JPH05172804A - Biochemical analyzing element and biochemical analyzing film - Google Patents

Abstract

PURPOSE:To conserve reagent layers in a dry condition without the need for a special conserving dry container and prevent the curling of an element. CONSTITUTION:A biochemical analyzing element consists of a long water- impermeable, light-transmissible support 1 made of polyethylene terephthalate (PET), e.g. and multilayer chips 2 made up with development layers 2a and reagent layers 2b laminated on the support 1 at equal spaces, the respective outer peripheries of the multilayer chips 2 being held in a gap to the support 1. It is formed with a shading film coating 3 to cover the multilayer chips 2 in such a manner that spaces 3a are provided above the centers of the multilayer chips 2.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a biochemical analysis element having a reagent layer which causes an optical density change due to a chemical reaction with a predetermined biochemical substance contained in a sample liquid such as blood or urine. The present invention relates to an improvement in the structure of an analytical element.

[0002]

2. Description of the Related Art Qualitative or quantitative analysis of a specific chemical component in a sample solution is a common operation in various industrial fields. Especially, quantitative analysis of chemical components or formed components in biological fluids such as blood and urine is extremely important in the field of clinical biochemistry.

In recent years, a dry type chemical analysis slide has been developed which can quantitatively analyze a specific chemical component or a formed component contained in a sample liquid simply by supplying a small drop of the sample liquid. (Japanese Patent Publication No. 53-21677 (US 3 992 1
58), JP-A-55-164356 (US Pat. No. 4,292,272), etc.) has been put to practical use. The use of this chemical analysis slide enables simple and quick analysis of sample liquids compared to conventional wet analysis methods, so its use is particularly important for medical institutions and research organizations that need to analyze a large number of sample liquids. It is preferable in some places.

In order to quantitatively analyze chemical components in a sample solution using such a chemical analysis slide, after the sample solution is spotted on the chemical analysis slide, it is placed in an incubator (incubator). Incubate for a predetermined time to allow a color reaction (dye formation reaction), and then measure the wavelength selected in advance by combining the predetermined biochemical substance in the sample solution with the reagent contained in the chemical analysis slide. This chemical analysis slide is irradiated with the irradiation light for use to measure its optical density, and from this optical density, a calibration curve showing the correspondence between the optical density and the substance concentration of the prescribed biochemical substance is obtained. A biochemical analyzer configured to determine the substance concentration of a predetermined biochemical substance in the sample liquid is used.

By the way, generally, the above chemical analysis slide comprises a reagent layer containing a reagent on a water-permeable and light-permeable support,
It is constituted by laminating a spreading layer for spreading the spotting liquid, and sandwiching these by a plastic frame.

The most important point in handling this chemical analysis slide is to keep the reagent layer in a dry state until the measurement is performed.

That is, although the reagents in the reagent layer do not react without water, there is a risk that the reaction will start as soon as water is absorbed, and it will be difficult to obtain accurate analysis results during actual measurement. This is because there is a risk.

Therefore, conventionally, in order to keep such a chemical analysis slide in a dry state, each slide is wrapped with a sealing wrapping material coated with, for example, aluminum, and when the slide is used, the wrapping material is broken and the slide is taken out. It is known that this was done.

It is also known that the chemical analysis slide is stored in a desiccator containing nitrogen and the slide is taken out from the desiccator at the time of use.

However, according to the above-mentioned conventional technique for packaging slides, the sealing operation increases the cost, and further, there is a problem that automation is difficult because the seal must be broken when the slide is used.

Further, depending on the prior art using the above desiccator, the chemical analysis slide is stored in the desiccator,
There is a problem that it takes time and effort to take out the desiccator, and a space for disposing the desiccator is required.

The present invention has been made to solve such a problem, and it is an object of the present invention to provide a biochemical analysis element which can be stored in a dry state without using a sealing packaging material or a desiccator. It is intended.

