WO2006043387A1 - Procede d'inspection immunologique d'un specimen et instrument d'inspection mis en œuvre a cet effet - Google Patents

Procede d'inspection immunologique d'un specimen et instrument d'inspection mis en œuvre a cet effet Download PDF

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Publication number
WO2006043387A1
WO2006043387A1 PCT/JP2005/017273 JP2005017273W WO2006043387A1 WO 2006043387 A1 WO2006043387 A1 WO 2006043387A1 JP 2005017273 W JP2005017273 W JP 2005017273W WO 2006043387 A1 WO2006043387 A1 WO 2006043387A1
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WO
WIPO (PCT)
Prior art keywords
column
specimen
filter
sample
container
Prior art date
Application number
PCT/JP2005/017273
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English (en)
Japanese (ja)
Inventor
Kiichiro Kobori
Michiko Kawamoto
Koji Ushizawa
Katsuhiro Ueda
Original Assignee
Daiichi Pure Chemicals Co., Ltd.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Daiichi Pure Chemicals Co., Ltd. filed Critical Daiichi Pure Chemicals Co., Ltd.
Priority to JP2006542288A priority Critical patent/JPWO2006043387A1/ja
Publication of WO2006043387A1 publication Critical patent/WO2006043387A1/fr

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Classifications

    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/543—Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
    • G01N33/54366—Apparatus specially adapted for solid-phase testing
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/569—Immunoassay; Biospecific binding assay; Materials therefor for microorganisms, e.g. protozoa, bacteria, viruses
    • G01N33/56983—Viruses
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/005—Assays involving biological materials from specific organisms or of a specific nature from viruses
    • G01N2333/08—RNA viruses
    • G01N2333/11—Orthomyxoviridae, e.g. influenza virus

