JP2015099095A - Sheet for examination diagnosis using three-dimensional immunochromatography system, device for examination diagnosis, and method of detecting target body - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a sheet for examination diagnosis, using a three-dimensional immunochromatography system, that has superior mass-productivity, and is simple.SOLUTION: There is provided a sheet for examination diagnosis using a three-dimensional immunochromatography system such that when a reagent part formation region sheet 48 which has at least one injection port 26a penetrating a sheet type base material 10a, and a first reagent part 20a, a second reagent part 22a, and an examination part 24a formed on one surface of the base material 10a, a flow passage formation region sheet 46 which has a first flow passage part 14a, a second flow passage part 16a, and a third flow passage part 18a formed on one surface of a base material 10c, and an adhesion part formation region sheet 44 which has both-side tapes 12a, 12b formed on both surfaces of a base material 10b and also a plurality of opening parts penetrating the base materia 10b and the both-sided tape 12b are stacked one over another, a flow passage is formed from the injection port 26a to the examination part 24a through the first reagent part 22a and second reagent part 24a.

Description

  The present invention relates to a test diagnostic sheet using a three-dimensional immunochromatography method, a test diagnostic device, and a target detection method using them.

  In immunochromatography, when a target molecule moves on the membrane by capillary action, a complex of the immobilized capture molecule and the target molecule is formed, and finally the target molecule labeled with the labeling dye is visually confirmed. This is a measurement method.

  Recently, as an immunochromatography that enables simultaneous inspection of multiple samples and multiple items, for example, Patent Document 1 proposes a chip for three-dimensional paper micro inspection using a three-dimensional microfluidic pathway.

  The chip for three-dimensional paper micro inspection diagnosis of Patent Document 1 is manufactured by fabricating an upper part, an intermediate part, and a lower part and then bonding them together. Also, the holes and flow paths in each part can be obtained by impregnating a non-woven fabric with a photo-curing resin, then curing the portions other than the holes and flow paths by the photoresist method, It is formed by a method of hardening after impregnating wax or the like in a portion other than the holes and the flow path by a printing method or the like.

  However, in the flow path forming method as described above, when the non-woven fabric or the like is impregnated with the photo-curing resin or wax, the photo-curing resin or wax is diffused in a portion other than the predetermined hole and the flow path, and the desired method It is inferior in mass productivity due to difficulty in processing into a shape.

International Publication No. 2012/105721 Pamphlet

  An object of the present invention is to provide a test diagnostic sheet, a test diagnostic device using a simple three-dimensional immunochromatography method which is excellent in mass productivity, and a target detection method using them.

The present invention
At least one injection part penetrating the sheet-like base material, and at least one reagent part in which at least one reagent part and inspection part of a set corresponding to the injection port are formed on one surface of the base material A forming area sheet;
At least one flow path part forming region sheet in which at least two flow path parts of a set corresponding to the injection port are formed on one surface of the sheet-like base material;
The first adhesive part is formed on one surface of the sheet-like base material, and the second adhesive part is formed on the other surface of the sheet-like base material, and the first adhesive part, the base material, and the second adhesive part At least one adhesive portion forming region sheet in which a plurality of openings corresponding to the injection port penetrating the inlet is formed;
Have
When the reagent part forming area sheet, the flow path part forming area sheet, and the adhesive part forming area sheet are overlapped, the inlet, the flow path part, and any of the openings, For diagnostic testing using a three-dimensional immunochromatography method, wherein the reagent part and the test part are communicated to form a flow path from the injection port to the test part through the reagent part. It is a sheet.

The present invention also provides:
One end part or intermediate part of the sheet-like base material,
A reagent part forming region in which at least one injection port penetrating the base material and at least one reagent part and a test part of a set corresponding to the injection port are formed on one surface of the base material;
A flow path part forming region in which at least two flow path parts of a set corresponding to the injection port are formed on one surface of the substrate;
And
The other end of the substrate is
The first adhesive part is formed on one surface, the second adhesive part is formed on the other surface, and a plurality of sets corresponding to the injection port penetrating the first adhesive part, the base material, and the second adhesive part An adhesion forming area where an opening is formed;
And
One end of the intermediate portion is folded so that the other end portion of the base material sandwiches the first adhesive portion, and the one end portion of the base material sandwiches the second adhesive portion. When folded to the surface side, the injection port, the flow channel unit, the reagent unit, and the test unit are communicated with each other through any of the openings, and the reagent unit is connected from the injection port. It is a sheet for inspection and diagnosis using a three-dimensional immunochromatography method in which a flow path to the inspection portion that passes is formed.

The present invention also provides:
One end or the other end of the sheet-like base material is
A reagent part forming region in which at least one injection port penetrating the base material and at least one reagent part and a test part of a set corresponding to the injection port are formed on one surface of the base material;
A flow path part forming region in which at least two flow path parts of a set corresponding to the injection port are formed on the other surface of the base material;
And
The intermediate part of the substrate is
The first adhesive part is formed on one surface, the second adhesive part is formed on the other surface, and a plurality of sets corresponding to the injection port penetrating the first adhesive part, the base material, and the second adhesive part An adhesion forming area where an opening is formed;
And
The other end of the intermediate portion is folded so that one end portion of the base material sandwiches the first adhesive portion, and the other end portion of the base material sandwiches the second adhesive portion. When folded to the surface side, the injection port, the flow channel unit, the reagent unit, and the test unit are communicated with each other through any of the openings, and the reagent unit is connected from the injection port. It is a sheet for inspection and diagnosis using a three-dimensional immunochromatography method in which a flow path to the inspection portion that passes is formed.

  In the inspection / diagnosis sheet, it is preferable that the water absorption force of the inspection unit is larger than the water absorption force of the flow channel unit and the reagent unit.

The present invention also provides:
At least one injection part penetrating the sheet-like base material, and at least one reagent part in which at least one reagent part and inspection part of a set corresponding to the injection port are formed on one surface of the base material A forming area sheet;
At least one flow path part forming region sheet in which at least two flow path parts of a set corresponding to the injection port are formed on one surface of the sheet-like base material;
The first adhesive part is formed on one surface of the sheet-like base material, and the second adhesive part is formed on the other surface of the sheet-like base material, and the first adhesive part, the base material, and the second adhesive part At least one adhesive portion forming region sheet in which a plurality of openings corresponding to the injection port penetrating the inlet is formed;
The inspection is conducted through any of the openings, and the injection port, the flow channel unit, the reagent unit, and the inspection unit communicate with each other and pass through the reagent unit from the injection port. This is a device for examination and diagnosis using a three-dimensional immunochromatography method, in which a flow path to the part is formed.

The present invention also provides:
One end part or intermediate part of the sheet-like base material,
A reagent part forming region in which at least one injection port penetrating the base material and at least one reagent part and a test part of a set corresponding to the injection port are formed on one surface of the base material;
A flow path part forming region in which at least two flow path parts of a set corresponding to the injection port are formed on one surface of the substrate;
And
The other end of the substrate is
The first adhesive part is formed on one surface, the second adhesive part is formed on the other surface, and a plurality of sets corresponding to the injection port penetrating the first adhesive part, the base material, and the second adhesive part An adhesion forming area where an opening is formed;
The test diagnostic sheet is folded to one surface side of the intermediate portion such that the other end portion of the base material sandwiches the first adhesive portion, and one end portion of the base material is attached to the second adhesive portion. Folded to one surface side of the intermediate portion so as to sandwich the portion, and through any of the openings, the injection port, the first flow path portion, the first reagent portion, and the first 2 flow path parts, the 2nd reagent part, the 3rd flow path part, and the above-mentioned inspection part are connected, and from the above-mentioned inlet to the above-mentioned inspection part which passes through the above-mentioned 1st reagent part and the above-mentioned 2nd reagent part Is a device for examination and diagnosis using a three-dimensional immunochromatography method.

