JPH01105135A - Test film cassette for biochemical analysis - Google Patents

Abstract

PURPOSE:To load a film in a device without exposing its unused part to a high-temperature, high-humidity atmosphere by forming the film storage part of an unused film cassette part nearly in a disk shape which is a little bit larger than the size of the roll of the entire film. CONSTITUTION:A cassette part 20 has an intermediate partition plate 25 which constitutes the film storage part 27 nearly in the disk shape a little bit larger than the roll wound with the whole of the film 10 and a passage for the film 10. The gap 26 between the partition plate 25 and the outermost surface of the roll is made as small as possible. The storage part 27 and the passage for the film 10 are formed airtightly so that they are open only at a film exit. A film exit hole 221 is formed in a flank 20a of the cassette part 20, and a plate member 222 is provided where it clamps the film 10 passing through the hole with a flank 20b, thereby forming a long and thin channel 224. A blocking member 226 which has a film passing hole 223 is formed at the inside terminal of the channel 224 and the film exit part 22 are composed of them. The height of the channel 224 is reduced enough not to impede the movement of the film 10.

Description

DETAILED DESCRIPTION OF THE INVENTION [Industrial Field of Application] The present invention relates to a test film cassette for biochemical analysis.

[Prior art and its period points] In current medical care, biological body fluids (whole blood, plasma, serum, urine, saliva, etc.) are used to perform accurate diagnosis and appropriate treatment.
Clinical chemistry tests that perform quantitative analysis of various components contained in these substances are gaining importance.

For this purpose, it is necessary to quickly perform a large number of clinical chemistry tests, and the above quantitative analysis is carried out at medical institutions, laboratories, etc.
What is needed is a method and apparatus that is simple, automatic, and continuous.

For the above-mentioned quantitative analysis, dry-type analysis methods have been proposed that use, for example, multilayer analysis slides that use spectroscopic measurements and analysis slides that measure ion activity using ion-selective electrodes. and has been put into practice.

Quantitative analysis using the above-mentioned multilayer analysis slide (hereinafter sometimes referred to as rcolorimetric analysis slide) involves spotting a small amount of the test liquid onto the multilayer analysis element within the colorimetric analysis slide. Maintain constant temperature (incubation) for a specified time,
The target component in the test liquid and the reagent in the colorimetric analysis slide undergo a color reaction, and the color density is measured spectrophotometrically to quantitatively analyze the target component.

In addition, in quantitative analysis using an analysis slide using an ion-selective electrode, a test liquid and a reference liquid are applied to each of the ion-selective layers of the sheet-shaped ion-selective electrode that are electrically separated from each other within the slide frame. The ionic activity of the test liquid is measured by measuring the potential difference between the ion selection electrodes while the two liquids are electrically connected to each other by a bridge.

When such analysis slides are used, one slide is used for each measurement, so in order to automatically and continuously measure the test liquid, it is necessary to handle a large number of slides, which makes the equipment complicated. There are problems in that it becomes larger and more expensive. Therefore, instead of the above-mentioned slide, a long tape-shaped test film containing a reagent is used, for example as shown in U.S. Pat. ,
It is convenient to perform incubation and measurement automatically and continuously, but when placing the long test film in the device, you may touch the long test film with your hand and the long test film will not be tested. There is a problem in that the film gets dirty and causes errors in the measurement results.

On the other hand, when such long test films are exposed to high temperature and high humidity air, their properties tend to deteriorate. For example, when a long test film of the following types is placed under a temperature and humidity condition of 20°C and 60% RH, its usable period is 1 day, and 5 days.
When placed under the temperature and humidity conditions of 45% RH, the usable period is 4 days, but when placed under the temperature and humidity conditions of 5° C. and 10% RH, the usable period increases to 28 days. Therefore, when handling an unused long test film, it is extremely important to keep it at low temperature and low humidity.

When a long test film is housed in a device, it is naturally necessary to place the unused portion of the long test film under predetermined temperature and humidity conditions, and furthermore, it is necessary to keep the long test film under certain conditions, such as processing capacity. There is a growing demand for a system that can be shared by multiple models.

