JPH11183473A - Test device equipped with a suction pressure generating means for sucking test liquid - Google Patents

Abstract

(57) [Problem] To provide a test device capable of quickly and accurately analyzing components contained in a test solution such as blood and urine. A flow path having an analysis section having one end communicating with a test liquid inlet, a gas-permeable and liquid-impermeable film closing the other end of the flow path. A pressure-generating means 5 communicating with the flow path via a film, wherein the inner surface of the flow path is hydrophobic at an intermediate portion and hydrophilic at portions other than the intermediate portion; The hydrophilic region serves as the analysis unit 61, and the hydrophobic region of the flow path 6 is provided with the air hole 4 communicating with the outside.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a test device for analyzing components contained in a test solution, particularly an aqueous solution such as blood or urine.

[0002]

2. Description of the Related Art Conventionally, when it is desired to rapidly analyze a specific component contained in a test solution such as blood or urine, a test device in which a test solution is applied to an analysis section, or a film containing a reagent is used in an analysis section. The installed test equipment is used. In this type of test device, a specific component in the test solution reacts with the reagent in the analysis section to generate a colored product, and as a result, the test solution or the reagent film is colored. The specific component in the test solution is analyzed by optically measuring the degree of the coloration using a device such as a densitometer.

When optically measuring the degree of coloration, it is necessary to protect the analysis section from external light. For this reason, in this type of test device, usually, by providing the analysis section at a distance from the test liquid inlet, external light entering from the test liquid inlet is prevented from reaching the analysis section. At this time, it is necessary to move the test liquid from the inlet to the analysis unit, and a general method for this movement is a method utilizing capillary action. Examples of the test device utilizing the capillary phenomenon include those described in JP-A-63-274839 or JP-A-4-188065.

[0004] In the analysis of plasma components, if the whole blood is reacted with a reagent for measurement, accurate values cannot be measured due to the influence of blood cell components. Therefore, when analyzing the plasma component, remove the blood cell component from the whole blood in advance by means such as filtration with a glass filter or centrifugation, and then use only the plasma for the test device, or place the blood cell removal layer inside. Use the test equipment provided in.

FIG. 4 is a cross-sectional view of an example of a test device in which a blood cell removing layer is provided. The test device 17 has a capillary tube 19 communicating with the test liquid inlet 18 and an analysis unit 191 in the capillary tube 19. The analysis unit 191 includes a blood cell removal layer
A film 20 having a 201, a light reflecting layer 202, and a reagent layer 203 laminated in this order from the test liquid inlet 17 side is provided. Further, a light entrance window 21 is provided above the analysis unit 191. When whole blood is supplied to the test solution inlet 18 of the test device 17, the whole blood moves to the analysis section 191 by capillary action, and subsequently permeates from the blood cell removal layer 201 in order. At this time, since the blood cell component is removed by the blood cell removal layer 201, only the plasma permeates to the reagent layer 203. When the plasma component to be analyzed reacts with the reagent, the reagent layer 203 becomes colored. The measurement of the degree of coloration is performed using a device such as a densitometer, that is, by irradiating the reagent layer 203 with light through the light entrance window 21 and detecting the light returned by the light reflection layer 202.

[0006]

However, the suction force due to the capillary phenomenon is weak and is easily influenced by the physical properties of the liquid. Further, in order for the capillary phenomenon to occur, the inside of the capillary must be constantly filled with liquid. Therefore, in a test device utilizing the capillary phenomenon, it takes time for the test solution to move to the analysis unit, the distance between the test solution inlet and the analysis unit cannot be increased, There are drawbacks in that a large amount of test solution is required, and the test solution in an amount necessary for analysis cannot reliably reach the analysis unit.

[0007] Further, the test device utilizing the capillary phenomenon has a drawback that the test solution which moves to the analysis section and reacts with the reagent cannot be adjusted to an appropriate amount. In particular, when a body fluid such as blood or urine is used as a test solution, the physical properties such as viscosity of the body fluid vary among individuals and vary depending on temperature conditions. It cannot be fixed. As a result, the amount of the body fluid that reacts with the reagent in the analysis unit becomes too small or too large, so that an accurate analysis result may not be obtained.