The present invention also provides:
One end or the other end of the sheet-like base material is
A reagent part forming region in which at least one injection port penetrating the base material and at least one reagent part and a test part of a set corresponding to the injection port are formed on one surface of the base material;
A flow path part forming region in which at least two flow path parts of a set corresponding to the injection port are formed on the other surface of the base material;
And
The intermediate part of the substrate is
The first adhesive part is formed on one surface, the second adhesive part is formed on the other surface, and a plurality of sets corresponding to the injection port penetrating the first adhesive part, the base material, and the second adhesive part An adhesion forming area where an opening is formed;
The test diagnostic sheet is folded to one surface side of the intermediate portion such that one end portion of the base material sandwiches the first adhesive portion, and the other end portion of the base material is the second adhesive portion. Folded to the other surface side of the intermediate portion so as to sandwich the portion, and through any of the openings, the inlet, the first flow path portion, the first reagent portion, and the first 2 flow path parts, the 2nd reagent part, the 3rd flow path part, and the above-mentioned inspection part are connected, and from the above-mentioned inlet to the above-mentioned inspection part which passes through the above-mentioned 1st reagent part and the above-mentioned 2nd reagent part Is a device for examination and diagnosis using a three-dimensional immunochromatography method.

  In the inspection / diagnosis device, it is preferable that the water absorption force of the inspection unit is larger than the water absorption force of the flow channel unit and the reagent unit.

  In addition, the present invention is a target object detection method for detecting a target object using an inspection / diagnosis device constituted by the inspection / diagnosis sheet.

  ADVANTAGE OF THE INVENTION According to this invention, it is excellent in mass-productivity, The test | inspection diagnostic sheet | seat using the simple three-dimensional immunochromatography system, the device for test | inspection diagnosis, and the detection method of the target object using them are provided.

It is a schematic block diagram which shows an example of the sheet | seat for a test | inspection diagnosis based on embodiment of this invention, (a) is a top view, (b) is a side view. It is the schematic which shows the cross section of the adhesion part formation area in the sheet | seat for test | inspection diagnosis based on embodiment of this invention. It is the schematic which shows the cross section of the flow-path formation area | region in the sheet | seat for test | inspection diagnosis based on embodiment of this invention. It is a schematic side view showing an example of the configuration of a test / diagnosis device configured by a test / diagnosis sheet according to an embodiment of the present invention. It is a schematic block diagram which shows the other example of the sheet | seat for test | inspection diagnosis based on embodiment of this invention, (a) is a top view, (b) is a side view. It is the schematic which shows an example of the usage method of the sheet | seat for a test | inspection diagnosis based on embodiment of this invention. It is a schematic side view showing an example of the configuration of a test / diagnosis device configured by a test / diagnosis sheet according to an embodiment of the present invention. It is the schematic which shows an example of the test | inspection diagnostic method using the device for test | inspection diagnosis comprised with the sheet | seat for test | inspection diagnosis which concerns on embodiment of this invention. It is a schematic block diagram which shows the other example of the sheet | seat for test | inspection diagnosis based on embodiment of this invention, (a) is a top view, (b) is a side view. It is the schematic which shows the other example of the usage method of the sheet | seat for a test | inspection diagnosis based on embodiment of this invention. It is a schematic block diagram which shows the other example of the sheet | seat for test | inspection diagnosis based on embodiment of this invention, (a) is a top view, (b) is a side view. It is the schematic which shows the other example of the usage method of the sheet | seat for a test | inspection diagnosis based on embodiment of this invention. It is a figure which shows an example of the reaction system of the detection of myo-inositol in embodiment of this invention.

  Embodiments of the present invention will be described below. This embodiment is an example for carrying out the present invention, and the present invention is not limited to this embodiment.

  An outline of an example of a test / diagnosis sheet according to an embodiment of the present invention is shown in FIG. The test diagnostic sheet 1 includes two sample inlets 26a and 26b penetrating the sheet-like base material 10a, first reagent parts 20a and 20b formed on one surface of the base material 10a, and a second Reagent part forming region sheet 48 having reagent parts 22a and 22b and inspection parts 24a and 24b; double-sided tape 12a as a first adhesive part formed on at least a part of one surface of substrate 10b on the sheet And the double-sided tape 12b as the second adhesive portion formed on at least a part of the other surface, the double-sided tape 12a, the base material 10b, and the double-sided tape 12b are penetrated and arranged in a line at a predetermined interval in the longitudinal direction. A set of a plurality of openings 30a, 32a, 34a, 36a, 38a, 40a, 42a corresponding to the sample injection port 26a, and another set of a plurality of openings corresponding to the sample injection port 26b. A bonding portion forming region sheet 44 having 0b, 32b, 34b, 36b, 38b, 40b, and 42b; corresponding to the sample injection port 26a formed on at least a part of one surface of the sheet-like substrate 10c. The first flow path part 14a, the second flow path part 16a, the third flow path part 18a, the first flow path part 14b, the second flow path part 16b, and the third flow path part 18b corresponding to the sample inlet 26b. And a flow path forming region sheet 46 having

  When the reagent portion forming region sheet 48, the adhesive portion forming region sheet 44, and the flow path forming region sheet 46 are overlapped with the adhesive portion forming region sheet 44 interposed therebetween, the inspection diagnostic sheet 1 has openings 30a and 32a. , 34a, 36a, 38a, 40a, the sample inlet 26a, the first flow path part 14a, the first reagent part 20a, the second flow path part 16a, the second reagent part 22a, and the third The flow path part 18a and the test part 24a are communicated to form a flow path from the sample injection port 26a to the test part 24a through the first reagent part 20a and the second reagent part 22a, and the openings 30b, 32b, 34b. , 36b, 38b, 40b, the sample inlet 26b, the first flow path part 14b, the first reagent part 20b, the second flow path part 16b, the second reagent part 22b, and the third flow path. Part 18b and inspection part 24b It communicates, the first reagent portion 20b from the sample inlet 26b, the flow path to the inspection unit 24b passing through the second reagent portion 22b is adapted to be formed. Not limited to the example of FIG. 1, at least one injection port, at least two flow path units, at least one reagent unit, and at least one test unit are communicated with each other through any of the openings, and at least It is only necessary to form a flow path from one injection port to at least one test part passing through at least one reagent part.

  When the test diagnostic sheet 1 is used as a diabetes test diagnostic sheet, for example, the first reagent unit 20 includes a glucose elimination reagent such as ATP, and the second reagent unit 22 includes a coenzyme such as NAD. The inspection unit 24 includes chromogenic substrates such as myo-inositol dehydrogenase and NTB.

  FIG. 2 shows an enlarged cross-sectional view of the bonding portion forming region 44 in the inspection / diagnosis sheet 1. A double-sided tape 12 a is affixed to one side of the substrate 10, and a double-sided tape 12 b is affixed to the other side of the substrate 10. The double-sided tape 12a has adhesive layers 52a and 54a on both sides of a double-sided tape base material 50a, and is adhered to one surface of the base material 10 by the adhesive layer 52a, and the adhesive layer 54a includes a release paper 56a. Similarly, the double-sided tape 12b has adhesive layers 52b and 54b on both sides of the double-sided tape substrate 50b, and is adhered to the other surface of the substrate 10 by the adhesive layer 52b, and the adhesive layer 54b includes a release paper 56b. .

  FIG. 3 shows an enlarged cross-sectional view of a part of the flow path forming region 46 in the inspection / diagnosis sheet 1. A first flow path portion 14 such as a nonwoven fabric is bonded to one surface side of the base material 10 with a strong and weak double-sided tape 58. In the strong and weak double-sided tape 58, the adhesive layer on the substrate 10 side is a weak adhesive layer 64, and the nonwoven fabric side adhesive layer is a strong adhesive layer 62. The weak adhesive layer 64 on the substrate 10 side of the strong and weak double-sided tape 58 has a lower adhesive strength than the strong adhesive layer 62 on the first flow path portion 14a side. The second channel portion 16 and the third channel portion 18 have the same configuration. The first reagent unit 20, the second reagent unit 22, and the test unit 24 in the reagent unit formation region 48 have the same configuration.

