JPH02190766A - Clinical inspecting body and production thereof - Google Patents

Abstract

PURPOSE:To prevent the deterioration in properties of inspecting reagent parts and the adhesion of dust by providing an adhesive layer and a gas impermeable base over the entire surface of a release film formed with the inspecting reagent parts by using inspecting reagent ink. CONSTITUTION:The inspecting reagent parts 2 are formed on the release film 1 by various printing methods using the ink composed of drugs which do not modify the inspecting reagent. The entire surface of the film 1 provided with the reagent parts 2 is then provided with the adhesive layer 3 consisting of a material which does not exert adverse influence, such as deterioration in property, degradation of activity or contamination, to the reagent. Further, the base 4 is provided on the layer 3 by heating, pressurizing, etc. The film 1 is stripped from a clinical inspecting body to expose a surface 6 to be exposed at the time of use on the front surface of the reagent parts 2, then the film is rapidly immersed into an inspecting sample or the liquid drop of the inspecting sample is dropped onto the exposed surface 6 to detect and determine the specific material. The deterioration in properties of the reagent parts by the moisture absorption of these parts themselves is prevented by this production process; in addition, the exposed surface is covered by the film simultaneously with the formation of the reagent parts and, therefore, the exposure to the air is obviated and the adhesion of the dust is prevented.

Description

[Detailed description of the invention] [Industrial application field]

The present invention relates to l) a clinical test specimen having a test reagent portion and a method for producing the same. Specifically, it is a clinical test specimen whose test reagent part has little deterioration over time, and which detects a specific substance in the test sample by contacting it with a test sample such as body fluid, and determines its presence or absence and quantifies the substance contained. It is related to. The clinical test specimen according to the present invention has a test reagent part that undergoes little deterioration over time and can perform reliable tests,
Further, according to the method for manufacturing a clinical test specimen according to the present invention, the above-mentioned clinical test specimen can be easily obtained. f.Prior Art The role that clinical test specimens play in testing health conditions and discovering, diagnosing, and treating diseases is important, and there is a strong demand for simplified testing methods. As a means of achieving this, simple clinical test specimens such as urine test strips have been developed, but this is contradictory. As a conventional clinical test specimen, there is a test paper sheet for chemical analysis in which a test paper for chemical analysis is fixed on a waterproof support film, and a waterproof release film is releasably laminated on the test paper. Test paper sheets for chemical analysis are made by impregnating a hygroscopic carrier such as a filter paper with a test reagent solution and then drying it to make a test paper for chemical analysis.Then, this is cut into an appropriate area and is waterproof. It is manufactured by adhesion or adhesive fixation onto a support film, and finally by laminating a waterproof release film onto this test paper for chemical analysis (Japanese Utility Model Publication No. 46369/1983).

[Problem to be solved by the invention]

However, there are problems that must be solved in the above-mentioned conventional clinical test specimens and methods for producing the same. The first problem is that chemical analysis test strips are hygroscopic, and during manufacturing, the exposed surface of the chemical analysis test strips (the surface that comes into direct contact with the test sample during testing) is exposed to the air. The problem is that the exposure to these chemicals causes deterioration in the quality and reactivity of the test reagents in the test strips for chemical analysis. Test strips for chemical analysis are made by impregnating a hygroscopic carrier with a test reagent, and are inherently hygroscopic. Therefore, oxygen and moisture in the air are absorbed during the manufacture of chemical analysis test strips and clinical test specimens. These react with the test reagent in the test reagent section and alter the quality of the test reagent. In particular, the surface exposed during use on the waterproof support film is the most important surface for inspection, but it is the most important surface because it is exposed to the air until it is covered with the waterproof release film. It is easy to cause chemical reactions with oxygen and moisture, and if the exposed surface is exposed to the air during use, there is an extremely high risk that dust and dirt will adhere to this surface.As a result, the substances in dust and dust reacts with the test reagent in the test reagent part, altering the quality of the test reagent or inhibiting its reactivity. The second problem is that the top surface of the chemical analysis test paper and the surface of the waterproof support film are not flush with each other. The problem is that it is difficult to conduct a thorough inspection. Since the test reagent portion is provided on the waterproof support film, only the portion where the test reagent portion is provided has a protruding shape. Therefore, when the test sample and the test paper for chemical analysis are brought into contact, the test sample does not stay on the test reagent part but flows down onto the waterproof support film, resulting in a lack of water retention on the test reagent part. As a result, the test sample may not react sufficiently with the test reagent in the test reagent section, or an accurate reaction cannot be expected during quantitative testing. If analytical test strips are provided in parallel, the test samples will mix and interfere with each other, making accurate determination impossible.

