JPH01138458A - Fluid inspection body - Google Patents

Abstract

PURPOSE:To exactly decide the content of a desired object by forming an inspecting reagent layer and color toner layer for criteria in such a manner that both the layers have the property to absorb a liquid to be inspected and that the coloration hue of the inspecting reagent layer and the hue of the color tone layer can be compared by comparing the wet colors with each other. CONSTITUTION:The reagent layer 1 to be inspected and the color toner layer 3 for criteria which encloses the circumference of the reagent layer 1 via a spacing 2 are provided on a sheet-shaped base material 5. Paper, nonwoven fabric, synthetic film, etc., are used as the base material 5. The reagent layer 1 consists of the reagent layer 1 which is formed by adequately adding a binder and water absorptive powder to a reagent compsn. meeting the purpose of the inspection to impart a water absorptive power thereto. Kaolin, synthetic silica, glass, etc., are used for the water absorptive powder. The uniform state of 'wetting' of both the reagent layer 1 and the color tone layer 3 by the liquid to be inspected is maintained and the wet colors are compared with each other, by which the content of the desired object is exactly discriminated.

Description

DETAILED DESCRIPTION OF THE INVENTION (Industrial Application Field) The present invention relates to a body fluid test specimen that can easily detect a component to be tested in a body fluid and simultaneously determine the amount of the detected component. More specifically, it detects glucose, protein, pH, etc. in body fluids, and at the same time detects the concentration in the test fluid.
The present invention relates to a body fluid test specimen that enables accurate and highly accurate determination of body fluid levels.

(Prior Art) When discovering, diagnosing, and treating diseases, it is extremely important to easily and quickly know the presence or absence and amount of various components contained in body fluids such as blood, lymph, and urine.

For example, quickly and easily knowing the amount of glucose in body fluids such as urine or blood is essential for early detection, diagnosis, and management of diabetes.

In addition, quickly and easily knowing the amount of protein in body fluids, especially urine, plays a major role in early detection, diagnosis, and treatment of kidney diseases. Furthermore, accurately knowing the pH of body fluids, especially urine, helps to accurately determine whether or not proteins are present in body fluids, as well as the possibility of bacterial urine causing nephritis, cystitis, etc. This will help you confirm.

It is extremely important to detect various test target components in body fluids simply and quickly, but for this purpose conventionally a test body consisting of a filter paper impregnated with a test reagent and attached to a support is used. has been used. Furthermore, to simplify the manufacturing process and prepare an ink composition suitable for printing or coating by mixing a test reagent with a polymeric binder, a water-absorbing carrier, etc. as a test body suitable for mass production, this ink composition A method has been proposed in which a test piece is produced by printing (including coating) an object on a support and then drying it.

The test reagent layer of the body fluid test sample obtained in this way changes color tone depending on the content of the test target substance in the test body fluid, and the color change occurs due to immersion in the test fluid. The content of the substance to be tested is detected by comparing this with a color tone table for judgment criteria printed on a summary separate from the test object.

On the other hand, after immersing these specimens in the liquid to be tested, comparing them with a separate color table for judgment standards is a complicated operation, and the test liquid itself is colored. The change in color tone caused by the reaction of the reagent with the test target substance in the test liquid is not accurately expressed as the coloration of the test sample, making it difficult to compare with the color tone used as the criterion, and accurate testing may not be possible. be. Therefore, in order to solve such problems, a test reagent layer containing a test reagent is provided on the base material of the test object, and a color tone layer for judgment standards printed with printing ink is placed near the test reagent layer. An inspection body equipped with the following has been proposed.

As described above, a test reagent layer and a color tone layer for judgment standards are formed on the base material of the test object and are immersed in the liquid to be tested, and the coloration of the test reagent layer is changed to the color tone for judgment standards. By comparing the layers, errors in judgment due to coloring of the liquid to be tested can be avoided.

However, when a color tone layer for judgment criteria is printed on a base material using ordinary ink as in the past, the surface tension between the printed surface of the color tone layer and the surface of the test reagent, and the physical shape or shape of the surface Due to the difference in conditions, uniform coloring occurs on the surface of the test reagent layer, but since the test liquid only adheres in droplets to the printed surface of the color tone layer, the color tone of the color tone layer becomes uneven. However, there is a drawback that it becomes difficult to compare the color development of the test reagent layer.

In addition, in conventional body fluid test specimens, there is a significant difference in water absorption between the reagent layer and the color tone layer, so comparisons of hues cannot be performed under equal conditions, which causes a problem in which test accuracy decreases. .

(Problems to be Solved by the Invention) The present invention solves the above-mentioned problems of the conventional description, and aims to provide a body fluid test specimen that enables simple and accurate determination.

(Means for Solving the Problems) In order to achieve the above object, the body fluid test body according to the present invention has the following features: A test reagent layer containing a test reagent whose color tone changes; and (b) a color tone layer that is colored with a dye or the like and serves as a criterion for determining the color hue of the test reagent layer. A body fluid test body, wherein both the test reagent layer and the color tone layer have the property of absorbing the test liquid, so that the color hue of the test reagent layer and the hue of the color tone layer can be compared between wet colors. It is characterized by making highly accurate body fluid testing possible.

(BEST MODE FOR CARRYING OUT THE INVENTION) As shown in the plan view of FIG. A color tone layer 3 for use as a criterion is provided so as to surround the periphery of 1 with an rVJ gap 2 in between. Further, in the body fluid test object of the present invention, high absorbency portions 4a and 4b may be provided around the color tone layer 3 with a gap therebetween.

In the present invention, both the test reagent layer 1 and the judgment reference color tone layer 3 have the property of absorbing the test liquid, and by making the state of "wetting" of both layers uniform with the test liquid, This makes it possible to accurately determine the content of the test target substance in the test liquid.

Note that there are various modifications to the shape and arrangement of the above-mentioned components in the present invention, and these modifications will be described later.

Each component of the present invention will be explained in detail below.

As the base material, materials conventionally used as base materials for body fluid test bodies can be used as appropriate.

The base material that can be used in the present invention is preferably one that does not react with the reagent composition and does not inhibit the coloring of the reagent layer described below. Specifically, paper, synthetic paper, nonwoven fabric, synthetic resin film, or a laminate of paper and synthetic resin film may be used.

Test Reagent Layer The test reagent layer in the present invention is made of a reagent composition suitable for the purpose of the test, with a binder and water-absorbing powder added as appropriate to impart water-absorbing ability to the test reagent layer. In addition, if the test reagent composition itself has a suitable water absorption capacity or if a filter paper is impregnated with the test reagent composition to form a test reagent layer, it is not necessarily necessary to add the above-mentioned water-absorbing powder.

When using self-purchased paper, the surface of the filter paper has fibers, so the liquid to be tested tends to stay there, and some of the liquid to be tested may remain on the surface without being absorbed.

As a method for forming a test reagent layer on a base material by printing, as described in Japanese Patent Publication No. 44-25953, water-based
Oxygen is dissolved in advance in an alcohol mixture, and an indicator, a pH buffer, a polymeric binder, a water-absorbing carrier, etc. are mixed therein, and an ink composition suitable for printing or coating is inked onto a substrate. There is a method in which a composition is prepared, the ink composition is printed (including coating) on a substrate, and then dried.

More preferably, the present invention is based on the patent application filed earlier in 1986-1.
The test reagent layer can be formed using each of the ink composition for glucose detection, the ink composition for protein detection, and the ink composition for pH measurement as described in No. 07871.

Such ink compositions are as follows.

(a) A reagent composition consisting of a sugar oxidase, peroxidase, an oxidizable indicator, a wetting agent, a sensitivity regulator, a stabilizer, a pH buffer, a binder, and a water-absorbing powder is dissolved or dispersed in a non-aqueous solvent. Ink composition for glucose detection.

(b) A protein prepared by dissolving or dispersing a reagent composition in a solvent, which includes an indicator for protein error, a pH 1l buffer, a wetting agent, a protein-adsorbing ion exchanger, a form-preserving agent, a binder, and a water-absorbing powder. Detection ink composition.

(c) pH indicator, quaternary ammonium salt or amine salt,
An ink composition for pH measurement comprising a reagent composition comprising a basic substance, a binder, and a water-absorbing powder dissolved or dispersed in a solvent.

Next, we will discuss the main components of the test reagents for each of the above ink compositions. oxidized to gluconic acid and hydrogen peroxide. The generated hydrogen peroxide solution produces nascent oxygen by the action of peroxidase, and this oxygen immediately reacts with an oxidizable indicator such as guaiac butter or 0-) lysine to cause the indicator to develop color. Depending on the degree of color development, the presence or absence of glucose in the body fluid and its amount are determined semi-quantitatively. Furthermore, by using an aliphatic carboxylic acid ester of ascorbic acid as a sensitivity regulator, the quantitative nature of the glucose detection test, that is, the linearity between the glucose concentration in the sample and the color density of the test reagent layer, can be improved. It can be improved.

Stabilizers are used to prevent oxidizable indicators from discoloring due to the action of peroxides in the atmosphere.
Ascorbic acid and fatty acid esters can be used as stabilizers, but in addition, compounds with known antioxidant activity, specific surfactants typified by glycerol esters, or mixtures thereof may be added as appropriate. You can also do it. The pH buffer is a pH buffer that causes the above-mentioned oxidized indicator to undergo a favorable color change in the ink composition for glucose detection.
It is added so as to maintain H, and for example, a combination of citric acid and sodium citrate is used.

