Concentrating appliance

Abstract

To provide a concentration device in which the concentration rate is less likely to deviate when a sample is concentrated. The concentration device of the present invention is a concentration device used in a concentration process for detecting a polymer contained in a liquid sample, the concentration device comprising: a water-absorbing polymer for absorbing at least a portion of the moisture of the liquid sample; and a container for containing the water-absorbing polymer and for introducing the liquid sample, at least a portion of the container being flexible, the concentration device being capable of pressing the water-absorbing polymer against the inner wall of the container, the water-absorbing polymer having a swelling rate of 0.2 g / g or more and 800 g / g or less.

Description

Technical Field

[0001] This invention relates to a concentrator. Background Technology

[0002] Immunological testing methods (especially immunochromatography) have been frequently used recently due to their ease of operation and ability to perform tests in a short time.

[0003] For example, when using immunochromatography to detect antigens such as influenza virus, the following procedure is performed.

[0004] First, an antibody-modified label (labeled antibody) is prepared and mixed with a liquid sample containing antibodies and other polymers (hereinafter also referred to as the "test solution"). The labeled antibody binds to the polymer to form a complex. In this state, when it is spread on an insoluble carrier with a detection line, the detection line is coated with an antibody that specifically reacts with the polymer. The complex reacts with the antibody on the detection line (test line) and is captured, and the detection is confirmed by visual inspection or other means.

[0005] In recent years, there has been a desire to apply immunoassay methods to test solutions with extremely low concentrations of high molecular weight antigens. In response, a concentrator equipped with a container holding a water-absorbing polymer has been proposed to concentrate the test solution (Patent Document 1).

[0006] Previous technical documents

[0007] Patent documents

[0008] Patent Document 1: Japanese Patent No. 7192146 Summary of the Invention

[0009] The technical problem to be solved by the invention

[0010] In this case, the inventors studied the concentration apparatus described in Patent Document 1 and found that it was sometimes difficult to remove the concentrate from the concentration apparatus, and the deviation of the concentration rate became larger.

[0011] Therefore, in view of the above-mentioned actual situation, the object of the present invention is to provide a concentration apparatus with a small deviation in concentration rate.

[0012] means for solving technical problems

[0013] The inventors conducted in-depth research on the above-mentioned problems and found that by making the container for the absorbent polymer a soft container and by allowing the absorbent polymer to be pressed through the inner wall of the container, the above-mentioned problems can be solved, thus completing the present invention.

[0014] That is, the inventors have discovered that the above-mentioned problems can be solved by the following structure.

[0015] (1) A concentration apparatus for performing concentration treatment in the detection of high molecular weight substances contained in liquid samples. The aforementioned concentration apparatus comprises: a water-absorbing polymer for absorbing at least a portion of the water in the aforementioned liquid sample; and A container for containing the aforementioned absorbent polymer and for introducing the aforementioned liquid sample, wherein at least a portion of the container is flexible. The aforementioned concentration apparatus can press the absorbent polymer through the inner wall of the aforementioned container. The swelling ratio of the above-mentioned water-absorbing polymer is 0.2 g / g or more and 800 g / g or less.

[0016] (2) The concentration apparatus according to (1) above, wherein the particle size of the absorbent polymer is 0.2 mm or more and 1.6 mm or less.

[0017] (3) The concentration apparatus according to (1) or (2) above, wherein the swelling ratio of the above-mentioned water-absorbing polymer is 10 g / g or more and 400 g / g or less.

[0018] (4) The concentrator according to any one of (1) to (3) above, wherein the water absorption rate of the above-mentioned water-absorbing polymer is more than 0.3 g / min and less than 3.0 g / min per 1 g.

[0019] Invention Effects

[0020] As shown below, according to the present invention, a concentration apparatus with small deviations in concentration ratio can be provided. Furthermore, according to the present invention, not only is usability improved, but the time required for user recycling can also be shortened. Moreover, according to the present invention, relative to the time required for recycling, the deviation in concentration ratio can be stabilized, robustness to ambient temperature is ensured, and the concentration ratio (concentration rate) is stabilized. Attached Figure Description

[0021] Figure 1 This is a diagram that conceptually illustrates an example of a concentration apparatus according to the present invention.

[0022] Figure 2 It is used for explanation Figure 1 A diagram illustrating the function of the concentration apparatus.

[0023] Figure 3 It is used for explanation Figure 1 A diagram illustrating the function of the concentration apparatus.

[0024] Figure 4 It is used for explanation Figure 1 A diagram illustrating the function of the concentration apparatus.

[0025] Figure 5This is a perspective view schematically illustrating an example of a concentration apparatus of the present invention.

[0026] Figure 6 yes Figure 5 An exploded perspective view of the concentration apparatus shown.

[0027] Figure 7 This is a perspective view schematically illustrating an example of the lid of the condensing apparatus of the present invention.

[0028] Figure 8 This is a perspective view schematically illustrating another example of the container body of the concentration apparatus of the present invention.

[0029] Figure 9 This is a perspective view schematically illustrating another example of the container body of the concentration apparatus of the present invention.

[0030] Figure 10 This is a perspective view schematically illustrating another example of the container body of the concentration apparatus of the present invention.

[0031] Figure 11 It is a diagram used to illustrate the relationship between the discharge direction of a liquid sample and a soft wall surface.

[0032] Figure 12 It is a diagram used to illustrate the variable volume of a container. Detailed Implementation

[0033] The concentration apparatus of the present invention will be described below.

[0034] In addition, in this specification, the numerical range indicated by “~” refers to the range included by taking the values ​​recorded before and after “~” as the lower limit and upper limit values.

[0035] Furthermore, in this specification, each ingredient may be used individually or in combination with two or more ingredients. When two or more ingredients are used together, unless otherwise specified, the content of that ingredient refers to the total content.