Definitions

  • the present invention relates to an immunological test method for a specimen and a test instrument used in the method. Specifically, the present invention relates to an immunological method for examining an antigen in a sample by a dipstick method, and relates to a column used for the method and a diagnostic kit including the column as a constituent member.
  • specimens such as blood, urine, feces, nasal secretions, sputum, or secreted fluid collected as sputum specimens, and specific antigens contained in these specimens are subjected to an antigen-antibody reaction.
  • Immunological test methods for detection are widely used. The general method is as follows.
  • the sample liquid as described above or a diluted liquid thereof is a color identification substance such as an enzyme, a metal colloid, a colored latex, or a dye.
  • a color identification substance such as an enzyme, a metal colloid, a colored latex, or a dye.
  • the amount of the immune complex is measured visually or as an optical change, and the qualitative or quantitative measurement of the antigen in the sample is performed.
  • Influenza virus is a spherical virus with a diameter of 80 to 120 nm belonging to the Orthomyxoviridae family, and is serologically classified into three types: A type, type A and type C. And have you in the Japan of influenza has become a cause of the epidemic in the winter, is mainly ⁇ type and ⁇ type of in-full E stanza virus n [0005]
  • Conventionally, symptomatic treatment using antibiotics or anti-inflammatory agents has been performed against influenza.
  • antiviral drugs have become applicable in recent years, it is necessary to select appropriate therapeutic agents as soon as possible and to administer them to patients from the viewpoint of treatment and infection prevention. Yes.
  • Patent Document 1 and Patent Document 2 introduce examples of these diagnostic kits.
  • Samples to be measured when differentiating and diagnosing the type of influenza virus using such a diagnostic kit include nasal discharge, nasal wipe, pharyngeal wipe, sputum and the like. These specimens contain mucopolysaccharides and glycoproteins present in the nasal discharge, nasal cavity, and pharynx in addition to the target virus, which may directly or indirectly interfere with virus measurement. is there. Therefore, it is preferable to use a diluted sample solution that has been filtered through a filter before reacting with the labeled antibody. (Hereinafter, the filtered diluted sample solution may be referred to as “sample filtered solution”.)
  • these diagnostic kits include a dipstick type and an immunochromatographic flow type, and there are a plurality of pretreatment work steps such as a sample filtering operation.
  • a sample is collected and examined using a commercially available diagnostic kit, it takes a considerable amount of time (more than 10 minutes) to obtain the result. Therefore, simplification of operation steps and shortening of measurement time are strongly desired so that a test result can be obtained as early as possible.
  • the conventional testing method there is a risk that the diluted sample solution may touch the inspector's hand when contacting the labeled antibody solution with the diluted sample solution or when the diluted sample solution is discharged out of the sample storage container.
  • Patent Document 1 JP 2001-124775 A
  • Patent Document 2 JP 2000-230931 A
  • Non-Patent Document 1 Minoru Kanazawa ⁇ Norio Kajitani “Influenza Medical Manual” Nanedo Co., Ltd. 2 February 20, 001, 1st edition, pages 110-115
  • Non-Patent Document 2 “Clinical Chemistry”, No. 30, pp. 68-71 (2001)
  • the present inventors have aimed to reduce the individual difference when mixing the diluted sample solution and the labeled antibody, and to improve the filtration operation of the diluted sample solution.
  • a cap containing a filter impregnated with is attached to the body of the specimen container containing the diluted specimen liquid, and the specimen filtrate containing the labeled antibody is injected from the specimen container into the test device.
  • a patent application has been filed for the development of a method for examining the presence and type of an antigen in a specimen by observing the reaction (Japanese Patent Application 2003-63832). This test method has the advantages of simple filtration operation and reducing the influence of individual differences among examiners and that the labeled antibody is less likely to aggregate during storage.
  • a solution containing a high concentration of labeled antibody may come out first.
  • the present inventors have incorporated a filter impregnated with a labeled antibody, fitted a sample storage container fitted with a cap, into the injection container, and the sample filtrate passed through the filter is sampled. Once discharged from the storage container into the injection container, the discharged sample filtrate is agitated and mixed in the injection container, and then discharged and injected into the test device from the injection container.
  • a patent application was filed for the development of a method for examining the presence and type of antigens in specimens (Japanese Patent Application No. 2004-55710). This test method is an epoch-making method that enables more accurate diagnosis because the specimen filtrate is made uniform, but there are problems that the number of required containers increases as the number of operation steps increases. . Regardless of the existence of such problems, immunological testing methods using antigen-antibody reactions and instruments used in these methods are always required to be more accurate, simplified, and safe. Yes.
