JP2001296298A - Device and method for detecting substance to be examined - Google Patents

Abstract

PROBLEM TO BE SOLVED: To dispense with binding/free separating operation and enable manufacture at a low cost, using simple detection in a device for detecting a substance to examined in a liquid sample. SOLUTION: This detection device is provided with a reaction tank 1 and an absorber 2, which are connected to each other through a passage 3. While a liquid sample is added, the liquid sample and a marker component dissolved therein are discharged gradually to the outside of the reaction tank 1 through the passage 3. When a substance to be examined exists in the liquid sample, the addition of the liquid sample to the reaction tank 1 causes an antigen- antibody reaction between the marker component held in the reaction tank 1 and the substance to be examined. The substance to be examined that is bonded to the marker component reacts with a fixed component that is fixed in the reaction tank 1. The reaction progresses concurrently with the discharge and is completed, when all of the liquid sample and the marker component dissolved therein are discharged to the outside of the reaction tank 1.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to an apparatus and a method for detecting a test substance for detecting the presence or absence of a test substance in a liquid sample (biological sample). The present invention relates to a test substance detection device and a test substance detection method for detecting the presence or absence of a test substance by utilizing a labeled component and a substance having a property.

[0002]

2. Description of the Related Art Hitherto, as a means for detecting a test substance in a biological sample, an immunological detection method using an antigen or an antibody has been known. This immunological detection method has high sensitivity and is widely used in the clinical laboratory field.

[0003] In particular, the enzyme immunoassay (EIA) using beads or microplates is widely known as a method having excellent reproducibility and quantification.

[0004]

However, the conventional test substance detection apparatus utilizing such an enzyme immunoassay (EIA) requires a B / F (Binding / Free) separation operation, and thus requires detection. There is a problem that the apparatus becomes complicated and expensive. Furthermore, the conventional test substance detection apparatus has a problem in that various steps are required for detection, and it is difficult to perform simple detection.

An object of the present invention is to solve the above-mentioned problems of the prior art. More specifically, the present invention provides a B / F
An object of the present invention is to provide a test substance detection device and a test substance detection method that do not require a separation operation, are inexpensive, and can be easily detected.

[0006]

According to a first aspect of the present invention, there is provided an apparatus for detecting a test substance, wherein a label component which reacts with the test substance and a predetermined substance which reacts with the test substance in the liquid sample are used for detecting the test substance. Of the test substance is detected. This analyte detection device includes a reaction tank and an absorber. In the reaction tank, a predetermined substance that reacts with the test substance is fixed, and the label component is held until a liquid sample is added. The absorber is connected to the reaction tank and absorbs the liquid sample added to the reaction tank and the label component dissolved therein. When the test substance is present in the liquid sample, a reaction occurs, and the labeling component and the predetermined substance bind via the test substance.

According to a second aspect of the present invention, there is provided a method for detecting a test substance in a liquid sample using a label component reacting with the test substance in the liquid sample and a predetermined substance reacting with the test substance. This is a method for detecting a test substance. This test substance detection method includes a step of adding a liquid sample to a reaction tank in which a predetermined substance is fixed and a labeling component is held until a liquid sample is added, and the test substance is present in the liquid sample. If
A step of binding the labeling component and the predetermined substance via the test substance, and a step of absorbing the liquid sample added to the reaction vessel and the labeling component dissolved therein to an absorber connected to the reaction vessel. including.

[0008]

(Embodiment 1) FIG. 1 is a sectional view of an analyte detection apparatus according to Embodiment 1. FIG.
As shown in (1), the analyte detection apparatus includes a reaction tank 1 and an absorber 2, and the reaction tank 1 and the absorber 2 are connected by a flow path 3. The flow path 3 is made of a porous material or a monoporous material that causes a capillary phenomenon. As the absorber 2, for example, a polymer absorbent is used. Next, the reaction tank 1 will be described in detail. An antigen or a substance having an immunological affinity with a substance to be detected in a liquid sample (biological sample) (hereinafter referred to as “test substance”) is provided at the bottom of the reaction tank 1 (portion indicated by arrow A). The antibody is immobilized (immobilized). Hereinafter, such an immobilized antigen or antibody,
Let's call it "fixed component".

Further, in the portion of the reaction tank 1 indicated by the arrow B,
An antigen or antibody having an immunological affinity with the test substance (an antibody different from the fixed component) is dried and solidified and retained.
This antigen or antibody is labeled with a marker that can be visually determined. Hereinafter, an antigen or an antibody (an antibody different from the fixed component) having immunological affinity with the test substance,
Those labeled with a marker are referred to as “labeled components”. The labeling component held in the portion of the reaction vessel 1 indicated by the arrow B is solubilized only after the liquid sample is added, and is in a state of being freely moved around in the liquid sample.

Next, the process of detecting a test substance will be described with reference to the drawings. First, there is a case where a test substance is present in a liquid sample.

FIG. 2 is a diagram for explaining a reaction occurring in the reaction tank 1 when a test substance is present in a liquid sample. When the liquid sample is added to the reaction tank 1, the dried and solidified label component 4 is dissolved, and an antigen-antibody reaction occurs with the test substance 6 in the liquid sample. Further, the test substance 6 bound to the labeling component 4 by the antigen-antibody reaction reacts with the fixing component 5 fixed to the bottom (the portion indicated by the arrow A) of the reaction tank 1 to form a sandwich-like conjugate. That is, the labeling component 4 and the fixing component 5 bind via the test substance 6.

On the other hand, as shown in FIG. 1, simultaneously with the addition of the liquid sample, the liquid sample and the label component dissolved therein are gradually discharged to the outside of the reaction tank 1 through the flow path 3. That is, the liquid sample and the label component dissolved therein are absorbed by the absorber 2 through the channel 3.

