JP6916102B2 - Device for immunochromatography - Google Patents

Description

The present invention belongs to the technical field of immunochromatography using an antigen-antibody reaction. The present invention specifically relates to a device used for an immunochromatographic test.

Immunochromatography as a clinical diagnostic method for simple and rapid diagnosis using the specificity based on the immune response of antigen-antibody from biological samples such as urine, feces, saliva, blood, serum, and pharyngeal sample. The grafing method is known. In the immunochromatography method, a member impregnated with a first antibody color-labeled with a carrier such as colloidal gold is placed at one end, and a second antibody is previously fixed at the other end to provide a capture site (test line). A complex formed by the antigen-antibody reaction between the sample, the first antibody, and the antigen in the sample and the first antibody by dropping a liquid biological sample onto the impregnated member on the arranged strip of nitrocellulose or the like. The mixture is developed in a strip-shaped carrier from one end to the other end by a capillary phenomenon. The complex is captured by an antigen-antibody reaction between an antigen and a second antibody at the capture site, accumulates, and develops color. The unbound primary antibody is captured by a control line located in front of the capture site. Then, the presence or absence of an antigen in the test sample can be determined by observing the degree of coloration of the strip carrier at the capture site with the naked eye or an optical detector.

Further, in an inspection institution, a test piece made of a strip for immunochromatography is typically used as a device housed in a housing made of a resin such as plastic in order to facilitate the inspection. This test device is provided with a dropping hole for dropping an extract obtained by extracting a sample collected from a patient onto a test piece, and a detection window for determining the presence or absence of an antigen by a color reaction or the like. The dropping method and dropping amount of the sample extract (hereinafter referred to as "sample solution") are specified in detail in the instruction manual or the like.

However, when a test institution drops a sample solution onto a test device, an excessive amount of the sample solution may be injected into the device due to an erroneous operation by the person in charge of the test, and accurate test results may not be obtained.

Cited Document 1 discloses an inspection container in which a test piece is supported by a plurality of supports and an inclined surface is provided to allow an excess sample to flow out rearward in the deployment direction. Reference 2 discloses a cartridge for lateral flow analysis provided with a sub-pad and a sample well for controlling the amount of sample introduced into the test piece. Cited Document 3 discloses a cassette for an immunochromatographic test in which the influence of variation in the dropping amount is eliminated by providing a structure in which a part of the peripheral edge of the determination window on the dropping hole side does not come into contact with the membrane.

Japanese Unexamined Patent Publication No. 2012-168051 Special Table 2015-535078 Gazette JP-A-2017-173009

Introducing an excessive amount of sample solution into an immunochromatographic test device adversely affects the test results due to various factors. A main object of the present invention is to provide a device for an immunochromatographic test capable of obtaining an accurate determination result even when a sample is dropped in an excessive amount, particularly in a variation in the amount of the sample dropped during the immunochromatographic test.

As a result of diligent studies, the present inventor has optimized the housing structure, particularly (1) optimization of the shape of the dropping hole, (2) in the device for immunochromatography consisting of the upper housing, the lower housing and the test piece. We have found that the above problems can be solved by optimizing the test piece support and (3) optimizing the structure for inducing an excessive amount of sample liquid, and have completed the present invention. That is, the present invention has the following configuration.

[1] A test piece, a lower housing having a plurality of supports for supporting the test piece, a dropping hole for dropping a sample on the test piece, and a sample introduced from the dropping hole. An examination device for lateral chromatography comprising an upper housing having a detection window in the direction of unfolding on the test piece.
An inspection device for an immunochromatography in which the width of a support base that supports a portion of the test piece exposed from the detection window is narrower than the width of the test piece.
[2] The lateral lateral flow test according to [1], wherein the width of the support base that supports the portion of the test piece exposed from the detection window is 0.5 mm to 3.0 mm narrower than the width of the test piece. Inspection device.
[3] The lateral flow test device according to [1] or [2], wherein the width of the support base that supports the portion of the test piece exposed from the detection window is narrower than the width of the detection window. ..
[4] Any of [1] to [3], wherein the height of at least one support of the support that supports the portion of the test piece exposed from the detection window from the lower housing is 0.4 mm or more. The testing device for immunochromatography according to the above item.
[5] The lateral flow test device according to any one of claims [1] to [4], wherein the shape of the support base that supports the portion of the test piece exposed from the detection window is a planar body. ..
[6] In any one of [1] to [5], the area of the support base supporting the portion of the test piece exposed from the detection window is 50% or more of the area of the test piece exposed from the detection window. The testing device for immunochromatography described.

