JP2007017151A - Filter holder and filter unit for inspection equipped therewith - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a new structure for inhibiting an excessive pressure from acting on a filter holder and on a filter unit for inspection to shorten the time necessary for filtration by decreasing resistance in filtering a diluted specimen solution, etc. while reducing the development of small bubbles acting as an error factor on filtered liquid capacity, as to the filter holder used for clinical examination to efficiently filter a specimen liquid or its diluted solution and as to the filter unit for inspection made by mounting a filter and a specimen container on the filter holder. <P>SOLUTION: This filter holder has a structure allowing the filter to be mounted therein, and this filter is formed as a funnel structure with its inner wall comprising an inward-narrowing tapered part extending from a filter mount part toward a discharge-side end part and a thin tube part while being provided with a plurality of ribs extending toward the tube part on the inner wall of the tapered part. Preferably, a suction-side end part of this filter holder is formed to have a structure mountable in a specimen housing container. In this filter unit for inspection, the filter is mounted in the filter holder and the housing container is mounted on its suction-side end part. <P>COPYRIGHT: (C)2007,JPO&INPIT

Description

  The present invention relates to a novel structure of a filter holder in which a filter can be mounted, and a novel structure of a test filter unit in which a specimen storage container is mounted on the filter holder. The filter holder according to the present invention and a test filter unit equipped with the filter holder are suitably used for filtering a sample liquid or a diluted liquid thereof in a clinical test or the like.

In clinical tests, immunology is to detect specific antigens contained in various specimens such as blood, urine, feces, nasal secretions, sputum, or secretions collected as swab specimens using antigen-antibody reactions. Inspecting methods are widely used. The general method is as follows.
(1) The sample liquid as described above or a diluted liquid thereof (hereinafter collectively referred to simply as “sample diluted liquid”) is used to produce an antibody with a color discriminating substance such as an enzyme, a precious metal colloid, a colored latex, or a dye. Contact with the labeled antibody solution.
(2) By contacting the sample diluent with the labeled antibody solution, the antigen in the sample and the labeled antibody are reacted specifically to form an antigen-antibody immune complex.
(3) The amount of the immune complex is measured visually or as an optical change, and the qualitative measurement or quantitative measurement of the antigen in the sample is performed.

  Various simple diagnostic kits have been developed and marketed as a means for simply and rapidly testing the presence of viral infection, pregnancy determination, morbidity confirmation of cancer diseases, etc. by applying the above-described testing methods. . As an example, a method for diagnosing the presence or absence of influenza virus infection will be described.

The influenza virus belongs to the Orthomyxoviridae family and is a spherical virus having a diameter of 80 to 120 nm. Serologically classified into three types, A type, B type, and C type, it is mainly A type and B type that cause the epidemic in winter in Japan.
Conventionally, symptomatic treatment using antibiotics and anti-inflammatory agents has been performed against influenza. However, in recent years, since antiviral drugs have become applicable, it is necessary to select an appropriate therapeutic agent as soon as possible and administer it to a patient from the viewpoint of treatment and infection prevention. With such a background, the practical use of a reagent kit capable of diagnosing the presence or absence of influenza virus infection has rapidly progressed, and various companies have developed simple diagnostic kits (reagent kits) based on ELISA (enzyme-linked immunosorbent assay). It is commercially available.

As an example of the method of using such a diagnostic kit, the operation procedure of the diagnostic kit previously developed by the present inventors is shown as follows.
(1) Put a cotton swab from a sample in a sample container that contains a predetermined amount of sample dilution, and squeeze it up and down several times while pushing the sample container with your finger. Squeeze out. After stirring, the cotton swab was pulled out while squeezing the cotton ball again to obtain a pretreatment specimen liquid. Attach a filter holder (equipment that holds and holds the filter) with a filter to the sample container that contains this pre-processed sample solution.
(2) Put a fixed amount of the labeled antibody solution in another empty sample container, drop the entire amount of the pretreatment sample solution in (1), attach a new filter holder and invert 5-6 turns. After mixing, leave it at room temperature for about 5 minutes to use as the reaction solution.
(3) This reaction solution is dropped to a fixed line (about 500 μL) of the elliptical hole of the test device, and the reaction solution passes through the reaction membrane in the elliptical hole and waits for the reaction solution to disappear from the reaction membrane.
(4) In the same manner, the cleaning liquid is dropped to a certain line of the elliptical hole (about 500 μL), and the cleaning liquid disappears from the reaction film of the elliptical hole.
(5) When the cleaning liquid disappears from the film, the determination is made based on the reddish purple part appearing at a predetermined position on the test device.

