WO2012120812A1 - Tampon absorbant - Google Patents

Tampon absorbant Download PDF

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Publication number
WO2012120812A1
WO2012120812A1 PCT/JP2012/001272 JP2012001272W WO2012120812A1 WO 2012120812 A1 WO2012120812 A1 WO 2012120812A1 JP 2012001272 W JP2012001272 W JP 2012001272W WO 2012120812 A1 WO2012120812 A1 WO 2012120812A1
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WIPO (PCT)
Prior art keywords
polymer particles
absorbent pad
absorbent
pad
superabsorbent polymer
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PCT/JP2012/001272
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English (en)
Japanese (ja)
Inventor
佑弥 加藤
伊藤 大輔
久彦 岩本
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田中貴金属工業株式会社
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Publication of WO2012120812A1 publication Critical patent/WO2012120812A1/fr

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    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • B01L3/502Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures
    • B01L3/5023Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures with a sample being transported to, and subsequently stored in an absorbent for analysis
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00Additional constructional details
    • B01L2300/16Surface properties and coatings
    • B01L2300/161Control and use of surface tension forces, e.g. hydrophobic, hydrophilic

Definitions

  • the present invention relates to an absorption pad used as a constituent member of an immunochromatographic test kit and an immunochromatographic test kit using the same.
  • POCT Point of care testing
  • POCT is a test performed in a clinic or home medical care, unlike the test used in a hospital's central laboratory or outsourced test center. Therefore, those who do not have sufficient knowledge of the test itself and are not familiar with measurement. Often handled. For this reason, a test reagent for POCT is required to have a simple operability so that anyone can obtain a reliable test result simply by receiving a simple explanation. However, even if the operation is as simple as possible, in practice, the amount of the test sample used is inadequate or the determination is not performed at the specified time. There is also a problem that the wrong operation is given. Therefore, in addition to simple operation, the test reagent for POCT may be designed so as not to affect the determination result even if an incorrect operation is performed, or to have the effect as small as possible. It is requested.
  • An immunochromatographic test kit mainly consists of a chromatographic medium, a sample addition part (sample pad), a labeling reagent holding part (conjugate pad), an absorption part (absorption pad), and so on. These members are affixed to a base material (backing sheet) and housed in a housing member.
  • a chromatographic medium made of nitrocellulose or the like has a function as a developing part for a liquid sample and also has a function as a determination part for a test result.
  • sample pad At one end in the longitudinal direction of the chromatographic medium, a sample addition part (sample pad) and a labeling reagent holding part (conjugate pad) containing a labeling reagent are installed so as to be able to pass through, and an excess is provided at the opposite end.
  • An absorption part (absorption pad) for absorbing a sample liquid is provided.
  • the test using the immunochromatography test kit is performed by adding a small amount (25 to 200 ⁇ l) of a sample solution to the sample addition section.
  • the added sample solution passes through the labeling reagent holding unit, moves in the chromatographic medium in the longitudinal direction by capillary action, passes through the determination unit, and is absorbed by the absorption pad.
  • the substance to be detected in the sample solution forms a complex with a colored labeling substance such as colloidal gold when passing through the labeling reagent holding part using the antigen-antibody reaction, and then the judgment part on the chromatographic medium. Captured.
  • the amount of the substance to be detected captured by the determination part of the chromatographic medium during the specified reaction time (10 to 15 minutes) is visually determined using the intensity of coloring derived from the labeling substance as an index. judge.
  • the absorbent pad is constructed using superabsorbent fibers in place of fibers such as glass fiber, cellulose fiber, and pulp that have been used as conventional absorbent pad components. It has also been attempted (see Patent Document 2).
  • the absorption pad containing superabsorbent fibers has a low absorption rate of the sample solution, and the sample solution is not sufficiently absorbed by the absorption pad within the specified reaction time (10 to 15 minutes).
  • the remaining excess liquid sample has a problem that a positive signal appearing in the determination part is blurred, or a background signal is increased because a colored labeling substance is not sufficiently collected.