[0036] Furthermore, in this specification, the characteristics of small deviation in concentration ratio, ability to shorten the recovery time of concentrate, and excellent durability to ambient temperature are collectively referred to as "the excellent effects of the present invention".

[0037] [Equipment for Concentration]

[0038] The concentration apparatus of the present invention is

[0039] Concentration equipment is used in the concentration process for detecting high molecular weight substances contained in liquid samples (hereinafter also referred to as "test liquid"). The aforementioned concentration apparatus comprises: a water-absorbing polymer for absorbing at least a portion of the water in the aforementioned liquid sample (hereinafter also referred to as a "superabsorbent polymer"); and A container for containing the aforementioned absorbent polymer and for introducing the aforementioned liquid sample, wherein at least a portion of the container is flexible. The aforementioned concentration apparatus can press the absorbent polymer through the inner wall of the aforementioned container. The swelling ratio of the above-mentioned water-absorbing polymer is 0.2 g / g or more and 800 g / g or less.

[0040] The concentration apparatus of the present invention is a fixture used for the concentration treatment of liquid samples in the detection of high molecular weights contained in liquid samples, such as immunochromatography.

[0041] The concentration apparatus of the present invention will now be described with reference to the accompanying drawings.

[0042] Figure 1 This is a diagram conceptually illustrating an example of a concentration apparatus according to the present invention. Furthermore, Figures 2-4 This is a diagram illustrating the function of the concentration apparatus of the present invention.

[0043] Figure 1 The concentration apparatus 200 shown has an absorbent polymer 230 and a container 214 for containing the absorbent polymer 230. Although not shown in the figure, the container 214 has an inlet for introducing a liquid sample (hereinafter also referred to as "test liquid") into the interior and a outlet for discharging the concentrated liquid sample (hereinafter also referred to as "concentrate"). The specific structure of the container 214 will be described later.

[0044] Superabsorbent polymer 230 is a highly absorbent polymer (SAP). For example... Figure 1 As shown, the absorbent polymer 230 is in particulate form, and multiple particulate absorbent polymers 230 are contained within container 214. The particulate absorbent polymers 230 are schematically illustrated as spheres of the same size, but the actual particle shape may not be spherical, and the sizes may vary. The absorbent polymer 230 will be described in detail later.

[0045] like Figure 2 As shown, if a liquid sample 240 is injected into a container 214 of a concentration apparatus 200 containing a water-absorbing polymer 230 before water absorption, the water-absorbing polymer 230 absorbs the water contained in the liquid sample 240, such as... Figure 3As shown, the absorbent polymer 232 swells after absorbing water. In the container 214 after water absorption, a portion of the liquid sample (concentrate) 241 that was not absorbed by the absorbent polymer 232 is concentrated and remains in the container 214. Furthermore, sometimes a test liquid concentrate 246, which is a concentrate of the liquid sample 240, is also generated.

[0046] Here, in this invention, at least a portion of the container 214 is soft, allowing the absorbent polymer 232 to be pressed against the inner wall of the container 214. Therefore, as... Figure 4 As shown, the concentrate 242 can be extracted by pressing the swollen, water-absorbing polymer 232 through the inner wall of container 214.

[0047] Furthermore, after the absorbent polymer 232 absorbs water, a small amount of recycled liquid can be added, and the swollen absorbent polymer 232 can be pressed through the inner wall of container 214 to extract the concentrated liquid 242 containing the recycled liquid.

[0048] According to the inventors' research, it has been clarified that in conventional concentration apparatuses using absorbent polymers, it is sometimes difficult to remove the concentrate from the apparatus after concentrating the liquid sample. Specifically, from the viewpoint of shortening the concentration time, a larger amount of absorbent polymer is preferred; however, if the amount of absorbent polymer is large, the amount of concentrate is insufficient, making it difficult to remove. Furthermore, adding a small amount of recovery liquid after concentration to remove the concentrate can be considered, but if the amount of absorbent polymer is large, the swollen and enlarged polymer reduces the air pockets in the container after absorbing water, making it difficult to spread the recovery liquid around the absorbent polymer. Therefore, it is difficult to properly recover the test liquid concentrate remaining near the absorbent polymer. Moreover, if the amount of absorbent polymer is large, water absorption will also occur during the removal of the concentrate, potentially resulting in insufficient recovery. On the other hand, if the amount of absorbent polymer is reduced or the amount of recovery liquid is increased to ensure the amount of concentrate, the concentration ratio of the concentrate will decrease.

[0049] In contrast, in the concentration apparatus 200 of the present invention, at least a portion of the container 214 is flexible, allowing the absorbent polymer 232 to be pressed against the inner wall of the container 214. This pressing deforms the absorbent polymer 232 and reduces the internal volume of the container 214, creating a stirring effect that allows unabsorbed portions of the liquid sample (concentrate 241) and / or recovered liquid to spread into the gaps between the absorbent polymers 232. This allows for the recovery of more of the concentrate 241 or test liquid concentrate 246 remaining near the absorbent polymers 232, increasing the concentration ratio of the concentrate 242. Furthermore, since the concentration apparatus 200 of the present invention allows the absorbent polymer 232 to be pressed against the inner wall of the container 214, the contents (concentrate 241) can be directly extruded toward the discharge port. Therefore, compared to structures that extrude the concentrate solely using air pressure based on a pump or the like, the concentrate can be easily removed. Furthermore, even with small amounts of concentrate, the concentrate can be effectively expanded and removed, thus increasing the concentration ratio of concentrate 242. Moreover, the required recovery amount of concentrate 242 is easily ensured, and the concentration ratio of the removed concentrate 242 can be kept constant. As a result, the deviation in concentration ratio is reduced.

