Urine collection tube

Abstract

Development of a urine collection tube that can selectively capture different biomolecules for each disease from collected urine, and that can safely transport the sample by mail without degradation. [Solution] A urine collection tube equipped with an absorbent member made of a material that selectively adsorbs biomolecules according to their physical properties and / or size can selectively capture different biomolecules from the collected urine depending on the disease, and can transport the sample safely and without deterioration by mail.

Description

Technical Field

[0001] The present invention relates to a urine collection tube.

Background Art

[0002] Urine specimens derived from humans and animals contain many biomarkers that reflect health status and diseases, and since they can be collected non-invasively and easily, OTC test drugs such as urine sugar and urine protein test drugs and pregnancy and ovulation test drugs are widely popular. However, since conventional urine collection tubes are designed only for the purpose of collecting urine, it is premised on collecting urine and performing tests at medical institutions, and transporting urine has not been assumed. (Only transportation to the extent of bringing it to a health check at school or company is assumed.)

[0003] If an existing urine collection tube is used to transport urine using a delivery service, there are risks such as the growth of bacteria during transportation, the decomposition of measurement target molecules due to spoilage, and further, urine leakage due to container breakage during transportation and the resulting virus infection to the transportation workers. Mail-in tests are also being conducted where the subject collects urine at home and mails it for various tests at medical institutions or inspection institutions. The mailing methods include a method of putting urine in a container and a method of using "filter paper urine" in which urine is soaked into filter paper and dried. Although the latter can reduce the risk of leakage during transportation, it is an issue whether test results equivalent to those of normal urine specimens can be obtained for filter paper urine. Furthermore, depending on various conditions such as the pH, salt concentration, and bacterial contamination of urine and the transportation environment, there is also a risk that the specimen will oxidize, deteriorate, or spoil, resulting in test results different from those of fresh urine.

[0004] The invention described in Patent Document 1 discloses that by using filter paper urine in which fresh urine is soaked into filter paper containing an aromatic alcohol, a phenol derivative, or a polyhydric aliphatic alcohol, the test results of the filter paper urine over time will be equivalent to those of fresh urine. Testing by mail of filter paper urine is also assumed.

Prior Art Documents

Patent Documents

[0005] [Patent Document 1] Patent Application No. 2022-530801 [Overview of the Initiative] [Problems that the invention aims to solve]

[0006] However, while the invention described in Patent Document 1 discloses preventing the deterioration of filter paper urine over time using reagents, it does not describe or suggest any "filter paper" that can efficiently capture different biomolecules depending on the disease.

[0007] Therefore, the present invention aims to develop a urine collection tube that can selectively capture different biomolecules from collected urine depending on the disease, and that can safely transport the sample by mail without deterioration. [Means for solving the problem]

[0008] To solve the above problems, [1] A urine collection tube comprising an absorbent member and a storage case for housing the absorbent member, wherein the absorbent member is made of a material that selectively adsorbs biomolecules according to their physical properties and / or size. [2] The urine collection tube according to [1], characterized in that the absorbent member can be selectively replaced depending on the physical properties and / or size of the biomolecule to be detected. [3] The urine collection tube according to [1], characterized by comprising a plurality of absorbent members. [4] The urine collection tube according to [1], characterized in that the absorbent member is provided with a recognition section capable of confirming the amount of absorbed urine. [5] The urine collection tube according to [1], characterized in that a stabilizer to prevent the denaturation of the absorbed urine is contained within a storage case. [6] The urine collection tube according to [1], characterized in that the absorbent member is coated with a substance different from the absorbent member. [7] A method for detecting biomolecules impregnated in the absorbent material described in [1], characterized by comprising the following steps: (1) A step of immersing the absorbent member in a solvent at a temperature of 3°C to 60°C, (2) A step of letting the absorbent member immersed in the solvent of (1) stand or shake it. (3) A method for detecting biomolecules, characterized by detecting the solution obtained in (2) using mass spectrometry, fluorescence spectrometry, gene amplification spectrometry and / or immunochromatography. [Effects of the Invention]