  After the release sheets 56a and 56b of the double-sided tape 12a shown in FIG. 2 are peeled off, the inspection / diagnosis sheet 1 is, as shown in FIG. 4, a reagent portion forming region sheet 48, an adhesive portion forming region sheet 44, and a flow path. The formation region sheet 46 is overlapped with the adhesive portion formation region sheet 44 interposed therebetween, and the surfaces of the first reagent portion 20, the second reagent portion 22, and the inspection portion 24 of the reagent portion formation region sheet 48 and the adhesive layer 54b of the double-sided tape 12b are stacked. And the surfaces of the first flow path part 14, the second flow path part 16 and the third flow path part 18 of the flow path forming region sheet 46 and the adhesive layer 54a of the double-sided tape 12a are joined, for inspection and diagnosis. Device 3 is fabricated.

  In the example of FIG. 4, the test / diagnosis device 3 has a structure in which one reagent portion forming region sheet 48, one adhesive portion forming region sheet 44, and one flow path forming region sheet 46 are overlapped. A multilayer structure in which two or more reagent part forming region sheets 48, two or more adhesive part forming region sheets 44, and two or more flow path forming region sheets 46 are superposed may be employed. Thereby, a plurality of processes can be performed by one device.

  An outline of another example of the examination diagnosis sheet according to the embodiment of the present invention is shown in FIG. 5 and the configuration thereof will be described. The inspection diagnostic sheet 2 penetrates through the base material 10 formed in the sheet-like base material 10 and the reagent part forming region 48 at one end obtained by dividing the longitudinal direction of the base material 10 into, for example, approximately three equal parts. Two sample injection ports 26a and 26b, a double-sided tape 12a as a first adhesive portion formed on at least a part of one surface of the adhesive portion forming region 44 at the other end of the base material 10, and an adhesive portion forming region The double-sided tape 12b as the second adhesive portion formed on at least a part of the other surface of 44, and the double-sided tape 12a, the base material 10 and the double-sided tape 12b formed in the adhesive portion forming region 44 penetrate the One set of a plurality of openings 30a, 32a, 34a, 36a, 38a, 40a, 42a corresponding to the sample injection port 26a and another set corresponding to the sample injection port 26b arranged in a line at a predetermined interval in the direction. Double Corresponding to the sample inlet 26a formed on at least a part of one surface of the flow path forming region 46 in the intermediate portion of the base material 10 and the openings 30b, 32b, 34b, 36b, 38b, 40b, 42b. The first flow path part 14a, the second flow path part 16a and the third flow path part 18a, and the first flow path part 14b, the second flow path part 16b and the third flow path part 18b corresponding to the sample inlet 26b, Have. Furthermore, it has 1st reagent part 20a, 20b, 2nd reagent part 22a, 22b, and test | inspection part 24a, 24b in one surface of the reagent part formation area 48 of the one end part of the base material 10. FIG.

  The inspection / diagnosis sheet 2 is folded to one surface side of the intermediate portion so that the other end portion of the base material 10 sandwiches the first adhesive portion 12a, and one end portion of the base material 10 sandwiches the second adhesive portion 12b. When folded to one surface side of the intermediate portion, the sample inlet 26a, the first flow path portion 14a, the first reagent portion 20a, and the like through the openings 30a, 32a, 34a, 36a, 38a, 40a The second flow path part 16a, the second reagent part 22a, the third flow path part 18a, and the test part 24a communicate with each other and pass through the first reagent part 20a and the second reagent part 22a from the sample inlet 26a. A flow path to the inspection section 24a is formed, and the sample inlet 26b, the first flow path section 14b, the first reagent section 20b, and the first reagent section are formed through the openings 30b, 32b, 34b, 36b, 38b, and 40b. Two flow path portions 16b, a second reagent portion 22b, and a third A road section 18b, passed through the inspection unit 24b communicate with each other, the first reagent portion 20b from the sample inlet 26b, the flow path to the inspection unit 24b passing through the second reagent portion 22b is adapted to be formed. Not limited to the example of FIG. 5, at least one injection port, at least two flow path units, at least one reagent unit, and at least one test unit are communicated with each other through any of the openings, and at least It is only necessary to form a flow path from one injection port to at least one test part passing through at least one reagent part.

  The inspection / diagnosis sheet 2 according to the present embodiment has at least one sample injection port 26 (two sample injection ports 26a and 26b in the example of FIG. 1) and at least one first flow path portion 14 on one sheet. (Two first channel portions 14a and 14b in the example of FIG. 1), at least one second channel portion 16 (two second channel portions 16a and 16b in the example of FIG. 1), and at least one third channel. The flow path portion 18 (two third flow path portions 18a and 18b in the example of FIG. 1), the double-sided tape 12a as the first adhesive portion, the double-sided tape 12b as the second adhesive portion, and at least one set of a plurality of openings Parts 30, 32, 34, 36, 38, 40, 42 (in the example of FIG. 1, two sets of openings 30a, 32a, 34a, 36a, 38a, 40a, 42a and openings 30b, 32b, 34b, 36b, 38b, 40b, 42b) It is formed, only folded just as will be described later, it is possible to construct a test device for diagnosis using a three-dimensional immunochromatography method. The test / diagnosis sheet 2 according to the present embodiment can be manufactured continuously, and is extremely excellent in mass productivity.

  The test diagnostic sheet 2 includes, for example, an inlet forming step for forming the sample inlet 26 penetrating the base material 10 in the reagent part forming region 48 at one end of the sheet-like base material 10, and a flow path formation at the intermediate part. A flow path portion forming step for forming the first flow path portion 14, the second flow path portion 16, and the third flow path portion 18 on at least a part of one surface of the region 46, and an adhesive portion forming region 44 at the other end portion. A first adhesive portion forming step of attaching the double-sided tape 12a as a first adhesive portion to at least a part of one surface of the adhesive, and a double-sided tape 12b as a second adhesive portion to at least a portion of the other surface of the adhesive portion formation region 44. And forming a plurality of openings 30, 32, 34, 36, 38, 40, and 42 penetrating the double-sided tape 12a, the base material 10, and the double-sided tape 12b in the adhesive portion forming region 44. Opening forming step and base material 10 A reagent part forming step for forming the first reagent part 20 and the second reagent part 22 in the reagent part forming region 48 at one end part, a test part forming process for forming the test part 24, and a reagent in each reagent part and test part It is obtained by a method including a coating step of coating the like. The manufacturing method of the test | inspection diagnostic sheet | seat 1 is not limited to this. Further, the order of these steps is not particularly limited as long as the target inspection / diagnosis sheet 2 is obtained.

  In the flow path portion forming step, a nonwoven fabric or the like is attached to a part of one surface of the flow path forming region 46 in the middle portion obtained by dividing the longitudinal direction of the sheet-like base material 10 by about 3 using a strong and weak double-sided tape 58. . In the strong and weak double-sided tape 58, the adhesive layer on the substrate 10 side may be a weak adhesive layer and the non-woven fabric side adhesive layer may be a strong adhesive layer.

  In the flow path formation region 48, for example, a punching process is performed to the interface between the base material 10 and the weak adhesive layer 64 of the strong and weak double-sided tape 58 so as to have a shape as shown in FIG. The first non-woven fabric is peeled off from the weak adhesive layer 64 of the strong and weak double-sided tape 58 to form the first flow path portion 14, the second flow path portion 16, and the third flow path portion 18.

  Similarly, the first reagent part 20 and the second reagent part 22 are formed in the reagent part forming region 48 in the reagent part forming step, and the inspection part 24 is formed in the inspection part forming step.

  Thereafter, in the application step, for example, a predetermined reagent or the like is applied to the first reagent unit 20 and the second reagent unit 22, respectively, and a predetermined color developing substrate or the like is applied to the inspection unit 24. In addition, the first reagent unit 20, the second reagent unit 22, and the test unit 24 are formed to manufacture the test diagnosis sheet 2, and before the test diagnosis, for example, the first reagent unit 20, the second reagent unit A reagent or the like may be applied to 22 and a coloring substrate or the like may be applied to the inspection unit 24.

