JP2015099094A - Sheet for diabetes examination diagnosis using three-dimensional immunochromatography system, device for diabetes examination diagnosis, and method of detecting myo-inositol - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a sheet for diabetes examination diagnosis capable of measuring myo-inositol.SOLUTION: There is provided a sheet for diabetes examination diagnosis using a three-dimensional immunochromatography system such that when a reagent part formation region sheet which has injection ports penetrating a sheet type base material, and a first reagent part, a second reagent part, and an examination part formed on one surface of the base material, a flow passage formation region sheet which has a first flow passage part, a second flow passage part, and a third flow passage part formed on one surface of a base material, and an adhesion part formation region sheet which has both-side tapes formed on both surfaces of a base material and also a plurality of opening parts penetrating the both-side tape, base materia, and the both-side tape are stacked one over another, the injection ports, first flow passage part, first reagent part, second flow passage part, second reagent part, third flow passage part, and examination part are linked together through one of the opening parts so as to form a flow passage from the examination port to the examination part through the first reagent part and second reagent part; the first reagent part and second reagent part include a glucose reagent and a coenzyme; and the examination part includes dehydrogenase and a coloring matrix.

Description

  The present invention relates to a sheet for diagnosis and diagnosis of diabetes using a three-dimensional immunochromatography method, a device for diagnosis and diagnosis of diabetes, and a method for detecting myo-inositol 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.

  Meanwhile, diabetes is one of the diseases in which the number of patients is increasing in recent years. Diabetes mellitus is a disease in which glucose (glucose) concentration in blood (blood glucose level) continues to be high. Diabetes generally has few symptoms and is easily left untreated, but if left untreated, complications may occur in various organs, so early detection and treatment are desired. Diagnosis of diabetes is usually performed based on fasting blood glucose level, occasional blood glucose level, glucose tolerance test, HbA1c value, etc., but blood sampling is required, and noninvasive diagnostic methods have been studied.

  Recent studies have shown that urinary myo-inositol (MI) is reflected in changes in blood glucose levels in diabetic patients. When glucose tolerance declines, glucose resorption is inhibited, and urine myo-inositol Since the concentration increases rapidly, it is considered that simple measurement of myo-inositol is effective for screening tests for diabetes and the like.

  Although measurement of myo-inositol can be performed non-invasively (urine), a large-scale device such as a biochemical automatic analyzer is required, and a simpler diagnostic method is desired.

International Publication No. 2012/105721 Pamphlet

  An object of the present invention is to provide a sheet for diagnosis and diagnosis of diabetes using a three-dimensional immunochromatography method that can easily detect myo-inositol, a device for diagnosis and diagnosis of diabetes, and a method for detecting myo-inositol.

The present invention
At least one injection port penetrating the sheet-like base material and at least one set of the first reagent part, the second reagent part, and the inspection part corresponding to the injection port is formed on one surface of the base material. One reagent part forming region sheet;
Formation of at least one flow path part in which a first flow path part, a second flow path part, and a third flow path part corresponding to the injection port are formed on one surface of the sheet-like base material An area sheet,
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 superposed, the injection port and the first flow path part via any of the openings And the first reagent part, the second flow path part, the second reagent part, the third flow path part, and the test part are communicated with each other, and the first reagent part, A flow path to the inspection part through the second reagent part is formed,
The first reagent part and the second reagent part include a glucose elimination reagent and a coenzyme, and the inspection part includes a dehydrogenase and a chromogenic substrate, and is a sheet for diagnosis and diagnosis of diabetes using a three-dimensional immunochromatography method.