In view of the above-mentioned problems, this long test film can be shared by the above-mentioned plurality of models, and this long test film can be housed in the device! In order to prevent the unused portion of the long test film from being touched when taking it out of the J and the apparatus, and to place the unused portion of the long test film under the specified temperature and humidity conditions, the applicant has We proposed a long test film cassette in which an unused film cassette section for storing long test films for biochemical analysis and a used film cassette section for storing used test films are separate (Japanese Patent Application No. 176566/1983). ).

However, even with this method, the following problems still occur. That is, the cassette section that accommodates the unused portion of the test film is generally made in a rectangular shape for ease and reliability of loading into the analyzer, while the test film is wound into a roll. In addition, a cavity of about 50% or more is inevitably formed within the cassette portion. Since the cassette part cannot be made into a sealed structure due to the need to easily take out the test film, when loading the film cassette into the analyzer, the film in the cassette part containing the unused portion of the test film is removed. Humid air from outside flows into the cavity in the cassette part through the outlet gap, exposing the unused portion of the test film to a high humidity and possibly high temperature atmosphere, resulting in the test film becoming It absorbs moisture, leading to a decrease in analysis accuracy as described above.

[Objective of the Invention] An object of the present invention is to be able to load an unused portion of the test film, which is maintained at a desired low temperature and low humidity state, into an analytical device without exposing it to a high temperature and high humidity atmosphere, and to achieve accurate and reproducible results. It is an object of the present invention to provide a test film cassette for biochemical analysis that can obtain certain analytical results.

[Summary of the Invention] The present invention provides an unused film cassette section containing an unused long test film for biochemical analysis in the form of a roll;
A test film for biochemical analysis, consisting of a used film cassette part for winding and storing the used film used for analysis in a roll, and the leading end of the film being fixed to a reel in the used film cassette part. The cassette is characterized in that the test film accommodating portion of the unused film cassette portion is approximately disk-shaped, which is slightly larger than the size of the entire roll of the unused long test film for biochemical analysis. It is in a test film cassette for biochemical analysis.

[Detailed description of the invention] The invention will now be described with reference to the accompanying drawings.

FIG. 1 is a perspective view of an embodiment of a test film cassette for biochemical analysis of the present invention. FIG. 2 is a sectional view of an unused film cassette portion of another embodiment of the test film cassette for biochemical analysis of the present invention.

In FIG. 1, a long test film 10 for biochemical analysis is shown.
The leading end of the film 10 is fixed or fixed to the glue 21 in the unused film cassette section 20, wound into a roll, and stored in the unused film cassette section 20, and the other end of the film 10 is attached to the unused film cassette section 20. The film is taken out from the film outlet part 22 of the used film cassette part 20, enters the used film cassette part 30 from the film inlet part 32 of the used film cassette part 30, and its leading end is fixed to the glue 31 inside the used film cassette part 30. ing. The test liquid is spotted, incubated, and measured on the film portion 10S of the test film 10 that is exposed outside the cassette sections 20 and 30.

The cassette section 20 includes a partition plate 25 that forms a generally disc-shaped test film storage section 27 that is slightly larger than the size of the roll formed by winding the entire amount of the film 10 and a passage 24 for the film 10. ing. The partition plate 25 is
It is preferable to provide the gap 26 between the partition plate 25 and the outermost surface of the roll of film 10 to be as small as possible. It is preferable that the substantially disk-shaped test film storage section 27 and the passage 24 for the film 10 are provided airtight so that they are open only at the film exit. The partition plate 25 may be formed integrally with the cassette section 20 when the cassette section 20 is molded, or may be formed separately and later attached to the cassette section 20 by adhesive, engagement, or other means. Further, as shown in FIG. 2, a suitable filler 2B may be filled between the cassette section 20 and the side wall to form a substantially disc-shaped test film storage section 27.

An example of a test film according to the invention is a colorimetric test film having a multilayer analytical element as shown in Figure 3a. In FIG. 3a, colorimetric test film 1
0, a reagent layer 12 is laminated on a light-transmitting support 11,
A developing layer 13 is laminated thereon. In biochemical analysis, a liquid to be tested is spotted on the spreading layer 13, the liquid to be tested spreads in the spreading layer 13, and the components to be analyzed move to the reagent layer 12 and react with the reagents contained in the reagent layer 12. The component to be analyzed in the liquid to be tested is analyzed by the principle of colorimetry by reflecting photometry from the support 11 side to measure the color density change developed by colorimetry.b The colorimetric analysis test film 10 further includes a , reflective layer, light shielding layer, filtration layer, registration
) layers, water absorbing layers, subbing layers, etc., other layers known in the art may be included. Further, the developing layer and the reagent layer may be a single layer.