  In the first adhesive portion forming step and the second adhesive portion forming step, the double-faced tapes 12a and 12b are respectively attached to both surfaces of the adhesive portion forming region 44 at the other end of the base material 10. Here, the release paper on the surface side of the double-sided tapes 12a and 12b is left attached.

  In the opening forming step, for example, a punching process for penetrating the base material 10 and the double-sided tapes 12a and 12b on the front and back sides in the bonding portion forming region 44 is performed so that the shape shown in FIG. 30, 32, 34, 36, 38, 40, 42 are formed. The opening 30 is formed at a position so as to communicate with the sample inlet 26 when the substrate 10 is folded as will be described later.

  In the injection port forming step, for example, a punching process for penetrating the base material 10 in the reagent part forming region 48 at the other end of the base material 10 is performed to form the sample injection port 26. The formation position of the sample injection port 26 is determined so as to communicate with the opening 30 when the substrate 10 is folded as will be described later.

  Affixing of the nonwoven fabric or the like in the flow path part forming process, the reagent part forming process, the inspection part forming process, and the attaching of the double-sided tapes 12a and 12b in the first adhesive part forming process and the second adhesive part forming process are, for example, rolls・ Two-roll method can be used. If the double-sided tape and non-woven fabric wound in a roll are pasted on one side of a base material wound in a roll, and the double-sided tape wound in a roll is pasted on the other side at the same time, Good. Such a method is very excellent in mass productivity since there is little misalignment during bonding.

  FIG. 6 shows an outline of an example of a method of using the inspection / diagnosis sheet 2. After the release paper 56a of the double-sided tape 12a shown in FIG. 2 is peeled off, as shown in FIG. 6, one side of the intermediate part is sandwiched between the adhesive tape forming region 44 side of the other end of the substrate 10 with the double-sided tape 12a interposed therebetween. Folded to the surface side, the surface of the first flow path part 14, the second flow path part 16, the third flow path part 18 and the adhesive layer 54a of the double-sided tape 12a are joined. Next, after peeling off the release paper 56b of the double-sided tape 12b, the reagent part forming region 48 side of one end is folded to one side of the intermediate part so as to sandwich the double-sided tape 12b, and the first reagent part 20 and the second reagent part 20 The surfaces of the reagent part 22 and the inspection part 24 and the adhesive layer 54b of the double-sided tape 12b are joined together to produce the inspection / diagnosis device 4.

  In this way, the first reagent part 20 via the opening 32 and the opening 34 so as to communicate the first flow path part 14 communicated with the sample injection port 26 and the second flow path part 16; The second reagent part 22 through the opening 36 and the opening 38 so as to communicate with the second flow path part 16 and the third flow path part 18, and the opening part so as to communicate with the third flow path part 18. Thus, an inspection / diagnosis device 4 having an inspection unit 24 via 40 is obtained.

  FIG. 7 shows a schematic side view of an inspection / diagnosis device manufactured using the inspection / diagnosis sheet 2 shown in FIG. As shown in FIG. 7, the adhesive portion forming region 44 side of the substrate 10 is folded to one surface side of the intermediate portion so as to sandwich the double-sided tape 12a, and the intermediate portion so that the reagent portion forming region 48 side sandwiches the double-sided tape 12b. When folded to one surface side, the sample inlet 26, the opening 30, and the first flow path portion 14 are communicated, and the first flow path portion 14, the first reagent portion 20, and the second flow path are communicated from the sample inlet 26. A flow path to the inspection section 24 is formed through the flow path section 16, the second reagent section 22, and the third flow path section 18.

  When the test diagnostic devices 3 and 4 are used as a diabetes test diagnostic device, the sample injection port 26 is a place for injecting a sample, and the first reagent unit 20 and the second reagent unit 22 have glucose elimination reagents such as ATP. And a coenzyme such as NAD, and the inspection unit 24 includes a dehydrogenase such as myo-inositol dehydrogenase and a chromogenic substrate such as NTB.

FIG. 8 shows an example of a diabetes test diagnosis method using a test diagnosis device configured using the test diagnosis sheet according to this embodiment, and FIG. 13 shows an example of a reaction system for diabetes test diagnosis. As shown in FIG. 8, urine or the like is appropriately treated as necessary, and then injected as a sample from the sample inlet 26, and the sample is stored in the first reagent unit 20 and the second reagent unit 22 such as hexokinase. It is mixed with a glucose elimination reagent and a coenzyme such as NAD, and glucose in the sample is eliminated by the glucose elimination reagent to become glucose-6-phosphate. Next, in the test unit 24, when myo-inositol (MI) is contained in the sample, myo-inositol is converted into myo-inosose by a dehydrogenase such as myo-inositol dehydrogenase (MIDH), and NADH is generated from NAD, Diaphorase (DI) and NADH reduce a chromogenic substrate such as NTB to produce a dye such as NTBH ₂ (formazan dye), which is visible.

  By having a plurality of paths, it is possible to simultaneously inspect many types of samples. Further, at least one of the plurality of routes may be used for the control sample. In the example of FIGS. 1 and 5, the number of reaction paths is from the sample inlet 26a to the first flow path part 14a, the first reagent part 20a, the second flow path part 16a, the second reagent part 22a, and the third flow path part. 18a, the path from the sample inlet 26b to the first flow path part 14b, the first reagent part 20b, the second flow path part 16b, the second reagent part 22b, and the third flow path part 18b. Then, there are two paths to the inspection unit 24b, but one or more paths may be used, and the path may be appropriately changed according to the number of samples.

  Although there is no restriction | limiting in particular as the base materials 10, 10a, 10b, 10c, For example, water-resistant thin film sheets, such as a resin film and metal foil, are mentioned, A resin film (sheet) is preferable from points, such as workability. Examples of the resin film (sheet) include, but are not limited to, a polyethylene terephthalate (PET) film, a polyvinyl chloride film, a polyolefin film, a polycarbonate film, and synthetic paper. Among these, it is particularly preferable to use a polyethylene terephthalate (PET) film from the viewpoints of punchability, rigidity, cost, storage stability, and the like.

  The thickness of the base material 10, 10a, 10b, 10c is not particularly limited, but is preferably in the range of 10 μm to 250 μm, and more preferably in the range of 25 μm to 100 μm.

  The members constituting the first flow path part 14, the second flow path part 16, the third flow path part 18, the first reagent part 20, the second reagent part 22, and the test part 24 are liquid permeable (permeable). There are no particular limitations as long as it is, for example, non-woven fabric, filter paper, printing paper, Japanese paper, cloth, foam, knit, etc., from the viewpoint of processability, moderate liquid permeability, cost, etc. Nonwoven fabric is preferred.

  The thicknesses of the first flow path part 14, the second flow path part 16, the third flow path part 18, the first reagent part 20, the second reagent part 22, and the test part 24 are not particularly limited. What is necessary is just to be 1000 micrometers, and a flow-path part and a reagent part should just be 50 micrometers-500 micrometers, and a test | inspection part should just be 200 micrometers-1000 micrometers.

  The widths of the first flow path part 14, the second flow path part 16, the third flow path part 18, the first reagent part 20, the second reagent part 22, and the test part 24 are not particularly limited. What is necessary is just to be 10 mm.

  In the example of FIGS. 1 and 5, the number of flow path portions is three, that is, the first flow path portion 14, the second flow path portion 16, and the third flow path portion 18, and the number of reagent portions is the first reagent. The number of the flow path parts is at least two, the number of the reagent parts is at least one, and the number of the test parts is one, What is necessary is just to change suitably according to the reaction system etc. to be used.

