KR102503011B1 - test kit - Google Patents

Abstract

An object of the present invention is to provide a test kit capable of reliably determining the presence or absence of a substance to be detected. In the test kit 11 of the present invention, a sample dropping pad 31, a labeling material holding pad 41, and an immobilization membrane 51 are connected in this order, and the dropped liquid sample is sequentially spread toward the immobilization membrane 51 to be detected on the immobilization membrane 51. A test kit equipped with a test strip 21 for detecting a substance, wherein the test strip 21 has a portion where at least a portion of the labeling substance holding pad 41 and a portion of the immobilization membrane 51 overlap each other, and is orthogonal to the spreading direction of the liquid sample at this portion. It is provided with a pressurizing portion 910 for pressurizing a part of the direction, and is a basin in which the liquid sample spreads in the immobilized membrane 51, other than the basin R immediately below the portion pressed by the pressurized portion 910 in which the liquid sample spreads. It is possible to confirm the detection of the substance to be detected from the outside in the watershed P.

Description

test kit

The present invention relates to a test kit.

As a device for collecting a sample such as saliva and determining whether or not the sample contains a substance to be measured, such as bacteria or viruses, an immunochromatography device is disclosed (for example, Patent Document 1 reference).

The apparatus inserts a test strip composed of a sample adding member, a sign holding member, a chromatographic membrane carrier, etc. into a case to supply the sample dropped into the sample adding member to the label holding member, and avoids colored particles (marker substances) to be the label. After binding to the substance to be measured, the presence or absence of the substance to be measured is visually determined by whether or not it is captured and accumulated by the antibody immobilized on the membrane carrier for chromatography.

In this apparatus, protrusions are formed on opposite portions of a pair of cases sandwiching test strips, and the sample-adding member sign-holding member is brought into close contact with the convex portion so that the sample dropped on the sample-adding member is placed on the label-holding member. is efficiently supplied, and the labeling substance can be bound to the substance to be measured reliably.

[Prior art literature]

[Patent Literature]

<Patent Document 1> Publication No. 2005-37384

However, in the conventional apparatus as described above, a large amount of the labeling substance held in the labeling substance holding member can develop in a large amount at once in the chromatographic membrane carrier. Therefore, when a large amount of the above development occurs, there is a tendency to misunderstand the coloring of this large amount of the labeling substance as being captured by the antibody on the chromatographic film alone, and even though the substance to be measured does not exist, it seems to exist. There is a risk of misjudgment.

The present invention has been made in accordance with the above circumstances, and its object is to provide a diagnostic kit capable of reliably determining the presence or absence of a substance to be detected (substance to be measured).

the present invention

(1) a sample loading pad for dropping a liquid sample containing a substance to be detected, and a pad for holding a labeled substance impregnated with a labeling substance that selectively binds to the substance to be detected and becomes a label; An immobilization membrane having an immobilization substance for immobilizing a substance to be detected is connected in this order so that the dropped liquid sample is sequentially developed toward the immobilization membrane, and a test strip for detecting the substance to be detected on the immobilized membrane is provided. It is a test kit,

The test strip has a region where at least a portion of the labeling material holding pad and a portion of the immobilization membrane overlap each other;

A pressurizing unit for pressing a part of a direction orthogonal to a direction in which the liquid sample expands at the overlapping portion,

It is a basin in which the liquid sample of the immobilization membrane develops, and is a basin other than the basin in which the liquid sample directly under the portion pressed by the pressurizing part develops, and the detection of the substance to be detected can be confirmed from the outside. testing kit

(2) The test kit according to (1) above, in which the pressing part is arranged to press both ends in a direction orthogonal to the direction in which the liquid sample spreads to the overlapping portion.

(3) The labeling substance holding pad has a portion containing a labeling substance and a portion adjacent to the containing portion and not containing the labeling substance, and the sample dropping pad and the non-containing portion are connected; , the test kit according to (1) or (2) above, wherein at least a part of the containing portion is connected to the immobilized membrane

(4) The test kit according to (1) or (2) above, wherein the overlapping portion has a structure in which at least a part of the sample dropping pad, a part of the labeling material holding pad, and a part of the immobilization membrane are laminated in this order,

(5) the first case;

Providing a second case disposed to face the first case through a test strip and sandwiching the test strip;

A test kit installed in the first and/or second case so as to press a part of a direction orthogonal to the direction in which the liquid sample spreads to the portion where the pressing part overlaps

(6) a window for confirming the detection of a substance to be detected from the outside;

