JPS63221244A - Test paper for inspection - Google Patents

Abstract

PURPOSE:To permit exact and easy decision of the concn. in liquid to be inspected by providing a spacing between a reagent layer for inspection and color tone layers and providing a highly water absorptive part adjacently to the reagent layer for inspection. CONSTITUTION:The reagent layer 1 for inspection is provided on a base material 5 and the color tone layers 2a-2f for criteria are provided apart at the slight spacing 3 from the reagent layer 1. The highly water absorptive layer 4 is provided adjacently to the reagent layer 1. The mutual interferences of the reagent 1 and the color tone layers 2a-2f are prevented by the above- mentioned spacing 3 if the test paper is constituted in such a manner. Since the water absorptive part 4 absorbs the liquid to be excessively adhered to the reagent layer for inspection, the flow down of the liquid to be inspected to the lower part of the reagent layer, the stagnation of the liquid in said part and the consequent uneven color formation are prevented when the inspection paper is pulled up.

Description

[Detailed description of the invention]

[Field of Industrial Application] The present invention relates to a test strip that can friml detect various components in body fluids and simultaneously determine the amount of detected components. This invention relates to a test strip that can detect 1)H of glucose and protein 2 body fluids and at the same time accurately determine the t1 degree in the fluid to be tested. K. Prior Art Discovery of Diseases 1 In diagnosis and treatment, it is extremely important to easily and quickly know the presence and extent 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 the detection, diagnosis, and treatment of kidney diseases. Furthermore, accurately knowing the pH of body fluids, especially urine, helps in accurately knowing whether or not proteins are present in body fluids, as well as nephritis. This will help confirm the possibility of bacteriuria causing cystitis, etc. Glucose in body fluids, especially urine, thus? II white matter. Although it is extremely important to detect pH easily and quickly,
For this purpose, a test body has conventionally been mainly used, which is a filter paper impregnated with a test reagent and adhered to a support. Furthermore, to simplify the manufacturing process, as a test material suitable for mass production, an ink composition suitable for printing or coating is prepared by mixing a test reagent with a polymer binder, a water-absorbing carrier, etc., and this ink composition is used. A method of manufacturing a test piece by printing (including coating) on a support and then drying has been proposed. The test reagent layer of the test specimen obtained in this way changes color depending on the content of the test target substance in the test liquid, and the coloration caused by immersion in the test liquid changes. The content of the substance to be tested is detected by comparing it with a color tone table prepared for the judgment criteria printed on a separate sheet of paper. On the other hand, after immersing these test specimens in the test liquid, comparing them with a separately provided color table for judgment standards is a complicated operation, and since the test liquid itself is colored, the test reagent When a change in color tone caused by a reaction 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 table for judgment standards, making accurate testing impossible. There is. Therefore, in order to solve this problem, a test reagent layer containing a test reagent is provided on the base material of the test object, and a color FA 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.

Problem 1 to be Solved by the Invention As described above, a test reagent layer and a color WA layer for judgment criteria are formed on the base material of a test object, and the test reagent layer is immersed in the test liquid. By comparing the coloration of the layer with the color tone layer used as a determination standard, it is possible to avoid errors in determination due to coloring of the test liquid, etc. However, when the color tone layer for judgment criteria is printed on the base material using ordinary ink as in the past, due to the difference in surface tension and physical shape of the surface between the printed surface of the color tone layer and the surface of the test reagent layer. , a uniform coloration occurs on the surface of the test reagent layer, but since the test liquid only adheres in the form of drops on the printed surface, the color tone of the tone layer becomes uneven and the coloration differs from that of the test reagent layer. There are drawbacks that make comparisons difficult. In order to solve these problems, the present inventors added a test reagent layer containing a test reagent whose color changes depending on the content of the target substance in the test liquid on the surface of the base material of the test strip. ,
The test exam G/7! By providing in the vicinity of the layer a color tone layer for judgment standards that substantially contains the test reagent layer constituent materials other than the main test reagent components contained in the test reagent layer and is colored with a dye or the like, the test reagent layer can be judged as the test reagent layer. Invented a test strip for testing body fluids that has the same wettability and absorption capacity of the test liquid as the standard color tone layer, making it possible to accurately determine the content of the substance to be tested in the test liquid, Patent application 1986-2396
The application was filed as No. 96. However, even if the test reagent layer and the judgment standard color tone layer are wetted by the test liquid the same, if the test reagent layer and color W/4m are provided on the base material in contact with each other, the adhered test As the liquid moves between the two layers, the coloration at the boundary changes, changing the color to 1iil.