These components are dissolved or dispersed in a non-aqueous solvent such as aromatic hydrocarbons, aliphatic ketones, esters, and alcohols other than lower alcohols that do not substantially contain water, along with the binder and water-absorbing powder described below. be done.

(b) Ink composition for protein detection The ink composition for protein detection uses a water-swellable resin having a carboxyl group as a functional group as a shape-retaining agent.

Detection of protein in a test fluid is carried out when the protein in the test fluid comes into contact with an indicator that shows protein error and is kept at an acidic pH.
The indicator and the protein form a complex and the color changes from an acidic yellow color to a basic color blue, and the degree of this color change corresponds to the amount of protein present in the sample liquid. This is done using this principle.

Indicators that indicate protein errors are indicators that behave according to the principles described above, and specifically include tetrabromophenol blue, tetrabromothymol blue, tetrabromophenolphthalein ethyl ester, tetrabromobenzaraline, and bromothymol. Blue etc. can be used. Among these, tetrabromophenol blue is preferable because it has excellent sensitivity.

Any pH buffer may be used as long as it maintains the reagent composition at a predetermined pH value, and a combination of citric acid and sodium citrate is preferably used. Examples of protein-adsorbing ion exchangers include strongly acidic cation exchangers (functional group -3O3M), weakly acidic cation exchangers (-COOM),
Strongly basic ion exchanger (-N″R,X-.

N'' (cH3) 2 <CHx CH30H) ) Weakly basic anion exchangers (N(R)2゜-NH(R), -NH, etc.) are used, and the base material of these ion exchangers is styrene. Synthetic resins such as acrylic, cellulose, and silica are used.

The shape-preserving agent used is one that does not impair the hydrophilicity of the printed test reagent and is insoluble in water, such as carboxymethyl cellulose, which has a carboxyl group as a functional group and is known as a disintegrant for pharmaceuticals. Examples include water-swellable resins such as calcium salts and sodium carboxymethyl cellulose salts, and superabsorbent gels.

The above reagents, binder and water-absorbing powder are aromatic hydrocarbons,
It is preferable to prepare an ink composition by dissolving or dispersing it in a nonaqueous solvent such as an aliphatic hydrocarbon, ester, or alcohol, or water, or a mixture thereof.

(c) Ink composition for pH measurement The pH in the liquid is measured by determining the pH of the test liquid using an indicator whose color tone changes depending on the pH.

Any pH indicator can be used as long as it changes color depending on the hydrogen ion concentration of the test liquid, and can be used over a wide pH range by appropriately selecting or combining multiple types of indicators. can be measured.

When an appropriate amount of quaternary ammonium salt is added to the reagent composition,
- The fading phenomenon of the color once developed over time is greatly suppressed, and a clear color can be obtained.Additionally, when a basic substance is added, the acidic substance is eluted after ink adjustment, and the color tone of the ink composition changes over time. It is possible to prevent changes from occurring.

The above reagents, together with a binder and a water-absorbing powder, are uniformly dissolved or dispersed in a non-aqueous solvent such as aromatic hydrocarbons, aliphatic hydrocarbons, esters, alcohols, water, or a mixture thereof.

Next, we will discuss the binder and water-absorbing powder as materials constituting the test reagent layer other than the main components of the test reagent mentioned above.
Substances other than these can be added to the test reagent layer and the judgment group 29I positive color tone layer as long as they do not cause a change in color depending on the components contained in the test liquid.
Furthermore, among the above-mentioned components, any component that does not cause a change in color tone depending on the component contained in the liquid to be tested can be added to the color tone layer.

Binder The binder is required to be one that does not affect the components, pH, etc. in the body fluid to be tested, does not affect reagents, especially enzymes, and oxidizable indicators, and does not interfere with the color reaction. Ru.

Binders that have been confirmed to meet these requirements include (I) polyester resins, alkyd resins, polyurethane resins, polystyrene resins, acrylic resins, epoxy resins, vinyl chloride resins or vinyl chloride copolymer resins, or hydrophilic resins; synthetic resins such as polyvinyl butyral resin, polyvinyl alcohol resin or polyvinylpyrrolidone resin, maleic anhydride copolymer,
(■) Cellulose derivatives such as methylcellulose, ethylcellulose, hydroxyethylcellulose, calpho-t-dimethylcellulose, (I [[) starch, polysaccharides,
Natural polymers such as gelatin, casein, or sodium alginate can be used. Furthermore, two or more of these binders may be combined.

Water-Absorbing Powder Addition of the water-absorbing powder increases the water absorption of the reagent composition provided on the base material, promotes contact between the test liquid and the reagent composition, and promotes the color reaction of the indicator.

When such water-absorbing powder comes in contact with water,
Those exhibiting extreme acidity or alkalinity are not preferred, and those with high color chromaticity are preferred. Specifically, kaolin, synthetic silica, glass, cellulose block, microcrystalline cellulose, ion exchange cellulose, ion exchange resin, calcium carbonate, magnesium carbonate, aluminum silicate, etc. can be used.

The binder and the water-absorbing powder should be used in an amount of 3 to 30 parts by weight, more preferably 5 to 20 parts by weight, per 100 parts by weight of the water-absorbing powder, from the viewpoint of film-forming ability and absorption of the test liquid. It is desirable to use it in proportion. If the binder is less than 3 parts by weight, the binding ability will be insufficient and it will disintegrate when it absorbs the test liquid, and if the binder exceeds 30 parts by weight, the absorbency of the test liquid will be poor. There is a drawback that the coloring property is decreased and the color development is hindered.

Wetting agents In addition to binders and water absorbing agents, wetting agents can optionally be included in the ink composition. Nonionic surfactants, polyethylene glycols, etc. are used as wetting agents.
This wetting agent helps to disperse each reagent, promotes the formation of a uniform reagent layer, and can improve water wettability.

In addition to the embodiments described above, the test reagent layer in the present invention includes the following compositions for detecting occult blood and compositions for detecting urobilinogen.

(6) Composition for detecting occult blood This composition for detecting occult blood consists of an organic hydroperoxide, an oxidizable indicator, a sensitizer, a pH buffer, a binder, and a water-absorbing powder dissolved or dispersed in a non-aqueous solvent. The organic hydroperoxide and the sensitizer are present in the same microcapsule.

According to the above embodiment, organic hydropeno-5-reoxide alone,
Or, because the organic hydroperoxide and sensitizer are used in microcapsules, the organic hydroperoxide does not react with other substances during storage, and because the sensitizer is used, the capsule collapses. It has an excellent effect of high sensitivity in subsequent reactions.

Each component of the composition for detecting occult blood will be explained in order below.

Among the many known compounds belonging to that group, organic hydroperoxides are known as organic hydroperoxides, which react with peroxide-active substances in the presence of a peroxide-sensitive indicator, resulting in a color change or Anything that can produce a detectable response, such as a change in light absorbed or reflected by the body, can be used, such as:

, cumene hydroperoxide, t-butyl hydroperoxide, 2,5-dimethylhexane-2,5-dihydroperoxide, diisopropylbenzene hydroperoxide, or paramenthane hydroperoxide, or a mixture thereof.

Among these, cumene hydroperoxide can be used.

The organic hydroperoxide is used in an amount of 1 to 30% by weight, preferably 2 to 25% by weight, based on the solid content of the composition for detecting occult blood.
It can be contained in an amount of

The coating material of the microcapsules used in the above composition is an emulsifier that forms a good emulsion when mixed with an organic hydroperoxide, and when it comes into contact with water in the test liquid, it quickly disintegrates and encapsulates it. It is desirable that the organic hydroperoxide has the function of causing the organic hydroperoxide to participate in a color reaction with the indicator.

Examples of microcapsule coating agents that have been confirmed to satisfy these conditions include the following.

(1) Water-soluble synthetic resins such as polyvinyl alcohol resin, polyvinylpyrrolidone resin, polyacrylamide resin, or polyvinyl acetate resin.

(2) Water-soluble cellulose derivatives such as methylcellulose, ethylcellulose, hydroxycellulose, or carboxymethylcellulose.

(3) Natural polymers such as starch, polysaccharides, gelatin, casein, gum arabic, or sodium alginate.

Among these, gum arabic, carboquine methylcellulose, and polyvinyl alcohol resin are particularly preferred.

The amount of the microcapsule coating material is 2 to 70% by weight, preferably 4 to 50% by weight based on the solid content of the composition for detecting occult blood.
Preferably, it exists.

Oxidizable Indicator The oxidizable indicator is an indicator that develops color when oxidized by oxygen, and a wide variety of conventionally known compounds such as benzidines and N-alkylated benzidines can be used. Among these, 0-tolidine, 3.3', 5.5'
-tetramethylbenzidine, 2,7-azafluorene,
etc., and it is particularly preferable to use 3.3', 5.5'-tetramethylbenzidine.

