JP2019109091A - Device for immunochromatographic testing - Google Patents

Abstract

To provide a device for immunochromatographic testing, which enables accurate assessment even when an excessive amount of sample liquid is introduced therein.SOLUTION: A device for immunochromatographic testing comprises: a test piece; a lower housing having a plurality of support bases for supporting the test piece; and an upper housing having a drop-hole for dripping a sample onto the test piece, and a detection window located in a direction in which the sample introduced through the drop-hole expands on the test piece. One of the support bases located between a position corresponding to the detection window and a position corresponding to the drop-hole in the lower housing has a width that is greater than that of the test piece.SELECTED DRAWING: Figure 1

Description

  The present invention belongs to the technical field of immunochromatography test using antigen-antibody reaction. The present invention relates in particular to devices used for immunochromatographic examinations.

  Immunochromatography as a clinical diagnostic method to diagnose easily and quickly from the sample of biological origin such as urine, feces, saliva, blood, serum, collection fluid of pharynx, etc. by utilizing the specificity based on the immune reaction of antigen-antibody. The graphic method is known. In the immunochromatography method, a member impregnated with a first antibody colored with a gold colloid or the like as a carrier is placed at one end, and a second antibody is fixed in advance at the other end to obtain a capture site (test line). A complex formed by an antigen-antibody reaction of 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 onto a strip of nitrocellulose or the like arranged The mixture is then developed by capillary action from the one end to the other end in a carrier in the form of a strip. The complex is captured by the antigen-antibody reaction between the antigen and the second antibody at the capture site, accumulates and develops color. Unbound first antibody is supplemented with a control line placed in front of the complement site. Then, the presence or absence of the antigen in the test sample can be determined by observing the degree of coloration at the capture site of the strip carrier with the naked eye or an optical detector.

  In addition, in order to facilitate examinations, examination laboratories are used as devices in which test strips composed of immunochromatographic strips are housed in a housing, which is typically a resin such as plastic. The test device is provided with a drop 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 the dropping amount of the sample extract (hereinafter, referred to as “sample liquid”) are specified in detail in the instruction manual or the like.

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

  Patent Document 1 discloses a test container provided with an inclined surface for supporting a test piece by a plurality of supports and allowing an excess sample to flow backward in the developing direction. Patent Document 2 discloses a lateral flow analysis cartridge provided with a subpad and a sample well for controlling the amount of sample introduced into a test piece. The cited reference 3 discloses an immunochromatographic test cassette in which the influence of the variation of the dropping amount is eliminated by providing a structure in which a part of the judgment window peripheral portion on the dropping hole side does not contact the membrane.

JP, 2012-168051, A JP-A-2015-535078 Unexamined-Japanese-Patent No. 2017-173009

  When an excess amount of sample liquid is introduced into the immunochromatographic test device, various factors adversely affect the test results. SUMMARY OF THE INVENTION The main object of the present invention is to provide an immunochromatographic test device capable of obtaining accurate determination results even when the amount of dropped sample drops, particularly excessive amount during immunochromatographic test.