Difficulties arise in comparing the color tone of one layer and the coloration of the reagent layer. Furthermore, if an excessive amount of the test liquid adheres to both layers, especially the test reagent layer, the adhesion to the layer surface becomes uneven, resulting in coloration inhibition and coloration spots. SUMMARY OF THE INVENTION An object of the present invention is to solve these problems and provide a test strip for testing body fluids that produces uniform coloration and allows accurate and easy determination based on coloration. [Means for Solving the Problems] As described above, the present invention includes a test reagent that changes color tone depending on the content of the test target substance in the test liquid on the surface of the base material of the test strip. A test reagent layer is provided, and a judgment standard color tone layer that substantially contains test reagent layer constituent materials other than the main components of the test reagent contained in the test reagent layer and is colored with a dye or the like is provided to determine the test reagent layer. The wetting by the test liquid and the absorption capacity of the test liquid are the same as that of the reference color tone layer, and the test reagent layer and the judgment reference color tone layer are separated with a slight gap of 0.2.
~2ffij! Provide the test reagent layer and color FIW! on the base material with a gap of about A highly water-absorbent portion is provided on the surface of the base material near J, and a test reagent layer is formed. The above-mentioned problem was solved by quickly absorbing and removing the excess test liquid adhering to the color tone layer so that the test liquid adhered uniformly. The gap between the test reagent layer and the judgment standard color tone layer is not limited to the above 0.2 to 27M, but the gap is narrow (
If it is less than 0.2, the boundary between the test reagent layer and the color tone layer cannot be clearly distinguished by visual inspection, and when the test liquid adheres, mutual interference may occur due to component migration between the test sample II layer and the color tone layer. cannot be prevented. On the other hand, if the gap between the test reagent layer and the color tone layer is wide enough to exceed 2 mm, it becomes difficult to compare the coloration of the test reagent layer with the color tone of the color tone layer, and the effect of providing the color tone layer near the test reagent layer is decreases. In the present invention, the test reagent layer and the color W are further provided as described above.
A highly water-absorbent portion can be provided near the A layer. The highly water-absorbent 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 layers. There is no particular restriction on the position and shape of the test reagent layer, and the test reagent layer is formed in the vicinity of the 9-color wJ diagram so as to be able to absorb excess test liquid adhering to the layer. However, it is not necessary to form the highly water-absorbent part in particular when a material with good drainage is used as the base material of the test strip. The highly water-absorbing portion can preferably be formed by printing in the same manner as the test sample IW, color ii1 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 super absorbent gel used in the present invention is, for example, a crosslinked or graft copolymer mainly composed of polyvinyl alcohol (PVA), acrylic M salt, acrylonitrile, starch, etc., and commercially available super absorbent gels. Examples include PVA-acrylate block copolymer (Sumikagel 5P520,
Sumitomo Chemical #@l), acrylic acid grafted starch with 1000 times the water absorption capacity (Sumitomo Ill-lN-100)
0, manufactured by Sanyo Kasei ■), and a reaction product of PVA-cyclic M anhydride (KT gel), which also has a water absorption capacity of 1000 times. The test sample II layer and the judgment standard color tone layer of the test paper in the present invention can be formed by any means such as filter paper impregnated with a reagent composition and pasted on the base material, or printed on the base material. However, the color tone layer should substantially contain the constituent materials of the test reagent layer other than the main components of the test reagent contained in the test reagent layer, and the wetting of the test reagent layer and the color tone layer by the test liquid may cause both layers to be tested. The water absorption capacity of the liquid should be the same. Preferably, the water absorption capacity of the color tone layer is made higher than the water absorption capacity of the test reagent layer. of the test liquid is quickly absorbed and removed, and the excess test liquid is transferred to test sample 1.