[0009] According to the above invention, even if a sample is mailed to a medical institution for testing, biomolecules that reflect health status or disease contained in urine can be detected with high accuracy. [Brief explanation of the drawing]

[0010] [Figure 1] This is a conceptual diagram of urine collection tube 1. [Figure 2] This is a conceptual diagram of a mail-order biomolecule testing service. [Figure 3] This is a comparative diagram showing the use of materials that selectively adsorb biomolecules based on their physical properties and size. [Modes for carrying out the invention]

[0011] Preferred embodiments of the present invention will be described below with reference to the drawings.

[0012] (Embodiment)

[0013] First, the urine collection tube of the present invention will be described. The urine collection tube 1 of the present invention adsorbs biomolecules from urine using an absorbent member made of a material that selectively adsorbs biomolecules to be detected according to their physical properties and / or size. Biomolecules refer to substances that indicate the state of the body or disease, such as viruses and biomarkers.

[0014] The absorbent material 10 is brought into contact with urine (by dropping it onto the urine collection tube 1, impregnation, etc.), and the absorbed urine that has soaked into the absorbent material 10 is used. The absorbed urine may be dried. It is preferable to use the absorbed urine within 14 days, preferably within 5 days, and more preferably within 2 days after urine collection. The means of drying the absorbed urine are not particularly limited. It may be dried in a vacuum dryer. The absorbent material 10 may also be dried by placing it in a sealed container with a desiccant.

[0015] The urinary components measured may be any of the components measured in a standard urine test, such as sugar, protein, occult blood, ketones, urobilinogen, bilirubin, albumin, creatine, creatinine, inulin, urea nitrogen (UN), cystatin C, uric acid (UA), amino acids, hydroxyproline, citrate, oxalic acid, nitrite, phosphate, amylase, lysozyme, N-acetylglucosaminidase, sodium, potassium, chloride, magnesium, calcium, inorganic phosphorus, iron, copper, zinc, manganese, lead, chromium, cadmium, mercury, acetone, methanol, 8-hydroxydeoxyguanosine (8-OHdG), isoplastane, pentosidine, interleukin-6, coproporphyrin, uroporphyrin, porphobi Examples of substances that can be included are linogen, δ-aminolevulinic acid, N-acetyl β-D-glucosaminidase, deoxypyrinolidine, estrone, estradiol, equol, isoflavones, indoxyl sulfate, cortisol, aldosterone, catecholamines, metanephrine fraction, human chorionic gonadotropin (hCG), pregnanediol, pregnanetriol, transferrin, type IV collagen, type I collagen cross-linked N-telopeptide, type II collagen cross-linked C-telopeptide, C-peptide, L-type fatty acid-binding protein (L-FABP), fatty acids, α1-microglobulin, β2-microglobulin, myoglobin, fibrin / fibrinogen degradation products, nicotine, cotinine, cAMP, folic acid, and various vitamins.

[0016] These urinary components are specifically present for each disease to be examined. In this specification, the material of the absorption member 10 is made of a material that selectively adsorbs depending on the physical properties and / or size of the biomolecule to be detected. Representative diseases identified by urine tests, biomolecules, and their classification based on physical properties and size are shown in the following examples, but are not limited thereto.

[0017] 1. Diabetes Urine sugar (glucose) / polar substance, ketone body / non-polar substance, urinary albumin (microalbuminuria) / protein, creatinine / polar substance, C-peptide / protein 2. Kidney diseases (such as chronic kidney disease, acute renal failure, etc.) Creatinine / polar substance, cystatin C / protein, urea nitrogen (BUN) / polar substance, albumin (proteinuria) / protein, β2-microglobulin / protein, sodium / polar substance, potassium / polar substance, chloride / polar substance, red blood cell (occult blood) / cell, uric acid / polar substance 3. Urinary tract infection (UTI) White blood cell (pyuria) / cell, nitrite / polar substance, bacteria / cell, red blood cell (occult blood) in urine / cell, lysozyme / protein 4. Liver diseases (such as hepatitis, cirrhosis, etc.) Bilirubin / polar substance, urobilinogen / polar substance, urinary amino acid / polar substance 5. Bladder cancer Blood in urine (occult blood) / cell, tumor marker in urine (NMP22, BTA) / protein, cytokeratin in urine / protein, hemoglobin in urine / protein 6. Prostate cancer PCA3 (prostate cancer antigen 3) in urine / protein, PSA (prostate specific antigen) in urine / protein 7. Hyperthyroidism Creatinine / polar substance, creatine / polar substance, acetone / non-polar substance, cortisol / polar substance

