JP2017134063A - Sensor chip - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a sensor chip that can perform multi stage reactions with high reproducibility.SOLUTION: A sensor chip includes: a base member 3 that has a sample supply position on a surface; a slide member 30 that has an electrode system formed at a spaced interval with the sample supply position on the base member 3, and a sample reception part 34 capable of receiving a sliding body and sample sliding to move on the base member 3; and a support part that supports the slide member 30. The sample reception part 34 includes: a first sample holding part 35 that is provided at a position apart from a surface of the base member 3 toward a direction perpendicular with respect to the surface thereof in a state with the slide member 30 supported by the support part; and a second sample holding part 36 that is provided by being connected to the first sample holding part 35 so as to protrude toward the base member 3 from the first sample holding part 35, and is contactable with the base member 3.SELECTED DRAWING: Figure 8

Description

  The present invention relates to a sensor chip that can be used for analysis of biological components.

  In recent years, 1,5-anhydroglucitol (hereinafter referred to as “1,5-AG”) has attracted attention as a marker for grasping the blood glucose control state of diabetic patients. 1,5-AG has advantages such as being less susceptible to meals and reflecting a relatively short-term blood glucose control state of the past week or so.

  For example, in order to detect 1,5-AG using human whole blood as a sample, a substance that inhibits the detection of 1,5-AG is first removed from the whole blood sample and then 1,5-AG is detected. Stage processing may be performed.

  As a detection device for performing multi-stage processing on a sample, for example, Patent Document 1 describes a biosensor that performs a two-stage reaction for detecting the concentration of glycoprotein in blood. This biosensor has a suction cavity that sucks up a sample by capillary action, an analysis cavity that performs an enzymatic reaction on the sample, and a flow path that connects the suction cavity and the analysis cavity. Reagent is immobilized. In this biosensor, when a sample is sucked into the suction cavity by capillary action, pretreatment is performed in the suction cavity, and the sample reaction after the pretreatment is moved from the suction cavity to the analysis cavity by centrifugal force, thereby causing an enzyme reaction. Done.

  Patent Document 2 discloses a detection device capable of performing a two-stage reaction including a pretreatment reaction by using a slide member that moves a sample supplied to a sample supply position to an electrode system. .

JP 2008-20287 A International Publication No. 2011/108576

  For example, when a multi-stage reaction is performed on a sample, the sample after the reaction is moved to a post-reaction field after the completion of the pre-stage reaction. At this time, if there is a variation in the amount of the sample sent from the former stage to the latter stage, the reproducibility of the latter stage reaction deteriorates. For this reason, it is preferable that the total amount or a predetermined amount of the sample after the previous reaction can be accurately moved to the subsequent reaction field.

  This invention is made | formed in view of the situation mentioned above, The objective is to provide the sensor chip which can perform multistep reaction with high reproducibility.

  One embodiment of the present invention includes a base member having a sample supply position on a surface to which a sample is supplied, a detection unit formed on the surface of the base member so as to be separated from the sample supply position, and the base member A slide body that slides relatively on the surface, a slide member that is provided on a part of the slide body and has a sample storage portion that can store the sample, and is fixed to the base member, A support portion that supports the slide member so as to be slidable relative to the member, and the sample storage portion is supported with respect to the surface of the base member in a state where the slide member is supported by the support portion. A first sample holding portion provided at a position spaced from the surface in the vertical direction and connected to the first sample holding portion so as to protrude from the first sample holding portion toward the surface. A second sample holding portion contactable with the surface of the base member has a protrusion shape provided, a sensor chip having a.

  The first sample holding unit has a sample holding surface directed to the surface of the base member in a state where the slide member is supported by the support unit, and the second sample holding unit is formed of the sample holding surface. A ridge shape extending in the surface direction may be formed.

  The second sample holding portion includes a first ridge structure portion provided to extend in a sliding direction of the slide member at a first position on the periphery of the sample holding surface, and the sample of the periphery of the sample holding surface. You may have the 2nd protruding item | line structure part extended and provided in the sliding direction of the said sliding member in the 2nd position on the opposite side to said 1st position on both sides of a holding surface.

  The sample holding surface and the second sample holding portion may be connected by a curved surface.

  The second sample holding portion may have a flat portion that is connected to the sample holding surface at an angle larger than 90 ° with respect to the sample holding surface at the boundary with the sample holding surface.

  In the sensor chip of the above aspect, the detection unit has an electrode system including a working electrode and a reference electrode formed on the surface of the base member so as to be separated from the sample supply position, and the electrode system is interposed therebetween. You may further have the ground pattern which consists of the conductor electrically connected mutually in the several place spaced apart.

  The sensor chip according to the aspect described above is for detecting the presence or absence of the sample in the first supply sensor provided at the sample supply position in order to detect whether or not the sample is supplied to the sample supply position. And a second supply sensor provided on the opposite side of the sample supply position with the detection portion interposed therebetween in the slide direction of the slide member.

  The sensor chip according to the aspect described above is provided with whether or not the sample is supplied to the sample supply position instead of including the first supply sensor and the second supply sensor, or in addition to the second supply sensor. The sensor further comprises a supply sensor provided at the sample supply position for detection, the supply sensor having a first electrode extending in a linear direction and a second electrode extending in parallel with the first electrode, The length of the first electrode and the second electrode is 60% or more of the dimension of the sample supply position in a direction parallel to the direction orthogonal to the sliding direction of the slide member among the directions along the surface of the base member. % Or less.

  The first electrode and the second electrode are made of a conductor printed on the surface of the base member, and the first electrode and the second electrode are 0.1 mm or more and 1 mm or less in the sliding direction of the slide member. They may be separated from each other by a distance.

  The sensor chip of the above aspect has a first electrode that forms a circular shape with a size that fits inside the contour of the sample storage portion when viewed from a direction perpendicular to the surface of the base member, An annular shape that is concentric with the first electrode, surrounds at least a portion of the first electrode, and fits inside the outline of the sample container when viewed from a direction perpendicular to the surface of the base member, or A second electrode that forms a partial ring and constitutes the detection unit, and is opposite to the sample supply position with the detection unit interposed in the sliding direction of the slide member to detect the presence or absence of the sample in the detection unit It may further include a partial annular supply sensor provided on the side and concentric with the first electrode and the second electrode.

  The supply sensor may have a partial annular shape extending over a range of 45 ° or more and 90 ° or less around the center of the first electrode.

  The detection unit is concentric with the first electrode and a circular first electrode having a size that fits inside the contour of the sample storage unit when viewed from a direction perpendicular to the surface of the base member. An annular or partially annular second electrode that surrounds at least a portion of the first electrode and fits inside the contour of the sample storage portion when viewed from a direction perpendicular to the surface of the base member; It may be.

  The sample storage portion includes a base end portion located on the slide body side and a tip end portion located on the opposite side to the base end portion in the sliding direction of the slide member, and the tip end portion is the slide member. A tip surface that is substantially along a plane perpendicular to the slide direction of the slide member and that has a smaller area than a cross section of the slide body perpendicular to the slide direction of the slide member may be provided.

  The sensor chip of the above aspect is formed on the support portion so as to be engageable with the engagement portion formed on the slide member to engage the slide member with the support portion. And a lock portion that can be disengaged from the engagement portion by a predetermined amount of force in the sliding direction of the slide member.

