WO2007026814A1

WO2007026814A1 - Test tool

Info

Publication number: WO2007026814A1
Application number: PCT/JP2006/317202
Authority: WO
Inventors: Mitsushi Gotanda
Original assignee: Fujirebio Inc.
Priority date: 2005-08-31
Filing date: 2006-08-31
Publication date: 2007-03-08
Also published as: JP2007064829A

Abstract

A test tool, wherein the seal member of a liquid container stored in a case body is broken out by the seal breaker of a cover part and a liquid in the liquid container is distributed up to a detection part so that when the seal member of the liquid container is broken by pushing down the seal breaker, the liquid in the liquid container can be prevented from being dispersed and the penetration of the liquid into a first absorber can be stably and uniformly performed. The seal breaker (9) comprises a breakage piece (22) and a pressing member (21) installed on the breakage piece (22) to cover the breakage piece. The breakage piece (22) is pressed by the pressing member (21) to directly break the seal member (3) of the liquid container (4) and dip the first absorber (5) in the liquid stored in the liquid container (4).

Description

Specification

Test tool

Technical field

The present invention relates to a disposable type test tool for detecting a measurement object in a specimen in immunoassay and the like.

Background art

[0002] Conventionally, as this type of test tool, there is known a type in which an object to be measured is developed with a developing solution and transferred to a detection unit, and is small, highly sensitive, and easily and quickly detected. It is supposed to be possible. One example of such a test tool is disclosed in Patent Document 1.

[0003] When this test tool is used, for example, in an enzyme immunoassay (EIA), as shown in FIGS. 5 and 6, the overall shape is an elongated box, and the case body 1 and the case body 1 schematically includes a lid 2 that covers 1. As shown in FIG. 6, the case body 1 contains a liquid container 4 that is hermetically sealed with a sealing member 3 such as an aluminum foil at one end in the longitudinal direction and filled with a developing liquid. The On the seal member 3 of the liquid container 4, a tape-shaped first absorbent material 5 is placed.

[0004] On one end side of the first absorbent material 5, one end of the tape-like second absorbent material 6 is located below the first absorbent material 5 and above the seal member 3. In addition, it is placed so as to overlap the first absorbent material 5. In addition, a third absorbent material 7 is placed on the second absorbent material 6 at a substantially intermediate position in the longitudinal direction. Furthermore, the fourth absorbent material 8 is placed on the other end side of the second absorbent material 6.

[0005] In the case of the first absorbent 5 described above, in the case of a specific enzyme, for example, alkaline hostase, a substrate that decomposes and develops color with this enzyme, such as sodium 5-bromo-4chloro-3-indolylphosphate ( BCIP) and water-absorbing non-woven fabric, filter paper, etc. containing p-trifluorophosphate are used. The second absorbent material 6 is a trocellulose membrane or the like having a detection part to which a first substance (for example, an antigen, an antibody, etc.) that specifically binds to the measurement target is immobilized. It is done.

[0006] The third absorbent 7 is labeled with the specific enzyme, for example, alkaline hostase. A water-absorbing nonwoven fabric or filter paper containing a second substance (for example, enzyme-labeled antigen, enzyme-labeled antibody, etc.) that specifically binds to the measurement object is used. For the fourth absorbent 8, a water-absorbing non-woven fabric, filter paper or the like is used without containing a reagent.

On the other hand, as shown in FIG. 5, a seal breaker 9, a specimen dropping window 10, a judgment window 11, and a transpiration window 12 are provided on the lid 2 covering the case body 1 from one end in the longitudinal direction. In order, they are provided at a predetermined interval toward the other end. The lid 2 has a seal breaker 9 on the liquid container 4 of the case body 1, a specimen dropping window 10 on the third absorbent 7, and a determination window 11 on the detector of the second absorbent 6. Above, the evaporating window 12 is superimposed on the case body 1 so as to stand on the fourth absorbent material 8;

As shown in FIG. 7, the seal breaker 9 has a large roof portion 13, a small roof portion 14 extending on the opposite side of the large roof portion 13, and lateral sides of the large roof portion 13 and the small roof portion 14. It is a dormitory-like member consisting of two side roof parts 15 and 15 that extend. Further, the ridge line portion that becomes the boundary of each of the roof portions 13, 14, 15 of the seal breaker 9 is a weakened line portion 16.