[0018] Examples of the material of the absorption member suitable for the physical properties and size of the above biomolecules include the materials in Table 1.

Table 1

[0019] 1. Absorbing member 10 when the target substance is a polar substance For example, uric acid and DNA are polar substances. Since polar substances generally have a high affinity for water and other polar solvents, it is preferable that the absorbent material also has the property of efficiently adsorbing polar substances. <Materials> Cellulose is a plant-derived polysaccharide with high hydrophilicity (polarity). It also strongly interacts with water and polar molecules, making it suitable for efficiently adsorbing polar substances. It can quickly absorb water from urine, allowing polar substances to be adsorbed onto the absorbent material. Silica gel has polar groups (silanol groups, Si-OH), giving it a high affinity for polar substances. Coating materials with silica gel or incorporating it into absorbent materials improves the adsorption capacity for polar substances. It can also adsorb polar substances even in a dry state. Silica-based absorbent materials are preferred because they can efficiently adsorb DNA through the interaction between the phosphate groups of DNA and the silanol groups on the silica surface. Glass wool is made primarily of glass fibers composed of silicon dioxide (SiO2), and its surface has hydrophilic silanol groups (Si-OH), allowing it to adsorb a certain amount of polar substances. Due to its hydrophilicity, glass wool readily interacts with moisture and polar substances. <pore diameter> For optimal adsorption of polar substances, a porous absorbent material (absorbent member 10) increases the adsorption surface area, allowing for greater adsorption of polar substances. An absorbent member 10 with a suitable pore size can be selected depending on the molecular size of the target polar substance. For adsorbing large molecules such as DNA, an absorbent material containing silica beads with a porous structure is preferable. <Surface area> The larger the surface area of ​​the absorbent material 10, the more polar substances it can adsorb. Absorbent material 10 with a rough surface or a structure in which fibers are finely intertwined can adsorb more substances. Zeolites are minerals with a porous structure that can efficiently adsorb polar molecules and ions. When the target substance is uric acid, it is preferable to select a zeolite with micropores that are suitable for the molecular size of uric acid. <Coating> By chemically modifying the surface of the absorbent member 10, it is possible to achieve higher adsorption efficiency for specific polar substances. Introducing polar groups such as amino groups and carboxyl groups to the surface of the absorbent member 10 enhances its interaction with polar substances. This allows for more specific adsorption of polar molecules. <Drying ability> If drying is slow, there is a risk that polar substances may be altered or decomposed. Therefore, it is important to quickly dry and store the absorbent material 10 after it has adsorbed polar substances in the urine. Cellulose and silica gel are preferred because they have high hygroscopicity and excellent quick-drying properties.

[0020] 2. Absorbent member 10 when the target substance is a protein <Materials> Nitrocellulose can efficiently adsorb proteins. Nitrocellulose has a strong interaction with the hydrophobic parts of proteins and readily forms hydrogen bonds with protein molecules, resulting in high protein adsorption capacity. Polyamide (nylon) has a balance of hydrophilic and hydrophobic properties and interacts with the hydrophobic parts of proteins. The nylon surface contains amide groups, which allow for hydrogen bonding and hydrophobic interactions with proteins, enabling protein adsorption, separation, and analysis. Hydroxyapatite can utilize its interaction with the phosphate and carboxyl groups of proteins. Nitrocellulose is particularly preferred. <Structure> Because proteins have relatively large molecular sizes, porous materials with a large surface area are suitable. The porous structure of the absorbent material 10 allows for efficient adsorption of proteins. Nitrocellulose membranes are porous and can adsorb protein molecules over a wide area, enabling highly sensitive analysis. Furthermore, because proteins bind uniformly to the nitrocellulose membrane, it is suitable for post-adsorption analysis and detection.

