JP5249534B2 - Test paper measuring container - Google Patents

Description

  The present invention relates to a test strip measuring container for detecting the concentration of an antibody contained in a sample.

In general, it is known that bacteria called Helicobacter pylori (HP) exist as a cause of gastric ulcer and gastritis.
If HP is present in the patient's stomach, it is necessary to perform sterilization treatment by administration of antibiotics. Therefore, it is important to check whether HP is present in the patient.
As a method for diagnosing HP infection, a method of detecting an antibody against HP in blood (antibody detection method) is known. Antibody detection methods are widely used because of their simplicity and economy.

In recent years, it has been known that HP infection diagnosis can be performed by detecting HP antibody present in urine instead of HP antibody in blood.
In order to detect this HP antibody in urine, a test paper measurement method is known in which a test paper is immersed in urine and the change in color is measured to determine positive or negative.
In this measurement method, a urine sample solution diluted with a sample solution diluent is dropped onto a sample solution window of a case containing a long and narrow test paper. The urine sample solution moves sideways across the test paper by capillary action, and is captured by reacting with the solid-phased HP antigen placed on the test paper (see Patent Documents 1 and 2 below).

Such a test strip measurement method not only detects HP antibodies present in urine, but generally samples fluids (blood such as whole blood, plasma and serum, urine, saliva, joint fluid, bone marrow fluid, etc.) Furthermore, it is used to capture specific antigens and specific antibodies contained in stool, sputum, pharyngeal and nasal wipes, and lung lavage fluid.
For this capture, (1) an antibody or an antigen is immobilized on a carrier such as nitrocellulose, plastic or filter paper. (2) Sandwiched antibody (antigen complex formation) with an antibody or antigen labeled with a colloidal gold or colored latex, and the antigen or antibody captured by the immobilized antibody or antigen. The structure of the immune complex formed includes (solid phase antibody: antigen in sample solution: labeled antibody), (solid phase antigen: antibody in sample solution: labeled antibody), (solid phase antigen: antibody in sample solution: Labeled antigen). (3) The portion where the sandwich is formed is colored with colloidal gold or colored latex. With such a mechanism, the determination can be made visually or by an apparatus.

Such a test strip measurement method is also referred to as an “immunochromatography measurement method”.
There are roughly two types of measurement systems for performing immunochromatographic measurement methods.
First, as shown in FIG. 12 and FIG. 13, a test paper 102 is built in a case 101 made of plastic or paper, and a sample solution is dropped into a window 103 provided on the case and measured. I do. The measurement systems described in Patent Documents 1 and 2 below are also of this type. A feature of this system is that once the sample solution is applied, the tester does not have to worry about touching the contaminated contents.

In the other method, as shown in FIGS. 14 and 15, a stick-shaped test paper 201 is placed vertically in a container 202 such as a test tube, and the sample liquid is sucked up onto the test paper to perform measurement. . In this measurement system, measurement can be performed in a vertically standing container 202. Therefore, there can be considered a merit in practice such as not requiring a place when measuring a large number of sample liquids.
However, when measuring in a vertically standing container 202, the line portion may be hidden depending on the structure of the container 202 used for the measurement, making it difficult to make a visual judgment result, and the stick-shaped test paper 201 is removed from the container 202. The situation to check out occurs. Since the sample liquid is infiltrated into the stick-shaped test paper 201, there is a high possibility that the tester directly touches it. There is a similar risk when presenting results to the patient.

Therefore, recently, measurement systems using cases are the mainstream from the viewpoint of preventing contamination.
JP 11-295311 A International publication WO 01/57502 A1 pamphlet

When the system using the case is adopted, the following problems have been pointed out.
(1) Clogging of test paper: When the above-mentioned HP antibody present in urine is carried out in a system that uses a case, minute sedimentation present in urine accumulates on the test paper and causes clogging. Has been reported.
The following points can be considered as a major reason for clogging in a measurement system using a case.

(1-1) The sample solution was applied to a test paper with a small pore size,
(1-2) The sample solution was applied to a small sample solution window (“ 104 ” in FIG. 13) having a diameter of about 5 mm on the case.
(1-3) The sample liquid was dropped from the top of the test paper,
From the above three factors, it is considered that urinary sediment was deposited on the small sample liquid window and clogged the test paper having a small pore size.

