JPH07333211A - Dry analytical film piece - Google Patents

Abstract

PURPOSE:To prevent the contamination of a press jig, the housing part of an incubator and a dry analytica film piece discharge part due to the liquid sample deposited and developed on a developing layer and the contamination of the dry analytical film piece through the press jig or the housing part of the incubator in the dry analytical film piece having a reagent layer generating the chemical reaction, biochemical reaction or immunoreaction with a predetermined biochemical substance contained in a liquid sample such as blood or urine to be changed in optical density. CONSTITUTION:A dry analytical film piece 1 is constituted so that molten parts 3 where the micropores of a developing layer preventing the arrival of a liquid sample are substantially closed are formed to the corner parts containing the contact regions (a) with the press jig of the developing layer 2 and/or the vicinities of them and a molten parts 4 where the micropores of the developing layer 2 preventing the arrival of the liquid sample are formed along all of edges. A reagent layer and a support are provided under the developing layer 2.

Description

Detailed Description of the Invention

[0001]

The present invention relates to a chemical reaction, a biochemical reaction or an immunoreaction with a predetermined biochemical substance (hereinafter referred to as a test component or an analyte) contained in a liquid sample such as blood or urine. A dry analysis film piece (dry analysis film chip) obtained by cutting a dry analysis film having a reagent layer whose optical density changes by cutting it into small pieces (chips) of a specific shape (square, rectangle, circle, ellipse, etc.) It is a thing.

[0002]

2. Description of the Related Art Generally, qualitative or quantitative analysis of the activity value of a specific chemical substance or biochemical substance in a liquid sample is performed in various industrial fields. In particular,
It is extremely important in the field of clinical biochemistry to quantitatively analyze the content or activity value of biochemical substances in biological fluids such as blood and urine, or the content of formed components.

In recent years, quantitative analysis of the content of a specific analyte contained in this liquid sample or its activity value or the content of a tangible component is possible by simply spotting and supplying small droplets of the liquid sample. An integrated type multilayer analysis film (also referred to as a multi-layer analysis element or a multi-layer analysis element) of a dry analysis method (dry chemistry) has been developed (Japanese Patent Publication No. 53-21677 (US Pat. No. 3,992,158), and Japanese Patent Application Laid-Open No. 55- 164356 (US patent
4,292,272), JP-A-57-42951 and the like), and are in practical use. In addition, a filter paper type test piece and a modified single-layer or multi-layer test piece (JP-A-57-53661 (US Pat.
77, 575), etc.) have been proposed, and some have been put into practical use. The use of these dry analytical films makes it possible to perform quantitative analysis of analytes in liquid samples more easily and quickly than conventional wet analytical methods (wet chemistry). It is useful in medical institutions, laboratories, etc. that need to analyze

In order to carry out quantitative analysis of an analyte in a liquid sample using such a dry analysis film, the liquid sample is used as a dry analysis film (a development layer having a development layer and a development layer having no development layer). After direct spotting (on the reagent layer), this is kept at a constant temperature (incubation) in the ink beta (constant temperature device) for a predetermined time to cause a color reaction (dye formation reaction), and then a predetermined sample in the liquid sample. By irradiating the dry analysis film with a measurement irradiation light containing a wavelength preselected by the combination of the light and the reagent contained in the dry analysis film, the reflection optical density is measured, and the optical density value is obtained in advance. The substance concentration of a specific analyte in a liquid sample is determined by the principle of a colorimetric method that uses a calibration curve that shows the correspondence between the optical density value and the substance concentration or activity value of a specific analyte. Or those seeking activity value.

By the way, the above dry analysis film has a structure in which at least one reagent layer containing a reagent is provided on a support made of an organic polymer, and a development layer is provided on the upper side of the reagent layer. And for automatic operation,
The dry analysis film is used as a dry analysis slide (hereinafter sometimes simply referred to as an analysis slide) housed in a slide frame made of an organic polymer. By accommodating a piece of dry analysis film in the slide frame, the dry analysis film, which tends to warp when dried, can be kept flat.

However, the analysis device using the dry analysis slide as described above tends to be large. That is, in a large medical institution, a large cartridge is used because it consumes a large amount of analysis slides in a short time, and it is necessary to provide a number of cartridges corresponding to the number of analytes to be analyzed. However, the space required for the cartridge was large.

Further, the analysis slide requires a large cost for the frame, which is one of the causes for increasing the cost of the analysis slide. Further, the presence of this frame causes the cartridge, the ink beta, etc. to become large. .

Therefore, the present inventors have made it possible to use a dry analysis film piece (dry analysis film chip) as it is (without housing the dry analysis film piece in a frame). Suggested
(Specification of Japanese Patent Application No. 04-99823, EP0 567 057 A).

An example of one embodiment of this dry analyzer is shown in FIG.
As shown in, the dry analysis film piece storage section 20 for storing the unused dry analysis film piece 10, and the dry analysis film piece transport section 30 for taking out the dry analysis film piece 10 from this storage section 20 and sending it to the ink beta described later. And a spotting portion 40 for spotting a liquid sample on the dry analytical film piece 1 in the middle of the transport path of the dry analytical film strip transporting portion 30, and a dry analytical film on which the liquid sample is spotted. Ink beta 50 that holds the strip 10 at a constant temperature for a predetermined time, a photometric unit 60 that measures the reflection optical density of the dry analysis film strip 10 that causes a color reaction with the ink beta 50, and the dry type photometric unit 60 that measures light. A dry type analytical film piece discharging section 70 for discharging the analytical film piece 10 from the ink beta 50 is provided.

The ink beta 50 has a disk-shaped ink beta main body 51 rotatably supported therein, and a heating means (not shown) is incorporated in the main body 51 to keep the inside at a constant temperature of around 37 ° C. ing. Further, on the side surface of the main body 51, there are carry-in holes for carrying in the dry analytical film pieces 10 at predetermined intervals on the circumference.
A large number of 52 are formed, and a storage portion 53 for storing the dry analytical film piece 10 is formed following the carry-in hole 52.