  • the present invention further improves accuracy and simplification and improves safety of an immunological test method for a specimen applying an antigen-antibody reaction and a test instrument used for the test method.
  • a first problem is to provide a method for testing a specimen and a test instrument used for the method. Specifically, the present invention avoids the risk of touching the diluted sample solution or the sample filtrate in clinical tests using the diluted sample solution, and improves the health and safety aspects.
  • the second task is to provide a method for testing specimens and testing instruments used in the testing methods.
  • a third object of the present invention is to provide a specimen testing method and a testing instrument used for the testing method that can prevent an excessive pressure from being applied to the filter and reduce the operation time required for filtration. Is.
  • the present inventors have found that the above problem can be solved basically by adopting a method of filtering the diluted sample liquid without discharging it from the sample storage container. As a result of further research, the method has been found. It was solved by developing a column with a structure that can be adapted to the above.
  • the invention described in claim 1 'Claim 1 is a hollow cylindrical shape in which a filter can be attached to the inside of one tip portion.
  • the immunology of the specimen is such that the outer wall of the tip can be in close contact with the inner wall near the bottom of the specimen storage container. It is a column for use in a physical inspection method.
  • the column of the present invention (also referred to as a separate column) has a hollow cylindrical shape in which a filter can be attached to the inside of one end portion.
  • the column is preferably cylindrical, but is not necessarily limited thereto.
  • the column of the present invention allows the outer wall of the tip to be in close contact with the inner wall near the bottom of the sample container when the filter is inserted into the bottomed cylindrical sample container. It is. With such a configuration, when the column of the present invention is inserted into the sample storage container, the filter attached to the column moves through the diluted sample solution at the same time. The diluted sample solution can be filtered simply by inserting it into the sample storage container.
  • the outer wall of the column is brought into close contact with the inner wall of the specimen storage container as described above, so that the column is fixed without creating a gap between the specimen storage container, and thus it is possible to perform filtration without leakage.
  • the column can be prevented from falling off when the specimen storage container is tilted.
  • the invention described in claim 2 is characterized in that a rib is provided on the outer wall of the tip portion on which the filter is mounted so as to adhere to the inner wall near the bottom of the specimen container. Column.
  • the column of the present invention is provided at the tip of the side where the filter is attached. It is preferable that a rib is provided on the outer wall to adhere to the inner wall near the bottom of the specimen container.
  • a rib is provided on the outer wall to adhere to the inner wall near the bottom of the specimen container.
  • the invention described in claim 3 is a diagnostic kit comprising at least the following members (1) to (4) and used for a method of immunological examination of a specimen.
  • the column and the sample storage container are combined in almost the same shape and the same size.
  • the outer diameter of the column is made almost the same as the inner diameter of the sample container, and the length of the column is made to match the length of the inner method of the sample container, and the column is inserted into the sample container.
  • the front end of the column is inserted to the bottom surface of the sample storage container, the outer wall of the front end of the column and the inner wall near the bottom surface of the sample storage container are in close contact, and the entire column fits perfectly with the inner wall of the sample storage container. It is preferable to be in such a state.
  • the filter is shaped and dimensioned so as to exactly match the inner diameter of the column.
  • the filter can be used as a general filter cloth or filter paper such as polyethylene polymer filter cloth, glass fiber filter paper, cellulose filter paper, etc.! preferable.
  • a plurality of different types of filters can be used, such as a filter made of polyethylene polymer filter cloth, a filter made of glass fiber filter paper, and a filter made of polyethylene polymer filter cloth.
  • a combination of the above may be used to form a multilayer structure.
  • a filter formed by closely fitting the inner diameter of the column with several small protrusions formed on the inner wall of the end of the column with a gap slightly larger than the thickness of the filter is also formed at one end of the column. It may be fitted on the bottom of the column and carried on the small protrusion.
  • the invention described in claim 4 is the diagnostic kit according to claim 3, which is used for inspection and diagnosis of influenza virus.
  • the invention described in claim 5 is the invention according to claim 1 or 2, wherein a filter is attached to one end portion of a bottomed cylindrical sample storage container storing a sample solution or a diluted solution thereof. Insert the column described in (1) into the tip of the one with the filter attached, and bring the outer wall of the tip into close contact with the inner wall near the bottom of the sample storage container. It is characterized by inserting a test dipstick into the column inside the specimen storage container without taking it out of the specimen storage container, observing the reaction, and examining and diagnosing the presence and type of antigen in the specimen. This is an immunological test method for specimens.
