JP5931709B2 - Body fluid component testing equipment - Google Patents

Description

The present invention relates to a test instrument for measuring biological fluid components such as glucose, neutral fat, uric acid, cholesterol and the like.

Conventionally, the thing of patent document 1 is known as this kind of test | inspection instrument. The contents include a sample supply port and a pump connection port, and a sample processing chamber and a measurement chamber are provided in communication with each other through a flow path. Then, the sample supplied to the sample supply port by the drive of the pump connected to the connection port is transferred from the sample processing chamber to the measurement chamber, and the sample is measured in this measurement chamber.

However, since the above-described inspection instrument uses a pump as a means for transferring the specimen, it is difficult to control when the specimen is transferred, and the overall structure is complicated, resulting in high product costs and high running costs. Become.

JP-A-8-114539

Accordingly, an object of the present invention is to make it possible to reliably transfer a specimen by a simple pressing operation without requiring mechanical force such as a pump, to perform reliable measurement of the specimen, and to reduce running costs. It is to provide a component inspection instrument.

In order to achieve the above object, a bodily fluid component testing instrument according to the present invention includes a sample supply port through which a sample is supplied, a measurement chamber in which the sample is measured, the sample supply port, and the measurement chamber. And a blood cell separation membrane that removes blood cells from the sample supplied to the sample supply port and supplies the blood cells to the flow channel, and has a through hole and a through groove, and is impermeable and breathable. The measurement chamber and the flow path are provided in a laminated plate formed by sandwiching a plate made of a porous material with two impermeable and impermeable plates in the thickness direction, and the measurement The chamber is defined by the through hole and the two impermeable and impermeable plates, and the flow path is defined by the through groove and the two impermeable and impermeable plates, On the substrate bonded to the laminate, Body supply port and the blood cell separation membrane is provided.

According to this test instrument, when the sample supplied into the sample supply port is transferred to the measurement chamber, the sample supply port is covered with a plug made of an elastic body, and the sample is pressed to pressurize the sample. Without requiring a large-scale mechanical device such as a pump, it can be reliably performed with a simple pressing operation, and the running cost is low. In addition, when the stopper is pressed to transfer the sample to the measurement chamber, the air accumulated in the flow path and the measurement chamber space escapes to the outside through the plate, so that the sample fills the space sequentially. As a result, a predetermined amount of the specimen is quickly transferred to the measurement chamber. Further, the blood cells are separated by the blood cell separation membrane, and only the plasma is transferred from the flow path to the measurement chamber and used for the blood test.

  And this inspection instrument can be manufactured easily because it is possible to separately manufacture a laminated plate formed by laminating plates and a substrate provided with a specimen supply port and a blood cell separation membrane, and to bond them together. Thus, the manufacturing cost can be reduced.

It is preferable to provide a reagent filling part in the measurement chamber or the flow path. This reagent filling section is filled with a reagent to react with the sample to measure the sample in the measurement chamber, or to remove a substance that interferes with the target substance during measurement of the sample or causes a measurement error. Let For example, when measuring blood glucose which is a body fluid component of a living body, NAD, 2- (4-iodophenyl) -3- (2,4dinitrophenyl) -5- (2,4disulfophenyl) -2H- A reagent containing tetrazolium, polyvinylpyrrolidone, phosphate buffer, glucose dehydrase, and diaphorase is dropped into a measurement chamber or a channel and dried. On the other hand, when measuring urea nitrogen or creatinine, a reagent containing ascorbic acid oxidase, sodium alginate, orthophenylenediamine, phosphate buffer, uric acid oxidase, and peroxidase is dropped into the measurement chamber or flow path and dried. deep.