  The first sample holding portion has a sample holding surface directed toward the surface of the base member in a state where the slide member is supported by the support portion, and the sample holding surface has an unevenness with an elevation difference of 20 μm or less. You may have a structure.

  The base member has holes provided in at least two places where a part of the support can be engaged and separated from each other, and the support has protrusions that can be simultaneously inserted into the holes. It may be.

  The base member may be hydrophobic on the side opposite to the surface on which the sample supply position is provided.

  The sensor chip of the above aspect may further include a sheet that covers a part of the base member so as to surround the sample supply position on the side opposite to the surface on which the sample supply position is provided in the base member. Good.

  The base member may have a three-dimensional structure formed on the surface of the base member having a flow path for stirring the sample between the sample supply position and the detection unit. .

  The sensor chip of the above aspect may further include a pretreatment reagent that is provided in at least one of the sample supply position and the sample storage unit and reacts with the sample supplied to the sample supply position.

  The pretreatment reagent may contain a dye.

  An oxidoreductase and a redox mediator may be disposed at least on the working electrode of the electrode system.

  ADVANTAGE OF THE INVENTION According to this invention, the sensor chip for in-vivo component measurement which performs multistage reaction with high reproducibility can be provided.

1 is an overall view of a biological component detection kit including a sensor chip according to an embodiment of the present invention. It is a top view of a sensor chip. It is sectional drawing of a sensor chip. FIG. 4 is an enlarged view of FIG. 3. It is a top view which abbreviate | omits and shows a part of sensor chip. It is a top view which shows the slide member provided in the sensor chip. It is a side view of a slide member. It is a front view which shows the state in which the slide member was attached to the base member. It is a front view which shows the state by which the slide member of the other structural example of the embodiment was attached to the base member. It is a top view of a support part. It is a front view of a support part. It is a typical top view showing the composition of the modification of the embodiment. It is sectional drawing which shows the structure of the modification. It is a graph which shows the correlation with the measurement result by the Example of this invention, and the measurement result by a well-known measuring method. It is a graph which shows the correlation with the measurement result by the Example of this invention, and the measurement result by a well-known measuring method. It is a graph which shows the correlation with the measurement result by the Example of this invention, and the measurement result by a well-known measuring method.

(First embodiment)
The sensor chip according to the first embodiment of the present invention will be described by taking, as an example, a biological component detection kit including a detector used together with the sensor chip. FIG. 1 is an overall view of a biological component detection kit including the sensor chip of the present embodiment. FIG. 2 is a plan view of the sensor chip. FIG. 3 is a cross-sectional view of the sensor chip. FIG. 4 is an enlarged view of FIG. FIG. 5 is a plan view in which a part of the sensor chip is omitted. FIG. 6 is a plan view showing a slide member provided on the sensor chip. FIG. 7 is a side view of the slide member. FIG. 8 is a front view showing a state in which the slide member is attached to the base member. FIG. 9 is a front view showing a state in which the slide member of another configuration example of the present embodiment is attached to the base member. FIG. 10 is a plan view of the support portion. FIG. 11 is a front view of the support portion.

The biological component detection kit 1 in this embodiment shown in FIG. 1 is a kit for measuring the concentration of biological components. As an example of a biological component that can be measured by the biological component detection kit 1 of the present embodiment, a case where 1,5-AG, which is a kind of biological component, is measured will be exemplified below.
The biological component detection kit 1 of this embodiment includes a sensor chip 2 and a detector 50. The sensor chip 2 of the present embodiment has a substantially rectangular shape in plan view, and can be used by attaching one end of the sensor chip 2 in the longitudinal direction to the detector 50.
In the present specification, the side on which the detector 50 is attached in the sensor chip 2 is referred to as a base end side of the sensor chip 2, and the side opposite to the base end side in the longitudinal direction of the sensor chip 2 is referred to as a front end side.

Next, the configuration of the sensor chip 2 will be described.
As shown in FIGS. 1 to 5, the sensor chip 2 is formed on the base member 3 made of an insulating material, the supply detection electrode 6 formed on the surface of the base member 3, and the surface of the base member 3. Ground pattern regions 11 and 12, a protective sheet 13 attached to the base member 3, an electrode system (detection unit) 20 formed on the surface of the base member 3, and a base member on the surface of the base member 3 3, and a support member 40 that supports the slide member 30 so as to be slidable relative to the base member 3.

  The base member 3 includes a substrate 4 formed in a plate shape and a resist layer 5 stacked on the substrate 4. Further, the base member 3 has holes 3a and 3b provided at two places where a part of the support portion 40 can be engaged and separated from each other.

One end of the substrate 4 is an insertion portion 4 </ b> A into which the detector 50 is inserted. The insulating material forming the substrate 4 is not particularly limited as long as it is a material having insulating properties and necessary strength. For example, a plastic film or the like can be used. The plastic film is not particularly limited as long as it is formed on a film containing a polymer compound as a main component. Preferred polymer compounds include, for example, polyethylene terephthalate (PET), polyethylene naphthalate (PEN), polycarbonate ( PC), polyarylate, polyethersulfone (PES), polyimide, polyamide, polypropylene (PP), polyethylene (PE), cycloolefin polymer (COP), polymethyl methacrylate (PMMA), polydimethylsiloxane (PDMS), tri Acetyl cellulose (TAC), diacetyl cellulose (DAC), polystyrene (PS), polyurethane, polyvinyl alcohol (PVA), Eval (ethylene-vinyl alcohol copolymer), polyvinyl chloride ( VC), and the like. In addition, glass or the like can be used as the material of the substrate 4. Among the materials described above, PET is preferable as the material of the substrate 4 because it is easy to handle.
The surface of the substrate 4 opposite to the side on which the resist layer 5 is formed has hydrophobicity due to the physical properties of the substrate 4 itself or by surface treatment. As a result, the sample hardly adheres to the surface of the substrate 4 opposite to the side on which the resist layer 5 is formed.

  The resist layer 5 is a layer in which, for example, a thermosetting or ultraviolet curable insulating paint is formed in a thin layer on the surface of the substrate 4 by screen printing or the like. The resist layer 5 of this embodiment has a hydrophobic surface exposed to the outside. The resist layer 5 is formed so as to expose a first electrode 7 and a second electrode 9 of a supply detection electrode 6 to be described later, a working electrode 24 of the electrode system 20, a reference electrode 27, and a second supply sensor 21 to the outside. Has been.

The supply detection electrode 6 is set at a sample supply position P1 described later. The supply detection electrode 6 has a first electrode 7 and a second electrode 9 which are disposed on the base member 3 so as to be separated from each other. When the sample is supplied to the sample supply position P1, the first electrode 7 and the second electrode 9 are conducted through the sample. The first electrode 7 and the second electrode 9 are disposed on the base member 3 so that both the first electrode 7 and the second electrode 9 face a space defined by a sample storage portion 34 described later. ing.
That is, when the sample container 34 is filled with the sample container 34 at the sample supply position P1, the first electrode 7 and the second electrode 9 are electrically connected. Since the first electrode 7 and the second electrode 9 are separated from each other, they can also be used as electrodes of a capacitance type level sensor.

  The first electrode 7 and the second electrode 9 are made of a conductor printed on the base member 3 by, for example, screen printing or the like. The first electrode 7 and the second electrode 9 are linear electrodes extending in a direction orthogonal to the longitudinal direction of the sensor chip 2 in plan view of the sensor chip 2. The first electrode 7 and the second electrode 9 are separated from each other by a distance of 0.1 mm or more and 1 mm or less in the slide direction of the slide member 30 (longitudinal direction of the sensor chip 2).

