JPH11352128A - Detection device and detection method - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a detection device having high sensitivity. SOLUTION: This detection device is equipped with a liquid collecting part 1 in contact with a measurement sample, a marker part 2 connected to the liquid collecting part 1, a membrane 5 connected to the marker part 2, and a liquid absorbing part 7 which is connected to the membrane 5 and by which the sample is transferred chromatographically in the liquid collecting part 1, the marker part 2 and the membrane 5. In the marker part 2, particles 3 which do not affect on the detection and a marker component 4 which has a smaller particle size than the particles 3 and is bonded with the particles 3 in the presence of test material are included, so that they can move freely against the membrane 5. An acquisition part 6, by which chromatographic transfer of the particles 3 and a reaction product produced by bonding between the particles 3 and the marker component 4 is prohibited and chromatographic transfer of the marker component which is not bonded with the particles 3 is allowed, is installed in the middle of the membrane 5.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a detection device and a detection method for detecting the presence or absence of a test substance in a measurement sample (liquid such as urine or serum) by a biochemical specific reaction between a labeled component and particles. It is about the method.

[0002]

2. Description of the Related Art Conventionally, immunochromatography has been widely known as a method for simply detecting the presence or absence of a test substance in a measurement sample. In a conventional detection device according to this method, a reagent that causes a biochemical reaction with a test substance and does not affect detection (hereinafter, referred to as “unlabeled component”) is immobilized on the membrane.

However, according to such a configuration, the amount of the unlabeled component is limited by the protein binding ability and the like, so that the amount that can be immobilized is limited. In addition, the detection of the test substance requires that the test substance be biochemically bound to both the unlabeled component and the labeled component. was there.

[0004] Further, the unlabeled component is bound to the membrane, and even if the test substance migrates in the membrane in a chromatographic manner, the reaction occurs only within a very short time when the test substance encounters the unlabeled component. There is no opportunity to wake up, and it tends to be less responsive.

[0005]

As described above, the conventional detection apparatus has a problem of low reactivity.

Accordingly, an object of the present invention is to provide a highly sensitive detection device and detection method.

[0007]

According to the detection apparatus of the present invention,
A sampling part to be brought into contact with the measurement sample, a reaction reagent part connected to the sampling part, and a porous carrier connected to the reaction reagent part,
The sample is connected to the porous carrier, and has a liquid sampling part. The reaction reagent part is bonded to particles that do not affect detection by a biochemical reaction through the particles and the test substance in the presence of the test substance. The labeling component is contained movably with respect to the porous carrier, and the chromatographic movement between the particles and the reaction product generated by the binding of the particles and the labeling component to the test substance is prohibited. And a capture unit that permits chromatographic movement of the label component not bound to the particles.

[0008] In the detection method of the present invention, the measurement sample is brought into contact with the sampling part, and the measurement sample is chromatographed in the order of the sampling part, the reaction reagent part, and the porous carrier. A particle that does not affect detection and a label component that is smaller than the particle and that binds to the particle in the presence of the substance to be detected are movably contained in the porous carrier. By the capturing part provided in the middle of
This inhibits the chromatographic movement of the particles and the reaction product generated by the binding of the particle and the labeling component, and permits the chromatographic movement of the labeling component not bound to the particle. With these configurations, the reactivity of the labeling component can be improved.

[0009]

According to a first aspect of the present invention, there is provided a detection device, comprising: a sampling part to be brought into contact with a measurement sample; a reaction reagent part connected to the sampling part; and a porous carrier connected to the reaction reagent part. , Which is connected to the porous carrier and has a liquid sampling part, and the reaction reagent part is bonded to particles that do not affect detection by a biochemical reaction via the particles and the test substance in the presence of the test substance. The labeling component is movably contained with respect to the porous carrier, and the chromatographic movement between the particles and the reaction product generated by the binding of the particle and the labeling component to the test substance. A capture unit is provided to prohibit and allow chromatographic movement of label components not bound to the particles.

[0010] With this configuration, the unlabeled component is not immobilized on the membrane, but is merely contained in the reaction reagent part. , A larger amount of unlabeled components can be present than in conventional detection devices, and the detection sensitivity can be improved. In addition, since the unlabeled components are not physically constrained by the membrane, they can move freely in the membrane, and the free movement (collision) of each component promotes a faster and more efficient reaction than before. Thus, the detection performance can be improved. In addition, even in this case, when the test substance is present, the labeling substance binds to the particles and becomes a reaction product, which is constrained by the capturing unit. Therefore, there is no problem in obtaining the detection result.

