JP2001296297A - Device for detecting substance to be examined - Google Patents

Abstract

PROBLEM TO BE SOLVED: To realize cost reduction and the improvement in safety and the convenience of handling, in a device for detecting a substance to be in a liquid sample. SOLUTION: The liquid sample is dropped down to elute a marker component in a marker pad 11, and then the liquid sample moves in a passage 9 together with the eluted marker component to reach a membrane 13. When a substance to be examined exists in the liquid sample, the substance to be examined bonded to the marker component is bonded to a specific reaction component. Since the specific reaction component is fixed on the membrane 13, a sign due to the marker component appears in the membrane 13. The use of a porous material, that is expensive and easy to break, is limited to a part of the detection device (the membrane 13), and a part for transferring the liquid sample is formed with a hollow passage 9. The liquid sample is fed from the lower surface of the membrane 13, and the sign that appears on the upper surface is observed.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a test substance detection apparatus for detecting the presence or absence of a test substance which may be present in a liquid sample such as urine or serum, and more particularly to a test substance, a labeled component and a specific reaction. The present invention relates to a test substance detection device that detects the presence or absence of a test substance by utilizing a reaction with a component.

[0002]

2. Description of the Related Art Immunochromatography has been widely known as a method for simply detecting the presence or absence of a test substance in a liquid sample. In a conventional detection device according to this method, a porous carrier is used as a reaction support.
Then, a specific reaction component capable of biochemically reacting with the test substance is immobilized on the porous carrier.

Further, in a conventional detection apparatus, another component which reacts with a test substance and is labeled with visible colored particles or the like (hereinafter, referred to as "labeled component") is used. The analyte, if present, migrates the porous carrier while reacting with the labeling component. Then, the labeling component binds to the specific reaction component immobilized on the porous carrier via the test substance. This combination
Since the label component is colored, the presence or absence of the test substance is detected by visually observing the color. Alternatively, sensing may be performed using desired equipment instead of visual inspection.

[0004] Here, the porous carrier is used not only for physically or chemically binding the specific reaction components in a line or spot form to be used for the reaction, but also for dropping the liquid sample and the porous carrier. (Hereinafter, referred to as a "reaction detection site"). That is, the dropped liquid sample moves the porous carrier together with the labeling component by capillary action, and reaches the immobilized specific reaction component to cause a reaction.

Further, as a device for easily detecting the presence or absence of a test substance in a liquid sample, a liquid sample is dropped on the upper surface of the detector, and comes out on the lower surface of the detector through a reaction inside the detector. 2. Description of the Related Art A detection device that detects the presence or absence of a test substance by visually determining the color of a liquid is known (for example, Japanese Patent Application Laid-Open No. H8-285849).

[0006]

As described above, in the conventional detection device, the dropped liquid sample moves in the porous carrier to the reaction detection site while reacting with the labeling component.
In addition, the porous carrier needs to have a certain length in order to secure a reaction time with the labeling component. For this reason, in the conventional detection device, the porous carrier is used in a wide area.

[0007] Since such a porous carrier is generally made of a material such as nitrocellulose and is expensive, the conventional detection device has a problem that it is expensive. Further, such a porous carrier has a property of being weak in strength and easily broken. For this reason, the conventional detection device has a problem that careful handling is required in storage and production processes.

Further, in the conventional detection device, since the color of the liquid coming out on the lower surface of the detection device is visually observed, there is a risk that the spilled liquid may enter the eyes.

[0009] It is an object of the present invention to solve the above-mentioned problems of the prior art. More specifically, an object of the present invention is to provide a test substance detection device which is inexpensive and easy to handle. It is another object of the present invention to provide a highly safe analyte detection device.

[0010]

According to a first aspect of the present invention, there is provided an apparatus for detecting a test substance, comprising a flow path, a labeling component-containing portion, and a porous carrier. The channel is hollow, and a liquid sample is introduced from one end thereof. The label component-containing section is provided in a part of the flow channel and contains a label component that binds to a test substance in the liquid sample. In the porous carrier, via the test substance,
The substance that binds to the labeling component is immobilized. The other end of the flow path
It is connected directly or indirectly to the porous carrier. When the test substance does not exist in the liquid sample, the substance immobilized on the porous carrier and the labeling component do not bind via the test substance. When the test substance is present in the liquid sample, the substance immobilized on the porous carrier binds to the labeling component via the test substance.