[0009] The weakened line portion 16 is a portion formed by reducing the thickness of the material forming the seal breaker 9, and the presence of the weakened line portion 16 allows the seal breaker 9 to be pressed when the seal breaker 9 is pushed down. Breaker 9 is irreversibly pushed. The large roof portion 13 of the seal breaker 9 is disposed on the second absorbent material 6 side.

Furthermore, a break protrusion 18 is provided to hang from the back side of the top of the large roof portion 13 of the seal breaker 9. When the seal breaker 9 is pushed down, the fracture protrusion 18 presses a part of the first absorbent material 5 downward, breaks the seal member 3 of the liquid container 4, and removes a part of the first absorbent material 5. The liquid container 4 is immersed in a developing solution filled therein. The fracture protrusion 18 is plate-shaped and is arranged so that its longitudinal direction is perpendicular to the longitudinal direction of the lid portion 2.

[0011] The case body 1 and the lid 2 are formed by precision injection molding of a thermoplastic resin such as low-density polyethylene or polypropylene, and a method of mechanically fitting the two is described. It is assembled by the method of heat welding!

[0012] In such a test tool, a sample solution is dropped onto the specimen dropping window 10, and the third absorbent 7 To absorb. Next, the large roof portion 13 of the seal breaker 9 is pushed down with a fingertip or the like. Thereby, as described above, the fracture protrusion 18 is pushed down, a part of the first absorbent material 5 is immersed in the developing solution in the liquid container 4, and the developing solution is absorbed from the first absorbent material 5 to the second absorbing material. Expands and moves to material 6, and further expands and moves toward fourth absorbent material 8. After a certain period of time, the detection part of the second absorbent material 6 is observed through the judgment window 11, the coloration in the judgment window 11 is confirmed, and the measurement object in the sample is judged positive or negative.

By the way, in using such a conventional test tool, as shown in FIG. 8 (a), an operation of pushing down the large roof portion 13 of the seal breaker 9 is performed. At this time, as shown in FIG. 8 (b), the fracture protrusion 18 first pushes down the first absorbent material 5 and then pushes down the seal member 3 of the liquid container 4 through the first absorbent material 5. , To break through.

[0014] In such a fractured state of the seal member 3, the first absorbent material 5 having a large thickness pushes through the seal member 3 and is pushed into the liquid. In some cases, the liquid could not be infiltrated. Further, depending on the pressing direction of the large roof portion 13, the seal breaker 9 pushes the absorbent material 5 into the liquid container 4 at an angle, so that the liquid permeation into the first absorbent material 5 may become uneven. It was.

Patent Document 1: Japanese Patent No. 3237540

Disclosure of the invention

Problems to be solved by the invention

[0015] Therefore, an object of the present invention is to prevent the liquid in the liquid container from splashing when the seal breaker is pushed down to break the seal member of the liquid container, and to the first absorbent material. It is to ensure that the liquid permeates in a stable and uniform manner.

Means for solving the problem

[0016] In order to solve the problem,

The case body, and

A lid covering the case body;

The case body is provided with a liquid container sealed with a seal member and a first absorbent material placed on the seal member of the liquid container,

A seal breaker is formed on the lid, and the seal breaker further The lid is attached to the case main body so as to be positioned on the first absorbent material, and the seal breaker includes a broken piece and a pressing member provided so as to cover the broken piece. ,

The broken piece, when pressed by the pressing member, directly breaks the sealing member of the liquid container and immerses the first absorbent in the liquid in the liquid container.

Provide test equipment.

[0017] Further, the present invention provides the above-described test tool,

The pressing member has a wall portion and a single-flow roof portion provided continuously to the wall portion,

The lower part of the roof part is rotatably attached to the lid part,

The lower force of the wall part is detachably attached to the lid part,

The broken piece is plate-shaped, and only one end portion in the longitudinal direction is rotatably attached to the lid portion, and a break protrusion is provided at the other end portion in the longitudinal direction.

Provided is a test tool provided so that the breaking protrusion is located outside the first absorbent material.

[0018] The present invention also provides

An engagement recess is formed in the wall of the pressing member,

The lid portion is provided with an engaging convex portion that is detachably locked to the engaging concave portion,

In the state where the pressing member is not pressed! /, The engaging convex portion and the engaging concave portion are engaged with each other, and the pressing member protrudes upward from the lid force.

In the state after the pressing member is pressed, the upper part of the wall part is locked by the engaging convex part and cannot return to the original position before the pressing! provide.

