JP3326004B2 - Dry analysis film piece - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a chemical reaction, a biochemical reaction or an immunoreaction with a predetermined biochemical substance (hereinafter referred to as "test component" or "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 thereby into small pieces (chips) of a specific shape (square, rectangular, circular, oval, etc.). Things.

[0002]

2. Description of the Related Art Generally, qualitatively or quantitatively analyzing 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, the quantitative analysis of the content of a specific analyte contained in the liquid sample or the activity value thereof, or the content of the formed material has been carried out simply by spotting and supplying small droplets of the liquid sample. An integrated multi-layer analytical film (also referred to as a multi-layer analytical element or a multi-layer analytical element) of a dry analytical method (dry chemistry) which can be used has been developed (Japanese Patent Publication No. 53-21677 (US Pat. No. 3,992,158), and 164356 (US Patent
No. 4,292,272) and JP-A-57-42951). Further, a filter paper type test piece or a monolayer or multilayer test piece obtained by improving the same (Japanese Patent Application Laid-Open No. 57-53661 (U.S. Pat.
No. 77,575) have been proposed and some of them have been put to practical use. The use of these dry analysis films makes it possible to carry out quantitative analysis of analytes in liquid samples more easily and quickly than conventional wet analysis methods (wet chemistry). It is useful in medical institutions, research laboratories, and the like where it is necessary to analyze.

To perform quantitative analysis of an analyte in a liquid sample using such a dry analysis film, a liquid sample is applied to a dry analysis film. In this case, after being spotted on the reagent layer (directly on the reagent layer), the ink is kept at a constant temperature (incubation) for a predetermined time in an ink beta (constant temperature device) to cause a color reaction (dye formation reaction). The reflection optical density is measured by irradiating this dry analysis film with irradiation light for measurement containing a wavelength selected in advance by a combination of a light and a reagent contained in the dry analysis film, and the reflection optical density is determined in advance from the optical density value. The substance concentration of a specific analyte in a liquid sample is determined by the principle of colorimetry using a calibration curve representing the correspondence between the set optical density value and the substance concentration or activity value of a predetermined analyte. Or those seeking activity value.

The above-mentioned 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 developing layer is provided above 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 (frame) made of an organic polymer. By accommodating the dry analysis film pieces in the slide frame, the dry analysis film that easily warps when dried can be maintained in a flat state.

However, an analyzer using the above-mentioned dry analysis slide has a tendency to increase in size. That is, large medical institutions consume large amounts of analysis slides in a short time, so large cartridges are used, and it is necessary to provide a number of cartridges corresponding to the number of analytes to be analyzed. This increases the space required for the cartridge.

[0007] 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, and further, the presence of the frame increases the size of the cartridge, the ink beta and the like. .

Accordingly, the present inventors have developed a dry analysis apparatus which enables a dry analysis film piece (dry analysis film chip) to be used as it is (without storing the dry analysis film piece in a frame). Suggested
(Japanese Patent Application No. 04-99823, EP 0 567 057 A).

FIG. 13 shows an example of an embodiment of the dry analyzer.
As shown in FIG. 3, a dry analysis film piece storage section 20 for storing unused dry analysis film pieces 10 and a dry analysis film piece transport section 30 for taking out the dry analysis film piece 10 from the storage section 20 and sending it to an ink beta described later. And a spotting section 40 for spotting the liquid sample on the dry analysis film piece 1 in the middle of the transport path of the dry analysis film piece transport section 30, and a dry analysis film on which the liquid sample is spotted by the spotting section 40. An ink beta 50 that holds the piece 10 at a constant temperature for a predetermined time, a photometric unit 60 that measures the reflection optical density of the dry analytical film piece 10 that has produced a color reaction with the ink beta 50, and a dry type photometer that is measured by the photometric unit 60. A dry analysis film piece discharging section 70 for discharging the analysis film piece 10 from the ink beta 50 is provided.

In the ink beta 50, a disk-shaped ink beta main body 51 is rotatably supported, and a heating means (not shown) is built in the main body 51 to maintain the inside at a constant temperature of about 37 ° C. ing. Also, on the side surface of the main body 51, a carry-in hole for carrying the dry analysis film pieces 10 at a predetermined interval on the circumference.
A large number of 52 are formed, and a storage section 53 for storing the dry analysis film piece 10 is formed following the carry-in hole 52.

As shown in FIGS. 14 and 15, the storage section 53 has a rectangular planar shape larger than the dry analysis film piece 10 and has four corners (four corners) of the stored dry analysis film piece 10. A corner portion corresponding to a corner has a corner portion 54 protruding inward. Further, a light metering window 55 is opened at a central portion of the storage portion 53, and a ring groove 56 into which a light measuring head described later is formed is formed at a lower portion of the light metering window 55. A tapered portion 57 for guiding the dry analysis film piece 10 is formed. Further, 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 a holding jig 59 for holding down the dry analysis film piece 10 to correct deformation is formed at four corners on the lower surface of the lid 58.

[0012]

However, in the above-described analyzer using the conventional dry analysis film piece, in the case of the dry analysis film piece having a development layer made of a microporous material, the analysis is not performed. The liquid sample may reach the edge and edge end face (peripheral end face) of the spreading layer and ooze out from the edge end face. In the case of a liquid sample having a low viscosity, the spreading layer or (dry analysis without the spreading layer) The liquid sample may diffuse on the surface of the reagent layer (especially in the case of a film piece) and reach the edges and edge end faces of the reagent layer, and may ooze out of the edge end face.
It has been found that there is a risk of contaminating the ink beta, the photometric unit, the discharge unit, and the like of the analyzer, and of contaminating other dry analytical film pieces that have not been subjected to photometry after the liquid sample has been spotted.