As shown in FIGS. 14 and 15, the accommodating portion 53 has a rectangular planar shape larger than that of the dry analysis film piece 10 and has four corners (four corners) of the accommodated dry analysis film piece 10. A corner portion corresponding to a corner has a corner portion 54 protruding inward. Further, a photometric window 55 is opened in the central portion of the storage portion 53, a ring groove 56 into which a photometric head to be described later is inserted is formed in the lower portion of the photometric window 55, and further, in the upper outer periphery of the storage portion 53. A taper portion 57 for guiding the dry analytical film piece 10 is formed. A lid for preventing evaporation of the liquid sample is provided above the storage section 54.
58 is provided so as to be movable up and down, and holding jigs 59 for pressing the dry analytical film piece 10 to correct the deformation are formed at four corners of the lower surface of the lid 58.

[0012]

However, in the analyzer using the conventional dry analysis film piece as described above, in the case of the dry analysis film piece having the development layer made of the microporous material, it was developed. The liquid sample may reach the edges and edge end faces (end faces of the peripheral edge) of the development layer and ooze out from the edge end face.In the case of a liquid sample with low viscosity, the development layer or (dry analysis without the development layer Especially in the case of a film piece, the liquid sample may diffuse to the surface of the reagent layer and reach the edges and edge end faces of the reagent layer, and may ooze out from the edge end face.
It has been found that there is a risk of contaminating the ink beta, photometric unit, discharge unit, etc. of the analyzer, and contaminating other dry photometric film pieces that have not been photometrically measured after the liquid sample has been spotted.

That is, since the dry analytical film piece is deformed by drying, it is pressed by the lid having the pressing jig in the storage part of the dry analytical film piece of the ink beta. Therefore, when the liquid sample spotted on the dry analysis film piece is developed and reaches the four corners and reaches the corners near the corner where the holding jig contacts, the dry analysis film piece is held down by the holding jig. At this time, the liquid sample adheres to the holding jig and contaminates the holding jig. When the next piece of dry analysis film sent is pressed by the holding jig that is contaminated with the previous liquid sample, the previous liquid sample attached to the holding jig adheres to the piece of dry analysis film this time. As a result, the dry analytical film piece of this time will be contaminated with the liquid sample of the previous time.

Further, when the liquid sample spotted on the dry analysis film piece is spread to the edge of the dry analysis film piece and arrives at the edge of the edge of the dry analysis film piece, the liquid sample wets the edge surface of the dry analysis film piece. Becomes
In the storage part of the dry analysis film piece of the ink beta, for the alignment of the dry analysis film piece, since the edge end surface of the dry analysis film piece and the inner wall surface of the storage part are in contact with each other, therefore, In some cases, the liquid sample spotted on the dry analysis film piece at the contact portion adheres to the side wall of the storage portion, and further the liquid sample adheres to the bottom surface of the storage portion to contaminate it. As a result, when the edge end surface of the next dry analysis film piece comes into contact with the contaminated part, the previous liquid sample that had adhered to the ink beta side wall surface adheres to the edge end surface of this dry analysis film piece. As a result, the dry analytical film piece of this time will be contaminated with the liquid sample of the previous time.

Since the dry analytical film pieces are sequentially transferred to the photometric section and the discharge section of the analyzer, the liquid sample oozing out on the edge face may adhere to the photometric section and the discharge section and contaminate them one after another. There is. In particular, when the liquid sample is a biological fluid represented by blood, contamination of the ink beta of the analyzer, the holding jig, the photometric part, the discharge part, etc. with the biological fluid is a cause of pathogenic bacteria. There is a risk of infection of the measurement operator by microorganisms and viruses, which is extremely unfavorable for hygiene.

Incidentally, if the amount of the spotted liquid of the liquid sample is reduced, the above-mentioned contamination may be avoided, but if the amount of the spotted liquid is reduced, the accuracy of the measurement deteriorates, which is not applicable.

Further, with the above-mentioned conventional dry analysis film piece, there is a possibility that accurate photometry cannot be performed. That is, in a dry analytical film piece having a spreading layer made of a porous material such as cloth, non-woven fabric or filter paper (hereinafter, these fibrous porous materials are sometimes referred to as cloth), the edges and edge facets of the spreading layer are In this case, the fabric was frayed, and fiber dust (dust) was generated from the fray, which adversely affected the photometric result.

The present invention provides a dry analysis film piece capable of preventing the contamination of the side wall of the ink beta accommodating part of the analyzer, the photometric part, the discharge part, etc. due to the liquid sample oozing out on the edge surface of the dry analysis film piece. The purpose is to do.

Further, the present invention prevents fraying at the edges and edge end faces of a spreading layer made of a fibrous microporous material such as a cloth, a non-woven fabric or a filter paper. In addition, it is an object of the present invention to provide a dry analysis film piece capable of preventing the generation of fibrous dust (fibrous dust; shredded fibrous dust). Below,
The fiber fraying and the generation of fibrous waste are sometimes referred to simply as fiber fraying.

[0020]

The present invention has been made to achieve the above objects, and a dry analytical film piece according to the first invention is provided on a support and at least an upper surface of the support. A dry analysis film piece having one reagent layer and a spreading layer provided on the upper surface of the reagent layer,
A liquid sample corner arrival prevention means for preventing the liquid sample spotted and spread on the spreading layer from reaching the corner is provided in the spreading layer.

The dry analytical film piece according to the second invention comprises:
In a dry analysis film piece having a support, at least one reagent layer provided on the upper surface of the support, and a development layer provided on the upper surface of the reagent layer, the dry analysis film piece was spotted and developed on the development layer. The liquid sample is the edge of the dry analysis film piece,
A liquid sample edge portion arrival preventing means for preventing the liquid sample edge portion from reaching the edge end surface and its vicinity is provided in the spreading layer.

The dry analytical film piece according to the third invention comprises:
A dry analytical film piece comprising a support, at least one reagent layer provided on the upper surface of the support, and a development layer made of a fibrous microporous material provided on the upper surface of the reagent layer, wherein a development layer is provided. And the fiber fray preventing means at the edges and the edge end faces of the are provided in the spreading layer.

The dry analytical film piece according to the fourth invention comprises:
In a dry analysis film piece having a support, at least one reagent layer provided on the upper surface of the support, and a development layer provided on the upper surface of the reagent layer, the dry analysis film piece was spotted and developed on the development layer. It is characterized in that a means for preventing the liquid sample from oozing out from the edges and edge end faces of the dry analysis film piece (hereinafter, may be simply referred to as a means for preventing oozing out to the liquid sample edge end face) is provided in the spreading layer. Has been done.

