JP2002014097A - Chromatographic measuring apparatus - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide an inexpensive, high-sensitivity, and high-performance chromatographic measuring apparatus which uses a reduced number of constituent members and in which the test piece preparing process is simplified. SOLUTION: At least an area of a chromatography test piece 1 from a labeling reagent holding section 3, which holds a labeling reagent at a specific protein immobilizing section 5 in which a color reaction is seen, is covered with a liquid-impermeable sheet material 6 composed of a plastic tape, etc., and another area of the test piece 1 is not covered but is opened.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a chromatographic measuring device for qualitatively or quantitatively measuring a test substance.

[0002]

2. Description of the Related Art Conventionally, as a method for performing a chemical test or a clinical test of a liquid sample such as a water quality test or a urine test, chromatographic measurement utilizing an antigen-antibody reaction or the like has been widely used. The chromatographic measurement refers to a method of separating a mixture according to its constituent components, and a chromatographic measurement device used for the chromatographic measurement includes:
In general, a sample adding section for adding a liquid sample, a labeling reagent holding section for holding a labeling reagent movable by the penetration of the liquid sample, and specifically binding to an analyte in the liquid sample flowing with the labeling reagent It consists of a specific protein-immobilized part on which proteins are immobilized, a reaction layer in which a specific binding reaction is performed, and a water-absorbing part that absorbs the flowing sample. It is configured in a state of being laminated or connected on a support that has been arranged.

Next, a description will be given of a chromatographic measurement using this general chromatographic measuring device.
When the liquid sample is added to the sample addition section, it next reaches the area of the labeling reagent holding section. Next, the labeling reagent held in the region of the labeling reagent holding unit is dissolved by the permeation of the liquid sample, and permeates into the region of the reaction layer together with the liquid sample. On the area of the reaction layer, there is a specific protein immobilization part,
When the analyte is contained in the liquid sample, the specific protein immobilized in the specific protein immobilizing section binds to the complex of the analyte and the labeling reagent with a color reaction or a coloring reaction. And the determination can be made by a visual detection method. On the other hand, when the analyte is not contained in the liquid sample, no binding reaction occurs and no coloration or coloring is observed. Finally, the liquid sample is
The reaction is terminated by absorption by the water absorbing portion provided in the lower end region of the chromatography measurement device.

As described above, the chromatographic measurement using the conventional chromatographic measurement apparatus has a very wide range of applications because it is very easy to judge the test results, and can be used for testing various analytes. It is.

[0005]

However, in the above-described chromatographic measurement using the conventional chromatographic measuring device, the water in the liquid sample added at the time of chromatographic development naturally evaporates from the upper surface and side surfaces of the chromatographic measuring device. In addition, the amount of analyte flowing into the measurement area becomes non-uniform, and the amount of the liquid sample and the amount of the labeling reagent flowing on the chromatographic measuring device during a certain period of time are not constant. Could not.

[0006] Further, the conventional chromatographic measurement apparatus comprises a test piece formed by laminating or connecting constituent members of a sample adding section, a labeling reagent holding section, a specific protein immobilizing section, a reaction layer, and a water absorbing section on a support. Since it is cut into large pieces, the laminated or connected member on the support peels off when cut into large test pieces.

Further, in order to carry out accurate chromatographic measurement using a conventional chromatographic measuring device, the above-mentioned constituent members of a sample adding section, a labeling reagent holding section, a specific protein immobilizing section, a reaction layer, and a water absorbing section are required. It was essential and could not be deleted. For this reason, a certain cost is required for the production of the chromatography measurement device, which has led to an increase in cost.

SUMMARY OF THE INVENTION The present invention has been made to solve such a problem. In a chromatography measuring apparatus, the number of constituent members is reduced, and the process of preparing a test piece is simplified. It is an object of the present invention to provide a high-performance chromatography measurement device.

[0009]

Means for Solving the Problems In order to solve these problems, the chromatographic measuring apparatus according to the first aspect of the present invention has a chromatographic test piece as a test piece for performing a chromatographic measurement. In a chromatography measurement device for qualitatively or quantitatively measuring a test substance to be added to a chromatographic test piece, a portion of the chromatographic test piece other than both end regions on a chromatographic upstream side and a chromatographic downstream side is a liquid-impermeable sheet material. , And is covered in a state of being closely attached to the cover.

[0010] Further, according to a second aspect of the present invention, there is provided a chromatographic measuring apparatus according to the first aspect, wherein
An upper surface other than both end regions on the upstream side of the chromatograph and the downstream side of the chromatograph is covered with a liquid-impermeable sheet material in close contact therewith.

[0011] Further, according to a third aspect of the present invention, there is provided the chromatographic measurement apparatus according to the first aspect, wherein
The upper surface and side surfaces other than both end regions on the upstream side of the chromatograph and the downstream side of the chromatograph are covered with a liquid-impermeable sheet material in close contact therewith.

[0012] According to a fourth aspect of the present invention, there is provided a chromatographic measuring apparatus according to the first aspect, wherein
The upper surface, the side surface, and the lower surface other than both end regions on the upstream side of the chromatograph and the downstream side of the chromatograph are covered with a liquid-impermeable sheet material in a state where they are in close contact with each other.

According to a fifth aspect of the present invention, there is provided a chromatographic measuring apparatus according to any one of the first to fourth aspects, wherein at least the chromatographic test piece is located on the upstream side of the chromatograph. The measurement area from the labeling reagent holding part holding the labeling reagent to the specific protein immobilization part where the specific protein located downstream of the chromatograph is immobilized is in close contact with the liquid impermeable sheet material. It is characterized by being covered with.

According to a sixth aspect of the present invention, there is provided a chromatographic measuring apparatus according to any one of the first to fifth aspects, wherein the chromatographic test piece comprises a plurality of porous materials. It is characterized by being laminated or connected.

According to a seventh aspect of the present invention, there is provided a chromatographic measuring apparatus according to any one of the first to fifth aspects, wherein the chromatographic test piece is a single-layer porous material. It is characterized by comprising.

[0016] Further, according to an eighth aspect of the present invention, there is provided the chromatography measuring apparatus according to the seventh aspect, wherein the single-layer porous material is nitrocellulose. is there.

According to a ninth aspect of the present invention, there is provided a chromatographic measuring device according to any one of the first to eighth aspects, wherein the chromatographic downstream portion is not covered with the liquid impermeable sheet material. The region is covered with a breathable material.

According to a tenth aspect of the present invention, there is provided the chromatography measuring apparatus according to the ninth aspect, wherein the gas permeable material is an arbitrary porous thin film material such as a nonwoven fabric. It is assumed that.

[0019] Further, according to an eleventh aspect of the present invention, in the chromatography measuring apparatus according to the ninth aspect, the air-permeable material is a network.

According to a twelfth aspect of the present invention, there is provided the chromatographic measuring apparatus according to any one of the first to eighth aspects, wherein the chromatographic downstream part is not covered with the liquid impermeable sheet material. It is characterized in that a space forming part for forming an arbitrary space is provided on the region.

According to a thirteenth aspect of the present invention, there is provided the chromatographic measuring device according to the twelfth aspect, wherein the end, the parallel side surface, or the upper surface of the space forming part in the downstream portion of the chromatography in the space forming part. Is provided with a gap portion so that air can flow into an arbitrary portion of the device.

According to a fourteenth aspect of the present invention, in the chromatographic measuring device according to the twelfth or thirteenth aspect, the space forming part is formed of a liquid-impermeable material. It is characterized by the following.

According to a fifteenth aspect of the present invention, there is provided the chromatographic measuring apparatus according to any one of the first to fourteenth aspects, wherein the chromatographic test strip is an immunoassay utilizing an antigen-antibody reaction. It is a chromatography test piece.

[0024] According to a second aspect of the present invention, there is provided the chromatographic apparatus according to any one of the first to fifteenth aspects, wherein the chromatographic test piece is a dry analytical element. It is a feature.

According to a seventeenth aspect of the present invention, there is provided the chromatography measurement apparatus according to any one of the first to sixteenth aspects, wherein the chromatography test piece is a one-step test piece. It is characterized by the following.

[0026]

Embodiments of the present invention will be described below with reference to the drawings. The embodiment described here is merely an example, and the present invention is not necessarily limited to this embodiment.

(Embodiment 1) Hereinafter, a chromatography measuring apparatus according to Embodiment 1 of the present invention will be described with reference to FIGS. FIG. 1 is a diagram showing a chromatography measurement device according to a first embodiment of the present invention, and FIG. 2 is a chromatography test piece of the chromatography measurement device excluding a liquid impermeable sheet material.