That is, since the dry analysis film piece is deformed by drying, the dry analysis film piece is held down by the lid having the holding jig in the storage portion of the dry analysis film piece of the ink beta. Accordingly, when the liquid sample spotted on the dry analysis film piece was spread and reached the four corners and reached the vicinity of the corner where the holding jig abuts, the dry analysis film piece was pressed by the holding jig. At this time, the liquid sample adheres to the holding jig and contaminates the holding jig. When the next dry analysis film piece is pressed by the holding jig contaminated with the previous liquid sample, the previous liquid sample attached to the holding jig adheres to the current dry analysis film piece. Therefore, the dry analysis film piece of this time is contaminated with the previous liquid sample.

Further, when the liquid sample spotted on the dry analysis film piece is spread and reaches the edge of the dry analysis film piece and oozes from the edge end face, the liquid sample wets the edge end face of the dry analysis film piece. Becomes
In the storage portion of the dry analysis film piece of the ink beta, since the edge surface of the dry analysis film piece and the inner wall surface of the storage portion are configured to be in contact with each other for the alignment of the dry analysis film piece, 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 unit, and further, the liquid sample adheres to the bottom surface of the storage unit and becomes contaminated. As a result, when the edge of the next dry analytical film piece comes in contact with the contaminated site, the previous liquid sample that had adhered to the ink beta side wall surface adhered to the edge end face of the current dry analytical film piece. Therefore, the dry analysis film piece of this time is contaminated with the previous liquid sample.

Since the dry analytical film pieces are sequentially transferred to the photometric section and the discharge section of the analyzer, the liquid sample that has oozed to the edge end 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, the contamination of the analyzer such as the ink beta, the holding jig, the photometric unit, the discharge unit, etc. with the biological fluid may be caused by pathogenic bacteria or bacteria. Since there is a risk that the measurement operator will be infected by microorganisms and viruses, this is extremely unfavorable in terms of hygiene.

When the amount of liquid applied to the liquid sample is reduced, the above-mentioned contamination may be avoided in some cases. However, when the amount of applied liquid is reduced, the accuracy of measurement deteriorates, and the method cannot be used.

Further, with the above-mentioned conventional dry analysis film piece, there was a possibility that highly accurate photometry could not be performed. That is, in the case of a dry analysis film piece having a development layer made of a porous material such as a cloth, a nonwoven fabric, or a filter paper (hereinafter, may be referred to as a cloth as a representative of these fibrous porous materials), the edge and the edge end face of the development layer In some cases, fraying occurs on the fabric, and fiber filings (dust) are generated from the fraying, which may adversely affect the photometric results.

The present invention provides a dry analysis film piece which can prevent contamination of a side wall, a photometry section, a discharge section, etc. of an ink beta storage section of an analyzer due to a liquid sample oozing at an edge end face of the dry analysis film piece. The purpose is to do.

The present invention also prevents fraying (fraying that has been disentangled but not shredded) at the edges and edge end faces of a spreading layer made of a fibrous microporous material such as cloth, nonwoven fabric, or filter paper. It is another object of the present invention to provide a dry analysis film piece that can prevent the generation of fibrous waste (fibrous waste; shredded fibrous waste). Below,
The combination of fiber fraying and generation of fibrous debris is sometimes referred to simply as fiber fraying.

[0020]

Means for Solving the Problems The present invention has been made to achieve the above-mentioned objects, and a dry analysis film piece according to the first invention comprises a support, and at least a support provided on an upper surface of the support. In a dry analysis film piece having one reagent layer and a development layer provided on the upper surface of the reagent layer,
A liquid sample corner arrival preventing means for preventing the liquid sample spotted and spread on the developing layer from reaching the corner is provided on the developing layer.

The dry analytical film piece according to the second invention is:
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, was spotted and developed on the development layer. The liquid sample is the edge of a dry analytical film strip,
A liquid sample edge portion prevention means for preventing the liquid sample from reaching the edge end face and the vicinity thereof is provided on the spread layer.

The dry analytical film piece according to the third invention is:
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 made of a fibrous microporous material provided on the upper surface of the reagent layer. And a fiber fray preventing means at the edge and the end face of the edge are provided on the spread layer.

The dry analysis film piece according to the fourth invention is:
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, was spotted and developed on the development layer. Means for preventing a liquid sample from oozing from the edge and edge end face of the dry analysis film piece (hereinafter, sometimes simply referred to as bleeding prevention means on the liquid sample edge end face) is provided on the spread layer. Have been.

[0024]

Detailed description of the means for solving the problems The developing layer of the dry analytical film piece (chip) of the present invention includes liquid sample corner preventing means, liquid sample edge preventing means, fiber fray preventing means, Alternatively, bleeding prevention means (or any two or three members) is provided on the edge surface of the liquid sample edge. The same method can be used to form the liquid sample corner arrival prevention means and the liquid sample edge arrival prevention means, except that the positions provided in the spreading layer are different. The means for preventing the liquid sample edge from oozing out may be the same as the means for preventing the liquid sample from reaching the edge portion. The same method can be used for forming the liquid sample edge portion arrival preventing means and the fiber fray preventing means. Further, the same method can be used for forming the liquid sample edge portion arrival preventing means, the fiber fray preventing means, and the liquid sample edge end face preventing means. In this specification, the edge and the end face of the edge of the dry analysis film piece have the meaning including the corner and the end face of the corner, respectively.