In the detecting device according to the second aspect, the pore size of the capturing portion is smaller than the particle size of the particles and the particle size of the reaction product.
In addition, the particle size is larger than the particle size of the label component not bound to the particles.

According to this configuration, the reaction product in which the labeling component is bonded to the particles is trapped and trapped by the trapping portion depending on the relationship between the pore diameter and the particle diameter.

[0013] In the detection device according to the third aspect, the particles are magnetic particles, and the capturing unit is a magnetic part that attracts the particles.

[0014] With this configuration, the reaction product in which the labeling component is bonded to the particles is captured by the capturing unit by the magnetic force in the capturing unit.

Next, an embodiment of the present invention will be described with reference to the drawings. (Embodiment 1) FIG. 1A shows Embodiment 1 of the present invention.
1 (b) is a front view of the detection device in FIG.

In FIG. 1, reference numeral 1 denotes a liquid sampling unit which is made of, for example, filter paper, and which comes into contact with a measurement sample such as urine by being dropped or immersed.
Reference numeral 2 denotes a reaction reagent part that is continuous with the liquid sampling part 1, and the reaction reagent part 2 contains particles 3 and a labeling component 4.

Here, the particles 3 have no influence on the judgment, and when visual judgment is performed, they are white or transparent. The labeling component 4 reacts with the particles 3 in a biochemical reaction (for example, an immune reaction) in the presence of the test substance.
To form a reaction product 8. For example, the particle 3 has a particle size of about 0.2 μm, and the labeling component 4 has a particle size of 0.02 μm.
m.

Reference numeral 5 denotes a membrane as a reaction reagent part which is continuous with the reaction reagent part 2. The membrane 5 has a function as a reaction support, and is made of, for example, a porous material. The pore size of the membrane 5 depends on the particle 3 and the reaction product 8.
(For example, about 8 μm) so that the labeling component 4 and, of course, the particles 3 and the reaction product 8 can freely move in the membrane 5 in a chromatographic manner.

Then, in the middle of the membrane 5 (specific location)
Is provided with a capturing unit 6. The pore size of the capturing part 6 is
Or smaller than the particle size of the reaction product 8 and larger than the particle size of the labeling component 4 (for example, 0.1 μm). The capturing section 6 and the membranes 5 before and after the capturing section 6 are joined in series. Furthermore, in order to move the measurement sample in a chromatographic manner, the membrane 5 is connected with a liquid absorbing part 7 made of filter paper or the like as necessary.

Next, the detection process by the detection device of FIG. 1 will be described with reference to FIG. Here, in FIG. 2, N indicates the moving direction of the measurement sample. First, the sampling part 1
When the measurement sample is brought into contact with the measurement sample, the measurement sample starts moving in the arrow N direction. When the measurement sample reaches the reaction reagent section 2, the particles 3 and the label component 4 in the reaction reagent section 2 start moving together with the measurement sample. Here, since the particles 3 are not fixed to the membrane 5 or the like, they can move freely.

If the test substance contains a test substance, a reaction product 8 is formed in the membrane 5 as shown in FIG. That is, the particle 3 binds to the test substance T, and the test substance T binds to the labeling component 4, whereby the labeling component 4 binds to the particle 3 via the test substance T. On the other hand, if the test substance T does not exist, the reaction product 8 as shown in FIG. 2C is not formed, and the labeling component 4 moves separately from the particles 3. Then, when reaching the capturing section 6, the particles 3
The reaction product 8 is captured by the capturing unit 6 and cannot move any more, but the labeling component 4 passes through the capturing unit 6 and reaches the liquid absorbing unit 7.

As a result, when the test substance is present and is positive, as shown in FIG. 2A, the reaction product 8 is constrained by the capturing section 6, and the labeling component 4 also stays in the capturing section 6. Conversely, when the test substance does not exist and is negative, only the particles 3 are constrained by the capturing unit 6, and the labeling component 4 passes through the capturing unit 6 and does not stay at the capturing unit 6. For this reason, by visually observing or sensing the capturing unit 6,
Positive or negative can be determined.