FIG. 1 shows a chromatographic measuring apparatus for qualitatively or quantitatively measuring a test substance added to a chromatographic test strip 1. The chromatographic test strip 1 has a portion other than both end regions on the upstream and downstream sides of the chromatograph. Is covered with the liquid-impermeable sheet material 6 in close contact therewith.

The chromatographic test piece 1 shown in FIG.
Is made of a porous material such as a non-woven fabric having a large water absorption, and a sample adding section 2 for adding or applying a liquid sample.
And a labeling reagent holding section 3 holding a labeling reagent movable by permeation of a liquid sample, and a specific binding reaction with an analyte in a flowing liquid sample, which is made of a porous material such as nitrocellulose. And a specific protein immobilization section 5 where a protein specifically binding to an analyte in the liquid sample flowing over the region of the reaction layer 4 is immobilized. .

Further, this chromatography test piece 1
Both portions of the sample addition section 2 and the reaction layer 4 made of a porous material are laminated or connected on a support 7 made of plastic or the like, and a label is formed on a member made of the porous material. It has a structure in which a reagent holding section 3 and a specific protein immobilizing section 5 are provided. In the present invention, lamination means that a plurality of different materials slightly overlap with adjacent members, and coupling means that different materials do not overlap with adjacent members. Indicates that they are in close contact.

Further, in the chromatography measuring apparatus according to the present invention, a portion of the chromatographic test piece 1 shown in FIG. 1 other than both end regions on the upstream side and the downstream side of the chromatography is formed of a liquid impermeable sheet material such as a plastic tape. 6 in close contact with each other.

In the present invention, an arbitrary surface is defined as
Preferably, the upstream and downstream regions of the chromatographic test piece 1 are equivalent or the downstream region is wider, but there is no problem in other states.

Next, a description will be given of a chromatographic measurement using the chromatographic measuring device according to the first embodiment of the present invention (see FIG. 1). When the liquid sample is added to the sample adding section 2 in the chromatography measurement apparatus shown in FIG. Next, the labeling reagent held in the area of the labeling reagent holding section 3 is dissolved by the permeation of the liquid sample, and permeates the area of the reaction layer 4 together with the liquid sample. On the region of the reaction layer 4, there is a specific protein immobilization unit 5, and when the liquid sample contains an analyte, the specific protein immobilized on the specific protein immobilization unit 5 is analyzed. A binding reaction occurs with the complex of the target substance and the labeling reagent, and a color reaction is observed in the region of the specific protein immobilization section 5.
On the other hand, when the analyte is not contained in the liquid sample, no binding reaction occurs and no color reaction is observed. Eventually, the liquid sample penetrates into the lower end region of the chromatographic test strip 1 and the reaction ends.

At this time, at least the labeling reagent holding section 3 located on the upstream side of the surface of the chromatography test piece 1
To the specific protein immobilization section 5 located downstream from the sample, in a state where the measurement area is in close contact with a liquid impermeable sheet material 6 made of plastic tape or the like, thereby evaporating water in the measurement area. Can be prevented,
In addition, the amount of the liquid sample that permeates the measurement region can be made uniform, and the concentrations of the liquid sample and the labeling reagent that flow in the measurement region for a certain period of time can be made constant, so that the chromatographic measurement can be performed accurately.

Further, by not covering the downstream region of the chromatography test piece 1 with the liquid impermeable sheet material 6,
When the liquid sample penetrates into the open lower end portion of the chromatographic test piece 1, which is the open end of the lower end, the water gradually evaporates. Since the evaporation rate of the liquid sample at the opening at the lower end is higher than the rate of penetration of the added liquid sample into the downstream region of the chromatography test piece 1, the liquid sample is dried without flowing back. In addition, sample addition section 2
A liquid sample is added to the sample, and the liquid sample is spread to the downstream region of the chromatographic test piece 1 in an attempt to maintain a uniform moisture ratio with the downstream region of the chromatographic test piece 1. In 4, the reaction is performed accurately.

As described above, according to the chromatographic measuring apparatus according to the first embodiment, at least the labeled reagent holding portion on the surface of the chromatographic test piece 1 other than both the upstream and downstream ends thereof. The area from 3 to the specific protein immobilization section 5 is
By covering the developed liquid sample in a state in which it is in close contact with the chromatographic test piece 1, it is possible to perform chromatographic development without absorbing water using a member having high water absorption in the downstream region of the chromatography test piece 1. . The chromatographic test piece 1 is composed of a sample adding section 2, a labeling reagent holding section 3, a specific protein immobilizing section 5, and a reaction layer 4, and further includes a support 7 for supporting these constituent members. By using the chromatographic measuring device having the above, it is possible to realize a low-cost, high-sensitivity, high-performance chromatographic measuring device in which the number of constituent members is reduced and the test piece preparation process is simplified.

Although the case where the specific area of the specific protein immobilization section 5 on the reaction layer 4 is one in the chromatographic measurement apparatus of the present invention has been described, it is not always necessary that the area be one. A specific protein immobilization region may be present on the region of the reaction layer 4. In addition, a specific binding protein has been described as a reaction component used in the chromatographic measurement, but the present invention is not limited to this.For example, a reaction component that uses a substance that causes some change before and after the reaction, such as an enzyme, for the chromatographic measurement. May be used.

Further, as an example of the structure of the support 7, a plastic or the like is given as an example.
Any liquid impermeable material such as (Polyethylene Terephthalate) is preferred. Further, the nonwoven fabric and nitrocellulose exemplified as the configuration examples of the sample addition section 2, the labeling reagent holding section 3, and the reaction layer 4 are merely examples, and there is no problem even if they are made of an arbitrary porous carrier.

Further, in the present invention, the chromatographic test piece 1 constituting the chromatographic measuring apparatus is formed by laminating or connecting arbitrary plural porous materials such as nitrocellulose and glass fiber filter paper. The chromatographic test strip 1 made of such a material can analyze and detect a specific substance and quantify it using an arbitrary measurement principle such as an antigen-antibody reaction. It can also measure liquid samples such as water and aqueous solutions, urine, blood, body fluids, solids and solutions in which powders and gases are dissolved,
Its uses include urinalysis, pregnancy test, water quality test, stool test, soil analysis, food analysis, and the like.

(Embodiment 2) Hereinafter, a chromatography measurement apparatus according to Embodiment 2 of the present invention will be described with reference to FIG.
This will be described with reference to FIG. FIG. 3 is a diagram illustrating the chromatography measurement device according to the second embodiment, and FIG.
Is a chromatography test piece from which the liquid impermeable sheet material of the chromatography measurement device is removed.

FIG. 3 shows a chromatographic measuring apparatus for qualitatively or quantitatively measuring a test substance added to the chromatographic test strip 1. The chromatographic test strip 1 has a portion other than both end regions on the upstream side and the downstream side of the chromatograph. Is covered with the liquid-impermeable sheet material 6 in close contact therewith.

FIG. 4 shows that the basic components of the chromatographic test piece are formed by a single layer of the reaction layer 4 alone by adding or applying the liquid sample directly on the reaction layer 4 without providing the liquid sample addition section 2. The configuration differs from the chromatography test piece 1 according to the first embodiment described with reference to FIG. 2 only in the configuration. Therefore, the same components as those of the chromatography measurement device according to the above-described first embodiment are denoted by the same reference numerals, and description thereof is omitted.

Next, the chromatographic measurement using the chromatographic measuring device according to the second embodiment of the present invention (see FIG. 3) will be described. When the liquid sample is added to the reaction layer 4 in the chromatographic measurement apparatus shown in FIG. next,
The labeling reagent held in the area of the labeling reagent holding section 3 is dissolved by the permeation of the liquid sample, and permeates into the area of the specific protein immobilization section 5 together with the liquid sample. When the analyte is contained in the liquid sample, the specific protein immobilized in the specific protein immobilization unit 5 causes a binding reaction to a complex of the analyte and the labeling reagent, and the specific protein is immobilized. A color reaction is observed in the region of the protein immobilization section 5. On the other hand, when the analyte is not contained in the liquid sample, no binding reaction occurs and no color reaction is observed. Eventually, the liquid sample permeates into the lower end region of the chromatographic test strip 1 and the reaction is completed.

At this time, at least the labeling reagent holding portion 3 located on the upstream side of the surface of the chromatography test piece 1
To the specific protein immobilization section 5 located downstream from the sample, in a state where the measurement area is in close contact with a liquid impermeable sheet material 6 made of plastic tape or the like, thereby evaporating water in the measurement area. Can be prevented,
In addition, the amount of the liquid sample that permeates the measurement region can be made uniform, and the concentrations of the liquid sample and the labeling reagent that flow in the measurement region for a certain period of time can be made constant, so that the chromatographic measurement can be performed accurately.