The means for preventing the liquid sample from reaching the corner, the means for preventing the liquid sample from reaching the edge, and the means for preventing the liquid sample from bleeding out from the edge are all formed at the corners, corners, edges, edges of the spreading layer made of a microporous material. The structure is such that the liquid sample cannot pass through the end faces and / or the vicinity thereof. Examples of structures that are impervious to liquid samples include melting the fibers of the microporous material or the polymer that constitutes the body, cooling and solidifying to a substantially non-porous structure, hydrophobic ink, wax, curing Clogging the micropores of the developing layer made of a microporous material with a hydrophobic (or water repellent) or lipophilic material such as a hydrophilic polymer, a curable glue, or a hot melt adhesive;
There is.

The means for preventing fiber fraying prevents fiber fraying (fiber debris that is loose and disturbed but not shredded) at the corners, edges and edge end faces of the spreading layer made of a fibrous microporous material, In addition, fibrous waste (fibrous waste;
The structure can prevent generation of shredded fiber waste. As an example of a structure for preventing fraying of fibers, there is a structure in which fibers of a fibrous microporous material are heated and melted, then cooled and solidified. Since the fiber of the fibrous microporous material is heated and melted, and then cooled and solidified, a substantially non-porous structure is also obtained. It can also serve as a prevention means. Nylon, polyethylene terephthalate are examples of fibrous microporous materials that can prevent fiber fraying by heating, melting, then cooling and solidifying the fiber.
There are blended fabrics (knitted fabrics, woven fabrics) of 100% or synthetic fibers of these and natural fibers such as cotton.

As an example of the heat treatment means used in the method of heating and melting the polymer or the fibrous material of the fibrous microporous material which constitutes the substantial part of the microporous material, the heat of the electric heater produced in the shape to be formed is used. There is an ultrasonic head for concentrating and injecting ultrasonic energy, and a laser light irradiation head for laser light energy irradiation. 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, so it cools after heating and melting compared to heating and melting with a heating iron or ultrasonic energy concentration injection head The width of the liquid sample sealing region obtained by solidification can be reduced. On the other hand, by increasing the irradiation energy, the spreading layer (in the embodiment of the dry analysis film including the spreading layer, the reagent layer and the support, all the layers including the support) are cut simultaneously with the melting of the fibers of the spread layer. Therefore, there is also an advantage that a cutting step as a separate step as in the case of a heating iron or ultrasonic energy heating can be omitted. That is, in the case of a heating iron or ultrasonic energy heating,
The support, the reagent layer and the developing layer are laminated to form a long-type dry analytical film. First, the developing layer is heated and melted into a predetermined shape using a heating iron or an ultrasonic head, and then the melted portion is cut with a cutter. It is necessary to add a step of cutting by cutting means such as, but in the case of laser light irradiation, the developing layer is melted into a predetermined shape only by irradiating the laser light, and at the same time, the developing layer (developing layer, reagent layer and In the embodiment of the dry analysis film including the support, all layers including the support can be cut. As described later, the developing layer of the dry analysis film piece may have a mode containing a reagent, or a reagent layer is provided below the developing layer. In some cases, enzymes that are weak to heat are contained, but surprisingly, even when the periphery of the developing layer is heated and melted, the enzyme in the reagent-containing developing layer or the reagent layer is substantially inactivated or has no activity. It was found not to decrease. Even for the reagent components other than the enzyme contained in the reagent-containing developing layer or the reagent layer and possibly other layers, even if the peripheral part of the developing layer is heated and melted, the deterioration of the reagent components does not substantially occur. Was found.

In the case of heating and melting treatment by laser light irradiation, the laser beam irradiation conditions are such that, in the case of heating and melting of the spread layer, no liquid leakage occurs at the end face of the porous spread layer solidified after heating and melting. The irradiation energy condition may be set as follows. In the case of cutting by heating and melting to the support as well as the heating and melting of the spreading layer, a dry analysis including no support at the end of the porous spreading layer solidified after heating and melting and simultaneously including 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, in the case of heating and melting cutting of the edge end surface of the developing layer, an output energy of about 10 W to about 25 W,
The heating / melting speed 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 melting / cutting the end face of the developing layer and heating / melting the entire dry analysis film including the support.
~ 150W range, heat melting cutting speed about 1m / min ~ about 20
m / min.

As a treatment means used in the method of plugging the micropores of the spreading layer made of the microporous material into a substantially nonporous structure, a hydrophobic (or water-repellent) material or a lipophilic material is used. There is a way to pack. Specific examples of materials used in these processes 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 the lipophilic material used in these treatments include the following.