The structure of a multilayer analysis element as shown in FIG. 3a is known per se.

For example, the support 11 is a film made of a material that is transparent to light and impermeable to water. Examples of such materials include polyethylene terephthalate, polycarbonate of bisphenol A, polystyrene, and cellulose ester. Examples include polymers such as cellulose diacetate, cellulose triacetate, cellulose acetate propionate, etc. The thickness of the support 11 is about 50 μm to about 300 μm1
In particular, it is preferably within the range of 80 to 200 μm,
Further, it is convenient that the width line is within a range of about 3 to 10 mm. Further, its length can be appropriately determined depending on the number of analyzes per roll, and although the number is not particularly limited, it is generally convenient to have an analysis area for 100 to 600 times.

The spreading layer 13 allows the liquid to be tested to be spotted and supplied on its surface.
It has the effect of spreading the components contained therein at a substantially constant rate per unit area in the lateral (horizontal) direction without substantially unevenly distributing them. The 13 spreading layers are made of paper such as filter paper, woven fabrics, non-woven fabrics, etc. made from natural fibers, synthetic fibers, etc. Further, the spreading layer 13 may be made of a porous material consisting of a finely divided polymer.

The spreading layer 13 further contains a cellulose derivative, a wood-philic polymer such as polyvinylpyrrolidone, polyvinyl alcohol, and polyacrylamide, and a nonionic, cationic, anionic, or amphoteric surfactant in order to control the spreading of the test liquid. It can be impregnated with various surfactants and appropriate buffers for stable analysis.

Reagent layer 12 contains a suitable reagent capable of reacting with the analyte to produce a colorimetrically detectable change in color density. The reagent layer 12 includes one or more reagents, such as gelatin, gelatin derivatives, or gelatin that acts as a binder.
Dispersions in hydrophilic colloids such as polyvinyl alcohol, polyacrylamide, and polyvinylpyrrolidone are preferred.

In the present invention, the multilayer analytical element may have any structure as long as the support 11 is a long film. For example, as shown in FIG. 2a, portions other than the support 11, such as the reagent layer 12, the development layer 13, etc., may be elongated like the support. Further, as shown in FIG. 3b, the reagent layer 12, development layer 13, etc. may be divided into each analysis area 14. Furthermore, as shown in FIG. 3c, when the reagent layer 12, the spreading layer 13, etc. are continuous, a barrier section 15 is provided at the boundary between the adjacent analysis regions 14 to prevent the movement of the test liquid. You can leave it there.

Another example of the test film in the present invention is to apply a test liquid and a reference liquid to each of the ion-selective layers electrically separated from each other of a sheet-shaped ion-selective electrode, and measure the potential difference of the ion-selective electrode. Accordingly, a test film having an ion-selective electrode for measuring the ion activity of the test liquid may be used.

The unused film cassette section 20 and the used film cassette section 30 are made to have approximately the same size, and are large enough to accommodate the entire amount of the test film 10 wound on the reel 21 or 31.

The cross-sectional shape of the cassette parts 20 and 30 does not necessarily have to be square as shown in FIG. 1, but may be rectangular, circular or other shapes. A rectangular shape is preferable for handling. The cassette part can be made by a method known per se. For example, the case and lid of the cassette part are made separately, and after loading an unused test film, the case and the lid are fitted, engaged, They may be fixed by screwing, gluing, or other means, or the case and the lid may be connected at one side of the lid, and the connecting portion may be formed into a hinge structure.

The diameters of the reels 21 and 31 should not be made too small because it is undesirable to wind the test film 10 with a radius that is too small due to the risk of cracks in the test film 10. Generally, its diameter is 40
It is preferable that it is 80 mm. In addition, the inside of the reel is designed to take up and stop the test film.
It has a suitable locking part.