[0021] 3. Absorbing member 10 when the target substance is a nonpolar substance Since nonpolar substances are highly hydrophobic with respect to water and polar solvents, materials with strong hydrophobicity are preferred. For the adsorption of nonpolar substances, it is preferable to focus on hydrophobic interactions. <Materials> Polypropylene (PP) and polytetrafluoroethylene (PTFE) are highly hydrophobic and can efficiently adsorb nonpolar substances. These materials are preferable because they repel water and have strong interactions with nonpolar solvents and substances. Silica gel is available in hydrophobic modified types, and by giving its surface hydrophobic functional groups (e.g., methyl groups or phenyl groups), it can selectively adsorb nonpolar substances. <Structure> Materials with a large surface area and a hydrophobic, porous structure are preferred. Activated carbon has a very large surface area and a hydrophobic, porous structure, and is preferred because it has a high ability to adsorb nonpolar and hydrophobic molecules. The porous structure of silica gel is preferred for the adsorption of nonpolar substances.

[0022] 4. Absorbing member 10 when the target substance is a cell Cells are large in size and have a flexible structure. In order to efficiently adsorb cells, it is preferable that the material of the absorbent member 10 has an appropriate interaction with the cell surface and is flexible enough not to damage the cells. Furthermore, it is preferable that the material of the absorbent member 10 has an appropriate adhesive force to the cells. <Materials> Cellulose is a highly hydrophilic material and readily interacts with the hydration layer on the cell surface. Cellulose membranes with a porous structure are preferable for cell retention. Nylon membranes can adsorb cells through hydrophobic interactions and hydrogen bonding with proteins and other molecules on the cell surface. They have a relatively flexible structure, causing less damage to cells, and are therefore preferable. Polycarbonate membranes have high mechanical strength and permeability, making them preferable for mechanically retaining cells. Hydrophilic materials readily retain cells by interacting with the hydration layer of cells. On the other hand, adsorption is enhanced by interaction with the hydrophobic portion of the cell membrane. Materials with a good balance of these properties are suitable for efficient cell adsorption. Nylon membranes have a good balance and are therefore preferable. Polyester nonwoven fabrics have excellent strength and durability, making them preferable for applications such as filtration and fluid filtration. <Structure> Because cells are relatively large in size, an absorbent material 10 with an appropriate pore size and porous structure is preferable. Flexibility is also required to prevent damage to the cells. The pore size should be selected to suit the size of the cells to be adsorbed. A porous structure with a pore size of 5-10 μm can efficiently adsorb cells such as red blood cells and white blood cells. Providing the surface of the absorbent member 10 with a mesh-like or fibrous structure makes it easier for cells to get caught, which is preferable. The structure of the polyester nonwoven fabric is formed by intertwined fibers and is porous, so it has a large surface area for capturing cells and is therefore preferable as a filter. <Coating> If it is necessary for cells to survive after being adsorbed, the adsorbent should preferably be highly biocompatible. Coating the cells with biomaterials such as collagen or gelatin is preferable as it improves cell survival rates.

[0023] 5. Absorbing member 10 when the target substance is a virus Because viruses are relatively large and possess specific biomolecules and structures on their surface, materials suitable for the polarity and size of the virus are preferable to achieve selective adsorption. <Materials and Structure> Since viruses generally have a size of about 20-300 nm, it is preferable to have nanoscale pore sizes in order to capture viruses. Since the surface of viruses is covered with proteins, it is preferable to have functional groups or chemical modifications that specifically interact with the surface proteins of viruses. Cellulose nanofibers are preferred, and silica nanoparticles that readily interact with the surface proteins and nucleic acids of viruses are preferred. The silica surface may be modified with amino groups or carboxyl groups. Hydroxyapatite is a highly biocompatible material containing calcium and phosphate groups, and is preferred for capturing viruses through binding with the phosphate groups and carboxyl groups contained in the surface structure of viruses.