The above (5), wherein the window portion is a portion facing the immobilized membrane of the first and/or second case, and is disposed at a portion facing a basin other than the basin directly below the basin in which the liquid sample flowing out from the region pressurized by the pressurization unit develops. The test kit described in and

(7) a sample dropping pad for dropping a liquid sample containing a substance to be detected; a pad for holding a labeled substance impregnated with a labeling substance that selectively binds to the substance to be detected and becomes a label; An immobilization membrane having an immobilization substance for immobilizing a substance to be detected is connected in this order so that the dropped liquid sample is sequentially developed toward the immobilization membrane, and a test strip for detecting the substance to be detected on the immobilized membrane is provided. As a method for detecting a substance to be detected using a test kit,

The test strip has a region where at least a portion of the labeling material holding pad and a portion of the immobilization membrane overlap each other;

A pressurizing unit for pressing a part of a direction orthogonal to a direction in which the liquid sample expands at the overlapping portion,

In the immobilized membrane, the detection of the substance to be detected is confirmed from the outside in a watershed other than the watershed in which the liquid sample develops, which is a watershed in which the liquid sample develops and is directly under a portion further pressurized by the pressurizing part. How to

It is about.

In addition, in this specification, "test strip" means a series of members composed of a sample dropping pad, a labeling material holding pad, an immobilizing membrane, and the like, through which a liquid sample normally flows. In addition, "a watershed other than the watershed in which the liquid sample expands immediately below the portion pressed by the pressing part" means, for example, as shown in FIG. 3 , in the expansion direction of the liquid sample etc. It means the region P within the immobilized membrane 51 other than the region R (shaded hatched portion) in plan view within the region pressed by the pressurizing portion 910) and the immobilized membrane 51 located directly below (downstream of) this region. . In Fig. 3, L1 indicates the width of the space R, L2 indicates the width of the region P, and L3 indicates the width of the window 915 based on their respective positional relationships. In addition, the 'window' is a concept that includes both a through hole that is physically opened and a site where the presence or absence of a substance to be detected can be observed or detected from the outside through a predetermined member.

In addition, in this specification, "sample loading pad" and "labeling substance holding pad" are only functional divisions, and do not necessarily have to be constituted by separate members for each function. For example, in the present specification, a "sample dropping pad" and a "labeling material holding pad" are impregnated with a labeling material that selectively binds a liquid sample containing a detection material to an area where a liquid sample is dropped and to the detection material and is marked. It is a concept that includes an integral member having a closed area.

In addition, in this specification, "at least a part of the labeling material holding pad and a part of the immobilization membrane overlap each other" is not limited to a form in which the labeling material holding pad and the immobilization membrane directly overlap each other, but the labeling material holding pad and the immobilization membrane It is a concept that includes forms overlapping each other through other members different from these members.

The present invention can provide a diagnostic kit capable of reliably determining the presence or absence of a substance to be detected.

1 is a schematic longitudinal sectional view showing a first embodiment of the present invention.
FIG. 2 is a schematic plan cross-sectional view of FIG. 1 .
Figure 3 is a partially enlarged schematic plan cross-sectional view for explaining the window portion of the present invention.
Fig. 4 is a schematic plan view showing a modified example of Fig. 2;
5 is a schematic longitudinal sectional view showing a second embodiment of the present invention.
Fig. 6 is a schematic plan view of Fig. 5;
7 is a schematic longitudinal sectional view showing a third embodiment of the present invention.
Fig. 8 is a schematic plan view of Fig. 7;

< Test kit >

The test kit of the present invention includes a sample loading pad for dropping a liquid sample containing a substance to be detected, a pad for holding a labeled substance impregnated with a labeling substance that selectively binds to the substance to be detected and becomes a label, and the labeling substance. An immobilization membrane having an immobilization substance for immobilizing the bound substance to be detected is connected in this order, and the dropped liquid sample is sequentially spread toward the immobilization membrane to form a test strip for detecting the substance to be detected on the immobilized membrane. A test kit equipped with, wherein the test strip has a portion where at least a portion of the labeling material holding pad and a portion of the immobilization membrane overlap each other, and presses a portion of a direction orthogonal to a direction in which the liquid sample spreads at the overlapping portion. A pressurizing unit is provided, and the liquid sample of the immobilized membrane is spread, and the liquid sample is spread in a region other than the liquid sample directly below the portion pressed by the pressurizing unit. It is characterized by being verifiable.

Next, the first to third embodiments of the test kit will be described with reference to the drawings, but the present invention is not limited only to the embodiments described in the drawings.