  Further, the supply detection electrode 6 includes a contact electrode 8 for enabling the first electrode 7 to be electrically connected to the detector 50 and a contact for enabling the second electrode 9 to be electrically connected to the detector 50. And an electrode 19.

The first electrode 7 and the second electrode 9 are formed on the substrate 4 by screen printing using conductive silver ink, conductive carbon ink, or conductive silver / carbon ink. In addition, the material of the 1st electrode 7 and the 2nd electrode 9 is not specifically limited. For example, the first electrode 7 and the second electrode 9 may be made of the same material as the wiring parts 22, 25 and 28. As an example, the first electrode 7, the second electrode 9, and the wiring parts 22, 25, 28 are formed of conductive silver / carbon ink. Since the conductive silver / carbon ink is a material having a lower electrical resistance than the conductive carbon ink, the first electrode 7, the second electrode 9, and the wiring portions 22, 25, 28 are formed of the conductive silver / carbon ink. If it is done, detection accuracy can be improved.
The first electrode 7 and the second electrode 9 may be the same material as a part of the electrode system 20. In this case, since the 1st electrode 7 and the 2nd electrode 9 can be formed in the formation process of the electrode system 20, manufacture is easy.
In addition, the conductor pattern extending along the outline of the base member 3 so as to surround the sample supply position P1 on the base member 3 is the first electrode 7 of the supply detection electrode 6 and ground pattern regions 11 and 12 described later. Similarly, it is a pattern for reducing the influence of surge voltage.

The ground pattern regions 11 and 12 are arranged at two locations spaced apart from each other with the working electrode 24 and the reference electrode 27 in between in the short direction of the base member 3. Both of the ground pattern regions 11 and 12 have conductivity and are exposed on the outer surface of the sensor chip 2.
The ground pattern regions 11 and 12 are both formed on the substrate 4 so as to be electrically connected to the contact electrode 8. For this reason, in the state where the sensor chip 2 is attached to the detector 50 described later, the ground pattern regions 11 and 12 are both electrically connected to the ground of the detector 50. The ground pattern regions 11 and 12 alleviate the influence of surge voltage due to static electricity or the like when the sensor chip 2 is attached to or detached from the detector 50. The ground pattern regions 11 and 12 are in contact with or close to the patient when the sample supply position P1 on the tip side of the sensor chip 2 is brought into contact with the fingertip of the patient (for example, in the present embodiment, the peripheral portion of the sample supply position P1). It is preferable that it is arranged. In this case, when blood is collected from the patient, the influence of the surge voltage due to static electricity or the like can be reduced when the patient and the sensor chip 2 come close to each other.
The positions of the ground pattern regions 11 and 12 preferably include a position where a human hand touches when the sensor chip 2 is attached to or detached from the detector 50.
In the present embodiment, one of the two ground pattern regions 11 and 12 (the ground pattern region 11 in the present embodiment) is also used as a wiring connecting the first electrode 7 and the contact electrode 8 of the supply detection electrode 6. Has been.

  The protective sheet 13 is a sheet-like member that covers a part of the base member 3 so as to surround the sample supply position P1. A part of the protective sheet 13 is fixed to the surface of the base member 3 opposite to the surface on which the sample supply position P1 is provided, and is attached to and detached from the slide member 30 or the support portion 40 on the base member 3. Can do. For example, the protective sheet 13 is an adhesive sheet that can adhere to the slide member 30, the support portion 40, and the like. The protective sheet 13 is attached to the sensor chip 2 when the sample is stored in the sample storage unit 34, when the sample overflows from the sample storage unit 34, or when the sample adheres in the vicinity of the sample storage unit 34. The detector 50 is protected from the sample so that the sample does not adhere to the detector 50. The protective sheet 13 prevents the sample from unintentionally adhering to the sample supply position P1 before the unused sensor chip 2 starts to be used, and the sample supply position P1 of the unused sensor chip 2 is removed from the sample. Protect.

  The electrode system 20 is formed in a thin film shape on the surface of the substrate 4 of the base member 3. The electrode system 20 is not covered with the resist layer 5 and is formed to be exposed to the outside. The electrode system 20 is a second supply detection electrode 21 (second supply sensor) formed so as to be exposed to the outside on the base member 3 in order to detect that the sample is properly supplied to the electrode system 20. And a working electrode 24 (first electrode) and a reference electrode 27 (second electrode) formed on the base member 3 so as to be exposed to the outside.

The second supply detection electrode 21 is provided on the side opposite to the sample supply position P1 (the base end side of the sensor chip 2) with the working electrode 24 and the reference electrode 27 interposed therebetween in the sliding direction of the slide member 30. The second supply detection electrode 21 is provided with a wiring part 22 extending to the insertion part 4A and a contact electrode 23 formed at the position of the insertion part 4A and conducting to the wiring part 22.
The second supply detection electrode 21 of the present embodiment is formed on the substrate 4 by screen printing using, for example, conductive carbon ink. The second supply detection electrode 21 is more basic than the working electrode 24 in order to detect whether or not the sample is properly supplied to the electrode system 20 based on the presence or absence of conduction between the working electrode 24 and the reference electrode 27. It is arranged on the end side or on the base end side with respect to the reference electrode 27. In the present embodiment, the second supply detection electrode 21 is disposed on the proximal side with respect to both the working electrode 24 and the reference electrode 27.

  The second supply detection electrode 21 has a certain gap between the working electrode 24 and is curved following the contour of the working electrode 24. The second supply detection electrode 21 extends in an arc shape that forms a part of a ring concentric with the working electrode 24. The second supply detection electrode 21 has a shape constituting a circular arc portion in a sector shape of 45 ° or more and 90 ° or less around the center of the working electrode 24. For example, the second supply detection electrode 21 has a shape constituting a circular arc portion in a 60 ° fan shape with the center of the working electrode 24 as the center. As a specific example, the second supply detection electrode 21 is 30 ° clockwise and counterclockwise about a straight line passing through the center of the working electrode 24 and extending in the longitudinal direction of the sensor chip 2 in plan view of the sensor chip 2. It has a curved shape that forms a circular arc in a sector shape having a central angle of 30 ° and a central angle of 60 ° as a whole. In addition, the fine outline shape of the 2nd supply detection electrode 21 in planar view of the sensor chip 2 is not specifically limited.

  In addition, the 2nd supply detection electrode 21 can also be used as a counter electrode in the electrochemical measurement with respect to a reagent with the working electrode 24 and the reference electrode 27. FIG.

  The working electrode 24 has a circular shape with a size that fits inside the contour of the sample storage portion 34 when viewed from the thickness direction of the base member 3 (direction perpendicular to the surface of the base member 3). The working electrode 24 is formed on the substrate 4 by screen printing using, for example, conductive carbon ink. The working electrode 24 is provided with a wiring part 25 extending to the insertion part 4A and a contact electrode 26 formed at the position of the insertion part 4A and conducting to the wiring part 25.

  The reference electrode 27 is a partially annular electrode that is concentric with the working electrode 24 and surrounds at least a part of the working electrode 24. The size of the reference electrode 27 is a size that fits inside the contour of the sample storage portion 34 when viewed from the thickness direction of the base member 3. The reference electrode 27 is a silver-silver chloride electrode formed on the substrate 4 by a screen printing method, for example. The reference electrode 27 is connected to a contact electrode 29 disposed in the insertion portion 4A portion by a wiring portion 28.