  The problem (1) can be solved by widening the contact surface between the test paper and the sample liquid and using a test paper having a large pore size. However, in a measurement system using a case, the sample liquid window Since the sample liquid is dropped on top, the sample liquid dropped due to the influence of gravity flows into the test paper in the case all at once and moves in a large amount in the test paper in a short time.

  (2) Difficulty in assembly: In a measurement system using a case, as shown in FIG. 16, it is essential to place a strip-shaped test paper 102 in a predetermined position inside the case and close the upper and lower lids of the case 101. Become. It is difficult to force the user to perform this assembling work, and a product form packaged in a case in advance is required. However, in the manufacturing process, it is complicated and expensive to close the case by placing a strip-shaped stick in the case at a predetermined position.

  Therefore, it is desired to develop a test paper measuring container in which clogging of the test paper is unlikely to occur and the user can easily and quickly place the test paper in a fixed position of the case.

In view of this, the present inventors have invented a structure of a test paper measuring container in which a test paper having a large pore size can be placed almost horizontally at a predetermined position of the case and sucked up in a horizontal direction or an oblique horizontal direction.
The test paper measuring container of the present invention uses an elongated case, and is connected to a test paper installation groove for installing the test paper on the upper surface of the case, and an extension line of the test paper installation groove, for storing the sample liquid. Forming a first recess, and a second recess for dropping the sample liquid transmitted through the gap between the case and the test paper, formed between the test paper installation groove and the first recess. Yes.

  The tester does not need any complicated operation or force, and simply installs the test paper in the test paper installation groove formed in the case or simply slides the test paper along the test paper installation groove. Paper can be placed in the case. The specimen is smoothly absorbed into the test paper, and visual observation is easy. Further, even if the sample liquid flows through the gap between the test paper and the case, the tester is hardly contaminated because it enters the second recess.

  The measuring method using this test paper measuring container is as follows. First, a test paper with a large pore size is installed in the test paper installation groove on the upper surface of the case. At this time, the leading end of the test paper is accommodated in the first recess. The “test paper having a large pore size” is a test paper that can be measured by sucking up a sample liquid vertically, and has a relatively large pore size and can easily suck up the sample liquid. Next, the sample liquid is dropped into the first recess, and the sample liquid is sucked up using a test paper. Thus, the tester can easily determine the measurement result visually without directly touching the test paper. In addition, the measurement result may be presented to the patient with the case portion. Since the tester can perform the measurement without touching the test paper, there is no need to worry too much about infection and contamination.

A bottom surface of the test paper installation groove, forms a lower surface at a predetermined angle of the case, we are inclined toward the first recess. If the test paper is installed along the inclined test paper installation groove, the tip of the test paper is thrust into the first recess, so that if the sample liquid is dropped into the first recess, the sample liquid Will be sucked out automatically.
A bottom surface of the first recess, that have a guide surface for along the tip of the installed test paper on the test paper installation groove. With this guide surface, the leading end of the test paper set along the inclined test paper setting groove easily enters the first recess.

  The case further includes a lid portion for covering the first recess, and the lid portion presses the tip of the test paper installed in the test paper installation groove against the bottom surface of the first recess. It may be a structure having a pressing piece. With this lid structure, when the lid is closed, the tip of the test paper installed in the test paper installation groove can be pressed against the bottom surface of the first recess. Even if it does not take the structure to incline, the front-end | tip of a test paper can be immersed in the sample liquid of the said 1st recessed part.

  It is preferable that the test paper installation groove is formed so as to open upward so that the test paper can be easily installed from above and can be visually observed.

  As described above, according to the present invention, since the sample liquid is sucked up from the horizontal direction or the oblique horizontal direction using the large pore size test paper having a wide contact area with the sample liquid, the tester has a complicated structure. Without requiring operation or force, simply place the test paper in the test paper installation groove formed on the upper surface of the case and open it, or simply slide the test paper along the test paper installation groove. Can be installed. Even if the sample liquid flows through the gap between the test paper and the case, it enters the second recess, so that the tester is rarely contaminated.

  Therefore, it is not necessary to manufacture the test paper in a form incorporated in the case, and the manufacturing cost can be reduced.