  In the present embodiment, the water absorption force of the inspection unit 24 is such that the flow path part (the first flow path part 14, the second flow path part 16, the third flow path part 18), the reagent part (the first reagent part 20 and the second flow path part). It is preferably greater than the water absorption capacity of the reagent part 22). Here, the water absorption power is obtained by immersing a nonwoven fabric in water, measuring a weight difference (g) before and after the immersion, and converting it into a volume (μL). The water absorption force of the inspection unit 24 is preferably 100 μL or more, and the water absorption of the first flow channel unit 14, the second flow channel unit 16, the third flow channel unit 18, the first reagent unit 20, and the second reagent unit 22. The force is preferably 10 μL or more and 60 μL or more. When the water absorption force of the inspection unit 24 is smaller than or equal to the water absorption force of the first flow channel unit 14, the second flow channel unit 16, the third flow channel unit 18, the first reagent unit 20 and the second reagent unit 22, It may be difficult for the sample to reach the inspection unit 24, and backflow from the inspection unit may occur.

  As the double-sided tapes 12 a and 12 b and the strong and weak double-sided tape 58, those having adhesive layers on both sides of the double-sided tape base materials 50 a and 50 b and the strong and weak double-sided tape base material 60 are used as described above. As the strong and weak double-sided tape 58, as described above, one having a weak adhesive layer on one surface of the strong and weak double-sided tape substrate 60 and a strong adhesive layer on the other surface is used. Adhesive strength is lower than the strong adhesive layer on the road side. Examples of the double-sided tape base materials 50a and 50b and the strong and weak double-sided tape base material 60 include a polyethylene terephthalate (PET) film, a polyvinyl chloride film, a polyolefin film, and the like. From the viewpoint of processability, water resistance, cost, etc., polyethylene A terephthalate (PET) film is preferred.

  The adhesive layer, weak adhesive layer and strong adhesive layer are not particularly limited, but include acrylic, rubber-based, urethane-based, silicone-based, polyester-based pressure-sensitive adhesives, etc., adhesiveness, workability, contamination, etc. From the viewpoint of the above, an acrylic pressure-sensitive adhesive is preferred.

  The adhesive strength of the adhesive layer and the strong adhesive layer is not particularly limited, but may be, for example, 3 N / 10 mm or more, and preferably 4 N / 10 mm to 10 N / 10 mm. Although there is no restriction | limiting in particular as adhesive force of a weak adhesive layer, For example, what is necessary is just to set it as the range of 0.1N / 10mm-3N / 10mm, Preferably it is set as the range of 0.5N / 10mm-2.0N / 10mm. That's fine. By setting the adhesive strength of the strong adhesive layer and the adhesive strength of the weak adhesive layer of the strong and weak double-sided tape 58 within the above ranges, peeling of the nonwoven fabric in portions other than the flow path portion after punching processing of the nonwoven fabric or the like can be performed. It can be performed well in the weak adhesive layer. The adhesive strength of the adhesive layer can be measured by the method shown in JIS Z0237.

  The thickness of the double-sided tape substrate and the strong and weak double-sided tape substrate is not particularly limited, but may be, for example, in the range of 10 μm to 250 μm, and preferably in the range of 20 μm to 120 μm. The thicknesses of the adhesive layer, the weak adhesive layer, and the strong adhesive layer are not particularly limited, but may be, for example, in the range of 5 μm to 150 μm, and preferably in the range of 10 μm to 80 μm.

  The test diagnostic sheet and the test diagnostic device according to the present embodiment can be used for, for example, diabetes diagnostic diagnosis, ELISA, etc. using myo-inositol as a target. For example, the target molecule can be visually confirmed by forming a complex of the target molecule and the capture molecule in the reagent part and labeling the complex with a labeling dye in the test part.

  When the test diagnostic sheet and the test diagnostic device according to the present embodiment are used for diabetes diagnostic diagnosis, examples of the glucose elimination reagent include hexokinase and ADP-hexokinase.

  The addition amount of the glucose elimination reagent to the first reagent unit 20 is not particularly limited as long as it is an amount capable of eliminating glucose in the sample.

  Examples of the coenzyme for the second reagent part 22 include NAD derivatives such as NAD and thio-NAD.

  The amount of coenzyme added is not particularly limited, but may be in the range of 0.01 mg to 0.5 mg, for example.

  Examples of the chromogenic substrate include tetrazolium salts such as NTB (nitrotetrazolium blue), WST-1,3,4,5,8,9,10,11 (Water Soluble Tetrazolium Salts: manufactured by interchim), and the like. NTB is preferable from the viewpoint of ease of handling.

  Examples of the dehydrogenase to the inspection unit 24 include myo-inositol dehydrogenase, diaphorase, and the like. The addition concentration of the dehydrogenase is not particularly limited, but may be in the range of 0 to 20 U (0 U for the control), for example.

  Although there is no restriction | limiting in particular as the addition amount of the color development substrate to the test | inspection part 24, For example, what is necessary is just to be the range of 0.01 mg-0.8 mg.

  The reagent part and the inspection part may contain a surfactant in order to adjust hydrophilicity. Examples of the surfactant include an anionic surfactant, a cationic surfactant, a nonionic surfactant, and an amphoteric surfactant. Specific examples include Triton X-100 and TWEEN20.

  The sample used in the present embodiment refers to a sample that is used as a sample after appropriately performing biological fluids such as urine, blood, saliva, sweat, and the like to be examined as necessary. Urine is preferable from the viewpoint that the test can be easily performed.

  FIG. 9 shows a schematic configuration of another example of the examination / diagnosis sheet according to the embodiment of the present invention. The test diagnostic sheet 5 penetrates through the base material 10 formed in the sheet-like base material 10 and the reagent part formation region 48 in the middle part obtained by dividing the longitudinal direction of the base material 10 into, for example, approximately three equal parts. Two sample injection ports 26a and 26b, a double-sided tape 12a as a first adhesive portion formed on at least a part of one surface of the adhesive portion forming region 44 at the other end of the base material 10, and an adhesive portion forming region The double-sided tape 12b as the second adhesive portion formed on at least a part of the other surface of 44, and the double-sided tape 12a, the base material 10 and the double-sided tape 12b formed in the adhesive portion forming region 44 penetrate the One set of a plurality of openings 30a, 32a, 34a, 36a, 38a, 40a, 42a corresponding to the sample injection port 26a and another set corresponding to the sample injection port 26b arranged in a line at a predetermined interval in the direction. Double Corresponding to the sample inlet 26a formed on at least a part of one surface of the flow path forming region 46 at one end of the substrate 10 and the openings 30b, 32b, 34b, 36b, 38b, 40b, 42b. The first flow path part 14a, the second flow path part 16a and the third flow path part 18a, and the first flow path part 14b, the second flow path part 16b and the third flow path part 18b corresponding to the sample inlet 26b, Have. Furthermore, it has 1st reagent part 20a, 20b, 2nd reagent part 22a, 22b, and test | inspection part 24a, 24b in one surface of the reagent part formation area 48 of the intermediate part of the base material 10. FIG.

  The inspection / diagnosis sheet 5 is folded to one surface side of the intermediate portion so that the other end portion of the base material 10 sandwiches the first adhesive portion 12a, and one end portion of the base material 10 sandwiches the second adhesive portion 12b. When folded to one surface side of the intermediate portion, the sample inlet 26a, the first flow path portion 14a, the first reagent portion 20a, and the like through the openings 30a, 32a, 34a, 36a, 38a, 40a The second flow path part 16a, the second reagent part 22a, the third flow path part 18a, and the test part 24a communicate with each other and pass through the first reagent part 20a and the second reagent part 22a from the sample inlet 26a. A flow path to the inspection section 24a is formed, and the sample inlet 26b, the first flow path section 14b, the first reagent section 20b, and the first reagent section are formed through the openings 30b, 32b, 34b, 36b, 38b, and 40b. Two flow path portions 16b, a second reagent portion 22b, and a third A road section 18b, passed through the inspection unit 24b communicate with each other, the first reagent portion 20b from the sample inlet 26b, the flow path to the inspection unit 24b passing through the second reagent portion 22b is adapted to be formed.