[0024]

Detailed Description of Means for Solving the Problems A liquid sample corner arrival prevention means, a liquid sample edge arrival prevention means, a fiber fray prevention means, in a development layer of a dry analysis film piece (chip) of the present invention, Alternatively, means for preventing oozing (or any two or three parties) is provided on the end surface of the liquid sample edge. The liquid sample corner portion arrival preventing means and the liquid sample edge portion arrival preventing means can be formed by the same method except that the positions provided in the development layer are different. As the means for preventing the liquid sample edge end from seeping out, the same method as the method for forming the liquid sample edge portion arrival preventing means can be adopted. The liquid sample edge portion arrival preventing means and the fiber fray preventing means can adopt the same method for forming them. Further, the liquid sample edge portion arrival preventing means, the fiber fraying preventing means, and the liquid sample edge end face bleeding preventing means can adopt the same method as the forming method. In the present specification, the edge of the dry analysis film piece and the end surface of the edge are meant to include the corner and the end surface of the corner, respectively.

The liquid sample corner arrival prevention means, the liquid sample edge arrival prevention means, and the liquid sample edge end surface bleeding prevention means are all the corners, corner end surfaces, edges, and edges of the spreading layer made of a microporous material. The end surface and / or the vicinity thereof have a structure in which a liquid sample cannot penetrate. Examples of structures that cannot be permeated by a liquid sample are to melt fibers of the microporous material or polymers forming the substantial part, and then cool and solidify them to form a substantially non-porous structure, hydrophobic ink, wax, and curing. To fill the micropores of the development layer made of a microporous material with a hydrophobic (or water repellent) or lipophilic material such as a water-soluble polymer, curable glue, or hot melt adhesive,
There is.

The fiber fray preventing means prevents fiber fraying (fiber scraps that are loose and disturbed but not shredded) at the corners, edges and edge end faces of the spreading layer made of a fibrous microporous material, Furthermore, fibrous waste (fibrous waste;
It has a structure that can prevent the generation of shredded fiber waste. As an example of the structure for preventing the fibers from fraying, there is a structure in which the fibers of the fibrous microporous material are heated and melted, and then cooled and solidified. By heating and melting the fibers of the fibrous microporous material and then cooling and solidifying the fibers, a substantially non-porous structure is also formed. Therefore, the liquid sample corner reaching prevention means and / or the liquid sample edge reaching It can also serve as a preventive measure. Nylon and polyethylene terephthalate are examples of fibrous microporous materials that can prevent fiber fraying by heating and melting fibers and then cooling and solidifying them.
There are 100% or a blended fabric of these synthetic fibers and natural fibers such as cotton (knitted fabric, woven fabric).

As an example of the heat treatment means used in the method of heating and melting the polymer or the fiber of the fibrous microporous material forming the substantial part of the microporous material, the heat of heating the electric heater prepared in the shape to be formed is used. There are an ultrasonic head for focusing and injecting ultrasonic energy and a laser light irradiation head for laser light energy irradiation. Since heating and melting by laser light irradiation from the laser light irradiation head can reduce the cross-sectional area and volume of the area to which heat is applied, cooling after heating and melting compared to heating and melting by a hot iron or ultrasonic energy intensive injection head The width of the liquid sample sealing region obtained by solidifying can be reduced. On the other hand, by increasing the irradiation energy, the fibers of the spreading layer are melted and the spreading layer (in the case of the dry analysis film including the spreading layer, the reagent layer and the support, all layers including the support) are also cut. Therefore, there is also an advantage that a cutting step as a separate step as in the case of hot iron or ultrasonic energy heating can be omitted. That is, in the case of hot iron or ultrasonic energy heating,
Laminated support, reagent layer and spreading layer A long piece of dry analysis film is first melted by heating the spreading layer into a predetermined shape with a hot iron or ultrasonic head, and then the melted portion is cut by a cutter. It is necessary to add a step of cutting with a cutting means such as, but in the case of laser light irradiation, the development layer (melting layer, reagent layer and In the embodiment of the dry analysis film including the support, all layers including the support can be cut. The development layer of the dry analysis film piece may have a reagent-containing aspect as described below, or a reagent layer is provided below the development layer, but the reagent-containing development layer or the reagent layer has many In some cases, an enzyme that is weak to heat is contained, but surprisingly, even if the peripheral portion of the spreading layer is heated and melted, the enzyme in the reagent-containing spreading layer or the reagent layer is substantially inactivated or has no activity. It was found not to drop. Regarding the reagent components other than the enzyme contained in the reagent-containing spreading layer or the reagent layer and optionally other layers, even if the peripheral portion of the spreading layer is heated and melted, the reagent components may not be substantially deteriorated. Was found.

In the case of the heating and melting treatment by laser light irradiation, the laser light irradiation conditions are such that, in the case of the heating and melting of the spreading layer, liquid leakage does not occur at the end face portion of the porous spreading layer which is solidified after heating and melting. The irradiation energy condition may be set as follows. When heating and melting the spreading layer as well as heating and cutting to the support, dry analysis that does not cause liquid leakage at the end surface of the porous spreading layer that is solidified by heating and at the same time includes the support The irradiation energy condition may be set so that the entire film can be cut. The irradiation conditions are, for example, in the case of a carbon dioxide laser, the output energy is in the range of about 10 W to about 25 W in the case of heating and melting the edge face of the spreading layer,
The heating and melting rate is in the range of about 8 m / min to about 10 m / min, and the output energy is about 10 W in the case of the melting and cutting of the end face of the spreading layer and the heating and melting of the entire dry analysis film including the support.
To about 150 W, heating and melting cutting speed about 1 m / min to about 20
It is in the range of m / min.

As a processing means used in the method of filling the micropores of the spreading layer made of a microporous material to form a substantially non-porous structure, a hydrophobic (or water repellent) material or a lipophilic material is used. There is a way to pack. Specific examples of materials used for these treatments include curable hydrophobic materials, waxes,
There are curable polymers, curable glues, hot melt adhesives and the like. Specific examples of the hydrophobic (or water repellent) material or lipophilic material used for these treatments are as follows.