The present invention also provides:
One end part or intermediate part of the sheet-like base material,
Reagent part formation in which at least one injection port penetrating the base material and a pair of first reagent part, second reagent part, and test part corresponding to the injection port are formed on one surface of the base material region,
A flow path portion forming region in which a first flow path portion, a second flow path portion, and a third flow path portion corresponding to the injection port are formed on one surface of the base material;
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 on the surface side, the injection port, the first flow path section, the first reagent section, the second flow path section, and the second reagent are passed through any of the openings. Part, the third flow path part, and the inspection part are communicated to form a flow path from the inlet to the inspection part through the first reagent part and the second reagent part. And
The first reagent part and the second reagent part include a glucose elimination reagent and a coenzyme, and the inspection part includes a dehydrogenase and a chromogenic substrate, and is a sheet for diagnosis and diagnosis of diabetes using a three-dimensional immunochromatography method.

The present invention also provides:
One end or the other end of the sheet-like base material is
Reagent part formation in which at least one injection port penetrating the base material and a pair of first reagent part, second reagent part, and test part corresponding to the injection port are formed on one surface of the base material region,
A flow path part forming region in which a first flow path part, a second flow path part, and a third flow path part of a set corresponding to the injection port are formed on the other surface of the substrate;
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 on the surface side, the injection port, the first flow path section, the first reagent section, the second flow path section, and the second reagent are passed through any of the openings. Part, the third flow path part, and the inspection part are communicated to form a flow path from the inlet to the inspection part through the first reagent part and the second reagent part. And
The first reagent part and the second reagent part include a glucose elimination reagent and a coenzyme, and the inspection part includes a dehydrogenase and a chromogenic substrate, and is a sheet for diagnosis and diagnosis of diabetes using a three-dimensional immunochromatography method.

  Further, in the sheet for diagnosis and diagnosis of diabetes, the water absorption power of the test section is such that the first flow path section, the second flow path section, the third flow path section, the first reagent section, and the second reagent section. It is preferable that it is larger than the water-absorbing power.

The present invention also provides:
At least one injection port penetrating the sheet-like base material and at least one set of the first reagent part, the second reagent part, and the inspection part corresponding to the injection port is formed on one surface of the base material. One reagent part forming region sheet;
Formation of at least one flow path part in which a first flow path part, a second flow path part, and a third flow path part corresponding to the injection port are formed on one surface of the sheet-like base material An area sheet,
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;
Are overlapped, and through any of the openings, the inlet, the first flow path section, the first reagent section, the second flow path section, the second reagent section, The third flow path part and the inspection part are communicated, and a flow path from the injection port to the inspection part passing through the first reagent part and the second reagent part is formed,
The first reagent part and the second reagent part include a glucose elimination reagent and a coenzyme, and the test part includes a dehydrogenase and a chromogenic substrate, and is a device for testing and diagnosing diabetes using a three-dimensional immunochromatography method.

The present invention also provides:
One end part or intermediate part of the sheet-like base material,
Reagent part formation in which at least one injection port penetrating the base material and a pair of first reagent part, second reagent part, and test part corresponding to the injection port are formed on one surface of the base material region,
A flow path portion forming region in which a first flow path portion, a second flow path portion, and a third flow path portion corresponding to the injection port are formed on one surface of the base material;
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 sheet for diagnosis and diagnosis of diabetes is folded to one surface side of the intermediate portion so that the other end portion of the base material sandwiches the first adhesive portion, and one end portion of the base material is the second end portion. Folded to one surface side of the intermediate part so as to sandwich the adhesive part, and through any of the openings, the inlet, the first flow path part, the first reagent part, and the The second flow path section, the second reagent section, the third flow path section, and the test section communicate with each other, and the test section passes through the first reagent section and the second reagent section from the inlet. The flow path to is formed,
The first reagent part and the second reagent part include a glucose elimination reagent and a coenzyme, and the test part includes a dehydrogenase and a chromogenic substrate, and is a device for testing and diagnosing diabetes using a three-dimensional immunochromatography method.