The device for immunochromatography according to the present invention (hereinafter referred to as "device of the present invention") has an optimum housing structure, so that even if the amount of a sample extracted from a patient is not appropriate, an accurate determination can be made. It is possible to do.

It is a figure which shows the lower housing of the device of this invention. (A) is a top view, (B) is a cross-sectional view of the broken line AA of (A), and (C) is a side view. It is a figure which shows the upper housing of the device of this invention. (A) is a top view, (B) is a back view, and (C) is a cross-sectional view of the broken line CC of (B). It is a figure which shows an example of the test piece used for the immunochromatographic test method. (A) is a perspective view of a test piece. (B) is a perspective view showing a usage state. FIG. 4 (A) is a top view of the lower housing of the device of the present invention, and FIG. 4 (B) is a cross-sectional view of a broken line BB of a variation of the regulation wall 104. It is a figure which shows the relationship of the width of one support stand of this invention, and a test piece. It is a figure which illustrated the difference of the deployment speed on a test piece. (A) is a top view of the lower housing, and (B) is the upper housing, which is a view showing a modified example of the regulation wall of the device of the present invention. It is sectional drawing in the state which the test piece of the device of this invention is attached, and is the figure which shows the modification about the regulation structure.

Hereinafter, the present invention will be described with reference to the drawings.
<Device of the present invention>
The device of the present invention includes a test piece 150 for inom chromatography (hereinafter, may be simply referred to as a “test piece”), a lower housing 100 on which the test piece is mounted at a predetermined position, and a lower housing on which the test piece is mounted. It comprises an upper housing 200 to cover. 1 (A) is a top view of the lower housing, FIG. 1 (B) is a cross-sectional view of the broken line AA'of the lower housing, FIG. 1 (C) is a side view of the lower housing, and FIG. 2 (A) is the upper housing. 2B is a top view showing the back surface of the upper housing, and FIG. 2C is a side sectional view taken along the broken line CC'of the upper housing.

FIG. 1 shows the configuration of the lower housing 100. The lower housing 100 includes a lower housing body 101, fixing protrusions 102 (arranged around the housing, eight locations in this figure), a pair of first regulating walls 103 for restricting the movement of the test piece in the width direction, and a first. The second regulation wall 104, the third regulation wall 105, the fourth regulation wall 106 for restricting the movement of the test piece in the longitudinal direction, the fifth regulation wall 107, and the test piece are above the upper surface of the lower housing body 101. A support base 108, a support base 109, a support base 110, a support base 111, a pair of convex portions 112 provided on both sides in the width direction of the test piece, and a water retention recess 130 for arranging the test pieces. Here, in the side view (C), the state in which the test piece 150 is mounted on the housing main body 101 is shown by a broken line.

FIG. 2 shows the configuration of the upper housing 200. The upper housing 200 includes an upper housing body 201, a dropping hole 202 for lowering a sample droplet, an inclined portion 203, an inclined portion 204, a detection window 205 in which a test piece is exposed to confirm the presence or absence of a reaction, an inclined portion 206, and an inclination. A hole 208, a test piece, which is provided around the upper housing (8 places in this figure) and engages with the fixing projection 102 of the lower housing body 101 to lock the upper housing body 201 and the lower housing body 101. Includes a convex portion 209 for pressing 150 toward the lower housing side, a convex portion 210, a convex portion 211 accommodated between a pair of convex portions 112 of the lower housing, and an upper surface 212 of the upper housing.

<Test piece for immunochromatography (test strip)>
FIG. 3 shows an example of an immunochromatographic test piece for determining influenza. When the sample solution obtained by diluting the patient sample (here, when the antigen 308 derived from influenza A is contained) is dropped onto the sample pad 301 of the test piece, the sample solution is applied to the conjugate pad 302 impregnated with the colloidal gold-labeled antibody 309. Upon permeation, the gold colloid-labeled antibody 309 and the antigen (analyte) 308 bind to form a complex. Subsequently, the complex reaches the membrane 303 made of nitrocellulose or the like together with the solution, and is developed on the membrane in the arrow direction (development direction) by a capillary phenomenon. In FIG. 3 (A), the liquid flow is indicated by 401. Subsequently, the antigen 308 binds to either the test line 1 (TL1) 305 or the supplementary antibody 310 or 311 which is a solid phase antibody of the test line 2 (TL2) 306. Since the supplementary antibody 310 has specificity for influenza A virus and the supplementary antibody 311 has specificity for influenza B virus, if the antigen 308 is derived from influenza A virus, it binds to the supplementary antibody 310 and TL1 305. Indicates color development. Further, the unreacted labeled antibody reaches the control line (CL) 307, binds to the immobilized antibody 312 having specificity to the labeled antibody, and develops color, so that the developed state can be grasped. Further, the sample solution is absorbed by the absorption pad 304.