When distinguishing and diagnosing influenza types using such a simple diagnostic kit, specimens to be measured include nasal discharge, nasal wipe, and pharyngeal wipe. These specimens contain mucopolysaccharides, glycoproteins, etc. present in the nasal discharge, nasal cavity and pharynx in addition to the target virus, and often interfere directly or indirectly with the virus measurement.
For this reason, in a clinical test, a conventionally used filter holder having a flat inner base (for example, the one shown in FIG. 2A), a specimen diluent (hereinafter simply referred to as “filter”) after passing through the filter. The direction of the flow path of “liquid” is not made, so that an opposing turbulent flow is likely to occur, and considerable pressure was required for filtration. In addition, since there are a lot of highly viscous mucopolysaccharides and glycoproteins in the sample, the pores of the filter can be easily blocked, and the pressure may increase. In such a case, small bubbles are generated in the filtrate, which may lead to an error in the filtrate volume or difficulty in mixing with the reagent in the next stage.

  The present inventors considered that the above-described problems in specimen filtration in clinical tests could be solved by improving the structure of the filter holder, and as a result of various research and trial production, the present invention was completed. .

  In the entire description of the present invention, the filter holder is an instrument that can mount and hold a filter therein. A filter unit is a unit in which a sample container is attached to a filter holder with a filter built in, and the sample diluent in the sample container can be filtered through the filter. A test filter unit is a test unit. -A filter unit used for diagnosis. Furthermore, in all the descriptions of the present invention, the sample diluent refers to the sample solution or a diluted solution thereof, and the filtrate refers to the sample diluent after passing through the filter.

JP 2001-124775 A Japanese Patent Laid-Open No. 10-192611

In view of the above situation, the present invention efficiently uses a sample diluent in a clinical test using a sample diluent such as blood, urine, feces, nasal fluid, sputum, or secreted fluid collected as a swab sample as a sample. It is an object of the present invention to provide a novel structure of a filter holder that can be filtered and a test filter unit in which a specimen storage container is mounted on the filter holder. More specifically, the present invention reduces the resistance when filtering the sample diluent, thereby reducing the pressure applied more than necessary, reducing the time required for filtration, and causing an error factor in the filtrate volume. It is an object of the present invention to provide a filter holder that can reduce the generation of small bubbles and a structure of an inspection filter unit equipped with the filter holder.
The above problem is to make a quick, accurate and specific determination when measuring the presence or absence of a virus simultaneously on the same membrane, as in the case of influenza A / B influenza measurement reagents by membrane immunoassay using flow-through method. It is an important factor.

  As a result of diligent investigations to solve the above problems, the present inventors have obtained a filter holder for filtering a specimen diluent such as blood, urine, feces, nasal fluid, sputum, or secreted fluid collected as a swab specimen. In addition, the present invention has been completed by finding that the interior of the filter unit for inspection equipped with the same can be efficiently filtered and the generation of small bubbles can be suppressed.

  The above-mentioned problems are as follows. In the test filter unit including the filter holder and the specimen storage container, basically (1) the inner wall on the discharge side after the filter mounting portion of the filter holder is composed of a tapered portion and a thin tube portion. This can be solved by providing a funnel structure and (2) providing a plurality of ribs extending toward the narrow tube portion of the funnel structure in the tapered portion of the funnel structure.