This oxidizable indicator is 0.5 to 10% by weight, preferably 0.6 to 6% by weight based on the solid content of the composition for detecting occult blood.
It is desirable that it be present in an amount of

Sensitizer In the above composition, a mixture of quinoline or a derivative thereof and a triethanolamine salt is used as a sensitizer to promote color formation of the specimen for detecting occult blood in the presence of blood and improve sensitivity. and color density can be improved.

As quinoline or its derivatives, quinoline, quinine, 6-methoxyquinoline, 6-methylquinoline, or 7-methylquinoline are used, among which 6
-Methoxyquinoline is particularly preferred.

As the triethanolamine salt, triethanolamine hydrochloride, triethanolamine phosphate, or triethanolamine sulfate is used, and among these, triethanolamine lauryl sulfate, which is a sulfate,
Polyoxyuralyl triethanolamine sulfate is preferred, and it is particularly preferred to use lauryl triethanolamine sulfate.

The amount of quinoline or its derivative is 0.5 to 10% by weight, preferably 0.6% by weight based on the solid content of the composition for detecting occult blood.
Desirably present in an amount of ~6% by weight.

Further, the triethanolamine salt is 1 to 20% by weight, preferably 2 to 15% by weight, based on the solid content of the composition for detecting occult blood.
Preferably present in an amount of % by weight.

Mild pH buffers are used to maintain pH values near the pH at which the oxidizable indicators described above will undergo a favorable color change in the occult blood detection composition.

As a pH buffer, a predetermined pH value (for example, pH 5) is used.
Any combination of citric acid and sodium citrate may be used as long as it can impart this to the composition for detecting occult blood. Specifically, it is preferable to use a combination of citric acid and sodium citrate.

As the binder, those mentioned above can be used, and it is desirable to use it in a proportion of 0.1 to 20% by weight, preferably 0.5 to 10% by weight, based on the solid content of the composition for detecting occult blood.

As the water-absorbing powder, those mentioned above can be used, and it is preferably used in a proportion of 30 to 90% by weight based on the solid content of the composition for detecting occult blood.

As the solvent, the same solvent as used in the ink composition for glucose detection can be used.

Further, in order to make the color tone of the indicator more visible, a background dye such as oil yellow may be added.

(e) Urobilinogen detection composition This detection composition is characterized in that Ehrlich's reagent, a strong acidic buffer, a binder, a water-absorbing powder, and a reaction activator are dissolved or dispersed in a non-aqueous solvent. There is.

According to the above composition, the cationic surfactant suppresses the Ehrlich reaction, while the anionic surfactant promotes the reaction between the test substance and urobilinogen. When the HLB is in the range of 6.0 to 11.0, an excellent effect of improving contact between the test reagent layer and urobilinogen can be obtained.

Below, each component of the above-mentioned composition for detecting urobilinogen will be explained in order.

〔principle〕

When the indicator p-di(alkyl)-aminobenzaldehyde is maintained at an acidic pH, it exhibits a yellow-pink to reddish-purple color depending on the concentration of urobilinogen, and this principle makes it possible to detect urobilinogen in the test liquid. Become.

Ehrlich Reagent (Indicator) Specific Ehrlich reagents are p-di(lower alkyl)aminobenzaldehydes such as p-dimethylaminobenzaldehyde and p-diethylaminobenzaldehyde. Among these, p-diethylaminobenzaldehyde has excellent sensitivity.

Ehrlich's reagent has a preferable value of 0.0 in the detection composition.
It is used in a proportion of 1 to 5% by weight.

Strongly acidic buffer The reaction between urobilinogen and the indicator proceeds in an acidic region, so in order to provide such a reaction environment and to suppress side reactions, a buffer that can adjust the pH to 3 or less, preferably a solid at room temperature, is used. Use acid. Specifically, sulfosalicylic acid, sidiic acid, p-)luenesulfonic acid, metaphosphoric acid, etc. are used alone or in combination.

The strong acidic buffer is preferably used in the detection composition in an amount of 2 to 30%.
Used in proportions by weight.

Binding agent As the binding agent, the same ones as those mentioned above can be used,
It is desirable to use it preferably in a proportion of 0.2 to 20% by weight in the detection composition.

Water-absorbing powder As the water-absorbing powder, those mentioned above can be used, and it is preferably used in a proportion of 15 to 50% by weight in the detection composition.

As the solvent, those mentioned above can be used, and it is preferably used in an amount of 30 to 85% by weight in the detection composition.

Reaction Activator As the reaction activator, an anionic surfactant or a nonionic surfactant is used, and these are preferably used in combination.

Examples of the anionic surfactant include sodium uralyl sulfate and sodium dodecyl sulfonate, which are preferably used in a proportion of 0.05 to 3% by weight in the detection composition.

The nonionic surfactants are used alone or in combination so that the HLB is in the range of 6.0 to 11.0. Specifically, polyoxyethylene ethers, fatty acid esters of sorbitan, esters of macrogol and fatty acids, or ethers of macrogol and alcohol are preferably used in the detection composition in an amount of 0.05 to 5 weight 1%
Use at a ratio of

Other Components The composition for detecting urobilinogen may contain many auxiliary components in addition to the above-mentioned main components. For example, the coloring sensitivity can be increased by adding caffeine, and technically acceptable ingredients such as antioxidants and chelating agents can be included. Also,
A background dye may be added for the purpose of making it easier to see the color tone of the indicator.

Preparation of Each Detection Composition The components of each detection composition are as follows: First, water-absorbing powder is ground into particles having a diameter of 50 μm or less.

Next, the obtained particles are added to a liquid in which other components have been dissolved or dispersed in a solvent, and the particles are added to a solution using a high-speed stirrer, a sand mill, etc.
Dispersion and mixing may be performed using a ball mill, three-roll mill, ultrasonic dispersion machine, or the like.

Formation of Test Reagent Layer Each detection composition is applied as an ink composition onto a support, and then dried to form each detection region and obtain a test reagent layer.

Application methods include printing methods, coating methods (for example,
Roll coating method, spray coating method, dip coating method, peter coating method, etc. are used.

In the above embodiment, the amount of each detection composition applied is relatively large, and it is preferable that the amount of application is constant, so each detection composition is Preferably, the composition is applied onto a substrate.

The amount of each detection composition applied onto the substrate depends on the type of composition, but is generally preferably 2 to 150 g/m' (dry).

Color tone layer The color tone layer used as a criterion in the present invention has the property of absorbing the liquid to be tested, and can be compared with the color hue of the test reagent layer in wet color (in other words, in a wet state). be. For this reason, the color tone layer has substantially the same constituent components as the test reagent layer except for the main component (ie, the active component as an indicator).

Therefore, the ink composition for the tone layer is prepared by dissolving or dispersing the test reagent layer constituent materials other than the main test reagent components in the same solvent as used in the ink composition, and then immersing the test reagent layer in the test liquid at a specified concentration. It can be obtained by coloring using a dye, such as a water-soluble dye, or a pigment, so as to have a color tone that matches the coloration at each concentration.

The binder and water-absorbing powder added as components of the color tone layer may be the same as those used in the test reagent layer. The tone layer forming ink composition can be formed by applying each color tone layer forming ink composition.

As a coating technique, a method similar to that used for forming the test reagent layer can be used. The coating amount varies depending on the type of ink composition, but is generally desirably 2 to 150 g/m'' (dry).

Adjustment of Water Absorption Capacity In the present invention, it is important that both the test reagent layer and the color tone layer have the property of absorbing the test liquid.

When using a test piece without a conventional color tone layer, immerse the test piece in the urine in the urine collection cup, then slide the end of the test piece into contact with the upper edge of the urine collection cup to remove excess urine. It is being removed.

However, when a test piece with a color tone layer is used as in the present invention, the removal method described above is not sufficient, especially when the color tone layer is removed from the test reagent layer. , the excess urine on the color tone layer can only be removed, and the excess urine on the reagent layer cannot be removed sufficiently. Therefore, the reagent layer and the color tone tool must have appropriate water absorption properties, and it is desirable that the excess urine on the test reagent layer be absorbed by the color tone layer when the test reagent layer is immersed in a urine collection cup and pulled up. However, if the color tone layer has excessive absorption capacity, there is a risk that the urine on the test reagent layer will also be absorbed, so adjust the thickness, width, composition, and gap between the color tone layer and the reagent layer to ensure appropriate absorption. Give it sex.

It is preferable that the water absorption of the test reagent layer and the water absorption of the color tone layer are similar, and as long as the difference in water absorption between the two is within a certain limit, there will be no problem in color development and determination.

If the difference in water absorbency between the two is too large, the following problems will occur.

(1) Water absorbency of the color tone layer In the case of water absorption of the test reagent layer, for example, a coloring reaction progresses after the specimen is immersed in urine and taken out. moves to the test reagent layer, which further causes a color reaction in the test reagent layer, and as a result, the color density at the periphery of the test reagent layer increases.

(2) Color layer water absorption ＞ ＞ In the case of water absorption of the test reagent layer, for example, in this case, the tendency that urine moves to the color layer side increases, so -drying the test reagent layer that has been colored is significantly promoted. However, since the color changes to a different hue from that in a wet state, errors are likely to occur in comparing the two layers.

The body fluid test object of the present invention as described above takes about 20 seconds from the time the test object is immersed in the body fluid to be tested until the coloring reaction proceeds, although it differs depending on the type of test reagent.
Visual judgment is performed within 40 seconds after the color reaction is complete.