When analyzing plasma components, it takes time and effort to remove blood cell components from whole blood by filtration or centrifugation using a glass filter or the like before the test, and as shown in FIG. When using a test device in which the blood cell removal layer 201 is provided, since plasma must pass through the light reflection layer 202 before reaching the reagent layer 203,
The plasma may be altered. Further, in the test device as shown in FIG. 4, since the blood cell removing layer 201 and the reagent layer 203 are laminated, it is possible to completely prevent the measurement error caused by the blood cell component although the light reflecting layer 202 is present therebetween. It is difficult. Therefore, an object of the present invention is to provide a test device that can quickly and accurately analyze components contained in a test solution such as blood and urine.

[0009]

In order to achieve the object, a test device according to the present invention comprises a flow path having an analysis section, one end of which is connected to a test liquid inlet, and the other end of the flow path being closed. A gas-permeable and liquid-impermeable film, and a pressure generating means communicating with the flow path through the film.

In the test device of the present invention, a strong suction action can be generated in the flow path by the suction pressure generating means, and the test solution is forced from the test solution inlet to the analysis section using this suction action. Can be moved. Therefore, unlike conventional test devices that use the capillary phenomenon,
The transfer time can be shortened, and the test solution can reliably reach the analysis section irrespective of the volume or physical properties. In addition, since the distance between the test solution inlet and the analyzer can be increased, when optically measuring the reaction result with the reagent, external light entering from the test solution inlet reaches the analyzer. Can be prevented. Further, in the test device of the present invention, the flow path communicates with the suction pressure generating means via the film, and since the film is gas permeable and liquid impervious, the test liquid flows through the suction pressure generating means. There is no fear to reach.

In order to adjust the amount of the test solution which reacts with the reagent in the analysis section to an appropriate amount, a hydrophobic area is provided in the middle of the flow path, the area other than the middle is made hydrophilic, and It is preferable that the hydrophilic region on the means side is an analysis unit. In this flow path, the analysis section is hydrophilic, the hydrophobic area is adjacent to the analysis section, and the second hydrophilic area is formed from the hydrophobic area to the test liquid inlet. Is quickly introduced into the flow path and moves toward the analysis unit. Further, since the test liquid in the flow channel is water-soluble and cannot be stopped in the hydrophobic region, the test liquid can always be supplied to the analysis unit in an amount corresponding to the volume of the analysis unit.

When an external force is applied to the test device even when the amount of the test solution that moves to the analysis unit by the suction pressure generating means becomes excessive, the excess test solution is removed from the analysis unit to the second hydrophilic region. The test solution reacting with the reagent can be adjusted to an appropriate amount. As an external force applied to the test device in order to adjust the amount of the test solution to an appropriate amount, an air hole communicating with the outside is provided in the hydrophobic region of the flow path, and the external air flowing from the air hole just before the stop of the suction pressure generating means is stopped. Although the inflow pressure is sufficient, an operator may slightly apply vibration to the test device. In addition, providing an air hole communicating with the outside in the hydrophobic region of the flow path eliminates air mixed in the flow path, and has an effect that excess test liquid easily moves to the second hydrophilic area. .

When analyzing a plasma component using the test device of the present invention, the flow channel may be connected to the test liquid inlet through a liquid-permeable and solid-impermeable filter. Since this filter transmits plasma but does not transmit blood cell components, even when whole blood is used as a test solution for the test device of the present invention, the blood cell components are removed by this filter, and only plasma enters the flow channel. . Further, since this filter is installed at a distance from the analysis unit, there is no concern that an error is caused by the influence of blood cell components when optically measuring the reaction result with the reagent.

If the suction pressure generating means in the present invention is a suction pressure generation chamber capable of changing the volume, the test tool can be reduced in size and weight, and the analysis operation can be facilitated. Further, when the reagent is contained in a gas-permeable and liquid-impermeable film between the flow path and the suction pressure generating means, it is not necessary to separately install the reagent film or apply the reagent.

[0015]

FIG. 1 is a perspective view showing a test device according to a first embodiment of the present invention. FIG. 2 shows the XY of FIG.
It is sectional drawing.