The invention's effect

According to the present invention, when the pressing member is pushed down with a finger or the like, the engagement between the engaging convex portion and the engaging concave portion is released, and the pressing member itself is rotated and pushed down. By pushing down the pressing member, the broken piece rotates and is pushed down. First, the breaking projection at the tip directly pushes the sealing member of the liquid container. In other words, the position of the fracture protrusion of the broken piece is determined so as to be outside the first absorbent material, so that the seal is provided via the first absorbent material. The member is not pushed through.

[0020] Subsequently, the broken piece pushes down the first absorbent material by further pushing down the pressing member, and the first absorbent material is immersed in the liquid in the liquid container by expanding the gap of the seal member that has already been broken. The By performing such an operation, when the first absorbent material is immersed in the liquid in the liquid container, it is not soaked rapidly, and the liquid does not scatter. In addition, since the first absorbent material is pushed by the plate-shaped fracture piece, the end of the first absorbent material is wide, and the liquid penetrates stably and evenly in the area. To be done.

[0021] Further, after the pressing-down operation of the pressing member is completed, the upper portion of the wall portion of the pressing member is locked to the engaging protrusion, and the upward rotation of the pressing member is prevented and the original state is restored. There is nothing. For this reason, it is easy to visually recognize whether the test tool has been used or after use.

[0022] Further, when the pressing member is not pushed down, the locking projection of the lid is fitted to the locking recess of the pressing member, and is not pushed down by applying a certain amount of force (1 to 2 kg). As long as the pressing member is not pushed down. For this reason, it is possible to prevent erroneous operation and to confirm that the appearance force test tool is not used.

Brief Description of Drawings

FIG. 1 is a schematic cross-sectional view showing an example of a main part of a test tool of the present invention and showing a state before use.

2 is a longitudinal sectional view taken along line II-II in FIG.

FIG. 3 is a schematic cross-sectional view showing a state after use in the test tool of the present invention.

FIG. 4 is a drawing showing an example of a combination of absorbent materials in the test tool of the present invention.

FIG. 5 is an upper plan view showing a conventional test tool.

FIG. 6 is a longitudinal sectional view taken along line II II ′ of FIG. 5 showing a conventional test device.

FIG. 7 is a schematic sectional view showing a seal breaker in a conventional test tool.

FIG. 8 is an explanatory view showing the operation of a seal breaker in a conventional test tool.

Explanation of symbols

[0024] 1. · · Case body

2 3 ... Seal material

4 ... Liquid container

5 ',' first absorbent material

6 ··· Second absorber

9 ··· Seal Breaker

21 ... Pressing member

22 ... Fragment

23Α ··· Wall

24 ... Roof

25 ··· engagement recess

29 ... Break protrusion

30 ... engagement convex

BEST MODE FOR CARRYING OUT THE INVENTION

Hereinafter, the present invention will be described in detail with reference to the drawings. FIG. 1 and FIG. 2 show an example of a seal breaker, which is a main part of the test tool of the present invention, and its peripheral part, and the other parts are the same as the conventional ones described above. Is omitted. FIG. 1 is a cross-sectional view of the test tool taken along the longitudinal direction, and the same reference numerals are given to the same constituent elements as those of the conventional device. 2 is a cross-sectional view taken along line II-II in FIG.

In this example, the seal breaker 9 is generally composed of a pressing member 21 and a broken piece 22. The pressing member 21 includes one wall portion 23A having a rectangular planar shape arranged in a substantially vertical direction, and two side wall portions (not shown) having a triangular planar shape extending to the side of the wall portion 23A. The roof portion 24 is composed of a wall portion 23A and a roof portion 24 which is slanted in a single stream and is connected to the upper portion of the side wall portion and has a rectangular planar shape. A groove-like engaging recess 25 extending in the horizontal direction is formed on the outer surface of the lower portion of the wall portion 23A.

[0026] A plurality of small hemispherical concave portions 26, 26, ... are formed on the outer surface of the roof portion 24 so as to function as a non-slip. The lower portion of the roof portion 24 is attached to the lid portion 2 so as to be rotatable. In other words, around the seal breaker 9 in the lid 2 The embankment 27 is formed so as to surround the embankment 27. A shaft support hole (not shown) is formed at two opposite locations of the embankment 27, and the roof 24 A shaft rod (not shown) extending in the lateral direction from the lower part is inserted into the press member 21, so that the pressing member 21 is rotatably attached to the lid 2. Further, two reinforcing ribs 21A and 21A extending in the longitudinal direction are provided in the inner space of the pressing member 21 in parallel with each other.