  As a result of intensive investigations, the inventor of the present invention has made it possible to optimize the housing structure, in particular (1) optimize the shape of the dropping hole, in the device for immunochromatographic examination comprising the upper housing, the lower housing and the test piece, (2) The inventors have found that the above problems can be solved by optimization of the test specimen support and (3) optimization of the structure for inducing an excess amount of sample liquid, and the present invention has been accomplished. 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, and a drop hole for dropping a sample onto the test piece, and a sample introduced from the drop hole An immunochromatographic test device comprising: an upper housing having a detection window in a developing direction on the test piece,
The test device for immunochromatography whose width of the support stand arrange | positioned between the position corresponding to a detection window in the lower housing among the said several support stands and the position corresponding to the said dripping hole is larger than the width | variety of a test piece.
[2] The length in the longitudinal direction of the test piece of the support base disposed between the position corresponding to the detection window and the position corresponding to the dropping hole in the lower housing is one half of the width of the test piece The test device for immunochromatography according to [1], which is also larger and narrower than the width of the test strip.
[3] A test piece, a lower housing having a plurality of supports for supporting the test piece, and a drop hole for dropping a sample onto the test piece, and the sample introduced from the drop hole An immunochromatographic test device comprising: an upper housing having a detection window in a developing direction on the test piece,
The control device for immunochromatography in which the control wall for fixing the position of a test piece is provided in the lower housing, and the thickness of the base by the side of the lower housing of the control wall is thicker than the thickness of the tip.
[4] A test piece, a lower housing having a plurality of supports for supporting the test piece, and a drop hole for dropping a sample onto the test piece, and the sample introduced from the drop hole is An immunochromatographic test device comprising: an upper housing having a detection window in a developing direction on the test piece,
The lower housing is provided with a plurality of restricting walls for fixing the position of the test piece, and is a part of the restricting wall that restricts the longitudinal movement of the test piece disposed on the dropping hole side of the test piece The test device for immunochromatography that is open.
[5] A test piece, a lower housing having a plurality of supports for supporting the test piece, and a drop hole for dropping a sample onto the test piece, and the sample introduced from the drop hole is An immunochromatographic test device comprising: an upper housing having a detection window in a developing direction on the test piece,
The lower housing of the test piece includes a control wall for fixing the position of the test piece, and the control wall for controlling the longitudinal direction of the drop hole side is the width direction of the drop hole side of the test piece The inspection device for immunochromatography, which is continuous with the restriction wall of and the height of the restriction wall in the width direction is reduced in the expansion direction of the lower housing.
[6] The immunochromatography according to any one of [1] to [5], wherein the height of at least one support from the lower housing among the plurality of supports is 0.6 mm or more. Inspection device.
[7] A test piece, a lower housing having a plurality of supports for supporting the test piece, and a drop hole for dropping a sample onto the test piece, and the sample introduced from the drop hole is An immunochromatographic test device comprising: an upper housing having a detection window in a developing direction on the test piece,
The upper housing is provided with a window frame having a sloping surface for dropping the sample around the dropping hole, and the sloping surface in the developing direction is not symmetrical with the sloping angle between the upstream sloping surface and the downstream sloping surface. There is a test device for immunochromatography.
[8] The test device for immunochromatography according to [7], wherein the upstream inclined surface in the deployment direction is more gentle than the downstream inclined surface.
[9] The dripping hole is rectangular, the width of the dripping hole in the width direction of the test piece is equal to the width of the test piece, and the length of the dripping hole in the longitudinal direction of the test piece is greater than the width of the test piece The test device for immunochromatography according to any one of [1] to [8]. [10] The immunochromatographic test device according to [9], wherein the shape of the window frame is semicircular.
[11] A test piece, a lower housing having a plurality of supports for supporting the test piece, and a drop hole for dropping a sample onto the test piece, and the sample introduced from the drop hole An immunochromatographic test device comprising: an upper housing having a detection window in a developing direction on the test piece,
An inspection device for immunochromatography, wherein an inclined surface for observation is provided around the detection window, the inclined surface in the width direction of the device is 30 to 50 degrees, and the inclined surface in the longitudinal direction of the device is 40 to 55 degrees .
[12] A test piece, a lower housing having a plurality of supports for supporting the test piece, and a drop hole for dropping a sample onto the test piece, and the sample introduced from the drop hole is An immunochromatographic test device comprising: an upper housing having a detection window in a developing direction on the test piece,
A test device for immunochromatography, wherein a control wall for guiding a leaked sample liquid shorter than a support on a top surface of the lower housing is provided.

  The device for immunochromatography test according to the present invention (hereinafter referred to as "the device of the present invention") has an optimal housing structure, so that even if the drop amount of the sample extracted from the patient is not appropriate, accurate determination It is possible to

FIG. 7 shows the lower housing of the device according to the invention. (A) is a top view, (B) is a cross-sectional view of dashed line A-A in (A), and (C) is a side view. Fig. 6 shows the upper housing of the device according to the invention. (A) is a top view, (B) is a reverse view, and (C) is a cross-sectional view of the broken line CC in (B). It is a figure which shows an example of the test piece used for an immuno chromatography test method. (A) is a perspective view of a test piece. (B) is a perspective view which shows use condition. FIG. 4A is a top view of the lower housing of the device of the present invention, and FIG. 4B is a cross-sectional view of a variation of the restriction wall 104 along the broken line B-B. It is a figure which shows the relationship of the width | variety of one support stand of this invention, and a test piece. It is the figure which illustrated the difference in deployment speed on a specimen. (A) is a top view of a lower housing, (B) is an upper housing, and is a figure showing the modification about the control wall of this invention device. It is sectional drawing of the state equipped with the test piece of this invention device, and is a figure which shows the modification regarding a control structure.