The present invention also provides:
One end or the other end of the sheet-like base material is
Reagent part formation in which at least one injection port penetrating the base material and a pair of first reagent part, second reagent part, and test part corresponding to the injection port are formed on one surface of the base material region,
A flow path part forming region in which a first flow path part, a second flow path part, and a third flow path part of a set corresponding to the injection port are formed on the other surface of the substrate;
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 diabetes test and diagnosis sheet is folded to one surface side of the intermediate portion so 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 end portion. Folded to the other surface side of the intermediate part so as to sandwich the adhesive part, and through any of the openings, the inlet, the first flow path part, the first reagent part, and the The second flow path section, the second reagent section, the third flow path section, and the test section communicate with each other, and the test section passes through the first reagent section and the second reagent section from the inlet. The flow path to is formed,
The first reagent part and the second reagent part include a glucose elimination reagent and a coenzyme, and the test part includes a dehydrogenase and a chromogenic substrate, and is a device for testing and diagnosing diabetes using a three-dimensional immunochromatography method.

  Further, in the device for diagnosis and diagnosis of diabetes, the water absorption power of the test unit is such that the first flow channel unit, the second flow channel unit, the third flow channel unit, the first reagent unit, and the second reagent unit. It is preferable that it is larger than the water-absorbing power.

  In addition, the present invention is a myo-inositol detection method for detecting myo-inositol using a diabetes test-diagnosis device constituted by the diabetes test-diagnosis sheet.

  ADVANTAGE OF THE INVENTION According to this invention, the sheet | seat for diabetes test | inspection diagnosis using the three-dimensional immunochromatography system which can detect myo-inositol simply, the device for diabetes test | inspection diagnosis, and the detection method of myo-inositol are provided.

It is a schematic block diagram which shows an example of the sheet | seat for diabetes test | diagnosis which concerns 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 | region in the sheet | seat for diabetes 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 diabetes test | inspection diagnosis based on embodiment of this invention. It is a schematic side view which shows an example of the structure of the device for diabetes test | inspection diagnosis comprised with the sheet | seat for diabetes 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 diabetes test | diagnosis which concerns 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 diabetes test | inspection diagnosis based on embodiment of this invention. It is a schematic side view which shows an example of the structure of the device for diabetes test | inspection diagnosis comprised with the sheet | seat for diabetes test | inspection diagnosis based on embodiment of this invention. It is the schematic which shows an example of the test | inspection diagnostic method using the device for diabetes test | inspection diagnosis comprised with the sheet | seat for diabetes 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 diabetes test | diagnosis which concerns 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 diabetes 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 diabetes test | diagnosis which concerns 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 diabetes 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 sheet for diagnosis and diagnosis of diabetes according to an embodiment of the present invention is shown in FIG. Diabetes test diagnostic sheet 1 includes two sample inlets 26a and 26b penetrating sheet-like base material 10a, first reagent parts 20a and 20b formed on one surface of base material 10a, Two reagent parts 22a, 22b and at least one reagent part forming region sheet 48 having inspection parts 24a, 24b; as a first adhesive part formed on at least a part of one surface of the substrate 10b on the sheet The double-sided tape 12a, the double-sided tape 12b as the second adhesive portion formed on at least a part of the other side, the double-sided tape 12a, the base material 10b, and the double-sided tape 12b are penetrated, and at predetermined intervals in the longitudinal direction. A set of a plurality of openings 30a, 32a, 34a, 36a, 38a, 40a, and 42a corresponding to the sample injection port 26a and the sample injection port 26b arranged in a line. And at least a part of one surface of the sheet-like base material 10c; and at least a part of one surface of the sheet-like base material 10c; and a pair of the plurality of openings 30b, 32b, 34b, 36b, 38b, 40b, 42b; The first channel portion 14a, the second channel portion 16a and the third channel portion 18a corresponding to the sample inlet 26a, the first channel portion 14b corresponding to the sample inlet 26b, and the second channel And at least one flow path forming region sheet 46 having a flow path portion 16b and a third flow path portion 18b.