Curable hydrophobic material; light or UV curable adhesive, liquid photoresist wax (wax); solid botanical wax (eg carnauba wax, cotton wax), solid animal wax (eg, wax) Beeswax) Curable polymer; Low melting point or low softening point organic polymer (eg waxy polyethylene oxide, amorphous polyethylene) Curable adhesive or curable glue; Two-part epoxy resin adhesive Hot melt adhesive; Melt Hot melt adhesive with low viscosity in the state (120 ° C to 200 ° C) and high viscosity at room temperature Examples of shape: sheet, string, thread hydrophobic material; ballpoint ink, oily quick-drying writing instrument (trade name) "Magic ink") ink, printing ink Water repellent material; Liquid or low melting point silicone polymer, Liquid or low melting point fluorine-containing polymer

The liquid sample corner arrival preventing means has at least four corners of the development layer (the shape of the dry analysis film piece is set so as to prevent the liquid sample from developing and reaching the area of the development layer which the pressing jig contacts. In the case of a shape without a corner such as a circular shape or an elliptical shape, the micropores of the development layer are clogged in (the part of the development layer where the pressing jig abuts) and its vicinity (hereinafter sometimes simply referred to as clogging). Alternatively, in a mode in which the fiber or polymer of the microporous material is heated and melted, and then cooled and solidified to form a substantially non-porous structure (hereinafter, may be simply referred to as melt-non-porous). is there. As an example,
The shape of the area larger than the tip of the pressing jig is included so as to include the shape of the tip of the area where the pressing jig abuts. There is linear filling or melt non-porosification on the center side (inside) of the layer.

The liquid sample edge portion arrival preventing means and the liquid sample edge end surface bleeding preventing means are arranged so that the liquid sample developed on the edge (periphery) and the edge end surface of the development layer of the dry analysis film piece reaches the edge end surface. In order to prevent it from coming out, the dry analysis film piece should be formed by filling or melting non-porosity in a shape that continuously surrounds the circumference of a predetermined development shape around the spotted part of the development layer. You can When the liquid sample edge portion arrival preventing means is formed on the center side (inner side) of the development layer from the portion in contact with the holding jig, it also has a function as the liquid sample corner portion arrival preventing means. Further, when the liquid sample edge portion arrival prevention means or the liquid sample edge end face bleeding prevention means is formed on all the edges (periphery) of the spreading layer, in a mode having the fibrous spreading layer, it also functions as a fiber fray preventing means. It is possible to prevent fraying of fibers on the edge face and generation of fiber scraps.

The liquid sample corner portion arrival preventing means, the liquid sample edge portion reaching and spreading preventing means, the fiber fraying preventing means, and the liquid sample edge end face bleeding preventing means are all formed by forming a large area on the surface of the spreading layer. Since the part can be mechanically gripped, it is possible to adopt a means for transporting the dry analytical film piece other than the vacuum suction pad.

The structure of the dry analysis film piece (chip) of the present invention will be described below. The dry analysis film piece is prepared by cutting the dry analysis film into a predetermined shape. The basic structure of the dry analytical film piece is such that a reagent layer and a spreading layer are laminated and integrated on a support in this order.

A reinforcing sheet-shaped member or thin plate-shaped member can be laminated and adhered to the lower portion of the support for the purpose of increasing the rigidity of the support (strengthening the waist). The support and the reinforcing sheet-shaped member or thin plate-shaped member each have a function of maintaining the flatness of the dry analytical film piece. further,
The support and the reinforcing sheet-like member or thin plate-like member that may be laminated and adhered are preferably light-transmitting.
Examples of the support and the reinforcing sheet-shaped member or thin plate-shaped member are organic polymer sheets such as polyethylene terephthalate (PET) and polystyrene. Generally, the reinforcing sheet-shaped member or thin plate-shaped member is preferably a sheet-shaped or thin plate-shaped member of an organic polymer having the same thickness as the support, or thicker than the support and having high rigidity (stiffness). The thickness of the support is in the range of about 100 μm to about 1000 μm, preferably about 150 μm to about 300 μm. The thickness of the reinforcing sheet member or thin plate member is about 150 μm to about 1000
μm, preferably in the range of about 180 μm to about 500 μm.

The support and the reinforcing sheet-like member or thin plate-like member which may be laminated and adhered are not particularly limited in shape and size as long as the flatness of the dry analytical film piece can be maintained. For example, the shape may be a square, a rectangle, a circle, or the like, and is usually the same as the shape of the reagent layer described later. The size may be the same as, smaller or larger than that of the reagent layer as long as the flatness of the dry analysis film piece can be maintained. When the support or the reinforcing sheet-like member or thin plate-like member that may be laminated and adhered has a shape protruding from the reagent layer, the protruding portion can be sandwiched at the time of transportation, so that the selection range of the transportation means is widened. become.

The support and the reinforcing sheet-like member or thin plate-like member which may be laminated and bonded together are generally configured to allow light to pass therethrough. In order to pass light, the support, the reinforcing sheet-shaped member or the thin plate-shaped member itself may be formed of a transparent material that allows light to pass through, or a light-passing hole should be provided in a portion through which light passes during photometry. You may make it pass light. Examples of materials that transmit light include polymers having excellent transparency such as polyethylene terephthalate, polystyrene, and acrylic polymers represented by polymethylmethacrylate. Also,
The light passage hole may be any one that allows light to pass therethrough at the time of photometry, and may have, for example, a circular shape, an elliptical shape, a square shape, a rectangular shape, or the like.

The reagent layer is formed, for example, in a hydrophilic polymer binder such as gelatin, polyacrylamide, polyvinyl alcohol or the like, directly or indirectly (with the reaction of the previous step) with an analyte (a biochemical component to be quantitatively analyzed). Via a chemical reaction, a biochemical reaction or an immunological reaction, thereby containing at least one reagent component necessary for a color development (dye formation) or a color change reaction for detecting and quantifying an analyte. It is composed of layers. However, some dry analytical films for quantification such as hemoglobin do not require a reagent component substantially only with a hydrophilic polymer binder.