Hereinafter, the present invention will be described with reference to the drawings.
<Invention Device>
The device according to the present invention comprises a test piece 150 for inomm chromatography (hereinafter sometimes referred to simply as "test piece"), a lower housing 100 for mounting the test piece in a predetermined position, and a lower housing on which the test piece is mounted. It consists of the upper housing 200 which covers. 1 (A) is a top view of the lower housing, FIG. 1 (B) is a cross-sectional view of the lower housing along dashed line AA ', FIG. 1 (C) is a side view of the lower housing, and FIG. 2 (A) is an upper housing 2 (B) shows a back surface of the upper housing, and FIG. 2 (C) shows a side sectional view of a dashed line CC 'of the upper housing.

  FIG. 1 shows the configuration of the lower housing 100. In the lower housing 100, a lower housing main body 101, fixing projections 102 (arranged around the housing, eight points in this figure), a pair of first restriction walls 103 for restricting the movement of the test strip in the width direction, The second restriction wall 104, the third restriction wall 105, the fourth restriction wall 106 for restricting the movement of the test piece in the longitudinal direction, the fifth restriction wall 107, the test piece above the upper surface of the lower housing main body 101 A support base 108, a support base 109, a support base 110, a support base 111, and a pair of convex portions 112 and water holding concave portions 130 provided on both sides in the width direction of the test piece. Here, in the side view (C), a 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. In the upper housing 200, the upper housing main body 201, the dropping hole 202 for dropping a sample droplet, the inclined portion 203, the inclined portion 204, the detection window 205 where the test piece is exposed to confirm the presence or absence of the reaction, the inclined portion 206, the inclination Part 207, a hole 208 provided around the upper housing (eight locations in this figure) and engaged with the fixing projection 102 of the lower housing main body 101 to lock the upper housing main body 201 and the lower housing main body 101, a test piece A protrusion 209 for pressing 150 toward the lower housing, a protrusion 210, a protrusion 211 accommodated between a pair of protrusions 112 of the lower housing, and an upper surface 212 of the upper housing are included.

<Test strip for immunochromatography (test strip)>
FIG. 3 shows an example of an immunochromatographic test strip for influenza determination. When a sample liquid (in the case where the antigen 308 derived from influenza A is included) obtained by diluting a patient sample is dropped onto the sample pad 301 of the test strip, the sample liquid is transferred to the conjugate pad 302 impregnated with the gold colloid labeled antibody 309. Then, 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 spread on the membrane by capillary action in the direction of the arrow (deployment direction). The flow of liquid is indicated at 401 in FIG. 3 (A). Subsequently, the antigen 308 binds to either of the test antibody 1 (TL1) 305 and the complement antibody 310 or 311, which is an immobilized antibody of the test line 2 (TL2) 306. Since the complement antibody 310 has specificity for influenza A virus and the complement antibody 311 has specificity for influenza B virus, if the antigen 308 is derived from influenza A virus, it binds to the complement antibody 310 and TL1 305 Indicates a color. Furthermore, since the unreacted labeled antibody reaches the control line (CL) 307 and binds to the immobilized antibody 312 having specificity for the labeled antibody to cause color development, the developed state can be grasped. Further, the sample liquid is absorbed by the absorption pad 304.

<Appearance of housing>
The device for immunochromatography according to the present invention comprises a lower housing, and an upper housing 200 disposed so as to cover the test piece with the test piece for immunochromatography mounted on the lower housing 100 and the test piece 150 mounted thereon. The top surface 212 of the upper housing is provided with a drop hole 202 for introducing the sample fluid to the sample pad of the test piece, and the colored state of the test lines 305 and 306 and the control line 307 with the naked eye or optically It has a detection window 205 for detecting.