  FIG. 10 shows an outline of an example of a method for using the examination diagnostic sheet 5. After the release paper 56a of the double-sided tape 12a shown in FIG. 2 is peeled off, as shown in FIG. 10, one side of the intermediate part is sandwiched between the adhesive tape forming region 44 side of the other end of the substrate 10 with the double-sided tape 12a interposed therebetween. Folded to the surface side, the surfaces of the first reagent part 20, the second reagent part 22, and the inspection part 24 and the adhesive layer 54a of the double-sided tape 12a are joined. Next, after the release paper 56b of the double-sided tape 12b is peeled off, the flow path forming region 46 side of one end is folded to one surface side of the intermediate part so as to sandwich the double-sided tape 12b. The surfaces of the second flow path part 16 and the third flow path part 18 and the adhesive layer 54b of the double-sided tape 12b are joined together to produce the inspection / diagnosis device 7.

  In this way, the first reagent part 20 via the opening 32 and the opening 34 so as to communicate the first flow path part 14 communicated with the sample injection port 26 and the second flow path part 16; The second reagent part 22 through the opening 36 and the opening 38 so as to communicate with the second flow path part 16 and the third flow path part 18, and the opening part so as to communicate with the third flow path part 18. Thus, an inspection / diagnosis device 7 having an inspection unit 24 via 40 is obtained.

  The base material 10 is folded on one side of the intermediate part so that the adhesive part forming region 44 side sandwiches the double-sided tape 12a, and the flow path forming region 46 side is folded on one side of the intermediate part so as to sandwich the double-sided tape 12b. As a result, the sample inlet 26, the opening 30 and the first flow path section 14 are communicated, and the first flow path section 14, the first reagent section 20, the second flow path section 16, and the second flow path are communicated from the sample injection port 26. Through the reagent part 22 and the third flow path part 18, a flow path to the inspection part 24 is formed.

  FIG. 11 shows a schematic configuration of another example of the examination / diagnosis sheet according to the embodiment of the present invention. The inspection / diagnosis sheet 9 penetrates through the base material 10 formed in a sheet-like base material 10 and a reagent part forming region 48 at one end obtained by dividing the longitudinal direction of the base material 10 into, for example, approximately three equal parts. Two sample injection ports 26a and 26b, a double-sided tape 12a as a first adhesive portion formed on at least a part of one surface of an adhesive portion forming region 44 at an intermediate portion of the substrate 10, and an adhesive portion forming region 44 The double-sided tape 12b as the second adhesive portion formed on at least a part of the other surface of the tape and the double-sided tape 12a, the base material 10 and the double-sided tape 12b formed in the adhesive portion forming region 44 are penetrated in the longitudinal direction. A set of a plurality of openings 30a, 32a, 34a, 36a, 38a, 40a, 42a corresponding to the sample injection port 26a and another set corresponding to the sample injection port 26b, which are arranged in a line at predetermined intervals. Duplicate Corresponding to the sample inlet 26a formed on at least part of the other surface of the flow path forming region 46 at the other end of the substrate 10 and the openings 30b, 32b, 34b, 36b, 38b, 40b, 42b. The first flow path part 14a, the second flow path part 16a, the third flow path part 18a, the first flow path part 14b, the second flow path part 16b, and the third flow path part 18b corresponding to the sample inlet 26b. And having. Furthermore, it has 1st reagent part 20a, 20b, 2nd reagent part 22a, 22b, and test | inspection part 24a, 24b in one surface of the reagent part formation area 48 of the one end part of the base material 10. FIG.

  The inspection / diagnosis sheet 9 is folded to the other surface side of the intermediate portion so that the other end portion of the base material 10 sandwiches the first adhesive portion 12b, and one end portion of the base material 10 sandwiches the second adhesive portion 12a. When folded to one surface side of the intermediate portion, the sample inlet 26a, the first flow path portion 14a, the first reagent portion 20a, and the like through the openings 30a, 32a, 34a, 36a, 38a, 40a The second flow path part 16a, the second reagent part 22a, the third flow path part 18a, and the test part 24a communicate with each other and pass through the first reagent part 20a and the second reagent part 22a from the sample inlet 26a. A flow path to the inspection section 24a is formed, and the sample inlet 26b, the first flow path section 14b, the first reagent section 20b, and the first reagent section are formed through the openings 30b, 32b, 34b, 36b, 38b, and 40b. Two flow path portions 16b, a second reagent portion 22b, and a third A road section 18b, passed through the inspection unit 24b communicate with each other, the first reagent portion 20b from the sample inlet 26b, the flow path to the inspection unit 24b passing through the second reagents portion 22b is adapted to be formed.

  An outline of an example of a method for using the inspection / diagnosis sheet 9 is shown in FIG. After the release paper 56b of the double-sided tape 12b shown in FIG. 2 is peeled off, as shown in FIG. 12, the other end of the base material 10 is placed on the other side of the flow path forming region 46 so that the double-sided tape 12b is sandwiched therebetween. Folded to the surface side, the surfaces of the first flow path part 14, the second flow path part 16, and the third flow path part 18 are joined to the adhesive layer 54b of the double-sided tape 12b. Next, after the release paper 56a of the double-sided tape 12a is peeled off, the reagent part forming region 48 side of one end is folded to one side of the intermediate part so as to sandwich the double-sided tape 12a, and the first reagent part 20 and the second reagent part 20 The surface of the reagent part 22 and the inspection part 24 and the adhesive layer 54a of the double-sided tape 12a are joined to produce the inspection / diagnosis device 11.

  In this way, the first reagent part 20 via the opening 32 and the opening 34 so as to communicate the first flow path part 14 communicated with the sample injection port 26 and the second flow path part 16; The second reagent part 22 through the opening 36 and the opening 38 so as to communicate with the second flow path part 16 and the third flow path part 18, and the opening part so as to communicate with the third flow path part 18. Thus, an inspection / diagnosis device 11 having an inspection unit 24 via 40 is obtained.

  The base material 10 is folded on the other surface side of the intermediate portion so that the double-sided tape 12b is sandwiched between the sides, and the reagent portion formation region 48 side is folded on one side of the intermediate portion so as to sandwich the double-sided tape 12a. As a result, the sample inlet 26, the opening 30 and the first flow path section 14 are communicated, and the first flow path section 14, the first reagent section 20, the second flow path section 16, and the second flow path are communicated from the sample injection port 26. Through the reagent part 22 and the third flow path part 18, a flow path to the inspection part 24 is formed. The folding order is not particularly limited, and after the reagent part forming region 48 side is folded to one surface side of the intermediate part so as to sandwich the double-sided tape 12a, the flow path forming region 46 side of the substrate 10 is double-sided tape 12b. It may be folded to the other surface side of the intermediate part so as to sandwich.

  According to the configuration of the diabetes test diagnosis sheet 2 shown in FIG. 5, the diabetes test diagnosis sheet 5 shown in FIG. 7, and the diabetes test diagnosis sheet 9 shown in FIG. 9, a device for test diagnosis can be easily produced simply by folding. be able to. Further, it is possible to easily align the opening with the flow path, reagent, and inspection unit.

  According to the test diagnostic sheet, the test diagnostic device, and the target object detection method according to the present embodiment, the target object can be easily detected.

  Hereinafter, although an example and a comparative example are given and the present invention is explained more concretely in detail, the present invention is not limited to the following examples.

Example 1
<Production of sheet for 3D inspection and diagnosis>
Using a PET film (thickness: 50 μm, length: 228 mm, width: 39 mm) as the base material 10, a part of one surface of the flow path formation region 46 in the middle part obtained by dividing the longitudinal direction of the base material 10 into about three equal parts Double-sided adhesive tape 58 (base material: PET, base material thickness: 25 μm, strong adhesive layer material: acrylic adhesive, strong adhesive layer adhesive strength: 7.0 N / 10 mm, strong adhesive layer thickness: 25 μm, weak adhesive layer Material: acrylic adhesive, weak adhesive layer adhesive strength: 1.0 N / 10 mm, weak adhesive layer thickness: 25 μm, length: 228 mm, width: 39 mm), non-woven fabric (material: cellulose 100%, water absorption: 40 μL) was applied. In the strong and weak double-sided tape 58, the adhesive layer on the substrate 10 side was a weak adhesive layer, and the adhesive layer on the nonwoven fabric side was a strong adhesive layer.