The spreading layer may be selected from known fibrous microporous materials and non-fibrous microporous materials. Examples of the spreading layer include JP-A-55-164356 (corresponding US Pat. No. 4,292,272) and JP-A-57-66359 (corresponding US Pat.
3,315) and the like (for example, plain knitted fabrics such as broad and poplin), JP-A-60-222769 (corresponding EP).
Japanese Patent No. 0,162,302A) and other knitted fabric spreading layers (eg, tricot knitted fabrics, double tricot knitted fabrics, Milanese knitted fabrics), organic polymer fiber pulp-containing papermaking spreading layers described in JP-A-57-148250, A fibrous porous spreading layer such as a spreading layer formed by applying a dispersion liquid of the fiber and hydrophilic polymer described in JP-A-57-125847; a membrane filter described in JP-B-53-21677 (corresponding US Pat. No. 3,992,158). Layer (brush polymer layer), continuous microvoid-containing isotropic porous development layer in which fine particles such as polymer microbeads are bonded in a point-contact manner with a hydrophilic polymer binder, JP-A-55-90859 (corresponding US Pat. No. 4,258,001). ) Etc., isotropic porous layer (three-dimensional lattice-like granular structure layer) spreading layer containing continuous microvoids formed by adhering in a point-contact manner with a polymer adhesive that does not swell with water Nonfibrous isotropic porous spreading layer; JP 61-4959 (corresponding to U.S. Patent 5,019,34
7), JP 62-138756, JP 62-138757, JP 62-
138758 (corresponding EP Patent No. 0,226,465A) and the like, a plurality of microporous layers (eg, two layers of woven fabric or knitted fabric and membrane filter, three layers of woven fabric or knitted fabric, membrane filter and woven fabric or knitted fabric) There is a spreading layer having excellent blood cell separation ability, which is obtained by laminating and adhering each of the above) with an adhesive having fine discontinuous dots or islands (dotted dots in the printing field) arranged at their mutual interfaces.

In the present specification, a dry analysis film piece is also prepared by adhering a filter paper type test element or a modified single layer or multi-layered test element to the above-mentioned substrate with a known suitable adhesive. include.

The shape of the dry analysis film piece (dry analysis film chip) is generally a small piece (chip) such as a square, a rectangle, a circle, and an ellipse, and the size (dimension) is
In the case of a square or rectangle, the length of one side is in the range of about 10 mm to about 20 mm, in the case of a circle, the diameter is in the range of about 10 mm to about 20 mm, and in the case of an ellipse, both the major axis and the minor axis are in the range of about 10 mm to about 20 mm, the thickness. The size is in the range of about 350 μm to about 1.5 mm for both shapes.
From the viewpoint of analytical operation and ease of production, the shape of the dry analytical film piece is preferably a square or a rectangle close to a square.

The biological components that can be quantitatively analyzed by the dry analytical film piece of the present invention include, for example, blood glucose (glucose),
Cholesterol, urea nitrogen (BUN), creatinine,
There are bilirubin, hemoglobin, GOT (glutamate oxaloacetate transferase), GPT (glutamate pyruvate transferase), amylase, and C-reactive protein (CRP).

[0043]

In the dry analytical film piece according to the first aspect of the invention, the means for preventing the liquid sample corner from reaching the corner of the spreading layer, which is in contact with the pressing jig for the ink beta, has the means for preventing the liquid sample from reaching the corner of the dry analytical film piece. By preventing the liquid sample from reaching, the contamination of the holding jig due to the adhesion of the liquid sample to the vicinity of the tip of the holding jig is prevented.

In the dry analytical film piece according to the second aspect of the invention, the liquid sample edge portion arrival preventing means prevents the liquid sample from reaching the edge and the edge end face from the spotted portion at the center of the dry analytical film piece, and is developed. Prevents the liquid sample from bleeding at the edge surface of the layer, prevents the liquid sample from adhering to and contaminating the ink beta, photometric unit, discharge unit, etc. of the analyzer, or not measuring light after spotting the liquid sample. It prevents the liquid sample from adhering to and contaminating the other dry analysis film pieces.

In the dry analytical film piece having the spreading layer made of the fibrous porous material such as the cloth, the non-woven fabric or the filter paper of the third invention, the fibers of the spreading layer are prevented from fraying at the edges and edge end faces of the spreading layer. The generation of (dust) is prevented, and as a result, the adverse effect on the photometric result is eliminated.

In the dry analysis film piece of the fourth invention, the means for preventing the liquid sample from bleeding from the edge and edge end face (also serving as preventing the liquid sample from reaching the corners) is spotted on the center of the dry analysis film piece. The liquid sample from the edges to the edges and edge end faces (including the corner end faces) to prevent the liquid sample from bleeding at the edge end face of the development layer, and to prevent the ink beta, photometric unit, and discharge of the analyzer. Prevents liquid sample from adhering to parts and contaminating,
Alternatively, the liquid sample is prevented from adhering to and contaminating other dry photometric film pieces that have not been measured after the liquid sample has been spotted, and the jig for holding the ink beta from the spotting point at the center of the dry analytical film piece. By preventing the liquid sample from reaching the abutting corners, the contamination of the holding jig due to the adhesion of the liquid sample to the vicinity of the tip of the holding jig is prevented.

[0047]

EXAMPLE An example of a dry analysis film piece according to the present invention will be described with reference to the drawings.

The fibrous spreading layer was heat-melted under the following conditions. 100% polyester (polyethylene terephthalate) thickness about 150μm ~ about 300μm knit fabric, 100% polyester thickness about 150μm ~
For plain weave fabrics of about 200 μm, 0.1 to 0 at 350 ° C to 450 ° C.
It was heated and melted for 5 seconds.

About 65% polyester, 35% cotton blend thickness
150μm-300μm knit fabric, polyester
In the case of a plain woven fabric having a thickness of about 150 μm to about 200 μm, which is a blended fabric of 65% and 35% cotton, it was heated and melted at 500 ° C. for 0.2 to 0.5 seconds.

FIGS. 1 to 4 are plan views of an embodiment of a dry analytical film piece in which a liquid sample corner arrival preventing means according to the first invention is provided in a spreading layer.

The dry analytical film piece 1 shown in FIG. 1 is melted by heating the corner of the spreading layer as a means for preventing the liquid sample corner from reaching the corner of the spreading layer 2 including the portion a where the pressing jig abuts. After that, the molten portion 3 is formed in a triangular shape by allowing it to stand at room temperature or sending cold air to cool and solidify it to make it substantially non-porous. Below the development layer 2, a reagent layer (not shown) and a support (not shown) are provided.