In a preferred state of the present invention, it is desirable that the water absorption properties of the test reagent layer and the color tone layer are similar; It's better not to be small.

In the present invention, when the absorbency of the test reagent layer liquid of the judgment standard color tone layer and test reagent layer is large, the test reagent layer or the test reagent layer is The liquid to be tested on the surface seeps into the inside of the layer, and even if it is small, droplets of the liquid to be tested remain on the surface of the layer for about 20 seconds after being pulled up.

In order to provide a preferable and similar absorbency of the test liquid in the test reagent layer and the color tone layer, the absorption amount (weight) that each layer can absorb the test liquid is 50 to 50% of the dry weight of each layer.
00%, more preferably 100 to 300%, and as long as it is within this range, there is no problem in testing even if the absorption amounts of both layers are different.

Such absorption is achieved by setting the weight ratio of absorbent powder to binder in each layer to 100/3 to 100/30, more preferably 10015 to 100/20, as described above.

In order to control the magnitude of absorption, wetting agents, which are components contained in the above-mentioned test reagent layer and are constituent materials of the test reagent layer other than the main components of the test reagent, and are also used as constituent materials of the color tone layer, Regarding pH buffers, binders, and fillers: ■ When containing a surfactant as a wetting agent, add the surfactant only to the test reagent layer, or adjust the surfactant content in the test reagent layer to the color tone layer. Make it more or less than the content in it.

■ Use a water-soluble powder as a pH buffer and add the pH buffer only to the test reagent layer, or
The content of H buffering agent is increased or decreased compared to the content in the tone layer.

(2) Use resins with different water absorption properties as binders, and mix resins with high water absorption into the components of the test reagent layer and mix resins with low absorption into the components of the color tone layer, or vice versa.

■ Make the amount of water-absorbing powder mixed in the test reagent layer larger or smaller than that in the color tone layer.

This can be carried out as appropriate by any method such as, or by using a combination of these methods.

As explained above, it is easier to approximate the absorbency of the test liquid by making the compositions of the color tone layer and the test reagent layer similar. However, for example, instead of creating a color tone layer for protein detection that approximates the composition of the protein test reagent layer, it is possible to create it based on the composition of another test reagent layer, such as a test reagent layer for glucose detection. It is possible if you pay attention only to However, in this case, it is necessary to confirm that the components in the test reagent layer for detecting glucose do not affect the test reagent layer for detecting protein.

Highly water-absorbing part As mentioned above, even if the test reagent layer and the judgment standard color tone layer are wetted by the test liquid at the same level, if an excessive amount of test liquid adheres, the amount of adhesion to the surfaces of both layers will be uneven. , coloration inhibition or coloration spots may occur.

In the present invention, a highly water-absorbing part is provided on the surface of the base material near the test reagent layer and the color tone layer to quickly absorb and remove excess test liquid adhering to the test reagent layer and the color tone layer. The above-mentioned problem can be solved by making it possible to adhere uniformly.

- Such a highly water-absorbing part may be provided on the base material so as to be in contact with either or both of the test reagent layer and the color tone layer, or may be provided at a certain interval, or may be provided so as to surround both. There is no particular restriction on the position and shape of the provision, and it is formed in the vicinity of the test reagent layer and the color tone layer so as to be able to absorb excess test liquid adhering to the core layer.

The highly water-absorbing portion can be preferably formed by printing as with the test reagent layer and color tone layer, which will be described later, using an ink composition containing a highly water-absorbing substance.

Such ink compositions include water-absorbing powders such as cellulose, starch, and superabsorbent gels, hydrophilic or hydrophobic resins, binders, additives such as inorganic fillers to make the film porous, and solvents. This includes: The superabsorbent gel used in the present invention is, for example, a crosslinked or graft copolymer mainly composed of polyvinyl alcohol (PVA), acrylate, acrylonitrile, starch, etc.
Commercially available super absorbent gels include Sumikagel 5P520 (PVA-acrylate block copo, reamer, commercially available from Sumitomo Chemical), which has an absorption capacity of 600 times, and Sunwet IM-1000 (commercially available from Sumitomo Chemical ■), which has a water absorption capacity of 1000 times.
Acrylic acid grafted starch (commercially available from Sanyo Chemical),
Similarly, KI gel (a reaction product of PVA and a cyclic acid anhydride) having a water absorption capacity of 1000 times can be mentioned.

The body fluid test object of the present invention can be formed into various forms such as a sheet shape, a stick shape, a roll shape, and a tape shape. Alternatively, the base material itself may be formed in a form capable of collecting the test liquid, such as a pot shape, a test tube shape, a dish shape, a tray shape, or a dropper shape. Regarding the arrangement of the color tone layer and the test reagent layer, it is particularly preferable that these layers are provided at a constant interval, for example, 0.2 to 2 mm, as shown in FIG.

In other words, even if the test reagent layer and the judgment standard color tone layer are uniformly wetted by the test liquid, if the test reagent layer and the color tone layer are provided on the base material so that they are in contact with each other, the adhering test liquid will be absorbed by both. Transition between layers changes the coloration at the boundary, making it difficult to compare the coloration of the tone layer and the reagent layer. In addition, if an excessive amount of the test liquid adheres to both layers, especially the test reagent layer, the amount of adhesion to the layer surface will be uneven, causing coloration inhibition and coloration spots. This can solve such problems.

The distance between the test reagent layer and the color tone layer for judgment criteria is not limited to the above 0.2 to 2 mm, but if the distance is narrow <0.2 mm, the test reagent layer and the color tone layer The boundary between the test reagent layer and the color tone layer cannot be clearly determined by visual inspection, and it is impossible to prevent mutual interference due to component migration between the test reagent layer and the color tone layer when the test liquid adheres to the test reagent layer and the color tone layer. On the other hand, if the gap between the test reagent layer and the color tone layer becomes wider than 2 mm, it becomes difficult to compare the coloration of the test reagent layer with the color tone layer, and the effect of providing the color tone layer near the test reagent layer decreases. do.

DESCRIPTION OF THE PREFERRED EMBODIMENTS Specific examples of the body fluid test body according to the present invention other than those shown in FIG. 1 will be described below with reference to the drawings.

FIG. 2 shows, for example, a test reagent layer 1 for detecting glucose is provided on a base material 5, and a test reagent layer 1 is provided with a slight gap 2 between the test reagent layer and the test reagent layer, and a test is performed at various concentrations from 0 to a predetermined concentration of glucose in the sample. a color tone layer 3a for judgment criteria indicated by the coloration of the reagent layer;
3b.

3C13d, 3a, 3f are provided by pasting or printing,
A body fluid test body is shown in which a highly absorbent portion 4 is provided adjacent to a test reagent layer 1. If a test is performed using such a test paper, since the gap 2 is provided between the test reagent layer 1 and the color tone layers 3a to 3f, it is possible to prevent mutual interference of each component of both layers and to prevent the boundaries between both layers. Furthermore, since the superabsorbent portion 4 absorbs the excess test liquid on the test reagent layer, when the test paper is pulled up, the test liquid flows down and stays below the reagent layer, causing the problem to occur. The color does not become non-uniform, and the concentration of the substance to be tested in the liquid to be tested can be determined accurately. Further, as shown in FIG. 4, a test reagent layer 1 and a color tone layer 3 for judgment criteria are provided on the base material 1 so as to surround the test reagent layer 1 with a gap 2 therebetween. As shown in FIG. 4, highly absorbent parts 4 are provided at intervals around the color tone layer 3. In this embodiment, if the color tone of the color tone layer 3 is set to indicate that the concentration of the substance to be tested in the liquid to be tested is at the upper limit of the normal range, the body fluid test sample can be immersed in the body. It is easy to determine whether the concentration of the test substance in the test material is within the normal range, and by providing a highly water-absorbing area around the test reagent layer and color tone layer, excess water deposited on the substrate can be easily determined. It is possible to prevent the test liquid from flowing down, the test liquid is evenly attached, and accurate determination is possible. In FIG. 3, the test reagent layer 1 and the color tone layer 3 are provided with a gap 2 in the same manner as in FIG. 1, except that the highly water-absorbing part 4 in FIG. If a material with good drainage is used as the material, such a structure can be adopted.

Furthermore, as shown in FIG. 5 and FIG.
g, 3h, or 31.3J, the test reagent layer and the color tone layer are provided with a gap 2, and the test reagent layer 1 and the color tone layer 3g.
, 3h, or 3i.

The super absorbent portion 4as4b or 4 may be provided adjacent to or surrounding 3j, and the same effect as described above can be obtained.

FIGS. 5 and 6 are for determining whether the concentration of the substance indicated by the broken line in the test liquid is within an appropriate range, and are effective for determining, for example, blood sugar level. That is, on one side of the base material 5, with the test reagent layer 1 in between, there is a tone layer 3g or 31 having a tone that shows a density that is the lower limit of the appropriate range, and a tone layer 3h that has a tone that shows a density that is the upper limit of the appropriate range. By providing a color tone layer for determination criteria consisting of 3J or 3J, it is possible to accurately determine whether the blood sugar level is within an appropriate range.