In the above description, an example was described in which the capturing portion 6 having a smaller hole diameter was used in series with the membrane 5 for use. However, the present invention is not limited to such a configuration. The pore size may be substantially reduced by performing a heat treatment or a chemical treatment on the 5 itself, or a chemical or physical treatment of embedding particles such as white latex into the membrane 5, and this may be used as the capturing section 6.

(Embodiment 2) Next, Embodiment 2 will be described with reference to FIGS. In the present embodiment, the capturing unit 6 in the first embodiment is changed.
That is, on the back surface side of the membrane 5, a capturing portion 9 made of a linear permanent magnet is provided. The particles 3 are magnetic particles.

Thus, as shown in FIGS. 4A and 4B, the particles 3 or the reaction products 8 can be captured by the capturing unit 9 by the magnetic force of the capturing unit 9. Of course, particle 3
The reaction component 4 that has not bound to the liquid can reach the liquid absorbing section 7. Therefore, as in the first embodiment, positive (FIG. 4A) and negative (FIG. 4B) can be easily distinguished.

As described above, according to the present invention, detection can be performed without the labeling component 4 being immobilized on the membrane 5. For this reason, in the conventional detection device, there is no restriction on the amount of the particles 3 and the labeling components 4 to be used, and the reaction amount itself can be greatly increased, and the detection sensitivity can be increased.

Further, since the use concentration of the particles 3 and the labeling component 4 can be freely adjusted, the production control becomes easy. Moreover,
In the conventional detection device, a special process is added in the manufacturing process in order to fix an unlabeled component on the membrane or to enhance the flow and stability in the membrane. The burden on the process can be reduced.

[0028]

The present invention is configured as described above.
The detection sensitivity can be improved by increasing the concentration of the label component or particle and smoothing the movement of the label component or particle. Also,
The burden on the manufacturing process can be reduced.

[Brief description of the drawings]

FIG. 1A is a front view of a detection device according to a first embodiment of the present invention, and FIG.

2A is a front view (positive) of the detection device according to the first embodiment of the present invention; FIG. 2B is a front view of the detection device; FIG.

FIG. 3 (a) is a front view of a detection device according to Embodiment 2 of the present invention, and (b) is a side view thereof.

FIG. 4A is a front view (positive) of the detection device according to the second embodiment of the present invention, and FIG.

[Explanation of symbols]

 DESCRIPTION OF SYMBOLS 1 Sampling part 2 Reaction reagent part 3 Particle 4 Labeling component 5 Membrane 6, 9 Capture part 7 Suction part 8 Reaction product

Claims (5)

[Claims] 1. A liquid sampling part to be brought into contact with a measurement sample, a reaction reagent part connected to the liquid sampling part, a porous carrier connected to the reaction reagent part, and a porous carrier connected to the porous carrier. And the sample collection unit, wherein the reaction reagent unit includes particles that do not affect detection, and a label component that binds by a biochemical reaction via the particles and the test substance in the presence of the test substance. Is contained movably with respect to the porous carrier, and inhibits chromatographic movement of the particles and a reaction product generated by binding of the particles and the labeling component to a test substance. And a capturing unit that permits chromatographic movement of the label component not bound to the particles. 2. The method according to claim 1, wherein the pore size of the capturing portion is smaller than the particle size of the particles and the particle size of the reaction product, and larger than the particle size of the label component not bound to the particles. The detection device according to claim 1, wherein 3. The detection device according to claim 1, wherein the particles are magnetic particles, and the capturing unit is a magnetic part that attracts the particles. 4. A detection method for detecting the presence of a test substance in a measurement sample, the method comprising: bringing a measurement sample into contact with a liquid sampling unit;
While moving the measurement sample chromatographically in the order of the liquid sampling part, the reaction reagent part, and the porous carrier, particles that do not affect the detection of the reaction reagent part, and the particles and the test substance in the presence of the test substance A labeling component that binds via a biochemical reaction via the porous carrier so as to be movably contained in the porous carrier, and the trapping section provided in the middle of the porous carrier allows the particle and the particle Detecting a chromatographic transfer of a reaction product generated by the binding of the label component with the label component, and permitting a chromatographic transfer of the label component not bound to the particles. . 5. The detection device according to claim 1, wherein the porous carrier is a membrane.