  Diabetes test diagnosis sheet 1 is configured such that when reagent part forming region sheet 48, adhesive part forming region sheet 44, and flow path forming region sheet 46 are overlapped with adhesive part forming region sheet 44 interposed therebetween, openings 30a, 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 second reagent part 32a, 34a, 36a, 38a, 40a are provided. The three flow path portions 18a and the test section 24a are communicated to form a flow path from the sample inlet 26a to the test section 24a through the first reagent section 20a and the second reagent section 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 Road section 18b and inspection section 2 b communicated passed, 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.

  In the diabetes test diagnostic sheet 1, the first reagent unit 20 and the second reagent unit 22 include a glucose elimination reagent such as ATP and a coenzyme such as NAD, and the test unit 24 includes a dehydrogenase such as myo-inositol dehydrogenase. And chromogenic substrates such as NTB.

  FIG. 2 shows an enlarged cross-sectional view of the adhesive portion forming region sheet 44 in the diabetes test diagnostic 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 sheet 46 in the diabetes test diagnostic 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 papers 56a and 56b of the double-sided tape 12a shown in FIG. 2 are peeled off, the diabetes test diagnostic sheet 1 has a reagent part forming region sheet 48, an adhesive part forming region sheet 44, and a flow as shown in FIG. The path formation region sheet 46 is overlapped with the adhesive portion formation region sheet 44 interposed therebetween, and the surface 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 of the double-sided tape 12b. 54b, and the surfaces of the first flow path portion 14, the second flow path portion 16, and the third flow path portion 18 of the flow path forming region sheet 46 and the adhesive layer 54a of the double-sided tape 12a are bonded to each other to test for diabetes. The diagnostic device 3 is produced.

  In the example of FIG. 4, the diabetes 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 superimposed. A multilayer structure in which two or more reagent part forming area sheets 48, two or more adhesive part forming area sheets 44, and two or more flow path forming area sheets 46 are superposed may be used. Thereby, a plurality of processes can be performed by one device.

  An outline of another example of the sheet for diagnosis and diagnosis of diabetes according to the embodiment of the present invention is shown in FIG. Diabetes test diagnostic sheet 2 penetrates base material 10 formed in sheet-like base material 10 and reagent part formation region 48 at one end obtained by dividing the longitudinal direction of 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 part formed on at least a part of one surface of the adhesive part forming region 44 at the other end of the base material 10, and adhesive part formation Penetrating the double-sided tape 12b as the second adhesive portion formed on at least a part of the other surface of the region 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; A set of a plurality of openings 30a, 32a, 34a, 36a, 38a, 40a, 42a corresponding to the sample injection port 26a, arranged in a line at a predetermined interval in the longitudinal direction, and another corresponding to the sample injection port 26b. A plurality of openings 30b, 32b, 34b, 36b, 38b, 40b, 42b and a sample injection port 26a formed on at least a part of one surface of the flow path forming region 46 in the intermediate part of the substrate 10. Corresponding first channel portion 14a, second channel portion 16a and third channel portion 18a, and first channel portion 14b, second channel portion 16b and third channel portion corresponding to sample inlet 26b 18b. 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 sheet 2 for diagnosis and diagnosis of diabetes 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 as described above, the sample inlet 26a, the first flow path portion 14a, and the first reagent portion 20a are passed through the openings 30a, 32a, 34a, 36a, 38a, and 40a. And 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 the first reagent part 20a and the second reagent part 22a are connected from the sample inlet 26a. A flow path to the testing section 24a is formed, and the sample inlet 26b, the first flow path section 14b, the first reagent section 20b, and the openings 30b, 32b, 34b, 36b, 38b, and 40b, A second flow path portion 16b, a second reagent portion 22b, The third flow path part 18b and the test part 24b are communicated to form a flow path from the sample inlet 26b to the test part 24b passing through the first reagent part 20b and the second reagent part 22b. .