Curable hydrophobic material; light or ultraviolet curable adhesive, liquid photoresist wax (wax); solid vegetable-derived wax (eg, carnauba wax, cotton wax); solid animal-derived wax (eg, Beeswax) curable polymer; low melting 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; Hot-melt adhesive with low viscosity in the state (120 ° C to 200 ° C) and high viscosity at room temperature Examples of shapes: Sheet, string, thread Hydrophobic material; Ballpoint pen ink, oil-based quick-drying writing instrument (trade name) "Magic ink" type ink, printing ink Water-repellent material; Liquid or low melting point silicone polymer, Liquid or low melting point fluorine-containing polymer

The means for preventing the liquid sample from reaching the corners has at least four corners (the shape of the dry analysis film piece) of the spread layer so that the liquid sample can be prevented from spreading and reaching the portion of the spread layer where the holding jig contacts. In a form having no corners such as a circle or an ellipse, micropores of the developing layer are plugged in and around the portion of the developing layer that the holding jig contacts (hereinafter sometimes simply referred to as plugging). In a mode in which a fiber or a polymer constituting a substantial part of a microporous material is heated and melted, then cooled and solidified to form a substantially non-porous structure (hereinafter sometimes simply referred to as melt non-porous). is there. As an example,
Includes the shape of the tip of the part where the holding jig comes into contact with, so that the shape of the area is larger than the tip of the holding jig. There is a linear plugging or melt non-porosity on the center side (inside) of the layer.

The means for preventing the liquid sample from reaching the edge portion and the means for preventing bleeding from the edge of the liquid sample edge are provided such that the liquid sample spread on the edge (periphery) of the spread layer of the dry analysis film piece and the edge of the edge reaches the edge end face. In order to prevent it from coming out, it should be formed by plugging or melting non-porous the shape surrounding the predetermined developed shape continuously around the spot of the spread layer of the dry analytical film piece. Can be. If the liquid sample edge portion preventing means is formed on the center side (inside) of the spread layer from a portion in contact with the holding jig, it also has a function as a liquid sample corner portion preventing means. In addition, when the liquid sample edge portion arrival prevention means or the liquid sample edge end prevention means is formed on all edges (periphery) of the spread layer, in a mode having the fibrous spread layer, it also functions as fiber fray prevention means. It is possible to prevent fraying of the fiber on the edge end face and generation of fiber waste.

The means for preventing the liquid sample from reaching the corner, the means for preventing the liquid sample from reaching the edge, the means for preventing the fiber from fraying, and the means for preventing the edge of the liquid sample from bleeding out are all formed when the area of the surface of the developing layer is increased. Since the portion can be mechanically gripped, it becomes possible to employ a transporting means for the dry analysis 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 a dry analytical film piece is such that a reagent layer and a developing layer are laminated and integrated on a support in this order.

For the purpose of increasing the rigidity (strengthening) of the support, a reinforcing sheet-like member or a thin plate-like member can be laminated and adhered to the lower portion of the support. Each of the support and the sheet-like member for reinforcement or the thin plate-like member has a function of maintaining the flatness of the dry analysis film piece. further,
It is preferable that the support and the sheet-like member for reinforcement or the sheet-like member which may be laminated and adhered are light-permeable.
Examples of the support and the sheet-like member or the sheet-like member for reinforcement include an organic polymer sheet such as polyethylene terephthalate (PET) and polystyrene. In general, it is preferable that the reinforcing sheet-like member or the thin plate-like member is a sheet-like or thin-plate-like member made of an organic polymer having the same thickness as the support or being thicker than the support and having high rigidity (toughness). The thickness of the support ranges from about 100 μm to about 1000 μm, preferably from about 150 μm to about 300 μm. The thickness of the reinforcing sheet or thin plate is from about 150μm to about 1000
μm, preferably in the range of about 180 μm to about 500 μm.

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

The support and the reinforcing sheet-like member or thin plate-like member which may be laminated and bonded are generally configured to allow light to pass therethrough. In order to allow light to pass, the support, the sheet-like member for reinforcement, or the thin plate-like member itself may be formed of a transparent material that allows light to pass therethrough, or a light passage hole may be provided in a portion through which light passes during photometry. The light may be allowed to pass through. As a material that transmits light, there is, for example, a polymer having excellent transparency such as an acrylic polymer represented by polyethylene terephthalate, polystyrene, and polymethyl methacrylate. Also,
The light passage hole may be any hole that allows light to pass therethrough at the time of photometry, and may have, for example, a circular, elliptical, square, or rectangular shape.

The reagent layer is formed, for example, by directly or indirectly reacting an analyte (a biochemical component to be quantitatively analyzed) in a hydrophilic polymer binder such as gelatin, polyacrylamide or polyvinyl alcohol. At least one reagent component necessary for color development (a dye is formed) for detecting and quantifying an analyte by a chemical reaction, a biochemical reaction or an immunoreaction, or a color change reaction. It is composed of layers. However, there are some such as a dry analytical film for quantification of hemoglobin or the like which does not require a reagent component substantially only with a hydrophilic polymer binder.

The spreading layer can be selected from known fibrous microporous materials and non-fibrous microporous materials. Examples of the spreading layer include JP-A-55-164356 (corresponding U.S. Pat. No. 4,292,272) and JP-A-57-66359 (corresponding U.S. Pat.
3,315), etc. (eg, flat knitted fabrics such as broad and poplin), JP-A-60-222769 (corresponding EP)
Patent No. 0,162,302A) etc. (eg, tricot knitted fabric, double tricot knitted fabric, Miranese knitted fabric) described in JP-A-57-148250, and organic polymer fiber pulp-containing papermaking layer described in JP-A-57-148250. Fibrous porous spreading layer such as a spreading layer formed by applying a dispersion of a fiber and a 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), isotropic porous developing layer containing continuous microvoids in which fine particles such as polymer microbeads are adhered in a point-contact manner with a hydrophilic polymer binder, and JP-A-55-90859 (corresponding US Pat. No. 4,258,001) ) And the like, a continuous microvoid-containing isotropic porous layer (three-dimensional lattice-like granular structure layer) developed by bonding the polymer microbeads in a point contact manner with a polymer adhesive that does not swell with water, etc. Nonfibrous isotropic porous spreading layer; JP 61-4959 (corresponding to U.S. Patent 5,019,34
7), JP-A-62-138756, JP-A-62-138757, JP-A-62-138756
No. 138758 (corresponding EP patent 0,226,465A) and the like, a plurality of microporous layers (eg, two layers of a woven or knitted fabric and a membrane filter, three layers of a woven or knitted fabric, a membrane filter, and a woven or knitted fabric) ) Are laminated at an interface between each other in the form of fine discontinuous dots or islands (dots in the printing field), and there is a spread layer having excellent blood cell separation ability.