According to a second aspect of the present invention, there is provided the analyte detection apparatus according to the first aspect, wherein the other end of the flow path includes:
It faces in the same direction as the surface on which the test substance is dropped.

[0012]

DESCRIPTION OF THE PREFERRED EMBODIMENTS (Embodiment 1) FIG.
FIG. 1B is a cross-sectional view of the analyte detection apparatus according to Embodiment 1 of the present invention, and FIG. FIG. 1 (a),
As shown in (b), the analyte detection apparatus includes a hollow flow path 9 formed by the member 1, the member 3, the member 5, and the member 7, and a marker provided in a part of the flow path 9. Pad 11, membrane 13 (as a porous carrier),
An absorber 15 and a protection sheet 17 are provided. One end of the flow path 9 is connected to the membrane 13, and the other end is connected to the drip port 10.
Connected to. FIG. 1B shows only the flow path 9, the drip port 10, and the membrane 13.

The members 1, 3, 5, and 7 are liquid samples (liquids such as urine and serum) and labeling components (components that react with the test substance, which are labeled with visible colored particles, etc.). )
It is made of a moisture-impermeable material that does not allow the penetration of water, for example, an impermeable resin. The label pad 11 contains a label component. For example, the label pad 11 contains colloidal gold as a labeling component. The membrane 13 is made of a porous material, for example, nitrocellulose.

A specific reaction component is immobilized (immobilized) on the membrane 13. Examples of the absorber 15 include a filter paper and the like. The protection sheet 17 is made of the membrane 1
3 has a function of pressing down.

Next, detection of a test substance will be described.
The liquid sample is dropped into the dropping port 10. Then, the liquid sample reaches the marker pad 11. This liquid sample elutes the label component in the label pad 11. The liquid sample is
The flow path 9 is moved together with the eluted label component, and the membrane 1
Reach 3.

Here, when a test substance (a substance to be detected) is present in the liquid sample, the liquid sample moves through the channel 9 while reacting with the labeling component, and reaches the membrane 13. Become. The liquid sample that has flowed while reacting with the labeling component reacts with the specific reaction component immobilized on the membrane 13 to form a reaction product, and shows a sign (a change that can be observed or sensed) by the labeling component. Next, the reaction product will be described in detail.

FIG. 2 is a schematic diagram showing a reaction product formed in the membrane 13 when a test substance is present in a liquid sample. As shown in FIG. 2, when the test substance 18 exists in the liquid sample, a reaction product 21 is generated in the membrane 13. That is, the test substance 18 bound to the labeling component 16 becomes the specific reaction component 14
To form a reaction product 21. Thus, the labeling component 16 binds to the specific reaction component 14 via the test substance 18. Specific reaction component 14
Is fixed to the membrane 13, so that a sign by the label component 16 appears on the membrane 13. In addition,
The unreacted components are absorbed by the absorber 15, so that the unreacted components can be separated.

On the other hand, when the test substance 18 does not exist in the liquid sample, the liquid sample moves through the flow channel 9 without reacting with the label component 16 and reaches the membrane 13. However, since the test substance 18 does not exist in the liquid sample, the labeling component 16 does not bind to the specific reaction component 14 immobilized on the membrane 13. That is, the reaction product 21 cannot be formed on the membrane 13.

Therefore, no sign by the labeling component 16 appears on the membrane 13. The liquid sample and the label component 16 are absorbed by the absorber 15 and pass through the membrane 13.

As described above, in the analyte detection apparatus according to the first embodiment, the use of the expensive porous material is limited to only the membrane 13 on which the specific reaction component is immobilized. That is, unlike the conventional case, the portion where the liquid sample or the labeling component moves toward the reaction detection site (see the section of the prior art) is not used as an expensive porous material (porous carrier), but is made hollow. The channel 9 is provided. As described above, instead of using a porous material (porous carrier), which is expensive as in the related art, in a large area, the porous material is used only for a part of the device (the membrane 13). Therefore, the analyte detection device according to the first embodiment can be manufactured at a low cost because the use of expensive carriers is reduced.

Further, in the analyte detection device according to the first embodiment, a porous material having a low strength and being easily damaged is used only for a part (membrane 13) of the device.
Easy handling in storage and production process.