  • the column according to claim 1 or 2 is mounted on a bottomed cylindrical sample storage container storing a diluted sample solution, and the filter of the column is mounted. Insert the sample from the tip of the sample container, bring the outer wall of the tip into close contact with the inner wall near the bottom of the sample container, and take out the diluted sample solution filtered by inserting the filter (i.e., the sample filtrate) out of the sample container. By inserting a test dipstick into the sample container (column) and observing the reaction, the risk of touching the diluted sample solution and sample filtrate is avoided, and the filter is used. Since more pressure than necessary is not applied, the time required for filtration can be shortened compared to the conventional method, and thus the time required for inspection can be shortened.
  • the filter i.e., the sample filtrate
  • the test method according to claim 5 is a method of performing an immunological test of a specimen by a dipstick method using a test tool set including the column of the present invention as a constituent member.
  • the dipstick used here is usually used for specimen immunological tests or clinical tests, and the test and diagnosis method is the same as the test method used in normal sample tests.
  • the invention described in claim 6 is the immunological test method for a specimen according to claim 5, wherein the antigen in the specimen is influenza virus.
  • the diluted sample liquid can be filtered simply by inserting the column of the present invention into the sample storage container storing the diluted sample liquid. Therefore, it is possible to easily perform the filtering operation without having to press the sample storage container containing the diluted sample solution for filtering the diluted sample solution. In addition, since no extra pressure is applied to the filter, the time required for filtration can be shortened, and thus the time required for inspection can be shortened. In addition, since the test method of the present invention can filter the diluted sample solution without taking it out of the sample container, there is no risk of the diluted sample solution or sample filtrate coming into contact with the hand of the examiner, which is unsafe for health and safety.
  • the combination of the column and the sample storage container according to the present invention is very convenient because it can be applied to all dipstick type inspection methods.
  • the test method of the present invention can be applied to many clinical tests, including testing and diagnosis for the presence or absence of influenza infection, and the test method can be further refined and simplified, and the safety of the test method can be improved. It can further improve sexuality and hygiene.
  • the column of the present invention Since the column of the present invention has the above-mentioned configuration, the method of use is simple, and it is optimal for use in a diagnostic kit for examining and diagnosing the presence or absence of various virus infections.
  • the specimen testing method according to the present invention and the testing instrument incorporating the column of the present invention used in the testing method are clinical specimens such as blood, urine, feces, nostrils, nasal cavity, pharynx * nasopharynx It is useful for immunological examination of various specimens such as nasal secretions, nasal aspirates, sputum, or secretions collected as sub-specimens, etc., and for infectious diseases such as influenza virus And can be suitably used for emergency emergency inspections. In particular, it is very useful as an inspection method and an inspection instrument for detecting and distinguishing the presence of human influenza A virus or human influenza B virus in a short time.
  • FIG. 1 is an explanatory diagram of an example of a column of the present invention.
  • FIG. 2 is an explanatory diagram of a method for inserting the column of the present invention into a specimen storage container. (Example 1 ⁇ Example 2)
  • FIG. 3 is an explanatory view of an example of the inspection method (dipstick type inspection method) of the present invention using the column of the present invention. (Example 2)
  • FIG. 4 is an explanatory diagram of an example of an immunochromatographic flow inspection method. (Reference Example 1)
  • FIG. 1 is an explanatory diagram of an example of the column of the present invention
  • FIG. 2 is an explanatory diagram of a method for inserting the column of the present invention into a specimen storage container.
  • FIG. 3 is an explanatory diagram showing an example of the inspection method (dipstick type inspection method) of the present invention using the column of the present invention.
  • Fig. 4 is an explanatory diagram of the inspection method using the immunochromatographic flow method as a reference example.
  • 1 is a hollow cylindrical column with polyethylene force
  • 11 is The bottom tip
  • 12 is the top tip.
  • the column 1 of the present embodiment is formed in a slightly tapered shape by directing force from the top tip 12 to the bottom tip 11, but the outer diameter of the tip 11 is the bottom surface of the specimen container 3.
  • the length of the entire column 1 is the same as the length of the internal method of the sample container 3.
  • the column 1 is provided with a flange-like rib 14 on the outer wall of the tip 11 so as to be integrally formed. Therefore, the column 1 can be easily adhered to the inner wall near the bottom of the specimen container 3 by the rib 14.