[0024] As described above, the absorbing member 10 can reliably capture target substances by selecting a material that adsorbs the biomolecules to be detected according to their physical properties and / or size.

[0025] The amount of urine sample used in the present invention is not particularly limited, but if the absorbed urine is to be dried, it is preferably 50 to 500 μL, and particularly preferably 100 to 200 μL. The preparation of the absorbed urine is preferably carried out in such a way that the amount of urine soaked into the absorbent member 10 is constant. The means of soaking the absorbent member with urine is not particularly limited, but for example, the means of dropping urine onto the absorbent member 10 using a dropper or the like, or the means of immersing the absorbent member 10 in urine in a urine cup for a predetermined time can be used.

[0026] In the urine collection tube 1 shown in Figure 1, the absorbent member 10 is placed on a support substrate 11. The support substrate 11 is preferably made of a material with mechanical strength. The absorbent member 10, which determines the presence or absence of biomolecules, is placed on the support substrate 11, and the recognition part 12 is placed downstream of the absorbent member 10, with reference to the direction in which the sample urine unfolds the absorbent member 10. The recognition part 12 may be coated with a known substance that changes color when it comes into contact with moisture. Examples of known substances include cobalt salts. The support substrate 11 to which the absorbent member 10 and the recognition part 12 are fixed is housed in a housing case 20. The housing case 20 is provided with an observation window 22 positioned to allow viewing of the recognition part 12 of the absorbent member 10 fixed to the mounted support substrate 11. The cap 21 fits into the housing case 20, and together with the housing case 20, it sealably houses the absorbent member 10, the recognition part 12, and the support substrate 11.

[0027] The urine sample is immersed in the absorbent material 10 from the upstream side and spreads to the downstream edge by capillary action. The recognition unit 12 located on the downstream side changes color, indicating that an appropriate amount of urine sample has been immersed in the absorbent material 10.

[0028] The absorbent material 10 containing the urine sample is dried as needed. The drying method is not limited, but a method that does not denature the biological components in the urine sample is preferred. It may be dried at room temperature or in lightly heated air as long as the biological components in the urine sample do not denature, or the urine may be frozen once by freeze-drying and then the ice may be directly sublimated in a vacuum, or the urine may be dried by evaporating the water in a vacuum. The urine may also be dried by bringing it into contact with a desiccant to adsorb the water.

[0029] By using silica gel or other desiccants, drying can be performed gently while preventing temperature-induced degradation. Silica gel may be applied inside the housing case 20 and / or cap 21, or it may be coated onto the absorbent member 10.

[0030] A stabilizer to prevent the denaturation of urine may be contained in the housing case 20 and / or cap 21 along with the absorbent member 10. The stabilizer may be an aqueous solution or a dried or freeze-dried aqueous solution. Since the housing case 20 is fitted and sealed with the cap 21, the sample urine and / or stabilizer will not leak outside the fitted housing case 20 and cap 21.

[0031] Any known substance can be used as a stabilizer. Citric acid, oxalic acid, tartaric acid, ascorbic acid, or any combination thereof can be used. Vitamins may also be used as stabilizers.

[0032] As shown in Figure 2, the absorbent member 10, which has been immersed in the urine sample, is placed inside the housing case 20 and cap 21, sealed, and sent to the testing company, where the urine sample is tested. The urine collection tube 1 and the sealed envelope may be included in the package beforehand.

[0033] Preferably, the absorbent member 10 can be selectively replaced depending on the physical properties and / or size of the biomolecule to be detected. As shown in Table 1 above, it is preferable that the most appropriate absorbent member 10 is selected and replaced depending on the polarity, size, etc., of the target substance.