Since it is possible to prevent uneven coloring from occurring due to the transition to 1i111, the reproducibility of coloring improves and the determination becomes accurate. The test paper of the present invention includes, for example, a test paper for detecting glucose in body fluids, a test paper for protein detection, and a test paper for pH detection. Products impregnated with the composition, such as test strips for detecting glucose in body fluids, such as glucose oxidase and peroxidase. A reagent composition consisting of an oxidizable indicator and a buffer is dissolved or dispersed in water or a water-alcoholic solvent containing gelatin, a filter paper is impregnated with the blued liquid, and then dried as a test reagent layer. On the other hand, a color II11111 for judgment criteria is produced by dissolving and dispersing dyes in water or water-alcoholic solvents containing gelatin in filter paper, and cutting each filter paper appropriately and placing it on a base material such as a plastic film. It can be attached and formed. Similarly, the protein detection reagent layer and the ρ■ detection reagent layer are impregnated with filter paper to form each test reagent layer. Each color wJ layer can be manufactured and formed similarly. Next, in order to provide a test reagent layer and a color tone layer on the substrate by printing, enzymes are dissolved in advance in a water-alcohol mixed solution as described in Japanese Patent Publication No. 44-25953, and an indicator, pHW! An ink composition suitable for printing or coating is prepared by mixing an i-agent, a polymeric binder, and a water-absorbing carrier, and this ink composition is printed (including coating) on a substrate and then dried. On the other hand, for the color tone layer for judgment standards, a polymer binder, a water-absorbing carrier, etc. are added to a water-alcohol mixed solution, and a dye, etc. is further dissolved and dispersed to form an ink composition. It can be formed by printing this ink composition on a substrate. More preferably, the patent application filed in 1986 by the present inventor is
An ink composition for detecting glucose and an ink composition for detecting protein as described in No. 107871, Akitomo. A test reagent layer is manufactured using each of the pHl standard ink compositions, and a color FIn for judgment criteria is applied to the test reagent layer, which contains the binder, water-absorbing powder, wetting agent, etc. used in the formation of each test reagent layer, and dyes, etc. It can be provided by printing with an ink composition in which is dissolved or dispersed. The ink composition forming the test reagent layer includes (a) IIM enzyme, peroxidase, oxidizable indicator, wetting agent, sensitivity regulator, stabilizer, p
H buffer. An ink composition for glucose detection comprising a reagent composition comprising a binder and a water-absorbing powder dissolved or dispersed in a non-aqueous solvent; (b) an indicator for protein error; an ON buffer; a wetting agent. An ink composition for protein detection comprising a reagent composition consisting of a protein-adsorbing ion exchanger, a form-retaining agent, a binder, and a water-absorbing powder dissolved or dispersed in a solvent; (c) a pH indicator, a quaternary ammonium salt; or amine salts. Examples include pH 1 ink compositions in which a reagent composition consisting of a basic substance, a binder, and a water-absorbing powder is dissolved or dispersed in a solvent. First, the main components of the test reagent of each ink composition are state (a) Glucose detection ink composition Glucose in the liquid reacts with oxygen in the air by the action of glucose oxidase such as glucose oxidase, and is finally oxidized to gluconic acid and hydrogen peroxide. The generated hydrogen peroxide produces nascent oxygen by the action of peroxidase, and this oxygen immediately reacts with an oxidizable indicator such as guaiac butter or O-tolidine 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 level are determined semi-quantitatively. Furthermore, by using an aliphatic carboxylic acid ester of ascorbic acid as a sensitivity regulator, it is possible to improve the quantitative properties of the test sample for glucose detection, that is, the linearity between the glucose concentration contained in the sample and the color density of the test reagent part. It can be improved. Stabilizers are used to prevent oxidizable indicators from discoloring due to the action of peroxides in the atmosphere, and fatty acid esters of ascorbic acid can also be used as stabilizers. In addition, compounds having known antioxidant activity, specific surfactants typified by glycerol esters, or mixtures thereof may be added as appropriate. The pH41 buffer agent is added so that the above-mentioned oxidizable indicator is maintained at a pH that causes a preferable i color change in the ink composition for detecting glucose. Combinations, etc. can be 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 the test solution is carried out when the protein in the test solution comes into contact with an indicator that indicates a protein error held in I)H on the acid side, and the indicator and protein form a complex, resulting in an acidic state. The color changes from yellow to basic blue, and the degree of this color change corresponds to the amount of protein present in the liquid to be tested, so this principle is used to conduct the test. 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, tetrabromobenzaalanine, and bromothymol blue. etc. can be used. Among these, tetrabromophenol blue is preferable because it is superior in terms of strength. 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 -503M), weakly acidic ion exchangers (-COOH), and strong basic ion exchangers (-14+).