  • the absorbent performance is not sufficiently exhibited. Therefore, when the absorbent pad is manufactured, the swelling is suppressed together with the superabsorbent fiber. Therefore, there is a problem in that the heat absorption performance of the entire absorbent pad is lowered and the cost is increased due to the fusion of the fibers.
  • the present invention is excellent in the absorption rate of the sample solution, can absorb the sample solution added to the test kit without delay, has excellent retention of the sample solution, and is chromatographed even after a prescribed reaction time has elapsed. It is an object of the present invention to provide an absorption pad for a test kit based on an immunochromatography method that can prevent a sample solution from flowing back into a medium.
  • the absorbent pad constituting the test kit by immunochromatography has a structure containing highly water-absorbing polymer particles in hydrophilic fibers.
  • the present inventors have found that the sample solution has an excellent absorption rate and holding power and can prevent the sample solution from flowing back into the chromatographic medium.
  • the present invention relates to an absorbent pad of an immunochromatographic test kit characterized by including an absorbent core containing highly water-absorbing polymer particles in hydrophilic fibers. Moreover, this invention relates to the test
  • the present invention relates to the following (1) to (10).
  • An absorbent pad used as a constituent member of an immunochromatographic test kit characterized in that the absorbent pad includes an absorbent core containing superabsorbent polymer particles in hydrophilic fibers. , Absorbent pad.
  • the absorbent pad according to (1) wherein the absorbent pad further includes a water-absorbing surface sheet, and the absorbent core is sandwiched between the surface sheets.
  • the ratio of hydrophilic fibers and superabsorbent polymer particles in the entire absorbent pad is 65 to 85% by weight of hydrophilic fibers and 35 to 15% by weight of superabsorbent polymer particles, (1) or The absorbent pad according to (2).
  • the absorbent pad according to any one of (1) to (6), wherein the superabsorbent polymer particles are made of a crosslinked poly (sodium acrylate).
  • the absorbent pad according to any one of (1) to (7), wherein the superabsorbent polymer particles have an average particle size of 100 to 700 ⁇ m.
  • the absorption pad in the inspection using the immunochromatographic test kit, even if the determination cannot be performed at the specified time, the absorption pad can prevent the backflow of the sample liquid, so that the determination unit The positive signal appearing in is not affected, the background signal rise is also suppressed, and an accurate determination can be made.
  • the absorbent pad of the present invention can rapidly absorb the sample liquid by allowing the sample liquid to permeate between the entangled hydrophilic fibers by capillary action, and the superabsorbent polymer particles can further absorb the hydrophilic fibers. Since the sample liquid that has permeated during this time is absorbed quickly, the sample liquid can be held without being backflowed.
  • the absorbent pad of the present invention has remarkable characteristics in the water absorption speed, the water absorption amount, and the water retention capacity.
  • the dispersion state of the superabsorbent polymer particles in the absorbent core containing the superabsorbent polymer particles in the hydrophilic fiber can be adjusted, and the deterioration of the absorption performance of the entire absorbent pad can be suppressed. it can.
  • the absorbent core comprising the superabsorbent polymer particles in the hydrophilic fiber of the present invention is obtained by mixing and dispersing the hydrophilic fiber and the particulate superabsorbent polymer particles, and compressing the mixture. Easy to manufacture.
  • FIG. 1 is a cross-sectional view showing one preferred embodiment of an immunochromatographic test kit having an absorption pad according to the present invention.
  • FIG. 2 is a cross-sectional view showing one preferred embodiment of an immunochromatographic test kit having an absorption pad according to the present invention.
  • an immunochromatographic test kit includes a chromatographic medium, a sample pad, a conjugation pad, an absorption pad, and the like.
  • the absorbent pad of the present invention is intended to absorb and retain the sample liquid that is added to the sample pad, passes through the conjugation pad, and moves through the chromatographic medium. It has an absorbent core that is contained.