[0034] The urine collection tube 1 may be equipped with multiple absorbent members 10 depending on the physical properties and / or size of the biomolecules to be detected. This allows for situations where a single absorbent member 10 cannot cover all biomolecules depending on their physical properties and / or size. In this case, providing multiple absorbent members 10 includes not only physically providing multiple absorbent members 10, but also arranging multiple absorbent members 10 of different materials on a single support substrate 11, and coating a single absorbent member 10 with a coating agent of a different material.

[0035] The dried absorbent material 10 can be used to extract the analyte with a suitable extraction solvent.

[0036] When redissolving polar substances, nonpolar substances, proteins, cells, and / or viruses adsorbed on the absorbent member 10 in a liquid, it is preferable to select appropriate solvents and conditions according to the characteristics of each substance. The dissolution conditions for each substance are described in detail below.

[0037] <Dissolution of polar substances> Polar substances are generally easily soluble in water and other polar solvents. To redissolve the polar substance adsorbed onto the absorbent material 10, the following conditions should be considered. • Solvent: Polar solvents such as water, ethanol (low concentration), methanol, and acetonitrile are preferred. Temperature: Polar substances dissolve relatively easily even at room temperature, but it is preferable to warm them to around 30-40°C to increase the dissolution rate. • pH adjustment: When polar substances are acidic or basic, it is preferable to adjust the pH of the solvent to promote dissolution. For example, a neutral to weakly acidic solvent is preferable for acidic substances, and a neutral to weakly basic solvent is preferable for basic substances. • Stirring: In order to efficiently dissolve the polar substance on the absorbent member 10, it is preferable to gently stir or shake the solvent.

[0038] <Dissolution of nonpolar substances> Since nonpolar substances are poorly soluble in polar solvents, it is preferable to choose a hydrophobic solvent. • Solvent: Non-polar solvents such as hexane, chloroform, benzene, and diethyl ether are preferred. Low-polarity alcohols (such as isopropanol) can also be used. • Temperature: Although it dissolves at room temperature, it is preferable to heat it to 35-50°C to increase the dissolution rate. Nonpolar substances tend to become more soluble as the temperature rises. • Stirring: It is preferable to promote redissolution in a nonpolar solvent by using stirring or ultrasonic treatment. This allows for efficient dissolution of the nonpolar substance evenly distributed on the absorbent member 10.

[0039] <Protein lysis> Since protein structure depends on pH, temperature, and salt concentration, it is preferable to set conditions accordingly. • Solvent: A physiological buffer (e.g., phosphate buffer (PBS) or Tris-HCl) is preferred. If necessary, a small amount of surfactant (SDS, Triton X-100) may be added to dissolve the hydrophobic protein. • pH adjustment: It is preferable to use a buffer solution with a pH corresponding to the isoelectric point (pI) of the protein. Dissolution can be promoted by setting the pH away from the isoelectric point of the protein (a pH slightly higher or lower than the pI is preferable). Temperature: Generally, a low temperature of 4°C to 25°C is preferable. If the temperature is too high, the protein may denature. • Stirring: While stirring can promote the redissolution of proteins, it is preferable to avoid excessive stirring.

[0040] <Cell Lysis> • Solvent: To dissolve lipids in the cell membrane, the use of surfactants (SDS, Triton X-100) or enzymes (trypsin, protease) is preferable. For the extraction of intracellular components, the use of physiological buffer solutions (such as PBS) is preferable. • Temperature: A temperature of around 37°C is generally preferred for cell lysis. This can enhance the effects of enzymes and surfactants. • Stirring: Gentle stirring or shaking is preferable to increase the dissolution rate. • Lysis buffer: To efficiently lyse cells, it is preferable to use a lysis buffer (RIPA buffer or NP-40 buffer).