  That is, among the present invention for solving the above-mentioned problems, the invention described in claim 1 of the claims is a structure in which a filter can be installed, and is directed from the filter interior to the end on the discharge side. In this filter holder, the inner wall is formed into a funnel structure composed of a tapered portion and a narrow tube portion, and a plurality of ribs extending toward the narrow tube portion are provided on the inner wall of the tapered portion.

  Among the present inventions, the invention described in claim 2 has a structure in which a filter can be housed, and a tapered portion and a thin tube portion having a constricted inner wall from the filter interior portion toward the discharge-side end portion. In addition, the inner wall of the tapered portion is provided with a plurality of ribs extending toward the narrow tube portion, while the end on the suction side is formed in a structure that can be attached to the specimen storage container. It is a filter holder.

  Of the present invention, the invention described in claim 3 is the filter holder according to claim 1 or 2, wherein one surface is fixed to the inner wall of the tapered portion of the funnel structure, and the other surface is the lower surface of the filter. Further, the other surface is a filter holder provided with a plurality of triangular plate-like ribs having three surfaces that form a flow path connected to the thin tube portion.

  Among the present inventions, the invention described in claim 4 is for a test in which a filter is provided in the filter holder according to claim 2 and 3, and a specimen storage container is attached to an end portion on the inhalation side. It is a filter unit.

  The invention described in claim 5 is the test filter unit according to claim 4, wherein the filter holder and the specimen storage container are detachable.

  Furthermore, the invention described in claim 6 is the test filter unit according to claim 4 or 5, wherein the specimen storage container has a flange for preventing rolling.

  The invention described in claim 7 is the test filter unit according to any one of claims 4 to 6, wherein the specimen storage container is made of a plastic material and can be pressurized by deformation with fingers.

  Further, the invention described in claim 8 is for filtering at least one specimen liquid selected from blood, urine, feces, nasal fluid, sputum, or secreted liquid collected as a swab specimen, or a diluted liquid thereof. It is a filter unit for a test | inspection in any one of Claim 4 to 7 used.

  The invention described in claim 9 is the test filter unit according to any one of claims 4 to 8 used for diagnosis of presence or absence of influenza virus infection.

  The invention described in claim 10 is the test filter unit according to any one of claims 4 to 9, which is incorporated in a diagnostic kit as a diagnostic instrument for the presence or absence of influenza virus infection.

  Since the filter holder according to the present invention has the above-described structure, when the filter is mounted on the sample storage container and used as a test filter unit, the end on the discharge side of the filter holder is a tapered portion. Since the inner wall of the tapered portion is provided with a plurality of ribs extending toward the thin tube portion, the flow path of the filtrate can be divided, Since it flows smoothly, turbulent flow does not occur and filtration can be performed efficiently.

  Therefore, the test filter unit according to the present invention has a low resistance at the time of filtration, and can perform filtration easily and quickly, and therefore, the filtration time can be shortened. In addition, since the pressure applied more than necessary is suppressed and small bubbles are less likely to be generated, it is possible to greatly improve the operability difficulties such as reducing the error in the filtrate volume.

  In addition, the filter holder according to the present invention and the test filter unit in which the filter holder is mounted on the specimen storage container can easily perform the filtration operation when filtering while pressing the specimen storage container with a finger. Individual differences are unlikely to occur, and it is ideal for use in a simple diagnostic kit for testing and diagnosing the presence or absence of influenza infection.

  In addition, when the filter holder according to the present invention is incorporated in a diagnostic kit, it is used when the pretreated specimen is filtered and then reacted with the labeled antibody solution, and when the reaction liquid is filtered and dropped onto the test device. It is very useful because it can be applied to the times, and by using this, anyone can operate the diagnostic kit instrument easily and reliably, and the accuracy of the inspection and diagnosis of the diagnostic kit can be greatly increased.

  Furthermore, since the test filter unit according to the present invention can be applied to the filtration operation of various specimens, clinical tests, in particular, nasal discharge, nasal discharge, sputum, nasal discharge, nasal cavity, pharynx, nasopharynx, etc. Or it is useful in the test | inspection using the secretion etc. which were collected as a swab specimen.