Further, in order to analyze a large amount of sample liquid at one time, there is known a so-called chemical analysis film in which chips composed of a reagent layer as described above are arranged on a long water-permeable and light-permeable support. Has been.

Similar to the above-mentioned chemical analysis slide, such a chemical analysis film must be stored in a dry state, and conventionally, in order to store such a chemical analysis film in a dry state. It is known that the film is housed in a drying container having a slightly opened window for taking out the film, and the film is spirally wound in the container so that the film can be taken out easily.

However, in such a conventional technique,
There are problems of cost and space required for the container, and curling of the film because the film is wound and stored.

The present invention has been made in order to solve such a problem, and an object thereof is to provide a biochemical analysis film which does not require a special drying container for storage and does not cause curling. To do.

Further, since the reagents contained in the reagent layer are different for each chemical substance to be measured, in order to automate the biochemical analysis, the biochemical analysis film is provided with information for recognizing the measurable chemical substance. It is desirable to keep a record so that this information can be read and judged when performing biochemical analysis. Further, it is desirable to similarly record the number information of analysis elements contained in the biochemical analysis film, their characteristic information, lot information, and the like.

The present invention has been made in view of such circumstances, and a biochemical analysis film capable of obtaining various kinds of information regarding a biochemical analysis element necessary for automation of biochemical analysis during biochemical analysis. It is intended to provide.

[0019]

A biochemical analysis element according to the present invention comprises a water-impermeable, light-transmissive support, a layered body including at least a reagent layer and laminated on the support, and this layer. A film-like covering body, which holds the outer peripheral portion of the body between the supporting body and the layer body so that a space is formed above the central portion of the layer body. To do.

The film-shaped cover is formed of a member that can be pierced by a point-fitting injection needle or the like.

The first biochemical analysis film according to the present invention is characterized in that the biochemical analysis elements described above are continuously arranged in a row.

The second biochemical analysis film according to the present invention is characterized in that it is provided with a notch for bending one or a plurality of biochemical analysis elements as described above. It is a thing.

It should be noted that this does not necessarily mean that all the adjacent cuts are equally spaced.

Furthermore, the third biochemical analysis film according to the present invention is characterized in that identification information is recorded at the leading position in the transport direction of the above-mentioned first or second biochemical analysis film. ..

The above-mentioned "water-impermeable light-transmitting support"
The water impermeability of means a support that does not permeate water, but does not necessarily exclude permeation of a trace amount of water. The light-transmissive property does not necessarily mean only a transparent support, and may be a colored one as long as it absorbs light in a wavelength range that does not affect the measurement.

[0026]

According to the biochemical analysis element of the present invention, the layer body including the reagent layer is covered with the film-shaped covering body that holds the layer body on the support,
This prevents external moisture from entering the reagent layer.

When the sample solution is spotted, the film-shaped covering body is pierced by using, for example, a spotting tip having a needle-like tip, and at the same time, the spotting tip is applied to the layer body including the reagent layer. If the sample solution is spotted, biochemical analysis can be performed without exposing the reagent layer to the outside air.

As described above, according to the first biochemical analysis element of the present invention, a packaging material for sealing, a desiccator or the like is not required at the time of storage, and deterioration of characteristics is left as it is. It does not occur and can be easily used for biochemical analysis.

That is, the conventional technology has occurred.
It is possible to solve all of the problems such as the cost increase due to sealing, the difficulty of automation accompanying the packaging removal, the labor required for putting the element in and out of the desiccator, the space for disposing the desiccator, and the like.

Further, according to the second biochemical analysis element of the present invention, since the reagent layer is kept in a dry state even if it is left as it is, a special storage container as in the prior art is not necessary.

Further, since it does not have to be stored in such a container, it can be placed in a straight line, or can be placed at a predetermined interval by bending, for example.
Therefore, it is possible to prevent curling or the like from occurring.