[0050] Furthermore, in the concentration apparatus 200 of the present invention, the container 214 can be deformed by pressing it with the user's finger, thus easily producing uneven deformation and being able to deform into various shapes. Moreover, the absorbent polymer 232 is movable, thereby preventing the absorbent polymer 232 from being pressed down and the gaps between the absorbent polymers 232 from narrowing, thus preventing the concentrate from being unable to move. Therefore, even if there is a large amount of absorbent polymer 232, the concentrate can be effectively expanded and effectively removed.

[0051] Furthermore, the concentration apparatus 200 of the present invention can remove the concentrate by pressing the container 214 with the user's finger, thus making the removal operation simple and shortening the recovery operation time.

[0052] As described above, the concentration apparatus 200 of the present invention introduces a liquid sample 240 into a container 214 and discharges a concentrate 242. Therefore, the container 214 has an inlet for introducing the liquid sample 240 and a outlet for discharging the concentrate 242. The inlet is not particularly limited; various structures can be used as long as the liquid sample 240 can be introduced into the container 214. Similarly, the outlet is not particularly limited; various structures can be used as long as the concentrate 242 can be discharged from the container 214. Furthermore, the inlet and outlet can be shared. However, from the viewpoint of being able to easily introduce the liquid sample 240 into the container 214 and to be able to place the absorbent polymer before water absorption into the container 214, the inlet is preferably a relatively large opening, preferably an opening larger than the particle size of the absorbent polymer before water absorption. On the other hand, from the viewpoints of being able to discharge the concentrate without discharging the absorbent polymer after absorbing water, and suppressing air leakage when discharging the concentrate 242 by pressing the container 214, which would make it difficult to remove the concentrate 242, the discharge section is preferably a relatively large opening smaller than the particle size of the absorbent polymer after absorbing water.

[0053] The following diagram illustrates the specific structure of the container.

[0054] 〔container〕

[0055] Figure 5 This is a perspective view schematically illustrating an example of a concentration apparatus of the present invention. Figure 6 yes Figure 5 The exploded 3D view of the container shown.

[0056] Figure 5 and Figure 6 The container 214a shown has a container body 210a that is at least partially flexible and has an opening 216, and a lid 212 that is detachably provided on the opening 216 of the container body 210a.

[0057] Figure 5 and Figure 6 The container 214a shown has a container body 210a consisting of a receiving portion 211a for containing a water-absorbing polymer and a neck 215 having an opening 216. In the example shown, the receiving portion 211a is formed in a generally cylindrical shape with a bottom surface, creating an internal space capable of containing the water-absorbing polymer. The neck 215 is connected to one of the bottom surfaces, and the opening 216 of the neck 215 communicates with the internal space of the receiving portion 211a. Furthermore, in... Figure 5 and Figure 6 In the example shown, the receiving portion 211a has a reduced diameter portion 217a at the end on the neck 215 side, which is reduced in diameter toward the neck 215.

[0058] The neck 215 is a generally cylindrical portion having an opening 216 extending from one bottom surface to another. In the example shown, the neck 215 is configured such that its central axis (the central axis of the cylinder) is substantially aligned with the central axis (the central axis of the cylinder) of the receiving portion 211a. Furthermore, the neck 215 has external threads on its outer peripheral surface.

[0059] The area of ​​the receiving portion 211a in the cross-section perpendicular to the central axis is larger than the area of ​​the neck 215. In the illustrated example, the diameter of the receiving portion 211a in the cross-section perpendicular to the central axis is larger than the diameter of the neck 215. Therefore, the area of ​​the receiving portion 211a at the connection point with the neck 215 is larger than the area of ​​the neck 215. Hereinafter, the bottom surface of the receiving portion 211a connected to the neck 215 will also be referred to as the shoulder.

[0060] Furthermore, at least a portion of the receiving portion 211a is soft, allowing the absorbent polymer contained within the receiving portion 211a to be pressed against the inner wall of the receiving portion 211a. In the example shown, at least a portion of the peripheral surface of the receiving portion 211a is preferably soft, and the entire receiving portion 211a may be soft.

[0061] exist Figure 5 and Figure 6 In the example shown, the cap 212 is a component that closes the opening 216 of the neck 215 of the container body 210a. Figure 7 The image shows a cross-sectional view of cover 212. (See image.) Figure 5 , Figure 6 and Figure 7 As shown, the cover 212 is a cylindrical component with a bottom surface and an internal thread on its inner circumferential surface. By screwing this internal thread into the external thread of the neck 215 of the container body 210, the cover 212 can be attached to or detached from the container body 210.

[0062] Furthermore, the cover 212 has a nozzle 213 protruding outward from the bottom surface, and a through hole is provided through the nozzle 213, which becomes the discharge part 219.

[0063] Furthermore, in Figure 7 In the example shown, as a preferred embodiment, a filter 220 is disposed on the bottom side inside the cover 212. The filter 220 allows the concentrate to pass through but prevents the water-absorbing polymer from passing through.

[0064] The container 214a, having a container body 210a and a cap 212, allows the cap 212 to be removed from the container body 210a, and the pre-absorbent polymer 230 to be inserted into the receiving portion 211a through the opening 216 of the neck 215. Furthermore, a liquid sample 240 can be inserted through the opening 216 of the neck 215. In other words, the opening 216 of the container body 210a serves as an inlet for introducing the liquid sample.

[0065] After the liquid sample is introduced, cap 212 is installed. Over a predetermined period, the absorbent polymer absorbs moisture from the liquid sample, concentrating the liquid sample. Then, the concentrate is stirred within container 214a as needed, and discharged from the discharge portion 219 of nozzle 213 provided on cap 212. At this time, at least a portion of container body 210a is flexible, allowing the absorbent polymer to be pressed against the inner wall of container body 210a. Therefore, the concentrated liquid can be removed by pressing the swollen, water-absorbing polymer against the inner wall of container body 210a.