  The sheet 2 for diagnosis and diagnosis of diabetes according to this embodiment includes at least one sample injection port 26 (two sample injection ports 26a and 26b in the example of FIG. 5) and at least one first flow path portion on one sheet. 14 (two first channel portions 14a and 14b in the example of FIG. 5), at least one second channel portion 16 (two second channel portions 16a and 16b in the example of FIG. 5), and at least one first channel portion. 3 flow path portions 18 (two third flow path portions 18a and 18b in the example of FIG. 5), double-sided tape 12a as a first adhesive portion, double-sided tape 12b as a second adhesive portion, and at least one set of a plurality of sets Openings 30, 32, 34, 36, 38, 40, 42 (in the example of FIG. 5, two sets of openings 30a, 32a, 34a, 36a, 38a, 40a, 42a and openings 30b, 32b, 34b, 36b) , 38b, 40b, 4 b) is formed, only folded just as will be described later, can be configured diabetes testing device for diagnosis using a three-dimensional immunochromatography method. The sheet 2 for diagnosis and diagnosis of diabetes according to the present embodiment can be manufactured continuously, and is extremely excellent in mass productivity.

  Diabetes test diagnostic sheet 2 includes, for example, an inlet forming step for forming sample inlet 26 penetrating through base material 10 in reagent part forming region 48 at one end of sheet-like base material 10, and a flow path at an intermediate portion. A flow path part forming step for forming the first flow path part 14, the second flow path part 16, and the third flow path part 18 on at least a part of one surface of the formation area 46, and an adhesive part forming area at the other end 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 side of the 44, and a double-sided tape as a second adhesive portion to at least a portion of the other surface of the adhesive portion formation region 44; A plurality of openings 30, 32, 34, 36, 38, 40, 42 penetrating the double-sided tape 12a, the base material 10, and the double-sided tape 12b in the adhesive forming region 44; An opening forming step to be formed, and a base 10, a reagent part forming step for forming the first reagent part 20 and the second reagent part 22, a test part forming process for forming the test part 24, and each reagent part and test part. And a coating step of coating a reagent or the like. The manufacturing method of the sheet | seat 1 for diabetes test | inspection diagnosis is not limited to this. Moreover, there is no restriction | limiting in particular about the order of these processes, as long as the target sheet | seat 2 for a diabetes test | inspection diagnosis 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 part 20, the second reagent part 22, and the test part 24 are formed to manufacture the diabetes test diagnostic sheet 2, and before the test diagnosis, for example, the first reagent part 20 and the second reagent A reagent or the like may be applied to the portion 22 and a coloring substrate or the like may be applied to the inspection portion 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.

  An outline of an example of a method for using the sheet 2 for diagnosis and diagnosis of diabetes is shown in FIG. 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 surface of the reagent part 22 and the test part 24 and the adhesive layer 54b of the double-sided tape 12b are joined together, and the diabetes test / diagnosis device 4 is manufactured.

  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. The device for diagnosis and diagnosis of diabetes 4 having the inspection unit 24 via 40 is obtained.

  FIG. 7 shows a schematic side view of a device for diagnosing diabetes test produced using the sheet 2 for diagnosing diabetes test 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.

  In the diabetes test and diagnosis devices 3 and 4, the sample injection port 26 is a place where a sample is injected, and the first reagent unit 20 and the second reagent unit 22 include a glucose elimination reagent such as ATP and a coenzyme such as NAD. 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 test diagnosis method using a diabetes test diagnosis device configured using the diabetes test diagnosis sheet according to the present 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 part 20 and the second reagent part 22 may be appropriately changed depending on the reaction system to be used.

  In the present embodiment, the water absorption force of the inspection unit 24 is greater than 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 is preferable. 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.