In the present specification, a filter paper type test element or a monolayer or multilayer test element obtained by improving the filter paper type adhesive element which is bonded and laminated on the above-mentioned substrate with a known suitable adhesive is also used as a dry analytical film piece. include.

The shape of a 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.
In the case of a square or a rectangle, the length of one side is in the range of about 10 mm to about 20 mm, in the case of a circle, in the range of about 10 mm to about 20 mm in diameter, in the case of an ellipse, both the long diameter and the short diameter are in the range of about 10 mm to about 20 mm, and the thickness The length for any shape ranges from about 350 μm to about 1.5 mm.
The shape of the dry analysis film piece is preferably a square or a rectangle close to a square from the viewpoint of the ease of analysis operation and production.

The biological components that can be quantitatively analyzed using the dry analytical film piece of the present invention include, for example, blood sugar (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 of the first invention, the means for preventing the liquid sample from reaching the corner portion is moved from the spot at the substantially center of the dry analytical film piece to the corner of the developing layer in contact with the ink beta holding jig. By preventing the liquid sample from reaching the holding jig, contamination of the holding jig due to adhesion of the liquid sample to the vicinity of the tip of the holding jig is prevented.

In the dry analysis film piece according to the second aspect of the invention, the means for preventing the liquid sample from reaching the edge portion prevents the liquid sample from reaching the edge and the edge end face from the spotting portion substantially at the center of the dry analysis film piece. Prevents bleeding of the liquid sample on the edge end of the layer, prevents the liquid sample from adhering to the analyzer, such as the ink beta, the photometric unit, and the discharge unit, and contaminating the liquid sample. To prevent the liquid sample from adhering and contaminating the other dry analysis film pieces.

In the dry analysis film piece having a developing layer made of a fibrous porous material such as a cloth, a nonwoven fabric, or a filter paper according to the third aspect of the present invention, the fray of the fiber on the edge of the developing layer and the end face of the edge is prevented, and the fibrous waste is removed. The generation of (dust) is prevented, and as a result, an adverse effect on the photometric result is eliminated.

In the dry analysis film piece according to the fourth aspect of the present invention, the means for preventing the liquid sample from oozing out from the edge and the end face of the liquid sample (also serving to prevent the liquid sample from reaching the corner) is spotted substantially at the center of the dry analysis film piece. By preventing the liquid sample from reaching the edge and the edge end face (including the corner end face) from the portion, the bleeding of the liquid sample at the edge end face of the developing layer is prevented, and the ink beta, the photometry section, and the discharge of the analyzer are provided. To prevent liquid samples from adhering to and contaminating parts
Alternatively, it is possible to prevent the liquid sample from adhering to and contaminating other dry analysis film pieces that have not been subjected to photometry after the liquid sample has been spotted, and to hold down the ink beta from the spotting portion at the center of the dry analysis film piece. By preventing the liquid sample from reaching the contacting corner of the holding jig, contamination of the holding jig due to the adhesion of the liquid sample to the vicinity of the tip of the holding jig is also prevented.

[0047]

DESCRIPTION OF THE PREFERRED EMBODIMENTS An embodiment of a dry analytical film piece according to the present invention will be described with reference to the drawings.

The fibrous spreading layer was subjected to a heating and melting treatment under the following conditions. Polyester (polyethylene terephthalate) 100% thickness about 150μm ~ about 300μm knit (knit) fabric, 100% polyester about 150μm ~
For plain woven fabrics of about 200 μm, 0.1 to 0.2 at 350 ° C to 450 ° C.
It was heated and melted for 5 seconds.

About 65% polyester and 35% cotton blend
Knitted fabric (knit) of 150 μm to about 300 μm, polyester
In the case of a plain woven fabric having a thickness of about 150 μm to about 200 μm with a blend of 65% and 35% cotton, heat-melting treatment was performed at 500 ° C. for 0.2 to 0.5 seconds.

FIGS. 1 to 4 are plan views of an embodiment of a dry analysis film piece provided with a liquid sample corner preventing means according to the first invention on a spreading layer.

In the dry analysis film piece 1 shown in FIG. 1, the corner of the developing layer 2 including the portion a where the holding jig comes in contact is heated and melted as a means for preventing the liquid sample from reaching the corner. After that, the melted portion 3 which is left at room temperature or sent by a cool air to be cooled and solidified to be substantially non-porous is formed in a triangular shape. A reagent layer (not shown) and a support (not shown) are provided below the spreading layer 2.

The dry analytical film piece 1 shown in FIG. 2 has a liquid sample corner which extends over two sides of an edge forming a corner including the abutting part a inside the part a of the spreading layer 2 where the holding jig abuts. As a means for preventing the portion from reaching, a fused portion 3 is formed in which the corner portion of the spread 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.