The plate made of the porous material can be provided with a plurality of flow paths leading to a plurality of measurement chambers. According to this configuration, a plurality of types of measurements of the same sample can be performed. In particular, when a plurality of flow paths and measurement chambers are provided, it is difficult to transfer a predetermined amount of sample to a plurality of measurement chambers via the respective flow paths by the conventional pump-driven transfer means. In the invention, the air accumulated in the flow path and the measurement chamber space escapes to the outside through the plate due to the pressing operation of the plug, so that the sample passes through the flow paths and enters each measurement chamber so as to fill the space. A predetermined amount is quickly transferred. In addition, if a part of each flow path is used as a reagent filling portion and the reagent is filled in each of them, it is convenient when placing a reagent that affects stability when placed together. Become.

A weir is preferably provided around the sample supply port to prevent the sample from flowing out. In this way, the sample can be reliably supplied without flowing out from the sample supply port.

As described above, according to the present invention, the sample can be reliably transferred by a simple pressing operation without requiring a large-scale mechanical device such as a pump, and the sample can be reliably measured. Will be cheaper. Moreover, since a laminated board and a board | substrate can be manufactured separately and these can be adhere | attached and comprised, manufacture is easy and can reduce manufacturing cost.

It is a longitudinal cross-sectional view which shows one Embodiment of the test | inspection instrument concerning this invention. It is a disassembled perspective view which shows one Embodiment of the test | inspection instrument concerning this invention. It is a longitudinal cross-sectional view which shows the procedure at the time of measuring a blood sample using the test | inspection instrument concerning this invention, (a) is the state which dripped the sample to the sample supply port, and covered the sample supply port with the plug (B) shows the state which pressed the stopper and transferred the sample to the measurement chamber. It is a graph which shows the measurement result of a blood sample.

Hereinafter, a blood test instrument as an embodiment of a test instrument according to the present invention will be described with reference to the drawings.
FIG. 1 is a longitudinal sectional view of a blood test instrument, and FIG. 2 is an exploded perspective view thereof. The inspection instrument 100 shown in each of these drawings is configured by bonding a substrate 1 and a laminated plate 20. A circular sample supply port 11 is formed in the substrate 1, and a weir 12 is provided around the upper portion thereof. The weir 12 is provided with an annular protrusion 12a that further protrudes from the upper surface. In addition, a protrusion 13 protruding in an arc shape is provided on the inner side of the weir 12. The weir 12 is configured so that the plug body 5 made of an elastic material such as butyl rubber is in close contact with the inner space to seal the interior space. Specifically, when the plug body 5 comes into contact with the weir 12, the annular protrusion 12a of the weir 12 bites into the edge 5a of the plug body 5, so that the internal space is reliably sealed. When the stopper 5 is pressed in this state, a pressure is applied to the sample (blood) supplied to the sample supply port 11. The plug body 5 is pressed by a pressing mechanism (not shown).

In addition, a circular concave insertion portion 14 is provided on the lower surface side of the substrate 1 at a portion facing the sample supply port 11, and a blood cell separation membrane 6 made of an asymmetric pore diameter membrane for separating and removing blood cells is inserted therein. Has been. The blood cell separation membrane 6 is fixed to the substrate 1 with an adhesive (not shown).

A two-dimensional barcode 15 is provided on the lower surface side of the substrate 1. By reading the two-dimensional barcode 15, the specimen can be identified. The two-dimensional barcode 15 can be provided at an arbitrary position in the inspection instrument 100. In addition, the material of the board | substrate 1 uses the resin material which is easy to process, for example, AS resin (styrene acrylonitrile resin) is used suitably.

Protrusions 16 and 17 are provided on the upper surface of the substrate 1. The protrusions 16 and 17 are used for positioning the inspection instrument 100 during optical measurement or electrical measurement.

The laminated plate 20 includes three first plates 2, a second plate 3 and a third plate 4 which are laminated and integrated in the vertical direction via an adhesive (not shown). In the laminated plate 20, a measurement chamber 7 for measuring the component of the sample A is formed inside the side of the sample supply port 11, and a flow path 8 for transferring the sample A between the measurement chamber 7 and the sample supply port 11. Is formed.