FIG. 7 shows that two test reagent layers 1a and 1b capable of testing two mutually different test items are provided on a base material 5, and a color tone layer 3 is provided on the base material 5, respectively.
a and 3b with a gap 2 in between, and super absorbent parts 4b are provided between each test reagent layer, and super absorbent parts 4a and 4C are provided at the beginning and end of the row of test reagent layers. It has been established.

FIG. 8 similarly shows three test reagent layers 1a and lb.

lc, color tone layer 3as3bs3c, super absorbent parts 4a, 4b
. It also includes aspects outside the above-mentioned sides. for example,
Although not shown, a body fluid test object in which the highly absorbent portion 4 or the gap 2 is not provided in the cases shown in FIGS. 1 to 6 is also within the scope of the present invention.

Furthermore, in the body fluid test body of the present invention, two or more test reagent layers comprising a plurality of types of test items and a plurality of judgment reference color tone layers corresponding to these test reagent layers are provided in one body fluid test body. It may be. The combination of inspection items in such cases is not particularly limited, but
As a preferable specific example, for example, in the case of two items,
Examples include combinations of glucose and protein, and urobilinogen and protein. In the case of three items, for example, there is a combination of glucose, protein, and pH.

Examples of the present invention will be described below, but the present invention is not limited to the description of these Examples.

Example A-1 The specimen shown in FIG. 2 (without the highly absorbent portion) was manufactured according to the method described below.

(Manufacture of test reagent layer) A test reagent solution having the following composition was prepared, filter paper (manufactured by Toyo Seishi Co., Ltd., Nα51) was impregnated with the test reagent solution, and dried at 50° C. for 2 hours to produce a test reagent layer.

Glucose test reagent solution Glucose oxidase (manufactured by Toyobo; Grade II)
0.61 Kabebe peroxidase (manufactured by Toyobo, Gra, de II [)
0.15 parts by weight o-) Lysine dihydrochloride 0.5 parts by weight Citric acid/sodium citrate buffer (pH 5,5) 80 parts by weight Aqueous gelatin solution (5%) 50 parts by weight Distilled water
20 parts by weight ethyl alcohol
30 parts by weight (manufacture of color tone layer) 5 On+ of normal urine and β-D-glucose in normal urine
g/dlS100mg/dl, 250+ng/di.

Using the test liquids dissolved to a concentration of 500 mg/dL and 2000 mg/dL, respectively,
Immediately after the test reagent layers obtained as described above were immersed in the liquid to be tested, they were taken out and allowed to stand for 1 minute, and the color development of each test reagent layer was observed.

A filter paper (manufactured by Toyosei Paper Co., Ltd., N[LSI) was impregnated with the following composition in which an oil-soluble dye was dissolved/dispersed and dried at 50° C. for 2 hours to produce a tone layer. The type and amount of disperse dye used in the production of each color tone layer is the color tone obtained when the color tone layer obtained by impregnating a filter paper with the following composition and disperse dye is taken out immediately after being immersed in the test liquid and left to stand for 1 minute. was set to match the coloration of the test reagent layer.

Glucose color composition for one layer Sorbitan monolaurate (manufactured by Kao Soap, Span 20) 14.4 parts by weight Citric acid 2.8 parts by weight Sodium citrate 11.0 parts by weight Polyvinylpyrrolidone (manufactured by BASF; Koliton 90) 12 .6 Electrostrictive part Polyvinyl butyral (Made by Block Chemical Co., Ltd., S-LEC BX-1) 2.25 parts by weight Cellulose fine powder (Made by Seikasei Co., Ltd., Avicel TG-7) 171 parts by weight n-amyl alcohol 171 parts by weight Butyl cellosolve acetate 50 tliflil oil-soluble Dye Black dye: Nippon Kayaku, Kayaset Black
151H trace blue dye: Nippon Kayaku, Kayaset Blue 8
14 Trace red dye Nippon Kayaku, Kayaset Red 80
2) Trace amount (manufacturing of test object) 5.
Test reagent layer 1 cut into a rectangle of mm x 30 mm was pasted, and the β-D-glucose concentration in the sample prepared as described above was 5'Qmg/dl, 10
0mg/old, 250mg/dl, 500mg/dl,
3a, 3b, 3c, 3e, 3 in which the color tone layer 3 indicating that it is 2000 mg/old is cut into a rectangle with one side of 5 mm
A body fluid test body shown in FIG. 2 was manufactured by pasting the marks f on each sample.

β-D-glucose 50mg/normal urine and normal urine
dL 100mg/old, 250mg/di, 500m
g/Old, 2000mg/Old and 2000mg/Old were used as test liquids, and the obtained test specimens were immersed in each test liquid, immediately taken out, left to stand for 1 minute, and observed for color development. did. 3a, 3b showing the color of the test reagent layer l and the concentration of the test liquid in the color tone layer 3 for each test liquid;
The color tone matched perfectly with any one of 3c, 3e, and 3r.

Comparative example A-1 (Manufacture of test reagent layer) It was manufactured in the same manner as in Example A-1.

(Manufacture of color tone layer) Using the test liquid prepared in the same manner as in Example Δ-1, the test reagent layer was immersed in the test liquid, immediately taken out and left to stand for 1 minute, and the color of each test reagent layer was determined. observed.

For the color tone layer, screen process ink (manufactured by Teikoku Ink, VG) was screen printed on a white polystyrene sheet with a thickness of 300 μm, which is the base material 5, so that the - side was 5 mm. Toned layers 3a to 3r were produced to match the coloration of the layers.

(Manufacture of test object) The test reagent layer 1 was cut into 5 mm x 3 Q mm, and the color tone 38 to 3 f was obtained by the above screen printing.
The specimen shown in FIG. 2 was manufactured by attaching the specimen in close proximity to the specimen.

Using test liquids containing β-D-glucose prepared in the same manner as in Example A-1, the obtained test strips were immersed in each test liquid, immediately taken out and left to stand for 1 minute,
Color development was observed. The test reagent layer absorbs the test liquid uniformly, whereas the test liquid is attached to the color tone layer in droplets, so for each test liquid, the coloring of the test reagent layer and the corresponding
The color tone did not match the color tone of the color tone layer indicating the concentration of the test liquid.

Example A-2 (Manufacture of test reagent layer) A test reagent composition having the following composition was finely divided into 11 parts using a homomixer.
After that, by screen printing, 5 m
Test reagent layer 1 is printed to form a square of m x 30 mm.
And so. The screen printing plate used had 80 meshes, and the total thickness of the resist and screen gauze was 130 μm.

Glucose oxidase (manufactured by Toyobo, Grade ll)
3.6 parts by weight peroxidase (manufactured by Toyobo, Grade III) 2
．． 4 parts by weight Guaac butter 4.8 parts by weight Sorbitan monolaurate (Nispan 20 manufactured by Kao Soap) 7.2 parts by weight L-
Ascorbyl stearate o, 24ft16B Citric acid 2.8 parts by weight Sodium citrate 11.0 parts by weight Polyvinylpyrrolidone (manufactured by BASF; Koliton 90) 12.6 parts by weight Polyvinyl butyral (manufactured by Building Block Chemical; S-LEC BX-1) 2.25 Heavy strain part cellulose fine powder (manufactured by Fukkasei Co., Ltd., Avicel TG-D>171 parts by weight n-amyl alcohol 171 heavy part butyl cellosolve acetate 67 1 part obtained test specimen was heated at 60°C 4
After drying for 0 minutes, a specimen was obtained.

(Production of color tone layer and production of test specimen) 50 mg/d of β-D-glucose in normal urine and normal urine
lS100mg/di, 250mg/di.

The test reagent layer was dissolved to a concentration of 500, 2,000 mg/dL, and 2,000 mg/dL. Immediately after immersing the test reagent layer in the test solution, it was taken out and allowed to stand for 1 minute. The color development of each test reagent layer was observed.

Next, the type and amount of disperse dye are set so that the color tone when the obtained color tone layer is immersed in the test liquid and immediately taken out and left to stand for 1 minute matches the coloration of each test reagent layer. A tone layer was obtained.

That is, after dissolving/dispersing the finely dispersed dye with a homomixer, the β-D-glucose concentration in the sample was 50 mg/old, 100 mg/di, 25 Qmg/dl, and 500 mg.
/di, and the color tone layer 2 indicating that it is 2000 mg/dl are squares 3as 3b, 3c, 3d, each side of which is 5 mm.
3e, 3f on the white polystyrene sheet of the base material 5 in proximity to the test reagent layer 1, and drying the obtained print at 60 ° C. for 40 minutes,
The specimen shown in FIG. 2 was manufactured. The screen plate used had 80 meshes, and the total thickness of the resist and screen gauze was 130 μm.

The composition for the tone layer is the same as in Example A-1.

β-D-glucose 50mg/normal urine and normal urine
di, 100mg/di, 250mg/63500m
g/di and 2000 mg/old was used as the liquid to be tested, and the resulting test specimen was taken out immediately after immersion, left to stand for 1 minute, and color development was observed. 3as 3b, 3C% 3d Indicates the color of the test reagent layer 1 and the concentration of the test liquid in the color tone layer 3 for each test liquid.
%3es3f completely matched any of the tone layers.

Comparative example A-2 (Manufacture of test reagent layer) It was manufactured in the same manner as in Example A-2.