The contact electrodes 23, 26 and 29 are connected to the detector 50 when the insertion portion 4 </ b> A is inserted into the detector 50.
The contact electrodes 23, 26, and 29 and the wiring portions 22, 25, and 28 are formed by, for example, a screen printing method using conductive silver / carbon ink.

  A region superimposed on the working electrode 24 and the reference electrode 27 on the surface of the base member 3 is a superimposed position P2 for performing electrochemical measurement on the sample. On the surface of the base member 3 in the overlapping position P2 including the surfaces of the working electrode 24 and the reference electrode 27, if necessary, a measuring reagent (not shown) for allowing electrochemical measurement by reacting with the sample. Is placed. The measuring reagent may be arranged by a method such as coating (dispensing), screen printing, ink jet coating, deposition coating, dot coating, or spin coating. The overlapping position P2 preferably has a shape surrounding the working electrode 24 and the reference electrode 27. In this embodiment, the overlapping position P2 covers all the working electrode 24 and the reference electrode 27 with the sample accommodated in the sample accommodating portion 34. Is set as an area that can. Moreover, it is preferable that the overlapping position P2 is an area where the second supply sensor 21 can be entirely covered by the sample accommodated in the sample accommodating portion 34.

  The content of the measurement reagent for performing electrochemical measurement on the sample may be appropriately determined by the reaction performed at the overlapping position P2. Only oxidase may be arranged in the measurement or the like for directly detecting the generated hydrogen peroxide. In the case of measurement of sodium ions, potassium ions, etc. that can be measured without requiring a reaction of the substance to be measured, the measurement reagent need not be arranged.

  In the sensor chip 2 of the present embodiment, an oxidoreductase having 1,5-AG oxidizing ability and a redox mediator responsible for mediating the exchange of electrons involved in the redox reaction are disposed in the electrode system 20.

  As 1,5-AG oxidoreductase, pyranose oxidase, L-sorbose oxidase, 1,5-AG dehydrogenase, L-sorbose dehydrogenase, 1,5-anhydroglucitol 6-phosphate dehydrogenase, etc. should be employed. Can do.

As the redox mediator, ruthenium derivatives, osmium derivatives, ferricyan derivatives, ferrocene derivatives, quinone derivatives, phenothiazine derivatives, phenoxazine derivatives, phenazine derivatives, indophenol derivatives, diphenylamine derivatives, phenol derivatives, and the like can be used. Specifically, [osmium (bipyridyl) ₂ imidazolyl Cl] Cl ₂ , [osmium (bipyridyl) ₂ Cl] complexed with polyvinylimidazoyl, potassium ferricyanide, sodium ferricyanide, ferrocene, ferrocenemethanol, ferrocene PEG, etc. It can be used.

  Examples of phenothiazine derivatives that can be used as redox mediators include thionine acetate, thionine chloride, methylene blue, methylene green, 10- (carboxymethylaminocarbonyl) -3,7'-bis (dimethylamino) -phenothiazine sodium salt, and toluidine blue. O, Azure C, Azure A, Azure I, Azure B, new methylene blue, or benzoylleucomethylene blue can be employed. Of these, methylene blue, thionine acetate, thionine chloride, azure C, azure A, azure I, azure B or toluidine blue O are preferable, and a thionine acetate is more preferable.

  As shown in FIGS. 3, 6, and 7, the slide member 30 includes a slide body 32 formed in a plate shape, a sample storage portion 34 provided on a part of one end side of the slide body 32, and A protrusion 38 that protrudes from the outer surface of the slide body 32 and is provided on a part of the other end side of the slide body 32, and an engagement portion 39 that removably connects the slide body 32 and the support portion 40. ing.

  Similar to the substrate 4, the slide body 32 is formed of a plastic mainly composed of a polymer compound. Examples of the material of the slide body 32 include polystyrene, polycarbonate, and polyethylene terephthalate. When the slide body 32 is made of polystyrene or polycarbonate, it is preferable because the slide body 32 can be produced by injection molding. In the present embodiment, the material of the slide body 32 is preferably polystyrene. Between the slide body 32 and the sample storage portion 34, a groove portion 33 for holding the sample in the sample storage portion 34 is provided. The groove 33 is a straight line that crosses the slide body 32 in a direction orthogonal to the advancing / retreating direction of the slide body 32 when the slide body 32 is supported by the support portion 40 and advances / retreats. The length of the groove 33 in the forward / backward direction of the slide body 32 (width of the groove 33) is applied after taking into consideration the length of the groove 33 in the plate thickness direction of the slide body 32 (depth of the groove 33). It is set according to the composition of the sample.

  As shown in FIGS. 6 to 8, the sample storage portion 34 is set to a part of the same plastic plate as the slide body 32. The sample storage part 34 has a base end part 34 a located on the slide body 32 side and a front end part 34 b located on the opposite side of the base end part 34 a in the sliding direction of the slide member 30. The tip end portion 34 b of the sample storage portion 34 has a tip end surface 34 c substantially along a plane orthogonal to the sliding direction of the slide member 30. The tip end surface 34 c of the sample storage portion 34 has a smaller area than a cross section orthogonal to the sliding direction of the slide member 30 in the slide body 32.

  The sample storage unit 34 includes a first sample holding unit 35 and a second sample holding unit 36. The first sample holder 35 and the second sample holder 36 are integrally molded as a part of the slide body 32, for example.

  The first sample holder 35 has a sample holding surface 35a that can contact the sample. Further, the end surface on the front end side of the first sample holding unit 35 is a front end surface 34c of the sample storage unit 34 in the present embodiment. The first sample holder 35 is formed in a plate shape whose plate thickness gradually decreases from the base end 34a side to the tip end 34b side of the sample container 34, thereby having a tip surface 34c with a small area. doing. In addition, even if the first sample holding portion 35 is generally thinner than the base end portion 34a portion of the slide body 32, the first sample holding portion 35 has a tip surface 34c having a small area.

The sample holding surface 35 a of the first sample holding part 35 is directed to the base member 3 side in a state where the slide member 30 is supported by the support part 40.
The sample holding surface 35 a has a planar shape that is spaced apart from the base member 3 in a state where the slide member 30 is attached to the base member 3. In the present embodiment, the sample can be held in the space formed between the sample holding surface 35a and the base member 3.

The sample holding surface 35a has a surface structure that can enhance the adhesion between the sample and the reagent.
For example, the sample holding surface 35a has a concavo-convex structure with a height difference of 20 μm or less. Since the surface area of the sample holding surface 35a is widened by the concavo-convex structure formed on the sample holding surface 35a, it is possible to improve the adhesion of the sample as compared with the case where the sample holding surface 35a is a smooth surface. Further, when the reagent is arranged on the sample holding surface 35a, the reagent solution is held by the uneven structure of the sample holding surface 35a, so that the adhesion of the reagent can be improved. By providing the concavo-convex structure on the sample holding surface 35a, when the reagent solution is dried, the reagent is prevented from peeling off from the sample holding surface 35a or being dried in a state of being lifted from the sample holding surface 35a. be able to.