As shown in FIGS. 1 and 2, the flow path 8 is formed as follows. That is, a through-hole 81 extending in the vertical direction is formed at a position concentric with the sample supply port 11 in the first plate 2, and the through-hole 81 is formed in the second plate 3 disposed below the first plate 2. A circular through hole 82 is provided in an opposing manner, and a linear through groove 83 is cut out sideways from the side, and the flow path 8 is formed by the through hole 81, the through hole 82, and the through groove 83. The measurement chamber 7 is formed as follows. That is, a circular through hole 71 is formed in communication with the through groove 83 on the tip end side of the through groove 83 provided in the second plate 3, and the inside of the through hole 71 is used as the measurement chamber 7 for the specimen A.

The inspection instrument 100 shown in FIGS. 1 and 2 has eight measurement chambers 7. Specifically, eight circular through holes 71 forming the measurement chamber 7 are formed in the second plate 3. In addition, a through hole 82 that is opposed to the through hole 81 provided in the first plate 2 is provided, and one through groove 83a extending from the through hole 82 branches into eight through grooves 83c at the branch portion 83b. And the through-hole 71 is formed in the front end side of these through-grooves 83c. The eight measurement chambers 7 are partitioned by the through hole 71, the first plate 2 and the third plate 4. The flow path 8 is defined by the through groove 83, the first plate 2, and the third plate 4. The flow path 8 also includes a through hole 81.

The first plate 2 and the third plate 4 are impervious and impervious plates, and as the material, a resin material that can be easily processed is used, for example, an AS resin (styrene acrylonitrile resin) is preferably used. It is done.

On the other hand, as the second plate 3, for example, a PTFE (tetrafluoroethylene resin) film that is a porous material that is impermeable and air permeable is preferably used. In this way, when the specimen 5 is transferred from the flow path 8 to the measurement chamber 7 by pressing the stopper 5, the air accumulated in the space of the flow path 8 and the measurement chamber 7 causes the second plate 3 to move. The sample A is sequentially transferred so as to fill the space, and a predetermined amount of the sample A is quickly transferred to the measurement chamber 7.

A reagent filling unit 9 is provided in the measurement chamber 7. The reagent filling unit 9 is made to react with the sample A in order to measure the sample A in the measurement chamber 7, or remove a substance that interferes with the reaction with the target substance or causes a measurement error when measuring the sample A. Fill the reagent for. As this reagent, for example, when measuring blood glucose which is a body fluid component of a living body, NAD, 2- (4-iodophenyl) -3- (2,4dinitrophenyl) -5- (2,4disulfo) is used. A reagent containing (phenyl) -2H-tetrazolium, polyvinyl pyrrolidone, phosphate buffer, glucose dehydrase, and diaphorase is dropped into the measurement chamber 7 and dried. On the other hand, when measuring urea nitrogen or creatinine, a reagent containing ascorbic acid oxidase, sodium alginate, orthophenylenediamine, phosphate buffer, uric acid oxidase, and peroxidase is dropped into the measurement chamber 7. And let it dry. The reagent filling unit 9 may be provided in a part of the channel 8.

In measuring the specimen A in the measurement chamber 7, optical measurement or electrical measurement using transmitted light or reflected light is employed. In the case of optical measurement using transmitted light, an adhesive layer (not shown) for providing a transparent portion T and adhering the plates to each other in the first plate 2 and the third plate 4 adjacent to the measurement chamber 7 is provided. In a location adjacent to the measurement chamber 7, a color reaction is performed with the reagent and the specimen A in the measurement chamber 7 so as not to prevent light transmission, and light is irradiated from below the third plate 4. The absorbance in the measurement chamber 7 is measured by receiving the transmitted light at the top of the 1 plate 2. As a method of providing the transparent portion T for the first plate 2 and the third plate 4, the first plate 2 and the third plate 4 are made of a transparent resin, and portions other than the transparent portion T are colored black. Is preferred.