Further, according to the second biochemical analysis film of the present invention, since the notches for bending the film are provided at predetermined intervals, the film can be easily made compact when stored, and , The film does not curl.

Further, according to the third biochemical analysis film of the present invention, since the identification information is recorded at the leading position in the transport direction of the biochemical analysis film, it is generated when it is transported to the spotting / analyzing unit. The identification information can be read at the leading position of the chemical analysis film, which is convenient for the subsequent biochemical analysis.

Further, when carrying out the biochemical analysis, information on the biochemical analysis element relating to the measurement can be obtained, which facilitates automation of the biochemical analysis.

[0035]

Embodiments of the present invention will be described below with reference to the drawings.

FIG. 1 is a schematic view showing a biochemical analysis element according to an embodiment of the present invention with a part broken away. This biochemical analysis element comprises a long water-impermeable, light-transmissive support 1 made of, for example, PET (polyethylene terephthalate),
On the support 1, a plurality of multilayer chips 2 composed of a spreading layer 2a and a reagent layer 2b, which are laminated at equal intervals, and the outer peripheral portion of each of the multilayer chips 2 are placed between the supports 1. The light-shielding film-like covering body 3 covers the multilayer body chip 2 so as to hold it and to form a space 3a above the central portion of the multilayer body chip 2.

The film-shaped cover 3 is formed of a material that can be easily pierced by, for example, a needle-shaped spotting tip, such as PE (polyethylene) or various laminated films. The width of the portion of the film-shaped covering 3 that presses the multilayer chip 2 is, for example, about 1 mm at the position where it is the smallest, and the height of the upwardly expanded portion in the central portion of the multilayer chip 2 is, for example, about 3 mm. The diameter of the bottom of the bulge is formed to be, for example, about 8 mm.

Further, the spreading layer 2a of the multilayer chip 2 is made of a material capable of spreading the sample solution on substantially the entire surface of the chip 2, and the reagent layer 2b is mixed with a predetermined sample solution component, It contains a reagent that causes a color reaction (dye formation reaction) after being kept at a constant temperature (incubation) for a predetermined time.

The multilayer chip 2 has a substantially square shape, and the length A of one side of the multilayer chip 2 is 10 mm and the pitch B of the multilayer chips 2 is 14 mm. ..

FIG. 2 is a perspective view showing a biochemical analysis film in which the biochemical analysis elements are arranged in a row.
A 1.5 × 2.3 mm square perforation 4 is formed between each multilayer chip 2 on one side edge of the support 1, and the perforation 4 is formed when the biochemical analysis film is conveyed. It meshes with the transfer gear and the feed speed can be controlled accurately.

The perforations 4 may be provided on both sides of the biochemical analysis film.

The width C of the support 1 is about 18 mm, and the width D of each side edge is about 2 mm.

As shown in FIG. 4, the biochemical analysis film has a notch 5 formed at the center thereof at predetermined intervals, for example, every 6 to 10 biochemical analysis elements, as shown in FIG. The portion 5a where the notch 5 is formed is easily bent. As described above, in the present embodiment, the long biochemical analysis film can be folded into a zigzag state as shown in FIG. 5 by bending at the forming portion 5a of each cut 5, and the film can be folded in the same direction. It can also be made in various shapes and is designed to facilitate storage.

The cut portion for bending the biochemical analysis film is not limited to the cut 5 shown in FIG. 3 and may have any shape so that the biochemical analysis film can be easily bent as shown in FIG. ..

For example, as shown in FIG. 6, notches 5A may be provided so as to face inward from both side edges of the biochemical analysis film at predetermined intervals. In this case, the notch 5A can also be configured to serve as a perforation.

Further, as shown in FIG. 7, for example, as shown in FIG.
It is also possible to bend the biochemical analysis film by providing cuts 5B formed by arranging perforations in rows at the positions where the cuts 5 are arranged as shown in FIG.