Further, in the analyte detection device according to the first embodiment, one end of the flow path 9 is connected to the membrane 13, and this one end faces in the same direction as the surface on which the analyte is dropped. That is, in the analyte detection apparatus according to Embodiment 1 of the present invention, instead of observing the liquid sample or the liquid containing the labeling component from the upper surface of the membrane 13 and coming out of the lower surface, the liquid sample is detected from the lower surface of the membrane 13. Observe the sign that appears on the top surface with the label components. For this reason, in the test substance detection device according to the first embodiment, in the case of visual determination, there is no possibility that liquid (which may contain infectious bacteria or viruses) may enter the eyes, and safe determination is possible. .

(Embodiment 2) FIG. 3A is a sectional view of an analyte detection apparatus according to Embodiment 2 of the present invention, and FIG.
(B) is the same top view. As shown in FIGS. 3A and 3B, the analyte detection apparatus according to the second embodiment includes a hollow flow path 25 formed by the members 19, 21, and the adhesive film 23, a marker pad 27, and a determination pad. Part 2
9 is provided. One end of the flow path 25 is connected to the drip port 26.

The materials of the members 19 and 21 are the same as those of the members 1, 3, 5, and 7 shown in FIG. The marker pad 27 is similar to the marker pad 11 shown in FIG. The adhesive film 23 is for bringing the member 19 and the member 21 into close contact with each other.

FIG. 4 is an enlarged view of the determination section 29 shown in FIG. The same parts as those in FIG. 3A are denoted by the same reference numerals.

As shown in FIG. 4, in the judging section 29, a prefilter 33 is provided below the adhesive film 23, and a membrane 31 (as a porous carrier) is provided above. Further, a determination window 28 is provided. The membrane 31 is the same as the membrane 13 shown in FIG. 1A, and has a specific reaction component immobilized (immobilized). The pre-filter 33 is for removing impurities.
As shown by arrow A, the membrane 31 and the pre-filter 3
Although there is a space between the liquid sample 3 and the liquid sample 3, the liquid sample or the labeling component does not prevent the liquid sample or the labeling component from reaching the membrane 31 because the adhesive film 23 is thin. The other end of the flow path 25 is connected to the membrane 31 indirectly, so to speak. As described above, the other end of the flow path may be connected not only directly to the porous carrier but also indirectly.

Next, detection of a test substance will be described with reference to FIGS. First, a liquid sample is dropped into the dropping port 26. Then, the liquid sample reaches the marker pad 27. This liquid sample elutes the label component in the label pad 27. The liquid sample moves along the channel 25 together with the eluted label component, and reaches the membrane 31 via the pre-filter 33.

Here, when a test substance (a substance to be detected) is present in the liquid sample, the liquid sample moves along the channel 25 while reacting with the labeling component, and reaches the membrane 31. Become. The liquid sample that has flowed while reacting with the labeling component reacts with the specific reaction component immobilized on the membrane 31 to form a reaction product, and shows a signature of the labeling component. This reaction product is the same as the reaction product 21 shown in FIG. That is, referring to FIG. 2, labeling component 16 binds to specific reaction component 14 via test substance 18. Since the specific reaction component 14 is fixed to the membrane 31, the signature of the label component 16 appears on the membrane 31. If it is necessary to absorb unreacted components, the area of the membrane 31 is increased, or an absorbent (for example, filter paper) is provided around the membrane 31 so as to be in contact with the membrane 31.

On the other hand, when the test substance 18 does not exist in the liquid sample, the liquid sample moves through the channel 25 without reacting with the label component 16 and reaches the membrane 31. However, since the test substance 18 does not exist in the liquid sample, the labeling component 16 does not bind to the specific reaction component 14 immobilized on the membrane 31. That is, the reaction product 21 cannot be formed on the membrane 31. For this reason, the labeling component 16
No sign by will appear. If absorption of a liquid sample or a label component is necessary, the area of the membrane 31 is increased, or an absorber (for example, filter paper) is provided around the membrane 31 so as to be in contact with the membrane 31.

Next, the configuration of the analyte detection apparatus according to Embodiment 2 of the present invention will be described in detail. FIG. 5 (a)
FIG. 4 is a plan view of the member 19 shown in FIG. FIG. 5 (b)
FIG. 4 is a plan view of the adhesive film 23 shown in FIG. FIG. 5C is a plan view of the member 21 shown in FIG. The members 19 and 21 are made of, for example, a plastic plate.