  • the hydrophilic fiber used in the present invention is not particularly limited as long as it is hydrophilic and fibrous, and examples thereof include cellulose fibers such as pulp, cotton linter, and crosslinked cellulose fibers, rayon, acetate, cotton, wool, glass fibers, and the like. And one of these may be used alone or two or more of them may be used in combination.
  • Cellulose fibers such as pulp, cotton linter, and crosslinked cellulose fiber are preferable from the viewpoint of the water absorption rate of the sample solution, and pulp is particularly preferable because the fiber length is short and the pad can be easily manufactured.
  • known polymers can be used, such as a cross-linked polyacrylate, a cross-linked vinyl alcohol-acrylate copolymer, and a starch-acrylate graft copolymer cross-linked.
  • a partially crosslinked product of a polymer compound having a carboxyl group or a salt thereof such as a crosslinked product of polyvinyl alcohol-polyanhydride maleate graft copolymer and a partially crosslinked product of polysaccharide such as a crosslinked product of carboxymethylcellulose salt.
  • 1 type of these can be used individually or in mixture of 2 or more types.
  • the shape of the highly water-absorbing polymer is preferably in the form of an irregularly crushed shape, a bunch of cocoons, or a spherical shape, in terms of form stability after water absorption and water absorption speed.
  • the average particle diameter of the superabsorbent polymer particles is preferably 100 to 700 ⁇ m, more preferably 150 to 600 ⁇ m, and still more preferably 170 to 420 ⁇ m. If the particle size of the superabsorbent polymer particles is too small, the superabsorbent polymer particles are difficult to be held in the network structure in which hydrophilic fibers are entangled, and this causes the superabsorbent polymer particles to leak from the water absorbent pad of the present invention.
  • the average particle diameter of the superabsorbent polymer particles can be measured, for example, by conducting a screening test using a standard sieve according to JIS Z8801-1 2006, or randomly using a photograph taken with an optical microscope. It is also possible to select 200 particles and measure the area equivalent circle diameter and calculate from the average value thereof.
  • the superabsorbent polymer particles preferably have an uneven shape on the surface. This is because the highly water-absorbent polymer particles have an uneven shape on the surface thereof, so that they are easily caught by hydrophilic fibers and are easily held in a network structure made of hydrophilic fibers. Further, the surface area becomes relatively large, and the rate of absorbing the sample liquid can be improved.
  • the bulk specific gravity serving as an index of the surface shape of the superabsorbent polymer particles can be measured, for example, according to JIS K6219-2 2005, preferably 0.40 to 0.90 g / ml, more preferably 0.50. ⁇ 0.80 g / ml.
  • the water absorption capacity of the superabsorbent polymer particles used in the present invention is preferably 20 g / g or more, more preferably 30 g / g or more, and still more preferably with respect to 0.9% by weight of physiological saline. Is 40 g / g or more.
  • the water-absorbing ability of the superabsorbent polymer particles is as follows: 1.0 g superabsorbent polymer particles are immersed in 1 L of 0.9 wt% physiological saline for 1 hour, drained for 15 minutes, and then centrifuged at 850 rpm for 90 seconds. Expressed by weight after.
  • the water absorption rate of the highly water-absorbing polymer particles is preferably 20 seconds or less, more preferably 10 seconds or less, according to the Vortex method.
  • the water absorption rate by the Vortex method is represented by the time required for 2.0 g of superabsorbent polymer particles to absorb 50 ml of 0.9 wt% physiological saline. The faster the water absorption speed of the highly water-absorbing polymer particles, the more the sample liquid is absorbed without delay, and the positive signal that appears in the determination section becomes clearer.
  • the absorbent pad of the present invention comprises an absorbent core containing hydrophilic fibers and superabsorbent polymer particles.
  • the absorbent core of the present invention can also have a structure in which superabsorbent polymer particles are dispersed in hydrophilic fibers.
  • the absorbent core of the present invention is a mixed state in which the superabsorbent polymer particles are dispersed throughout the hydrophilic fibers by mixing and dispersing the hydrophilic fibers and the superabsorbent polymer particles, and then forming into a sheet shape. It can also be set as this structure. Moreover, it can also be set as the sandwich-like structure which disperse
  • a layer made of hydrophilic fibers was further provided above and below the layer in which the superabsorbent polymer particles were dispersed in the hydrophilic fibers, so that a mixed / dispersed layer of the hydrophilic fibers and superabsorbent polymer particles was present.