[Means to solve the problem]

In the clinical test specimen of the present invention, a test reagent part is provided on a gas-impermeable release film by a printing method using an ink containing a test reagent as a main component, and the release film is provided on the side where the test reagent part is provided. An adhesive layer is provided on the entire surface of the adhesive layer, and a gas-impermeable support is provided on the adhesive layer. In addition, the method for producing a clinical test specimen according to the present invention includes forming a test reagent part on a gas-impermeable release film by a printing method using ink containing a test reagent as a main component, and forming a test reagent part on the side where the test reagent part is provided. It is characterized in that an adhesive layer is provided on the entire surface of the release film, and a gas-impermeable support is provided on the adhesive layer. The clinical test specimen and its manufacturing method according to the present invention will be explained in detail below with further reference to the drawings. FIG. 1 is a process diagram of the method for manufacturing a clinical test specimen of the present invention. FIG. 2 is a cross-sectional view of the clinical specimen of the present invention in use. FIG. 3 is a sectional view showing another embodiment of the clinical test specimen of the present invention. In FIG. 6, 1 is a release film, 2 is a test reagent part,
3 is an adhesive layer, 4 is a support, 5 is a spacer, and 6 is an exposed surface during use. The material of the release film l may be any material as long as it is gas impermeable. For example, polyvinyl alcohol, polyvinyl halide, polyacrylonitrile, polyolefin, fluororesin, polyamide, polyethylene terephthalate, nylon, cellulose triacetate, Examples include polyvinyl chloride and other resins (homopolymers or copolymers). In addition, resin films made of these materials and other resin films, laminated sheets of two or more types of resin films, composite sheets of resin films and paper,
Composite sheets of resin film and aluminum foil, composite sheets of resin film and cloth, etc. can also be used. This release film 1 is peeled off from the test reagent portion 2 and the adhesive layer 3 during use. Therefore, if necessary, a release film 1 with excellent releasability may be used, or a release layer laminated on the release film 1 may be used. When this mold release layer is provided, a material is used that has properties that do not adversely affect the constituent components of the test reagent portion 2, which are stacked directly above and in contact with each other, such as deterioration. Furthermore, if the release layer is made of a gas-impermeable material, the gas-impermeability of the release film 1 can be strengthened. Furthermore, the use of a resin that is opaque to ultraviolet rays is advantageous for protecting the test reagent section 2. A test reagent portion 2 is provided on this release film 1 (FIG. 1(a)). The test reagent part 2 provided on the release film 1 is capable of detecting a substance produced when a chemical reaction occurs with a specific substance of a component in a test sample such as a human or animal body fluid, or a substance produced when a decomposition reaction occurs. It is used to determine and quantify the presence or absence of a substance in a test sample and the size of the contained components by using properties. This mainly consists of the following test reagents. For example, oxidizing enzymes such as uricase, catalase, glucose oxidase, and cholesterol oxidase, transferases such as acetokinase, glucokinase, and hexokinase, hydrolytic enzymes such as glucoamylase, maltase, and urease, citrate lyase,
In addition to splitting enzymes such as lipase, isomerases such as phosphoglucose isomerase, pi indicators such as 0-)luidine, 4-aminoantipyrine, phenol, methyl orange, promuchimo blue, and other acids such as acetic acid and oxalic acid, It is selected from various reagents such as alkalis such as ammonia and sodium hydroxide, sodium nitrite, magnesium sulfate, barium chloride, cumene hydroperoxide, 2,4-dichlorohenzendiazonium, fluoroborate, and iodine. The test reagent described above contains a resin binder that does not cause any denaturation to the test reagent, a solvent, a dispersant, a white water-absorbing powder, and a