  • filter 2 glass fiber filter paper sandwiched between two polyethylene polymer filter cloths
  • Reference numeral 13 denotes a small hole provided above the column 1 for venting air. As described above, it is convenient to provide the small hole 13 above the column 1 because the column 1 can be inserted into the sample container 3 with the top 12 of the column 1 covered. .
  • Fig. 2 (i) 3 is a polyethylene-bottomed cylindrical specimen storage container containing diluted specimen liquid a
  • 31 is a cap mounting part
  • 32 is a collar part
  • 33 is This is a container for diluted sample liquid.
  • the sample liquid is extracted by inserting the cotton swab 4 containing the sample liquid into the sample storage part 33 of the sample storage container 3 in which the extraction liquid for dilution has been put in advance, and then the sample storage container Push 3 with your finger and pull the cotton swab 4 while rubbing the cotton ball, and stir to make a diluted sample solution a in which the sample solution and the extract are mixed.
  • FIG. 2 (C) shows the state of the sample container 3 after the column 1 is inserted into the sample container 3.
  • both the column 1 and the specimen container 3 are made of polyethylene.
  • the column and the specimen storage container of the present invention are not limited to polyethylene.
  • the column or diagnostic kit of the present invention is intended to filter the diluted sample liquid in the sample storage container by lowering the tip of the column to the bottom surface of the sample storage container.
  • the material of the column and the specimen container can be selected as appropriate.
  • the material of the sample container may be any material that can perform the filtration in the above manner! Specific examples when selecting each material are as follows. For the column, a flexible material is preferred.
  • a plastic-based resin material such as polyethylene, polystyrene, polypropylene, PET, and ABS may be appropriately selected.
  • the sample container since it is necessary to squeeze out the force sample liquid such as a cotton swab, it has a squeeze property and can be appropriately deformed by pressurization, such as polyethylene, polypropylene, silicon rubber.
  • a resin material such as a thermoplastic elastomer or a salty mulberry is preferably used.
  • the elastic modulus of the plastic material may be appropriately adjusted by a known method.
  • the force provided with the small hole 13 above the column 1 is convenient if the small hole 13 is provided, but is provided for the purpose of venting and adjusting the column insertion speed. It is not always necessary. Further, the buttock 32 of the sample container 3 is not necessarily required.
  • the column 1 of the present embodiment is formed in a slightly tapered shape by directing force from the top tip 12 to the bottom tip 11, and rib-like ribs 14 are formed on the outer wall of the tip 11 in the column.
  • the column of the present invention is not limited to such a shape.
  • the outer wall of the tip of the column (the one to which the filter is attached) can be removed by any means. Any material that can be in close contact with the inner wall of the container is acceptable.
  • the column and the sample storage container are cylindrical, but it is not necessarily required to be cylindrical as long as the outer wall of the column and the inner wall of the sample storage container can be in close contact with each other.
  • the column and the specimen container may be in the shape of a square tube or a semi-cylinder.
  • Example of dipstick inspection method using the column of the present invention Using the column 1 of Example 1 (with the filter 2 of Example 1 attached), the sample was inserted into the specimen container 3 in the same manner as in Example 1, and the diluted specimen liquid a was filtered to obtain the specimen filtrate. got a '.
  • the dipstick X was inserted into the column 1 inserted into the sample container 3 and the reaction was observed as shown in FIG. 3 where the sample filtrate a ′ was taken out.
  • FIG. 3 shows a state where the device is trying to insert the device D into the column 1 inside the sample container 3 containing the sample filtrate a '.
  • the state after insertion is shown.
  • the specimen filtrate a ′ gradually permeates from the tip of the dipstick X and displays the required data. This operation is not different from the usual dipstick type inspection method, but it will be explained below by taking the influenza virus inspection method as an example.
  • the antigen in the sample filtrate a ′ is the sample pad of the dipstick.
  • the conjugate pad to form a complex with the colloidal gold-labeled antibody, move to the membrane, and fix the anti-influenza A antibody, anti-fluenza B antibody or anti-mouse IgG antibody immobilized on the membrane. Bind specifically. Excess liquid is absorbed by the end pad. If there is an influenza antigen, a red-purple line is observed at a predetermined part of the dipstick, so that the presence or type of the antigen can be differentiated and diagnosed.
  • the diluted sample liquid a can be easily filtered simply by inserting the column 1 into the sample storage container 3 storing the diluted sample liquid a. Therefore, there is no need to press the specimen container 3 containing the diluted specimen liquid a for filtration of the diluted specimen liquid a, and no extra pressure is applied to the filter 2, so the test can be performed easily. In addition, the time required for inspection can be shortened. In addition, in this embodiment, the diluted specimen liquid a can be filtered without exiting the specimen storage container 3 and the specimen filtrate a ′ can be retained in the specimen storage container 3 without exiting. It is possible to carry out a test without worrying about the safety and health aspects that a or the specimen filtrate a 'may touch the hands of the inspector.