The dry-type analytical film piece 1 shown in FIG. 3 is used as a means for preventing liquid sample corners from reaching the corners of the spreading layer 2 on two opposing sides inside the portion a where the holding jig of the spreading layer 2 contacts. Is heated and melted, and then left at room temperature or by sending a cool air to cool and solidify to form a substantially non-porous molten portion 3.

The dry analytical film piece 1 shown in FIG. 4 has a corner a of the developing layer as a means for preventing the liquid sample from reaching the corner, including a portion a where the holding jig of the spreading layer 2 comes into contact. Is heated and melted, and then left at room temperature or by sending a cool air to cool and solidify to form a substantially non-porous molten 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 prevention means according to the second invention is provided on the spread layer. Some embodiments also serve as embodiments in which the liquid sample corner 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. 5 has a spread layer 2 on the inner side of the portion a where the holding jig comes into contact.
As a means for preventing the liquid sample from reaching the edge portion, a molten portion 4 is formed in which the spreading layer is heated and melted in an annular shape, and then left at room temperature or cooled by blowing cool air to be solidified to be substantially non-porous. I have. This embodiment also has an effect as a means for preventing the liquid sample from reaching the corner.

The dry analysis film piece 1 shown in FIG. 6 is provided on the developing layer 2 outside the portion a where the holding jig comes into contact.
As a means for preventing the liquid sample from reaching the edge, the spreading layer is heated and made useful in a quadrilateral shape along all the edges, and then left at room temperature or cooled by sending cold air to be solidified and cooled to make it substantially non-porous. A part 4 is formed. In this embodiment, in the mode having the fibrous spreading layer, it is possible to prevent the fibers of the edges of the spreading layer 2 and the edge end faces from fraying.

The dry-type analytical film piece 1 shown in FIG. 7 has a spread layer 2 on the outer side of the portion a where the holding jig comes into contact.
As a means for preventing the liquid sample edge portion parallel to the edge,
Heating and melting the spreading layer in a quadrilateral shape along the edge and then leaving at room temperature or sending cool air to cool and solidify to form a substantially non-porous molten portion 4 and a corner portion As a means for preventing the liquid sample from reaching the corner, the inside of the portion a where the holding jig comes into contact is heated and melted at the corner of the spread layer, and then left at room temperature or cooled by cooling with air to be substantially non-porous. A brace-shaped molten portion 3 is formed.
In this embodiment, it has an effect as a means for preventing the liquid sample from reaching the corners, and in the aspect having the fibrous spreading layer, it is possible to prevent fraying of the edge of the spreading layer 2 and the fiber at the edge end face.

In the dry analysis film piece 1 shown in FIG. 8, the developing layer was heated and melted as a means for preventing the liquid sample from reaching the corners in the developing layer 2 at the corner including the portion a where the holding jig came into contact. After that, the molten portion 3 is left at room temperature or sent by a cool air to be cooled and solidified to be substantially non-porous, and the liquid sample edge portion is prevented from reaching the liquid sample edge portion in a quadrilateral shape along all edges. After the developing layer is heated and melted, it is allowed to stand at room temperature or send a cool air to cool and solidify to form a substantially non-porous molten portion 4. In this embodiment, the developing layer 2 has a function and effect as a liquid sample corner arrival preventing means and has a fibrous spreading layer.
Of the fibers on the edges and edge end faces of the sheet can be prevented.

In the dry analytical film piece 1 shown in FIG. 9, the developing layer was heated and melted as a means for preventing the liquid sample from reaching the corners of the developing layer 2 at the corner including the portion a where the holding jig came into contact. After that, the molten portion 3 is left at room temperature or sent by cooling air to be cooled and solidified to be substantially non-porous, and the liquid sample edge portion is prevented from reaching the two opposite edges. After heating and melting the spread layer in a wide band shape along, it is allowed to stand at room temperature or send cold air to cool and solidify to form a substantially non-porous molten portion 4 and the other two opposing edges. A narrow, substantially non-porous, fused portion 4 is formed along. In this embodiment, it has the effect of preventing the liquid from reaching the corners of the liquid sample, and in the embodiment having the fibrous spreading layer, it is possible to prevent fraying of the edges of the spreading layer 2 and the fibers at the edge end faces.

The dry-type analytical film piece 1 shown in FIG. 10 has a spread layer 2 on the inner side of a portion a where the holding jig contacts.
As a means for preventing the liquid sample from reaching the edge portion, a molten portion 4 is formed in which the spreading layer is heated and melted in an annular shape, and then left at room temperature or cooled by blowing cool air to be solidified to be substantially non-porous. At the same time, as a means for preventing the liquid sample edge from reaching the portion a where the holding jig comes into contact, the developing 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 solidified and substantially non-porous fused zone 4 is formed. In this embodiment, the liquid sample has the function and effect of preventing the liquid from reaching the corner, and
In the embodiment having the fibrous spreading layer, it is possible to prevent the fibers of the edges of the spreading layer 2 and the edge end faces from fraying.

In the dry analysis film piece 1 shown in FIG. 11, the periphery of the spotted portion, which is almost the center point, was left circular, and the remaining region was heated and melted as a means for preventing the liquid sample from reaching the edge portion. After that, the molten portion 4 is left at room temperature or sent by a cool air to be cooled and solidified to be substantially non-porous. In this embodiment, it has the effect of preventing the liquid from reaching the corners of the liquid sample, and in the embodiment having the fibrous spreading layer, it is possible to prevent fraying of the edges of the spreading layer 2 and the fibers at the edge end faces.