[First Embodiment]

1 is a schematic longitudinal sectional view showing a first embodiment of the present invention. 2 is a schematic plan view of FIG. 1 . As schematically shown in FIGS. 1 and 2 , the test kit 11 includes a test slip 21 and a backing sheet 71 having a sample loading pad 31, a labeling material holding pad 41, an immobilization membrane 51 and an absorbent pad 61; It is composed of a case 81 and a second case 91.

In the test strip 21, a sample dropping pad 31, a labeling material holding pad 41, an immobilization membrane 51, and an absorption pad 61 are connected in this order so that the dropped liquid sample sequentially spreads toward the immobilization membrane 51 while passing through the immobilization membrane 51. Detect the target substance.

The sample dropping pad 31 is a member on which a liquid sample containing a substance to be detected is dropped. The sample dropping pad 31 is provided with a dropping portion 31a for dropping a liquid sample. The sample loading pad 31 is formed of a material with a large gap and low water absorption compared to the labeling substance holding pad 41 and the immobilization membrane 51 described later. Examples of the material constituting the sample dropping pad 31 include nylon, polyether sulfone, polyvinyl alcohol, polyester, glass fiber, polyolefin, cellulose, or a non-woven fabric formed of these mixed fibers. In addition, there are antigens, such as influenza virus, etc. as a substance to be detected, for example.

The labeling substance holding pad 41 is a member impregnated with a labeling substance that is labeled by selectively binding to a substance to be detected. The labeling material holding pad 41 is in contact with the sample dropping pad 31 via the interface k11 on the upstream side of the liquid sample spreading direction, and includes a protrusion 912 provided on the second case 91 and a protrusion 812 provided on the first case 81, which will be described later. , and is further pressed along the entire width direction of the test strip 21 (a direction orthogonal to the direction in which the liquid sample spreads) along these projections 812 and 912 . The labeling material holding pad 41 receives the liquid sample loaded on the sample loading pad 31, mixes the liquid sample with the labeling material stored in the labeling material holding pad 41, and binds the antigen and antibody by antigen-antibody reaction. do. In this embodiment, the labeling material is uniformly impregnated throughout the labeling material holding pad 41 .

Compared to the above-mentioned sample dropping pad 31, the labeling substance holding pad 41 is formed of a material with finer spacing and higher absorbency. In this way, the liquid sample can be reliably transferred from the sample dropping pad 31 to the labeling material holding pad 41 . Examples of the material constituting the marking material holding pad 4 1 include nylon, polyether sulfone, polyvinyl alcohol, polyester, glass fiber, polyolefin, cellulose, or a non-woven fabric formed of these mixed fibers. .

The labeling material is not particularly limited as long as it selectively binds to the substance to be detected and is colored, and examples thereof include gold colloids, platinum colloids, insoluble carrier particles such as colored particles and fluorescent particles, enzyme-labeled ligands, and fluorescent-labeled ligands. or chemically bonded materials. Specific examples of the labeling material include, for example, antibodies to which colored particles are bound.

The immobilization membrane 51 is a member having an immobilization material for immobilizing a target substance to which a labeling substance is bound. This immobilization membrane 51 has a portion where a part of the labeling substance holding pad 41 overlaps each other, specifically, the upstream side in the liquid sample spreading direction is in contact with the signaling substance holding pad 41 via the interface k12. there is. The immobilization membrane 51 receives the liquid sample and the labeling material mixed in the labeling material holding pad 41 and spreads them toward the absorption pad 61 .

Specifically, the immobilization membrane 51 is formed of a material with fine spacing and high absorbency compared to the above-described labeling material holding pad 41 . In this way, the liquid sample can be reliably transferred from the labeling material holding pad 41 to the immobilization membrane 51 . Examples of the material constituting the immobilized membrane 51 include a porous material made of nitrocellulose and the like, and a fiber material made of polyester and the like.

In addition, the immobilized membrane 51 is provided with a detection area 51a for detecting a target substance. An immobilization material is fixed to the sensing region 51a, and the immobilization material selectively binds to the detection target substance to fix the detection target substance to the detection region 51a. Here, the immobilized substance to be detected is bonded to the labeled substance as described above. Therefore, by fixing the substance to be detected in the detection area 51a, the colored labeled substance can be accumulated in the detection region 51a, and the presence of the substance to be detected is detected by visual recognition of the color or detection of the labeled substance using a sensing device. can determine whether Examples of the immobilization material include antibodies and the like.

The shape of the detection region 51a is not particularly limited, but, for example, as shown in FIG. 2 , it may be provided in a strip shape extending in a direction orthogonal to the sample spreading direction of the immobilized membrane 51 . This makes it easy and reliable to judge.