Hereinafter, embodiments of the present invention will be described in detail with reference to the accompanying drawings.
FIG. 1 is a plan view showing a test strip measuring container according to the first embodiment of the present invention, and FIG. 2 is a side sectional view. FIG. 3 is a perspective view showing the entire test paper measuring container.
The test paper measuring container is connected to an elongated case 2, a test paper installation groove 3 formed on the upper surface of the case 2 for installing the test paper, and an extension line of the test paper installation groove 3 formed on the upper surface of the case 2, A first recess 4 for storing the sample liquid and a second recess 5 formed between the test paper installation groove 3 and the first recess 4 are provided.

The case 2 as a whole is made of synthetic resin and can be folded, a lid portion 6 that can be folded, an intermediate portion 2i in which the first concave portion 4 and the second concave portion 5 are formed, and a test paper placement portion in which the test paper placement groove 3 is formed. 2j.
On both sides of the test paper placement portion 2j, there are walls 7 that are tall and raised, and a test paper placement groove 3 is formed in the middle of these raised walls 7. The test paper installation groove 3 is formed to open upward so that the test paper can be installed from above.

  The width w of the test paper installation groove 3 is wider than the width e of the test paper so that the tester can easily install the test paper from above the case 2 without requiring a complicated operation or force. It has become. Specifically, the difference (w−e) between the width w of the test paper installation groove 3 and the width e of the test paper may be 0.2 to 3.0 mm, and preferably 0.4 to 2.0 mm. The bottom surface of the test paper installation groove 3 is a substantially flat surface and is inclined toward the first recess 4 at a predetermined angle θ with the lower surface 2k of the case 2 (see FIG. 2). Since the lower surface 2k of the case 2 is normally installed horizontally, the bottom surface of the test paper installation groove 3 is inclined toward the first recess 4 at an angle θ from the horizontal plane. A preferable range of the angle θ is 5 to 20 degrees, desirably 8 to 12 degrees. If θ is smaller than 5 degrees, it becomes difficult for the tip of the test paper to contact the sample liquid dropped on the first recess 4. If θ is greater than 20 degrees, the test paper may be bent and deformed when the leading edge of the test paper contacts the first recess 4.

  The 1st recessed part 4 formed in the intermediate part 2i is a recessed part for storing a sample liquid. Of the bottom surface of the first recess 4, a portion on the extension of the test paper installation groove 3 serves as a guide surface 4 a for keeping the tip of the test paper installed in the test paper installation groove 3 along. The guide surface 4a on the bottom surface of the first recess 4 preferably forms a flat surface smoothly connected to the bottom surface of the test paper installation groove 3. This is because the leading edge of the test paper introduced into the test paper installation groove 3 is smoothly accommodated in the first recess 4 if the flat surface is smoothly connected.

  The second concave portion 5 formed between the test paper setting groove 3 and the first concave portion 4 is a sample that rises along the gap between the test paper set in the test paper setting groove 3 and the case 2. It is a recessed part for trapping a liquid. The installation position of the second recess 5 is 8 to 20 mm, preferably 12 to 18 mm, where y is the distance between the second recess 5 and the tip of the guide surface 4a. The width x of the second recess 5 along the test paper introduction direction is 2 to 8 mm, preferably 3 to 6 mm.

  Between the intermediate part 2i and the lid part 6, the thickness of the resin is thin, and the lid part 6 can be folded by folding back the thin part. An opening 8 is provided at the center of the lid 6 so that the sample liquid can be dropped into the first concave portion 4 so that the test paper can be in contact with the collected sample liquid. A protrusion 10 that engages with a small hole 9 formed in the intermediate portion 2 i when the lid 6 is folded is provided at the tip of the lid 6.

  FIG. 4 is a cross-sectional view showing the usage state of the test paper measuring container. A test paper T is installed in the test paper installation groove 3 so that the tip of the test paper T enters the first recess 4. The sample liquid S is dropped from the opening 8 with the lid 6 folded. The sample liquid S accumulates in the first concave portion 4 and comes into contact with the tip of the test paper T and is sucked up obliquely upward. At this time, the sample liquid S rising through the gap between the upper surface of the test paper installation groove 3 and the lower surface of the test paper T by the capillary phenomenon is trapped in the second recess 5 and accumulated in the second recess 5. Go. Therefore, the possibility that the sample liquid S adheres to the test paper setting portion 2j of the case 2 is reduced, and even if the tester touches the case 2, the possibility that the tester's finger touches the sample liquid S is reduced.