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 sample liquid introduction, but the sample liquid is evenly distributed in the width direction of the test piece. It is convenient to have a rectangular shape such as an ellipse or a rectangle having a width substantially equal to that of the test piece from the viewpoint of introducing. Among these, a rectangle is preferable. As for the rectangle of the dropping hole, it is desirable that the width of the dropping hole in the width direction of the test piece be equal to the width of the test piece and the length of the dropping hole in the longitudinal direction of the test piece be narrower than the width of the test piece . In FIG. 2 (A) 202, the long side is equal to the width of the test piece, and the short side is shown as a dripping hole narrower than the width of the test piece.
In addition, a window frame having a slope is provided around the dropping hole, and it is preferable that the window frame has a rounded semicircular shape because the dropping operation is easy. In FIG. 2A, a semicircular window frame is configured on the upstream side in the deployment direction by the inclined surfaces 203 and 204. By employing the quadrangular shape of the dropping hole and the rounded semicircular shape of the window frame, it is easy to drop the sample liquid, and the uniform development on the test piece becomes possible.
In addition, the inclined surface in the longitudinal direction (longitudinal direction in the device) of the window frame around the dropping hole 202 is a slope 203 with a gentle slope from the viewpoint of handling of sample liquid introduction and the sample liquid from the slope to the dropping hole with certainty. It is desirable to have a steep slope 204 so that is introduced. A gentle slope is preferably a slope in the range of 15 degrees 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 degrees 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 it may have a plurality of inclinations intermittently or continuously so as to finally reach the angle from a gentle angle. As described above, both the handling of the dropping operation and the appropriate introduction of the sample liquid can be realized by making the inclination of the introduction portion into the dropping hole asymmetric with respect to the longitudinal direction of the device. That is, when the sample liquid is introduced from a dropper or a pipette by a gentle slope, it is easy to operate since it can be confirmed to be dropped on the test piece, and the sample liquid is easily dropped and introduced into the test piece by a steep slope.
In addition, it is particularly convenient if the distance between the test piece 150 and the bottom portion 231 of the dropping hole 202 is 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 and the control line 307 of the test piece 150 can be detected with the naked eye or optically, and the number of openings can be determined as long as it functions as a detection window. The shape, formation site, etc. are not limited. For example, in the present embodiment, the openings along the longitudinal direction of the test piece in which each line can be confirmed simultaneously are illustrated, but for each line, a plurality of lines are simultaneously exposed, or only a part of those lines is exposed. It is good also as an opening part.
In addition, the inclined surfaces 206 and 207 around the detection window 205 are advantageously inclined surfaces with a gentle inclination, preferably 30 degrees to 60 degrees with respect to the upper surface of the housing.
When the length of the detection window opening is about the same as the width of the test piece 150, if the angle of the inclined surface (for example, the slope 207) is 40 degrees to 50 degrees, the test piece is detected from the outside with the naked eye or optical It is possible to prevent the shadow of the upper housing from falling onto 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 slope 206) is preferably 30 degrees to 60 degrees. These angles may have a plurality of slopes so as to finally become those angles from mild angles. In particular, when optically detecting, it is necessary to irradiate light from an oblique direction, and the configuration in which a shadow is not easily generated is even more important.
Also, in order to prevent the shadow of the upper housing from being applied to the test piece 150, the distance between the test piece 150 and the bottom 232 of the detection window 205 is 0 to 2.0 mm, preferably 0 to 0.5 mm. convenient. However, when the test piece is sandwiched between the bottom portion 232 and the lower housing support 110, if the bottom portion is not in contact with the test piece so as not to press it, the spread of the sample liquid on the test piece is affected. It is preferable because it is not given. In addition, the surface of the detection window 205 can be covered with a transparent plastic or the like to be a non-release window in the air. This makes it possible to reduce the influence of each line on the outside world.

The material of the housing of the device of the present invention is preferably a synthetic resin such as plastic, which is opaque, and acrylic, polyethylene, polypropylene, polystyrene such as high impact polystyrene, polystyrene alone or a combination thereof, etc., or an appropriate amount of filler 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. Furthermore, when each structural member is comprised from a different material, it can form by integral molding. Although the example which mounts one test piece was shown in this example, it may be constituted so that a plurality of test pieces may be arranged in the cross direction of a test piece.

<Internal structure of housing>
<Lower housing>
The lower housing 100 has a configuration for holding the test piece 150.
1. Restriction Wall The restriction walls 103 to 107 have a function of restricting the in-plane movement of the test piece 150 disposed on the lower housing 100 on the upper surface 120 of the lower housing 100. The restriction walls may be disposed at least one place in the longitudinal direction of the test piece in the longitudinal direction (regulation walls 106 and 107). In addition, with respect to the width direction of the test piece, at least one pair may be disposed on the side surface of the test piece, and an example in which three pairs are arranged in the longitudinal direction is shown in FIG. ).
The variation of the standing structure of the restriction wall in the present embodiment is shown in FIG. 4 (B) to FIG. 4 (F) as a vertical sectional view at the position of the broken line B-B 'in FIG. 4 (A). In these figures, the tops of the restriction walls 104 are all separated from the inserted test piece relative to the base, so that the test pieces can be easily inserted between the restriction walls. In (B), the cross-sectional shape of the regulation wall 104 is an isosceles triangle, (C) is a vertical triangle with the outer side being a right angle, and (D) is an example in which the tip portion of (B) is further narrowed. (E) is an example which has the same thickness from the base to the tip, and the tip is bent outward.
In (F), a projection 113 is provided immediately above the height at which the test piece 150 is positioned, to prevent the test piece from being removed from the normal position. In the figure of (F), although 113 is a protrusion, it is good also as a convex line object projected to the same height.
Here, although the control wall 104 is shown as an example, the other control walls can be configured similarly. The control wall is preferably injection-molded from the same material as the lower housing, but for example, a plate-shaped control wall made of a metal plate such as aluminum can be formed integrally with the resin of the lower housing. In this case, it is possible to insert and hold the test piece by deforming the shape of the restriction wall and inserting the test piece and then deforming to the original shape.