Further, for example, although the cuts 5A and 5B in FIGS. 6 and 7 have the cutout portions, it is possible to provide a simple cutout without the cutout portions.

In this embodiment, 100 to 200 biochemical analysis elements are formed on one biochemical analysis film.

Further, as shown in FIG. 3, at the beginning of the biochemical analysis film, analytical element type information, lot correction information,
A bar code 6 indicating the analysis item information, quantity, etc. is printed.

As a result, when the biochemical analysis film is conveyed to the measuring section of the device described later, the optical information reading mechanism first reads and records the bar code 6 recorded on the leading portion of the film. Information is determined. This device is adapted to perform a biochemical analysis operation based on this discriminated information, and the automation can be smoothly performed.

The mode of the code for recording the identification information on the biochemical analysis film is not limited to the above bar code 6, and for example, another optical information code such as a column code, or a magnetic recording using magnetic recording. It may be a stripe code or a perforation having a predetermined shape.

However, the information reading mechanism on the apparatus side must be a mechanism capable of reading the code of the biochemical analysis film.

Next, how the biochemical analysis of the sample liquid is carried out by the biochemical analysis element of this embodiment will be described with reference to FIG.

When performing a biochemical analysis, a biochemical analysis element related to the analysis is set on the incubator (incubator) 21. The incubator 21 keeps the element at a constant temperature for a predetermined time, and has a hole of a predetermined size in the center thereof. A photometric head for measuring the optical density of the reagent layer 2b of the multilayer chip 2 is arranged below this hole.

The sample liquid 32 (for example, blood or urine) is spotted by the spotting tip 31 having an injection needle type nozzle. That is, the spotting tip 31 that has sucked a predetermined amount of the sample liquid 32 moves to the central position of the biochemical analysis element, and then moves downward to break through the film-shaped covering 3 and penetrate right above the spreading layer 2a. After this, a predetermined amount of the sample liquid 32 is dropped from the spotting tip 31 onto the spreading layer 2a. The dropped sample liquid 32 is diffused in the spreading layer 2a, and the lower reagent layer
Leach into 2b. The sample liquid 32 leached into the reagent layer 2b mixes with the reagent contained in the reagent layer 2b.

In this state, when the incubator 21 is heated to a predetermined temperature, the reagent layer 2b causes a color reaction (dye formation reaction).

The optical density of the dye produced by this color reaction is measured by the photometric head described above. That is, the measurement irradiation light emitted from the light source 11 and including light of a predetermined wavelength
12 is focused by the focusing lens 13 on the reagent layer 2b via the transparent support 1. The reflected light from this reagent layer 2b is the reagent layer.
The optical information (specifically, the amount of light) corresponding to the amount of dye generated in 2b is carried, and the reflected light carrying this optical information is incident on the photodetector 14 and photoelectrically converted, and the amplifier 15 is turned on. It is sent to the dye determination unit via the. The dye determination unit determines the optical concentration of the dye generated in the reagent layer 2b based on the level of the input electric signal, and identifies the substance concentration of a predetermined biochemical substance in the sample liquid 32.

The biochemical analysis measurement of the sample liquid 32 is performed for each element of the biochemical analysis film.

Since each chemical substance to be measured (eg glucose, cholesterol, etc.) has a different reagent, if a plurality of elements having reagent layers containing different reagents are arranged in order, a plurality of biochemical analysis films can be used. It becomes possible to perform biochemical analysis measurement for chemical substances.

Further, element units having the same reagent layer are arranged in one biochemical analysis film 7 and a plurality of biochemical analysis films 7 prepared for each chemical component to be measured are shown in FIG.
The biochemical analysis films 7 are sequentially arranged in the width direction, as shown in Fig. 11, and incubators 21a, 21b, 21c are provided so that the corresponding elements of each biochemical analysis film 7 can be simultaneously heated to a predetermined temperature. By moving the photometric heads 22a, 22b, 22c in the left and right directions in the figure so that the optical density of the reagent layer 2b of the corresponding element of the film 7 can be measured at a time, a large amount of a plurality of chemical substances in the sample liquid 32 can be obtained. It becomes possible to quickly perform biochemical analysis measurement.