The broken piece 22 is positioned below the pressing member 21 and is provided so as to be covered by the pressing member 21. The fracture piece 22 is made of a plate material having a rectangular planar shape, and reinforcing ribs 28 are formed along its longitudinal direction. In addition, the fracture piece 22 is attached to the bank portion 27 of the lid portion 2 via the hinge portion 27A only at the base end portion in the longitudinal direction, and the other peripheral portions are separated from the bank portion 27, and Therefore, the broken piece 22 is rotatable with respect to the lid 2.

Further, on the lower surface side of the distal end portion in the longitudinal direction of the fracture piece 22, four small fracture projections 29, 29,... Are arranged in a row in the lateral direction.

[0028] The bank portion 27 is provided with a bank-like engaging convex portion 30 protruding in the horizontal direction at a position corresponding to the engaging concave portion 25 formed in the wall portion 23 of the pressing member 21. The engaging convex portion 30 and the engaging concave portion 25 are elastically deformed so that they can be locked or separated from each other, so that the pressing member 21 can be detached from the lid portion 2. .

[0029] Furthermore, the lower end surfaces of the two reinforcing ribs 21A, 21A provided in the inner space of the pressing member 21 and the side wall portion are in contact with the pressing member 21 so that the upper surface of the fracture piece 22 is substantially in contact. Fragments 22 and are positioned.

[0030] In addition, the position of the tip of the first absorbent member 5 is inwardly lower than the position of the breaking protrusions 29, 29 · at the tip of the broken piece 22, and the breaking protrusions 29, 29 · · This prevents it from hitting the first absorbent 5 when it goes down.

In the figure, reference numeral 4 indicates a liquid container provided in the case body 1, and reference numeral 3 indicates a sealing member such as an aluminum foil that seals the opening of the liquid container 4. In the liquid container 4 in this example, the shape of the bottom 31 is slightly different from the conventional one. As shown, the bottom 31 includes a front part 32 inclined rearward and a substantially horizontal intermediate part 33 and a front part inclined forward. Part 34 is also powerful.

[0032] The length of the rear portion 34 occupies almost half of the length of the liquid container 2, and the length of the front portion 32 is considerably shorter than that. As a result, a large amount of liquid is accumulated in the tank. As a result, even with a small amount of liquid, the liquid can be reliably infiltrated without remaining in the liquid container 2. The state shown in FIGS. 1 and 2 is a depiction of the state before using the test tool.

[0033] When the test tool of this example is used, the pressing member 21 of the seal breaker 9 is pushed down with a fingertip or the like. At this time, since the engaging concave portion 25 of the pressing member 21 and the engaging convex portion 30 of the bank portion 27 are in a locked state, the force applied is released only when a force of about 1 to 2 kg is applied. Thus, the pressing member 21 is rotated about the shaft rod and pushed down.

[0034] Since the lower end surfaces of the reinforcing rib 21A and the side wall portion of the pressing member 21 are substantially in contact with the upper surface of the fracture piece 22, the fracture piece 22 is also pushed downward simultaneously with the pressing of the pressing member 21. When the broken piece 22 is pushed down, the broken projections 29, 29... Hit the seal member 3 of the liquid container 4 and break through it.

[0035] By further pressing down the pressing member 21 and the broken piece 22, the first absorbent member 5 is pushed into the liquid container 4 while expanding the gap generated by breaking through the partial force seal member 3 on the tip side. The first absorbent material 5 is immersed in the liquid. As shown in FIG. 2, the first absorbent material 5 immersed in the liquid of the liquid container 4 is pushed in the entire broken piece 22 and conforms to the shape of the bottom 31 of the liquid container 4. Become a state and speak.

FIG. 3 shows a state in which the pressing member 21 is pushed down. In this state, the upper portion of the wall portion 23A of the pressing member 21 hits the engaging convex portion 30 provided on the bank portion 27 and moves upward. The movement is prevented, and the pressing member 21 and the broken piece 22 do not return to the original state before use.

[0037] For this reason, in the test tool of this example, when the pressing member 21 is pushed down, the broken piece 22 2 is rotated and pushed down. First, the breaking protrusions 29 · 29 · · · The seal member 3 is directly pushed through. That is, the sealing member 3 is not pushed through the first absorbent material 5.