  Further, referring to FIG. 1A, the regulation wall 103 and the regulation wall 106 constitute a space for accommodating the end portion of the test piece on the lower side of the sample droplet, and excess sample liquid is contained in the area a divided by them. Can be held. Here, when the excess sample liquid exceeding the maximum holding amount of the area a is injected, the excess sample liquid is discharged from the gap s provided between the control walls 106. The gap s may be provided in a part of the restriction wall 106, preferably in the center. Furthermore, in the present embodiment, the height of the wall of the restriction wall 103 is as shown in FIG. 1C so that the excess sample liquid held in the area a does not further leak in the spreading direction through the support table 103. The lower part in the direction of development, the majority of the held sample liquid is adsorbed and held on the rear side of the control wall 106 by surface tension. In addition, a water absorption pad may be disposed on the upper surface of the area a or the outer side of the gap s to reduce the influence of leakage. Further, in the area a, a recess 130 communicating with the gap s is provided, and excess sample liquid is retained in the recess 130.

2. Supports The supports 108 to 111 support the test piece to be separated from the upper surface of the lower housing body 101. As a result, it is possible to prevent the sample liquid which has leaked from the sample pad and deviated from the original development route of the test strip from reaching the test strip again through the upper surface of the lower housing body. As a result, the risk of an erroneous determination can be reduced. The support base preferably has at least three elements for supporting the lower part of the dropping hole, the lower part of the test line and the control line, and the lower part of the end of the test piece in the developing direction (water absorption pad). If the height of the support table 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. In addition, it is convenient for the height of a support stand to be 2 mm or less from restrictions of the height of a housing.

Referring to FIG. 5, in the present embodiment, the width (W2) of the width direction (width direction of the test piece) of the support base 110 supporting the portion of the test piece exposed from the detection window among the supports is the test piece It is desirable for the width to be smaller than the width (W1), and more preferable to be smaller than the width of the detection window. With this configuration, the area of the test piece sandwiched between the bottom in the width direction of the detection window of the upper housing and the support 110 is small, preferably eliminated, and an unintended pressing force is applied to the test In the width direction of the test piece. The overhang length a of 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 for supporting the test piece portion exposed from the detection window is preferably 0.5 mm to 3.0 mm narrower than the test piece, more preferably 1.0 mm to 2.4 mm, still more preferably 1 It is .0 mm to 2.0 mm.
The height h of the support 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 for supporting the portion of the test piece exposed from the detection window is a group of several linear bodies or groups of point bodies in addition to a planar body such as a rectangular parallelepiped. It may be. Of these, sheet-like bodies are preferred. In the case of the linear body and the point body, the width of the support base may be such that the outermost distance of the linear body and the point body is smaller than the width of the test piece. The uppermost surface of the sheet, 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 for supporting the portion of the test piece exposed from the detection window contacts the test piece with an area and distance that does not bend by weight when the test piece absorbs the sample. The area of the support when the support is a sheet is desirably 50% or more of the area of the test piece exposed from the detection window, and more preferably 80% or more. When the support is a point or linear member other than a sheet, the contact area between the test piece and the support is 50% or more of the area of the test piece exposed from the detection window. Is desirable.

Referring to FIGS. 1A and 1B, in the present embodiment, a support 109 is added in addition to the supports 108, 110, and 111. The support stand 109 is a support stand disposed between the position corresponding to the detection window of the upper housing and the position corresponding to the dropping hole, and the width of the support stand is preferably larger than the width of the test piece . The width of the support is desirably 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 invading in the developing direction of the device when the sample liquid introduced in excess at the sample pad portion leaks, and the width of the sample liquid on the test strip on the support base 109 It has a function (rectifying action) to reduce the difference in the development speed in the direction. In order to make this rectifying action appropriate, the length of the support base 109 in the longitudinal direction (longitudinal direction of the test piece) is preferably 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 109 is closer to the support 110 than the middle of the support 108 and the support 110.