<Appearance of housing>
The device for immunochromatography of the present invention includes a lower housing and an upper housing 200 in which the test piece for immunochromatography is mounted on the lower housing 100 and further mounted on the test piece 150 so as to cover the test piece. On the upper surface 212 of the upper housing, a dropping hole 202 for introducing the sample solution into the sample pad of the test piece, and the coloration state of the test lines 305, 306 and the control line 307 can be visually or optically observed. It has a detection window 205 for detection.

The dropping hole 202 is formed to supply the sample liquid to the test piece 150, and the shape, formation site, etc. are not limited as long as it plays a role of introducing the sample liquid, but the sample liquid is evenly formed in the width direction of the test piece. From the viewpoint of introducing the above, it is convenient to have a quadrangular shape such as an ellipse or a rectangle having a width substantially equal to that of the test piece. Of these, a rectangle is preferable. In the rectangular shape of the dropping hole, it is desirable that the width of the dropping hole in the width direction of the test piece is equal to the width of the test piece and the length of the dropping hole in the longitudinal direction of the test piece is narrower than the width of the test piece. .. In FIG. 2A, 202 is shown as a dropping hole whose long side is equal to the width of the test piece and whose short side is narrower than the width of the test piece.
Further, a window frame having an inclination is provided around the dropping hole, and it is preferable that the window frame shape is a rounded semicircle because the dropping operation is easy. In FIG. 2A, a semicircular window frame is formed on the upstream side in the deployment direction by the inclined surfaces 203 and 204. By adopting the square shape of the dropping hole and the rounded semicircular shape of the window frame, it is easy to drop the sample solution and it is possible to spread it uniformly on the test piece.
Further, the inclined surface of the window frame around the dropping hole 202 in the longitudinal direction (longitudinal direction in the device) is the slope 203 having a gentle inclination from the viewpoint of handling of the sample liquid introduction, and the sample liquid surely from the inclined portion to the dropping hole. It is desirable to have a steep slope 204 and so that A gentle slope is preferably a slope in the range of 15 to 45 degrees with respect to the upper surface 212 of the upper housing, and a steep slope is a slope in the range of 45 to 90 degrees with respect to the upper surface 212 of the upper housing. desirable. The angle of inclination is preferably in the above-mentioned range, but a plurality of inclinations may be intermittently or continuously provided so as to finally reach those angles from a gentler angle. In this way, by making the inclination of the introduction portion into the dropping hole asymmetric with respect to the longitudinal direction of the device, both handling of the dropping operation and proper introduction of the sample liquid can be realized. That is, the gentle slope makes it easy to operate because it is possible to confirm that the sample liquid is dropped onto the test piece when it is introduced from a dropper, pipette, or the like, and the steep slope makes it easy for the sample liquid to fall and be introduced into the test piece.
Further, it is particularly convenient to set the distance between the test piece 150 and the bottom 231 of the dropping hole 202 to be 0 to 0.8 mm so that the sample liquid can be easily introduced into the sample pad 301.

The detection window 205 is formed so that the coloration state of the test lines 305 and 306 of the test piece 150 and the control line 307 can be detected with the naked eye or optically. The shape, formation site, etc. are not limited. For example, in this embodiment, an opening having a shape along the longitudinal direction of the test piece in which each line can be confirmed at the same time is illustrated, but for each line, a plurality of lines are exposed at the same time, or only a part of those lines is exposed. It may be an opening to be opened.
Further, it is convenient that the inclined surfaces 206 and 207 around the detection window 205 are inclined surfaces with a gentle inclination, and it is preferably 30 to 60 degrees with respect to the upper surface of the housing.
When the length of the opening of the detection window is about the same as the width of the test piece 150, if the angle of the inclined surface (for example, the inclined surface 207) is 40 to 50 degrees, the test piece is detected from the outside with the naked eye or optically. It is possible to prevent the shadow of the upper housing from falling on the membrane when doing so. Similarly, when the length of the opening is twice or more the width of the test piece, the angle of the inclined surface (for example, the inclined surface 206) is preferably 30 to 60 degrees. These angles may have a plurality of slopes from even gentler angles to those angles in the end. In particular, the configuration in which shadows are less likely to be formed is even more important because light irradiation from an angle is unavoidable during optical detection.
Further, in order to prevent the shadow of the upper housing from being formed on the test piece 150, the distance between the test piece 150 and the bottom 232 of the detection window 205 is particularly set to 0 to 2.0 mm, preferably 0 to 0.5 mm. convenient. However, if the test piece is sandwiched between the bottom 232 and the support 110 of the lower housing, preventing the bottom from contacting the test piece without applying pressure will affect the deployment of the sample solution on the test piece. It is preferable because it is not given. Further, the surface of the detection window 205 can be covered with a transparent plastic or the like to make the detection window 205 a non-open window in the air. As a result, the influence on the outside world on each line can be reduced.