R,X", -N" (CH3) 2 (CH2CH
30H)) Weakly basic anion exchanger (-N(R)2.
-NH(R), -NH2, etc.), and the base materials for these ion exchangers include styrene, acrylic, etc. Synthesis 4! ! 1lllf, cellulose, silica, etc. 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 carboxymethylcellulose, which has a carboxyl group as a functional group and is known as a disintegrant for pharmaceuticals. Examples include water-swellable 4#l fats such as calcium salts and carboxymethyl cellulose sodium salts, and highly water-absorbent gels. The above reagents, binder and water-absorbing powder are aromatic hydrocarbons,
An ink composition is prepared 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 solution, and by appropriately selecting or combining multiple types of indicators, a wide range of pHfI4 can be used. can also be measured. When an appropriate amount of quaternary ammonium salt is added to the reagent composition,
Once a color has been developed, the phenomenon of fading over time is greatly suppressed, and a clear color can be obtained.Additionally, when a basic substance is added, an acidic substance is eluted after ink preparation, and the color tone of the ink composition changes over time. This can prevent changes to occur. The above reagents are uniformly dissolved or dispersed together with a binder and a water-absorbing powder in a nonaqueous solvent such as an aromatic hydrocarbon, aliphatic hydrocarbon, ester, or alcohol, water, or a mixture thereof. Next, we will discuss binders and water-absorbing powders as test reagent layer constituent materials other than the main test reagent components mentioned above, but even substances other than these may cause color changes depending on the components contained in the test liquid. If the substance is not present, it can be added to the test reagent layer and the color tone layer for judgment criteria, and among the above-mentioned components, if it does not cause a change in color tone depending on the components contained in the test liquid, It can also be added in the tone layer. Satsuma - One Meal, One Look The binder does not affect the components in the test liquid and l) H, etc., and does not affect the reagents, especially enzymes and oxidizable indicators, and does not interfere with the color reaction. It is required that it be a thing. Binders that have been confirmed to meet these requirements include (I) polyester resins, alkyd resins, polyurethane resins, polystyrene resins, and acrylic resins. Epoxy resin, vinyl chloride resin, vinyl chloride copolymer resin, polyvinyl butyral resin, polyvinyl alcohol resin, polyvinyl goloridone resin. Synthetic resins such as maleic anhydride copolymers, (n) natural polymers such as methylcellulose, ethylcellulose, hydroxyethylcellulose, gelatin, casein, or sodium alginate, etc. are used. Furthermore, two or more of these binders may be combined. I mentioned JL! The addition of IJ water-absorbing powder increases the water absorption of the reagent composition provided on the support, promotes contact between the test liquid and the reagent composition, and creates a haze that promotes the color reaction of the indicator. . Such water-absorbing powders, when in contact with water,
Those exhibiting extreme acidity or alkalinity are not preferred, and those with high whiteness are preferred. Specifically, kaolin, synthetic silica, glass, cellulose block, microcrystalline cellulose, ion exchange cellulose, ion exchange resin, calcium carbonate, magnesium carbonate, aluminum silicate, etc. are used. Optionally, in addition to binders and water-absorbing agents, wetting agents can be included in the ink composition. Wetting agents include nonionic surfactants, anionic surfactants, cationic surfactants, and zwitterionic surfactants. Polyethylene glycols and the like are used, and this wetting agent helps disperse each reagent, promotes the formation of a uniform reagent layer, and can improve water wettability. The color UA layer for judgment criteria in the present invention is similar to the case where the test reagent layer constituent materials other than the above-mentioned main test reagent components, such as a binder, water-absorbing powder, and wetting agent, are used in the ink composition constituting the test reagent layer. Obtained by clearing or dispersing the test reagent layer in a solvent and coloring it with a dye or pigment so that the color tone matches the coloration at each concentration when the test reagent layer is immersed in the test liquid at a specified concentration. . The test reagent layer, color tone layer, and super absorbent area are formed by respectively applying an ink composition containing various test reagents, an ink composition for forming a 9-tone layer, and an ink composition containing a super absorbent layer onto the base material. be able to. As a coating technique, a printing method, a coating method (for example, roll coating, spray coating, dip coating, solid coating), etc. are used. Since it is preferable that the amount of the ink composition applied is relatively large and constant, it is preferable to apply the ink composition on the substrate by a silk screen printing method, an intaglio printing method, a gravure printing method, or the like. The coating amount varies depending on the type of ink composition, but is generally 2 to 150 g/TI.