  A strong double-sided tape 58 (base material: PET, base material thickness: 25 μm, strong adhesive layer material: a part of one surface of the reagent part forming region 48 at one end portion obtained by dividing the longitudinal direction of the base material 10 into about three equal parts. Acrylic adhesive, strong adhesive layer adhesive strength: 7.0 N / 10 mm, strong adhesive layer thickness: 25 μm, weak adhesive layer material: acrylic adhesive, weak adhesive layer adhesive strength: 1.0 N / 10 mm, weak adhesive layer thickness : 25 μm, length: 228 mm, width: 39 mm), a non-woven fabric (material: 100% cellulose, water absorption: 40 μL) serving as a reagent part is pasted on an area of about 2/3, and the end side is about 1 / A non-woven fabric (material: cellulose 100%, water absorption: 120 μL) serving as an inspection part was attached to the region 3. In the strong and weak double-sided tape 58, the adhesive layer on the substrate 10 side was a weak adhesive layer, and the adhesive layer on the nonwoven fabric side was a strong adhesive layer.

  Double-sided tapes 12a and 12b (base material: PET, base material thickness: 25 μm, adhesive layer material: acrylic adhesive, adhesive layer adhesive strength: both sides of the adhesive portion forming region 44 at the other end of the base material 10: 7.0 N / 10 mm, adhesive layer thickness: 25 μm, length: 76 mm, width: 39 mm) were attached. The release paper on the surface side of the double-sided tapes 12a and 12b was left attached. The adhesive strength of the adhesive layer was measured by the method shown in JIS Z0237.

  Next, a punching process is performed to the interface between the base material 10 and the weak adhesive layer of the strong and weak double-sided tape 58 in the flow path forming region 46 so that the shape as shown in FIG. Peeling from the weak adhesive layer of the strong and weak double-sided tape 58, three sets of first flow path portions (thickness: 150 μm, length: 15 mm, width: 5 mm), three sets of second flow path portions (thickness: 150 μm, long) Length: 14 mm, width: 5 mm), and three sets of third flow path portions (thickness: 150 μm, length: 14 mm, width: 5 mm) were formed.

  In addition, a non-woven fabric is formed in a portion other than the reagent portion and the inspection portion by punching up to the interface between the base material 10 and the weak adhesive layer of the strong and weak double-sided tape 58 in the reagent portion forming region 48 so as to have a shape as shown in FIG. Are peeled from the weak adhesive layer of the strong and weak double-sided tape 58, and three sets of first reagent parts (thickness: 150 μm, length: 15 mm, width: 5 mm) and three sets of second reagent parts (thickness: 150 μm, length) : 15 mm, width: 5 mm), three sets of inspection parts (thickness: 300 μm, length: 20 mm, width: 8 mm) were formed.

  In order to obtain the shape as shown in FIG. 5, the punching process is performed to penetrate the base material 10 and the double-sided tapes 12a and 12b on the front and back sides in the bonding portion forming region 44, and three sets arranged in a line at predetermined intervals in the longitudinal direction. Seven openings 30, 32, 34, 36, 38, 40, 42 were formed. Similarly, a punching process for penetrating the base material 10 in the reagent part forming region 48 at one end of the base material 10 was performed to form three sample injection ports 26. Via the openings 30, 32, 34, 36, 38, 40, the three-way sample inlet 26, the first flow path section 14, the first reagent section 20, the second flow path section 16, The formation positions of the two reagent part 22, the third flow path part 18 and the inspection part 24 were determined so as to communicate with each other when the base material 10 was folded.

For detecting myo-inositol, a reaction system using myo-inositol dehydrogenase (MIDH), NAD as a coenzyme, and NTB as a chromogenic substrate was used. First, glucose is erased by hexokinase or the like in the first reagent part 20 and the second reagent part 22 to become glucose-6-phosphate, mixed with NAD, and in the test part 24, myo-inositol (MI) is contained in the sample. When myo-inositol is converted into myo-inosose by myo-inositol dehydrogenase (MIDH), NADH is produced from NAD, diaphorase (DI) and NADH reduce NTB, and NTBH ₂ (formazan dye) is produced. It becomes possible.

  0.085 mg of hexokinase (HKIII), 0.15 mg of ADP hexokinase (HKPII), and 0.06 mg of NAD are applied to the first reagent part 20 and the second reagent part 22, and myo-inositol dehydrogenase (MIDH) is applied to the test part 24. It was applied so that 0 to 5 U and DI were 0.3 U and NTB was 0.05 mg. In this way, a sheet 1 for testing and diagnosis of diabetes was prepared.

  In addition, the water absorption power of the nonwoven fabric was evaluated by the following method with reference to “JIS L 1907 Textile Absorption Test Method”.

A 10 mm × 20 mm test piece is taken from the nonwoven fabric, immersed in water for about 10 seconds for 10 seconds while holding one of the short sides of the test piece, then immediately taken out, and the weight difference (g) before and after immersion is measured. After the measurement, the unit was converted from the weight (g) to the volume (μL) by the following formula, and the average value of 10 times was defined as the water absorption force.
Volume absorbed water = weight difference ÷ specific gravity (however, the specific gravity uses the temperature corrected value)

  The water absorption capacity of various nonwoven fabrics is evaluated by the above method. A nonwoven fabric having a high water absorption capacity (material: 100% cellulose, water absorption capacity: 120 μL) is used as the nonwoven fabric for the inspection section 24, and the nonwoven fabric (material) having a lower water absorption capacity than the inspection section 24. : 100% cellulose, water absorption capacity: 40 μL) was selected as the non-woven fabric for the first flow path section 14, the first reagent section 20, the second flow path section 16, the second reagent section 22, and the third flow path section 18. By using this combination, the sample reached from the sample development within 2 minutes, and no back flow (2 hours after standing) was observed.

<Production of 3D inspection / diagnosis device>
In the same manner as in FIG. 6, after the test diagnostic sheet 1 produced as described above is peeled off the release paper of the double-sided tape 12a, the double-sided tape 12a is attached to the other end portion of the substrate 10 on the adhesive portion forming region 44 side. Folding to one surface side of the intermediate part so as to sandwich, the surface of the first flow path part 14, the second flow path part 16 and the third flow path part 18 and the adhesive layer of the double-sided tape 12a were joined. Next, after the release paper of the double-sided tape 12b is peeled off, the reagent part forming region 48 side of one end of the substrate 10 is folded to one side of the intermediate part so as to sandwich the double-sided tape 12b. Then, the surfaces of the second reagent part 22 and the inspection part 24 and the adhesive layer 54b of the double-sided tape 12b were joined together to produce the inspection / diagnosis device 3. As a result, the sample inlet 26, the first flow path section 14, the first reagent section 20, the second flow path section 16, and the first flow path via the openings 30, 32, 34, 36, 38, 40. The second reagent part 22, the third flow path part 18, and the test part 24 are communicated, and the first flow path part 14, the first reagent part 20, the second flow path part 16, and the second reagent are communicated from the sample inlet 26. Through the section 22 and the third flow path section 18, a flow path to the inspection section 24 is formed.

<Measurement of MI using a device for three-dimensional inspection and diagnosis>
As a sample, an aqueous solution of myo-inositol with a myo-inositol (MI) concentration of 50,200 μM was developed.

  As a result, a weak signal was obtained in about 3 minutes when 50 μM myo-inositol was developed, and a clear signal was obtained in about 3 minutes when 200 μM myo-inositol was developed.

  Thus, since myo-inositol was able to be detected, it turned out that it can apply as a simple test | inspection diagnostic sheet of diabetes and a device for test | inspection diagnosis.