  The present invention can be applied to the filtration of specimen liquid such as blood, urine, feces, nasal secretions, sputum, or secreted liquid collected as a swab specimen, or a diluted liquid thereof. In particular, a method for detecting and distinguishing the presence of human influenza A virus or human influenza B virus using a sample diluent such as a nasal discharge, sputum, or a secreted fluid collected as a swab sample, and therefore It can be applied to the reagent kit.

  As a matter of course, the filter holder of the present invention needs to have a structure capable of securely mounting and holding the filter. In the entire description of the filter holder of the present invention, the side through which the filtrate passes through the filter is referred to as the discharge side, and the side flowing into the filter is referred to as the suction side, centering on the inner wall portion that houses the filter. The end of the filter holder on the inhalation side is not particularly limited, but has a structure that can be attached to the specimen storage container, for example, when a constriction or a screw shape is provided, and the specimen storage container is attached and deformed with fingers and pressurized However, it is preferably formed so as not to be easily detached. Further, the discharge-side end portion of the filter holder is formed in a funnel structure composed of a tapered portion and a thin tube portion. A filter may be provided in the middle of the tapered portion of the funnel structure. In short, a structure in which the filtrate can pass through the tapered portion after passing through the filter may be used. The inclination angle of the taper can be arbitrarily designed according to the properties of the filtrate.

  A plurality of ribs extending toward the thin tube portion are provided on the inner wall of the tapered portion of the filter holder according to the present invention. In other words, the ribs of the tapered portion are arranged radially with respect to the center point of the funnel structure, but are fixed to the inner wall independently of each other without being joined at the center point, It extends toward the part. By providing such a rib, a divided flow path toward the tip of the funnel structure is formed.

  In the present invention, the number of ribs is not particularly limited, but is 3 or more, preferably about 4 to 12, and more preferably about 6 to 8. As an example of the size of the rib, when the inner diameter of the filter holder is 6.6 mm, the length of the surface supporting the filter is about 2.8 mm, assuming that the triangular plate-shaped rib of Example 1 described later is used. The length of the surface that forms the flow path of the filtrate is about 2.4 mm, and the flow path has a diameter of about 1.0 mm reaching the narrow tube portion, that is, the inner diameter of the narrow tube portion, but a slightly larger diameter than that. It is preferred that a flow path be created. However, in the present invention, the number, width, size (height), shape, etc. of the ribs may be arbitrarily designed according to the properties of the filtrate and the size of the filter holder.

  The material of the specimen storage container of the present invention can be appropriately deformed by pressurization with fingers, and there is no particular limitation as long as it is a material and structure that can be appropriately pressurized when filtering the specimen, Preferably, plastic materials such as polyethylene, polypropylene and polystyrene, particularly polyethylene is preferably used. The bending elastic modulus of the plastic material used for the specimen storage container may be appropriately adjusted by a known method. In addition, when the sample storage container is cylindrical, it is preferable to have a collar for preventing rolling.

In addition, there is no restriction | limiting in particular in the material of the filter used by this invention, The member generally used as filter cloth or filter paper, such as a high density polyethylene polymer filter cloth, a glass fiber filter paper, and a cellulose filter paper, may be used. .
Hereinafter, the present invention will be further described by way of examples.

<Structure example of filter holder with 8 ribs>
As an example of the structure of the filter holder according to the present invention, FIG. 1 shows the structure of the filter holder 1 provided with eight ribs. FIG. 1A is a plan view of the filter holder 1, and FIG. 1B is a cross-sectional view thereof.