[0038] For this reason, when the first absorbent 5 is immersed in the liquid in the liquid container 4, it is immersed rapidly. And no liquid scatters. Further, since the first absorbent 5 is pushed by the plate-shaped fracture piece 22, the first absorbent 5 is submerged in the liquid over a large area, so that the liquid permeation is stably and uniformly performed. Is called.

[0039] After the pressing-down operation of the pressing member 21, the upper portion of the wall portion 23A of the pressing member 21 is locked to the engaging convex portion 30, and the upward rotation of the pressing member 21 is prevented. There is no return to the original state. For this reason, it is easy to visually recognize that the test tool has been used.

[0040] Further, in a state where the pressing member 21 is not pushed down, the locking convex portion 30 of the lid portion 2 is fitted to the locking concave portion 25 of the pressing member 21, and a certain amount of force (l to 2kg) The pressing member 21 is not pushed down unless it is pushed down by adding. For this reason, it is possible to prevent erroneous operation and to confirm that the appearance force of the test tool is not used.

[0041] In addition, since the shape of the bottom 31 of the liquid container 4 is as shown in the figure, most of the liquid is absorbed by the first absorbent 5 and the waste of the liquid is eliminated.

[0042] Figs. 4 (a) to (d) show two examples of an absorbent material for performing an immunoassay with the test device of the present invention. (A) and (b) are the first examples. For example, (a) is a plan view and (b) is a cross-sectional view. Further, (c) and (d) show a second example, (c) is a plan view, and (d) is a sectional view. In these drawings, the same components as those of the conventional one shown in FIG. 6 are denoted by the same reference numerals.

[0043] In the case body 1 of the test tool, a member composed of a plurality of absorbent members is mounted. A plurality of these members constitute an absorbent material for a test tool by cutting a nitrocellulose membrane, filter paper, non-woven fabric, etc. into a predetermined length and then superposing them. In the test tool of the present invention, as described above, the seal breaker 9 and the first absorbent material 5 that are pushed down by the pressing member 21 are close to the fracture protrusion 29 provided on the seal breaker 9, but do not come in contact! Positioning is preferred for efficient testing.

Therefore, as shown in FIGS. 4 (a) to (d), the plurality of members used in the test tool are preferably attached and fixed at predetermined positions on the water-insoluble sheet 26. Examples of the water-insoluble sheet 26 include thermoplastic resin such as polyethylene, polypropylene, and polystyrene. It is preferable to use water-impermeable coated paper or the like. The sheet 26 may have the same width as the plurality of absorbent materials as shown in FIG. 4 (a), or may be wider than the absorbent as shown in FIG. 4 (c). In order to fix a plurality of absorbent materials to the sheet 26, it is possible to use an adhesive that does not affect the development speed and inspection, or use a fixing needle or the like.

Further, as shown in FIGS. 4 (a) to (d), a protrusion (not shown) provided on the case body 1 is formed at the end of the sheet 26 prepared by the above method on the fourth absorbent material 8 side. An opening 37 can be provided. This opening 37 facilitates positioning of a plurality of absorbent members to the case body 1 and improves the manufacturing process as well as providing a reproducible performance in which the seal breaker 9 and the first absorbent member 5 are positioned. It is possible to produce a test tool having the same.

Industrial applicability

[0046] In the test device of the present invention, when the seal breaker is pushed down to break the seal member of the liquid container, the liquid in the liquid container is prevented from splashing and the liquid permeation into the absorbent material is stable. And can be performed uniformly. It can be used as a disposal-type test tool for detecting an object to be measured in a sample for immunoassay.

Claims

The scope of the claims

[1] case body, and

The lid force that covers the case body;

The case body is provided with a liquid container sealed with a sealing member, and a first absorbent material placed on the sealing member of the liquid container,

A seal breaker is formed on the lid,

The lid portion is attached to the case body so that the seal break force is located on the first absorbent material.

The seal breaker includes a broken piece and a pressing member provided so as to cover the broken piece.

Test tool.

[2] The pressing member has a wall portion and a single-flow roof portion continuously provided on the wall portion,

The lower part of the roof part is rotatably attached to the lid part,

The lower part of the wall is removably attached to the lid,

The test tool according to claim 1, wherein the breaking protrusion is provided so as to be located outside the first absorbent material.

[3] An engagement recess is formed in the wall portion of the pressing member,

In the state after pressing the pressing member, the upper part of the wall part is locked by the engaging convex part, and it cannot return to the original position before pressing!

The test device according to claim 2.