[0066] Furthermore, after the water-absorbing polymer absorbs the moisture from the liquid sample, the recovery liquid can be added from the opening 216 of the neck 215, then the cap 212 can be installed, the recovery liquid can be stirred in the container 214a as needed, and the concentrate can be taken out from the discharge part 219 of the nozzle 213 provided on the cap 212.

[0067] Furthermore, when stirring the concentrate and / or the recovered liquid, a cap without a nozzle 213 (discharge section 219) can be used as a cap to seal the container 214a and stir it. When discharging the concentrate, the cap 212 with a nozzle 213 can be used to remove the concentrate.

[0068] In addition, Figure 5 and Figure 6 In the example shown, the area of ​​the receiving portion 211a at the connection position between the receiving portion 211a and the neck 215 is larger than the area of ​​the neck 215, and the receiving portion 211a has a shoulder structure, but it is not limited to this. For example, as Figure 8 The example shown could be a structure in which the end of the receiving portion 211b of the container body 210b on the neck 215 side has a tapered portion 217b that tapers towards the neck 215 to the same diameter as the neck 215 and is connected to the neck 215. That is, Figure 8 The example shown is an example where the area (diameter) of the receiving portion 211b at the connection position with the neck 215 is equal to the area (diameter) of the neck 215, and the receiving portion 211b does not have a shoulder.

[0069] In addition, in order to suppress deformation of the neck 215 with the cap 212 installed when the receiving part 211a is pressed to remove the concentrate, it is preferable that the receiving part 211a has a shoulder structure, that is, the area of ​​the receiving part 211a at the connection position with the neck 215 is larger than the area of ​​the neck 215.

[0070] Furthermore, in Figure 5 and Figure 6In the example shown, the structure is provided with a reduced diameter portion 217a at the end on the neck 215 side, but it can also be a shape without the reduced diameter portion 217a. In terms of ease of removing the concentrate, the structure with the reduced diameter portion 217a at the end on the neck 215 side is preferred.

[0071] Furthermore, in Figure 5 and Figure 6 In the example shown, the receiving portion 211a of the container body 210 is set to a generally cylindrical shape, but it is not limited to this. For example, the receiving portion 211a can be a triangular cylindrical shape, a square cylindrical shape, or an elliptical cylindrical shape.

[0072] Furthermore, the receiving portion 211a is not limited to a generally cylindrical shape and can be configured in various shapes. For example, such as Figure 9 In the example shown, the receiving portion 211c of the container body 210c is on the neck 215 side, and its cross-sectional shape can be approximately circular, or flattened and with a smaller cross-sectional area on the side opposite to the neck 215.

[0073] And, as Figure 10 As shown, the container body 210d can be a structure having a removable cap 212, a neck 215 with an opening 216, and a bag-shaped receiving portion 218 for containing absorbent polymer. Furthermore, "bag-shaped" refers to a container made of a material that does not possess self-supporting properties.

[0074] Furthermore, in the above example, the container body 210 (210a to 210d) and the cover 212 have external threads and internal threads respectively, and are configured to be threaded together. However, this is not a limitation. The structure can also be fixed by various known detachable fixing methods, such as a method for installation by fitting, a method in which one part has a protrusion and the other part has a concave part so that the concave part and the protrusion are locked together.

[0075] In this invention, "at least a portion of the container is flexible" means that the flexible portion of the container is made of resin or elastomer materials such as polyethylene (PE), polyethylene terephthalate (PET), polystyrene (PS), polypropylene (PP), polyvinyl chloride (PVC), and acrylic resin (PMMA), with a thickness of 1000 μm or less. Furthermore, it can also be a composite material containing materials that, in addition to the aforementioned materials, possess the desired functions such as low moisture permeability, gas barrier properties, light-blocking properties, and decorative properties.

[0076] Hereinafter, containers that are at least partially flexible will also be referred to as "flexible containers".

[0077] From the perspectives of high flexibility and strength, chemical resistance, and cost, the resin material for the flexible part of the container is preferably either polyethylene (PE) or polypropylene (PP).

[0078] For reasons of superior effects of the present invention, the thickness of the soft portion of the container is preferably 1000 μm or less, more preferably 800 μm or less, even more preferably 600 μm or less, and particularly preferably 400 μm or less. There is no particular limitation on the lower limit, but for reasons of superior effects of the present invention, it is preferably 20 μm or more, and more preferably 100 μm or more.

[0079] In this invention, the wall surface of the container's discharge section, which is parallel to the discharge direction of the concentrated liquid sample (concentrate), is preferably soft. Regarding this aspect, using... Figure 11 Please provide an explanation.

[0080] Figure 11 This is a schematic cross-sectional view of the container 214 of the concentration apparatus of the present invention. Figure 11 In the container 214 shown, a discharge section 219 is provided on the upper side of the container 214 in the figure. That is, as shown by arrow D, the direction of discharge of the concentrate from the discharge section 219 in the example is the upper direction in the figure. Therefore, the wall surface 221 of the container 214, which is parallel to arrow D, is preferably flexible.

[0081] The container 214 is flexible due to its wall surface 221, which is parallel to the discharge direction of the concentrate from the discharge section 219. The container 214 can be pressed in a direction approximately orthogonal to the discharge direction of the concentrate. This prevents the water-absorbing polymer from being pressed down and the gaps between the water-absorbing polymers from narrowing, thus preventing the concentrate (recovered liquid) from moving. As a result, the concentrate (recovered liquid) can be effectively spread out and easily removed.

[0082] For example, in Figure 5 In the example shown, the discharge direction of the concentrate is the upper direction in the figure. Therefore, at least a portion of the periphery of the receiving portion 211a of the container body 210a is preferably soft, and more preferably the entire periphery is soft.

[0083] Furthermore, in this invention, the variable amount of the container's volume is preferably greater than the difference between the container's volume V and the volume Vs of the liquid sample contained in the container and the volume Vp of the water-absorbing polymer, V - (Vs + Vp). Regarding this aspect, using... Figure 12 Please provide an explanation.