  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 sheet for diagnosis and diagnosis of diabetes according to the embodiment of the present invention. The sheet 5 for diagnosis and diagnosis of diabetes penetrates 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 part formed on at least a part of one surface of the adhesive part forming region 44 at the other end of the base material 10, and adhesive part formation Penetrating the double-sided tape 12b as the second adhesive portion formed on at least a part of the other surface of the region 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; A set of a plurality of openings 30a, 32a, 34a, 36a, 38a, 40a, 42a corresponding to the sample injection port 26a, arranged in a line at a predetermined interval in the longitudinal direction, and another corresponding to the sample injection port 26b. A plurality of openings 30b, 32b, 34b, 36b, 38b, 40b, 42b and a sample injection port 26a formed on at least a part of one surface of the flow path forming region 46 at one end of the substrate 10. Corresponding first channel portion 14a, second channel portion 16a and third channel portion 18a, and first channel portion 14b, second channel portion 16b and third channel portion corresponding to sample inlet 26b 18b. 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 sheet 5 for diabetes test and diagnosis 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 as described above, the sample inlet 26a, the first flow path portion 14a, and the first reagent portion 20a are passed through the openings 30a, 32a, 34a, 36a, 38a, and 40a. And 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 the first reagent part 20a and the second reagent part 22a are connected from the sample inlet 26a. A flow path to the testing section 24a is formed, and the sample inlet 26b, the first flow path section 14b, the first reagent section 20b, and the openings 30b, 32b, 34b, 36b, 38b, and 40b, A second flow path portion 16b, a second reagent portion 22b, The third flow path part 18b and the test part 24b are communicated to form a flow path from the sample inlet 26b to the test part 24b passing through the first reagent part 20b and the second reagent part 22b. .

  FIG. 10 shows an outline of an example of a method for using the diabetes test 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 surface of the second flow path portion 16 and the third flow path portion 18 and the adhesive layer 54b of the double-sided tape 12b are joined together to produce the diabetes test / 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, a device for diagnosis and diagnosis 7 of diabetes 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 sheet for diagnosis and diagnosis of diabetes according to the embodiment of the present invention. Diabetes test diagnosis sheet 9 penetrates through base material 10 formed in sheet-like base material 10 and reagent part formation region 48 at one end obtained by dividing the longitudinal direction of 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 intermediate portion 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 A set of a plurality of openings 30a, 32a, 34a, 36a, 38a, 40a, 42a corresponding to the sample injection port 26a, which are arranged in a line at predetermined intervals in the direction, and another corresponding to the sample injection port 26b. A plurality of openings 30b, 32b, 34b, 36b, 38b, 40b, 42b, and a sample inlet 26a formed on at least a part of the other surface of the flow path forming region 46 at the other end of the substrate 10. The first flow path part 14a, the second flow path part 16a and the third flow path part 18a corresponding to the first flow path part 14b, the second flow path part 16b and the third flow path corresponding to the sample inlet 26b. Part 18b. 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 sheet 9 for diagnosis and diagnosis of diabetes 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 as described above, the sample inlet 26a, the first flow path portion 14a, and the first reagent portion 20a are passed through the openings 30a, 32a, 34a, 36a, 38a, and 40a. And 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 the first reagent part 20a and the second reagent part 22a are connected from the sample inlet 26a. A flow path to the testing section 24a is formed, and the sample inlet 26b, the first flow path section 14b, the first reagent section 20b, and the openings 30b, 32b, 34b, 36b, 38b, and 40b, A second flow path portion 16b, a second reagent portion 22b, The third flow path part 18b and the test part 24b are communicated to form a flow path from the sample inlet 26b to the test part 24b passing through the first reagent part 20b and the second reagent part 22b. .

  FIG. 12 shows an outline of an example of a method for using the diabetes test diagnostic sheet 9. 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 test part 24 and the adhesive layer 54a of the double-sided tape 12a are joined together to produce the device 11 for diabetes test and diagnosis.