t (when dry) is preferable. The base material is preferably one that does not react with the reagent composition and does not inhibit the color development of the reagent, and specifically, for example, paper 2 synthetic paper, nonwoven fabric, or synthetic resin film, or paper and synthetic resin film. Although a laminate or the like is used, in the present invention, it is preferable to use a polystyrene sheet. K Embodiment] Specific examples of the test strip for testing according to the present invention will be explained below with reference to the drawings. In FIG. 1, for example, a test reagent layer 1 for detecting glucose is provided on a base material 5, and a test reagent layer 1 is placed with a slight gap 3 between the test reagent layer and the test reagent layer, and the glucose concentration in the sample is tested at various concentrations from O to a predetermined concentration. Color F1 layer 2a for judgment criteria indicating the coloration of each reagent layer
, 2b, 2c, 2d. 2e and 2f are provided by pasting or printing, and
11 is a diagram showing a test strip 6 for inspection in which a superabsorbent portion 4 is provided adjacent to a portion 11. If a test is performed using such a test paper, since a gap 3 is provided between the test reagent layer 1 and the color tone layers 2a to 2f, it is possible to prevent mutual interference of each component of both layers, and also to prevent the boundaries between both layers. It is clear that the super absorbent portion 4 absorbs the excess test liquid on the test reagent layer, so when the test paper is pulled up, the test liquid flows down and stays below the reagent layer. One color does not become non-uniform, and semi-quantification of the concentration of the test substance in the test liquid can be accurately performed. In addition, as shown in FIGS. 2 and 4, a test reagent layer 1 is provided on the base material 5, and a color: 14 layer 2 for judgment criteria provided so as to surround the test reagent layer 1 with a gap 3 therebetween. , and furthermore, super absorbent parts 4 or 4, 4' are provided at intervals around the color tone layer 2.
will be established. In this embodiment, if the color tone of the color tone layer 2 is set to indicate that the concentration of the test substance in the test liquid is at the upper limit of the normal range, the test strip 6 can be immersed in the sample. This makes it easy to determine whether the concentration of the test substance in the sample is within the normal range, and by providing a highly water-absorbing part around the 2-color LF1 test reagent layer, it is possible to easily determine whether the concentration of the test substance in the sample is within the normal range. It is possible to prevent excess liquid to be inspected from flowing upstream, and the adhesion of the liquid to be inspected becomes uniform, allowing accurate determination. In FIG. 3, the test reagent layer 1 and the color tone layer 2 are provided with a gap 3 in the same manner as in FIG. 2, except that the highly absorbent part 4 in FIG. 2 is not provided. If a material with good drainage is used, such a structure can be adopted. Furthermore, as shown in FIGS. 5 and 6, the color tone layer for determination criteria is divided into two layers, sandwiching the test reagent layer 1, into two color tone layers 2cs and 2h. Or 2i, 2j, the test reagent layer and the color tone layer are provided with a gap 3, and the super absorbent portion 4, is further provided adjacent to or surrounding the test reagent layer 1 and the color tone layer 2a, 2h, or 2i, 2j.
4' or 4 may be provided, and the same effect as above can be obtained. FIGS. 5 and 6 are for determining whether the concentration of the test substance in the test liquid is within an appropriate range, and are effective for determining, for example, blood sugar level. That is, the test reagent layer 1 is sandwiched between the base material 5, and on one side there is a tone layer 29 or 21 with a tone that shows a density that is the lower limit of the appropriate range, and a tone layer 2h that has a tone that shows a density that is the upper limit of the appropriate range. By providing a color tone layer for judgment criteria consisting of or 2j, blood Wl
It is possible to accurately determine whether ii is within an appropriate range. Next, details of the production of test strips according to the present invention will be explained with reference to examples. Example 1 After the superabsorbent composition shown below was subjected to a slight aolysis using a homomixer, it was applied to a white polystyrene sheet with a thickness of 300 μm, which is the base material 5 shown in FIG. 18 Two 2js that are dark
The super absorbent portion 4.4' was screen printed to form a square shape of MX20M. The screen plate used was 150 mesh, and the total thickness of the resist and screen gauze was 88μ.