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

<Upper housing>
Referring to FIG. 2, the upper housing is provided with protrusions 209 and 210 for pressing the test piece 150 toward the lower housing.
3. The convex portion 209 and the convex portion 210 prevent the test piece 150 from rising from the lower housing 100, and the leaked sample liquid travels along the inner surface of the upper housing 200 to reach the test piece in front of the control line again. Prevent adverse effects on inspection results.
4. Dropper Hole The bottom 231 of the dropper hole 202 is designed to be close to the surface of the test piece 150 mounted on the device at an interval of 0 mm to 1 mm. Since the width of the dropping hole in the width direction of the test piece 150 is designed between a size about 3 mm smaller than the width of the test piece to a substantially equal size, the sample liquid is introduced into the test piece uniformly in the width direction of the test piece Ru. 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 uniform introduction 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 strip 150 mounted on the device at a spacing of 0 mm to 2 mm. Accordingly, the bottom portion 232 of the detection window 205 can prevent the test piece 150 from rising. The width of the opening in the width direction of the test piece 150 is designed to be about 1.5 mm smaller than the width of the test piece to about 0.5 mm smaller, so that dust etc. may enter the inside of the housing from the gap. There is not. In addition, the test piece overlaps with the support 110 excessively to give uneven load to the test piece and does not affect the determination result.

(Evaluation experiment 1)
The following experiment was conducted to investigate the relationship between the height of the support 110 supporting the test piece portion exposed from the detection window and the wrap around of the specimen extract (dilution liquid).
1. Experimental Method (1) Testing Device As the testing device, the upper housing 200 and the lower housing 100 of the present invention, and the test pieces 150 inserted into them were fixed to the support bases 108 to 111 were used. 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 110 (the height from the upper surface of the lower housing 101 to the position of the loading surface of the support, h in FIG. 5) was 0.3 mm in steps from 0 mm to 0.9 mm. On the test strip, a line was drawn with magic to confirm a defect in the sample extract flow behind the test line position on which the antibody was immobilized.
(2) Evaluation method Originally, when using 3 drops (80 to 120 μl) of the sample extract as the amount of sample to be dropped to the device of the present invention, 5 drops of physiological saline are dropped from the drop hole, and the same operation as the examination is performed. The test device was opened for 10 minutes, the test device was observed and the test piece was observed, and the line drawn by the magic on the back of the test piece rejected those that were blurred and those that did not smear were regarded as acceptable.
The experiment was repeated three times for the test devices of the supports 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 (the height from the upper surface of the lower housing of the test piece loading surface of the support) of the support supporting the test piece exposed from the detection window is more than 0.3 mm, more preferably 0.4 mm. As mentioned above, it turned out that it is 0.6 mm or more more preferably. With such a height, it is possible to avoid the influence of excess sample liquid flowing along the upper surface of the lower housing. In addition, it is convenient for the upper limit of the height of a support stand to be 2 mm or less from restrictions of the height of a housing. Physiological saline was used in this experiment, but similar results were obtained using other extracts.

(Evaluation experiment 2)
The following experiment was conducted to investigate the relationship between the height of the support 110 supporting the test piece portion exposed from the detection window and the wrap around of the specimen extract (dilution liquid). The difference from Evaluation Experiment 1 is that the width of the support 110 was smaller than that of the test piece.
1. Experimental Method (1) Testing Device The upper housing and the lower housing of the present invention as testing devices, and the test piece inserted into them, the width of the support 110 is set to be shorter by 1 mm 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 110 (h from the top surface of the lower housing 101 to the position of the loading surface of the support in FIG. 5) was set in steps of 0.2 mm from 0 mm to 1.2 mm.
(2) Evaluation method Originally, when using 3 drops (80 to 120 μl) of the sample extract as the amount of sample to be dropped to the device of the present invention, 5 drops of physiological saline are dropped from the drop hole, and the same operation as the examination is performed. The test piece was allowed to stand for 10 minutes, and the test piece was visually observed from the detection window, and the test piece rejected water absorption from both ends and rejected it as not-water absorption. The experiment was repeated 10 times for the test devices of the supports 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 (the height from the upper surface of the lower housing of the support) supporting the test piece exposed from the detection window may be 0.4 mm or more, preferably 0.6 mm or more. It turned out that it is preferably 0.8 mm or more. With such a height, the influence of extra sample fluid could be avoided. In addition, it is convenient for the upper limit of the height of a support stand to be 2 mm or less from restrictions of the height of a housing. Physiological saline was used in this experiment, but similar results were obtained using other extracts.