  • the diluted sample solution a is stored in the sample storage container 3 in the same manner as in Example 1.
  • the cap mounting portion of the sample container 3 containing the diluted sample liquid a is attached to the cap mounting portion 5 having the nozzle 52 having the small hole 51 at the tip (the filter 2 used in Example 1 is mounted). ), Press the specimen container 3 with your finger with the small hole 51 facing down, and drop a few drops of the sample filtrate a ′ from the small hole 51 onto the test device Y.
  • (I) of FIG. 4 shows a state in which the cap 5 is attached to the sample container 3.
  • 4 (mouth) shows a state in which the sample filtrate a ′ is dripped onto the test device Y from the sample container 3 through the filter 2 attached to the cap 5.
  • Subsequent operations are not different from the operation of the test cell ⁇ chair in the usual immunochromatographic flow type inspection method, but will be explained as follows, taking the influenza virus inspection method as an example.
  • the test device Y of this reference example drops the specimen filtrate a 'into the sample drop opening on the surface, and the antigen in the specimen filtrate a' After passing through the sample pad, it reacts with the gold colloid-labeled anti-influenza A mouse antibody or gold colloid-labeled anti-influenza B mouse antibody at the conjugate pad to form a complex and move on the membrane.
  • This complex is observed as a red-purple line when bound to an anti-influenza A antibody or anti-influenza B antibody immobilized on a membrane.
  • surplus gold colloid-labeled anti-influenza A mouse antibody or gold colloid-labeled anti-influenza B mouse antibody binds to anti-mouse IgG antibody immobilized on the membrane and is observed as a red-purple control line .
  • a red-purple line is observed at a predetermined part of the test device, so that the presence or type of the antigen can be differentiated and diagnosed.
  • a gold colloid-labeled antibody mixed solution in which colloid-labeled antibody was mixed and produced was prepared.
  • Tween20 Kishida Chemical
  • the application interval and the application amount may be determined in consideration of the visibility after reaction of each antibody. It is also possible to select a mixture of human influenza A and B antigens instead of antibodies against anti-mouse IgG.
  • Optimum amounts of anti-influenza A mouse antibody, anti-influenza B mouse antibody and anti-mouse IgG antibody were applied as a line to a predetermined location of the test device on a membrane meeting the selected flow rate conditions.
  • the shape to be applied can be any shape, and the application interval and the application amount were determined in consideration of the visibility after the reaction.
  • the opening (sample dropping part) for dropping the specimen filtrate may be any of a circle, an ellipse, a long rectangle, a diamond, a trapezoid, and the like.
  • a mixture of human influenza A and B antigens may be selected in place of the antibody against anti-mouse IgG.
  • sample dilution extract e.g., the extract shown in Reference Example 2
  • a glass fiber filter paper was placed on top and bottom of a polyethylene polymer filter cloth to form a filter.
  • A. Inspection method of the present invention dipstick type
  • Example 1 Insert the column used in Example 1 (equipped with the filter of Example 1) into the sample container (Example 1) containing the diluted sample solution, and the same as in Example 1 Method
  • the sample filtrate was prepared in the sample container, and the dipstick prepared in Reference Example 2 was inserted into the column inside the sample container by the test method of Example 2, and the reaction was observed.
  • Table 1 Table 1
  • the inspection method of the present invention has high accuracy and the same accuracy as the lateral flow inspection method shown as a reference example.
  • the time required for the test was measured and compared for the immunochromatographic flow test method. That is, in the test method of the present invention, the time required from the start of the preparation of the diluted specimen solution to the insertion of the dipstick is measured. In the immunochromatographic flow type test method, the preparation of the diluted specimen solution is started. The time required until 5 drops of the diluted sample solution was completely dropped on each cell was measured. As for the measurement method, five panelists (all of them were inexperienced in immunological testing methods of specimens) were selected for each test method, and both tests were performed, and the required time was measured. [0053] (2) Test results
  • Table 4 shows the test results obtained by the inspection method of the present invention
  • Table 5 shows the test results obtained by the immunochromatographic flow inspection method
  • Table 6 shows the average time required for each test method.
  • the specimen testing method according to the present invention and the testing instrument used for the method are clinical tests such as blood, urine, stool, nostril, nasal cavity, pharynx, nasopharynx, etc. It is useful for immunological examination of various types of specimens such as fluid, nasal aspirate, sputum, or secreted liquid collected as a specimen, for example for infectious diseases such as influenza virus and simple emergency tests. Suitable for use. In particular, it is very useful as a method for detecting and distinguishing the presence of human influenza A virus or human influenza B virus in a short time, and a test instrument used in the method.