By not covering the downstream area of the chromatographic test piece 1 with the liquid impermeable sheet material 6,
When the liquid sample penetrates into the open lower end portion of the chromatographic test piece 1, which is the open end of the lower end, the water gradually evaporates. Since the evaporation rate of the liquid sample at the opening at the lower end is higher than the rate of penetration of the added liquid sample into the downstream region of the chromatography test piece 1, the liquid sample is dried without flowing back.

Further, by adding or applying a liquid sample directly onto the reaction layer 4, the chromatographic test piece 1 can be formed as a single-layer porous material having only the reaction layer 4 without providing the sample addition section 2. Since it can be composed of a qualitative material, the number of components constituting the chromatography measurement device can be reduced. When the single-layer porous material is composed of nitrocellulose, the amount of the liquid sample to be added is very small and sufficient, and it is possible to realize a sample miniaturization chromatography measuring apparatus.

As described above, according to the second embodiment,
Without providing the sample addition section 2, any surface of the chromatographic test piece 1 made of a single-layer porous material other than the upstream and downstream ends thereof is impermeable to liquid made of a plastic tape or the like. By covering the sample in close contact with the non-conductive sheet material 6, there is no need to provide a water-absorbing section for absorbing the sample in the downstream region of the chromatographic test piece 1. It is possible to realize a simplified, low-cost, high-sensitivity, high-performance chromatography measurement apparatus.

It is to be noted that the reaction layer 4
Although the chromatographic measurement apparatus for directly adding or applying a liquid sample has been described above, since the reaction layer 4 is made of a porous material, the added amount of the liquid sample is
The measurement can be performed sufficiently with a very small amount.

(Embodiment 3) The following describes the state of covering the chromatographic test piece 1 with the liquid-impermeable sheet material 6 in the above-described chromatography measuring apparatus according to Embodiment 1 with reference to FIGS. I do.

FIGS. 5 and 6 are views for explaining the state of the chromatography apparatus shown in FIG. 1 covered with the liquid impermeable sheet material 6. FIG. 5 is a view showing the chromatographic measuring apparatus shown in FIG.
Called the chromatographic direction. 6) is a cross-sectional view of the chromatographic measurement device shown in FIG. 1 cut perpendicularly to the chromatographic direction. Note that the same components as those in the chromatography measurement device according to the first embodiment are denoted by the same reference numerals, and description thereof will be omitted.

At this time, at least the labeling reagent holding portion 3 located on the upstream side of the surface of the chromatography test piece 1
, The upper surface and the side surface of the measurement region up to the specific protein immobilization unit 5 located on the downstream side are covered with a liquid-impermeable sheet material 6 made of a plastic tape or the like in a state where they are in close contact with each other. Water can be prevented from evaporating in the measurement area, the amount of the liquid sample permeating the measurement area can be made uniform, and the concentration of the liquid sample and the labeling reagent flowing through the measurement area for a certain period of time can be made constant. As a result, the chromatographic measurement can be performed accurately.

By not covering the downstream area of the chromatographic test piece 1 with the liquid impermeable sheet material 6,
When the liquid sample penetrates into the open lower end portion of the chromatographic test piece 1, which is the open end of the lower end, the water gradually evaporates. Since the evaporation rate of the liquid sample at the opening at the lower end is higher than the rate of penetration of the added liquid sample into the downstream region of the chromatography test piece 1, the liquid sample is dried without flowing back. In addition, sample addition section 2
A liquid sample is added to the sample, and the liquid sample is spread to the downstream region of the chromatographic test piece 1 in an attempt to maintain a uniform moisture ratio with the downstream region of the chromatographic test piece 1. In 4, the reaction is performed accurately.

As described above, according to the chromatographic measuring apparatus according to the third embodiment, at least the specific reagent positioned on the downstream side from the labeled reagent holding section 3 positioned on the upstream side of the surface of the chromatographic measuring apparatus. By covering the upper surface and the side surfaces of the measurement area up to the target protein immobilization section 5 in a state in which the liquid impermeable sheet material 6 made of a plastic tape or the like is in close contact therewith, evaporation of moisture in the measurement area can be prevented. Therefore, the chromatographic development is performed uniformly, the chromatographic measurement is performed accurately, and there is no need to provide a water absorbing portion for absorbing the liquid sample in the downstream region of the chromatographic test piece 1.
It is possible to realize a low-cost, high-sensitivity, high-performance chromatographic measurement device in which the number of constituent members is reduced and the test piece preparation process is simplified.

In the third embodiment, the state of the chromatography apparatus according to the first embodiment covered with the liquid impermeable sheet material 6 has been described. The same effect as that of the third embodiment can be obtained for the one whose front surface and side surfaces are covered with the liquid impermeable sheet material 6.

(Embodiment 4) Hereinafter, the liquid impermeable sheet material 6 of the chromatographic test piece 1 in the chromatographic measuring apparatus according to Embodiments 1 and 2 described above.
With reference to FIGS. 7 and 8, a description will be given of the state of covering by the method.

FIGS. 7 and 8 are diagrams for explaining the state of the chromatography apparatus shown in FIG. 1 covered with the liquid-impermeable sheet material 6. 7 is a cut-away view of the chromatographic measurement device shown in FIG. 1 cut in parallel to the chromatographic direction, and FIG. 8 is a cut-away view of the chromatographic measurement device shown in FIG. 1 cut perpendicularly to the chromatographic direction. is there. Note that the same components as those in the chromatography measurement device according to the first embodiment are denoted by the same reference numerals, and description thereof will be omitted.

At this time, at least the labeling reagent holding section 3 located on the upstream side of the surface of the chromatography test piece 1
, The upper surface of the measurement region up to the specific protein immobilization section 5 located on the downstream side is covered with a liquid-impermeable sheet material 6 made of a plastic tape or the like so as to be in close contact with the measurement region. Water can be prevented from evaporating, and the amount of the liquid sample permeating the measurement region can be made uniform, and the concentration of the liquid sample and the labeling reagent flowing through the measurement region for a certain period of time can be made constant. Chromatographic measurements can be made accurately.

Further, by not covering the downstream area of the chromatography test piece 1 with the liquid impermeable sheet material 6,
When the liquid sample penetrates into the open lower end portion of the chromatographic test piece 1, which is the open end of the lower end, the water gradually evaporates. Since the evaporation rate of the liquid sample at the opening at the lower end is higher than the rate of penetration of the added liquid sample into the downstream region of the chromatography test piece 1, the liquid sample is dried without flowing back. In addition, sample addition section 2
A liquid sample is added to the sample, and the liquid sample is spread to the downstream region of the chromatographic test piece 1 in an attempt to maintain a uniform moisture ratio with the downstream region of the chromatographic test piece 1. In 4, the reaction is performed accurately.

Further, as shown in FIG. 8, since the liquid-impermeable sheet material 6 covers only the upper surface of the chromatographic measuring device in close contact, the liquid-impermeable sheet material is used when the chromatographic measuring device is manufactured. The material 6 does not need to be rolled up to the back surface of the chromatographic test piece 1, and when the prepared chromatographic sheet is cut into a large chromatographic test piece, the chromatographic sheet surface is covered with the liquid-impermeable sheet material 6 in a state of being in close contact therewith. Therefore, there is no need to worry about peeling of the member during cutting.

As described above, according to the chromatographic measuring apparatus according to the fourth embodiment, at least the labeling reagent holding section 3 located on the upstream side of the surface of the chromatographic measuring apparatus is different from the specific reagent located on the downstream side. By covering the upper surface of the measurement area up to the target protein immobilization section 5 in a state in which the liquid impermeable sheet material 6 made of a plastic tape or the like is in close contact therewith, evaporation of water in the measurement area can be prevented. The chromatographic development is performed uniformly, the chromatographic measurement is performed accurately, and there is no need to provide a water absorbing portion for absorbing the liquid sample in the downstream region of the chromatographic test piece 1. This makes it possible to realize a low-cost, high-sensitivity, high-performance chromatographic measurement device that simplifies the test piece preparation process. That.

In the fourth embodiment, the state of the chromatography apparatus according to the first embodiment covered with the liquid impermeable sheet 6 has been described. The same effect as in the fourth embodiment can be obtained also for the one covered with the liquid impermeable sheet material 6.

(Embodiment 5) Hereinafter, a chromatography measuring apparatus according to Embodiment 5 of the present invention will be described with reference to FIGS. 9, 10 and 11. FIG. 9 is a diagram illustrating a chromatography measurement device according to a fifth embodiment of the present invention. FIGS. 10 and 11 show the liquid impermeable sheet material 6 of the chromatographic measurement device shown in FIG.
FIG. 10 is a view for explaining a covering state by
FIG. 11 is a cut-away view of the chromatographic measurement device shown in FIG. 9 cut parallel to the chromatographic direction, and FIG. 11 is a cut-away view of the chromatographic measurement device shown in FIG. 9 cut perpendicularly to the chromatographic direction.