  • a three-layer structure can also be used. Moreover, it can also be set as the laminated body which laminated
  • stacked the layer in which the superabsorbent polymer particle from which dispersion amount and dispersion state differ in a hydrophilic fiber and the layer which consists of hydrophilic fibers were laminated
  • the sample liquid absorbed from the chromatographic medium is not only absorbed by the superabsorbent polymer particles, but also entangled between the entangled hydrophilic fibers by capillary action. As it penetrates, it is absorbed quickly. The sample liquid that has penetrated between the hydrophilic fibers is quickly absorbed and retained by the highly water-absorbing polymer particles. Absorption by the superabsorbent polymer particles dries between the hydrophilic fibers, allowing further absorption. For this reason, the absorbent pad of the present invention has remarkable characteristics in the water absorption speed, the water absorption amount, and the water retention capacity.
  • the superabsorbent polymer particles are It is preferably dispersed and held in the hydrophilic fiber in a state of being separated from each other.
  • the basis weight of the hydrophilic fiber is preferably in the range of 100 to 300 g / m 2 , more preferably 140 to 300 g / m 2 , and still more preferably 140 to 300 to 300 g / m 2 . The range is 250 g / m 2 .
  • the absorbent pad of the present invention may have a structure in which an absorbent core composed of hydrophilic fibers and highly water-absorbing polymer particles is covered with a water-absorbent surface sheet, or the sheet-like absorbent core The structure may be sandwiched between the top sheets.
  • the absorbent pad of the present invention has a surface sheet, leakage of the superabsorbent polymer particles from the absorbent core can be prevented, and the handleability is also improved.
  • the absorption pad of the present invention is laminated so as to allow only a part of the chromatographic medium to pass through as shown in FIG. 2, the surface is disposed between the absorbent core and the chromatographic medium or the substrate. More preferably, the sheet is present.
  • the absorbent pad of the present invention Since the water-absorbing surface sheet has a higher water absorption rate than the hydrophilic fiber layer containing the highly water-absorbing polymer particles, if the absorbent pad of the present invention has a surface sheet, the sample liquid is contained in the entire absorbent pad. This is because the water absorption efficiency of the absorbent core that easily penetrates and includes the highly water-absorbing polymer particles is increased.
  • a non-woven fabric made of hydrophilic fibers, particularly pulp can be used, but a paper having high water absorption, for example, sanitary paper such as tissue paper and toilet paper can be preferably used.
  • tissue paper base paper to which a wet paper strength enhancer is added is preferable because it has a certain strength even after absorption of the sample liquid.
  • the density of the top sheet is not particularly limited as long as leakage of the superabsorbent polymer particles can be prevented. For example, when tissue paper is used as the top sheet, the basis weight is in the range of 5 to 15 g / m 2. .
  • the mixing ratio of the hydrophilic fibers and the superabsorbent polymer particles in the absorbent pad of the present invention is preferably 65 to 85% by weight of the hydrophilic fibers and 35 to 15% by weight of the superabsorbent polymer particles, more preferably. Is 70 to 80% by weight of hydrophilic fibers and 30 to 20% by weight of superabsorbent polymer particles.
  • the content of the superabsorbent polymer particles exceeds 50% by weight, the absorption rate of the absorption pad is reduced, and bleeding of a positive signal appearing in the determination part and the labeling substance remain on the chromatographic medium. Cause an increase in background signal.
  • the entanglement of the hydrophilic fibers is hindered, and the handleability of the absorbent pad is lowered.
  • the content of the highly water-absorbing polymer particles is less than 10% by weight, the retention of the sample liquid is reduced, and it is difficult to prevent the backflow of the sample liquid when the test kit is left standing.