The test device 1 of FIG. 1 has a rectangular parallelepiped main body 2, and a main surface of the main body 2 is provided with a test liquid inlet 3, an air hole 4, and a suction pressure generating chamber 5. The suction pressure generating chamber 5 is installed so as to protrude from the main surface of the main body 2 and is hollow. Further, as shown in FIG. 2, a flow path 6 from the test liquid inlet 3 to the suction pressure generating chamber 5 is provided inside the test device 1. The flow path 6 communicates with the outside air through the air hole 4 on the way. Both ends of the flow path 6 are closed by a blood cell removal filter 7 on the test liquid inlet 3 side and by a reagent film 8 on the suction pressure generating chamber 5 side. On the inner surface of the flow channel 6, a hydrophilic analysis part 61 and a hydrophobic region
62, a second hydrophilic region 63 is formed in series. The air holes 4 are provided in the hydrophobic region 62.

As the material of the main body 2, a light-transmitting plastic is used. For example, ABS, polystyrene, polyethylene, polyvinyl chloride, polyethylene terephthalate (P
ET) or the like. The material of the suction pressure generating chamber 5 needs to have elasticity so that the volume of the chamber can be changed. Examples of the material that can be used for the suction pressure generating chamber 5 include rubber, polyethylene, polyvinyl chloride, and PET.

A matrix such as a glass filter is used for the blood cell removing filter 7 in order to impart liquid permeability and solid impermeability. Lectin may be used as a filtering agent to further enhance the ability to remove blood cell components. The reagent film 8 needs to be gas-permeable and liquid-impermeable. Therefore, a porous resin is used for the reagent film 8. The reagent film 8 contains a reagent for analyzing a specific component and a light reflecting agent such as titanium dioxide. At this time, the lower half of the reagent film 8 is a reagent layer 81 containing a reagent, and the upper half is a light reflection layer 82 containing a light reflecting agent. However, a reagent and a light reflecting agent may be mixed.

On the inner surface of the flow channel 6, a hydrophilic analysis part 61,
In order to form the hydrophobic region 62 and the second hydrophilic region 63 in series, for example, the following is performed. If a hydrophobic plastic such as ABS is used for the material of the main body 2, the analysis unit
The portion where the 61 and the second hydrophilic region 63 are to be formed is irradiated with ultraviolet light using a low-pressure mercury lamp as a light source. Thereby, the irradiated portion is modified to be hydrophilic. When the material of the main body 2 is hydrophilic, a hydrophobic agent such as alkoxysilane may be applied to a portion where the hydrophobic region 62 is to be formed. Further, the volume of the analysis unit 61 is determined according to the volume of the test solution suitable for reacting with the reagent.

The analysis of plasma components using the test device 1 is performed as follows. First, after the whole blood is supplied to the test liquid inlet 3, the volume is reduced by pressing the suction pressure generating chamber 5 with a finger, and at the same time, excess air is removed from the air holes 4. Subsequently, the air hole 4 is closed with another finger, and the finger holding the suction pressure generating chamber 5 is released. Since the suction pressure generating chamber 5 is made of a material having elasticity, an attempt is made to return the reduced volume to the original state. At this time, a drawing pressure is generated, and the whole blood in the test liquid inlet 3 enters the flow channel 6 and attempts to move toward the analysis unit 61. However, since the blood cell removing filter 7 allows the liquid to pass through but not the solid, the blood cell component is removed, and only the plasma enters the flow channel 6 and moves toward the analyzer 61.

Next, the finger that has closed the air hole 4 is released, and is left still for a while. By doing so, a certain amount of plasma can be supplied to the analysis unit 61. That is, the analysis unit 61
Since it is surrounded by the hydrophilic and hydrophobic region 62 and the gas-permeable and liquid-impermeable reagent film 8, the amount of plasma supplied to the analyzer 61 is always equal to the volume of the analyzer 61. Becomes However, excessive plasma may remain in the hydrophobic region 62 due to the insufficient water repellency of the hydrophobic region 62 in spite of the strong suction force of the suction pressure generating chamber 5. In this case, the excess amount may be returned to the second hydrophilic region 63 by gently shaking the test device 1 by hand or the like. At this time, if there is air mixed in the flow path 6, it is removed from the air hole 4.