(Evaluation experiment 3)
The following experiment was conducted to examine the relationship between the height of the support 110 supporting the test piece portion exposed from the detection window and the width of the test piece.
1. Experimental Method (1) Test Device As the test device, the upper housing and the lower housing of the present invention and a test piece used for a normal test were used. The height (h in FIG. 5) of the support 110 is 0.6 mm, and the overhanging length of the test piece from the support (the distance from the end in the width direction of the support 110 to the end in the width direction of the test) In FIG. 5, a) from 0 mm to 1.5 mm were made in 0.25 mm steps.
(2) Evaluation method Originally, three drops (80 to 120 μl) of the sample extract used for a normal test are used for the test as the sample to be dropped to the device of the present invention. Five drops of physiological saline are dropped from the drop hole, Perform the same operation as at the time of inspection and leave it for 10 minutes, observe the test piece from the detection window visually, and reach the control line (CL) when the saline reaches the position of the control line and the saline reach The distance (L in FIG. 6) to the site (DL) at which it was delayed was rejected if it was 3 mm or more, and it was accepted if it was less than 3 mm. Each experiment was repeated 10 times, and the number of rejections 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 "Fail", for the cause of the failure, the expansion speed at both ends in the width direction of the test paper was slow due to the ends of the test piece being crushed in the housing etc. The samples were not in contact with the bottom of the housing, and the sample solution did not settle on both ends.
From the results, the optimum value of the overhang length a was determined to be 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 for supporting the test piece portion exposed from the detection window is preferably 0.5 mm to 3.0 mm narrower than the test piece, more preferably 1.0 mm to 2.4 mm, still more preferably 1 It is .0 mm to 2.0 mm. The same tendency was observed when the height of the support was 0.4 mm to 1.2 mm.

(Modification 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.
The example which provided the additional convex part 114 and the convex part 115 in the lower housing 100 to (A), and provided the additional convex part 215 to the upper housing 200 to (B) is shown. Each of the convex portions 114, 115, 215 has a liquid introducing structure for preventing the sample liquid leaked from the sample pad from contacting the test piece. The heights of these supplementary regulation structures are lower than the height of the support and the projections 209 and 210, and they do not directly contact the test piece. Particularly, the convex portion 114 in the lower housing 100 prevents the leaked liquid from the area a where the sample liquid can be accumulated from being transmitted in the developing direction of the sample, and the convex portion 115 is a judgment region (test line) And prevent the proximity of the area containing the control line). The convex portion 215 in the upper housing 100 prevents the leaked sample liquid from traveling further along the inner surface of the upper housing from the dropping window 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 convex portions 701 and 702 for regulating the test piece 150 in the height direction of the device.
The additional convex portion 701 is in contact with the lower surface of the test piece 150 and has a function of leading excess sample liquid to the area a. The additional protrusion 702 projects from the inner surface of the upper housing toward the test piece 150 and biases the opposite end of the test piece 150 in the deployment direction toward the lower housing.
As a result, excess sample liquid is introduced to the area a. 703 is a bottom portion located on the sample pad side in the longitudinal direction of the detection window opening, and by slightly contacting the test piece, prevents the rising of the test piece and brings about a rectifying action of the sample liquid in the width direction . Reference numeral 704 denotes a bottom portion located on the side of the longitudinal absorption pad of the detection window opening, which prevents the backflow of the sample fluid by slightly contacting the test piece. Even in this case, it is convenient if the bottom in the width direction of the opening of the detection window is not in contact with the test piece.

  As mentioned above, although the embodiment of the present invention was illustrated, the above-mentioned embodiment is an example to the last, and limiting the scope of the invention is not intended. The above embodiment can be implemented in other various forms, and various omissions, substitutions, and changes can be made without departing from the scope of the invention. Moreover, each structure, a shape, a magnitude | size, length, width, thickness, height, a number, etc. can be changed suitably and can be implemented. Furthermore, each embodiment can be combined to make a new embodiment.

  According to the present invention, it is possible to perform stable and accurate determination even when the drop amount of the sample is not appropriate when performing the test using the immunochromatographic test device.