The sample holding surface 35a may have hydrophilicity. Examples of the hydrophilic treatment for hydrophilizing the sample holding surface 35a include a corona treatment, a plasma treatment, a UV / ozone treatment, and a flame treatment. In addition, examples include a method of applying a hydrophilic compound such as polyvinyl alcohol, hydroxyalkyl cellulose, or agarose to the wall surface of the sample holding surface 35a, and a method of forming a silicon oxide film on the wall surface of the sample holding surface 35a by itro treatment. You can also.
In addition, also when hydrophilizing the outer surface of the resist layer 5 of the base member 3 described above, the above-described hydrophilic treatment can be appropriately employed. Alternatively, the slide body 32 may be formed of a triacetyl cellulose film, and the surface layer of the sample holding surface 35a may be made hydrophilic by performing an alkali treatment.

  The second sample holding part 36 has a convex shape extending in the surface direction of the sample holding surface 35a. As a specific example, the second sample holding part 36 has a first ridge structure part 36a and a second ridge structure part 36b.

The 1st protruding item | line structure part 36a and the 2nd protruding item | line structure part 36b have the rod-shaped structure extended along a mutually parallel straight line on both sides of the sample holding surface 35a. That is, the sample holding surface 35a is disposed between the first ridge structure portion 36a and the second ridge structure portion 36b.
The first ridge structure portion 36a is formed at the first position on the periphery of the sample holding surface 35a so as to extend along the periphery of the sample holding surface 35a. The second ridge structure portion 36b is formed to extend along the periphery of the sample holding surface 35a at a second position that is opposite to the first position among the periphery of the sample holding surface 35a.
The first ridge structure portion 36 a and the second ridge structure portion 36 b extend in the slide movement direction of the slide member 30. The first ridge structure portion 36a and the second ridge structure portion 36b protrude from the sample holding surface 35a and can contact the base member 3.

  The first ridge structure portion 36 a and the second ridge structure portion 36 b protrude toward the base member 3. The protruding ends protruding toward the base member 3 in the first ridge structure portion 36a and the second ridge structure portion 36b can be in line contact or surface contact with the base member 3 while being slidable with respect to the base member 3. It is. For example, in the configuration shown in FIG. 8, the protruding ends protruding toward the base member 3 in the first ridge structure portion 36 a and the second ridge structure portion 36 b can make surface contact with the base member 3.

When viewed from the slide movement direction of the slide member 30, the sample storage portion 34 can contact the sample by a U-shaped or U-shaped surface that defines a space for holding the sample.
The contact area where the first sample holder 35 and the second sample holder 36 constituting the sample holder 34 are in contact with the sample in a state where the sample is filled in the space between the sample holder 34 and the base member 3. Is wider than the contact area where the base member 3 contacts the sample. For this reason, the adhesion force of the sample to the sample accommodating portion 34 is higher than the adhesion force of the sample to the base member 3.

  As an example of the shape of the boundary portion between the first sample holding unit 35 and the second sample holding unit 36, the sample holding surface 35a and the second sample holding unit 36 are connected by a curved surface (indicated by reference numeral 37a). When the first sample holder 35 and the second sample holder 36 are connected by a curved surface having no clear boundary line at the boundary between the first sample holder 35 and the second sample holder 36, the sample holder The sample contained in the sample 34 is unlikely to stay, and the reagent etc. is quickly and uniformly diffused into the sample contained in the sample containing unit 34, thereby allowing the first stage reaction (eg, pretreatment reagent D to be used). The pretreatment reaction) can be performed with high reproducibility and accuracy.

  As another example of the shape of the boundary portion between the first sample holding part 35 and the second sample holding part 36, the second sample holding part 36 forms an angle larger than 90 ° with respect to the sample holding surface 35a. It has a plane portion (indicated by reference numeral 37b) connected to the sample holding surface 35a. In this case, compared with the case where the angle is 90 ° or less with respect to the sample holding surface 35a, the sample accommodated in the sample accommodating portion 34 is less likely to stay, and the reagent relative to the sample accommodated in the sample accommodating portion 34 By diffusing etc. quickly and uniformly, the same effect as the curved surface is obtained.

  Even if the boundary between the first sample holder 35 and the second sample holder 36 is a right angle (indicated by reference numeral 37 c), the sample fills the space between the sample container 34 and the base member 3. In this state, the contact area where the first sample holder 35 and the second sample holder 36 constituting the sample container 34 are in contact with the sample is wider than the contact area where the base member 3 is in contact with the sample. Therefore, from the viewpoint of reducing the amount of the sample remaining on the base member 3 in the process of moving from the sample supply position P1 to the overlapping position P2, the boundary portion between the first sample holder 35 and the second sample holder 36 is at a right angle. It does not matter.

  As shown in FIG. 9, the second sample holder 36 and the base member 3 may be in line contact. Even in this case, the same effect as the configuration shown in FIG. Further, the amount of the sample that enters between the second sample holding part 36 and the base member 3 is smaller in the configuration in which the second sample holding part 36 and the base member 3 can be in line contact.

  As shown in FIGS. 3, 10, and 11, the support portion 40 spans between a pair of plate-like guide portions 41 fixed to the resist layer 5 of the base member 3 and the guide portions 41. And a lock member 43 for connecting the engagement portion 39 formed on the slide member 30 and the cover member 42 to each other. In this embodiment, the guide part 41, the cover member 42, and the lock member 43 are integrally molded.

  The guide part 41 holds the cover member 42 at a position where the cover member 42 and the base member 3 are spaced apart from each other with a gap through which the slide body 32 can be advanced and retracted, and the slide member 30 is moved in a predetermined direction. Restricts reciprocation in one direction. A pair of guide portions 41 are provided apart from each other in a direction orthogonal to the advancing / retreating direction of the slide body 32. Further, guide surfaces 41 a and 41 b extending in parallel to the direction along the surface of the base member 3 are formed in the opposing portions of the pair of guide portions 41. Furthermore, the guide part 41 provided in the support part 40 has two protrusions 41 c and 41 d that can be simultaneously inserted into holes 3 a and 3 b formed in the base member 3. When the guide part 41 is fixed to the base member 3 with the two protrusions 41c and 41d inserted into the holes 3a and 3b formed in the base member 3, the direction in which the slide member 30 moves back and forth is supplied to the sample. The direction can be adjusted from the position P1 to the superimposition position P2. Examples of the method for fixing the guide portion 41 to the base member 3 include adhesion using a double-sided adhesive tape, thermocompression bonding, UV adhesion, and ultrasonic adhesion.

The cover member 42 is fixed to the guide portion 41, and has a gap slightly larger than the plate thickness of the slide member 30 in the plate thickness direction of the base member 3, and the working electrode 24 and the reference electrode 27 on the base member 3. In addition, the second supply sensor 21 is covered.
A slide member 30 is inserted into a hollow portion formed by the guide portion 41 and the cover member 42. For this reason, the slide member 30 is guided in the direction in which the guide surfaces 41a and 41b extend, and the slide member 30 slides relative to the base member 3 in one direction regulated by the guide surfaces 41a and 41b. It is like that. When the slide member 30 moves while being regulated by the guide surfaces 41 a and 41 b, the guide portion 41 and the cover member 42 are connected to the first ridge structure portion 36 a and the second ridge structure portion 36 a of the second sample holding portion 36 formed on the slide member 30. The two ridge structure portions 36 b can slide while being in contact with the base member 3.

The lock member 43 is a substantially plate-like piece that can be elastically deformed, and has a recess 43 a into which the engaging portion 39 formed in the slide body 32 of the slide member 30 enters.
When the engagement portion 39 of the slide body 32 is engaged with the recess 43a of the lock member 43, the position where the resist layer 5 and the sample storage portion 34 overlap when viewed from the plate thickness direction of the base member 3 It is set as a sample supply position P <b> 1 for supplying to the sample storage unit 34.