As shown in FIG. 9, the chromatographic measurement apparatus according to the fifth embodiment has a liquid impermeable sheet material 6 in which the upper surface, side surfaces, and lower surface of the chromatographic test piece 1 are in close contact with each other. Support 7 to cover
There is no need to provide That is, the components of the chromatography measurement apparatus according to the fifth embodiment are different from the components of the chromatography measurement apparatus according to the first embodiment described with reference to FIG. 1 only in that the support 7 is not provided. . Accordingly, the same components as those of the chromatography measurement device according to the above-described first embodiment are denoted by the same reference numerals, and description thereof will be omitted.

Next, the chromatographic measurement using the chromatographic measurement device according to the fifth embodiment of the present invention (see FIG. 9) will be described. When the liquid sample is added to the sample addition section 2 in the chromatography measurement apparatus shown in FIG. Next, the labeling reagent held in the area of the label holding section 3 is
It is dissolved by the permeation of the liquid sample and permeates the reaction layer 4 together with the liquid sample. On the region of the reaction layer 4, there is a specific protein immobilization unit 5, and when the liquid sample contains an analyte, the specific protein immobilized on the specific protein immobilization unit 5 is analyzed. A binding reaction occurs with the complex of the target substance and the labeling reagent, and a color reaction is observed in the region of the specific protein immobilization section 5. On the other hand, when the analyte is not contained in the liquid sample, no binding reaction occurs and no color reaction is observed. Eventually, the liquid sample penetrates into the lower end region of the chromatographic specimen,
The reaction ends.

At this time, at least the labeling reagent holding section 3 located on the upstream side of the surface of the chromatography test piece 1
, The upper surface, the side surface, and the lower surface of the measurement region from the downstream to the specific protein immobilization unit 5 are covered with a liquid impermeable sheet material 6 made of a plastic tape or the like. Thereby, the evaporation of water in the measurement area can be prevented, the amount of the liquid sample permeating the measurement area can be made uniform, and the concentrations of the liquid sample and the labeling reagent flowing through the measurement area for a certain period of time can be kept constant. And the chromatographic measurement can be performed accurately.

Further, since the downstream area of the chromatographic test piece 1 is not covered with the liquid impermeable sheet material 6,
When the liquid sample penetrates into the open lower end portion of the chromatographic test piece 1, which is the open end of the lower end, the water gradually evaporates. Since the evaporation rate of the liquid sample at the opening at the lower end is higher than the rate of penetration of the added liquid sample into the downstream region of the chromatography test piece 1, the liquid sample is dried without flowing back. In addition, sample addition section 2
A liquid sample is added to the sample, and the liquid sample is spread to the downstream region of the chromatographic test piece 1 in an attempt to maintain a uniform moisture ratio with the downstream region of the chromatographic test piece 1. In 4, the reaction is performed accurately. Further, since the liquid impermeable sheet material 6 also has the role of the support 7, the number of components constituting the chromatography measurement device can be reduced.

As described above, according to the chromatography measuring apparatus of the fifth embodiment, any surface of the chromatographic test piece 1 other than the upstream and downstream ends is made of a liquid such as a plastic tape. By covering in the state of being adhered by the impermeable sheet material 6, evaporation of water in the measurement area can be prevented, so that chromatographic development is performed uniformly, chromatographic measurement is performed accurately, and the chromatographic test piece 1 There is no need to provide a water absorbing section for absorbing the liquid sample in the downstream region of the liquid sample. Furthermore, since the upper surface, the side surface, and the lower surface of the chromatographic specimen 1 are tightly covered with the liquid-impermeable sheet material 6, there is no need to provide the support 7. Thus, a low-cost, high-sensitivity, high-performance chromatographic measurement apparatus that has simplified the test piece preparation process can be realized.

Although the fifth embodiment has been described using the configuration of the chromatographic test piece 1 of the chromatographic measuring apparatus according to the first embodiment, the basic members described in the second embodiment are reacted with each other. The same effect as in the fifth embodiment can be obtained for the chromatographic test piece 1 composed of a single layer of only the layer 4.

(Embodiment 6) Hereinafter, a chromatography measuring apparatus according to Embodiment 6 of the present invention will be described with reference to FIG. FIG. 12 is a diagram illustrating a chromatography measurement device according to a sixth embodiment of the present invention.

FIG. 12 shows a chromatographic measuring apparatus for qualitatively or quantitatively measuring the test substance added to the chromatographic test piece 1. Both ends of the chromatographic test piece 1 on the upstream and downstream sides of the chromatograph are shown. The portion other than the region is covered with the liquid impermeable sheet material 6 in a state of being in close contact therewith.

As shown in FIG. 12, the chromatographic measurement apparatus according to the sixth embodiment of the present invention differs only in that the downstream region of the chromatogram not covered with the liquid impermeable sheet 6 is covered with the gas permeable material 8. 1 is different from the chromatography measurement device according to the first embodiment described with reference to FIG. Therefore, the same components as those of the chromatography measurement device according to the above-described first embodiment are denoted by the same reference numerals, and description thereof is omitted. The gas permeable material 8 may be any material as long as it is a mesh-like material having fine pores, and is preferably a material having poor water absorption.

Next, the chromatographic measurement using the chromatographic measurement apparatus according to the sixth embodiment of the present invention will be described. In the chromatography measurement device shown in FIG. 12, when a liquid sample is added to the sample addition section 2,
Next, it reaches the area of the labeling reagent holding unit 3. Next, the labeling reagent held in the area of the labeling reagent holding section 3 is dissolved by the permeation of the liquid sample, and permeates the area of the reaction layer 4 together with the liquid sample. On the region of the reaction layer 4, there is a specific protein immobilization unit 5, and when the liquid sample contains an analyte, the specific protein immobilized on the specific protein immobilization unit 5 is analyzed. A binding reaction occurs with the complex of the target substance and the labeling reagent, and a color reaction is observed in the region of the specific protein immobilization section 5. On the other hand, when the analyte is not contained in the liquid sample, no binding reaction occurs and no color reaction is observed. Eventually, the liquid sample penetrates into the lower end region of the chromatographic test strip and the reaction ends.

At this time, at least the measurement area from the labeling reagent holding section 3 located on the upstream side to the specific protein immobilization section 5 located on the downstream side of the surface of the chromatographic test strip 1 is covered with a liquid made of plastic tape or the like. By covering in a state of being adhered by the impermeable sheet material 6, evaporation of water in the measurement area can be prevented, and the amount of the liquid sample permeating the measurement area can be made uniform, and measurement can be performed in a certain time. The concentration of the liquid reagent flowing through the region and the concentration of the labeling reagent can be kept constant, and the chromatographic measurement can be performed accurately.

Since the downstream area of the chromatographic test piece 1 is not covered with the liquid impermeable sheet material 6 but covered with the gas permeable material 8, the liquid sample gradually penetrates into the lower end area of the chromatographic test piece 1. The water evaporates. Since the evaporation rate of the liquid sample in the lower end region is higher than the permeation speed of the added liquid sample into the downstream region of the chromatography test piece 1, the liquid sample is dried without flowing backward. The air permeable material may be any porous thin film material such as a nonwoven fabric. The porous thin film material is porous and has excellent air permeability, and has a thickness of 1 mm or less. Those having low water absorption are preferred. Further, the air-permeable material may be a network, and the network shown here indicates a network formed by forming a fiber or a resin into a mesh, and indicates whether the material has a capillary activity or absorbability. Does not matter. The shape of the mesh at this time may be any shape as long as it is a polygon, and its size does not matter, but it is preferable that the mesh is regularly arranged. This network also
Preferably, it is a single layer.

Further, a liquid sample is added to the sample adding section 2, and the liquid sample is placed downstream of the chromatographic test piece 1 in order to maintain a uniform water content with the downstream region of the chromatographic test piece 1. The reaction is developed in the side region, and the reaction is accurately performed in the reaction layer 4.

Further, as shown in FIG. 12, since the gas permeable material 8 covers the downstream region of the chromatograph,
Is not only discernible by the naked eye, but also the reaction layer 4 in the downstream region cannot be directly touched by hand. Therefore, there is no danger of contaminating the reaction layer 4 with a substance attached to the hand, and there is no need to worry about deterioration of water absorption of the reaction layer 4 caused by contamination, and there is no danger of the liquid sample adhering to the hand. It can be measured safely and hygienically.