In addition, the immobilized membrane 51 may be provided with a control region 51b for notifying that a liquid sample has arrived between the detection region 51a and an absorption pad 61 described later. In a related case, for example, a control region 51b for fixing a control substance to the immobilized membrane 51 is formed, and at the same time, a labeling substance for control selectively bound to the control substance and to which the label is bound is attached to the labeling substance holding pad 41 impregnated in Then, after the dropped liquid sample is mixed with the labeling material for control, when this mixture reaches the control area 51b, the liquid sample in which the labeling material for control is immobilized by the control material passes through the detection area 51a (the inspection is performed). Successfully progressing) can be confirmed by color recognition by the naked eye or detection of a labeled material by a sensing device.

The absorbent pad 61 is a member that absorbs at least a portion of the liquid sample spreading the immobilized membrane 51 . The absorbent pad 61, upstream of the absorbent pad 61, is in contact with the immobilized membrane 51 via the interface k13, receives a liquid sample or the like spread through the immobilized membrane 51, and absorbs it. The test slip 21 has an absorbent pad 61, and the liquid sample or the like can be absorbed by the absorbent pad 61 to promote the spread (flow) of the liquid sample or the like in the immobilization membrane 51, and the liquid sample dropped on the sample dropping pad 31 The back can be smoothly extended.

The absorbent pad 61 is not particularly limited as long as it can absorb a large amount of liquid sample, etc., and for example, a filter paper, a nonwoven fabric made of glass fibers, or the like, an absorbent polymer sheet, or the like can be employed.

The backing sheet 71 is installed between the test strip 21 and the first case 81 and integrally fixes the sample dropping pad 31, the labeling material holding pad 41, the immobilization membrane 51 and the absorbent pad 61 constituting the test strip 21. Specifically, the backing sheet 71 has a pressure-sensitive adhesive layer 71a formed on the end surface of the backing sheet 71, and the pressure-sensitive adhesive layer 71a constitutes a test strip 21, a sample dropping pad 31, a labeling material holding pad 41, an immobilized membrane 51, and an absorbent. By adhering to the pad 61, these sample dropping pads 31 and the like are integrally fixed to the backing sheet 71. As a material for forming the above-described backing sheet 71 and the pressure-sensitive adhesive layer 71a, a known waterproof material or the like can be employed, for example. Therefore, each pad can be stably held by the said test kit 11 being provided with the backing sheet 71.

The first case 81 loads the test strip 21. The second case 91 is disposed to face the first case 81 via the test strip 21, and clamps the test strip 21. As a material constituting the first and second cases 81 and 91, for example, polypropylene, ABS, or the like can be employed.

Here, at least a part between the above-mentioned backing sheet 71 and the first casing 81 is provided with a gap g. As shown in FIG. 1 , the gap g is formed by contacting the lower surface of the backing sheet 71 with the ends of the protrusions 811 to 813 provided in the first case 81 . The gap g interval is preferably formed to such an extent that the liquid sample or the like that has entered the gap g does not propagate due to surface tension. The gap g is preferably 0.1 mm or more, and more preferably 0.5 mm or more. In this way, the liquid sample can be suppressed from permeating between the test strip 21 and the first case 81, the loss of the liquid sample can be suppressed, and the presence or absence of the substance to be detected can be reliably detected.

The second case 91 is provided with a pressurizing part 910, and the pressurizing part 910 is located at a portion where a part of the labeling material holding pad 41 overlaps a part of the immobilization membrane 51 in a direction orthogonal to the direction in which the liquid sample is spread. Only a part is pressurized (see FIG. 2). Specifically, the pressing portion 910 is formed by providing a protruding portion 911 on the second case 91, and is disposed so as to press only both ends in a direction orthogonal to the direction in which the liquid sample spreads at the portion where the protruding portion 911 overlaps.

With the pressurization unit 910 installed in this way, the labeling material holding pad 41 and the immobilization membrane 51 can be brought into close contact, and the liquid sample or the like can be spread from the labeling material holding pad 41 to the immobilization membrane 51 reliably and smoothly. can In addition, since the pressing portion 910 (protrusion portion 911) is disposed to press both ends, the overlapped portion can be symmetrically pressed in the direction of deployment, and the liquid sample inside the immobilized membrane 51 is spread toward the absorbent pad 61 in a balanced manner. can make it

In the second case 91, a sample input port 914 for inserting a liquid sample into the test kit 11 is provided. This sample inlet 914 opens to the position adjacent to the dropping part 31a of the sample loading pad 31 of the second case 91, and a liquid sample can be injected into the dropping part 31a through the sample inlet 914.