Met. Super absorbent composition Super absorbent resin (Sumitomo Chemical: Sumikagel SP-520) 150 parts by weight Adhesive (Teikal Ink: Sericol 13-002 Medium) 280 Middle part solvent (Teikal Ink: Sericol 13-002 Solvent) )
The obtained printed matter of 70ΦΦ was dried at 60°C for 1 hour to form a highly water-absorbent part. Manufacture of test reagent H After finely dispersing the test reagent composition with the following composition in a homomixer, screen printing was performed to form two super absorbent parts 4 of a white polystyrene sheet with a thickness of 300 μm, with the above super absorbent parts formed. A test reagent layer 1 was printed in the middle of 4' to form a rectangle of 5flXsfRw. The screen version used was 80 meshes. The total thickness of the resist and screen gauze was 130μ. Test reagent composition glucose oxidase (manufactured by Toyobo: arade U) 3
．． 6 parts by weight peroxidase (manufactured by Toyobo; Grade I [[)
2.4 parts by weight Guaiac butter 4.8 parts by weight Sorbitan monolaurate (manufactured by Hanako Soap; Span 20) 7.2 parts by weight Ascorbyl stearate 0.24 mm
Citric acid 2.8 parts by weight Sodium citrate 1 part in 11.0 Polyvinylpyrrolidone (manufactured by 8^SF; Koliton 90) 12.
6 Hanging part polyvinyl butyral (Sekisui Chemical; Eslec 8X-1) 2.25
ff11 parts Cellulose fine powder (Fishikasei: Avicel SF) 171fi
Parts by weight n-amyl alcohol 228 parts by weight Butyl cellosolve acetate 33.5 parts by weight ffi
Part obtained mark! The second product was dried at 60°C for 40 minutes.
Test reagent layer 1 shown in the figure was obtained. Turtle H @ H'ti Ec U Present M Fn K Jut
lit 1 m 50μ of β-D-glucose in normal urine
The test reagent layer obtained as described above was immersed in the test solution and immediately taken out and left to stand for 1 minute. Color development was observed. Next, the type and color of the oil-soluble 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 the test reagent layer 1. , tone layer 2 was obtained. That is, after dissolving/dispersing an oil-soluble dye in the following color tone layer composition finely dispersed with a homomixer, the β-D-glucose concentration in the sample was 50IRg/
The color Fj layer 2, which indicates that it is old, is a rectangular shape with 6 dark rectangular notches in the center and 15 sides on each side, with a gap of 0.54M between it and the test reagent layer 1. , by screen printing on a 300μ thick white polystyrene sheet on which the above-mentioned super absorbent parts 4, 4' and test strip 1 layer 1 were formed, and drying the obtained printed matter at 60 ° C. for 40 minutes. An inspection test paper 6 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. Color tone layer composition Sorbitan monolaurate (Nispan 20 manufactured by Kao Soap) 14.4 parts by weight Citric acid 2.8 parts by weight Sodium citrate 11.011 parts Polyvinylpyrrolidone (manufactured by BASF: Kollidon 90) 12.
6 parts by weight polyvinyl butyral (MA water hydrate special varnish L/t'y BX-1)
2.25 ff 11 parts Cellulose fine powder (Fushikasei: Avicel SF) 171 parts by weight n-amyl alcohol 228 weight hanging weight Thircellosolve acetate 33.5 ffifi
1 part normal urine and β-D-glucose in normal urine 50I#
g/Old, 1007IIF/Old, dissolved to a concentration of 1007IIF/Old, was used as the test liquid, and the resulting test strip was immersed in each test liquid, immediately taken out, left to stand for 1 minute, and colored. observed. The coloration is uniform and clear,
β-D-glucose concentration of test liquid is 50ffig/d
In the case of +, 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 IRy/dl, the color of the test reagent layer and the color tone of the tone layer could be clearly distinguished. Comparative Example 1 The gap between the test reagent layer and the color tone layer shown in Example 1 was set to 0.1.