An ink composition containing a H buffering agent and the like is constituted. The test reagent portion 2 is formed of one or more types of test reagents on the release film l. If two or more layers are laminated using different test reagents and there is a risk of reaction occurring at the interface between the test reagent parts 2 and deterioration, it is necessary to take measures such as providing an appropriate spacer layer 5 between the test reagent parts 2. It is. It is also conceivable to provide the test reagent sections 2 at two or more locations using different test reagents, but in this case, a certain distance is required between each test reagent section 2. The specific means for forming the test reagent portion 2 on the release film 1 is a general printing method such as a screen printing method, a gravure printing method, a letterpress printing method, a lithographic offset printing method, a spin code method, a dip method, etc.・There are coating methods such as barcode method and roll coating method. Next, an adhesive layer 3 is provided on the entire surface of the release film 1 on which the test reagent part 2 is provided (FIG. 1(b)). It is preferable to use a material that does not cause any adverse effects such as a decrease in quality or contamination, and which allows the support 4 to be bonded at low temperatures. Moreover, it is more preferable to form the adhesive layer 3 with a material having water-repellent properties.Specific methods for forming the adhesive layer 3 include general methods such as screen printing, gravure printing, letterpress printing, and lithographic offset printing. There are various printing methods, spin code methods, dip methods, bar code methods, roll coating methods, and other coating methods. Next, a step of providing a support 4 on the side of the adhesive layer 3 is performed to obtain a final product (FIG. 1(C)). In the step of forming this support 4, for example, a method of adhering the support 4 to the adhesive layer 3 by heating and pressing with a hot roll or the like, or a method of applying a resin onto the adhesive layer 3 and curing it, etc. can be adopted. can. In the case of the former method, heating, pressurization, or both are used;
Conditions such as temperature, pressure, atmosphere, etc. are adjusted within a range that does not affect the test reagent in the test reagent section 2 by deterioration or the like. The support 4 may be made of any gas-impermeable material 6 For example, plastic sheets, plastic films, various molded bodies such as ceramic molded bodies and plastic foamed bodies, plastic sheets laminated with aluminum foil, or any of these. A gas-impermeable material such as a composite or a single substance thereof is used. The shape of the surface is not limited to a flat surface, but may be a curved surface. Furthermore, letters or designs may be provided between the release film 2 and the adhesive layer 3 or between the adhesive layer 3 and the support 4 of the clinical test specimen thus produced. In this way, when test reagent portions 2 of different test reagents are provided in parallel, it is convenient to distinguish the test items by forming letters or designs displaying the respective item names. In order to actually use the clinical test specimen completed in this way, proceed as follows. First, just before contacting or immersing the test sample in the test, the release film l is peeled off from the clinical test sample to expose the upper surface 6 of the test reagent section 2 that is exposed during use (Figure 2).
, and immediately immerse the exposed part in the test sample, or place a droplet of the test sample on the exposed part during use.
The specific substance in the test sample to be detected causes a chemical reaction with the test reagent in the test reagent section 2, resulting in coloration. After a certain period of time, the specific substance in the test sample is detected and quantified by comparing the color tone of the test reagent part 2 with the standard display color, or by setting it in a colorimetric photometer and measuring the absorbance at a specific wavelength. Test samples tested using such test reagents include body fluids such as urine, blood, lymph, gastric juice, pancreatic juice, bile, saliva, sweat, fluid, pleural effusion, and ascites; more specifically, urine and blood. proteins such as albumin, globulin, and hemoglobin; nitrogen oxides such as urea and uric acid; sugars such as glucose; lipids such as cholesterol; inorganic components such as sodium salts and potassium salts; It is an aqueous body fluid component that contains biocatalysts such as vitamins. Note that these can be applied to animals as well as humans. When using the clinical test specimen of the present invention, the exposed surface 6 during use is formed after forming the test reagent part 2 in the first manufacturing process until the release film I is peeled off during actual use.
- is covered with a release film 1 throughout; therefore,
It is not exposed to the air and remains a very clean surface, protected from deterioration, contamination, and destruction. Furthermore, since the test reagent part is formed by printing, there is no intrusion of gases in the air. Furthermore, since the test reagent parts are isolated by the resin of the adhesive layer filled between them, the water retention of the test sample is good, and the test sample is difficult to penetrate into other test reagent parts. Therefore, precise determination is possible.