In order to color portions other than the transparent portion T in black, a black portion is formed by printing on the inner surfaces of the first plate 2 and the third plate 4 (that is, the surface on the second plate 3 side). Is preferred. If it does in this way, since a printing layer covers except a transparent part T, but there is no printing layer in the transparent part T, a hollow is formed in the transparent part T. If a liquid reagent is applied to the depression and dried, the reagent can be easily placed in the measurement chamber.

As described above, if a plurality of flow paths 8 and measurement chambers 7 are formed in the second plate 3 made of a porous material, a plurality of types of measurements can be performed from one specimen A. In particular, when a plurality of measurement chambers 7 and flow paths 8 are provided, it is difficult to transfer a predetermined amount of specimen A to the plurality of measurement chambers 7 through the respective flow paths 8 by a conventional pump-driven transfer means. On the other hand, the air accumulated in the flow path 8 and the space of the measurement chamber 7 escapes to the outside through the second plate 3 by the pressing operation of the plug 5, so that the specimen A passes through the flow paths 8 so as to fill the space. Then, a predetermined amount is quickly transferred to each measurement chamber 7. In addition, if a part of each measurement chamber 7 or channel 8 is used as a reagent filling part and each of them is filled with a reagent separately, a reagent that affects stability when placed together is placed. When it comes to convenience.

In measuring the specimen A in the measurement chamber 7, electrical measurement can also be performed. That is, by arranging a pair of electrodes in the measurement chamber 7 and energizing them, the conductivity of the specimen A is measured.

Further, the laminated plate 20 is provided with two notches 21 and 22 on one side thereof. The notches 21 and 22 are configured by overlapping notches 2a, 3a, and 4a and notches 2b, 3b, and 4b provided at the same position on one side of each plate. The notches 21 and 22 are used to position the inspection instrument 100 during optical measurement or electrical measurement.

Next, a procedure for performing a blood test using the above-described test instrument 100 will be described with reference to FIG.
First, the sample A is supplied onto the blood cell separation membrane 6 from the sample supply port 11 provided in the substrate 1 (see FIG. 3A). At this time, since the weir 12 is provided around the sample supply port 11, the sample A can be reliably supplied into the sample supply port 11 without causing the sample A to flow out. Further, since the protruding portion 13 protruding in an arc shape is provided on the inside of the weir 12, the specimen supply port can be obtained by puncturing the surface of the fingertip skin and scooping blood from the puncturing portion with the protruding portion 13. The blood can be induced toward the head 11. Thereafter, the plug 5 is fitted into the sample supply port 11 as shown in the figure, and then the plug 5 is pressed by a pressing mechanism, whereby the pressure applied to the sample A supplied onto the blood cell separation membrane 6 is increased. The specimen A passes through the blood cell separation membrane 6, and at this time, the blood cells are separated, and only the plasma is transferred to the measurement chamber 7 through the flow path 8 (see FIG. 3B). The specimen A transferred to the inside of the plate 20 is not shown). As described above, by pressing the stopper 5 and transferring the sample A supplied into the sample supply port 11 from the flow path 8 to the measurement chamber 7, a simple operation can be performed without requiring mechanical force such as a pump. Thus, the sample A can be reliably transferred and the running cost can be reduced.