The material of the housing of the device of the present invention is preferably a synthetic resin such as plastic and is opaque, and polystyrene such as acrylic, polyethylene, polypropylene and impact resistant polystyrene or PET or the like is used alone or in combination, or an appropriate amount of filler is added thereto. The added synthetic resin can be used.
Further, the housing of this embodiment can be formed by injection molding or cutting from a bulk member. Further, when each component is made of a different material, it can be formed by integral molding. Although one test piece is mounted in this embodiment, a plurality of test pieces may be arranged so as to be arranged in the width direction of the test pieces.

<Internal structure of housing>
<Lower housing>
The lower housing 100 has a configuration for holding the test piece 150.
1. 1. Restriction wall The regulation walls 103 to 107 have a function of restricting the in-plane movement of the test piece 150 arranged on the lower housing 100 on the upper surface 120 of the lower housing 100. The regulating walls may be arranged at least one in the front-rear direction in the longitudinal direction of the test piece (regulating walls 106, 107). Further, regarding the width direction of the test piece, at least one pair may be arranged on the side surface of the test piece, and FIG. 1 shows an example in which three pairs are arranged in the longitudinal direction (regulatory walls 103, 104, 105). ).
The variation of the upright structure of the regulation wall in this embodiment is shown in FIGS. 4 (B) to 4 (F) as a vertical cross-sectional view at the position of the BB'broken line in FIG. 4 (A). In these figures, the tops of the regulating walls 104 are all designed to be separated from the test piece to be inserted as compared with the base, so that the test pieces can be easily inserted between the regulating walls. (B) is an example in which the cross-sectional shape of the regulation wall 104 is an isosceles triangle, (C) is a vertical triangle having a right angle on the outside, and (D) is an example in which the tip portion of (B) is further thinned. Yes, (E) is an example in which the thickness is the same from the base to the tip, and the tip is bent outward.
In (F), the protrusion 113 is provided directly above the height at which the test piece 150 is positioned to prevent the test piece from deviating from the normal position. In the figure of (F), 113 is a protrusion, but it may be a convex linear body protruding at the same height.
Here, the regulation wall 104 is shown as an example, but other regulation walls may have the same configuration. The regulation wall is preferably injection-molded from the same material as the lower housing, but for example, a plate-shaped regulation wall made of a metal plate such as aluminum can be integrally molded with the resin of the lower housing. In this case, the test piece can be inserted and held by deforming the shape of the regulation wall, inserting the test piece, and then deforming the test piece to the original shape.

Further, referring to FIG. 1 (A), the regulation wall 103 and the regulation wall 106 form a space for accommodating the lower end portion of the sample droplet of the test piece, and the excess sample liquid is placed in the area a partitioned by them. Can be retained. Here, when an excess sample solution exceeding the maximum holding amount of the area a is injected, the excess sample solution is discharged from the gap s provided between the regulation walls 106. The gap s may be provided in a part of the regulation wall 106, preferably in the center. Further, in this embodiment, the height of the wall of the regulation wall 103 is shown in FIG. 1 (C) so that the excess sample liquid held in the area a does not further leak in the deployment direction via the support base 103. It is lowered in the development direction, and most of the retained sample liquid is adsorbed and retained on the rear regulation wall 106 side by surface tension. Further, a water absorption pad can be arranged on the upper surface of the area a or outside the gap s to reduce the influence of leakage. Further, the area a is provided with a recess 130 communicating with the gap s, and excess sample liquid is retained in the recess 130.