  In a state where the slide member 30 is supported by the support portion 40 and disposed on the base member 3, the groove portion 33 is located between the sample supply position P2 and the overlapping position P2. That is, the groove portion 33 stops the flow of the sample from the sample supply position P1 to the overlapping position P2 through the gap between the slide body 32 and the base member 3 without sliding movement of the slide member 30.

That is, when the sample container 34 is at the sample supply position P1, the edge of the groove 33 on the sample container 34 side is positioned between the overlap position P2 and the sample supply position P1. For this reason, when the sample storage part 34 is in the sample supply position P1, the sample stored in the sample storage part 34 stops with the edge part on the sample storage part 34 side in the groove 33 as a boundary, and enters the superposition position P2. Intrusion is suppressed.
Thus, in this embodiment, the edge part by the side of the sample accommodating part 34 in the groove part 33 is a flow stop part which stops the flow of a sample.

  On the surface of the resist layer 5 and the sample holding surface 35a in the region of the sample supply position P1, glucose in the sample, which is an interfering substance for 1,5-AG measurement, is not decomposed, removed, captured, or electrochemically measured. A pretreatment reagent D for a pretreatment reaction for conversion into another substance is fixedly arranged. As a method for fixing and arranging the pretreatment reagent D, coating drying, screen printing, ink jet coating, deposition coating, dot coating, spin coating, or the like can be employed. The pretreatment reagent D of this embodiment contains an enzyme having an activity of degrading or converting glucose.

  Specifically, when oxidizing glucose, it contains glucose oxidase, a mixture of glucose dehydrogenase and coenzyme nicotinamide adenine dinucleotide (NAD), nicotinamide adenine dinucleotide phosphate (NADP), etc. Is an example of the pretreatment reagent D. In the case of phosphorylating glucose, examples of the pretreatment reagent D include hexokinase and glucokinase.

  Needless to say, the composition of the pretreatment reagent D can be appropriately changed according to the required pretreatment reaction when the measurement method for the sample is different or when the target substance to be measured is different. The content of the pretreatment reaction is not particularly limited, and in addition to various reactions such as decomposition, removal, and conversion, trapping (capturing) such as ion adsorption, affinity adsorption, or adsorption by microbeads using a boric acid complex, etc. Any pretreatment reaction may be performed as long as the reaction is possible on the sensor chip 2.

  Further, the pretreatment reagent D may contain a dye having a composition that does not inhibit the pretreatment reaction and the subsequent reaction that occurs in the electrode system 20. By including the dye in the pretreatment reagent D, it is possible to easily distinguish and grasp whether or not the pretreatment reagent D is fixed.

Next, an example of the configuration of the detector 50 used with the sensor chip 2 will be described.
The detector 50 can be connected to a moving means for moving the slide member 30 relative to the base member 3 and the contact electrodes 8, 19, 23, 26, 29 of the sensor chip 2, and performs electrochemical measurement. Detection means and the like. The detector 50 can detect the supply state of the sample using the supply detection electrode 6 and the second supply detection electrode 21 and determine whether or not the measurement operation can be performed.

  The detector 50 performs a predetermined analysis on the sample (for example, concentration measurement of a measurement object included in the sample disposed in the electrode system 20). The analysis content and the procedure performed by the detector 50 are not particularly limited.

  Other specific configurations of the detector 50 are not particularly limited. For example, the detector 50 has a display unit for outputting the result of the analysis, a connector, an antenna, and the like for transmitting the result of the analysis to an external device and the like, and control means thereof. Also good. The detector 50 may have a means for performing calibration to maintain the reproducibility of the predetermined analysis.

The operation of the sensor chip 2 of this embodiment will be described.
When using the sensor chip 2 of the present embodiment, first, the sensor chip 2 is connected to the detector 50. Subsequently, the sensor chip 2 can be used by, for example, an operator starting up the detector 50.

  First, the detector 50 is in a state in which the slide member 30 is disposed on the base member 3 so that the sample storage portion 34 is positioned at the sample supply position P1. In this state, the operator fills the sample container 34 with the sample. For example, by bringing a part of the sample storage portion 34 into contact with the whole blood sample, the whole blood sample is drawn into the space between the sample storage portion 34 and the base member 3 using the capillary phenomenon. When the sample storage portion 34 is brought into contact with the whole blood sample, the whole blood sample may adhere to the tip surface 34 c of the sample storage portion 34. In the present embodiment, since the tip surface 34c has a small area, the amount of the whole blood sample adhering to the tip surface 34c of the sample container 34 is small.

  When viewed from the slide movement direction of the slide member 30, the periphery of the space for holding the sample is surrounded by the first sample holding portion 35, the second sample holding portion 36, and the base member 3 constituting the sample storage portion 34. . For this reason, the evaporation of the sample accommodated in the sample accommodating part 34 is suppressed little. As a result, it is possible to prevent the concentration of the measurement object contained in the sample from increasing as the evaporation proceeds.

  Next, the detector 50 performs a first-stage reaction in a state where the slide member 30 is disposed on the base member 3 so that the sample storage portion 34 is positioned at the sample supply position P1. The first stage reaction occurs when the pretreatment reagent D diffuses into the sample.

  After the first-stage reaction at the sample supply position P <b> 1 is completed, the detector 50 slides the slide member 30 relative to the base member 3 by the protrusion 38 of the slide member 30. The completion of the first-stage reaction may be a time point after a certain time has elapsed after the start of the first-stage reaction, depending on the type of the first-stage reaction. When the detector 50 slides the slide member 30 as described above, the sample storage unit 34 moves from the sample supply position P1 toward the overlapping position P2. The sample filled in the sample storage unit 34 is attached to the first sample holding unit 35 and the second sample holding unit 36 of the sample storage unit 34 so as to be dragged to the slide member 30 up to the overlapping position P2. Moving.

  Since the contact area between the sample container 34 and the sample is larger than the contact area between the sample and the base member 3 at each position on the path along which the sample moves from the sample supply position P1 to the overlapping position P2, the sample is placed on the base member 3. Remains small, and a certain amount of sample supplied to the sample supply position P1 is carried by the slide member 30 as it is to the overlapping position P2. For this reason, it can be considered that the quantity of the sample used for the measurement in the superimposition position P2 is the same as the quantity of the sample supplied to the sample supply position P1. Therefore, in the present embodiment, the measuring reagent corresponding to the amount of sample that can be accommodated in the sample accommodating portion 34 at the sample supply position P1 is arranged at the superimposing position P2, so that the slide member 30 superimposes the superimposing position P2. Appropriate analysis can be performed with high reproducibility on the sample carried to the position P2.

  As described above, according to the sensor chip 2 of the present embodiment, the sample storage portion 34 includes the second sample holding portion 36 in addition to the first sample holding portion 35, so Since it can be considered that the amount of the sample used for the measurement is the same as the amount of the sample supplied to the sample supply position P1, a two-stage reaction can be performed with high reproducibility.

  The technique disclosed in the present embodiment can also be applied to the case where the sample after the second-stage reaction is further moved to perform the third-stage reaction. In this case, the technique has high reproducibility. Thus, a multistage reaction can be performed.