In addition, the second case 91 has a window 915 for confirming the detection of the substance to be detected from the outside, and this window 915 is a portion adjacent to the immobilized membrane 51, and the liquid is immediately below the portion pressed by the pressurizing portion 910. It is arranged at a site adjacent to a watershed P other than the watershed R in which the sample develops. As the window portion 915, for example, a configuration in which an opening is formed in the second case 91, a member transparent to visible light, a configuration in which a member that transmits the fluorescence when the labeling material fluoresces, or the like can be employed. Also, in this embodiment, the window portion 915 formed with the opening of the second case 91 is used.

In addition, from the viewpoint of more reliably determining the presence or absence of the substance to be detected, the basin R is preferably shielded so that detection of the substance to be detected is not confirmed from the outside. In this form, for example, the color of the labeling material in which the first and/or the second case develops the watershed R is invisible (e.g., the printing of letters or symbols on the opaque case of the case or the attachment of a label). etc.) or a form composed of a material that interferes with the detection of the labeled substance by the sensing device, or a member (first and second cases A form covered with a shielding member other than), etc. are mentioned. A material or member that hinders the detection includes, for example, a material that blocks transmission of a specific wavelength required for search.

Next, a method for detecting a substance to be detected using the detection kit 11 of the present embodiment will be described. Here, an antigen to be detected, an antibody to which colored particles are bound as a labeling material, and an antibody to which colored particles are bound as a control labeling material are used as an immobilization material, and an antibody to which colored particles are bound as a control labeling material (among the immobilization materials) An antibody different from the antibody) and an antigen as a control substance in the control region 51b (an antigen different from the antigen in the substance to be detected) will be described. In addition, the antibody contained in the antigen and labeling material as the detection material, the antigen as the detection material and the antibody as the immobilized material, and the antibody contained in the labeling material for control and the antigen as the control material are each antigen-antibody reaction combined by

First, a liquid sample is prepared and an appropriate amount of the liquid sample is introduced into the loading portion 31a of the sample loading pad 31 through the sample loading port 914 of the test kit 11, and the liquid sample permeates the sample loading pad 31, retaining a portion of the labeled material. Deploy towards pad 41.

Subsequently, the liquid sample that has reached the interface k11 penetrates into the labeling material holding pad 41 through the interface k11, and the liquid sample that has penetrated spreads toward the immobilized membrane 51. At this time, the liquid sample is mixed with the labeling material impregnated in the labeling material holding pad 41 and the labeling material for control, and when the liquid sample contains an antigen, it binds to the antibody in the labeling material by the antigen-antibody reaction, Deploy towards the immobilization membrane 51 together with the labeling material.

Subsequently, the liquid sample or the like that has reached the interface k12 permeates into the immobilized membrane 51 through the interface k12. At this time, since the labeling material holding pad 41 and the immobilization membrane 51 are pressed and brought into close contact with each other by the protruding portion 911, the liquid sample or the like is rapidly spread on the immobilization membrane 51. Subsequently, the liquid sample or the like spread on the immobilized membrane 51 extends toward the absorption pad 61 and sequentially passes through the sensing region 51a and the control region 51b installed on the immobilized membrane 51 .

In the detection area 51a, when the liquid sample contains an antigen, the antigen bound to the labeling material is also bound and immobilized by the immobilization material impregnated into the detection area 51a. By this immobilization, the colored labeled substance accumulates in the detection area 51a. However, the test kit 11 is a basin in which the liquid sample spreads in the immobilized membrane 51, and is directly below the portion further pressed by the pressurization part 910. Since the detection of the substance to be detected can be confirmed from the outside through the window 915 in the watershed P other than the watershed R where the liquid sample develops (confirmation with the naked eye or a detection device), the presence or absence of an antigen can be determined.

　On the other hand, a part of the liquid sample passes through the detection area 51a and reaches the control area 51b, and is fixed with the labeling material for control mixed with the liquid sample in the labeling material holding pad 41 and the control area 51b and combined with the control material. It is fixed. As the process proceeds in this way, since the labeling material for control is accumulated in the control area 51b, the presence or absence of the color of the control area 51b is visually checked through the window 915 to confirm that the liquid sample has passed the detection area 51a (the test is successfully performed). ) can be seen with the naked eye. Then, a portion of the liquid sample or the like passes through the control area 51b and is absorbed by the absorbent pad 61 .

By the way, when a liquid sample or the like is spread from the labeling material holding pad 41 to the immobilization membrane 51, a large amount of the labeling material may spread to the immobilization membrane 51 at once. This phenomenon tends to occur when a liquid sample or the like finally passes through the interface k12. When this phenomenon occurs, a specific region with a high concentration of the labeling material moves inside the immobilized membrane 51, and may cause an erroneous determination. That is, even though the substance to be measured (antigen) does not exist, the immobilized membrane 51 is colored as if it exists.