As described above, according to the chromatographic measurement apparatus according to the sixth embodiment, at least the labeling reagent holding portion 3 located on the upstream side of the surface of the chromatographic measurement apparatus has the specific position located on the downstream side. By covering the measurement area up to the protein immobilization section 5 in a state in which the liquid impermeable sheet material 6 made of a plastic tape or the like is in close contact therewith, evaporation of water in the measurement area can be prevented. Done evenly,
Chromatographic measurements are made accurately. Further, by covering the downstream area of the chromatographic test piece 1 with the air-permeable material 8, not only the water evaporation is promoted, but also the sample addition part 2 can be easily identified, and the deterioration of the water absorption of the reaction layer due to contaminants is prevented. Becomes possible. This makes it possible to realize a low-cost, high-sensitivity, high-performance chromatographic measurement device that can be used more safely and sanitarily without the liquid sample adhering to the hand.

Although the case where the gas permeable material 8 covers the downstream region in the chromatography measurement apparatus of the present invention has been described, the upper surface and the side surface of the downstream region described in the third to fifth embodiments may be covered with the gas permeable material. 8 or only the surface is covered with a breathable material 8, or
Any form may be used as long as the gas permeable material 8 exists in the downstream region, such as the upper surface, the side surface, and the lower surface covered with the gas permeable material 8.

Although the sixth embodiment has been described using the configuration of the chromatographic test piece 1 of the chromatographic measuring apparatus according to the first embodiment, the basic members described in the second embodiment are reacted. The same effect as in the sixth embodiment can be obtained for the chromatographic test piece 1 composed of a single layer of only the layer 4.

(Embodiment 7) Hereinafter, a chromatography measurement apparatus according to Embodiment 7 of the present invention will be described with reference to FIGS. 13, 14, 15, 16, 17, and 18. FIG. FIGS. 13, 16, and 17 are diagrams showing a chromatographic measuring device according to a seventh embodiment of the present invention. FIGS. 14 and 15 show the chromatographic measuring device shown in FIG. 13 in a direction perpendicular to the chromatographic direction. FIG. 5 is a view of a cross section cut along a line from a downstream side of the chromatograph. FIG.
FIG. 8 is a cross-sectional view of the chromatography measuring apparatus shown in FIG. 16 cut in a direction parallel to a chromatographic direction.

FIGS. 13, 16 and 17 show a chromatographic measuring apparatus for qualitatively or quantitatively measuring a test substance added to the chromatographic test piece 1. The chromatographic test piece 1 has a chromatographic upstream side and a chromatographic upstream side. The portion other than the both end regions on the downstream side is covered with the liquid impermeable sheet material 6 in a state of being in close contact therewith.

As shown in FIG. 13, FIG. 16 and FIG. 17, the chromatographic measuring apparatus according to the seventh embodiment of the present invention uses a space forming material 9 for the downstream region of the chromatogram not covered by the liquid impermeable sheet material 6. Only at the point of cover,
This is different from the chromatography measurement device according to the first embodiment described with reference to FIG. Therefore, the same components as those of the chromatography measurement device according to the above-described first embodiment are denoted by the same reference numerals, and description thereof is omitted.

The space forming material 9 is an arbitrary liquid-impermeable material, which may be transparent, translucent or opaque, but has sufficient strength to form and maintain a space on the reaction layer 4. Preferably, it is a material. At this time,
The space forming material 9 is formed so as to be laminated on the end of the liquid impermeable sheet material 6 as shown in FIG. 18, or is connected to the liquid impermeable sheet material 6 (not shown). May be formed.

The space forming portion 11 is a space formed by the space forming material 9 and has an arbitrary distance from the reaction layer 4.
It is preferable that air be allowed to flow in. The space portion 10 is provided at the downstream end of the chromatograph as shown in FIG. 13, provided on the side surface parallel to the chromatograph as shown in FIG. 16, or provided on the surface of the space forming portion 11 as shown in FIG. There is no problem even if an arbitrary number is provided in an arbitrary part of nine. The number of gaps shown here is one or more and there is no problem at all.

Next, a description will be given of the chromatography measurement using the chromatography measurement apparatus according to the seventh embodiment of the present invention. In the chromatographic measurement apparatus shown in FIGS. 13, 16, and 17, when the liquid sample is added to the sample addition section 2, the liquid sample reaches the area of the labeling reagent holding section 3. Next, the labeling reagent held in the area of the labeling reagent holding section 3 is dissolved by the permeation of the liquid sample, and permeates the area of the reaction layer 4 together with the liquid sample. On the region of the reaction layer 4, there is a specific protein immobilization unit 5, and when the liquid sample contains an analyte, the specific protein immobilized on the specific protein immobilization unit 5 is analyzed. A binding reaction occurs with the complex of the target substance and the labeling reagent,
A color reaction is observed in the region of the specific protein immobilization section 5. On the other hand, when the analyte is not contained in the liquid sample, no binding reaction occurs and no color reaction is observed. Eventually, the liquid sample penetrates into the lower end region of the chromatographic test strip and the reaction ends.

At this time, at least the measurement area from the labeling reagent holding section 3 located on the upstream side to the specific protein immobilizing section 5 located on the downstream side of the surface of the chromatographic test strip 1 is covered with a liquid made of plastic tape or the like. By covering in a state of being adhered by the impermeable sheet material 6, evaporation of water in the measurement area can be prevented, and the amount of the liquid sample permeating the measurement area can be made uniform, and measurement can be performed in a certain time. The concentration of the liquid reagent flowing through the region and the concentration of the labeling reagent can be kept constant, and the chromatographic measurement can be performed accurately.

Further, since the downstream area of the chromatographic test piece 1 is not covered with the liquid impermeable sheet material 6 but is covered with the space forming material 9, the liquid sample gradually penetrates into the lower end area of the chromatographic test piece 1. The water evaporates. Since the space forming material 9 has the gap 10, the evaporation rate of the liquid sample in the lower end region is higher than the permeation speed of the added liquid sample into the downstream region of the chromatography test piece 1. The liquid sample dries without backflow. In addition, a liquid sample is added to the sample addition section 2, and the liquid sample is transferred to the downstream area of the chromatographic test piece 1 in order to maintain a uniform water content with the downstream area of the chromatographic test piece 1. The reaction is accurately performed in the reaction layer 4.

Further, as shown in FIG. 13, FIG. 16, and FIG. 17, since the space forming material 9 covers the downstream area of the chromatograph, not only the sample addition section 2 can be visually identified but also the reaction area of the downstream area can be recognized. Layer 4 cannot be touched directly by hand. Therefore, there is no danger of contaminating the reaction layer 4 with a substance attached to the hand, and there is no need to worry about deterioration in water absorption of the reaction layer 4 caused by contamination, and there is no danger of the liquid sample adhering to the hand. Can be measured safely and hygienically.

As described above, according to the chromatographic measuring apparatus according to the seventh embodiment, at least the labeling reagent holding section 3 located on the upstream side of the surface of the chromatographic measuring apparatus has the specific position located on the downstream side. By covering the measurement area up to the protein immobilization section 5 in a state in which the liquid impermeable sheet material 6 made of a plastic tape or the like is in close contact therewith, evaporation of water in the measurement area can be prevented. Done evenly,
Chromatographic measurements are made accurately. Further, by covering the downstream area of the chromatographic test piece 1 with the space forming material 9, not only the water evaporation is promoted, but also the sample addition part 2 can be easily identified, and the deterioration of the water absorption of the reaction layer due to contaminants is prevented. Becomes possible. This makes it possible to realize a low-cost, high-sensitivity, high-performance chromatographic measurement device that can be used more safely and sanitarily without the liquid sample adhering to the hand.

Although the case where the space forming material 9 covers the downstream region in the chromatographic measurement apparatus of the present invention has been described, specifically, as shown in FIG. 9 may be formed. Further, as shown in FIG. 15, the space forming material 9 is formed on the upper surface and the side surface of the chromatography measurement device, or the space forming material 9 is formed on the upper surface, the side surface, and the lower surface (not shown). Any form may be used as long as the space forming material 9 exists in the downstream region.

In the seventh embodiment, the description has been made using the configuration of the chromatography test piece 1 of the chromatography measuring apparatus according to the first embodiment. However, the basic members described in the second embodiment are reacted. The same effect as in the seventh embodiment can be obtained for the chromatographic test piece 1 composed of only the single layer 4.

Further, in the chromatographic measurement apparatus of the present invention, the test piece may be a dry analysis element. The dry analysis element shown here is a sample addition section constituting the test piece,
This shows a test piece in which all components such as a reaction layer and a water absorption part are in a dry state, and reagents such as sample reagents and specific proteins carried or immobilized on these members are also in a dry state. By making the test piece dry, denaturation of proteins and the like can be minimized, and long-term storage is possible.