FIG. 5 is a plan view showing a test paper measuring container according to the second embodiment of the present invention, and FIG. 6 is a side sectional view. FIG. 7 is a perspective view showing the entire test paper measuring container.
The test paper measuring container includes an elongated case 2, two side walls 7 formed on the upper surface of the case 2, a test paper installation groove 3 formed between the side walls 7 for installing the test paper, and a case The first recess 4 is formed on the upper surface of the test paper 2 and is connected to the extension line of the test paper installation groove 3 to store the sample liquid S. The first recess 4 is formed between the test paper installation groove 3 and the first recess 4. 2 recesses 5.

The entire case 2 is formed of a synthetic resin, and includes a lid portion 6 that can be folded, an intermediate portion 2i in which the first concave portion 4 and the second concave portion 5 are formed, and a test paper installation groove 3 for installing the test paper. It can be divided into the formed test paper placement section 2j.
The test paper installation groove 3 formed in the test paper installation unit 2j is formed to open upward so that the test paper can be installed from above. The width w of the test paper installation groove 3 is wider than the width e of the test paper, so that the tester can easily install the test paper from above the case 2 without requiring a complicated operation or force. ing. Specifically, the difference (we) between the width w of the test paper installation groove 3 and the width e of the test paper may be 0.2 to 3.0 mm, and is preferably 0.4 to 2.0 mm.

  The 1st recessed part 4 formed in the intermediate part 2i is a recessed part formed in order to accumulate the sample liquid S dripped. A guide surface 4b that is deeper than the bottom surface of the first recess 4 is formed on a part of the bottom surface of the first recess 4 so that the front end of the test paper T installed in the test paper installation groove 3 is aligned. ing. The bottom surface of the guide surface 4b is a straight line when viewed from the side (see FIGS. 6 and 8).

  The second concave portion 5 formed in the intermediate portion 2 i is a concave portion for trapping the sample liquid S that rises in the gap between the test paper set in the test paper setting groove 3 and the test paper setting groove 3. The installation position of the second recess 5 is 8 to 20 mm, preferably 12 to 18 mm, where y is the distance between the second recess 5 and the tip of the guide surface 4b. The width x of the second recess 5 along the test paper introduction direction is 2 to 8 mm, preferably 3 to 6 mm.

The surface around the first recess 4, the surface around the second recess 5, and the test paper placement groove 3 are in the same plane. This plane is represented by “2u”. The plane 2u is parallel to the lower surface 2k of the case 2. Therefore, when the case 2 is installed on a horizontal base, the plane 2u also becomes a horizontal plane.
Between the intermediate part 2i and the lid part 6, the thickness of the resin is thin, and the lid part 6 can be folded by folding back the thin part. The lid portion 6 is formed by two pieces 6a and 6b connected from the intermediate portion 2i. The space existing between the pieces 6a and 6b is an opening 8 through which the sample liquid S can be dropped into the first recess 4. Through this opening 8, it is possible to visually check whether or not the test paper T is in contact with the collected sample liquid S. Each piece 6a, 6b is provided with a protrusion 10 that engages with a small hole 9 formed in the intermediate portion 2i when the lid portion 6 is folded.

  Further, folded pieces 12a and 12b are formed on the pieces 6a and 6b, respectively, which are folded back from the tip of the lid 6 toward the center of the opening 8. On the folded pieces 12a and 12b, pressing pieces 11a and 11b for pressing the tip of the test paper installed in the test paper installation groove 3 against the guide surface 4b of the first recess 4 are erected. The shape of the pressing pieces 11 a and 11 b is a shape corresponding to the guide surface 4 b of the first recess 4. The distance between the holding piece 11a and the holding piece 11b is represented by “v”. This distance v is preferably smaller than the width e of the test paper. Specifically, the difference (e−w) between the width e of the test paper and the width v of the test paper installation groove 3 may be 0.2 to 3.0 mm, and is preferably 0.4 to 2.0 mm.