The member 19 is provided with a groove 35. The adhesive film 23 is adhered on the member 19. This adhesive film 23 is provided with holes 37 and 39,
The holes 37 and 39 respectively overlap both ends of the groove 35 of the member 19. The member 21 is attached to the adhesive film 23. The member 21 is provided with a dropping port 26 and a determination window 28. The dropping port 26 overlaps the hole 37 of the adhesive film 23, and the judgment window 28
9 overlaps. That is, the flow path 25 is formed by attaching the adhesive film 23 and the member 21 on the member 19 having the groove 35. For example, the thickness of the adhesive film 23 is 25 to 50 μ. In the description of FIG. 5, the membrane 31 and the prefilter 33 are omitted.

As described above, in the analyte detection apparatus according to the second embodiment, the use of the expensive porous material is limited to only the membrane 31 on which the specific reaction component is immobilized. That is, unlike the conventional case, the portion where the liquid sample or the labeling component moves toward the reaction detection site (see the section of the prior art) is not used as an expensive porous material (porous carrier), but is made hollow. The channel 25 is provided. As described above, instead of using a porous material (porous carrier), which is expensive as in the related art, in a large area, the porous material is used only for a part of the device (the membrane 31). Therefore, the analyte detection apparatus according to Embodiment 2 can be manufactured at low cost.

Further, in the analyte detection apparatus according to the second embodiment, since a porous material having low strength and being easily damaged is used only for a part (membrane 31) of the apparatus,
Easy handling in storage and production process.

Further, in the analyte detection device according to the second embodiment, one end of the flow path 25 is connected to the membrane 31, and this one end faces the same direction as the surface on which the analyte is dropped. That is, in the analyte detection apparatus according to Embodiment 2, instead of observing the liquid sample or the label component entering from the upper surface of the membrane 31 and coming out to the lower surface, the liquid sample or the marker component is detected from the lower surface of the membrane 31. Observe the sign that appears on the upper surface. For this reason, in the test substance detection device according to the second embodiment, when the visual determination is performed, the liquid does not enter the eyes, and a safe determination can be performed.

[0035]

According to the first aspect of the present invention, there is provided an analyte detection apparatus.
The use of porous materials is limited to porous carriers in which the substance that binds to the labeling component via the test substance is immobilized, and the part where the liquid sample or labeling component moves toward the porous carrier is porous. A hollow channel is used instead of a qualitative material. Thus, the use of expensive and fragile porous materials is limited to a portion of the device. As a result, the test substance detection device according to claim 1 of the present invention can be manufactured at low cost, and is easy to handle in storage and production processes.

[0036] In the analyte detecting device according to the second aspect, the other end of the flow path connected to the porous carrier is oriented in the same direction as the surface on which the analyte is dropped. The sign that appears on the upper surface of the porous carrier after the liquid sample or the labeling component enters from the lower surface of the substrate. As a result, in the analyte detection device according to the second aspect of the present invention, when the visual determination is performed, the liquid does not enter the eyes, and a safe determination is possible.

[Brief description of the drawings]

FIG. 1A is a cross-sectional view of an analyte detection device according to a first embodiment of the present invention. FIG.

FIG. 2 is a schematic diagram showing a reaction product formed on a porous carrier when a test substance is present in a liquid sample.

FIG. 3A is a cross-sectional view of the analyte detection device according to the second embodiment of the present invention, and FIG.

FIG. 4 is a detailed diagram of a determination unit of the analyte detection device according to the second embodiment of the present invention.

FIG. 5 is a configuration diagram of an analyte detection device according to Embodiment 2 of the present invention.

[Explanation of symbols]

 1, 3, 5, 7, 19, 21 Member 9, 25 Channel 10, 26 Droplet 11, 27 Label pad 13, 31 Membrane 14 Specific reaction component 15 Absorber 16 Label component 17 Protective sheet 18 Test substance 21 Reaction product 23 Adhesive film 28 Judgment window 29 Judgment part 33 Pre-filter 35 Groove 37, 39 hole

Claims (2)

[Claims] 1. A flow path into which a liquid sample is introduced from one end thereof, and a label component provided in a part of the flow path and binding to a test substance in the liquid sample. A labeling component-containing portion, and a porous carrier to which a substance that binds to the labeling component is immobilized via the test substance, and the other end of the flow path is formed on the porous carrier. Directly or indirectly connected, when the test substance is not present in the liquid sample, the substance immobilized on the porous carrier and the labeling component are bonded via the test substance. In the case where the test substance is present in the liquid sample, the substance immobilized on the porous carrier binds to the labeling component via the test substance. Test substance inspection equipment. 2. The apparatus according to claim 1, wherein said other end of said flow path faces in the same direction as a surface on which a test substance is dropped.
An apparatus for detecting a test substance according to claim 1.