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Abstract

L'invention concerne une colonne destinée à être utilisée dans un procédé d'inspection immunologique d'un spécimen disposée de façon à ce que, lorsqu'une colonne tubulaire creuse possédant une extrémité distale pouvant fixer un filtre à l'intérieur est insérée dans un réceptacle de spécimen tubulaire avec fond depuis l'extrémité distale pour fixer un filtre, la paroi extérieure au niveau de l'extrémité distale peut toucher de manière très ajustée la paroi intérieure située au voisinage du fond du réceptacle de spécimen. La trousse de diagnostic ci-décrite est constituée de quatre éléments, à savoir d'au moins la colonne, un réceptacle de spécimen tubulaire avec fond disposé de façon à ce que l'extrémité distale de la colonne utilisée pour fixer un filtre puisse toucher de manière très ajustée la paroi intérieure située au voisinage du fond, un filtre pouvant être fixé à l'intérieur de la colonne au niveau de l'extrémité distale de celle-ci, et une bandelette réactive d'inspection pouvant être insérée dans le réceptacle de spécimen. Le procédé ci-décrit permet d'observer une réaction à la bandelette réactive d'inspection insérée dans la colonne à l'intérieur du réceptacle de spécimen sans enlever le diluant de spécimen, filtré en insérant le filtre à l'extérieur du réceptacle de spécimen, en insérant la colonne depuis l'extrémité distale fixée avec le filtre de façon à ce que l'extrémité distale touche de manière très ajustée la paroi intérieure située au voisinage du fond du réceptacle de spécimen. La présente invention est employée de manière appropriée dans l'inspection et le diagnostic du virus de la grippe.
PCT/JP2005/017273 2004-09-28 2005-09-20 Procede d'inspection immunologique d'un specimen et instrument d'inspection mis en œuvre a cet effet WO2006043387A1 (fr)

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JP2006542288A JPWO2006043387A1 (ja) 2004-09-28 2005-09-20 検体の免疫学的検査方法及びその方法に用いる検査器具

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JP2004281513 2004-09-28
JP2004-281513 2004-09-28

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JP2010038797A (ja) * 2008-08-06 2010-02-18 Sumitomo Bakelite Co Ltd 検体採取用容器及び検査キット
JP2010526297A (ja) * 2007-04-30 2010-07-29 ナノゲン・インコーポレイテッド 多分析物アッセイ
JP2013053869A (ja) * 2011-09-01 2013-03-21 Furukawa Electric Co Ltd:The イムノクロマトグラフィー用試験キット、これを用いた検出方法及びこれに用いられる標識試薬
JP2016195614A (ja) * 2010-11-24 2016-11-24 株式会社カネカ 増幅核酸検出方法及び検出デバイス
JP2018059776A (ja) * 2016-10-04 2018-04-12 メディカテック株式会社 採便容器、および、便検査装置
US10392652B2 (en) 2013-11-22 2019-08-27 Kaneka Corporation Micro RNA detection method using two primers to produce an amplified double stranded DNA fragment having a single stranded region at one end
WO2024090518A1 (fr) * 2022-10-28 2024-05-02 東洋紡株式会社 Éprouvette immunochromatographique

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JPH04231874A (ja) * 1990-05-25 1992-08-20 Becton Dickinson & Co 固相ウレアーゼイムノアッセイのための基質組成物及び方法
JPH09510774A (ja) * 1993-12-16 1997-10-28 アプライド リサーチ システムス エー アール エス ホールディング エヌ ヴイ サンドイッチ分析用センサ装置
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JPH11501732A (ja) * 1995-06-07 1999-02-09 ビエックス インコーポレイテッド 流体採集用のキット及び方法

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2010526297A (ja) * 2007-04-30 2010-07-29 ナノゲン・インコーポレイテッド 多分析物アッセイ
JP2010038797A (ja) * 2008-08-06 2010-02-18 Sumitomo Bakelite Co Ltd 検体採取用容器及び検査キット
JP2016195614A (ja) * 2010-11-24 2016-11-24 株式会社カネカ 増幅核酸検出方法及び検出デバイス
US9920356B2 (en) 2010-11-24 2018-03-20 Kaneka Corporation Amplified nucleic acid detection method and detection device
JP2019080581A (ja) * 2010-11-24 2019-05-30 株式会社カネカ 増幅核酸検出方法及び検出デバイス
US10829805B2 (en) 2010-11-24 2020-11-10 Kaneka Corporation Amplified nucleic acid detection method and detection device
JP2013053869A (ja) * 2011-09-01 2013-03-21 Furukawa Electric Co Ltd:The イムノクロマトグラフィー用試験キット、これを用いた検出方法及びこれに用いられる標識試薬
US10392652B2 (en) 2013-11-22 2019-08-27 Kaneka Corporation Micro RNA detection method using two primers to produce an amplified double stranded DNA fragment having a single stranded region at one end
JP2018059776A (ja) * 2016-10-04 2018-04-12 メディカテック株式会社 採便容器、および、便検査装置
WO2024090518A1 (fr) * 2022-10-28 2024-05-02 東洋紡株式会社 Éprouvette immunochromatographique

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