2. Support base Support bases 108 to 111 have a role of supporting the test piece by separating it from the upper surface of the lower housing main body 101. As a result, it is possible to prevent the sample liquid that leaks from the sample pad and deviates from the original deployment route of the test piece, travels along the upper surface of the lower housing body, and reaches the test piece again. As a result, the risk of erroneous determination can be reduced. It is preferable that the support base has at least three elements that support the lower part of the dropping hole, the lower part of the test line or the control line, and the lower part of the development direction end (water absorption pad) of the test piece. If the height of the support base loading surface from the upper surface of the lower housing is 0.4 mm or more, preferably 0.6 mm or more, the influence of excess sample liquid can be avoided. Due to the height limitation of the housing, it is convenient that the height of the support base is 2 mm or less.

With reference to FIG. 5, in this embodiment, the width (W2) of the support base 110 that supports the portion of the test piece exposed from the detection window in the width direction (width direction of the test piece) is the test piece. It is desirable that it is narrower than the width of (W1), and it is more desirable that it is narrower than the width of the detection window. With this configuration, the area of the test piece sandwiched between the bottom of the detection window of the upper housing in the width direction and the support 110 is small and preferably eliminated, an unintended pressing force is applied to the test piece, and the unfolding speed of the sample liquid. This is because it is possible to prevent a difference in the width direction of the test piece. The overhang length a on one side of the test piece from the support 110 is 0.25 mm to 1.5 mm, preferably 0.5 mm to 1.2 mm, and more preferably 0.5 mm to 1.0 mm. Therefore, the width of the support base that supports the test piece portion exposed from the detection window is preferably 0.5 mm to 3.0 mm narrower than that of the test piece, more preferably 1.0 mm to 2.4 mm, still more preferably 1. It is 0.0 mm to 2.0 mm.
The height h of the support base 110 is 0.4 mm or more, preferably 0.6 mm or more, and more preferably 0.8 mm or more.
The shape of the support base 110 that supports the portion of the test piece exposed from the detection window is formed by a planar body such as a rectangular parallelepiped, or a group of several linear or punctate bodies. There may be. Of these, a planar body is preferable. In the case of a linear body or a punctate body, the width of the support base may be such that the outermost distance between the linear body and the punctate body is narrower than the width of the test piece. The uppermost surface of the planar body, that is, the surface in contact with the test piece may be a smooth flat surface, or may be an embossed surface that supports the test piece by point contact.
It is desirable that the support base that supports the portion of the test piece exposed from the detection window comes into contact with the test piece at an area and an interval that does not bend due to the weight when the test piece absorbs the sample. When the support base is a planar body, the area of the support base is preferably 50% or more, more preferably 80% or more of the area of the test piece exposed from the detection window portion. When the support base is a point-like body or a linear body other than a planar body, the contact area between the test piece area and the support base is 50% or more of the test piece area exposed from the detection window. Is desirable.

With reference to FIGS. 1A and 1B, in this embodiment, the support base 109 is added in addition to the support bases 108, 110, and 111. The support base 109 is a support base arranged between a position corresponding to the detection window of the upper housing and a position corresponding to the dropping hole, and the width of the support base is preferably larger than the width of the test piece. .. The width of the support base is preferably 0.5 mm to 5 mm larger than the width of the test piece, and the range of 1 mm to 4 mm and 2 mm to 4 mm can be exemplified. The support base 109 prevents the sample liquid from entering in the deployment direction of the device when the sample liquid excessively introduced in the sample pad portion leaks, and the width of the sample liquid on the test piece on the support base 109. It has a function (rectifying action) to reduce the difference in deployment speed in the direction. In order to make this rectifying action appropriate, it is convenient that the length of the support base 109 in the longitudinal direction (longitudinal direction of the test piece) is 1/3 or more, preferably 1/2 or more of the width of the test piece 150. Is good.
Further, it is convenient that the position of the support base 109 is closer to the support base 110 than between the support base 108 and the support base 110.

Preferably, the support base is formed by injection molding with the same material as the lower housing, but it may be formed of a metal, glass, ceramic or the like made of a material that does not react with the sample liquid, and may be formed by integral molding.