  FIG. 8 is a cross-sectional view showing a use state of the test paper measuring container. The test paper T is set in the test paper setting groove 3 so that the front end of the test paper T covers the first recess 4 in a plan view. When the lid portion 6 is folded in this state, the pressing pieces 11 a and 11 b of the lid portion 6 press the leading end portion of the test paper T, and the leading end portion of the test paper T is formed on the bottom surface of the first recess 4. Press against surface 4b. By this pressing, the leading end of the test paper T is bent downward. Thereafter, when the sample liquid S is dropped from the opening 8 into the first recess 4, the tip of the test paper T comes into contact with the sample liquid S and sucks up the sample liquid S. At this time, the sample liquid S rising through the gap between the upper surface of the test paper installation groove 3 and the lower surface of the test paper T is trapped in the second concave portion 5 and accumulated in the second concave portion 5 due to capillary action. To go. Therefore, the sample liquid S is less likely to adhere to the case 2, and even if the tester touches the case 2, the possibility that the tester's finger touches the sample liquid S is low.

  Next, the structure of the test paper T used for the test paper measuring container of the present invention is shown in FIG. The test paper T includes a sample liquid suction pad 22 for applying a sample liquid to an elongated plastic mount, a nitrocellulose membrane 23 coated with an antibody and an antigen connected to the sample liquid suction pad 22, and a nitrocellulose membrane. A sample solution absorption pad 24 that absorbs and holds the sample solution, which is connected to the substrate 23, is attached. Further, a gold colloid-labeled antibody pad 25 in which the colloidal gold-labeled antibody is held dry is attached on the sample liquid suction pad 22. Further, a laminate seal 26 is attached to the entire surface in order to prevent each member from being destroyed during use. The nitrocellulose membrane 23 is designed and manufactured so that only two lines of the test line 23a and the control line 23b or one of the control lines 23b appears at the end of the measurement. By visually confirming the appearance of the test line 23a, it can be determined that the antibody is present in the sample. The appearance of the control line 23b means that the measurement has been established. If the control line 23b does not appear, it is determined that a remeasurement is necessary because some problem has occurred in the measurement.

A material having a large bore size that does not cause clogging even if there is urine sedimentation or the like is selected for the sample liquid suction pad 22. The sample liquid suction pad 22 is glass fiber or paper having a pore size of 1 to 30 μm, preferably 10 to 20 μm. The thickness of the sample liquid suction pad 22 is 0.1 to 3.0 mm, preferably 0.2 to 1.5 mm.
The sample solution absorption pad 24 is glass fiber or paper having an absorption of water of 10 to 300 mg / cm ² , preferably 20 to 200 mg / cm ² . The thickness of the sample solution absorbing pad 24 is 0.1 to 3.0 mm, preferably 0.2 to 1.5 mm.

As described above, the pore size of the sample liquid suction pad 22 and the sample liquid absorption pad 24 is increased so as not to cause clogging during the development of the sample liquid. It is possible to provide a test paper T in which an extract can also be used as a sample solution.
Conventionally, before applying a viscous sample solution or an insoluble sample solution, a “pretreatment” is required in which the sample solution is filtered with a filter for filtration (not shown) and the filtered sample solution is applied to the test paper T. However, the test paper T of the material selected this time can be developed even with urine containing extremely high viscosity wrinkles and fine particles, so that it is not necessary to perform a filtering operation before applying the sample liquid.

The gold colloid-labeled antibody pad 25 is a glass fiber or paper having a thickness of 0.1 to 1.5 mm, preferably 0.3 to 0.8 mm. The installation location is on the sample liquid suction pad 22. The length t of the gold colloid-labeled antibody pad 25 is about 10 mm, and the distance z from the gold colloid-labeled antibody pad 25 to the suction end Ta of the test paper T is 4 to 18 mm, preferably 6 to 15 mm.
The reason why the colloidal gold labeled antibody pad 25 is arranged on the sample liquid suction pad 22 is as follows. In the test paper of a small pore size used in the measurement system using the conventional case shown in FIGS. 12 and 13, the gold colloid-labeled antibody pad 25 is composed of the sample liquid suction pad 22 and the nitro as shown in FIG. It was inserted between the cellulose membrane 23.