When the plasma is supplied to the analyzer 61, the reagent contained in the reagent film 8 elutes. Then, as a result of reacting with a specific component of the plasma, a colored substance is generated, and the plasma is colored. Since the main body 2 is light-transmissive and the reagent film 8 has a light reflection layer 82, the degree of coloration is determined by a device including a light irradiation unit 9 such as a densitometer and a light detection unit 10. Can be measured.

FIG. 3 shows a second embodiment of the present invention in which a roller for automatically increasing / decreasing the volume of a suction pressure generating chamber and automatically opening / closing an air hole is added to the test device 1. FIG. 3 shows the state of the test device at the time of analyzing the plasma component in each step. (A), (B), (C) is a sectional view showing the state of the test device 11 in the preparation stage, blood cell removal stage, and plasma volume adjustment stage, respectively.

In the preparation stage (A), the roller 14 presses the suction pressure generating chamber 5 from above to reduce the volume. (B)
In this stage, the roller 14 rolls down from the suction pressure generating chamber 5 and stops on the air hole 4 to shut out the air.
At this time, since the volume of the suction pressure generating chamber 5 is about to return to the original,
Suction occurs. Therefore, blood cells are removed from the whole blood 15,
Plasma 16 enters the channel. At the stage (C), the roller 14
Rolls again, and the air hole 4 is opened. At this stage, the amount of plasma supplied to the analysis unit is adjusted.

In the test device 1 shown in FIG. 3, since the roller 14 is automatically operated, it is not necessary for an operator to press down the pressure generating chamber 5 with a finger or to close the air hole 4. Therefore, the operation becomes easier, and an operation error by the operator can be prevented. In the above embodiment, the reagent film 8 contains a reagent. However, the reagent film 8 is simply replaced with a gas-permeable and liquid-impermeable film, and a reagent is applied to the surface of the analysis unit 61 facing the film. Is also good.

[0026]

According to the test device of the present invention, components contained in a test solution such as blood and urine can be analyzed quickly and accurately.

[Brief description of the drawings]

FIG. 1 is a perspective view showing a test device according to a first embodiment of the present invention.

FIG. 2 is an XY cross-sectional view of FIG.

FIG. 3 shows a second embodiment of the present invention, wherein (A), (B), (C)
FIG. 3 is a cross-sectional view showing the state of the test device in the preparation stage, the blood cell removal stage, and the plasma volume adjustment stage, respectively.

FIG. 4 is a cross-sectional view of a conventional test device.

[Explanation of symbols]

Reference Signs List 1, 17 Test tool 2 Main body 3, 18 Test liquid inlet 4 Air hole 5 Suction pressure generating chamber 6 Flow path 61 Analytical unit, 62 Hydrophobic area, 63 Second hydrophilic area 7 Blood cell removal filter 8 Reagent film 81 Reagent Layer, 82 light reflection layer 9 light irradiation section 10 light detection section 14 roller 15 whole blood 16 plasma 19 capillary 191 analysis section 20 film 201 blood cell removal layer, 202 light reflection layer, 203 reagent layer 21 light entrance window

Claims (7)

[Claims] 1. A flow path having an analysis section having one end communicating with a test liquid inlet, a gas-permeable and liquid-impermeable film closing the other end of the flow path, and A test pressure generating means communicating with the flow path. 2. The test device according to claim 1, wherein the inner surface of the flow path is hydrophobic at an intermediate portion and hydrophilic at portions other than the intermediate portion, and the hydrophilic region on the side of the pressure generating means is an analysis portion. . 3. The test device according to claim 2, wherein an air hole communicating with the outside is provided in a hydrophobic region of the flow path. 4. The test device according to claim 1, wherein the film contains a reagent for analyzing a specific component. 5. The test device according to claim 1, wherein a reagent is applied to a surface of the analysis section. 6. The test device according to claim 1, wherein the test solution inlet is closed with a liquid-permeable and solid-impermeable filter. 7. The test tool according to claim 1, wherein the suction pressure generating means is a suction pressure generation chamber capable of changing a volume.