[0084] Figure 12 This is a schematic diagram illustrating the concentration apparatus 200 of the present invention. Figure 12As shown, if the overall volume of container 214 is set as V, the total volume of all water-absorbing polymers 230 in container 214 before water absorption is set as Vp, and the volume of liquid sample 240 placed in container 214 is set as Vs, then the difference between the volume of container V, the volume of water-absorbing polymer 230 Vp, and the volume of liquid sample 240 Vs is V-(Vs+Vp), which is the volume Va of the space in container 214 that is not filled with water-absorbing polymer 230 and / or liquid sample 240.

[0085] The sum of the volume of the absorbent polymer after water absorption and the volume of the remaining concentrate is approximately equal to the sum of the volume Vp of the absorbent polymer 230 before water absorption and the volume Vs of the liquid sample 240. Therefore, by making the volume variation of container 214 greater than the difference V - (Vs + Vp), that is, by making the volume variation of container 214 greater than the volume Va of the void portion Va within container 214 before deformation, which is the space within container 214 that is not filled with absorbent polymer 230 and / or liquid sample 240, even when at least a portion of the air within container 214 is expelled when the concentrate is discharged from container 214, the concentrate can be discharged more reliably.

[0086] Furthermore, in this invention, the ratio of the surface area S2 of the flexible wall to the total surface area S1 of the container wall is preferably 50% or more. By setting the ratio of the surface area S2 of the flexible wall to the total surface area S1 of the container wall to 50% or more, the variable capacity of the container can be increased, and the concentrate can be discharged more reliably when it is discharged from the container 214.

[0087] like Figure 5 In the example shown, when container 214 has container body 210 and lid 212, it is preferable that at least a portion of the circumferential surface of the receiving portion 211 of container body 210 is flexible, more preferably the entire circumferential surface is flexible. Furthermore, the entire receiving portion 211 can be flexible. The neck 215 and lid 212 can be flexible or not, but are preferably not flexible. When the receiving portion 211 and neck 215 are integrally formed from the same material, by making their thicknesses different, it is possible to make the receiving portion 211 flexible and the neck 215 not flexible. Furthermore, the receiving portion 211 and neck 215 can be formed from different materials.

[0088] Furthermore, in this invention, the distance from the front end of the discharge section of the container to the soft wall surface (i.e., the pressing part) in the direction parallel to the discharge direction of the concentrate is preferably 70 mm or less, more preferably 50 mm or less, and even more preferably 30 mm or less. There is no particular limitation on the lower limit, but it is preferably 1 mm or more. Therefore, when discharging the concentrate from the container, the concentrate can be discharged more reliably.

[0089] Furthermore, in this invention, the ratio of the width (or the diameter of the cross-section if cylindrical) of the container's portion containing the absorbent polymer in the direction orthogonal to the height direction to the height of the concentrate discharge direction is preferably 8 or less, more preferably 5 or less, and even more preferably 3 or less. The lower limit of the ratio is not particularly limited, but it is preferably 0.5 or more. This allows for more reliable discharge of the concentrate when it is discharged from the container.

[0090] [Specific superabsorbent polymers]

[0091] The superabsorbent polymer used in the concentration apparatus of this invention is a superabsorbent polymer (SAP) that is contained within the container and absorbs moisture from the liquid sample. Figure 1 In the examples shown, the water-absorbing polymer is schematically represented as spherical particles of uniform size, but is not limited to this.

[0092] The water-absorbing polymer used in the concentration apparatus of the present invention has a swelling ratio of 0.2 g / g or more and 800 g / g or less. Hereinafter, water-absorbing polymers with a swelling ratio of 0.2 g / g or more and 800 g / g or less will also be referred to as "specific superabsorbent polymers".

[0093] As for specific superabsorbent polymers, there are no particular limitations as long as the swelling rate is within the above-mentioned range, and various known superabsorbent polymers such as polyacrylic acid-based, polyacrylamide-based, cellulose-based, and polyethylene oxide-based polymers can be appropriately used. Among these, considering the superior effects of the present invention, polymers based on polyacrylic acid or polyacrylamide are more preferred.

[0094] <Swelling rate>

[0095] The swelling ratio of certain superabsorbent polymers is above 0.2 g / g and below 800 g / g.

[0096] From the perspective of superior effects of the present invention, the swelling rate is more preferably 1.0 g / g or more and 600 g / g or less, further preferably 10 g / g or more and 400 g / g or less, and especially preferably 20 g / g or more and 200 g / g or less.

[0097] Here, the swelling ratio is defined as the value of "the mass (g) of water held by 1g of water-absorbing polymer".

[0098] (Method for determining swelling ratio)

[0099] The mass of the absorbent polymer stored at 25°C and 5% RH (relative humidity) for 10 days was determined, and then it was immediately immersed in a large amount of distilled water. After 120 minutes, the absorbent polymer was removed, the surface water was removed, and the mass was determined again. The swelling rate was determined using the following formula.

[0100] {(mass after water absorption (g) - initial mass before water absorption (g)) / initial mass before water absorption (g)}

[0101] There are no particular limitations on the methods for adjusting the swelling ratio to the specific range mentioned above. Examples include changing the type of polymer, changing the molecular weight of the polymer, changing the degree of crosslinking, and changing the particle size.

[0102] <Water absorption rate>

[0103] There is no particular limitation on the water absorption rate of a specific superabsorbent polymer, but for reasons of superior effect of the present invention, it is preferable to have a rate of 0.01 g / min or more and 40 g / min or less per 1 g of the specific superabsorbent polymer, more preferably 0.1 g / min or more and 10.0 g / min or less per 1 g of the specific superabsorbent polymer, and even more preferably 0.3 g / min or more and 3.0 g / min or less per 1 g of the specific superabsorbent polymer.

[0104] The water absorption rate was measured as follows.