(Production of color tone layer and production of test object) Using the test liquid prepared in the same manner as in Example A-2, the test reagent layer obtained in the same manner as in Example A-2 as described above was subjected to test. Immediately take it out after immersing it in the liquid and leave it for 1 minute.
The color development of each test reagent layer was observed.

Close to the test reagent layer, a screen process ink (manufactured by Teikoku Ink; VG) was applied to the base material 5, a white polystyrene sheet with a thickness of 300 μm, so as to form a square with 5 openings on each side.
The test reagent layers 3a to 3f were screen-printed to match the coloration of each of the test reagent layers, thereby producing the test body shown in FIG. 2 (but without the superabsorbent portion).

Using test solutions containing β-D-glucose prepared in the same manner as in Example A-2, the obtained test strips were immersed in each test solution, immediately taken out, left to stand for 1 minute, and then tested. I observed the color. While the test reagent layer absorbs the test liquid uniformly, the test liquid adheres to the color tone layer in droplets. The color tone of the color tone layer indicating the liquid concentration did not match.

Example A-3 (Manufacture of test reagent layer) Testing was carried out in the same manner as in Example A-2, except that the test reagent layer was printed on a 300μ thick white polystyrene sheet as the base material 5 so as to form a 5 mm x 5 mm square. A reagent layer was produced.

(Production of color tone layer and production of test object) Test reagent layer obtained as described above using normal urine with β-D-glucose dissolved at a concentration of 50 mg/dl as the test liquid. Immediately after being immersed in the test liquid, it was taken out and allowed to stand for 1 minute, and the color development of the test reagent layer was observed.

One side is 1 with a square notch of 5 mm on each side in the center.
The test body shown in FIG. 1 was manufactured by manufacturing the tone layer 3 in the same manner as in Example A-2, except that it was printed in a square shape of 5+ nm (excluding the highly water-absorbing parts 4a and 4b). ). The type and amount of the disperse dye were set so that the color tone when the resulting color tone layer was immersed in the test liquid and immediately taken out and left to stand for 1 minute matched the coloration of the test reagent layer.

β-D-glucose in normal urine 50mg/di, 100
A solution dissolved to a concentration of H/dl was used as the liquid to be tested, and the resulting test paper was immersed in each liquid to be tested, then immediately taken out and allowed to stand for 1 minute to observe color development. . The β-D-glucose concentration of the test liquid is 50 mg/d.
In the case of 1, the coloration of the test reagent layer and the color tone of the tone layer completely matched. When the test liquid was normal urine or when the β-D-glucose concentration of the test liquid was 100 mg/d1, the color of the test reagent layer and the color tone of the color tone layer could be clearly distinguished.

Comparative Example Δ-3 (Manufacture of color tone layer) Using a test liquid prepared in the same manner as in Example A-3, the test reagent layer described below was immersed in the test liquid (a), then immediately taken out and left to stand for 1 minute. The color development of the test reagent layer was then observed.

A white polystyrene sheet with a thickness of 300μ has a negative side of 15
Screen process ink (
A color tone layer having a color tone matching the coloration of the test reagent layer was manufactured by screen printing a sample (manufactured by Teikoku Ink, VG).

(Manufacture of test reagent layer and manufacture of test object) Test reagent layer 1 was manufactured in the same manner as in Example A-3 except for printing in a square shape of 5 mm x 5 mm on top of color tone layer 2. A test specimen shown in (However, one without a highly water-absorbent portion) was manufactured.

Using a test liquid containing β-D-glucose 50+++g/dl prepared in the same manner as in Example A-3, the obtained test strip was immersed in the test liquid, immediately taken out and left to stand for 1 minute, Color development was observed. When the β-D-glucose concentration of the test liquid is 50 +++ g/dl, the test reagent layer absorbs the test liquid uniformly, but the test liquid adheres to the color tone layer in droplets. The coloration of the test reagent layer and the color tone of the tone layer did not match.

(Manufacture of test reagent layer) After finely dispersing the test reagent composition with the following composition using a homomixer, the base material was coated using a screen printing method as shown in FIG. Thickness 3 which is 5
5mm x 15m on 00μ white polystyrene sheet
The test reagent layer 1 was printed to form a rectangle of m. The thickness of the screen-lean plate used was 80 mm, and the total thickness of the resist and screen gauze was 190 μm.

Composition for protein test reagent layer Tetrabromophenol blue 0.40 parts by weight Citric acid 25.7 parts Liumium citrate 11.0 parts Sorbitan monolaurate (Kao Soap Co., Ltd., Span 20) 4.0 parts by weight Part carboxymethylcellulose sodium salt (manufactured by Whatman;
CM-32) 50.0 parts by weight carboxymethyl cellulose calcium salt (manufactured by Daicel Chemical) 10
．． 0 electrostrictive parts methyl vinyl ether/maleic anhydride copolymer (G, A, F, manufactured by GANTREZ AN-169) amyl alcohol esterified product 4.97 parts by weight Cellulose fine powder (manufactured by Fukaisei; Avicel TG-D ) 108 parts by weight n-amyl alcohol 28.1 parts by weight Butyl cellosolve 107.7 parts by weight Butyl cellosolve acetate
) 50.2 parts by weight The obtained printed matter was dried at 60° C. for 30 minutes to obtain test reagent layer 1.

(Production of color tone layer and production of test specimen) Bovine serum albumin dissolved in normal urine to a concentration of 15 mg/old was used as the test liquid, and the test reagent layer obtained as described above was coated. Immediately after being immersed in the test solution, it was taken out and allowed to stand for 1 minute, and the color development of the test reagent layer was observed.

After dissolving/dispersing the disperse dye in the following color tone layer composition finely dispersed with a homomixer, a 5 mm x 15 mm area is placed in the center.
5mm x 15mm square 3 with a square notch
1.3j in the vicinity of the test reagent layer 1 provided on the base material 5 as described above, and by drying the obtained printed matter at 60° C. for 30 minutes, as shown in FIG. The specimen shown in Figure 1 was manufactured. The screen version used was 8
The total thickness of the 0 mesh, resist and screen gauze was 190μ. The type and amount of the disperse dye were set so that the color tone when the resulting color tone layer was immersed in the test liquid and immediately taken out and left to stand for 1 minute matched the coloration of the test reagent layer.

Composition for protein color tone layer Sorbicum monolaurate (manufactured by Kao Soap, Span 20) 4.0 parts by weight Carboxymethyl cellulose sodium salt (manufactured by Whatman; C
M-32) 50.0 weight 1 part carboxymethyl cellulose calcium salt (manufactured by Daicel Chemical) 1.0
．． 0 parts by weight Amyl alcohol ester of methyl vinyl ether/maleic anhydride copolymer (G, A, F, manufactured by GANTREZ AN-16'9) 4.97 parts by weight Cellulose fine powder (manufactured by Fukaisei; Avicel TG- D) 40 parts n-amyl alcohol 28.1 parts by weight Butyl cellosolve 28 parts by weight Butyl cellosolve acetate 38 parts by weight Fat-soluble dye: Kayaset Yellow
937 Trace Blue Dye Nippon Kayaku: Kayaset Blue
814 Trace amount of normal urine and 15 mg of bovine serum albumin in normal urine
/dl and 3Qmg/di dissolved to a concentration of 3Qmg/di was used as the test liquid, and the obtained test strip was immersed. Immediately after a, the sample was taken out and allowed to stand for 1 minute, and the color development was observed.

When the bovine serum albumin concentration of the test liquid is 15 mg/dl, the coloration of test reagent layer 1 and color 1 [3i.

The color tone matched perfectly with 3J. If the test fluid is normal urine or the bovine serum albumin concentration of the test fluid is 30mg/
In the old case, the color development of test reagent layer 1 and the color tone layer of 31.3
It could be clearly distinguished from the tone layer of j.

It was manufactured in the same manner as in Example A-4.

(Manufacture of color tone layer and manufacturing of test object) Using the test liquid prepared in the same manner as in Example A-4, the obtained test reagent layer was immersed in the test liquid, then immediately taken out and left to stand for 1 minute. The color development of the test reagent layer was then observed.

Close to the test reagent layer 1 printed on a 300 μ thick white Bo-Restyrene sheet as the base material 5 to form a 5 mm x 5 mm rectangle, a 5 mm x l 5 square was placed in the center.
Add screen process ink (
Color tone layer 3+s3t screen-printed with Teikoku Ink (VC) and having a color tone that matches the coloration of the test reagent layer 1.
] By manufacturing the specimen shown in Fig. 6 (however,
(without a super absorbent part) was manufactured.

Using a test liquid prepared in the same manner as in Example A-4, the resulting test paper was taken out immediately after immersion, left to stand for 1 minute, and color development was observed. When the bovine serum albumin concentration of the test liquid is 15 mg/old, the test reagent layer 1 absorbs the test liquid uniformly, whereas the test liquid adheres in droplets to the color tone layers 3i and 3j. Therefore, the coloration of the test reagent layer 1 and the color tone of the color tone layer 31.3j did not match.