  In addition, since the second sample holding unit 36 connected to the first sample holding unit 35 is provided on the slide member 30, the amount of evaporation of the sample can be reduced.

  The second sample holding part 36 has a first ridge structure part 36 a and a second ridge structure part 36 b, and the first ridge structure part 36 a and the second ridge structure part 36 b come into contact with the base member 3. Therefore, it is difficult for the sample to leak from the sample storage portion 34.

  In addition, since the sample holding surface 35a and the second sample holding portion 36 are connected by a curved surface or a flat portion having an obtuse angle, the fluidity of the sample is excellent, and the first-stage reaction with the pretreatment reagent D is reliably performed. Can do.

(Modification)
A modification of the above embodiment will be described. FIG. 12 is a schematic plan view showing the configuration of this modification. FIG. 13 is a cross-sectional view showing the configuration of this modification.
As shown in FIGS. 12 and 13, in this modification, the base member 3 disclosed in the above embodiment has a three-dimensional structure 14 constituting a flow path for stirring the sample.

  The three-dimensional structure 14 in the present modification is disposed in the movement path of the sample storage portion 34 in the process in which the slide member 30 slides on the base member 3. As a specific example, the three-dimensional structure 14 is disposed between the sample supply position P <b> 1 and the electrode system 20. During the sliding movement of the slide member 30, the space defined by the first sample holding part 35 and the second sample holding part 36 constituting the sample storage part 34 passes over the three-dimensional structure 14. Yes.

  About the shape and arrangement | positioning of the three-dimensional structure 14, it is a shape and arrangement | positioning considering that the sample in the sample accommodating part 34 and the pretreatment reagent D can be mixed uniformly. That is, the three-dimensional structure 14 is provided on the base member 3 with a shape and an arrangement capable of stirring the sample in the sample storage unit 34. The three-dimensional structure 14 has a volume such that the sample accommodated in the sample accommodating portion 34 does not overflow from the sample accommodating portion 34.

  As a specific example, a plurality of three-dimensional structures 14 are arranged on the base member 3. The plurality of three-dimensional structures 14 are arranged at positions separated from each other on the base member 3. The shape of the three-dimensional structure 14 is a wedge shape that gradually decreases toward the tip end side of the sensor chip 2 in a plan view of the sensor chip 2.

  In the process in which the slide member 30 slides on the base member 3, the three-dimensional structure 14 is in a state in which the sample in the sample storage unit 34 is easily stirred by blocking a part of the sample in the sample storage unit 34. .

  In this modification, the three-dimensional structure 14 urges the sample to be agitated in the process of moving the sample from the sample supply position P1 to the overlapping position P2, thereby promoting the first-stage reaction using the pretreatment reagent D. can do. Further, since the stirring of the sample is promoted in the process of moving the sample from the sample supply position P1 over the three-dimensional structure 14 to the overlapping position P2, the unreacted pretreatment reagent D is less likely to stay. Increases reproducibility of eye reaction. As a result, reproducibility can be enhanced as a whole of the two-stage reaction of the above embodiment.

  Next, an example of measurement using the sensor chip of the above embodiment will be shown. 14 to 16 are graphs showing the correlation between the measurement result (vertical axis) by electrochemical measurement and the measurement result (horizontal axis) by a known 1,5AG measurement method in each example. In the known 1,5-AG measurement method, plasma is obtained from the venous blood measured in the Examples by centrifugation, and the plasma is obtained from Rana 1,5AG Auto Liquid (manufactured by Nippon Kayaku Co., Ltd.) and Hitachi 7150. This is a measurement performed using an automatic analyzer.

Example 1
In this example, electrochemical measurement was performed using the sensor chip 2 of the above embodiment using EDTA-added venous blood of 7 diabetic patients and 8 non-diabetics as samples.
In this embodiment, a sensor chip having a structure in which the boundary between the first sample holding portion 35 and the second sample holding portion 36 is a right angle as shown by reference numeral 37c in FIG.
A specific measurement procedure will be described. First, the EDTA-added venous blood was dropped on the parafilm, and the tip of the sample supply position P1 of the sensor chip 2 was immersed in the droplet to naturally suck the EDTA-added venous blood (sample). Subsequently, the sensor chip 2 was placed on the heat block heated to 37 ° C. (At this time, the sample supply position P1 and the overlapping position P2 are both in contact with the heat block). Then, the sensor chip 2 was connected to a commercially available electrochemical detector (multipotentiostat MODEL PS-08; Toho Giken Co., Ltd.), and the sensor chip 2 was placed on a heat block heated to 37 ° C. After 3 minutes, the sample storage unit 34 was moved to the overlapping position P2 by moving the slide member 30 by 1 mm every second. Thereafter, 0 V was applied to the working electrode 24 based on the reference electrode 27, and the current value after 5 seconds from the application was measured.
FIG. 14 shows the correlation between the measurement result by electrochemical measurement (average value of four measurements) in this example and the measurement result by a known 1,5AG measurement method.
As shown in FIG. 14, the correlation between the measurement result of this example and the measurement result of a known measurement method was good (correlation coefficient R = 0.976).

(Example 2)
In this example, electrochemical measurement was performed using the sensor chip 2 of the above embodiment using EDTA-added venous blood of 7 diabetic patients and 8 non-diabetics as samples.
In this embodiment, as shown by the reference numeral 37b in FIG. 9, a sensor chip having a structure in which the first sample holding part 35 and the second sample holding part 36 are connected at an angle of 90 ° or more is used. In the present embodiment, the second sample holder 36 can be in line contact with the base member 3.
The specific measurement procedure is the same as in Example 1 above.
FIG. 15 shows the correlation between the measurement result by electrochemical measurement (average value of four measurements) in this example and the measurement result by a known 1,5AG measurement method.
As shown in FIG. 15, the correlation between the measurement result of this example and the measurement result of a known measurement method was good (correlation coefficient R = 0.383).

(Example 3)
In this example, electrochemical measurement was performed using the sensor chip 2 of the above embodiment using EDTA-added venous blood of 7 diabetic patients and 8 non-diabetics as samples.
In this embodiment, a sensor chip having a structure in which the boundary between the first sample holder 35 and the second sample holder 36 is a curved surface as indicated by reference numeral 37a in FIG.
The specific measurement procedure is the same as in Example 1 above.
FIG. 16 shows the correlation between the measurement result obtained by electrochemical measurement in this example and the measurement result obtained by a known 1,5AG measurement method.
As shown in FIG. 16, the correlation between the measurement result of this example and the measurement result of a known measurement method was good (correlation coefficient R = 0.996).

Example 4
Next, a result is shown about the mixing state of a sample in case the above-mentioned three-dimensional structure 14 is formed in the base member 3.
In this example, human whole blood is used as a sample.

  When the sample did not have the three-dimensional structure 14, the blood cell (X1) and plasma (X2) were clearly separated after the sample was moved from the sample supply position P1 to the superposition position P2.

  When the three-dimensional structure 14 is provided on the base member 3, the state after the sample is moved from the sample supply position P1 to the superposition position P2 is the superposition position P2 through the gap between the sample supply position P1 and the three-dimensional structure 14. No separation of blood cells (X1) and plasma (X2) was observed in the sample that had migrated to a uniform state.

  In the case of a sample that can be easily separated, such as the above-mentioned human whole blood, the reproducibility of the measurement result can be enhanced by providing the three-dimensional structure 14 on the base member 3.