[0105] The mass (M0, in g) of a water-absorbing polymer stored at 15–30°C and 5% RH (relative humidity) for more than 10 days was determined, and then the polymer was immersed in a large volume of artificial urine (JIS T3214). After immersion for 10 minutes, the polymer was removed, surface water was removed, and the mass was measured. The mass of the polymer removed after 10 minutes was designated as M10, and the water absorption capacity (ΔM) was defined as follows.

[0106] ΔM = (M10 - M0) / M0

[0107] Based on the above, the water absorption rate (V) per unit time (minute) is defined as follows.

[0108] V=ΔM / 10

[0109] <Particle size>

[0110] For reasons of superior performance and other considerations, the particle size of the specific superabsorbent polymer is preferably 5 mm or less, more preferably 3 mm or less, and even more preferably 1.5 mm or less. For reasons of superior performance and other considerations, the lower limit of the particle size of the specific superabsorbent polymer is preferably 0.01 mm or more, more preferably 0.1 mm or more, and even more preferably 0.2 mm or more. The above-mentioned particle size is generally non-uniform and has a distribution. The above-mentioned particle size can be obtained by measuring the diameter of 50 polymer particles using an optical microscope and calculating their arithmetic mean.

[0111] <Quantity>

[0112] The amount of a specific superabsorbent polymer is not particularly limited, but for reasons of superior effect of the present invention, it is preferably 0.01 to 100 g, more preferably 0.1 to 1 g, relative to 1 mL of the test solution.

[0113] [A binding substance that specifically binds to high molecular weight substances contained in biological fluids]

[0114] From the viewpoint that the detection sensitivity is increased when using the concentrated solution concentrated by the concentrator of the present invention for testing, the container preferably also contains a binding substance that specifically binds to the high molecular weight contained in the body fluids in the test solution (described later). When the container contains the aforementioned binding substance, for example, the concentration of the test solution and the antigen-antibody reaction occur simultaneously, and a complex of antigen and labeled antibody in the test solution is formed in the concentrated state, thereby contributing to improved detection sensitivity.

[0115] Examples of the aforementioned binding substances include, for instance, the first binding substance described later (especially an antibody). That is, in this invention, it is preferable that the polymer contained in the aforementioned bodily fluids is an antigen, and the aforementioned binding substance is an antibody.

[0116] The aforementioned binding substance is preferably contained in the container as a complex with the labeled substance. Examples of such complexes include labeled antibodies. Here, a labeled antibody is an antibody bound to a detectable labeled substance. The labeled substance is, for example, a detectable substance that can be directly detected, such as a substance that generates electromagnetic waves like color, fluorescence, or light, or a substance that scatters electromagnetic waves like color, fluorescence, or light, and is a substance or state containing enzymes that form a luminescent or chromogenic body through interaction with a luminescent or chromogenic precursor.

[0117] The labeled antibody is preferably an antibody modified with metal particles that exhibit a bright hue when irradiated with electromagnetic waves such as visible light. The metal particles are more preferably gold particles. The labeled antibody is preferably an antibody labeled with gold particles, i.e., gold particles modified with antibody (described later as modified gold particles).

[0118] The aforementioned labeled antibody can also be included in the container as a pad (gold colloidal holding pad) holding modified gold colloidal particles that are modified with the antibody.

[0119] [Casein, Tris(hydroxymethyl)methylglycine]

[0120] From the viewpoint that the detection sensitivity is increased when using the concentrated liquid concentrated by the concentrator of the present invention for inspection, the container preferably further contains at least one of the group consisting of casein and tris(hydroxymethyl)glycine, and more preferably contains both casein and tris(hydroxymethyl)glycine.

[0121] Casein is believed to have the effect of inhibiting false positives. Furthermore, false positives are more likely to occur when the pH of the test solution, such as urine, is acidic; however, tris(hydroxymethyl)glycine is believed to have the effect of adjusting the pH to neutral to alkaline to inhibit false positives.

[0122] [How to use]

[0123] There are no particular restrictions on the use of concentration equipment; for example, the following methods can be cited.

[0124] First, the test solution is placed into the inlet of the concentration apparatus and allowed to stand for a specified time to absorb water. During the water absorption process, the antigens and other macromolecules in the test solution are not absorbed by the polymer and remain. Then, the test solution (concentrated solution) that has not been absorbed by the absorbent polymer is removed from the outlet of the concentration apparatus. This mechanism means that the degree of concentration of the target substance, i.e., the antigens and other macromolecules, depends on the amount absorbed by the absorbent polymer. Alternatively, as described above, a small amount of recovery solution can be added to the concentration apparatus, and the concentrated solution containing the recovery solution can be removed.

[0125] [Test liquid (liquid sample)]

[0126] The test liquid (liquid sample) is a liquid sample containing polymers. Preferably, it is an aqueous solution containing polymers found in biological body fluids.

[0127] Specific examples of test fluids include bodily fluids of animals (especially humans) (e.g., blood, serum, plasma, cerebrospinal fluid, tears, sweat, urine, pus, nasal discharge, or sputum), mouthwash, etc. Among these, serum, plasma, urine, and nasal discharge are preferred as test subjects containing antigens as high molecular weights, and urine is particularly preferred from the viewpoint that the concentration apparatus of the present invention can be used more effectively.

[0128] <High molecules contained in biological fluids>

[0129] Examples of macromolecules (especially antigens) contained in the aforementioned bodily fluids, primarily those useful for disease diagnosis, include bacteria, bacteria (e.g., Mycobacterium tuberculosis, and the lipoarabinomannan (LAM) contained in Mycobacterium tuberculosis), bacteria (bacteria), viruses (e.g., influenza virus), or their nucleoproteins, which are detected in bodily fluids. Furthermore, LAM is a major antigen in tuberculosis and is a major component of the cell membrane and cell wall, namely glycolipids.