  1, 2, 5, 9 Inspection diagnostic sheet, 3, 4, 7, 11 Inspection diagnostic device 10, 10a, 10b, 10c Base material, 12a, 12b Double-sided tape, 14, 14a, 14b First flow path section 16, 16a, 16b Second flow path part, 18, 18a, 18b Third flow path part, 20, 20a, 20b First reagent part, 22, 22a, 22b Second reagent part, 24, 24a, 24b Inspection part 26a, 26b Sample inlet, 30, 30a, 30b, 32, 32a, 32b, 34, 34a, 34b, 36, 36a, 36b, 38, 38a, 38b, 40, 40a, 40b, 42, 42a, 42b , 44 Adhesive part forming area sheet (adhesive part forming area), 46 Flow path forming area sheet (flow path forming area), 48 Reagent part forming area sheet (reagent part forming area), 50a, 50 Double-sided tape base material, 52a, 52 b, 54a, 54b adhesive layer, 56a, 56b release paper 58 strength double-sided tape, 60 strength double-sided tape substrate 62 strongly adhesive layer, 64 a little less than the adhesive layer.

Claims (9)

At least one injection part penetrating the sheet-like base material, and at least one reagent part in which at least one reagent part and inspection part of a set corresponding to the injection port are formed on one surface of the base material A forming area sheet;
At least one flow path part forming region sheet in which at least two flow path parts of a set corresponding to the injection port are formed on one surface of the sheet-like base material;
The first adhesive part is formed on one surface of the sheet-like base material, and the second adhesive part is formed on the other surface of the sheet-like base material, and the first adhesive part, the base material, and the second adhesive part At least one adhesive portion forming region sheet in which a plurality of openings corresponding to the injection port penetrating the inlet is formed;
Have
When the reagent part forming area sheet, the flow path part forming area sheet, and the adhesive part forming area sheet are overlapped, the inlet, the flow path part, and any of the openings, A three-dimensional immunochromatography method characterized in that the reagent part and the test part are communicated to form a flow path from the injection port to the test part through the reagent part. The diagnostic sheet used. One end part or intermediate part of the sheet-like base material,
A reagent part forming region in which at least one injection port penetrating the base material and at least one reagent part and a test part of a set corresponding to the injection port are formed on one surface of the base material;
A flow path part forming region in which at least two flow path parts of a set corresponding to the injection port are formed on one surface of the substrate;
And
The other end of the substrate is
The first adhesive part is formed on one surface, the second adhesive part is formed on the other surface, and a plurality of sets corresponding to the injection port penetrating the first adhesive part, the base material, and the second adhesive part An adhesion forming area where an opening is formed;
And
One end of the intermediate portion is folded so that the other end portion of the base material sandwiches the first adhesive portion, and the one end portion of the base material sandwiches the second adhesive portion. When folded to the surface side, the injection port, the flow channel unit, the reagent unit, and the test unit are communicated with each other through any of the openings, and the reagent unit is connected from the injection port. A sheet for inspection and diagnosis using a three-dimensional immunochromatography system, characterized in that a flow path to the inspection section is formed. One end or the other end of the sheet-like base material is
A reagent part forming region in which at least one injection port penetrating the base material and at least one reagent part and a test part of a set corresponding to the injection port are formed on one surface of the base material;
A flow path part forming region in which at least two flow path parts of a set corresponding to the injection port are formed on the other surface of the base material;
And
The intermediate part of the substrate is
The first adhesive part is formed on one surface, the second adhesive part is formed on the other surface, and a plurality of sets corresponding to the injection port penetrating the first adhesive part, the base material, and the second adhesive part An adhesion forming area where an opening is formed;
And
The other end of the intermediate portion is folded so that one end portion of the base material sandwiches the first adhesive portion, and the other end portion of the base material sandwiches the second adhesive portion. When folded to the surface side, the injection port, the flow channel unit, the reagent unit, and the test unit are communicated with each other through any of the openings, and the reagent unit is connected from the injection port. A sheet for inspection and diagnosis using a three-dimensional immunochromatography system, characterized in that a flow path to the inspection section is formed. It is a sheet | seat for a test | inspection diagnosis of any one of Claims 1-3,
A sheet for inspection and diagnosis using a three-dimensional immunochromatography method, wherein the water absorption power of the inspection section is larger than the water absorption power of the flow path section and the reagent section. At least one reagent part in which at least one injection port penetrating the sheet-like base material and at least one reagent part and test part of a set corresponding to the injection port are formed on one surface of the base material A forming area sheet;
At least one flow path part forming region sheet in which at least two flow path parts of a set corresponding to the injection port are formed on one surface of the sheet-like base material;
The first adhesive part is formed on one surface of the sheet-like base material, and the second adhesive part is formed on the other surface of the sheet-like base material, and the first adhesive part, the base material, and the second adhesive part At least one adhesive portion forming region sheet in which a plurality of openings corresponding to the injection port penetrating the inlet is formed;
The inspection is conducted through any of the openings, and the injection port, the flow channel unit, the reagent unit, and the inspection unit communicate with each other and pass through the reagent unit from the injection port. An inspection / diagnosis device using a three-dimensional immunochromatography method, characterized in that a flow path to a part is formed. One end part or intermediate part of the sheet-like base material,
A reagent part forming region in which at least one injection port penetrating the base material and at least one reagent part and a test part of a set corresponding to the injection port are formed on one surface of the base material;
A flow path part forming region in which at least two flow path parts of a set corresponding to the injection port are formed on one surface of the substrate;
And
The other end of the substrate is
The first adhesive part is formed on one surface, the second adhesive part is formed on the other surface, and a plurality of sets corresponding to the injection port penetrating the first adhesive part, the base material, and the second adhesive part An adhesion forming area where an opening is formed;
The test diagnostic sheet is folded to one surface side of the intermediate portion such that the other end portion of the base material sandwiches the first adhesive portion, and one end portion of the base material is attached to the second adhesive portion. Folded to one surface side of the intermediate portion so as to sandwich the portion, and through any of the openings, the injection port, the first flow path portion, the first reagent portion, and the first 2 flow path parts, the 2nd reagent part, the 3rd flow path part, and the inspection part are connected, and from the inlet to the inspection part which passes through the 1st reagent part and the 2nd reagent part A diagnostic device using a three-dimensional immunochromatography method, characterized in that a flow path is formed. One end or the other end of the sheet-like base material is
A reagent part forming region in which at least one injection port penetrating the base material and at least one reagent part and a test part of a set corresponding to the injection port are formed on one surface of the base material;
A flow path part forming region in which at least two flow path parts of a set corresponding to the injection port are formed on the other surface of the base material;
And
The intermediate part of the substrate is
The first adhesive part is formed on one surface, the second adhesive part is formed on the other surface, and a plurality of sets corresponding to the injection port penetrating the first adhesive part, the base material, and the second adhesive part An adhesion forming area where an opening is formed;
The test diagnostic sheet is folded to one surface side of the intermediate portion such that one end portion of the base material sandwiches the first adhesive portion, and the other end portion of the base material is the second adhesive portion. Folded to the other surface side of the intermediate portion so as to sandwich the portion, and through any of the openings, the inlet, the first flow path portion, the first reagent portion, and the first 2 flow path parts, the 2nd reagent part, the 3rd flow path part, and the above-mentioned inspection part are connected, and from the above-mentioned inlet to the above-mentioned inspection part which passes through the above-mentioned 1st reagent part and the above-mentioned 2nd reagent part An inspection / diagnosis device using a three-dimensional immunochromatography system, characterized in that a flow path is formed. The inspection diagnostic device according to any one of claims 5 to 7,
A device for examination and diagnosis using a three-dimensional immunochromatography method, wherein the water absorption power of the inspection section is larger than the water absorption power of the flow path section and the reagent section.   A target detection method, comprising: detecting a target using the test / diagnosis device configured by the test / diagnosis sheet according to claim 1.

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