  • the absorbent pad of the present invention can be manufactured based on a known technique. If necessary, the absorbent core included in the absorbent pad of the present invention may fix hydrophilic fibers or a part or all of hydrophilic fibers and superabsorbent polymer particles by a method such as adhesion. A known binder resin can be used as an adhesive for bonding.
  • the absorbent core of the present invention for example, after forming a web by dispersing hydrophilic fibers and superabsorbent polymer particles in the air by the airlaid method, spraying an aqueous adhesive as necessary, and drying, It can be obtained as a nonwoven fabric containing superabsorbent polymer particles.
  • an absorbent pad having a desired density and thickness By compressing the obtained nonwoven fabric, an absorbent pad having a desired density and thickness can be obtained.
  • the absorbent core of the present invention has a structure in which a layer made of hydrophilic fibers, a layer of a mixture of hydrophilic fibers and superabsorbent polymer particles is laminated, each layer is made into a nonwoven fabric using a known method. After being obtained, it can be produced by bonding using a known method such as adhesion or embossing.
  • the thickness of the absorbent pad of the present invention is preferably 1.2 mm or less, more preferably 1.0 mm or less, and still more preferably 0.8 mm or less.
  • the absorption pad of the present invention has a structure having a surface sheet, the surface sheet, an absorbent core composed of hydrophilic fibers and highly water-absorbing polymer particles, and a surface sheet are stacked in this order, and are subjected to thermocompression bonding.
  • the absorbent pad of the present invention can be obtained.
  • a known adhesive can be used as necessary.
  • the hydrophilic fiber and the superabsorbent polymer particles constituting the absorbent core can be fixed in advance and then coated with a topsheet, but the hydrophilic fiber and superabsorbent polymer particles are dispersed on the topsheet, Furthermore, it is possible to stack the top sheets and fix them all at once.
  • the entire absorbent pad can be pressed and adhered uniformly, but it is preferable to partially adhere it by embossing or the like in order to improve water absorption performance.
  • the absorption pad of the present invention can be used as a constituent member of an inspection kit by immunochromatography.
  • other components of the immunochromatography test kit for example, a chromatographic medium, a sample pad, a conjugation pad, a housing member, and the like can be used, and are not limited at all.
  • the absorption pad of the present invention can be arranged so that the whole can overlap with the chromatographic medium, or can be arranged so that only a part thereof overlaps as shown in FIG. You can also.
  • the substance to be detected that can be detected using the immunochromatography test kit having the absorption pad of the present invention can form a complex with a labeling substance using an antigen-antibody reaction, and can be chromatographed. There is no particular limitation as long as it can be captured by the determination unit on the medium.
  • the substance to be detected include carcinoembryonic antigen (CEA), HER2 protein, prostate specific antigen (PSA), CA19-9, ⁇ -fetoprotein (AFP), immunosuppressive acidic protein (IPA), CA15- 3, CA125, estrogen receptor, progesterone receptor, fecal occult blood, troponin I, troponin T, CK-MB, CRP, human chorionic gonadotropin (HCG), luteinizing hormone (LH), follicle stimulating hormone (FSH), syphilis antibody, Examples include influenza virus, chlamydia antigen, group A ⁇ -streptococcal antigen, HBs antibody, HBs antigen, rotavirus, adenovirus, albumin, glycated albumin, and allergens such as pollen, mites, indoor dust, foods, and allergen-specific IgE.
  • CEA carcinoembryonic antigen
  • PSA prostate specific antigen
  • AFP
  • sample containing the substance to be detected examples include biological samples, that is, whole blood, serum, plasma, urine, saliva, nasal discharge, nasal cavity or pharyngeal wiping liquid, stool extraction liquid, and other extracts of foods, etc.
  • liquid sample examples include, but are not limited to.
  • the test using the test kit by the immunochromatography method of the present invention is performed by adding the sample solution to the sample pad.
  • the sample solution is diluted with a known developing solution, for example, physiological saline, phosphate buffer, Tris-HCl buffer, or the like, if necessary, and is used for testing.