  However, in the structure of the test paper T of the present invention, the pore sizes of the sample liquid suction pad 22 and the sample liquid absorption pad 24 are increased so as not to cause clogging when the sample liquid is developed. As a result, since the flow rate of the sample solution is large, in the structure shown in FIG. 11, the colloidal gold-labeled antibody held on the colloidal gold-labeled antibody pad 25 flows away all at once, and the antibody detection sensitivity may decrease.

  Therefore, in order to gradually dissolve and flow a large amount of colloidal gold labeled antibody held on the colloidal gold labeled antibody pad 25, in the embodiment of the present invention, as shown in FIG. Then, it was arranged on the sample liquid suction pad 22. As a result, the colloidal gold labeled antibody is gradually dissolved in accordance with the flow of the sample solution and flows toward the nitrocellulose membrane 23. The conventional structure (FIG. 11) does not flow away at once. Therefore, the antibody detection sensitivity can be maintained at an appropriate value.

By using the test paper T having the above structure, it is possible to measure a biological component without clogging by eliminating the need to filter the sample liquid before the measurement operation.
The embodiment of the present invention has been described above. However, the implementation of the present invention is not limited to the above description, and various modifications can be made within the scope of the present invention.

It is a top view which shows the test strip measuring container which concerns on the 1st Embodiment of this invention. It is a sectional side view which shows a test paper measuring container. It is a perspective view which shows the whole test-paper measurement container. It is an expanded sectional view which shows the use condition of a test paper measuring container. It is a top view which shows the test paper measuring container which concerns on the 2nd Embodiment of this invention. It is a sectional side view of a test paper measuring container. It is a perspective view which shows the whole test-paper measurement container. It is an expanded sectional view which shows the use condition of a test paper measuring container. It is a figure which shows the structure of the test paper used for the test paper measuring container of this invention. It is a partially expanded sectional view which shows the structure of a test paper. It is a partially expanded sectional view which shows the structure of the conventional test paper. It is the schematic which shows the conventional measuring system with which the test paper 102 was incorporated in the case 101 made from a plastics or paper. FIG. 6 is a diagram for explaining a method of performing measurement by dropping a sample solution on a window 103 provided on a case 101. It is a general-view figure of the conventional stick-shaped test paper. It is a figure which shows the state which puts the stick-shaped test paper 201 perpendicularly to containers 202, such as a test tube, and makes a test liquid suck up to a test paper and performs a measurement. It is explanatory drawing which shows the operation | work which puts the strip-shaped test paper 102 in a predetermined position in a case, and closes the upper and lower cover of case 101. FIG.

Explanation of symbols

2 Case 2i Intermediate part 2j Test paper installation part 2k Lower surface 2u Plane 3 Test paper installation groove 4 1st recessed part 4a, 4b Guide surface 5 2nd recessed part 6 Lid part 6
7 Wall 8 Opening 9 Small hole 10 Protrusion 12a, 12b Folded piece 11a, 11b Holding piece S Sample T Test paper

Claims (5)

Case and
Formed on the upper surface of the case, a test paper installation groove for installing the test paper,
A first recess formed on the upper surface of the case, connected to an extension of the test paper installation groove, and for storing a sample solution;
A second recess formed on the upper surface of the case and formed between the test paper installation groove and the first recess;
The bottom surface of the test paper installation groove is inclined toward the first recess at a predetermined angle with the lower surface of the case, and the bottom surface of the first recess is installed in the test paper installation groove A test paper measuring container having a guide surface for allowing the front end of the test paper to extend to the bottom surface of the first recess.   The test strip measuring container according to claim 1, wherein the predetermined angle is 5 degrees to 20 degrees.   The test paper measuring container according to claim 1, wherein the guide surface forms a flat surface smoothly connected to a bottom surface of the test paper installation groove. The case further includes a lid for covering the first recess,
2. The test paper measuring container according to claim 1, wherein the lid portion has a pressing piece for pressing the tip of the test paper installed in the test paper installation groove against the bottom surface of the first recess. 2. The test paper measuring container according to claim 1, wherein the test paper installation groove is formed to open upward so that the test paper can be installed from above.

Images