Further, the chromatography measuring apparatus of the present invention may have a one-step test piece. The one step shown here means that in the measurement operation, no pretreatment of the sample solution is required, only the sample solution is spotted on the test piece, and the sample solution is spread using the developing solution after the spotting, Since the operation does not require a washing operation, the measurement can be performed easily.

[0094]

The following examples further illustrate the practice of the present invention. It should be noted that the present invention is not limited to the following embodiments. (Quality of urinary hCG) Anti-hCG in nitrocellulose membrane
An immunochromatographic measurement device including a -β antibody immobilization line and a wide band of a complex of anti-hCG-α antibody and colloidal gold was produced. This chromatographic measurement device is shown in FIG. In the figure, a chromatographic measurement device is a labeling reagent which is a region containing a specific protein-immobilized portion 5 on which an antibody is immobilized and a complex containing an anti-hCG-α antibody and a gold colloid in front thereof. A holding section 3 and a sample adding section 2 are included. These chromatography measuring devices were manufactured as follows.

A) Preparation of Chromatography Measurement Device Anti-hCG-
A β antibody solution was prepared. By applying this antibody solution on a nitrocellulose membrane using a solution ejection device,
An antibody immobilization line for detection was obtained on the membrane. After drying the membrane, Tris-HCl containing 1% skim milk
Dipped in buffer solution and gently shaken for 30 minutes. After 30 minutes, the membrane was moved to a Tris-HCl buffer solution tank and gently shaken for 10 minutes, and then gently shaken in another Tris-HCl buffer solution tank for another 10 minutes to wash the membrane. After washing twice, remove the membrane from the liquid tank,
Dry at room temperature.

The colloidal gold was prepared by adding a 1% citric acid solution to a refluxing 100 ° C. solution of 0.01% chloroauric acid. After continuing the reflux for 30 minutes, the mixture was cooled by standing at room temperature. With a 0.2 M potassium carbonate solution, p
An anti-hCG-α antibody was added to the gold colloid solution prepared in H9, and the mixture was stirred for several minutes.
(Bovine serum albumin) solution was added to a final amount of 1% and stirred to prepare an antibody-colloidal gold complex (labeled antibody). The labeled antibody solution was heated at 4 ° C.
The labeled antibody was isolated by centrifugation at 0 G for 50 minutes, suspended in a washing buffer (1% BSA / phosphate buffer), and then centrifuged again to wash the labeled antibody. Isolated. The labeled antibody was suspended in a washing buffer, filtered using a 0.8 μm filter, adjusted to one-tenth of the original colloidal gold solution, and stored at 4 ° C.

The labeled antibody solution was set in a solution discharging apparatus, applied to a position away from the antibody immobilization position on the anti-hCG-β antibody immobilized dry film, and then dried. As a result, a chromatography test piece 1 having the labeled antibody holding part 3 on the antibody-immobilized membrane was obtained. Then, after attaching the chromatographic test piece 1 to the support 7, the transparent tape (from a position 1.5 cm away from the upstream end to a position 1.0 cm away from the downstream end of the chromatographic test piece 1) ( The reaction layer surface is covered in close contact with a PP tape (manufactured by Nitto Denko) to obtain a chromatography measurement device.

B) Preparation of sample Human male urine containing no hCG was prepared. By adding a constant concentration hCG solution to the urine, various known concentrations of hCG solution were prepared.

C) Measurement of Color Degree on Chromatographic Measuring Apparatus About 40 μl of urine containing hCG was added to the sample addition section on the chromatographic measuring apparatus, and developed on the downstream side of the chromatographic test strip 1 to obtain an antigen. An antibody reaction was performed to perform a color reaction in the antibody-immobilized portion. The coloration status 5 minutes after the sample was added to the measuring device was visually determined.

As a result, the chromatographic development of the sample was developed smoothly without backflow, and a color reaction accompanying the presence of hCG was confirmed. In this example, colloidal gold is used as a labeling reagent, but any labeling substance may be used as long as the labeling reagent can be colored. Further, as described above, the chromatographic measurement apparatus in the present embodiment uses a test piece formed by laminating or connecting arbitrary porous materials such as nitrocellulose. A test piece made of such a material can be used to analyze and detect a specific substance and qualitatively or quantitatively, using any measurement principle such as an antigen-antibody reaction.

[0101]

As described above, according to the chromatographic measuring device of the first aspect of the present invention, there is provided a chromatographic test piece which is a test piece for performing a chromatographic measurement. A chromatographic measuring device for qualitatively or quantitatively measuring the test substance,
It is characterized in that portions other than both end regions on the upstream side of the chromatograph and the downstream side of the chromatograph are covered with a liquid impermeable sheet material in a state of being in close contact therewith. Therefore, the added liquid sample permeates downstream of the chromatograph by capillary action, and in the area covered with the liquid impermeable sheet material, water evaporation does not occur, and the liquid sample reaches the open portion. Then, the sample evaporates and the sample dries. On the other hand, since the liquid sample is held in the sample addition section, the liquid sample is developed downstream of the chromatograph without backflow. This makes it possible to make the permeation direction and permeation state of the liquid sample uniform, not only to allow the liquid sample and the labeling reagent flowing for a certain time to flow out at a uniform concentration, but also to absorb the sample in the downstream region. This eliminates the necessity of providing, and it is possible to realize a low-cost, high-sensitivity, high-performance, low-cost chromatographic measurement apparatus equivalent to or higher than the conventional one, in which the number of constituent members is reduced and the test piece preparation process is simplified.

According to the second aspect of the present invention, there is provided the chromatography measuring apparatus according to the first aspect, wherein:
An upper surface other than both end regions on the upstream side of the chromatograph and the downstream side of the chromatograph is covered with a liquid-impermeable sheet material in close contact therewith. Therefore, the added liquid sample permeates in the downstream direction of the chromatogram by capillary action, and in the area covered with the liquid impermeable sheet material in a state in which the liquid sample is in close contact with the liquid sample, the water sample does not evaporate and the liquid sample does not evaporate. When the sample reaches the open portion, the moisture of the sample evaporates and the sample dries.
On the other hand, since the liquid sample is held in the sample addition section, the liquid sample is developed downstream of the chromatograph without backflow. Also, since only the surface of the chromatographic measurement device is covered with the liquid impermeable sheet material, it is not necessary to wrap the liquid impermeable sheet material up to the back surface of the chromatographic test piece when manufacturing the chromatographic measurement device,
In addition, when the prepared chromatographic sheet is cut into a large chromatographic test piece, the surface of the chromatographic sheet is covered in close contact with the liquid impermeable sheet material, so that there is no need to worry about peeling of the member at the time of cutting. This eliminates the need to provide a water absorption section in the downstream area to absorb the sample, reduces the number of components, and simplifies the test piece preparation process. It is possible to realize a chromatography measurement device.

According to the third aspect of the present invention, there is provided the chromatographic measuring apparatus according to the first aspect, wherein
The upper surface and the side surfaces other than both end regions on the upstream side of the chromatograph and the downstream side of the chromatograph are covered with a liquid-impermeable sheet material in a state in which they are in close contact with each other. Therefore, the added liquid sample permeates in the downstream direction of the chromatogram by capillary action, and in the area covered with the liquid impermeable sheet material in a state in which the liquid sample is in close contact with the liquid sample, the water sample does not evaporate and the liquid sample does not evaporate. When the sample reaches the open portion, the moisture of the sample evaporates and the sample dries. On the other hand, since the liquid sample is held in the sample addition section, the liquid sample is developed downstream of the chromatograph without backflow. This eliminates the need to provide a water absorption section in the downstream area to absorb the sample, reduces the number of components, and simplifies the test piece preparation process. It is possible to realize a chromatography measurement device.

According to the fourth aspect of the present invention, there is provided the chromatography measuring apparatus according to the first aspect, wherein
The upper surface, the side surface, and the lower surface other than both end regions on the upstream side of the chromatograph and the downstream side of the chromatograph are covered with a liquid-impermeable sheet material in a state where they are in close contact with each other. Therefore, the added liquid sample permeates in the downstream direction of the chromatogram by capillary action, and in the area covered with the liquid impermeable sheet material in a state in which the liquid sample is in close contact with the liquid sample, the water sample does not evaporate and the liquid sample does not evaporate. When the sample reaches the open portion, the moisture of the sample evaporates and the sample dries. On the other hand, since the liquid sample is held in the sample addition section, the liquid sample is developed downstream of the chromatograph without backflow. In addition, the liquid impermeable sheet material can also serve as a support for the reaction layer, so that the number of components constituting the chromatography measurement device can be reduced. This eliminates the need to provide a water absorption section in the downstream area to absorb the sample, reduces the number of components, and simplifies the test piece preparation process. It is possible to realize a chromatography measurement device.

