding body are set as shown in FIG. 7D, for example, the gripping body and the holding body are rotatably fixed by a rivet or the like. A concave portion indicated by reference numeral 20 in the gripping body is configured to pinch and rotate the holding body when used as a device. When the device is used, the holding body is pinched by the concave portion 20 and rotated to be used for the inspection as shown in FIG. In addition, FIG.7 (e) has reduced and shown relatively compared with FIG.7 (a)-(d).
[0043]
In the example shown in FIG. 8, the holding body 3 holding the sheet-like strips with respect to the sheet-like holding body 21 is gripped so as to be rotatable in a hinge shape. FIGS. 8A and 8B show a state before use of the present embodiment, FIG. 8A is a plan view thereof, and FIG. 8B is a side view thereof. 8 (c) to (e) show the state in use, among which FIGS. 8 (c) to (d) are side views and FIG. 8 (e) is a plan view. The part shown as the code | symbol 22 in FIG. 8 is a hinge part. At the time of use as a device, the holding body 3 is opened in a direction indicated by a curved arrow (↑) in FIG. 8B to be in a state shown in FIGS.
[0044]
The structure of the hinge-shaped portion 22 is sufficient as long as the sheet-like gripping body 21 and the holding body 3 can be rotatably connected. As an example, for example, the surface of the holding body 3 and the surface of the gripping body 21 It can be formed by interposing a foldable sheet (for example, a flexible sheet made of plastic or the like) across the sheet. In FIG. 8C, reference numeral 23 denotes the sheet. In the embodiment of FIG. 8 (c), the sheet is interposed between both surfaces and is pasted over only a part thereof, but the sheet is attached to the surface of the holding body 3 as indicated by reference numeral 24 in FIG. 8 (d). You may affix over the whole surface of the holding body 21. FIG. In this case, since the sheet also covers the judgment window and the end window, the sheet is made of a transparent material, but when the foldable sheet is made of an opaque material, The portions corresponding to the determination window and the end confirmation window are provided with openings corresponding to the determination window and the end window.
[0045]
【The invention's effect】
The inspection device according to the present invention is compact, extremely easy to handle, and hygienic. In addition, since the amount of device components used can be greatly reduced, not only can the cost be reduced by that amount, but also various effective advantages and effects such as being able to solve the problem of used waste disposal can be obtained. .
[Brief description of the drawings]
FIG. 1 is a view showing an example of an embodiment of a device main body (a sheet-like strip held by a holding body) according to the present invention.
FIG. 2 is a view showing another embodiment of the device main body (sheet-like strip held by the holding body) according to the present invention.
FIG. 3 is a view showing various embodiments of sheet-like strips (= membranes) held by a holding body according to the present invention.
FIG. 4 is a diagram showing an example of a gripping body for gripping a device main body according to the present invention.
FIG. 5 is a view showing an example of a mode in which a device main body (a sheet-like strip held by a holding body) is held by a holding body according to the present invention.
6 is a diagram showing a usage mode of the inspection device of FIG. 6;
FIG. 7 is a diagram showing another example of an inspection device according to the present invention.
FIG. 8 is a diagram showing another example of an inspection device according to the present invention.
[Explanation of symbols]
1 Membrane (sheet-like strip)
2 Wick 3 Holding body 4 Fixing member 5 Mobility marker component 6 Permanently fixed first bond component 7 Permanently fixed second bond component 8 Judgment window 9 End confirmation window (confirmation window)
10 Contact between wick and holder, fixed part 11 Seal (thin film)
12 Backing member 13 Grasping body 14, 15 Holes 16, 17 Upper and lower two sheets 18 Hole for pivotally supporting the retaining body 19 Holding body hole 20 Recessed portion 21 Sheet-shaped gripping body 22 Hinge portion 23, 24 Foldable Sheet of

Claims (9)

It consists of one or a plurality of connected sheet-like strips made of a material having a starting end area, an intermediate section and a terminal end section and capable of transporting the test solution by capillary action. It is equipped with a wick for impregnating and absorbing the solution, includes a mobile label component at the end of the start area, and is permanently fixed and arranged at predetermined positions in the intermediate area at sequential intervals. An inspection device comprising one or more binding hand components, wherein the sheet-shaped strip or a sheet-shaped strip including a part or all of the wick is held by a holding body, the holding member holding the sheet-like strip, including some or all of the strips or wick, the wick and opposite side, at the end of the sheet gripper, relative to the plane of the sheet-shaped gripping member Fold at right angles In the inspection device, characterized by comprising rotatably gripped. 2. The inspection device according to claim 1, wherein the inspection device is configured such that the holding body holding the sheet-like strips with respect to the sheet-like holding body is rotatably held in a hinge shape. The inspection device according to claim 1 or 2, wherein the sheet-like strip is a sheet-like strip formed by sealing with a moisture-impermeable thin film. The inspection device according to claim 1, wherein the sheet-like strip is a sheet-like strip formed by lining with a reinforcing sheet. The holding body holding the sheet-like strip is made of plastic, hard paper, metal sheet, or a sheet in which one or more of them are laminated, and one or more judgment windows and confirmation windows are sequentially provided. The inspection device according to claim 1, wherein the inspection device is a holder. 6. The inspection device according to claim 1, wherein the sheet-like gripping body is a gripping body made of plastic, hard paper, a metal sheet, or a sheet obtained by laminating one or more of them. The inspection device according to claim 1, wherein all or a part of the holding body and / or the sheet-like gripping body is sealed with a moisture-impermeable thin film. 8. The inspection device according to claim 1, wherein the inspection device is an in-vitro inspection device. 9. The test device according to claim 1, wherein the test device is a diagnostic device for fecal occult blood test, pregnancy test or ovulation test.

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