The dry analysis film piece 1 shown in FIG. 12 has the spreading layer 2 on the outside of the portion a where the holding jig comes into contact.
As a means for preventing the liquid sample from reaching the edge, the spreading layer is heated and melted in a quadrilateral shape along all the edges, and then left at room temperature or cooled by blowing cool air to be solidified and substantially non-porous. The portion 4 is formed, and inside the portion a where the holding jig comes into contact, as a means for preventing the liquid sample from reaching the corner, it is heated and melted in a parallel narrow line along two opposing edges. After that, the molten portion 3 is left substantially at room temperature or sent by cooling air to be cooled and solidified to be substantially non-porous. In this embodiment, it has an effect as a means for preventing the liquid sample from reaching the corner, and in the aspect having the fibrous spreading layer, it is possible to prevent fraying of the edge of the spreading layer 2 and the fiber at the edge end face.

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-volatile by heating and melting the spread layer and then leaving it at room temperature or sending cool air to cool and solidify. Although it is formed by a molten portion that has been made porous, the micropores of the spreading layer can also be filled with a hydrophobic (or water-repellent) or lipophilic material to form the pores shown in FIGS.
The liquid sample corner preventing device, the liquid sample edge device preventing device, and the fiber fray preventing device can be formed in the same shape as shown in FIG. Specific examples of preferred materials for plugging the micropores in the spreading layer include waxes that are solid at room temperature, waxy polyethylene oxide, amorphous polyethylene, hot melt adhesives, liquid photoresists,
There is.

[0065]

According to the dry analytical film piece of the first invention,
The liquid sample corner arrival prevention means prevents the liquid sample from reaching the corner where the holding jig of the ink beta abuts from the spotting portion substantially at the center of the dry analysis film piece, so that it is close to the tip of the holding jig. The contamination of the holding jig due to the adhesion of the liquid sample is prevented.

In the dry analysis film piece according to the second invention, the liquid sample edge portion preventing means prevents the liquid sample from reaching the edge and the edge end face from the spotting portion substantially at the center of the dry analysis film piece, thereby developing the sample. This prevents the liquid sample from oozing out at the edge end surface of the layer, and prevents the liquid sample from adhering to and contaminating the ink beta, the photometry unit, the discharge unit, etc. of the analyzer, or prevents the liquid sample from being applied after the liquid sample The liquid sample is prevented from adhering to and contaminating the other dry analysis film pieces of photometry.

In the dry analysis film piece having a spreading layer made of a fibrous porous material such as a fabric, a nonwoven fabric or a filter paper according to the third aspect of the present invention, the fray of the fiber at the edge of the spreading layer and the end face of the edge is prevented, and the fiber waste The generation of (dust) is prevented, and as a result, an 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 the end face of the liquid sample (also serving to prevent the liquid sample from reaching the corner) is provided at the spot at the substantially center of the dry analysis film piece. Also prevents the liquid sample from reaching the edge and the edge end face (including the corner end face) from the surface, thereby preventing the liquid sample from oozing at the edge end face of the development layer, and the ink beta, the photometry section, and the discharge section of the analyzer. Prevents liquid samples from adhering and contaminating
Alternatively, it is possible to prevent the liquid sample from adhering to and contaminating the other dry analysis film pieces that have not been subjected to photometry after the liquid sample has been spotted, and to hold down the ink beta from the spotting portion substantially at the center of the dry analysis film piece. By preventing the liquid sample from reaching the corners where the tool abuts, contamination of the holding jig due to adhesion of the liquid sample near the tip of the holding jig is also 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 portion and the holding jig inside the ink beta of the analyzer are provided. Through the liquid sample attached to
Contamination of the dry analysis film piece stored later is prevented. Further, since the liquid sample does not bleed from the edge end surface of the developing layer, the amount of spotting of the liquid sample can be increased, so that the measurement accuracy can be improved. In addition, since it is not necessary to precisely position the liquid sample on the dry analysis film piece at the center of the dry analysis film piece, the accuracy of the liquid sample mounting pipette tip or the like may be gradual. Can be inexpensive.

[0070]

Preferred Embodiment of the Invention

(1) The dry analytical film according to claim 1, wherein the liquid sample corner arrival preventing means is formed by heating and melting the developing layer, then cooling and solidifying the developing layer to make it substantially nonporous. Pieces.

(2) The liquid sample cornering means according to claim 1, wherein the liquid sample corner reaching prevention means is formed by impregnating the micropores of the spreading layer with a hydrophobic or lipophilic substance and plugging the micropores. Dry analytical film piece.

(3) The means for preventing the liquid sample from reaching the edge portion is formed by heating and melting the spread layer, then cooling and solidifying the spread layer to make it substantially nonporous.
Dry analysis film piece according to 1.

(4) The liquid sample edge-preventing means according to claim 2, wherein the means for preventing the liquid sample from reaching the edge portion is formed by impregnating the micropores of the spreading layer with a hydrophobic or lipophilic substance and plugging the micropores. Dry analytical film piece.

(5) The fiber fray preventing means is formed by heating and melting the fibrous microporous material forming the spreading layer, then cooling and solidifying the material to make it substantially non-porous. Item 4. A dry analysis film piece according to item 3.

(6) The fiber fray preventing means is formed by impregnating the micropores of the fibrous microporous material forming the spreading layer with a hydrophobic or lipophilic substance and plugging the micropores. Item 4. A dry analysis film piece according to item 3.