  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, the device 11 for diagnosis and diagnosis of diabetes having the 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 diagnostic sheet 2 shown in FIG. 5, the diabetes test diagnostic sheet 5 shown in FIG. 7, and the diabetes test diagnostic sheet 9 shown in FIG. 9, a device for diabetes test diagnosis can be easily produced simply by folding. can do. Further, it is possible to easily align the opening with the flow path, reagent, and inspection unit.

  According to the diabetes test and diagnosis sheet, the diabetes test and diagnosis device, and the myo-inositol detection method according to the present embodiment, myo-inositol 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 manner, a sheet 1 for diagnosis 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 sheet for diagnosis and diagnosis 1 prepared as described above is peeled off the release paper of the double-sided tape 12 a, the adhesive portion forming region 44 side of the other end of the substrate 10 is placed on the double-sided tape 12 a. Folded to one surface side of the intermediate part so as to sandwich the surface, the surfaces 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. The surface of the 2nd reagent part 22 and the test | inspection part 24, and the contact bonding layer 54b of the double-sided tape 12b were joined, and the device 3 for a diabetes test | inspection diagnosis was produced. 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 Diabetes test diagnosis sheet, 3,4,7,11 Diabetes test diagnosis device 10, 10a, 10b, 10c Base material, 12a, 12b Double-sided tape, 14, 14a, 14b First flow Road part, 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 injection port, 30, 30a, 30b, 32, 32a, 32b, 34, 34a, 34b, 36, 36a, 36b, 38, 38a, 38b, 40, 40a, 40b, 42, 42a, 42b Opening part, 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), 0a, 50b sided tape substrate 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 port penetrating the sheet-like base material and at least one set of the first reagent part, the second reagent part, and the inspection part corresponding to the injection port is formed on one surface of the base material. One reagent part forming region sheet;
Formation of at least one flow path part in which a first flow path part, a second flow path part, and a third flow path part corresponding to the injection port are formed on one surface of the sheet-like base material An area sheet,
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 superposed, the injection port and the first flow path part via any of the openings And the first reagent part, the second flow path part, the second reagent part, the third flow path part, and the test part are communicated with each other, and the first reagent part, A flow path to the inspection part through the second reagent part is formed,
Diabetes test diagnosis using a three-dimensional immunochromatography method, wherein the first reagent part and the second reagent part include a glucose elimination reagent and a coenzyme, and the test part includes a dehydrogenase and a chromogenic substrate. Sheet. One end part or intermediate part of the sheet-like base material,
Reagent part formation in which at least one injection port penetrating the base material and a pair of first reagent part, second reagent part, and test part corresponding to the injection port are formed on one surface of the base material region,
A flow path portion forming region in which a first flow path portion, a second flow path portion, and a third flow path portion corresponding to the injection port are formed on one surface of the base material;
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 on the surface side, the injection port, the first flow path section, the first reagent section, the second flow path section, and the second reagent are passed through any of the openings. Part, the third flow path part, and the inspection part are communicated to form a flow path from the inlet to the inspection part through the first reagent part and the second reagent part. And
Diabetes test diagnosis using a three-dimensional immunochromatography method, wherein the first reagent part and the second reagent part include a glucose elimination reagent and a coenzyme, and the test part includes a dehydrogenase and a chromogenic substrate. Sheet. One end or the other end of the sheet-like base material is
Reagent part formation in which at least one injection port penetrating the base material and a pair of first reagent part, second reagent part, and test part corresponding to the injection port are formed on one surface of the base material region,
A flow path part forming region in which a first flow path part, a second flow path part, and a third flow path part of a set corresponding to the injection port are formed on the other surface of the substrate;
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 on the surface side, the injection port, the first flow path section, the first reagent section, the second flow path section, and the second reagent are passed through any of the openings. Part, the third flow path part, and the inspection part are communicated to form a flow path from the inlet to the inspection part through the first reagent part and the second reagent part. And