  • the amount of sample liquid that is added to the sample pad, moves through the chromatographic medium, and is finally absorbed by the absorption pad is 25 to 500 ⁇ l, depending on the amount of water that the sample pad can temporarily hold. Is more preferable, 25 to 200 ⁇ l, more preferably 25 to 100 ⁇ l.
  • the sample solution added to the sample pad passes through the conjugation pad and reaches the chromatographic medium.
  • the conjugation pad contains a labeled antibody in which a labeling substance is bound (conjugated) to an antibody that specifically binds to the substance to be detected.
  • labeling substance used in the present invention known labeling substances can be used.
  • enzymes such as alkaline phosphatase, horseradish peroxidase, ⁇ -galactosidase, and colored colloidal gold particles, latex particles, etc. Insoluble carriers can be mentioned.
  • Conjugation pads contain an excess of labeled antibodies against the substance to be detected, and these labeled antibodies dissolve in the sample solution that passes through the conjugation pad, move through the chromatographic medium, and then enter the absorption pad. Absorbed.
  • the absorbent pad of the present invention absorbs the sample solution, the superabsorbent polymer particles contained therein swell and gel.
  • the water absorption performance of the superabsorbent polymer not only inhibits the backflow of the sample solution, but also gels the superabsorbent Since the polymer suppresses the movement of the insoluble carrier accommodated in the absorption pad, the labeled substance once absorbed is unlikely to return to the chromatographic medium.
  • the absorption pad of the present invention is preferably used in an immunochromatography test kit using an insoluble carrier as a labeling substance, from the viewpoint that it is possible to more efficiently suppress an increase in background signal due to the reversing labeling substance.
  • the gelled superabsorbent polymer has a high affinity with the colloidal gold particles, and the reversal of the colloidal gold particles can be suppressed more efficiently. More preferably, it is used for the immunochromatography test kit used in the above.
  • a determination unit is formed in which an antibody that specifically binds to the substance to be detected is applied, for example, in a line shape.
  • the substance to be detected contained in the sample solution forms a complex with the labeling substance by the antigen-antibody reaction, and is captured by the antibody applied thereto when passing through the determination unit.
  • the amount of the substance to be detected captured by the determination unit is measured visually or by a densitometer using the intensity of coloring derived from the labeling substance as an index, and a positive or negative determination is made.
  • the reaction time from when the sample solution is added to the test kit until the determination is made is the time until the sample solution added to the sample pad is almost absorbed by the absorption pad, and at the speed at which the sample solution moves through the chromatographic medium.
  • the absorption pad of the present invention can absorb the sample liquid that has moved through the chromatographic medium and reached the absorption pad without delay, so that there is an excess of sample liquid on the chromatographic medium until the reaction time ends.
  • the positive signal that appears in the determination unit is not blurred.
  • the absorbed sample liquid can be retained even after the prescribed reaction time is completed, the bleeding of a positive signal due to the backflow of the sample liquid does not occur.
  • the colored labeling substance does not diffuse throughout the chromatographic medium due to the backflow of the sample solution, the S / N ratio does not decrease due to an increase in the background signal.
  • the detected substance that forms a complex with the labeling substance due to the backflow of the sample solution passes through the determination section again, and extra detected substance is additionally captured, or the backflowed labeled substance is captured nonspecifically.
  • a test sample that should be determined to be negative is not determined to be positive. Therefore, even when the test kit of the present invention is left for a long time after the reaction time has ended, an accurate determination can be made.
  • a superabsorbent resin “Aquaclick CA (W4S)” (average particle diameter of 100 to 300 ⁇ m) manufactured by Nippon Shokubai Co., Ltd. was used.
  • Sanitary base paper (tissue paper base paper) “NPE” manufactured by Okura Paper Co., Ltd. was used as the water-absorbing surface sheet.
  • the laminate surface sheet / pulp and superabsorbent polymer particles / surface sheet
  • the thickness of the absorbent pad is 0.8 mm
  • the diameter of the recesses that appear on the surface of the absorbent pad by the thermocompression treatment is 1.0 mm
  • the density of the recesses is 30 / cm 2 .