<Upper housing>
Referring to FIG. 2, the upper housing is provided with protrusions 209 and 210 that press the test piece 150 toward the lower housing.
3. 3. The convex portion 209 and the convex portion 210 prevent the test piece 150 from floating from the lower housing 100, and the leaked sample liquid travels through the inner surface of the upper housing 200 and reaches the test piece again in front of the control line. Prevent adverse effects on test results.
4. Drop hole The bottom 231 of the drop hole 202 is designed to be close to the surface of the test piece 150 mounted on the device at intervals of 0 mm to 1 mm. Since the width of the dropping hole in the width direction of the test piece 150 is designed from a size smaller than the width of the test piece by about 3 mm to a size approximately equal to the width of the test piece, the sample solution is uniformly introduced into the test piece in the width direction of the test piece. NS. The width of the drop window in the longitudinal direction of the test piece is designed to be 2 mm to 4 mm from the viewpoint of being uniformly introduced in the longitudinal direction.
5. Detection window The bottom 232 of the detection window 205 is designed to be close to the surface of the test piece 150 mounted on the device at intervals of 0 mm to 2 mm. As a result, the bottom 232 of the detection window 205 can prevent the test piece 150 from floating. Since the width of the opening in the width direction of the test piece 150 is designed to be between a size that is about 1.5 mm smaller than the width of the test piece and a size that is about 0.5 mm smaller, dust and the like can enter the inside of the housing through the gap. There is no. Further, it does not excessively overlap with the support base 110 and give an uneven load to the test piece, which does not affect the determination result.

(Evaluation experiment 1)
The following experiment was conducted to investigate the relationship between the height of the support base 110 that supports the part of the test piece exposed from the detection window and the wraparound of the sample extract (diluted solution) around the test piece.
1. 1. Experimental Method (1) Inspection Device As the inspection device, the upper housing 200 and the lower housing 100 of the present invention and the test piece 150 to be inserted into them are fixed to the supports 108 to 111. The width of the test piece was almost the same as the width of the support (W1 = W2 in FIG. 5). The height of the support base 110 (height from the upper surface of the lower housing 101 to the position of the loading surface of the support base, h in FIG. 5) was set in 0.3 mm increments from 0 mm to 0.9 mm. A line was drawn on the test piece by magic to confirm the poor wraparound of the sample extract behind the test line position where the antibody was immobilized.
(2) Evaluation method Originally, 3 drops (80 to 120 μl) of the sample extract was used as the amount of the sample to be dropped on the device, but 5 drops of physiological saline was dropped from the dropping hole, and the same operation as at the time of the test was performed. After that, the test piece was left for 10 minutes, the inspection device was opened, and the test piece was observed.
The experiment was repeated 3 times for each of the inspection devices of the support bases at each height.

２．実験結果
結果を表１に示す。本結果より、検出窓から露出する試験片部分を支持する支持台の高さ（支持台の試験片積載面の下部ハウジング上面からの高さ）が０．３ｍｍより高く、さらに好ましくは０．４ｍｍ以上、いっそう好ましくは０．６ｍｍ以上であることがわかった。このような高さであれば、下部ハウジング上面を伝わって流れる余分の検体液の影響を避けることができるからである。なお、ハウジングの高さの制約から、支持台の高さの上限は２ｍｍ以下であると都合が良い。本実験では生理食塩水を用いたが他の抽出液を使っても同様の結果が得られた。

2. Experimental results The results are shown in Table 1. From this result, the height of the support base that supports the test piece portion exposed from the detection window (the height of the test piece loading surface of the support base from the upper surface of the lower housing) is higher than 0.3 mm, more preferably 0.4 mm. As described above, it was found that the thickness is more preferably 0.6 mm or more. This is because such a height can avoid the influence of the excess sample liquid flowing along the upper surface of the lower housing. Due to the height limitation of the housing, it is convenient that the upper limit of the height of the support base is 2 mm or less. In this experiment, physiological saline was used, but similar results were obtained when other extracts were used.

(Evaluation experiment 2)
The following experiment was conducted to investigate the relationship between the height of the support base 110 that supports the part of the test piece exposed from the detection window and the wraparound of the sample extract (diluted solution) around the test piece. The difference from the evaluation experiment 1 is that the width of the support base 110 is made smaller than that of the test piece.
1. 1. Experimental method (1) Inspection device As an inspection device, the upper housing and the lower housing of the present invention, and as a test piece to be inserted into them, the width of the support base 110 is set to be 1 mm shorter than both ends of the test piece. .. That is, in FIG. 5, W1 = W2 + 2 (mm) and a = 1 (mm). The height of the support base 110 (height from the upper surface of the lower housing 101 to the position of the loading surface of the support base h in FIG. 5) was set in 0.2 mm increments from 0 mm to 1.2 mm.
(2) Evaluation method Originally, 3 drops (80 to 120 μl) of the sample extract was used as the amount of the sample to be dropped on the device, but 5 drops of physiological saline was dropped from the dropping hole, and the same operation as at the time of the test was performed. Then, the test piece was left for 10 minutes, and the test piece was visually observed from the detection window. The test piece that absorbed water from both ends was rejected, and the test piece that did not absorb water was regarded as acceptable. The experiment was repeated 10 times for each of the inspection devices of the support bases at each height.