Diabetes test diagnosis using a three-dimensional immunochromatography method, wherein the first reagent part and the second reagent part include a glucose elimination reagent and a coenzyme, and the test part includes a dehydrogenase and a chromogenic substrate. Sheet. The sheet for diagnosis and diagnosis of diabetes according to any one of claims 1 to 3,
The water absorption force of the inspection unit is greater than the water absorption force of the first flow channel unit, the second flow channel unit, the third flow channel unit, the first reagent unit, and the second reagent unit. Diabetes test sheet using a three-dimensional immunochromatography method. At least one injection port penetrating the sheet-like base material and at least one set of the first reagent part, the second reagent part, and the inspection part corresponding to the injection port is formed on one surface of the base material. One reagent part forming region sheet;
Formation of at least one flow path part in which a first flow path part, a second flow path part, and a third flow path part corresponding to the injection port are formed on one surface of the sheet-like base material An area sheet,
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;
Are overlapped, and through any of the openings, the inlet, the first flow path section, the first reagent section, the second flow path section, the second reagent section, The third flow path part and the inspection part are communicated, and a flow path from the injection port to the inspection part passing through the first reagent part and the second reagent part is formed,
Diabetes test diagnosis using a three-dimensional immunochromatography method, wherein the first reagent part and the second reagent part include a glucose elimination reagent and a coenzyme, and the test part includes a dehydrogenase and a chromogenic substrate. Device. One end part or intermediate part of the sheet-like base material,
Reagent part formation in which at least one injection port penetrating the base material and a pair of first reagent part, second reagent part, and test part corresponding to the injection port are formed on one surface of the base material region,
A flow path portion forming region in which a first flow path portion, a second flow path portion, and a third flow path portion corresponding to the injection port are formed on one surface of the base material;
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 sheet for diagnosis and diagnosis of diabetes is folded to one surface side of the intermediate portion so that the other end portion of the base material sandwiches the first adhesive portion, and one end portion of the base material is the second end portion. Folded to one surface side of the intermediate part so as to sandwich the adhesive part, and through any of the openings, the inlet, the first flow path part, the first reagent part, and the The second flow path section, the second reagent section, the third flow path section, and the test section communicate with each other, and the test section passes through the first reagent section and the second reagent section from the inlet. The flow path to is formed,
Diabetes test diagnosis using a three-dimensional immunochromatography method, wherein the first reagent part and the second reagent part include a glucose elimination reagent and a coenzyme, and the test part includes a dehydrogenase and a chromogenic substrate. Device. One end or the other end of the sheet-like base material is
Reagent part formation in which at least one injection port penetrating the base material and a pair of first reagent part, second reagent part, and test part corresponding to the injection port are formed on one surface of the base material region,
A flow path part forming region in which a first flow path part, a second flow path part, and a third flow path part of a set corresponding to the injection port are formed on the other surface of the substrate;
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 diabetes test and diagnosis sheet is folded to one surface side of the intermediate portion so 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 end portion. Folded to the other surface side of the intermediate part so as to sandwich the adhesive part, and through any of the openings, the inlet, the first flow path part, the first reagent part, and the The second flow path section, the second reagent section, the third flow path section, and the test section communicate with each other, and the test section passes through the first reagent section and the second reagent section from the inlet. The flow path to is formed,
Diabetes test diagnosis using a three-dimensional immunochromatography method, wherein the first reagent part and the second reagent part include a glucose elimination reagent and a coenzyme, and the test part includes a dehydrogenase and a chromogenic substrate. Device. A device for diagnosis and diagnosis of diabetes according to any one of claims 5 to 7,
The water absorption force of the inspection unit is greater than the water absorption force of the first flow channel unit, the second flow channel unit, the third flow channel unit, the first reagent unit, and the second reagent unit. Diabetes testing and diagnosis device using a three-dimensional immunochromatography method.   A myo-inositol detection method, comprising: detecting a myo-inositol using the diabetes test-diagnosis device comprising the diabetes test-diagnosis sheet according to any one of claims 1 to 4.

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