According to a fifth aspect of the present invention, there is provided the chromatographic measuring apparatus according to any one of the first to fourth aspects, wherein at least the chromatographic test piece is located at an upstream side of the chromatograph. The measurement area from the labeling reagent holding part holding the labeling reagent to the specific protein immobilization part where the specific protein located downstream of the chromatograph is immobilized is in close contact with the liquid impermeable sheet material. It is characterized by being covered with. Therefore, between the reagent holding region and the specific protein holding region, the added liquid sample permeates in the downstream direction of the chromatogram by capillary action while performing a reaction, and is in a state of being adhered by the liquid impermeable sheet material. In the covered area, water evaporation does not occur, and when the liquid sample reaches the open portion, the water evaporation of the sample proceeds and the sample dries. On the other hand, since the liquid sample is held in the sample addition section, the liquid sample is developed downstream of the chromatograph without backflow. This eliminates the need to provide a water absorption section in the downstream area to absorb the sample, reduces the number of components, and simplifies the test piece preparation process. It is possible to realize a chromatography measurement device.

According to the chromatographic measuring device according to the sixth aspect of the present invention, in the chromatographic measuring device according to any one of the first to fifth aspects, the chromatographic test piece comprises a plurality of porous materials. It is characterized by being laminated or connected. Therefore, the added liquid sample permeates in the downstream direction of the chromatogram by capillary action, and in the area covered with the liquid impermeable sheet material in a state in which the liquid sample is in close contact with the liquid sample, the water sample does not evaporate and the liquid sample does not evaporate. When the sample reaches the open portion, the moisture of the sample evaporates and the sample dries.
On the other hand, since the liquid sample is held in the sample addition section, the liquid sample is developed downstream of the chromatograph without backflow. This eliminates the need to provide a water absorption section in the downstream area to absorb the sample, reduces the number of components, and simplifies the test piece preparation process. It is possible to realize a chromatography measurement device.

According to the chromatographic measuring device according to claim 7 of the present invention, in the chromatographic measuring device according to any one of claims 1 to 5, the chromatographic test piece is a single-layer porous material. Characterized by the following. Therefore, the added liquid sample permeates in the downstream direction of the chromatogram by capillary action, and in the area covered with the liquid impermeable sheet material in a state in which the liquid sample is in close contact with the liquid sample, the water sample does not evaporate and the liquid sample does not evaporate. When the sample reaches the open portion, the moisture of the sample evaporates and the sample dries. On the other hand, since the liquid sample is held in the sample addition section, the liquid sample is developed downstream of the chromatograph without backflow. This eliminates the need to provide a water absorbing section for absorbing the sample in the downstream area. In addition, since the basic members that make up the chromatographic test piece are a single layer, the number of constituent members was reduced, and the test piece manufacturing process was simplified. It is possible to realize a chromatography measurement device.

According to an eighth aspect of the present invention, in the chromatography measuring apparatus according to the seventh aspect, the single-layer porous material is nitrocellulose. Therefore, the amount of liquid to be added is not only a very small amount, but also the added liquid sample permeates downstream of the chromatogram due to the capillary phenomenon, and is covered in a state of being adhered by the liquid impermeable sheet material. In the region where the liquid sample does not evaporate, when the liquid sample reaches the open portion, the sample evaporates and dries. On the other hand, in the sample addition section, since the liquid sample is held, the effect that the liquid sample is developed in the downstream direction of the chromatograph without backflow is more efficiently performed. This eliminates the need to provide a water absorption section in the downstream area for absorbing the required sample. In addition, since the basic member constituting the cutography test piece is a single layer, the number of constituent members is reduced, and the process of preparing the test piece is simplified. low cost,
It is possible to realize a sample miniaturization chromatography measurement device.

According to the chromatographic measuring device according to the ninth aspect of the present invention, in the chromatographic measuring device according to any one of the first to eighth aspects, the chromatographic downstream not covered by the liquid impermeable sheet material. The region was characterized by being covered by a breathable material. Therefore, the added liquid sample permeates in the downstream direction of the chromatogram due to the capillary phenomenon, and in the area covered with the liquid impermeable sheet material in a state in which the liquid sample is in close contact with the liquid sample, the water sample does not evaporate. Upon reaching the downstream area covered by the breathable material, the sample evaporates and dries. On the other hand, since the liquid sample is held in the sample addition section, the liquid sample is developed in the downstream direction of the chromatograph without backflow. In addition, since the downstream region is covered with a gas-permeable material, the exposed reaction layer cannot be directly touched by a hand, so that the reaction layer is not contaminated by substances attached to the hand, and water absorption is maintained. Is done. Further, even when the downstream area of the test piece is touched by hand, the liquid sample does not adhere to the hand. This eliminates the need to provide a water-absorbing section in the downstream area to absorb the sample, reduces the number of constituent materials, simplifies the test piece preparation process, is safer and more hygienic, and is equivalent to or better than conventional , A high-sensitivity, high-performance, low-cost chromatography measurement apparatus can be realized.

According to a tenth aspect of the present invention, in the tenth aspect of the present invention, the gas permeable material is any porous thin film material such as a nonwoven fabric. And Therefore, since it is a thin film material having excellent air permeability, its water absorbing power itself is poor, and when the liquid sample reaches the downstream region, not only the water evaporation of the sample proceeds and it is possible to dry, but also the downstream region is air permeable. By covering with a material, the exposed reaction layer cannot be directly touched by a hand, so that the reaction layer is not contaminated by a substance attached to the hand, and water absorption is maintained. Further, even when the downstream area of the test piece is touched by hand, the liquid sample does not adhere to the hand. This eliminates the need to provide a water-absorbing section in the downstream area to absorb the sample, reduces the number of constituent materials, simplifies the test piece preparation process, is safer and more hygienic, and is equivalent to or better than conventional , A high-sensitivity, high-performance, low-cost chromatography measurement apparatus can be realized.

According to the eleventh aspect of the present invention, in the eleventh aspect of the present invention, the gas permeable material is a network. Therefore, the network structure is excellent in air permeability due to its network structure, but has poor water absorbing power of itself, and when the liquid sample reaches the downstream region, not only the water evaporation of the sample is advanced and it is possible to dry, but also the downstream region. Is covered with a gas-permeable material, the exposed reaction layer cannot be directly touched by a hand, so that the reaction layer is not contaminated by a substance attached to the hand and water absorption is maintained. Further, even when the downstream area of the test piece is touched by hand, the liquid sample does not adhere to the hand. This eliminates the need to provide a water-absorbing section in the downstream area to absorb the sample, reduces the number of constituent materials, simplifies the test piece preparation process, is safer and more hygienic, and is equivalent to or better than conventional , A high-sensitivity, high-performance, low-cost chromatography measurement apparatus can be realized.

According to the chromatographic measuring device of the present invention, in the chromatographic measuring device of any one of claims 1 to 8, the chromatographic downstream not covered by the liquid impermeable sheet material. It is characterized in that a space forming portion for forming an arbitrary space is provided on the region. Therefore, since the exposed reaction layer cannot be directly touched with the hand by providing the space forming portion in the downstream area, the reaction layer is not contaminated by the substance attached to the hand, and the water absorption is maintained. Is done. Further, even when the downstream area of the test piece is touched by hand, the liquid sample does not adhere to the hand. Further, since a space is formed in the downstream area, when the liquid sample reaches the downstream area, the water of the sample evaporates and can be dried. This eliminates the need to provide a water absorbing section for absorbing the sample in the downstream region, reduces the number of constituent materials, and simplifies the test piece production process.
It is possible to realize a low-cost chromatography apparatus that is safer and more hygienic, and that has high sensitivity and high performance equal to or higher than conventional ones.

According to the chromatographic measuring apparatus of the present invention, in the chromatographic measuring apparatus of the twelfth aspect, the end, the parallel side surface, or the upper surface of the space forming section of the chromatographic downstream region in the space forming section. Is characterized in that a gap portion is provided at an arbitrary portion to allow air to flow. Therefore, since the exposed reaction layer cannot be directly touched with the hand by providing the space forming portion in the downstream area, the reaction layer is not contaminated by the substance attached to the hand, and the water absorption is maintained. Is done. Further, even when the downstream area of the test piece is touched by hand, the liquid sample does not adhere to the hand. In addition, since a space is formed in the downstream region and a gap is provided at an arbitrary position, the air permeability is good, and when the liquid sample reaches the downstream region,
The sample evaporates and the sample can be dried. This eliminates the need to provide a water-absorbing section for absorbing the sample in the downstream region, reduces the number of constituent materials, and simplifies the test piece preparation process, making it safer and more hygienic,
It is possible to realize a low-cost chromatography apparatus with high sensitivity and high performance equal to or higher than the conventional one.