２．実験結果
結果を表２に示す。本結果より、検出窓から露出する試験片部分を支持する支持台の高さ（支持台の下部ハウジング上面からの高さ）が０．４ｍｍ以上であればよく、好ましくは０．６ｍｍ以上、さらに好ましくは０．８ｍｍ以上であることがわかった。このような高さであれば、余分の検体液の影響を避けることができた。なお、ハウジングの高さの制約から、支持台の高さの上限は２ｍｍ以下であると都合が良い。本実験では生理食塩水を用いたが他の抽出液を使っても同様の結果が得られた。

2. Experimental results The results are shown in Table 2. From this result, the height of the support base (height from the upper surface of the lower housing of the support base) that supports the test piece portion exposed from the detection window may be 0.4 mm or more, preferably 0.6 mm or more. It was found that it was preferably 0.8 mm or more. With such a height, the influence of excess sample solution could be avoided. Due to the height limitation of the housing, it is convenient that the upper limit of the height of the support base is 2 mm or less. In this experiment, physiological saline was used, but similar results were obtained when other extracts were used.

(Evaluation experiment 3)
The following experiment was conducted to investigate the relationship between the height of the support base 110 that supports the test piece portion exposed from the detection window and the width of the test piece.
1. 1. Experimental method (1) Inspection device As the inspection device, the upper housing and lower housing of the present invention and the test piece used for normal inspection were used. The height of the support base 110 (h in FIG. 5) is set to 0.6 mm, and the overhang length of the test piece from the support base (distance from the widthwise end of the support base 110 to the widthwise end of the test piece). , A) in FIG. 5 was prepared from 0 mm to 1.5 mm in 0.25 mm increments.
(2) Evaluation method Originally, as a sample to be dropped on the device, 3 drops (80 to 120 μl) of the sample extract used in a normal test was used for the test, and 5 drops of physiological saline was dropped from the dropping hole. Perform the same operation as during the inspection, leave it for 10 minutes, visually observe the test piece from the detection window, and when the saline reaches the position of the control line, the control line (CL) and the saline will reach. Those having a distance (L in FIG. 6) of 3 mm or more from the slow part (DL) were rejected, and those having a distance of less than 3 mm were accepted. The experiment was repeated 10 times each, and the number of failures is shown below.

２．実験結果
結果を表１に示す。「不合格」のうち、その原因について、試験片の両端がハウジングでつぶされるなどの原因により試験紙の幅方向の両端の展開速度が遅かったものを「干渉による展開不良」、試験片の片側がハウジングの底に接触し、検体液が入ってしまうなどの原因により両端に展開不良が固まっていなかったものを試験紙の「脇ダレ、浮上による展開不良」として評価した。
本結果より、張出長さａの最適値は、０．２５ｍｍから１．５ｍｍ、好ましくは０．５ｍｍから１．２ｍｍ、さらに好ましくは０．５ｍｍから１．０ｍｍと判定した。したがって、検出窓部から露出する試験片部分を支持する支持台の幅は、試験片より０．５ｍｍから３．０ｍｍ狭いことが好ましく、さらに好ましくは１．０ｍｍから２．４ｍｍ、さらに好ましくは１．０ｍｍから２．０ｍｍである。支持台の高さが０．４ｍｍ〜１．２ｍｍでも同様の傾向がみられた。

2. Experimental results The results are shown in Table 1. Among the "failures", the cause is that the unfolding speed of both ends in the width direction of the test paper is slow due to the fact that both ends of the test piece are crushed by the housing, etc. Was not solidified at both ends due to contact with the bottom of the housing and the sample liquid entered, and was evaluated as "deviation failure due to side sagging or floating" on the test paper.
From this result, it was determined that the optimum value of the overhang length a was 0.25 mm to 1.5 mm, preferably 0.5 mm to 1.2 mm, and more preferably 0.5 mm to 1.0 mm. Therefore, the width of the support base that supports the test piece portion exposed from the detection window is preferably 0.5 mm to 3.0 mm narrower than that of the test piece, more preferably 1.0 mm to 2.4 mm, still more preferably 1. It is 0.0 mm to 2.0 mm. The same tendency was observed even when the height of the support base was 0.4 mm to 1.2 mm.