The dry analytical film piece 1 shown in FIG. 2 has a liquid sample corner formed on the inside of a portion a of the spreading layer 2 where the pressing jig abuts, over two sides of an edge forming a corner including the abutting portion a. As a means for preventing partial arrival, a melting portion 3 is formed in which the corner portion of the spreading layer is heated and melted and then left at room temperature or cooled by blowing cool air to be solidified to be substantially non-porous.

The dry analytical film piece 1 shown in FIG. 3 has a corner portion of the spreading layer as a liquid sample corner portion arrival preventing means inside the portion a of the spreading layer 2 where the pressing jig abuts, over two opposite sides. Is melted by heating and then left at room temperature or by sending cold air to be cooled and solidified to form a substantially non-porous melting portion 3.

The dry analytical film piece 1 shown in FIG. 4 is parallel to two opposing sides including a portion a of the spreading layer 2 where the pressing jig abuts, and is a corner portion of the spreading layer as a means for preventing the liquid sample corner portion from reaching. Is melted by heating and then left at room temperature or by sending cold air to be cooled and solidified to form a substantially non-porous melting portion 3.

FIGS. 5 to 12 are plan views of an embodiment of a dry analytical film piece in which the liquid sample edge portion arrival preventing means according to the second invention is provided in the spreading layer. Depending on the embodiment, it also serves as an embodiment in which the liquid sample corner arrival preventing means according to the first invention or the fiber fray preventing means according to the third invention is provided in the spreading layer.

The dry analytical film piece 1 shown in FIG.
As a means for preventing the liquid sample edge portion from reaching, a melting portion 4 is formed which is substantially non-porous by heating and melting the development layer in an annular shape and then leaving it at room temperature or sending cold air to cool and solidify it. There is. In this embodiment, it also has the function and effect as a means for preventing the liquid sample corner portion from reaching.

The dry analytical film piece 1 shown in FIG. 6 has the development layer 2 on the outside of the portion a where the pressing jig contacts.
As a means to prevent the liquid sample from reaching the edge part, the development layer is heated in a quadrilateral shape along all edges to make it useful, and then left at room temperature or cooled by blowing cool air to solidify it and make it substantially non-porous. The part 4 is formed. In this embodiment, it is possible to prevent the fibers from fraying on the edges and edge end faces of the spreading layer 2 in the mode having the fibrous spreading layer.

The dry analytical film piece 1 shown in FIG. 7 has the development layer 2 on the outside of the portion a where the pressing jig contacts.
As a means to prevent the liquid sample edge from reaching the edge parallel to
A quadrilaterally shaped spreading layer is heated along the edge and melted, and then left at room temperature or cooled by blowing cold air to be solidified to be substantially non-porous to form a melting portion 4 and a corner portion. As a means for preventing the liquid sample corner from reaching the portion a where the pressing jig abuts, the corner of the spreading layer is heated and melted and then left at room temperature or cooled by blowing cool air to solidify to substantially non-hole. The liquefied brace-shaped melted portion 3 is formed.
In this embodiment, it is possible to prevent the fibers from fraying on the edges and edge end faces of the spreading layer 2 in the embodiment having the fibrous spreading layer, as well as having the function and effect as the liquid sample corner arrival preventing means.

In the dry analysis film piece 1 shown in FIG. 8, the development layer was heated and melted in the development layer 2 at the corner portion including the portion a where the pressing jig abuts, as the liquid sample corner arrival prevention means. After that, the molten portion 3 which is left at room temperature or cooled by blowing cold air to be solidified to be substantially non-porous is formed, and as a liquid sample edge portion arrival preventing means, a quadrilateral shape is formed along all edges. A molten portion 4 is formed in which the spread layer is heated and melted and then left standing at room temperature or cooled by blowing cold air to be solidified to be substantially non-porous. In this embodiment, the spreading layer 2 has a function and effect as a means for preventing the liquid sample corner portion from reaching, and has a fibrous spreading layer.
It is possible to prevent the fibers from fraying on the edges and edge end faces.

In the dry analysis film piece 1 shown in FIG. 9, the development layer was heated and melted at the corner portion of the development layer 2 including the portion a where the pressing jig abuts, as a liquid sample corner arrival prevention means. After that, the molten portion 3 which is left at room temperature or cooled by blowing cold air to be solidified to be substantially non-porous is formed, and as a means for preventing the liquid sample edge portion from reaching, one of the two edges facing each other is formed. A wide strip of the spreading layer is heated and melted, and then left at room temperature or cooled by blowing cold air to be solidified to be substantially non-porous to the melted portion 4 and the other two edge edges facing each other. A narrow, linear, substantially non-porous fusion zone 4 is formed along the side. In this embodiment, it is possible to prevent the fibers from fraying on the edges and the edge end faces of the spreading layer 2 in the mode having the fibrous spreading layer, as well as having the function and effect as the liquid sample corner arrival preventing means.

The dry analytical film piece 1 shown in FIG.
As a means for preventing the liquid sample edge portion from reaching, a melting portion 4 is formed which is substantially non-porous by heating and melting the development layer in an annular shape and then leaving it at room temperature or sending cold air to cool and solidify it. At the same time, as a means for preventing the arrival of the liquid sample edge portion on the outside of the portion a where the pressing jig comes into contact, the spread layer is heated and melted in a quadrilateral shape along the edge and then left at room temperature or cooled by sending cool air. A melted portion 4 that is solidified to be substantially non-porous is formed. In this embodiment, it has a function and effect as a means for preventing the liquid sample corner portion from reaching, and
In the embodiment having a fibrous spreading layer, it is possible to prevent the fibers of the edges and edge end faces of the spreading layer 2 from fraying.

In the dry analysis film piece 1 shown in FIG. 11, the periphery of the spotting portion, which is the center point, is left in a circular shape, and the remaining region is used as a means for preventing the liquid sample edge portion from reaching, and the spreading layer is heated and melted. After that, the molten portion 4 is formed by leaving it to be at room temperature or sending cool air to cool and solidify it to make it substantially non-porous. In this embodiment, it is possible to prevent the fibers from fraying on the edges and the edge end faces of the spreading layer 2 in the mode having the fibrous spreading layer, as well as having the function and effect as the liquid sample corner arrival preventing means.