  The filter holder 1 shown in (2) of FIG. 1 is supplied with sample dilution liquid from above (FIG. 1 (2), “inhalation side”), and is mounted and held in the inner center of the filter router 13 in the center. The filter 2 is passed through and filtered, and the filtrate is sent to the lower side (“discharge side” in the present invention) of FIG. That is, the filter holder 1 has a container mounting part 12 and a funnel structure part 11 that are detachably fitted to a discharge port of a specimen storage container (not shown) in addition to the filter interior part 13. The funnel structure 11 of the filter holder 1 includes a tapered portion 111 formed in a tapered shape immediately confined from the end of the filter interior portion 13 and a narrow tube portion 112 formed in a thin straight pipe. It is configured. Reference numeral 14 denotes a support portion for fitting the filter holder 1 to another device.

  As shown in FIGS. 1 (1) and (2), eight thin triangular ribs 3, 3,... Are attached to the inner wall of the tapered portion 111 of the filter holder 1 while maintaining an even feeling. is there. Each of the ribs 3 is configured such that the side surface on the suction side is in contact with and supports the lower surface of the filter 2 mounted on the filter interior portion 13, and the side surface on the discharge side is at the inlet of the narrow tube portion 112. It ’s like that. That is, eight flow paths through which the filtrate passes through the thin tube portion 112 are formed by the eight ribs 3.

  Next, an operation when the specimen diluent is filtered using the filter holder 1 having the above configuration will be described. A sample diluent discharged from the sample storage container by deforming and pressurizing a sample storage container (not shown) with a finger passes through the container mounting portion 12 of the filter holder 1 and is embedded and held in the filter interior portion 13. When the filter 2 (which is composed of one or several sheets) reaches the interval between the constricted tapered portions 111 constituting the funnel structure, the rib 3. .. flowing through the flow path formed by At this time, the filtrate is formed in a tapered shape with the tapered portion 111 confined, and the flow is directed by the ribs 3, 3. , No large pressure is required, so that no turbulent flow occurs in the filtrate and no small bubbles occur in the filtrate. The filtrate is smoothly discharged out of the filter holder 1 through the narrow tube portion 112. Hereinafter, the present invention will be further described with test examples.

Test example 1

<Passing time confirmation test of filtrate>
(1) Test method As shown in FIG. 2, a filter holder A having a conventional bottom plane structure without ribs, a filter holder B having a conventional bottom plane structure having eight ribs, and the funnel structure of the present invention For the filter holder C (Example 1) provided with eight ribs, the same specimen storage container with the bottom cut out is attached to each of the filter holders C (Example 1) without attaching a filter, and the container 50 has viscosity therein. 2 mL of% saccharose solution was added all at once, and the time required for 2 mL of the liquid to spontaneously fall was measured five times from the moment when the liquid began to be discharged from the outlet of the discharge side thin tube section. The filter area of each filter holder and the inner diameter of the discharge side narrow tube part are the same.

(2) Test results The test results are as shown in Table 1.

(3) Findings From Table 1, it is the filter holder C according to the present invention that has the shortest passage time of the filtrate according to the present invention, that is, the filter holder according to the present invention. It was confirmed that C could flow the filtrate most smoothly. It was also confirmed that the passage time of the filtrate could not be shortened at all by simply providing ribs on the conventional “bottom plane structure filter holder”.

Test example 2

<Confirmation test for easy discharge of filtrate>
(1) Test method Twelve filter holders A (conventional product) and twelve filter holders C (product of the present invention) used in Test Example 1 are prepared, all of which have the same glass fiber filter and porous high density. A polyethylene filter cloth was attached. Since there are three testers A, B, and C, each filter holder is divided into three, and for each tester, filter holder A (conventional product) and filter holder C (present product) Then, four specimen storage containers having the same shape, each containing 2 mL each of physiological saline and specimen diluents 1 to 3 (both nasal discharge), were mounted. Using the test filter unit (FIG. 3) in this state, three persons A, B, and C filtered each specimen dilution and tested for ease of ejection (ease of extrusion).

(2) Test results The test results are as shown in Table 2.