[0041] <Virus lysis> When redissolving the virus impregnated in the absorbent material 10 in a liquid, it is preferable to set conditions that allow for the recovery of the virus in an appropriate state without damaging its structure. Since viruses have RNA or DNA as nucleic acids and proteins or lipid membranes on their exterior, it is preferable to redissolve them in a way that does not damage these components, depending on the target to be detected. • Solvent: PBS or Tris-HCl buffer (pH 7.0-8.0) and surfactant (such as Triton X-100 or Tween 20 in concentrations of approximately 0.1-1%) are preferred. pH: Neutral to slightly alkaline (6.8-7.4) is preferred. • Temperature: Processing at low temperatures (4°C to 25°C) is preferable to prevent denaturation of the target substance for virus detection due to high temperatures. • Stirring or shaking: It is preferable to uniformly dissolve the virus by gentle stirring or ultrasonic treatment. • Duration: Stirring should ideally be 10-30 minutes, and ultrasonic treatment 1-5 minutes.

[0042] The solution obtained from the absorbent member 10 is detected using mass spectrometry, fluorescence spectrometry, gene amplification spectrometry, and / or immunochromatography. Mass spectrometry, fluorescence spectrometry, gene amplification spectrometry, and / or immunochromatography can be performed using known methods.

[0043] <Mass spectrometry> Mass spectrometry ionizes molecules in a sample, and from the mass of the detected ions, it is possible to estimate the molecular weight and structural information of the substances contained in the sample. It is used for the identification and quantitative analysis of organic compounds and the structural analysis of proteins.

[0044] <Fluorescence Method> This method involves irradiating a sample with light of a specific wavelength and detecting the light emitted when fluorescent molecules return to a low-energy state, thereby measuring the fluorescence intensity and emission wavelength. It is used for detecting DNA and proteins, analyzing enzyme reactions, and observing intracellular components.

[0045] <Genetic amplification method (PCR)> This method involves amplifying specific sequences of target DNA or RNA to a detectable level. The amplified DNA fragments are then detected using methods such as gel electrophoresis or real-time PCR. It is used in applications such as genetic diagnosis and infectious disease diagnosis.

[0046] <Immunochromatography> This is a rapid analytical technique that detects specific substances in a sample by utilizing the specific binding of antibodies and antigens. As the sample flows through the test strip, specific antigens bind to antibodies and are captured. The captured antigen-antibody complex is visualized on the strip, and the result is determined by the presence or absence of a line. It is used in home pregnancy test kits, rapid influenza diagnostic kits, and other applications.

[0047] There are no limitations on how test results are notified to users. Test results may be encrypted and uploaded to a server. In this case, a barcode or QR code (registered trademark) that can individually identify each urine collection tube 1 may be printed on the urine collection tube 1 in advance. Test results may also be uploaded linked to a barcode or QR code (registered trademark) or other symbol. The testing company may notify the test subject of the test results while keeping the identity of the test subject confidential by publishing a barcode or QR code (registered trademark) that can individually identify each urine collection tube 1 and the completion of the test on the web, etc., or the test results may be notified to the address or email address provided by the test subject.

[0048] Users may obtain inspection results by transmitting symbols such as the aforementioned barcode or QR code (registered trademark) and passwords from their own devices. [Examples]

[0049] The present invention will be described in detail below with reference to examples, but the present invention is not limited in any way to these examples.

[0050] <Detection of daidzein and equol, types of soy isoflavones> Daidzein is a type of isoflavone found in soybeans and possesses a phenolic hydroxyl group (-OH). Because the phenolic hydroxyl group is polar, it readily forms hydrogen bonds, and daidzein in urine is glycoside-formed, giving it polar properties. However, the aromatic ring portion of the molecule is hydrophobic, so the compound as a whole also possesses partially hydrophobic properties, making it a compound with moderate polarity. Equol is a substance produced by the metabolism of daidzein by intestinal bacteria. Equol contains a hydroxyl group (-OH), which gives it polarity. Because equol has a hydroxyl group and can form hydrogen bonds, and because equol in urine is glycoside, it is easily soluble in polar solvents. However, because equol also has an aromatic ring, it exhibits partial hydrophobic properties, making it a compound with moderate polarity.