  The embodiment of the present invention has been described in detail with reference to the drawings and the like. However, the specific configuration is not limited to this embodiment, and design changes and the like within the scope of the present invention are included.

DESCRIPTION OF SYMBOLS 1 Biological component detection kit 2 Sensor chip 3 Base member 4 Board | substrate 4A Insertion part 5 Resist layer 6 Supply detection electrode (1st supply sensor)
7 First electrode 8 Contact electrode 9 Second electrode 11 Ground pattern region 12 Ground pattern region 13 Protective sheet 14 Three-dimensional structure 19 Contact electrode 20 Electrode system (detection unit)
21 Second supply detection electrode (second supply sensor)
DESCRIPTION OF SYMBOLS 22 Wiring part 23 Contact electrode 24 Working electrode 25 Wiring part 26 Contact electrode 27 Reference electrode 28 Wiring part 29 Contact electrode 30 Slide member 32 Slide body 32a, 32b Notch 33 Groove part 34 Sample accommodating part 34a Base end part 34b of sample accommodating part Sample Front end portion of the storage portion 34c Front end surface of the sample storage portion 35 First sample holding portion 35a Sample holding surface 36 Second sample holding portion 36a First convex stripe structure portion 36b Second convex stripe structure portion 37a First sample holding portion and first Boundary portion with two sample holding portions 37b Planar portion 37c Boundary portion between first sample holding portion and second sample holding portion 38 Projection 39 Engaging portion 40 Supporting portion 41 Guide portions 41a, 41b Guide surface 42 Cover member (covering portion) )
43 Locking member 50 Detector D Pretreatment reagent

Claims (22)

A base member having a sample supply position on the surface to which a sample is supplied;
A detection unit formed on the surface of the base member so as to be separated from the sample supply position;
A slide body that slides relative to the base member on the surface, and a slide member that is provided in a part of the slide body and has a sample storage portion that can store the sample;
A support portion fixed to the base member and supporting the slide member so as to be slidable relative to the base member;
With
The sample container is
A first sample holding portion provided at a position spaced from the surface in a direction perpendicular to the surface of the base member in a state where the slide member is supported by the support portion;
A second sample holding portion that has a protrusion shape connected to the first sample holding portion so as to protrude from the first sample holding portion toward the surface, and is capable of contacting the surface of the base member;
Having a sensor chip. The first sample holding portion has a sample holding surface directed to the surface of the base member in a state where the slide member is supported by the support portion,
The sensor chip according to claim 1, wherein the second sample holding portion has a ridge shape extending in a surface direction of the sample holding surface. The second sample holder is
A first ridge structure portion provided extending in the sliding direction of the slide member at a first position on the periphery of the sample holding surface;
A second ridge structure portion provided extending in the sliding direction of the slide member at a second position opposite to the first position across the sample holding surface of the periphery of the sample holding surface; ,
The sensor chip according to claim 2. The sensor chip according to claim 2 or 3, wherein the sample holding surface and the second sample holding portion are connected by a curved surface. The said 2nd sample holding part has a plane part which makes an angle larger than 90 degrees with respect to the said sample holding surface in the boundary with the said sample holding surface, and is connected with the said sample holding surface. Sensor chip. The detection unit has an electrode system including a working electrode and a reference electrode formed on the surface of the base member so as to be separated from the sample supply position,
The sensor chip according to any one of claims 1 to 5, further comprising ground patterns made of conductors that are electrically connected to each other at a plurality of positions that are spaced apart from each other with the electrode system interposed therebetween. A first supply sensor provided at the sample supply position for detecting whether or not the sample is supplied to the sample supply position;
A second supply sensor provided on the opposite side of the sample supply position across the detection unit in the sliding direction of the slide member in order to detect the presence or absence of the sample in the detection unit;
The sensor chip according to claim 1, further comprising: A supply sensor provided at the sample supply position for detecting whether or not the sample is supplied to the sample supply position;
The supply sensor
A first electrode extending in a linear direction;
A second electrode extending parallel to the first electrode;
Have
The lengths of the first electrode and the second electrode are 60% or more of the dimension of the sample supply position in a direction parallel to the direction orthogonal to the sliding direction of the slide member among the directions along the surface of the base member. The sensor chip according to claim 1, wherein the sensor chip is 100% or less. The first electrode and the second electrode are made of a conductor printed on the surface of the base member,
The sensor chip according to claim 8, wherein the first electrode and the second electrode are separated from each other by a distance of 0.1 mm or more and 1 mm or less in a sliding direction of the slide member. A first electrode that forms a circular shape with a size that fits inside the contour of the sample storage portion when viewed from a direction perpendicular to the surface of the base member; and
An annular shape that is concentric with the first electrode, surrounds at least a portion of the first electrode, and fits inside the outline of the sample container when viewed from a direction perpendicular to the surface of the base member, or A second electrode that forms a partial ring and constitutes the detection unit;
In order to detect the presence or absence of the sample in the detection unit, the detection unit is provided on the opposite side of the sample supply position in the sliding direction of the slide member and is concentric with the first electrode and the second electrode A partial annular supply sensor,
The sensor chip according to claim 1, further comprising: The sensor chip according to claim 10, wherein the supply sensor has a partial annular shape extending over a range of 45 ° or more and 90 ° or less around the center of the first electrode. The detector is
A circular first electrode of a size that fits inside the contour of the sample container when viewed from a direction perpendicular to the surface of the base member;
An annular shape that is concentric with the first electrode, surrounds at least a portion of the first electrode, and fits inside the outline of the sample container when viewed from a direction perpendicular to the surface of the base member, or A partially annular second electrode;
The sensor chip according to claim 1. The sample container is
A proximal end located on the slide body side;
A distal end located on the opposite side of the base end in the sliding direction of the slide member;
Have
The tip portion has a tip surface that is substantially along a plane orthogonal to the slide direction of the slide member and has a smaller area than a cross section of the slide body orthogonal to the slide direction of the slide member. Item 2. The sensor chip according to Item 1. An engagement portion formed on the slide member to engage the slide member with the support portion;
A lock portion formed on the support portion so as to be engageable with the engagement portion, and capable of releasing engagement with the engagement portion by a predetermined amount of force in a sliding direction of the slide member;
The sensor chip according to claim 1, further comprising: The first sample holding portion has a sample holding surface directed toward the surface of the base member in a state where the slide member is supported by the support portion,
The sensor chip according to claim 1, wherein the sample holding surface has an uneven structure with a height difference of 20 μm or less. The base member has holes provided in at least two places where a part of the support portion can be engaged and separated from each other,
The sensor chip according to claim 1, wherein the support portion has a protrusion that can be simultaneously inserted into the hole portion.   The sensor chip according to claim 1, wherein a side of the base member opposite to the surface on which the sample supply position is provided is hydrophobic.   The sensor chip according to claim 1, further comprising a sheet that covers a part of the base member so as to surround the sample supply position on a side opposite to the surface on which the sample supply position is provided in the base member. The said base member has a flow path for stirring the said sample, and has the three-dimensional structure formed in the said surface of the said base member between a sample supply position and the said detection part. Sensor chip. The sensor chip according to claim 1, further comprising a pretreatment reagent that is provided in at least one of the sample supply position and the sample storage unit and reacts with the sample supplied to the sample supply position.   The sensor chip according to claim 20, wherein the pretreatment reagent contains a dye.   The sensor chip according to claim 6, wherein an oxidoreductase and a redox mediator are disposed at least on the working electrode of the electrode system.

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