  • the mixing ratio of pulp components (total of tissue paper and pulp) and superabsorbent polymer particles in the absorbent pad was 78% by weight to 22% by weight.
  • a colloidal gold suspension (manufactured by Tanaka Kikinzoku Kogyo Co., Ltd .: average particle diameter of 40 nm, gold concentration of 0.36 mM) was used as a labeling substance.
  • a phosphate buffer (pH 7.4) containing 1% by weight of bovine serum albumin (BSA) was added, and the mixture was allowed to stand at room temperature for 10 minutes. Then, after sufficiently stirring, centrifugation was performed at 8000 ⁇ g for 15 minutes to remove the supernatant, and 2 ml of phosphate buffer (pH 7.4) containing 0.5 wt% BSA was added.
  • a labeled antibody solution was prepared by the above procedure.
  • test kit by immunochromatography method
  • the above-prepared labeled antibody solution was uniformly added to a 15 mm x 300 mm glass fiber pad (manufactured by Millipore), then dried in a vacuum dryer, and a conjugation pad Was made.
  • the above-prepared chromatographic medium, conjugation pad, sample pad (Millipore: 300 mm ⁇ 30 mm), and absorption pad, which are prepared as described above, are bonded to a base material made of a backing sheet as shown in FIG.
  • An inspection kit was prepared by immunochromatography by cutting to a width of 5 mm.
  • the size of the absorbent pad per kit was 260 mm ⁇ 5 mm, and the gold content in the labeling reagent was 3 ⁇ g.
  • test kit Having Absorbent Pad
  • the test was performed using a sample obtained from a subject who was determined to be negative by an influenza A infection test using the PCR method.
  • sample solution dropped on the test kit, insert one tube of the suction trap into the suction pump and the other tube to the back of the subject's nasal cavity, collect the nasal discharge using the suction pump with negative pressure, and use the developing solution. It was prepared by diluting 20 times.
  • This sample solution is developed in the test kit prepared as described above, and the presence or absence of background coloring at the time of 15 minutes from the start of the test, the backflow of the sample solution at the time of 60 minutes from the start of the test, and the presence or absence of false positives are observed. did.
  • the test results are shown in Table 1.
  • the background color is derived from the developed labeling substance (gold nanoparticles). When the red gold nanoparticles are completely absorbed by the absorption pad, the background color is lost and the original white color of the chromatographic medium is observed. Will come to be.
  • the presence or absence of false positives was determined by observing whether or not a red line derived from the labeling substance (gold nanoparticles) was generated in the determination part of the chromatographic medium at 60 minutes from the start of the test.
  • the sample used was a sample that was determined to be negative in the PCR test, and even in a test using an immunochromatography test kit, a red line indicating positive in the determination part was not observed at 15 minutes after the start of the test. It was. However, when there is a backflow of the sample solution, a red line may appear in the determination unit at 60 minutes from the start of the test. In this case, it was determined that there was a false positive.
  • An absorbent pad was prepared in the same manner as in Example 1 except that the content of pulp (140 g / m 2 ) and superabsorbent polymer particles (80 g / m 2 ) was changed.
  • a test kit by an immunochromatography method was prepared in the same manner as in Example 1, and the water absorption performance of the absorption pad was tested. The test results are shown in Table 1.
  • An absorbent pad was prepared in the same manner as in Example 1 except that the content of pulp (250 g / m 2 ) and superabsorbent polymer particles (55 g / m 2 ) was changed.
  • a test kit by an immunochromatography method was prepared in the same manner as in Example 1, and the water absorption performance of the absorption pad was tested. The test results are shown in Table 1.
  • an immunochromatographic test kit was prepared in the same manner as in Example 1, and the water absorption performance of the absorbent pad was tested.
  • an absorber CF7 manufactured by whatman was used.
  • an absorber 113 manufactured by Pall was used.
  • an absorber 133 manufactured by Pall was used.
  • an absorber 165 manufactured by Pall Co. was used.
  • an absorber 197 manufactured by Pall Co. was used.