The dry analytical film piece 1 shown in FIG. 12 has the development layer 2 on the outside of the portion a where the pressing jig abuts,
As a means to prevent the liquid sample from reaching the edge, it melts by heating the spread layer in a quadrilateral shape along all edges and then leaving it at room temperature or by sending cold air to cool and solidify it to make it substantially non-porous. Inside the part a where the part 4 is formed and the pressing jig abuts, as a liquid sample corner arrival prevention means, it is heated and melted in parallel narrow lines along two opposing edges. After that, the molten portion 3 is left to stand at room temperature or cooled by blowing cold air to be solidified to be substantially non-porous to form the molten portion 3. In this embodiment, it is possible to prevent the fibers from fraying on the edges and the edge end faces of the spreading layer 2 in the embodiment having the function and effect as a means for preventing the liquid sample corner portion from reaching and also having the fibrous spreading layer.

In the embodiment shown in FIGS. 1 to 12,
The liquid sample corner arrival prevention means, the liquid sample edge arrival prevention means and the fiber fray prevention means are all substantially non-existent by heating and melting the spread layer and then leaving it at room temperature or sending cold air to cool and solidify. Although it is formed by the molten portion that has been made porous, it is also possible to fill the pores of the spreading layer with a hydrophobic (or water-repellent) or lipophilic material so that the pores shown in FIGS.
The liquid sample corner arrival prevention means, the liquid sample edge arrival prevention means, and the fiber fray prevention means having a shape similar to that shown in FIG. Specific examples of preferable materials for filling the micropores of the development layer include solid waxes at room temperature (wax), waxy polyethylene oxide, amorphous polyethylene, hot melt adhesives, liquid photoresists,
There is.

[0065]

According to the dry analytical film piece of the first invention,
By preventing the liquid sample from reaching the corner of the dry analysis film piece from the spotted portion at the substantially center of the dry analysis film piece to the corner where the holding jig of the ink beta comes into contact, the liquid sample reaches the vicinity of the tip of the holding jig. Contamination of the pressing jig due to the attachment of the liquid sample is prevented.

In the dry analytical film piece according to the second aspect of the invention, the liquid sample edge portion arrival preventing means prevents the liquid sample from reaching the edge and the edge end face from the spotted portion substantially at the center of the dry analytical film piece. The bleeding of the liquid sample on the edge end surface of the layer is prevented, and the liquid sample is prevented from adhering to and contaminating the ink beta, the photometric section, the discharge section, etc. of the analyzer. The liquid sample is prevented from adhering to and contaminating the other dry analysis film pieces for photometry.

In the dry analytical film piece having the spreading layer made of the fibrous porous material such as the cloth, the non-woven fabric or the filter paper of the third invention, the fibers of the spreading layer are prevented from fraying at the edges and edge end faces of the spreading layer. The generation of (dust) is prevented, and as a result, the adverse effect on the photometric result is eliminated.

In the dry analysis film piece of the fourth invention, the means for preventing bleeding from the edge of the liquid sample and the edge end face (which also serves as the prevention of reaching the corner of the liquid sample) is a spot on the center of the dry analysis film piece. It also prevents the liquid sample from reaching the edges and edge end faces (including the corner end faces) from bleeding at the edge end face of the development layer, and prevents the ink beta, photometric unit, and discharge unit of the analyzer. It prevents liquid sample from adhering to and contaminating
Alternatively, the liquid sample can be prevented from adhering to and contaminating other dry photometric film pieces that have not been measured after the liquid sample has been spotted, and the ink beta can be suppressed from the spotted spot in the center of the dry analytical film strip. By preventing the liquid sample from reaching the corners of the tool where it abuts, contamination of the pressing jig due to the adhesion of the liquid sample to the vicinity of the tip of the pressing jig is prevented.

Further, in any of the dry analysis film pieces of the first invention, the second invention, the third invention and the fourth invention, the dry analysis film piece storage section and the pressing jig inside the ink beta of the analyzer. Via the liquid sample attached to
The dry analysis film pieces stored later are prevented from being contaminated. Further, since the liquid sample does not ooze out from the edge end surface of the spreading layer, the spotting amount of the liquid sample can be increased, so that the measurement accuracy can be improved. Further, since it is not necessary to position the liquid sample on the dry analysis film piece with high precision at the center of the dry analysis film piece, the accuracy of the liquid sample spotting pipette tip etc. may be gentle, so the liquid sample spotting device Can be cheaper.

[0070]

Preferred Embodiment of the Invention

(1) The dry analytical film according to claim 1, wherein the liquid sample corner portion arrival preventing means is formed by heating and melting the spreading layer, and then cooling and solidifying to substantially non-porous. One piece.

(2) The liquid sample corner arrival preventing means is formed by impregnating the fine pores of the spreading layer with a hydrophobic or lipophilic substance to fill the fine pores. A piece of dry analytical film.

(3) The liquid sample edge portion arrival preventing means is formed by heating and melting the spreading layer, then cooling and solidifying to substantially non-porous.
The dry analytical film piece described in 1.

(4) The liquid sample edge portion arrival preventing means is formed by impregnating the fine pores of the spreading layer with a hydrophobic or lipophilic substance to fill the fine pores. A piece of dry analytical film.

(5) The fiber fray preventing means is formed by heating and melting the fibrous microporous material forming the spreading layer, then cooling and solidifying to substantially non-porous. Item 5. A dry analytical film piece according to item 3.

(6) The fiber fray preventing means is formed by impregnating the fine pores of the fibrous microporous material forming the spreading layer with a hydrophobic or lipophilic substance to fill the fine pores. Item 5. A dry analytical film piece according to item 3.

(7) The spread layer comprises a woven fabric, a knitted fabric, a non-woven fabric or a filter paper.
The dry analytical film piece according to any one of (3) and (4).

(8) The means for preventing oozing from the edges and edge surfaces of the liquid sample is formed by heating and melting the spreading layer, then cooling and solidifying to substantially non-porous. The dry analytical film piece according to claim 4.

(9) The means for preventing bleeding from the edge and edge surface of the liquid sample is formed by impregnating the fine pores of the spreading layer with a hydrophobic or lipophilic substance to fill the fine pores. The dry analytical film piece according to claim 4.

(10) The embodiment (3) or the embodiment in which the liquid sample edge portion arrival preventing means also serves as the fiber fray preventing means.
The dry analytical film piece according to (4).

(11) The means for heating and melting the spread layer is either an electric heater heating iron, an ultrasonic head for concentrating and injecting ultrasonic energy, or a laser light irradiation head for concentrating laser light energy. Certain embodiment terms
The dry analytical film piece according to (1).