[0130] From the perspective of superior effects of the present invention, the polymer contained in the above-mentioned biological fluid is preferably an antigen, more preferably a virus (especially an influenza virus) or LAM, and even more preferably LAM.

[0131] The molecular weight of the polymers contained in biological fluids is preferably 1000 or more, more preferably 2000 or more. When the polymer is useful for disease diagnosis and its structural formula is known, the molecular weight can be calculated using a theoretical value derived from the structural formula. Furthermore, when the structural formula is undetermined, it can be determined by methods such as electrophoresis compared to substances with known molecular weights, or by liquid chromatography-mass spectrometry (LC-MS).

[0132] [Recovered liquid]

[0133] As the recovery solution, solvents commonly used in immunological assays (e.g., water, physiological saline, or buffer solutions) can be used, or water-miscible organic solvents that can be directly used for antigen-antibody reactions by dilution with such solvents. Furthermore, the recovery solution can be functionalized as needed by adding buffers, surfactants, and other additives. The recovery solution is preferably a buffer solution, more preferably PBS (Phosphate buffered salts). Additionally, a portion of the test solution can also be used as the recovery solution.

[0134] Furthermore, the recovered solution preferably contains salt. Specifically, the recovered solution preferably contains either sodium chloride or magnesium chloride. The concentration of salt in the recovered solution is preferably 25 mg / mL or higher. By adding a specified amount of salt to the recovered solution, the absorption of the recovered solution by the water-absorbing polymer can be suppressed, and the deviation in the amount of concentrated solution recovered can be reduced.

[0135] From the viewpoint of concentrating the test solution, the amount of recovered solution is less than the amount of test solution injected into the container. The ratio of the amount of recovered solution to the amount of test solution injected into the container (recovered solution / test solution) by volume is only required to be less than 100%, preferably 30% or less, more preferably 20% or less, and even more preferably 0.01% or more and 10% or less.

[0136] [examine]

[0137] This invention relates to a method for testing a test solution containing polymers in an aqueous solution (test solution) concentrated using the concentration apparatus of the present invention. The polymers in the concentrated solution obtained by concentrating the test solution using the concentration apparatus can be detected by various known methods.

[0138] The concentrate concentrated using the concentration apparatus of the present invention can increase the concentration ratio and reliably extract the concentrate, thus achieving high detection sensitivity.

[0139] As a method for detecting high molecular weight molecules in a concentrated solution, an antigen-antibody reaction method is preferred. Examples of such methods include enzyme immunoassay (EIA), solid-phase enzyme immunoassay (ELISA), radioimmunoassay (RIA), fluorescence immunoassay (FIA), Western blotting, and immunochromatography. The concentration apparatus of the present invention is preferably used to concentrate the test solution for immunochromatography.

[0140] Specific methods for detecting polymers in concentrates and the structure of test kits for detecting polymers in test solutions (concentrates) containing polymers are described, for example, in Japanese Patent Application Publication No. 2009-150869 and International Publication No. 2021 / 065300.

[0141] Example

[0142] The present invention will be further described in detail below through embodiments, but the present invention is not limited thereto.

[0143] [1] Preparation of concentration equipment

[0144] [Examples 1-3]

[0145] Made such as Figures 5-7 The concentration apparatus shown.

[0146] Here, the container body 210a (capacity: 15 mL) is made of polyethylene. Furthermore, the thickness of the receiving portion 211a is 200 μm. Therefore, the receiving portion 211a is flexible. And, 3.0 g of SAP Sphere 1.0 mm (not shown), manufactured by M2 Polymer Technologies Inc., is contained in the receiving portion 211a. As described above, the receiving portion 211a is flexible, thus allowing the SAP to be pressed against the inner wall of the container.

[0147] [Examples 4-7]

[0148] [SAP particle classification]

[0149] SAP particles were obtained by grading Aqualic CA H2 manufactured by NIPPON SHOKUBAI CO.,LTD. Specifically, the grading method involved using two sieves with different mesh sizes, grading the SAP particles by obtaining those that passed through the larger mesh sieve but not the smaller mesh sieve. This time, grading was performed using sieves with mesh sizes of 1.0 mm and 0.65 mm, 0.65 mm and 0.44 mm, 0.44 mm and 0.33 mm, and 0.33 mm and 0.15 mm, resulting in four different SAP particle sizes. Furthermore, the SAP particle sizes obtained through this grading were 0.83 mm, 0.54 mm, 0.38 mm, and 0.25 mm.

[0150] [Example 4]

[0151] The above-mentioned SAP particles (particle size: 0.83 mm) were used as SAP. Otherwise, a concentration apparatus was prepared according to the same steps as in Examples 1 to 3.

[0152] [Example 5]

[0153] The above-mentioned SAP particles (particle size: 0.54 mm) were used as SAP. Otherwise, a concentration apparatus was prepared according to the same steps as in Examples 1 to 3.

[0154] [Example 6]

[0155] The above-mentioned SAP particles (particle size: 0.38 mm) were used as SAP. Otherwise, a concentration apparatus was prepared according to the same steps as in Examples 1 to 3.

[0156] [Example 7]

[0157] The above-mentioned SAP particles (particle size: 0.25 mm) were used as SAP. Otherwise, a concentration apparatus was prepared according to the same steps as in Examples 1 to 3.

[0158] [Examples 8-9]

[0159] As SAP, superabsorbent polymer particles (model 197-12451) manufactured by FUJIFILM Wako Pure Chemical Corporation were used. Otherwise, a concentration apparatus was prepared following the same steps as in Examples 1 to 3.

[0160] [Comparative Example 1]

[0161] Produced such as International Publication No. 2021 / 065300 Figure 2 The concentration apparatus shown.