[0051] <Sample Preparation> A urine collection device was constructed incorporating a cellulose absorbent material measuring 1 cm wide, 8 cm long, and 0.37 mm thick, and a fiberglass absorbent material measuring 1 cm wide, 8 cm long, and 0.48 mm thick. Urine immediately after urination was brought into contact with each absorbent material to impregnate them. The cellulose absorbent material and the fiberglass absorbent material, both impregnated with urine, were left to stand at room temperature for three days before being transported to a testing laboratory. At the testing facility, the absorbent material was transferred to a 15 mL tube, and the components adsorbed onto the absorbent material were extracted with 5 mL of ultrapure water. 125 μL was taken from the extract from the cellulose absorbent material, the extract from the glass fiber absorbent material, and a urine sample collected by a conventional method for comparison. β-glucuronidase solution was added to each sample to a concentration of 85 Unit / mL, and the samples were incubated overnight at 37°C.

[0052] <Mass spectrometry> After incubation, 170 μL of saturated sodium chloride solution and 170 μL of ethyl acetate were added and thoroughly mixed. The mixture was then separated into two layers by centrifugation: an ethyl acetate layer (organic layer) and a saturated sodium chloride aqueous solution (saltwater, polar layer). Since nonpolar or weakly polar components in urine tend to migrate to the ethyl acetate layer, daidzein and equol are extracted into the ethyl acetate layer (organic layer). The ethyl acetate layer was collected in a separate tube, air-dried, and then the ethyl acetate was removed. The residue was redissolved in 30 μL of acetonitrile. Daidzein and equol, types of soy isoflavones, contained in this acetonitrile were analyzed by mass spectrometry.

[0053] <Rating> The peak intensity ratio of observed daidzein and equol (an indicator of equol production capacity) was calculated and compared with the values ​​of urine samples collected using a standard urine collection device. The results are shown in Figure 3. In Figure 3, the values ​​for urine samples collected using a standard urine collection device represent the peak intensity ratio of daidzein and equol in urine samples collected by the conventional method. By comparing this with the peak intensity ratio obtained from urine samples using an absorbent material, it is possible to determine which method more accurately reflects equol production capacity. Even among substances classified as polar, for compounds with moderate polarity such as daidzein and equol, it has been found that glass wool is able to adsorb more of the target substance than cellulose. [Industrial applicability]

[0054] This invention allows for the selective capture of different biomolecules from collected urine depending on the disease, and enables the safe and non-degradable transport of samples by mail, thus having great industrial value. [Explanation of Symbols]

[0055] 1. Urine collection tube 10. Absorbent material 11. Support board 12...Recognition part 13. Absorbent part 20 Housing Cases 21... Cap 22... Observation window

Claims

1. A urine collection tube, Absorbing material, A storage case for housing the absorbent member, Equipped with, The urine collection tube is characterized in that the absorbent member is made of a material that selectively adsorbs biomolecules depending on their physical properties and / or size.

2. The urine collection tube according to claim 1, characterized in that the absorbent member can be selectively replaced depending on the physical properties and / or size of the biomolecule to be detected.

3. The urine collection tube according to claim 1, characterized in that it comprises a plurality of the absorbent members.

4. The urine collection tube according to claim 1, characterized in that the absorbent member is equipped with a recognition unit capable of confirming the amount of absorbed urine.

5. The urine collection tube according to claim 1, characterized in that a stabilizing agent to prevent the degradation of the absorbed urine is contained within the storage case.

6. The urine collection tube according to claim 1, characterized in that the absorbent member is coated with a substance different from the absorbent member.

7. A method for detecting biomolecules impregnated in an absorbent material according to claim 1, characterized by comprising the following steps: (1) A step of immersing the absorbent member in a solvent at a temperature of 3°C to 60°C, (2) A step of letting the absorbent member immersed in the solvent of (1) stand or shake it. (3) A method for detecting biomolecules, characterized by detecting the solution obtained in (2) using mass spectrometry, fluorescence spectrometry, gene amplification spectrometry and / or immunochromatography.

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