In addition, as shown in FIGS. 1 and 2, the second plate 3 forming a part of the flow path 8 is formed of a porous material (eg, PTFE) that is impermeable and breathable, so that the specimen A is measured in the measurement chamber 7. When the plug body 5 is pressed to transfer the sample A, the air accumulated in the space of the flow path 8 and the measurement chamber 7 escapes to the outside through the second plate 3, so that the specimen A is sequentially transferred to fill the space. Then, a predetermined amount of the specimen A is quickly transferred to the measurement chamber 7. In particular, as shown in FIGS. 1 and 2, when a plurality of flow paths 8 and a part of the measurement chamber 7 are formed on the second plate 3 made of a porous material, each flow path 8 is formed by a conventional pump-driven transfer means. It is difficult to transfer a predetermined amount of the specimen A to the plurality of measurement chambers 7 through the air, but the air accumulated in the space of the flow path 8 and the measurement chamber 7 by the pressing operation of the plug 5 is the second plate. By escaping to the outside through 3, the specimen A can be quickly transferred from each flow path 8 to each measurement chamber 7.

The sample A sent to the measurement chamber 7 is measured for the sample A by measuring the absorbance in the measurement chamber 7. Alternatively, when a pair of electrodes is provided in the measurement chamber 7, electrical measurement of the specimen A is performed by the electrodes.

Next, specific examples will be described. In this embodiment, a case where glucose in blood is measured will be described.
The substrate 1, the first plate 2 and the third plate 4 were made of AS resin (styrene / acrylonitrile resin), and the second plate 3 was a PTFE film having a thickness of 75 μm and a pore diameter of 1 μm. In addition, a plug made of butyl rubber was used as the plug body 5, and an asymmetric pore diameter membrane was used as the blood cell separation membrane 6.

In addition, NAD 3.6 wt%, WST-3 [2- (4-iodophenyl) -3- (2,4 dinitrophenyl) -5- (2,4 disulfophenyl) is contained in the measurement chamber 7 which is the reagent filling unit 9. ) -2H-tetrazolium; manufactured by Dojin Chemical Co.], a reagent containing 5.2 wt%, polyvinylpyrrolidone 0.1 wt%, pH 7.5 50 mM phosphate buffer, glucose dehydrase 2 KU / ml, diaphorase 1 KU / ml 10 μl was added dropwise and dried.

Then, a blood sample A having glucose concentrations of 70 mg / dl, 150 mg / dl, and 300 mg / dl is dropped from the sample supply port 11 into the inside, and then the plug 5 is fitted into the sample supply port 11. The specimen A was transferred from the flow path 8 to the measurement chamber 7 by pressing this.

The specimen A was measured for its absorbance using 430 nm transmitted light. As a result, it is as shown in the graph of FIG. As is apparent from the graph, any sample A can be reliably measured.

DESCRIPTION OF SYMBOLS 100 Inspection instrument 11 Specimen supply port 12 Weir 1 Board | substrate 20 Laminated board 2 1st plate 3 2nd plate (plate which consists of porous materials)
4 Third plate 6 Blood cell separation membrane 7 Measurement chamber 71 Through hole 8 Channel 82 Through hole 83 Through groove A Sample

Claims (3)

A sample supply port through which a sample is supplied;
A measurement chamber in which measurement of the specimen is performed;
A flow path communicating the sample supply port and the measurement chamber;
A blood cell separation membrane that removes blood cells from the sample supplied to the sample supply port and supplies them to the flow path;
In a laminated plate constituted by sandwiching a plate made of a porous material having water permeability and air permeability provided with a through hole and a through groove between two impermeable and air-permeable plates in the thickness direction, The measurement chamber and the flow path are provided;
The measurement chamber is defined by the through hole and the two impermeable and impermeable plates, and the flow path is defined by the through groove and the two impermeable and impermeable plates. And
The sample supply port and the blood cell separation membrane are provided on the substrate bonded to the laminate,
A weir is provided around the sample supply port to prevent the sample from flowing out,
A bodily fluid component testing instrument , wherein a protrusion projecting in an arc shape is provided inside the weir . The bodily fluid component testing instrument according to claim 1, wherein an annular protrusion further protruding from the upper surface is provided on the upper surface of the weir . 3. The body fluid component testing instrument according to claim 1 , wherein a plurality of the through holes and a plurality of the through grooves are formed in the plate made of the porous material .

Images