(7) The embodiment according to the third embodiment, wherein the spreading layer is made of a woven fabric, a knitted fabric, a nonwoven fabric or a filter paper.
The dry analytical film piece according to any one of (3) and (4).

(8) The means for preventing the liquid sample from bleeding from the edge and the edge end face is formed by heating and melting the spread layer, then cooling and solidifying it to make it substantially nonporous. A dry analytical film piece according to claim 4.

(9) The means for preventing bleeding from the edge of the liquid sample and from the edge end face is formed by impregnating the micropores of the spread layer with a hydrophobic or lipophilic substance and plugging the micropores. A dry analytical film piece according to claim 4.

(10) The embodiment (3) wherein the means for preventing the liquid sample from reaching the edge portion also serves as a means for preventing fiber fraying.
A dry analysis film piece according to (4).

(11) The means for heating and melting the spread layer may be 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
A dry analysis film piece according to (1).

(12) The means for heating and melting the spreading layer may be 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
A dry analysis film piece according to (3).

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

(14) The means for heating and melting the spread layer may be 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
A dry analysis film piece according to (8).

[Brief description of the drawings]

FIG. 1 is a plan view of one embodiment of a dry analysis film piece provided with a liquid sample corner reaching prevention means in a spreading layer.

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

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

FIG. 4 is a plan view of another embodiment of a dry analysis film piece provided with a liquid sample corner reaching prevention means in a spreading layer.

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

FIG. 6 is a plan view of another embodiment of a dry analysis film piece provided with a liquid sample edge portion prevention means (also serving as a fiber fray prevention means) in a spreading layer.

FIG. 7 is a plan view of another embodiment of a dry analysis film piece provided with a liquid sample edge portion prevention unit (also serving as a liquid sample corner portion prevention unit and a fiber fray prevention unit) in a spreading layer.

FIG. 8 is a plan view of another embodiment of a dry analysis film piece provided with a liquid sample edge portion arrival prevention means (also serving as a liquid sample corner arrival prevention means and a fiber fray prevention means) in a spreading layer.

FIG. 9 is a plan view of another embodiment of a dry analysis film piece provided with a liquid sample edge portion arrival prevention means (also serving as a liquid sample corner arrival prevention means and a fiber fray prevention means) in a spreading layer.

FIG. 10 is a plan view of another embodiment of a dry analysis film piece provided with a liquid sample edge portion arrival prevention unit (also serving as a liquid sample corner arrival prevention unit and a fiber fray prevention unit) in a development layer.

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

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

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

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

FIG. 15 is a sectional view taken along the line AA in FIG. 14;

[Explanation of symbols]

DESCRIPTION OF SYMBOLS 1 ... Dry analysis film piece 2 ... Spread layer 3 ... Molten non-porous part of the spread layer outside the portion where the holding jig comes into contact (means for preventing the liquid sample from reaching the corners) Non-porous part (means for preventing liquid sample edge portion from reaching and / or preventing fiber fraying) 5 ... Molten non-porous portion (developing liquid sample edge portion) of the spreading layer on the center side (inside) of the part where the pressing jig contacts Arriving prevention means) a: a part to which the holding jig comes in contact 10: a dry analysis film piece 20 ... a dry analysis film piece storage part 30 ... a dry analysis film piece conveyance part 40 ... a liquid sample spotting part 50 ... an ink beta 51 ... an ink beta Main body 52 ... Dry analysis film piece loading hole 53 ... Dry analysis film piece storage 54 ... Corner 55 ... Photometric window 56 ... Ring groove 57 ... Tapered part for guiding dry analysis film piece 58 ... Prevent evaporation of liquid sample Lid 59 ... Dry analysis film piece Pressing jig 60 ... metering portion 70 ... dry analytical film chip discharge portion for holding

Continuation of the front page (72) Inventor Osamu Shishimoto 3-1-146 Izumi, Asaka-shi, Saitama Fuji Photo Film Co., Ltd. (56) References JP-A-6-242108 (JP, A) JP-A-3 JP-A-7-92156 (JP, A) JP-A-60-88277 (JP, A) (58) Fields investigated (Int. Cl. ⁷ , DB name) G01N 31/22 121 G01N 33/52

Claims (4)

(57) [Claims] 1. A dry analytical film piece comprising a support, at least one reagent layer provided on an upper surface of the support, and a developing layer provided on the upper surface of the reagent layer, wherein a point on the developing layer is A dry analytical film piece, characterized in that a liquid sample corner arrival preventing means for preventing the liquid sample spread and spread from reaching the corner is provided in the spreading layer. 2. A dry analytical film piece comprising a support, at least one reagent layer provided on an upper surface of the support, and a developing layer provided on the upper surface of the reagent layer, wherein a point on the developing layer is The dry type, wherein a liquid sample edge portion prevention means for preventing the attached and developed liquid sample from reaching the edge of the dry analytical film piece, the edge end face and the vicinity thereof is provided in the developing layer. Analytical film pieces. 3. A dry analysis film 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. A dry analytical film piece, wherein a fiber fray preventing means at an edge and an edge end face of the spread layer is provided on the spread layer. 4. A dry analytical film piece comprising a support, at least one reagent layer provided on the upper surface of the support, and a developing layer provided on the upper surface of the reagent layer, wherein a point on the developing layer is A dry analytical film piece, characterized in that means for preventing the applied and spread liquid sample from oozing out of the edge and edge end face of the dry analytical film piece is provided in the spread layer.