However, the test kit 11 includes a pressurizing portion that presses a part of a direction orthogonal to the direction in which the liquid sample spreads at the overlapping portion, and is a basin in which the liquid sample of the immobilized membrane 51 expands, and the portion pressed by the pressurized portion 910 In the watershed P other than the watershed R in which the liquid sample immediately below develops, since the detection of the substance to be detected from the outside can be confirmed, at least the watershed in which the labeled substance is stably developed without pressurization of the pressurization unit 910. can be observed from the outside, and the presence or absence of the substance to be detected can be reliably determined. In addition, when a large amount of liquid sample or the like is simultaneously developed by pressurizing the overlapping portion, the liquid sample or the like tends to stay in the pressurized portion of the interface k12, and when the liquid sample etc. ) is presumed to be due to

[Second Embodiment]

5 is a schematic longitudinal sectional view showing a second embodiment of the present invention. 6 is a schematic plan view of FIG. 5 . As shown in Figs. 5 and 6, schematically, the test kit 12 includes a test slip 22 having a sample loading pad 31, a labeling material holding pad 42, an immobilization membrane 51 and an absorbent pad 61, a backing sheet 71, a first It is composed of a case 81 and a second case 91.

In this embodiment, the configuration of the labeling substance holding pad 42 is different from that of the first embodiment. In addition, since the sample dropping pad 31, the immobilization membrane 51, the absorption pad 61, the backing sheet 71, the first case 81 and the second case 91 have the same configurations as those in the first embodiment, the same reference numerals are assigned to the same parts, and detailed descriptions thereof are omitted. do. In addition, since the labeling substance holding pad 42 has the same structure as that of the first embodiment except that the portion containing the labeling substance is different, detailed explanations other than the description of the above containing portion are omitted.

The labeling substance holding pad 42 is a member impregnated with a labeling substance that selectively binds to and marks a substance to be detected. The labeling substance holding pad 42 of the present embodiment has a portion containing a labeling substance 42a and a portion 42b adjacent to the containing portion 42a and not containing a labeling substance, and is not included with the sample dropping pad 31. Portion 42b is connected, and at least a portion of the containment portion 42a is connected to the immobilized membrane 51.

In the labeling substance holding pad 42 of this embodiment, at least the entire interface k21 should just be in contact with the non-containing portion 42b. In addition, the ratio (for example, volume ratio, etc.) of the labeling material-containing portion 42a and the non-containing portion 42b of the labeling material holding pad 42 is not particularly limited and various ratios can be taken as long as the above configuration is satisfied.

Next, a method for detecting a substance to be detected using the detection kit 12 of the present embodiment will be described. In addition, here, a description will be given of a part that exhibits an action different from that of the detection method described in the first embodiment.

First, when an appropriate amount of liquid sample is put into the loading part 31a of the sample loading pad 31 through the sample inlet 914 of the test kit 12, the liquid sample permeates the sample loading pad 31 and partially flows in the direction of the labeling substance holding pad 42 unfold with

Subsequently, the liquid sample that has reached the interface k21 is spread into the labeling substance holding pad 42 through the interface k21, and the spread liquid sample is mixed with the labeling substance and the labeling substance for control, together with the immobilized membrane 51 unfold towards At this time, in this test kit 12, since only the non-containing portion 42b of the labeling substance holding pad 42 is in contact with the sample dropping pad 31, the labeling substance does not stay at the interface k21, and the retention at the interface k21 Therefore, misjudgment of the substance to be detected can be suppressed, and the presence or absence of the substance to be detected can be determined more reliably.

Subsequently, the liquid sample or the like that has reached the interface k22 spreads through the interface k22 into the immobilized membrane 51, and then proceeds in the same manner as in the first embodiment described above.

[Third Embodiment]

7 is a schematic longitudinal sectional view showing a third embodiment of the present invention. 8 is a schematic plan view of FIG. 7 . The test kit 13 schematically as shown in FIGS. 7 and 8 includes a test slip 23 and a backing sheet 71 having a sample loading pad 31, a labeling material holding pad 43, an immobilization membrane 51 and an absorbent pad 61, a first case 83, and a first case 83. It consists of 2 cases 93.

In this embodiment, the structure in which the sample dropping pad 31, the labeling substance holding pad 43, and the immobilization membrane 51 overlap is different from that of the first embodiment. In addition, since the configuration of each member such as the sample dropping pad 31 is the same as that of the first embodiment, these descriptions refer to the description of the first embodiment and are omitted.