100 lower housing 101 lower housing body 102 fixing projection
103 to 107 first to fifth regulation walls 108 to 111 support 112 convex portion 114 to 115 additional convex portion 130 water holding concave portion 150 test sample for inomu chromatography 200 upper housing 201 upper housing main body 202 dropping hole 203 for dropping sample droplets 204 inclined surface 205 detection window 206 to 207 inclined surface 208 hole 209 convex portion 210 concave portion 215 additional convex portion 231 drip hole bottom 232 detection window bottom 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 gold colloid labeled antibody 310, 311 Supplement antibody 312 Immobilized antibody 701-702 Additional convex portion 703-704 Bottom of detection window

Claims (12)

A test piece, a lower housing having a plurality of supports for supporting the test piece, and a dropping hole for dropping a sample onto the test piece, and a sample introduced from the dropping hole is on the test piece An immunochromatographic test device comprising an upper housing having a detection window in a developing direction,
The test device for immunochromatography whose width of the support stand arrange | positioned between the position corresponding to a detection window in the lower housing among the said several support stands and the position corresponding to the said dripping hole is larger than the width | variety of a test piece.   The length in the longitudinal direction of the test piece of the support table disposed between the position corresponding to the detection window and the position corresponding to the dropping hole in the lower housing is larger than 1/2 of the width of the test piece, The immunochromatographic test device according to claim 1, wherein the test device is narrower than the width of the test strip. A test piece, a lower housing having a plurality of supports for supporting the test piece, and a dropping hole for dropping a sample onto the test piece, and a sample introduced from the dropping hole is on the test piece An immunochromatographic test device comprising an upper housing having a detection window in a developing direction,
The control device for immunochromatography in which the control wall for fixing the position of a test piece is provided in the lower housing, and the thickness of the base by the side of the lower housing of the control wall is thicker than the thickness of the tip. A test piece, a lower housing having a plurality of supports for supporting the test piece, and a dropping hole for dropping a sample onto the test piece, and a sample introduced from the dropping hole is on the test piece An immunochromatographic test device comprising an upper housing having a detection window in a developing direction,
The lower housing is provided with a plurality of restricting walls for fixing the position of the test piece, and is a part of the restricting wall that restricts the longitudinal movement of the test piece disposed on the dropping hole side of the test piece The test device for immunochromatography that is open. A test piece, a lower housing having a plurality of supports for supporting the test piece, and a dropping hole for dropping a sample onto the test piece, and a sample introduced from the dropping hole is on the test piece An immunochromatographic test device comprising an upper housing having a detection window in a developing direction,
The lower housing of the test piece includes a control wall for fixing the position of the test piece, and the control wall for controlling the longitudinal direction of the drop hole side is the width direction of the drop hole side of the test piece The inspection device for immunochromatography, which is continuous with the restriction wall of and the height of the restriction wall in the width direction is reduced in the expansion direction of the lower housing.   The test device for immunochromatography according to any one of claims 1 to 5, wherein the height from the lower housing of at least one of the plurality of supports is at least 0.6 mm. A test piece, a lower housing having a plurality of supports for supporting the test piece, and a dropping hole for dropping a sample onto the test piece, and a sample introduced from the dropping hole is on the test piece An immunochromatographic test device comprising an upper housing having a detection window in a developing direction,
The upper housing is provided with a window frame having a sloping surface for dropping the sample around the dropping hole, and the sloping surface in the developing direction is not symmetrical with the sloping angle between the upstream sloping surface and the downstream sloping surface. There is a test device for immunochromatography.   The test device for immunochromatography according to claim 7, wherein the upstream inclined surface in the deployment direction is gentler than the downstream inclined surface.   The dripping hole is rectangular, the width of the dripping hole in the width direction of the test piece is equal to the width of the test piece, and the length of the dripping hole in the longitudinal direction of the test piece is narrower than the width of the test piece The test device for immunochromatography as described in any one of Claims 1-8.   The immunochromatographic test device according to claim 9, wherein the shape of the window frame is semicircular. A test piece, a lower housing having a plurality of supports for supporting the test piece, and a dropping hole for dropping a sample onto the test piece, and a sample introduced from the dropping hole is on the test piece An immunochromatographic test device comprising an upper housing having a detection window in a developing direction,
An inspection device for immunochromatography, wherein an inclined surface for observation is provided around the detection window, the inclined surface in the width direction of the device is 30 to 50 degrees, and the inclined surface in the longitudinal direction of the device is 40 to 55 degrees . A test piece, a lower housing having a plurality of supports for supporting the test piece, and a dropping hole for dropping a sample onto the test piece, and a sample introduced from the dropping hole is on the test piece An immunochromatographic test device comprising an upper housing having a detection window in a developing direction,
A test device for immunochromatography, wherein a control wall for guiding a leaked sample liquid shorter than a support on a top surface of the lower housing is provided.

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