  • an absorber A / B manufactured by Pall Co. was used.
  • an absorber A / C manufactured by Pall Co. was used.
  • the absorption pad was produced similarly to Example 1 except having changed and used content of a pulp (300 g / m ⁇ 2 >) and a super absorbent polymer particle (35 g / m ⁇ 2 >) (Comparative Example 14). . Furthermore, the pulp (100 g / m 2) and was used instead of changing the content of the superabsorbent polymer particles (117 g / m 2), was prepared absorbent pad in the same manner as in Example 1 (Comparative Example 15) . Using the absorption pad prepared above, a test kit by an immunochromatography method was prepared in the same manner as in Example 1, and the water absorption performance of the absorption pad was tested. The test results are shown in Table 1.
  • the absorption pad of the present invention when used in an immunochromatographic test kit, prevents backflow of the sample liquid and enables accurate determination regardless of the standing time after the end of the reaction time, and is highly reliable. It has industrial applicability that a test reagent for POCT can be provided.
  • Sample addition part 2 Labeling reagent holding part 3: Chromatograph medium 4: Absorption pad 5: Base material

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  • Chemical & Material Sciences (AREA)
  • Analytical Chemistry (AREA)
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  • Solid-Sorbent Or Filter-Aiding Compositions (AREA)

Abstract

La présente invention concerne un tampon absorbant à utiliser dans un kit de test d'immunochromatographie ; ledit tampon absorbant affiche un taux élevé d'absorption du liquide d'échantillon, est capable d'absorber immédiatement un liquide d'échantillon qui est ajouté au kit de test, possède une bonne capacité de rétention du liquide d'échantillon, et empêche un reflux du liquide d'échantillon vers le milieu de chromatographie même après l'écoulement d'un temps de réaction prédéfini. La présente invention concerne un tampon absorbant constitué d'un noyau absorbant qui comprend des particules de polymères à fort pouvoir d'absorption d'eau contenues dans des fibres hydrophiles. La présente invention concerne également un kit de test d'immunochromatographie qui comprend le tampon absorbant susmentionné comme organe constitutif.
PCT/JP2012/001272 2011-03-09 2012-02-24 Tampon absorbant WO2012120812A1 (fr)

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JP2011050943A JP2012189346A (ja) 2011-03-09 2011-03-09 吸収パッド

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JP6180761B2 (ja) * 2013-03-13 2017-08-16 デンカ生研株式会社 検査キット
JP6226624B2 (ja) 2013-08-08 2017-11-08 田中貴金属工業株式会社 溶血性レンサ球菌診断イムノクロマト試薬、キット及び検出方法
JP6439307B2 (ja) * 2013-09-19 2018-12-19 株式会社リコー 流体デバイス、転写材、および流体デバイスの製造方法
JP5792859B1 (ja) 2014-04-04 2015-10-14 田中貴金属工業株式会社 免疫クロマト分析方法
US10138344B2 (en) 2015-03-19 2018-11-27 Ricoh Company, Ltd. Particulate polyamide, and method for preparing the particulate polyamide
JP6659406B2 (ja) 2016-03-04 2020-03-04 田中貴金属工業株式会社 イムノクロマトグラフィー装置
JP7248513B2 (ja) 2018-06-14 2023-03-29 田中貴金属工業株式会社 イムノクロマトグラフィー装置用パッド、これを用いたイムノクロマトグラフィー装置、イムノクロマトキット並びにイムノクロマト検出方法
CN113474656A (zh) 2019-01-31 2021-10-01 旭化成株式会社 免疫层析诊断试剂盒用吸收垫
KR20210107781A (ko) 2019-05-14 2021-09-01 아사히 가세이 가부시키가이샤 이뮤노크로마토 진단 키트용 흡수 패드 및 이뮤노크로마토 진단 키트
JPWO2022124137A1 (fr) * 2020-12-09 2022-06-16
KR102601981B1 (ko) 2021-01-04 2023-11-13 인하대학교 산학협력단 변형된 측면 유동 면역진단 스트립

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