The test paper shown in FIG. 2 was manufactured in the same manner as in Example 1 except that the test paper was set to 1fi. Normal urine with β-D-glucose dissolved at a concentration of 50 ay/dl was used as the test solution, and the obtained test strip was immersed in the test solution, then immediately taken out and allowed to stand for 1 minute. , 7 colors were observed. Since the gap between the test reagent layer and the color tone layer is small, the boundary between the test reagent layer and the color tone layer is unclear, making it difficult to compare the color tone of the test reagent layer and the color tone of the color tone layer. Further, since the gap between the test reagent layer and the color tone layer was small, mutual interference occurred between the test reagent layer and the color tone layer, and the color tone of the test reagent layer and the color tone of the color tone layer did not match. Comparative Example 2 The test paper shown in FIG. 2 was produced in the same manner as in Example 1, except that the gap between the test reagent layer and the color tone layer was changed to three. Normal urine and β-D-glucose in normal urine 50/d
1, 100IIy/dl was used as the test liquid, and the resulting test paper was immersed in each test liquid, immediately taken out, left to stand for 1 minute, and observed for color development. did. Since the gap between the test reagent layer and the color tone layer was large, it was difficult to compare the color tone of the test reagent layer and the color tone of the color W4 layer. Effects of the Invention 1 The present invention provides a reagent layer containing a test reagent that changes color tone depending on the content of the substance to be tested in the liquid to be tested, on the surface of the base material of a test strip for testing, and A color tone layer for judgment criteria indicating the content of the test target substance in the test liquid colored with dye etc., which contains test reagent layer constituent materials other than the main components of the test reagent contained, is 0.2~ They are provided with a slight gap of about 2yIn, and the material constituting the color tone layer is made as similar as the material constituting the test reagent layer as much as possible to adjust the wetting and water absorption ability by the test liquid, and if necessary, add a layer with high water absorption. By providing this section, the following effects can be obtained. (1) By providing a gap between the test reagent layer and the color tone layer, the boundary between the test reagent layer and the color tone layer becomes clear, and mutual interference between the test reagent layer and the color tone layer can be prevented, making judgments easier. Become easier and more accurate. (2) By providing a highly water-absorbing part, when the test strip is immersed in the test liquid, the excess test liquid adhering to the test reagent layer and/or color tone layer is quickly absorbed and removed. Since it is possible to prevent seven-color inhibition and coal extraction caused by the adhesion of the test liquid, the reproducibility of color development is improved and judgments are accurate. (3) By making the water absorption capacity of color 1 equal to or higher than the water absorption capacity of the test reagent layer, the color tone is different from that of the test reagent layer when the test strip is immersed in the test liquid. Excess test liquid that adheres to the gap between the test reagent layer and the test reagent layer is quickly absorbed and removed, preventing excess test liquid from migrating to the test reagent layer and causing color spots, improving color reproducibility. The judgment will be accurate. In addition, since the test strip for testing according to the present invention has a configuration as shown in the drawing, anyone can easily check whether the test substance in the test liquid is within the normal range by simply immersing it in the test liquid. It is extremely useful for the detection and treatment of diseases, as it is possible to judge whether or not a thorough examination at a hospital or laboratory is necessary based on the judgment.

[Brief explanation of the drawing]

1 to 6 are schematic plan views showing specific examples of test strips according to the present invention. 1... Test reagent layer, 2... Color rA layer. 3... Gap, 4... Highly absorbent part.

Claims (1)

[Scope of Claims] 1. A test reagent layer containing a test reagent that changes color tone depending on the content of the target substance in the test liquid on the surface of the base material of the test strip; A color tone layer for judgment standards, which substantially contains the constituent materials of the test reagent layer other than the main components of the test reagent contained in the test reagent layer, and is colored with a dye or the like, is provided with a slight gap nearby. Characteristic test strips. 2. The gap provided between the test reagent layer and the color tone layer is 0.
．． The test strip for inspection according to claim 1, which has a diameter of 2 to 2 mm. 3. A patent in which the components of the color tone layer and the test reagent layer are adjusted so that the water absorption capacity of the color tone layer for judgment criteria is equal to or higher than that of the test reagent layer. An inspection test strip according to claim 1. 4. The test strip for testing according to claim 1, which comprises a highly water-absorbing portion in the vicinity of the test reagent layer and the color tone layer. 5. The test for inspection according to claim 4, wherein the super absorbent portion provided in the vicinity of the test reagent layer and the color tone layer contains a super absorbent polymer with a water absorption capacity of 10 times or more. paper.