(Modification example 1)
FIG. 7 shows the configuration of a device of a modified example of the present invention provided with an additional convex portion for controlling the flow of excess sample liquid.
(A) shows an example in which an additional convex portion 114 and a convex portion 115 are provided in the lower housing 100, and (B) shows an example in which an additional convex portion 215 is provided in the upper housing 200. Each of the protrusions 114, 115, and 215 has a liquid guide structure for preventing the sample liquid leaking from the sample pad from coming into contact with the test piece. The height of these auxiliary regulatory structures is lower than the height of the support base and the protrusions 209 and 210, and they do not come into direct contact with the test piece. The convex portion 114 of the lower housing 100 prevents the leaked liquid from the area a where the sample liquid can be accumulated from being transmitted in the development direction of the sample, and the convex portion 115 is a determination region (test line) where the leaked liquid of the dropped sample liquid is determined. And the area containing the control line) Prevents approaching the vicinity. The convex portion 215 in the upper housing 100 prevents the sample liquid leaked from the dropping window along the inner surface of the upper housing from further transmitted in the developing direction.

(Modification 2)
FIG. 8 shows the configuration of a device of a modified example of the present invention provided with additional protrusions 701 and 702 that regulate the test piece 150 in the height direction of the device.
The additional convex portion 701 has a function of contacting the lower surface of the test piece 150 and guiding the excess sample liquid to the area a. The additional convex portion 702 is a convex portion protruding from the inner surface of the upper housing toward the test piece 150, and urges the end portion of the test piece 150 opposite to the deployment direction toward the lower housing.
As a result, excess sample liquid is guided to the area a. Reference numeral 703 is a bottom portion located on the sample pad side in the longitudinal direction of the opening of the detection window, and by slightly contacting the test piece, the test piece is prevented from floating and a rectifying action in the width direction of the sample liquid is provided. .. Reference numeral 704 is a bottom portion located on the absorption pad side in the longitudinal direction of the opening of the detection window, and the sample liquid is prevented from flowing back by slightly contacting the test piece. Even in this case, it is convenient that the bottom portion of the opening of the detection window in the width direction is configured so as not to come into contact with the test piece.

Although the embodiments of the present invention have been illustrated above, the above embodiments are merely examples and are not intended to limit the scope of the invention. The above-described embodiment can be implemented in various other forms, and various omissions, substitutions, and changes can be made without departing from the gist of the invention. In addition, each configuration, shape, size, length, width, thickness, height, number, etc. can be appropriately changed for implementation. Further, each embodiment can be combined into a new embodiment.

According to the present invention, it is possible to perform a stable and accurate determination even when the amount of a sample dropped is not appropriate when performing an examination using an examination device for later later chromatography.

100 Lower housing 101 Lower housing body 102 Fixing protrusion
103 to 107 Regulation walls 108 to 111 of the first to fifth support base 112 Convex part 114 to 115 Additional convex part 130 Water retention recess 150 Test piece for inom chromatography 200 Upper housing 201 Upper housing body 202 Drop hole for lower sample droplets 203 to 204 Inclined surface 205 Detection window 206 to 207 Inclined surface 208 Hole 209 Convex 210 Concave 215 Additional convex 231 Bottom of drop hole 232 Bottom of detection window 301 Sample pad 302 Conjugate pad 303 Membrane 304 Absorption pad 305 Test line 1
306 test line 2
307 Control Line 308 Influenza A Derived Antigen 309 Colloidal Gold Labeled Antibodies 310, 311 Supplemental Antibodies 312 Immobilization Antibodies 701-702 Additional Convex 703-704 Bottom of Detection Window

Claims (5)

The test piece, a lower housing having a plurality of supports for supporting the test piece, and a dropping hole for dropping the sample on the test piece, and the sample introduced from the dropping hole is on the test piece. in a immunochromatographic test device for chromatography consisting of an upper housing having a detection window in the direction of deployment, the detection window rather narrower than the width of the support width of the test piece for supporting a portion of the test piece exposed from Moreover, the area of the support base that supports the portion of the test piece exposed from the detection window is 50% or more of the area of the test piece exposed from the detection window . The lateral flow test device according to claim 1, wherein the width of the support base that supports the portion of the test piece exposed from the detection window is 0.5 mm to 3.0 mm narrower than the width of the test piece. The inspection device for later later chromatography according to claim 1 or 2, wherein the width of the support base that supports the portion of the test piece exposed from the detection window is narrower than the width of the detection window. Any one of claims 1 to 3, wherein the height of at least one support of the support that supports the portion of the test piece exposed from the detection window from the lower housing is 0.4 mm or more. The testing device for immunochromatography described in. The inspection device for lateral chromatography according to any one of claims 1 to 4, wherein the shape of the support base that supports the portion of the test piece exposed from the detection window is a planar body.

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