Example A-5 (Manufacture of test reagent layer) After dissolving and dispersing the following reagent composition in a homomixer except for 0.098 parts by weight of sodium hydroxide and 2 parts by weight of water, 0.0. A test reagent composition was prepared by adding a solution of 098 parts by weight in 2 parts by weight of water and thoroughly dissolving and dispersing the mixture using a homomixer.

pH test reagent layer composition Sodium hydroxide 01088 Shigesatobe water
2 parts by weight methyl red
0.070 parts by weight Bromthymol blue
1.0 parts by weight Dodenrutrimethylammonium chloride 1.0 parts by weight Polyvinylpyrrolidone (manufactured by BASF, Koliton 90) 8.3 parts by weight Polyvinyl butyral (manufactured by Block Chemical; S-LEC BX-1) 4.1 mm parts Cellulose fine powder (fatty (manufactured by Kasei; Avicel TG-D) 174 parts by weight Butylceronlube 226 parts by weight Butyl cellosolve acetate 22 parts by weight The obtained test reagent composition was printed on a white polystyrene sheet with a thickness of 300μ, which is the base material 5 shown in FIG. 2, by screen printing. 5mm x 2 on the sheet
It was printed in a 5 mm square. The screen plate used had 80 meshes, and the total thickness of the resist and screen gauze was 190 μm. The resulting printed matter was heated to 60°C.
The test reagent layer 1 was obtained by drying for 30 minutes.

Production of color tone layer and production of test specimen Adjust the pH of normal urine using hydrochloric acid or sodium hydroxide.
The liquids adjusted to pH 5, 6, 7, 8, and 9 were used as test liquids, and the test reagent layer was taken out immediately after immersion, left to stand for 1 minute, and color development was observed.

After dissolving/dispersing the disperse dye in the following color tone composition finely dispersed with a homomixer, the pH of the test liquid is 5.6.7.
．． 8.9, one side forming the tone layer 2 is 5
By screen printing near the test reagent layer 1 so as to form rectangles 3as3b, 3c, 3d, 3e, and 3f of mm, and drying the obtained printed matter at 60°C for 30 minutes, the test body shown in FIG. 2 ( However, a sample without the super absorbent portion 4 was manufactured. The screen plate used had 80 meshes, and the total thickness of the resist and screen gauze was 190 μm. The type and amount of the disperse dye were set so that the color tone obtained when the obtained color tone layer was immersed in the test liquid and immediately taken out and left to stand for 1 minute matched the color development described above.

pH tone layer composition Polyvinylpyrrolidone (manufactured by BASF, Koliton 90) 8.3 parts by weight Polyvinyl butyral (manufactured by 82 Mizu Kagaku; S-LEC BX-1) 4.1 parts by weight, fine cellulose powder (manufactured by Brittle Synthesis; Avicel TG- D) 174 parts butyl cellosolve 226 parts by weight butyl cellosolve acetate 22 parts by weight Oil-soluble dye Yellow dye Nippon Kayaku Kayaset Yellow
937 trace red dye: Kayaset Red 802 manufactured by Nippon Kayaku Co., Ltd.
Trace blue dye Nippon Kayaku Kayaset Blue 81
4 Trace amount of black dye: Kayaset Black 15 manufactured by Nippon Kayaku Co., Ltd.
1) 1 Slightly Precious However, red dye and yellow dye were used on the acidic side, and yellow dye, blue dye, and black dye were used on the alkaline side.

Adjust the pH of normal urine using hydrochloric acid or sodium hydroxide.
The liquids adjusted to pH 5, 6, 7, 8, and 9 were used as test liquids, and the resulting test paper 4 was taken out immediately after immersion, left to stand for 1 minute, and color development was observed. 3 a - 3 b - 3 c 13 Indicates the color of the test reagent layer 1 and the pH of the test liquid in the color tone layer 3 for each test liquid.
d It completely matched the tone layer of either s3e or 3f.

Comparative example A-5 (Test reagent layer production) It was manufactured in the same manner as in Example A-5. .

(Production of color tone layer and production of test object) Using the test liquid prepared in the same manner as in Example A-5, the obtained test reagent layer was immediately taken out after immersion, left to stand for 1 minute, and observed for color development. did.

A screen process ink (manufactured by Teikoku Ink; manufactured by Teikoku Ink;
The test body shown in FIG. 2 was manufactured by screen printing VC) and manufacturing color tone layers 3a to 3f having a color tone matching that of each test reagent layer. Example A-5
Using test liquids prepared in the same manner as above, the obtained test strips were immersed in each test liquid and immediately taken out.
The mixture was allowed to stand for a minute and the color development was observed. The test reagent layer absorbs the test liquid uniformly, whereas the test liquid is attached to the color tone layer in droplets, so the color tone of each test liquid and the color tone that indicates the pH of the test liquid are different. The color tone of the layer did not match.

Example B-1 Using the following composition for forming a test reagent layer and composition for forming a tone layer, a body fluid test body (highly absorbent portion 4as4b) as shown in FIG. (excluding).

Composition for forming a test reagent layer for detecting occult blood Cumene hydroperoxide 3.6 parts by weight 6-medoxyquinolin 1.0 parts by weight (in the capsule) Gum arabic 9.4 parts by weight, 3.3 parts by weight
, 5.5'-tetramethylbenzidine 1.5 parts by weight citric acid
0.56 parts by weight sodium citrate
5.2 parts by weight Triethanolamine lauric acid 1.62 parts by weight Polyethylene glycol 2.52 parts by weight Polyvinyl butyral (manufactured by Block Chemical; S-LEC BX-1) 3.6 parts by weight Cellulose fine powder (manufactured by Fukaisei; Avicel TO- D) 22.4 parts by weight n-amyl alcohol 39.7 parts by weight Butyl cellosolve acetate 13.0 parts by weight Composition for forming a tone layer Gum Arabic 9.4 parts by weight Citric acid
0.56 parts by weight sodium citrate
2.2 parts by weight polyethylene glycol 2.
52 parts by weight Polyvinyl butyral (manufactured by Block Chemical; S-LEC BX-1) 3.6 parts by weight Cellulose fine powder, (manufactured by Fukaisei; Avicel TG-D> 22.4 parts by weight n-amyl alcohol 39.7 parts by weight butyl cellosolve acetate) 13.0 parts by weight Oil-soluble dye Yellow dye: ayaset Yellow from Nippon Kayaku Co., Ltd.
937 trace blue dye Nippon Kayaku Kayaset Blue 81
4 Small amount Example B-2 After preparing a composition for detecting urobilinogen and a composition for a color tone layer having the following compositions by finely dispersing them with a high-speed stirrer, they were printed on a white polystyrene sheet with a thickness of 300 μm with a side of 5 mm by screen printing method. squares were printed and dried at a temperature of 40° C. for 30 minutes after printing. The number of lines of the plate used for printing was 80 meshes, and the total thickness of the resist and screen gauze was 180 μm.

Composition for detecting urobilinogen.

p-diethylaminobenzaldehyde 2.45 parts by weight Sulfosalicyl 125 parts by weight Sodium laurate 2.40 parts by weight Sorbitan monourarate (HLB 8.6) 1.3 parts by weight Caffeine 16 parts by weight Methyl vinyl ether/maleic anhydride copolymer (Aluminum alcohol 1-phester of Gantrets AN-169, manufactured by GAF)
75 parts by weight ethylene glycol monomethyl ether 121 parts by weight ethylene glycol monomethyl ether acetate
125 parts by weight Sodium carboxymethyl cellulose 31 parts by weight Microcrystalline cellulose (Fukasei: Avicel TG-D)
156 parts by weight Composition for forming a tone layer Sulfosalicylic acid 125 parts by weight Caffeine 16 parts by weight Sorbitan monouralate 1.3 parts by weight 11 m Methyl vinyl ether/
Aluminum alcohol ester of maleic anhydride copolymer (manufactured by GΔF, GANTREZ AN-169) 11 parts by weight Methyl cellosolve 121 parts by weight Methyl cellosolve acetate 125 parts by weight Methyl cellulose sodium 31 parts by weight Cellulose fine powder (fat) Made by Kasei; Avicel TG-7)
156 parts by weight amyl alcohol
64 parts by weight Oil-soluble dye Yellow dye: Kayaset Yellow manufactured by Nippon Kayaku Co., Ltd.
937 trace blue dye: Kayaset Red 802 manufactured by Nippon Kayaku Co., Ltd.
Trace black dye: Kayaset BIack15 manufactured by Nippon Kayaku Co., Ltd.
1H Micro I Test liquid: ■Normal urine■IEU/di urobilinogen-containing urine■5EU/di
Prepare three types of urine containing urobilinogen (in each case, EU means Ehrlich unit), immerse the test specimen obtained above in the liquid to be tested from ■ to ■, and take it out immediately after immersion. Observe the color development after leaving it for 60 seconds.
The following results were obtained.

Using Example C- as a test reagent layer composition and a tone layer forming composition as described in Example A-2 and Example A-4,
In the same manner as in Example A-2, a test specimen shown in FIG. 7 was prepared on a white polystyrene sheet with a width of 3 mm, a length of 90 mm, and a thickness of 300 μm (excluding the highly water-absorbent portion), Example C-2 Test reagent The test body shown in FIG. 7 was prepared using the layer composition and tone layer forming composition described in Example A-2 and Example B-2, and in the same manner as in Example C-1. .