(3) Findings According to Table 2, the test filter unit using the conventional filter holder has determined that it is difficult for two of the three testers to push out the sample diluents 1 and 2. It was confirmed that it was difficult to use. On the other hand, the test filter unit using the filter holder of the present invention can be easily or very easily pushed out by each tester for all of the physiological saline and the sample diluents 1 to 3. It was confirmed that it was extremely easy to use.

Test example 3

<Confirmation test of small bubble generation>
(1) Test method Using the test filter unit used in Test Example 2, and using the same specimen (physiological saline and specimen diluents 4 to 6 (both nasal discharge)) as in Test Example 2, Two of E filtered each specimen and confirmed the appearance of small bubbles.

(2) Test results The test results are as shown in Table 3.

(3) Findings From Table 3, when the specimen diluents 4 to 6 are filtered, the test filter unit using the conventional filter holder has the occurrence of small bubbles in both testers (except for one example). ). Further, when the physiological saline not containing the sample was filtered, small bubbles were observed in the tester D, and it was confirmed that small bubbles appeared frequently in the conventional product. On the other hand, in the filter unit for inspection using the filter holder of the product of the present invention, it was determined that the generation of small bubbles was not recognized by two testers (except for one example). When used, it was confirmed that small bubbles hardly appear.

   As described above in detail, the filter holder according to the present invention and the test filter unit equipped with the filter holder can be applied to the filtration operation of various specimens. Therefore, clinical tests, in particular, blood, urine, feces, nasal fluid, Since tests using secretions collected as sputum or swab samples can be performed efficiently and reliably, confirmation of the presence of various viral infections including influenza virus, judgment of pregnancy, cancer disease It is extremely useful as a means for quickly and reliably inspecting with simple confirmation.

It is the top view and sectional drawing of the filter holder of Example 1. It is explanatory drawing of the structure of the filter holder used in Test Examples 1-3. It is explanatory drawing of an example of the filter unit for a test | inspection of this invention.

Explanation of symbols

1: Filter holder
11: Funnel structure of filter holder 1
111: Tapered portion of funnel structure 11
112: The narrow tube part of the funnel structure 11
12: Container holder of filter holder 1
13: Filter interior of filter holder 1
14: Support part of filter holder 1 2: Filter 3: Rib

Claims (10)

  The filter can be built in, and the inner wall is formed into a funnel structure consisting of a tapered portion and a narrow tube portion from the filter inner portion toward the discharge side end, and the inner wall of the tapered portion Has a filter holder with a plurality of ribs extending toward the narrow tube.   The filter can be built in, and the inner wall is formed into a funnel structure consisting of a tapered portion and a narrow tube portion from the filter inner portion toward the discharge side end, and the inner wall of the tapered portion The filter holder is provided with a plurality of ribs extending toward the narrow tube portion, while the end portion on the suction side is formed in a structure that can be attached to the specimen storage container.   3. The filter holder according to claim 1, wherein one surface is fixed to the inner wall of the tapered portion of the funnel structure, the other surface supports the lower surface of the filter, and the other surface is a flow path continuous to the narrow tube portion. A filter holder provided with a plurality of triangular plate-like ribs having three surfaces forming the surface.   A filter unit for testing, wherein a filter is provided in the filter holder according to claim 2 and a sample container is attached to an end portion on an inhalation side.   The test filter unit according to claim 4, wherein the filter holder and the specimen storage container are detachable.   The test filter unit according to claim 4 or 5, wherein the specimen storage container has a flange for preventing rolling.   The test filter unit according to any one of claims 4 to 6, wherein the sample container is made of a plastic material and can be pressurized by deformation with a finger.   8. The method according to any one of claims 4 to 7, which is used for filtering at least one specimen liquid selected from blood, urine, feces, nasal secretions, sputum, or a secreted liquid collected as a swab specimen, or a diluted liquid thereof. Inspection filter unit.   The test filter unit according to any one of claims 4 to 8, which is used for diagnosis of presence or absence of influenza virus infection.   The test filter unit according to any one of claims 4 to 9, which is incorporated in a diagnostic kit as a diagnostic instrument for the presence or absence of influenza virus infection.

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