(12) The means for heating and melting the spreading layer is either an electric heater heating iron, an ultrasonic head for concentrating and injecting ultrasonic energy, or a laser light irradiation head for concentrating laser light energy. Certain embodiment terms
The dry analytical film piece according to (3).

(13) The means for heating and melting the fibrous microporous material forming the spreading layer is an electric heater heating iron, an ultrasonic head for concentrating and injecting ultrasonic energy, and a laser light energy concentrating means. The dry analytical film piece according to item (5) or (7), which is one of a laser beam irradiation head.

(14) The means for heating and melting the spreading layer is either an electric heater heating iron, an ultrasonic head for concentrating and injecting ultrasonic energy, or a laser light irradiation head for concentrating laser light energy. Certain embodiment terms
The dry analytical film piece according to (8).

[Brief description of drawings]

FIG. 1 is a plan view of an example of a dry analysis film piece in which a liquid sample corner arrival prevention unit is provided in a spreading layer.

FIG. 2 is a plan view of another embodiment of the dry analysis film piece in which the liquid sample corner arrival prevention means is provided in the spreading layer.

FIG. 3 is a plan view of another embodiment of the dry analysis film piece in which the liquid sample corner arrival preventing means is provided in the spreading layer.

FIG. 4 is a plan view of another embodiment of the dry analytical film piece in which the liquid sample corner arrival preventing means is provided in the spreading layer.

FIG. 5 is a plan view of an embodiment of a dry analysis film piece in which a liquid sample edge portion arrival preventing means (also serving as a liquid sample corner portion arrival preventing means) is provided in the development layer.

FIG. 6 is a plan view of another embodiment of the dry analytical film piece in which the liquid sample edge portion arrival preventing means (also serving as fiber fray preventing means) is provided in the spreading layer.

FIG. 7 is a plan view of another embodiment of the dry analysis film piece in which the liquid sample edge portion arrival preventing means (which also serves as the liquid sample corner portion arrival preventing means and the fiber fray preventing means) is provided in the development layer.

FIG. 8 is a plan view of another embodiment of the dry analytical film piece in which the liquid sample edge portion arrival preventing means (which also serves as the liquid sample corner portion arrival preventing means and the fiber fray preventing means) is provided in the spreading layer.

FIG. 9 is a plan view of another embodiment of the dry analytical film piece in which the liquid sample edge portion arrival preventing means (also serving as the liquid sample corner portion arrival preventing means and the fiber fray preventing means) is provided in the development layer.

FIG. 10 is a plan view of another embodiment of the dry analytical film piece in which the liquid sample edge portion arrival preventing means (also serving as the liquid sample corner portion arrival preventing means and the fiber fray preventing means) is provided in the development layer.

FIG. 11 is a plan view of another embodiment of the dry analysis film piece in which the liquid sample edge portion arrival preventing means (also serving as the liquid sample corner portion arrival preventing means and the fiber fray preventing means) is provided in the development layer.

FIG. 12 is a plan view of another embodiment of the dry analysis film piece in which the liquid sample edge portion arrival preventing means (which also serves as the liquid sample corner portion arrival preventing means and the fiber fray preventing means) is provided in the spreading layer.

FIG. 13 is a schematic view of an analyzer using a dry analysis film piece.

FIG. 14 is a lateral cross-sectional view of a storage portion of an ink beta of an analyzer using a dry analysis film piece.

15 is a cross-sectional view taken along the line AA in FIG.

[Explanation of symbols]

DESCRIPTION OF SYMBOLS 1 ... Dry analytical film piece 2 ... Development layer 3 ... Melt non-perforated part of the development layer outside the portion where the pressing jig abuts (liquid sample corner portion arrival preventing means) 4 ... Melt part at the edge periphery of the development layer Non-porous portion (liquid sample edge portion arrival preventing means and / or fiber fraying preventing means) 5 ... Melt non-porous portion (liquid sample edge portion) of the spreading layer on the center side (inner side) from the portion where the pressing jig contacts Reaching prevention means) a ... A part where the pressing jig contacts 10 ... Dry analysis film piece 20 ... Dry analysis film piece storage section 30 ... Dry analysis film piece transport section 40 ... Liquid sample spotting section 50 ... Ink beta 51 ... Ink beta Main body 52 ... Dry analysis film piece carry-in hole 53 ... Dry analysis film piece storage section 54 ... Corner section 55 ... Photometric window 56 ... Ring groove 57 ... Tapered section for guiding dry analysis film piece 58 ... For preventing evaporation of liquid sample Lid 59 ... Piece of dry analysis film Pressing jig 60 ... metering portion 70 ... dry analytical film chip discharge portion for holding

Front page continuation (72) Inventor Osamu Soshimoto 3-11-46 Izumi, Asaka-shi, Saitama Fuji Shashin Film Co., Ltd.

Claims (4)

[Claims] 1. A dry analytical film piece having a support, at least one reagent layer provided on the upper surface of the support, and a development layer provided on the upper surface of the reagent layer, wherein a dot is provided on the development layer. A dry analytical film piece, wherein the spread layer is provided with a liquid sample corner arrival preventing means for preventing the deposited and spread liquid sample from reaching the corner. 2. A dry analytical film piece having a support, at least one reagent layer provided on the upper surface of the support, and a development layer provided on the upper surface of the reagent layer, wherein a dot is provided on the development layer. A dry sample characterized in that the spread sample is provided with a liquid sample edge portion arrival preventing means for preventing the deposited and spread liquid sample from reaching the edge of the dry analysis film piece, the edge end face and the vicinity thereof. Analytical film strip. 3. A dry analysis film having a support, at least one reagent layer provided on the upper surface of the support, and a development layer made of a fibrous microporous material provided on the upper surface of the reagent layer. In the strip, the dry analysis film strip is characterized in that edges of the spreading layer and fiber fray preventing means at the edge end face are provided in the spreading layer. 4. A dry analytical film piece having a support, at least one reagent layer provided on the upper surface of the support, and a development layer provided on the upper surface of the reagent layer, wherein the development layer has dots. A dry analysis film piece, wherein the spread layer is provided with means for preventing the deposited and spread liquid sample from oozing out from the edges and edge end faces of the dry analysis film piece.