FIG. 10 is a schematic view showing an apparatus embodying the principle shown in FIG.

That is, each biochemical analysis film 7 is stored in the stock section 41, is sent from the stock section 41 and is conveyed to the measuring section 46, and in the measuring section 46, the spotting tip 45 is used as described above. The sample liquid 32 is spotted and the photometric head 22 performs photometry. When the measurement of this biochemical analysis is completed, each biochemical analysis film 7 is transported again, the measured element parts are stored in the discharging section 42, and the element sections to be used for the next measurement are transferred from the stock section 41 to the measuring section. It is transported to 46.

A rotary table 43 is provided on the side of the measuring section 46, a sample container 44 containing a predetermined sample liquid 32 is provided on the inner peripheral portion thereof, and an outer peripheral portion thereof is provided on the outer peripheral portion thereof. The spotting tips 45 are arranged so that it is easy to insert the spotting tips 45 into the spotting arms (not shown) and to suck the sample solution 32 into the spotting tips 45.

The biochemical analysis film of the present invention may be composed of a plurality of biochemical analysis elements arrayed as in the above embodiment, or may be composed of one element.

Further, the shape of the biochemical analysis element is not limited to that of the above-mentioned embodiment, and various other modes can be modified.

For example, the layered body laminated on the support 1 may be a multi-layered body having three or more layers, or a single layered body having only a reagent layer.

Further, by enclosing an inert gas (for example, nitrogen) in the space of the biochemical analysis element, it is possible to reduce the change with time of the layered body.

[Brief description of drawings]

FIG. 1 is a schematic diagram showing a biochemical analysis element according to an embodiment of the present invention.

FIG. 2 is a perspective view of a biochemical analysis film in which the biochemical analysis elements shown in FIG. 1 are connected in series.

FIG. 3 is a plan view of the biochemical analysis film shown in FIG.

FIG. 4 is a side view of the biochemical analysis film shown in FIG.

FIG. 5 is a schematic view showing a folded state of the biochemical analysis film shown in FIG.

FIG. 6 is a plan view of a biochemical analysis film provided with a cut different from the cut shown in FIG.

FIG. 7 is a plan view of a biochemical analysis film in which another notch shown in FIG. 3 is provided.

FIG. 8 is a schematic diagram showing how the biochemical analysis measurement is performed using the biochemical analysis shown in FIG.

FIG. 9 is a schematic diagram showing a measuring method using a plurality of biochemical analysis films shown in FIG.

10 is a schematic view showing an apparatus for carrying out the measuring method shown in FIG.

[Explanation of symbols]

 1 Water-impermeable light-transmissive support 2 Multilayer chip 2a Development layer 2b Reagent layer 3 Film-like coating 4 Perforation 5, 5A, 5B Notch 7 Biochemical analysis film 21, 21a-c Incubator 22, 22a-c Photometry Head 31, 45 Pointing tip 44 Sample container

Claims (4)

[Claims] 1. A water-impermeable, light-transmissive support, a layered body which is laminated on the support and includes at least a reagent layer, and an outer peripheral portion of the layered body is sandwiched between the support and the support. In addition, a biochemical analysis element comprising a film-shaped covering body that covers the layer body so that a space is formed substantially above the center of the layer body. 2. A biochemical analysis film comprising the biochemical analysis element according to claim 1 continuous in a row. 3. The biochemical analysis film according to claim 2, further comprising a notch for bending the biochemical analysis film for each one or a plurality of the biochemical analysis elements. 4. The biochemical analysis film according to claim 2, wherein identification information regarding the biochemical analysis element is recorded at a leading portion of the biochemical analysis film in the transport direction.