【Example】

Thickness 30 with a release layer formed on the surface by melamine resin
Glucose detection indicators (glucose oxidase, bar oxidase, o-tolidine) were added to a well-mixed mixture of cellulose powder, polyvinyl alcohol, and Al15.0 buffer on a release film made of μ-polyethylene terephthalate film. The test reagent solution was printed and dried in a square pattern of 511I11 sides to form a test reagent part. On the entire surface of the release film on the side where the test reagent part is provided, use a vinyl adhesive (TS-1280 Medium A, Okuchihon Ink) to print a square pattern with a side of 9m+* and dry to form an adhesive layer. did. Next, a polyester substrate with a thickness of 200 μm was laminated on the adhesive layer, and a heat roll method was applied at a roll temperature of 130°C, a roll linear pressure of 100 kg linear pressure, and a roll speed of 10 ca.
Bonding was carried out under the conditions of /s. A glucose detection test was conducted using the clinical specimen for glucose detection produced as described above. After peeling off the release film immediately before use, this clinical specimen was immersed in a glucose solution, and when taken out, the test reagent portion, which was white before immersion, immediately turned blue. Tests using various concentrations of glucose solutions and control urine showed results ranging from approximately 20+ u/di to 1. 000mg/
It was confirmed that glucose at a concentration of di could be detected and quantified.

【effect】

The clinical test specimen according to the present invention does not use hygroscopic chemical analysis test paper as the test reagent part and provide it on a waterproof support film, but instead uses ink containing a test reagent as the main component. Since the test reagent is formed on a release film using a printing method, deterioration due to moisture absorption between the test reagent parts can be prevented.Furthermore, the exposed surface during use is covered by the release film at the same time as the test reagent part is formed, so there is no exposure during use. Since the surface is never exposed to the air, no dust or dirt in the air can adhere to this surface. In addition, in the clinical specimen obtained by the manufacturing method of the present invention, an adhesive layer is formed to cover each test reagent portion on the release film, so that when actually used, the adhesive layer is attached to the exposed surface of the test reagent portion during use. The layers become different. Further, the adhesive layer has more repellency to the test sample than the test reagent portion. Therefore, the test sample remains in the test reagent portion, improving water retention and reacting sufficiently. In addition, interference between adjacent test reagent sections due to outflow of each reaction solution from each test reagent section can be prevented, and proper test results without reaction misidentification can be obtained.

[Brief explanation of the drawing]

FIG. 1 is a process diagram of the method for manufacturing a clinical test specimen of the present invention. FIG. 2 is a cross-sectional view of the clinical specimen of the present invention in use. FIG. 3 is a sectional view showing another embodiment of the clinical specimen of the present invention. l...Peeling film, 2...Test reagent part, 3...
Adhesive layer, 4... Support, 5... Spacer layer, 6.
・Exposed surface during use. Patent applicant: Nissha Printing Co., Ltd. / Noboru (b) (c) ...Peeling film...Test reagent part...Adhesive layer...Support...Spacer...Second surface exposed during use figure

Claims (1)

[Scope of Claims] 1. A test reagent part (2) is provided on a gas-impermeable release film (1) by a printing method using ink containing a test reagent as a main component; ) is provided with an adhesive layer (3) on the entire surface of the release film (1), and a gas-impermeable support (4) is provided on the adhesive layer (3). . 2. A test reagent part (2) is provided on the gas-impermeable release film (1) by a printing method using ink containing a test reagent as a main component, and the side on which the test reagent part (2) is provided is peeled off. A method for producing a clinical test specimen, which comprises providing an adhesive layer (3) on the entire surface of a film (1), and providing a gas-impermeable support (4) thereon.