[0162] Here, the cylinder 10 is made of polypropylene. Furthermore, the thickness of the cylinder 10 is 1.1 mm. Therefore, the cylinder 10 is not flexible. And, 3.0 g of SAP Sphere 1.0 mm, manufactured by M2 Polymer Technologies Inc., which is a specific superabsorbent polymer 30 (SAP), is contained within the cylinder 10. As described above, since the cylinder 10 is not flexible, SAP cannot be pressed through the inner wall of the container.

[0163] [Comparative Example 2]

[0164] As SAP used superabsorbent polymer particles (model 197-12451) manufactured by FUJIFILM Wako Pure Chemical Corporation, a concentration apparatus was prepared following the same procedure as in Comparative Example 1.

[0165] [Comparative Example 3]

[0166] Produced such as International Publication No. 2021 / 065300 Figure 4 The concentration apparatus shown.

[0167] Here, the tube 70 is made of polypropylene. Furthermore, the thickness of the tube 70 is 1.1 mm. Therefore, the tube 70 is not flexible. And, 3.0 g of SAP Sphere 1.0 mm, manufactured by M2 Polymer Technologies Inc., which is a specific superabsorbent polymer 30 (SAP), is contained within the tube 70. As described above, because the tube 70 is not flexible, SAP cannot be pressed through the inner wall of the container.

[0168] [Comparative Example 4]

[0169] As SAP used superabsorbent polymer particles (model 197-12451) manufactured by FUJIFILM Wako Pure Chemical Corporation, a concentration apparatus was prepared following the same procedure as in Comparative Example 3.

[0170] [2] Concentration of the test solution

[0171] The test solution was concentrated using the prepared concentration apparatus.

[0172] Specifically, 12 mL of artificial urine (JIS T3214) was added to the concentration apparatus as the test solution and allowed to stand for 10 minutes. After standing, the SAP (Strained Acid Pump) was pressed against the inner wall of the flexible container of the concentration apparatus to recover the test solution (concentrate) that was not absorbed by the SAP. The recovery was performed within the time specified in the "Recovery Time" column of Table 1. The weight of the recovered concentrate was then measured, and the concentration ratio was calculated by dividing the weight of the added test solution by the weight of the concentrate.

[0173] In each example, the same concentration was performed 10 times, and the coefficient of variation of the concentration ratio (1 SD / average) was calculated. The results are shown in Table 1. In practice, a coefficient of 0.40 or less is preferred.

[0174] Furthermore, the test solution does not contain polymers such as LAM. However, assuming the test solution does contain polymers, these polymers are unlikely to enter the SAP (Symptom Acid Processing Unit), and will concentrate to an amount equivalent to the amount of test solution that enters the SAP. Therefore, the concentration rate is approximately the same as the concentration rate when the test solution contains polymers.

[0175] [Table 1]

[0176] In Table 1, the columns for “particle size”, “swelling rate”, and “water absorption rate” represent the particle size, swelling rate, and water absorption rate of the superabsorbent polymers used in each example, respectively.

[0177] Furthermore, the swelling rates of the superabsorbent polymers listed in Table 1 are all above 0.2 g / g and below 800 g / g, and therefore all correspond to the specific superabsorbent polymers mentioned above.

[0178] As shown in Table 1, when the test liquid is concentrated using the concentration apparatus of Examples 1 to 9, which have a specific superabsorbent polymer and a soft container containing the specific superabsorbent polymer and are capable of pressing the specific superabsorbent polymer through the inner wall of the container, the coefficient of variation of the concentration rate is small.

[0179] On the other hand, when the test liquid was concentrated using the concentration apparatus of Comparative Examples 1 to 4, which used containers other than flexible containers, the coefficient of variation of the concentration rate was large.

[0180] Furthermore, a comparison of Examples 1-9 shows that the coefficient of variation of the concentration ratio in Examples 1-7 is smaller for the specific superabsorbent polymer with a particle size of 0.2 mm or more. It can be considered that because the specific superabsorbent polymer has a large particle size, the particles are less likely to aggregate, making it easier to recover the concentrate. In addition, this tendency was not clearly observed in the comparison of Comparative Examples 1-4; therefore, it is believed that the effect of reducing the coefficient of variation of the concentration ratio by setting the particle size to 0.2 mm or more was achieved for the first time through the combination with a flexible container.

[0181] Symbol Explanation

[0182] 200 - Concentration apparatus; 210, 210a, 210b, 210c, 210d - Container body; 211, 211a, 211b, 211c - Reception section; 212 - Cover; 213 - Nozzle; 214, 214a - Container; 215 - Neck; 216 - Opening; 217a, 217b - Narrowing section; 218 - Bag-shaped reception section; 219 - Discharge section; 220 - Filter; 221 - Wall surface; 230 - Water-absorbing polymer (water-absorbing polymer before water absorption); 232 - Water-absorbing polymer (water-absorbing polymer after water absorption, swollen water-absorbing polymer); 240 - Liquid sample (test liquid); 241 - Concentrate; 242 - Taken concentrate; 246 - Concentrate of test liquid.

Claims

1. A concentration apparatus for performing concentration processing in the detection of high molecular weight substances contained in liquid samples. The concentration apparatus has the following features: A water-absorbing polymer for absorbing at least a portion of the moisture in the liquid sample; and A container for containing the absorbent polymer and for introducing the liquid sample, wherein at least a portion of the container is flexible. The concentration apparatus can press the absorbent polymer through the inner wall of the container. The swelling ratio of the water-absorbing polymer is above 0.2 g / g and below 800 g / g.

2. The concentration apparatus according to claim 1, wherein, The absorbent polymer has a particle size of 0.2 mm or more and 1.6 mm or less.

3. The concentration apparatus according to claim 1 or 2, wherein, The swelling rate of the water-absorbing polymer is above 10 g / g and below 400 g / g.

4. The concentration apparatus according to claim 1 or 2, wherein, The absorbent polymer has an absorption rate of more than 0.3 g / min and less than 3.0 g / min per 1g.

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