Example C-3 Further, the test reagent layer composition and color tone layer forming composition used in Example A-5 were used, and the test body shown in FIG. 8 was created in the same manner as in Example C-1. .

EXAMPLES Body fluid test specimens having the super absorbent portion 4 which was omitted in Examples A-1 to A-5, B-1 and B-2, and C-1 to C-3 were manufactured. An example of the method for manufacturing the highly absorbent portion 4 in this case is as follows.

Production of super absorbent parts After finely dispersing the following super absorbent composition using a homomixer, super absorbent parts 4a and 4b were screen printed at predetermined positions. The screen plate used had a mesh size of 150, and the total thickness of the resist and screen gauze was 88 μm.

Super absorbent composition Super absorbent resin (manufactured by Sumitomo Chemical; Sumikagel SP: 520
) 150 parts by weight adhesive (manufactured by Teikoku Ink; Sericol 13-002 medium)
280 parts by weight Solvent (manufactured by Teikoku Ink; Sericol 13-002 solvent) 70 parts by weight The obtained printed matter was dried at 60°C for 1 hour to obtain a highly water-absorbent part.

In the case where a highly water-absorbing part was provided, when the test object was immersed in the test liquid and pulled up, the test liquid that adhered to the base material and flowed down was absorbed by the highly water-absorbent part. In the case of the shape shown in FIG. 1, the highly water-absorbing portion was in contact with the reagent layer, so the test liquid was slightly lacking in the portion of the reagent layer on the side of the highly water-absorbing portion. In addition, in the case of the shape shown in FIG. 6, there was a slight lack of the test liquid at the upper and lower ends of the reagent layer, and at the edge portions in contact with the highly water-absorbing parts of the left and right color tone layers.

Effects of the Invention The body fluid test body of the present invention approximates the surface state, surface tension, and physical shape of the test reagent layer and the judgment reference color tone layer, so that the surface of each layer is uniformly wetted by the test liquid.
Since the color hue can be compared between wet colors, the content of the target substance in the test reagent layer in the liquid to be tested can be determined very precisely.

In addition, the body fluid test body according to the present invention allows anyone to easily and quickly determine whether the concentration of the test substance in the test liquid is within a normal range by simply immersing it in the test reagent layer liquid, for example. Based on the judgment, it can be determined whether detailed examination at a hospital or laboratory is necessary, making it extremely useful for the detection and treatment of diseases.

Therefore, the body fluid test body according to the present invention can accurately and quickly detect test target components such as glucose, protein, pH 1 occult blood, and urobilinogen in body fluids, and is therefore a body fluid test body used in hospitals and testing institutions. It can be widely used as

[Brief explanation of the drawing]

1 to 8 are plan views of body fluid test objects according to embodiments of the present invention, respectively. ■・・・・・・Test reagent layer 2・・・・・・Gap 3−・・・・・・Color layer 4・・・・・・Highly absorbent part 5・・・−−− ---Base material cylinder 12 t320 Fig. 3 34 Fig. 050 16 Fig. 5n l
Figure 37 f380 40 41) 4C4d Procedural amendment Written by Kunio Ogawa, Commissioner of the Patent Office, December 8, 1988 1. Indication of case: Patent Application No. 295761 of 1988 2. Title of invention: Body fluid test device 3. Relationship with the case of the person making the amendment Patent Applicant's address Buttock 纺'IIj SM Taiwan trade flute 1 resistant tablet 1 name on the back (289) Shoki Kinuki Uma company representative 1r Gosou 4, agent 〒 162 Address: 1-1 Ichigaya Kagacho-chome, Shinjuku-ku, Tokyo Spontaneous (1) The scope of the claims is amended as shown in the attached sheet. (2) [Water-absorbing powder] in the 5th line from the bottom of No. 29 of the specification is corrected to "-sujikari! Natsume woodworking." (3) Insert "benzene" between "dodecyl" and "sulfonic acid" on line 30, true 9 of the specification. Claims (1) A color tone layer is formed on the l& material and (a) serves as a judgment standard for containing a test reagent whose color tone changes depending on the content of the substance to be tested in the test liquid. The test reagent layer and the color tone layer both have the property of absorbing the liquid to be tested, and the coloring hue of the test reagent layer and the hue of the color tone layer are different from each other in wet color. A body fluid test body further comprising: enabling highly accurate body fluid tests by making comparisons possible. (2) The body fluid test body according to claim 1, wherein the ability of the test reagent layer to absorb the test liquid and the ability of the criterion color tone layer to absorb the test liquid are almost similar. (3) The absorption amount of the test reagent layer and color tone layer that can absorb the test liquid is 50 to 50 of the weight of each layer (when dry).
The body fluid test specimen according to claim 1, which has a concentration of 0%. (4) The body fluid test specimen according to claim 3, which has an absorption amount of 100 to 300%. (5) The body fluid test body according to claim 1, wherein the criteria color tone layer consists essentially of components other than the main test reagent components contained in the test reagent layer and a colorant. (6) The body fluid test object according to claim 5, wherein the components other than the main components for test reagents essentially consist of a binder and a water-absorbing powder. (7) The weight ratio of water-absorbing powder/binder is 100/3 to 1
The body fluid test specimen according to claim 6, which is 00/30. (8) The weight ratio of water-absorbing powder/binder is 10015-1
The body fluid test specimen according to claim 7, which is 00/20. (9) The body fluid test object according to claim 6, wherein the binder comprises a hydrophilic resin, a natural polymer, or a mixture thereof. 0■ The water-absorbing powder is an inorganic powder, a cellulose powder,
The body fluid test object according to claim 6, which is selected from ion exchange resin powder or a mixture thereof. 00 The body fluid test body according to claim 6, further comprising a wetting agent. 02) The body fluid test object according to claim 1, further comprising a highly absorbent portion. The test reagent layer contains (a) an ink composition for glucose detection, (b) an ink composition for protein detection, and (c) P
The body fluid test object according to claim 1, which contains at least one ink composition for H measurement. The body fluid test body according to claim 1, wherein the test reagent layer contains a composition for detecting blood sugar. 0 The body fluid test body according to claim 1, wherein the test reagent layer contains a composition for detecting urobilinogen. The body fluid test body according to claim 1, wherein the θe test reagent layer and the color tone layer are formed with a slight gap therebetween. G force The gap between the test reagent layer and the color tone layer is 0°2~2
The body fluid test object according to claim 16, which is mm. θ skewer The ability of the color tone layer to absorb the test liquid is slightly smaller than the ability of the test reagent layer to absorb the test liquid.
A body fluid test specimen according to claim 1.

Claims (18)

[Claims] (1) On the base material, (a) a test reagent layer containing a test reagent whose color tone changes depending on the content of the test target substance in the test liquid; and (b) a test reagent layer colored with a dye etc. A body fluid test body comprising a color tone layer for determining the color hue of the reagent layer, the test reagent layer and the color tone layer both having the property of absorbing the test liquid, A body fluid test body, characterized in that a highly accurate body fluid test is made possible by making it possible to compare the coloring hue of the test reagent layer and the hue of the tone layer in wet colors. (2) The body fluid test body according to claim 1, wherein the ability of the test reagent layer to absorb the test liquid and the ability of the criterion color tone layer to absorb the test liquid are almost similar. (3) The amount of absorption of the test liquid in the test reagent layer and color tone layer is 50 to 500% of the weight (dry) of each layer.
The body fluid test specimen according to claim 1. (4) The body fluid test specimen according to claim 3, which has an absorption amount of 100 to 300%. (5) The body fluid test body according to claim 1, wherein the criteria color tone layer consists essentially of components other than the main test reagent components contained in the test reagent layer and a colorant. (6) The body fluid test object according to claim 5, wherein the components other than the main components for test reagents essentially consist of a binder and a water-absorbing powder. (7) The weight ratio of water-absorbing powder/binder is 100/3 to 1
The body fluid test specimen according to claim 6, which is 00/30. (8) The weight ratio of water-absorbing powder/binder is 100/5 to 1
The body fluid test specimen according to claim 7, which is 00/20. (9) The body fluid test object according to claim 6, wherein the binder comprises a hydrophilic resin, a natural polymer, or a mixture thereof. (10) The body fluid test object according to claim 6, wherein the water-absorbing powder is selected from an inorganic powder, a cellulose powder, an ion exchange resin powder, or a mixture thereof. (11) The body fluid test body according to claim 6, further comprising a wetting agent. (12) The body fluid test object according to claim 1, further comprising a highly absorbent portion. (13) The test reagent layer includes (a) an ink composition for detecting glucose, (b) an ink composition for detecting protein, and (c)
containing at least one ink composition for pH measurement;
A body fluid test specimen according to claim 1. (14) The body fluid test body according to claim 1, wherein the test reagent layer contains a composition for detecting urobilinogen. (15) The body fluid test body according to claim 1, wherein the test reagent layer contains a composition for detecting urobilinogen. (16) The body fluid test body according to claim 1, wherein the test reagent layer and the color tone layer are formed with a slight gap therebetween. (17) The gap between the test reagent layer and the color tone layer is 0.2~
The body fluid test object according to claim 16, which has a diameter of 2 mm. (18) The body fluid test body according to claim 1, wherein the ability of the color tone layer to absorb the test liquid is slightly smaller than the ability of the test reagent layer to absorb the test liquid.