The above-described reaction and discharge are carried out simultaneously, and the point in time when the liquid sample and the label component dissolved therein have all been discharged to the outside of the reaction tank 1 is the end point of the reaction. That is, the reaction proceeds while the liquid sample and the label component dissolved therein are discharged. The reaction time can be changed depending on the diameter and / or the material of the flow channel 3, and can be appropriately selected according to the required reaction time. After discharge, reaction tank 1
When the bottom of the sample is visually observed, the presence of the test substance can be confirmed by the labeling component.

When the test substance is not present in the liquid sample, the above-mentioned reaction (see FIG. 2) does not occur, and the liquid sample and the label components dissolved therein are all transferred to the outside of the reaction tank 1 through the flow path 3. Is discharged. For this reason, no labeling component remains at the bottom of the reaction tank 1, and when the bottom of the reaction tank 1 is visually observed, the state is the same as before the addition of the liquid sample.

The structure of the analyte detection apparatus is as follows.
A plastic container such as a test tube or a microplate may be used as the base material of the reaction tank 1. The material of the reaction tank 1 can be appropriately selected from those having hydrophilicity or water repellency according to the purpose.

As described above, in the analyte detection apparatus according to the first embodiment, the liquid sample and the label component dissolved therein are discharged from the reaction tank 1 while the fixed component is fixed in the reaction tank 1. The sandwich-like combination produced by the reaction (see FIG. 2) is fixed to the reaction tank 1. As described above, since the B / F separation operation is not required and the detection mechanism is simplified, it is possible to manufacture the detection device at low cost. Furthermore, the test substance can be detected simply by adding a liquid sample, and simple detection is possible. For this reason,
Useful as a bedside test.

(Embodiment 2) FIG. 3 is a sectional view of an analyte detection apparatus according to Embodiment 2. As shown in FIG. 3, the analyte detection apparatus comprises a reaction tank 1 and an absorber 2
The reaction vessel 1 and the absorber 2 are connected by a tube 7. The tube 7 is made of a porous material or a monoporous material that causes a capillary phenomenon. The same parts as those in FIG. 1 are denoted by the same reference numerals, and description thereof will be omitted.

The test substance detecting apparatus shown in FIG. 1 and the test substance detecting apparatus shown in FIG. 3 differ only in the following points. That is, in the analyte detection apparatus of FIG. 3, the liquid sample and the label component dissolved therein are discharged to the outside of the reaction tank 1 through the tube 7, whereas in the analyte detection apparatus of FIG. The difference between the two is that the liquid sample and the label component dissolved therein are discharged to the outside of the reaction tank 1 through the passage 3.

As described above, the analyte detection apparatus according to the second embodiment and the analyte detection apparatus according to the first embodiment differ only in the path for discharging the liquid sample and the label component dissolved therein. Therefore, the analyte detection apparatus according to the second embodiment has the same effect as the analyte detection apparatus according to the first embodiment.

[0020]

According to the first aspect of the present invention, there is provided an analyte detection apparatus.
While the liquid sample added to the reaction tank and the labeled component dissolved therein are discharged to the outside of the reaction tank by the absorber, the predetermined substance is fixed in the reaction tank, so that the label component, the test substance, and the predetermined substance are fixed. Is fixed to the reaction tank. As described above, since the B / F separation operation is not required and the detection mechanism is simplified, it is possible to manufacture the detection device at low cost.
Furthermore, the test substance can be detected simply by adding a liquid sample, and simple detection is possible.

In the method for detecting a test substance according to the second aspect, the liquid sample added to the reaction tank and the label component dissolved therein are discharged to the outside of the reaction tank by the absorber, while the predetermined substance is contained in the reaction tank. Since it is immobilized, the conjugate of the labeling component, the test substance, and the predetermined substance is immobilized in the reaction tank. As described above, since the B / F separation operation is not required and the detection mechanism is simplified, an inexpensive apparatus for performing this detection method can be manufactured. Furthermore, the test substance can be detected simply by adding a liquid sample, and simple detection is possible.

[Brief description of the drawings]

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

FIG. 2 is a diagram illustrating a reaction that occurs in a reaction tank when a test substance is present in a liquid sample.

FIG. 3 is a sectional view of an analyte detection device according to a second embodiment of the present invention.

[Explanation of symbols]

 DESCRIPTION OF SYMBOLS 1 Reaction tank 2 Absorber 3 Flow path 4 Labeling component 5 Fixed component 6 Test substance 7 Tube

Claims (2)

[Claims] 1. A test substance detection apparatus for detecting a test substance in a liquid sample using a label component reacting with the test substance in a liquid sample and a predetermined substance reacting with the test substance. A reaction vessel in which the predetermined substance is fixed, and the labeling component is held until the liquid sample is added; and a liquid sample connected to the reaction vessel and added to the reaction vessel; and An absorber for absorbing the label component dissolved in the liquid sample, when the test substance is present in the liquid sample, a reaction occurs, and the label component and the predetermined substance are interposed through the test substance. An analyte detection device, characterized in that the analyte is combined. 2. A test substance detection method for detecting the test substance in the liquid sample by using a label component reacting with the test substance in the liquid sample and a predetermined substance reacting with the test substance. Adding the liquid sample to a reaction vessel in which the predetermined substance is fixed and the labeling component is held until the liquid sample is added; and the test substance is present in the liquid sample. In this case, the step of binding the labeling component and the predetermined substance via the test substance is performed, and the liquid sample added to the reaction tank and the labeling component dissolved therein are added to the reaction tank. And a step of absorbing by the connected absorber.