According to the chromatographic measuring device of the present invention, in the chromatographic measuring device of the twelfth or thirteenth aspect, the space forming part is formed of a liquid impermeable material. It was characterized. Therefore, by providing a space forming portion using a liquid impermeable material in the downstream region, the exposed reaction layer is not directly touched by a hand, and the reaction layer is contaminated by a substance attached to the hand. No water absorption is maintained.
Further, even when the downstream area of the test piece is touched by hand, the liquid sample does not adhere to the hand. Further, since a space is formed in the downstream area, when the liquid sample reaches the downstream area, the water of the sample evaporates and can be dried. This eliminates the need to provide a water-absorbing section in the downstream area to absorb the sample, reduces the number of constituent materials, simplifies the test piece preparation process, is safer and more hygienic, and is equivalent to or better than conventional , A high-sensitivity, high-performance, low-cost chromatography measurement apparatus can be realized.

According to the chromatographic measuring device according to the fifteenth aspect of the present invention, the chromatographic measuring device according to any one of the first to fourteenth aspects, wherein the chromatographic test piece is an immunoassay utilizing an antigen-antibody reaction. It was characterized as a chromatographic test strip. Therefore, high-sensitivity, high-performance, low-cost chromatographic measurement that can be used more safely and sanitarily, and can be used more safely and hygienically by obtaining antibodies or antigens for the measurement target. The device can be realized. The immunochromatographic test piece shown here is a test piece that detects a test substance in a sample solution using an antigen-antibody reaction on a carrier that develops on chromatography.

According to the chromatographic measuring device of the present invention, in the chromatographic measuring device of any one of the first to fifteenth aspects, it is preferable that the chromatographic test piece is a dry analytical element. Features. Therefore, denaturation of proteins and the like can be minimized, and the measurement device can be stored for a long period of time.

According to the chromatographic measuring device of the present invention, in the chromatographic measuring device according to any one of claims 1 to 16, the chromatographic test piece is a one-step test piece. It was characterized. Therefore, since the pretreatment of the sample solution is not required and only the sample solution needs to be spotted on the test piece, the operation is simple.

[Brief description of the drawings]

FIG. 1 is a diagram illustrating a configuration of a chromatography measurement device according to a first embodiment of the present invention.

FIG. 2 is a diagram illustrating a configuration of a chromatographic test piece of the chromatographic measurement device according to the first embodiment of the present invention, from which a liquid impermeable sheet material is removed.

FIG. 3 is a diagram illustrating a configuration of a chromatography measurement device according to a second embodiment of the present invention.

FIG. 4 is a diagram illustrating a configuration of a chromatographic test piece of a chromatographic measuring device according to a second embodiment of the present invention, from which a liquid impermeable sheet material is removed.

FIG. 5 is a cut-away view of the chromatographic measurement device according to the third embodiment of the present invention cut in parallel to a chromatographic direction.

FIG. 6 is a cross-sectional view of the chromatography measurement device according to the third embodiment of the present invention, which is cut perpendicularly to a chromatographic direction.

FIG. 7 is a cut-away view of the chromatographic measurement device according to the fourth embodiment of the present invention, cut in parallel to a chromatographic direction.

FIG. 8 is a cut-away view of the chromatography measuring device according to the fourth embodiment of the present invention, which is cut perpendicularly to a chromatographic direction.

FIG. 9 is a diagram showing a configuration of a chromatography measurement device according to a fifth embodiment of the present invention.

FIG. 10 is a cut-away view of a chromatographic measurement device according to a fifth embodiment of the present invention cut in parallel to a chromatographic direction.

FIG. 11 is a cut-away view of the chromatography measuring device according to the fifth embodiment of the present invention, which is cut perpendicularly to the chromatographic direction.

FIG. 12 is a diagram showing a configuration of a chromatography measurement device according to a sixth embodiment of the present invention.

FIG. 13 is a diagram showing a configuration of a chromatography measurement device according to a seventh embodiment of the present invention.

FIG. 14 is a cut-away view of the chromatographic measurement device according to the seventh embodiment of the present invention, which is cut perpendicularly to the chromatographic direction.

FIG. 15 is a cut-away view of the chromatographic measurement device according to the seventh embodiment of the present invention, which is cut perpendicularly to the chromatographic direction.

FIG. 16 is a diagram showing a configuration of a chromatography measurement device according to a seventh embodiment of the present invention.

FIG. 17 is a diagram illustrating a configuration of a chromatography measurement device according to a seventh embodiment of the present invention.

FIG. 18 is a cut-away view of the chromatographic measurement device according to the seventh embodiment of the present invention, which is cut parallel to the chromatographic direction.

[Explanation of symbols]

 DESCRIPTION OF SYMBOLS 1 Chromatography test piece 2 Sample addition part 3 Labeling reagent holding part 4 Reaction layer 5 Protein immobilization part 6 Liquid impermeable sheet material 7 Support 8 Gas permeable material 9 Space forming material 10 Gap

Continued on the front page (72) Inventor Hirohashi Tanaka 8-1, Koshinmachi, Takamatsu City, Kagawa Prefecture Inside Matsushita Hisashi Denshi Kogyo Co., Ltd. (72) Inventor Fumihisa Kitawaki 1006 Kadoma Kadoma, Kadoma City, Osaka Matsushita Electric Industrial Co., Ltd.

Claims (17)

[Claims] 1. A chromatographic measurement apparatus for qualitatively or quantitatively measuring a test substance added to a chromatographic test piece, the chromatographic test piece having a chromatographic test piece that is a test piece for performing a chromatographic measurement. A chromatographic measuring apparatus characterized in that portions other than both end regions on the upstream side and the downstream side of the chromatograph are covered with a liquid impermeable sheet material in close contact therewith. 2. The chromatography measurement apparatus according to claim 1, wherein the upper surface of the chromatography test piece other than both end regions on the upstream side and the downstream side of the chromatograph is in close contact with a liquid impermeable sheet material. A chromatographic measuring device characterized by being covered. 3. The chromatography measurement apparatus according to claim 1, wherein the upper surface and the side surface of the chromatography test piece other than both end regions on the upstream side and the downstream side of the chromatograph are adhered by a liquid impermeable sheet material. A chromatographic measurement device characterized by being covered in an inclined state. 4. The chromatographic measurement apparatus according to claim 1, wherein an upper surface, a side surface, and a lower surface of the chromatographic test piece other than both end regions on an upstream side and a downstream side of the chromatograph are liquid-impermeable sheet materials. A chromatographic measuring device, which is covered in a state in which it is in close contact with. 5. The chromatographic measurement apparatus according to claim 1, wherein at least a chromatographic test piece is separated from a chromatographic test strip by a labeling reagent holding section that holds a labeling reagent located upstream of the chromatographic test piece. A chromatographic measurement apparatus, wherein a measurement region up to a specific protein immobilization section on which a specific protein located on the downstream side is immobilized is covered with a liquid impermeable sheet material in close contact therewith. 6. The chromatography measurement apparatus according to claim 1, wherein the chromatography test piece is formed by laminating or connecting a plurality of porous materials. . 7. The chromatographic measuring device according to claim 1, wherein the chromatographic test piece is made of a single-layer porous material. 8. The chromatography measuring apparatus according to claim 7, wherein the single-layer porous material is nitrocellulose. 9. The chromatographic measuring apparatus according to claim 1, wherein a downstream region of the chromatogram not covered by the liquid impermeable sheet material is covered by a gas permeable material. Chromatography measurement device. 10. The chromatography measuring apparatus according to claim 9, wherein the gas-permeable material is any porous thin film material such as a nonwoven fabric. 11. The chromatography measurement apparatus according to claim 9, wherein the air-permeable material is a network. 12. The chromatography measuring apparatus according to claim 1, wherein a space forming section for forming an arbitrary space is formed on a downstream region of the chromatograph which is not covered with the liquid impermeable sheet material. A chromatography measurement device, comprising: 13. The chromatography measurement apparatus according to claim 12, wherein an end portion of the chromatographic downstream region in the space forming portion, a parallel side surface, or an arbitrary portion of the upper surface of the space forming portion,
A chromatographic measuring device comprising a gap so that air can flow in. 14. The chromatography measurement apparatus according to claim 12, wherein the space forming portion is formed of a liquid-impermeable material. 15. The chromatography measurement apparatus according to claim 1, wherein the chromatography test piece is an immunochromatography test piece utilizing an antigen-antibody reaction. 16. The chromatography measurement apparatus according to claim 1, wherein the chromatography test piece is a dry analysis element. 17. The chromatography measurement apparatus according to claim 1, wherein the chromatography test piece is a one-step test piece.