In the present embodiment, at least a portion of the sample dropping pad 31, a portion of the labeling material holding pad 43, and a portion of the immobilization membrane 51 are stacked in this order at the overlapping portion of the test strip 23. In the present embodiment, in the test kit 13, an immobilization membrane 51, a labeling material holding pad 43, and a sample dropping pad 31 are stacked on a backing sheet 71, and the three-layer structure member includes a convex portion 831 and a protruding portion 931 (pressing portion 930 ) is integrally sandwiched between

Next, a method for detecting a substance to be detected using the detection kit 13 of the present embodiment will be described. In addition, here, parts exhibiting effects different from those of the detection method described in the first embodiment will be described.

First, when an appropriate amount of liquid sample is put into the loading part 31a of the sample loading pad 31 through the sample loading port 914 of the test kit 13, the liquid sample penetrates the sample loading pad 31 and a part of it spreads toward the pad 43 holding the labeling material. do.

Subsequently, the liquid sample reaching the interface k31 is spread in the labeling material holding pad 43 through the interface k31, and then spreads into the immobilized membrane 51 through the interface k32 while mixing with the labeling material and the labeling material for control. At this time, the test kit 13 has a three-layer structure on which the sample dropping pad 31, the labeling material holding pad 43, and the immobilization membrane 51 are integrally pressed by the protruding portion 931 serving as the pressing portion 930, and the sample is dropped on the above sample. The pad 31 and the like can be integrally brought into close contact with each other with a simple configuration, and the presence or absence of the substance to be detected can be quickly and stably detected by accelerating the spread of the liquid sample.

Subsequently, the liquid sample or the like that has reached the interface k32 permeates into the immobilized membrane 51 through the interface k32, and then proceeds in the same manner as in the first embodiment described above.

<Method of detecting target substance>

The method for detecting a target substance of the present invention includes a sample dropping pad for dropping a liquid sample containing the target substance, a labeling material holding pad impregnated with a labeling substance that selectively binds to the target substance and becomes a label, and the above An immobilization membrane having an immobilization material for immobilizing the target substance to which the labeling substance is bound is connected in this order, so that the dropped liquid sample sequentially spreads toward the immobilization membrane, thereby removing the target substance from the immobilization membrane. A method of detecting a substance to be detected using a test kit equipped with a test strip for detection, wherein the test strip has a portion where at least a portion of a membrane fixed to a labeled material holding pad overlaps each other, and the liquid is detected at the overlapping portion. A pressurizing part pressurizing a part of a direction orthogonal to the direction in which the sample spreads is provided, and the liquid sample of the immobilized membrane is a basin in which the liquid sample expands, and the liquid sample directly below the portion further pressurized by the pressurized part expands. In a watershed other than the watershed, it is characterized in that the detection of the substance to be detected is confirmed from the outside.

In addition, since the detailed description of the method of detecting the corresponding target substance is the same as that of [First Embodiment] in the <test kit> section described above, the above description is used and the description is omitted here.

In addition, this invention is not limited to the structure of the above-mentioned embodiment, It is intended that the meaning of the claim and equality shown by the claim, and all the changes within the range are included.

For example, in the above-described embodiment, the test kits 11 to 13 provided with the first and second cases have been described, but test kits without these cases are also within the scope of the present invention. As such a form, for example, an inspection kit or the like that presses a part of the overlapping portion with a clamping means such as a clip may be mentioned.

In addition, when using the above-mentioned clamping means and shield member, you may wrap the test strip using these in another case (case other than the 1st and 2nd case).

In addition, in the above-described embodiment, the test kits 11, 12, and 13 are arranged so that both ends of the liquid sample in the direction orthogonal to the direction of spread (the width direction of the test strip) are pressed at the portion where the pressurizing parts 910, 920, and 930 overlap. It is not particularly limited as long as the part is pressed in a direction orthogonal to the direction in which the liquid sample spreads to the portion where the part overlaps.

Further, in the above-described embodiment, the test kits 11 to 13 equipped with the absorbent pad 61 have been described, but as long as the liquid sample or the like dropped on the sample dropping pad 31 is smoothly spread toward the immobilized membrane 51, the absorbent pad A test kit not equipped with (61) is also within the scope contemplated by the present invention.

Further, in the above-described embodiment, the sample dropping pad 31 and the labeling material holding pads 41 and 42 are pressed by the convex portions 912 and 922 throughout the width direction of the test strips 21 and 22 (the direction perpendicular to the direction in which the liquid sample spreads). Although the test kits 11 and 12 have been described, a part of the width direction of the test strip (a part in the direction orthogonal to the direction in which the liquid sample is spread) may be used as a portion where the sample dropping pad and the labeling substance holding pad are pressed.

Among them, in the case of a test kit in which the labeling material is uniformly impregnated throughout the labeling material holding pad, the pressing portion 940 is, for example, as shown in FIG. It is desirable that it is a site where is not installed. Therefore, it is possible to reduce misjudgment due to the retention of the labeling material at the interface between the sample dropping pad and the labeling material holding pad, and it is possible to more reliably determine the presence or absence of the detected material.

Further, in the above-described embodiment, the test kits 11 to 13 provided with the backing sheet 71 have been described, but as long as the sample dropping pad, the labeling material holding pad, and the immobilization membrane satisfy the above relationship and do not impair the effects of the present invention. Alternatively, an inspection kit without the backing sheet 71 may be used.

In addition, in the above-described embodiment, the test kits 11 to 13 in which both the sample inlet 914 and the window 915 are provided in the second cases 91 and 93 have been described, but a test kit in which at least one of them is provided in the first case is also described in the present invention. is within the purpose of

g gap
11,12,13 test kits
21,22,23 test strips
31 sample dropping pad
41,42,43 Labeling material holding pad
42a containing part
Part not containing 42b
51 Immobilized Membrane
61 absorbent pad
71 backing sheet
81,83 Case 1
91,93 2nd case
910,920,930 Pressing part
915 prostitute

Claims (7)

A sample dropping pad for dropping a liquid sample containing a substance to be detected, a labeled substance holding pad impregnated with a labeling substance that selectively binds to the substance to be detected and becomes a label, and a substance to be detected in which the labeled substance is bound An immobilization membrane having an immobilization material for immobilizing is connected in this order, and the liquid sample dropped is sequentially developed toward the immobilization membrane while a test kit equipped with a test strip for detecting the substance to be detected from the immobilization membrane. ,
The test strip has a region where at least a portion of the labeling material holding pad and a portion of the immobilization membrane overlap each other;
A pressurizing unit for pressing a part of a direction orthogonal to a direction in which the liquid sample expands at the overlapping portion,
Among the basins in which the liquid sample of the immobilization membrane is deployed, the detection of the substance to be detected can be confirmed from the outside only in a basin other than the basin in which the liquid sample is deployed directly below the portion pressed by the pressurizing unit. inspection kit.
The test kit according to claim 1, wherein the pressing unit is disposed to press both ends of the overlapping portion in a direction orthogonal to the spreading direction of the liquid sample.
The method according to claim 1 or 2, wherein the labeling substance holding pad has a portion containing the labeling substance and a portion adjacent to the containing portion and not containing the labeling substance, the sample dropping pad and The test kit of claim 1 , wherein the free portion is connected, and at least a part of the containing portion is connected with the immobilized membrane.
The test kit according to claim 1 or 2, wherein the overlapping portion has a structure in which at least a portion of the sample dropping pad, a portion of the labeling material holding pad, and a portion of the immobilization membrane are laminated in this order.
According to claim 1 or 2,
In the first case,
A second case disposed to face the first case through a test strip and holding the test strip;
A test kit in which a pressurizing portion is provided in the first and/or second cases so as to press a portion of the overlapping portion in a direction orthogonal to a direction in which the liquid sample spreads.
According to claim 5,
Equipped with a window for confirming detection of a substance to be detected from the outside,
The window portion is a portion toward the immobilized membrane of the first and/or second case, and among the basins in which the liquid sample is spread in the immobilized membrane, other than a basin directly below the liquid sample flowing out from the portion pressurized by the pressurization portion, Test kits placed in areas facing only watersheds.
A sample dropping pad for dropping a liquid sample containing a substance to be detected, a labeled substance holding pad impregnated with a labeling substance that selectively binds to the substance to be detected and becomes a label, and a substance to be detected in which the labeled substance is bound An immobilization membrane having an immobilization substance immobilizing is connected in this order, and the test kit having a test strip for detecting the substance to be detected on the immobilization membrane while the dropped liquid sample is sequentially developed toward the immobilization membrane. As a method for detecting a substance to be detected using,
The test strip has a region where at least a portion of the labeling material holding pad and a portion of the immobilization membrane overlap each other;
A pressurizing unit for pressing a part of a direction orthogonal to a direction in which the liquid sample expands at the overlapping portion,
Among the basins in which the liquid sample of the immobilization membrane is deployed, the detection of the target substance is confirmed from the outside only in a basin other than the basin in which the liquid sample is developed directly under the portion pressed by the pressurizing part. How to.

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