The cassette section and reel are generally made of various thermoplastic resins, such as polyolefin resins such as polyethylene and polypropylene, polystyrene, load-bearing polystyrene,
Styrene acrylonitrile resin, styrene resin such as ABS resin, vinyl chloride resin, nylon, polyester,
It can be easily manufactured from polycarbonate, polyacetal, or other resins using techniques used to manufacture audio and video cassette tapes.

The structure of the test film outlet section of the unused film cassette section will be explained in more detail.

FIG. 4 is an enlarged cross-sectional view of the circular portion in FIG. 1 showing the test film exit portion of the unused film cassette portion of an embodiment of the film cassette of the present invention, and FIG. It is a sectional view taken along the line A- in the figure.

4 and 5, the unused film cassette section 20 has a film exit hole 221 formed on its side surface 20a, and the unused test film 10 passing through the film exit hole 221 is inserted into the unused film cassette section 20. A plate member 2 is placed between the side surfaces 20b of the film cassette section 20.
22 are provided to form an elongated channel 224. A closing member 226 is provided on the opposite side of the channel 224 from the film exit hole 221, in which a film passage hole 223 of a size that allows the passage of the test film 10 is formed. It is 22.

A guide roller 225 is provided close to the film exit section 22 for guiding the test film 10 and facilitating the transfer of the test film 10 to the film exit section 22. The height of the channel 224 is so small that it does not become an obstacle to the movement of the test film 10, and the length of the channel 224 is so long that it can be accommodated inside the unused film cassette section 20 that accommodates the test film 10. It is preferable to form. The closing member 226 may not be provided depending on the shape of the channel 224. In FIG. 4, the channel 224 is formed by the side surface 20b of the unused film cassette portion 20 and the plate member 222, but it may be formed by two plate members. The plate member 222 and the closing member 226 may be made integrally during the production of the unused film cassette section 20, or may be made separately and assembled or bonded together.

FIG. 6 is an enlarged cross-sectional view showing a test film exit portion of an unused film cassette portion of another embodiment of the film cassette of the present invention.

In the embodiment shown in FIG. 6, the closure member 226 in FIG.
It is the same as that shown in FIG. 3 except that an elastic member 226A is provided instead. The elastic member 226A is connected to the channel 22
4 is slightly inclined toward the inside of the film 4, and its tip is provided in such a way that it lightly contacts the test film 10. Elastic member 2
Preferably, 26A is a film or sheet made of rubber, thermoplastic resin, or the like. In addition, the elastic member 22
6A may be provided in an appropriate number inside the channel 224.

FIG. 7 is an enlarged cross-sectional view showing a test film exit portion of an unused film cassette section of another embodiment of the film cassette of the present invention.

The embodiment shown in FIG.
A raised material 227 is provided in the test film 4 so as to sandwich the test film 10 therebetween. Note that in this embodiment, the closing member 226
does not necessarily need to be provided. As the raised material 227,
For example, velvet, matte, velveteen, and other materials known per se can be appropriately selected and used. Also,
A base fabric on which fibers or threads are electrostatically flocked can also be used as the raised material 227. In addition, felt is also a brushed material 22
Can be used in place of 7.

FIG. 8 is an enlarged cross-sectional view showing the test film exit portion of the unused film cassette section of another embodiment of the film cassette of the present invention.

The embodiment shown in FIG. 8 is the raised material 2 of the embodiment shown in FIG.
27 is replaced by a soft foam 228.

As the soft foam 228, sponge, foamed polystyrene, foamed polyurethane, etc. can be used.

The test film cassette for biochemical analysis of the present invention is arranged so that the unused film cassette part and the used film cassette part can be easily separated without twisting the test film until it is used for analysis. It is preferable that the two force setting parts are joined to each other or packaged in the same container in such a manner that the two force setting parts do not move significantly.

The above joining form is not particularly limited as long as it satisfies the above conditions, and may be in various forms.For example, the double force setting part may be fixed with adhesive tape, or a convex part may be formed on the side surface of the - side cassette part. , by providing a recess in the other cassette part and engaging and joining them, or by engaging the double-force setting part with another engaging member, or inserting a locking member into the rotating shaft hole of the double-force setting part. The ends of the cassette parts may be fitted together, or the cassette parts may be connected at minute portions and molded integrally. Also,
The double force setting part can also be housed and packaged in a bag-like container or a box-like container having a recess corresponding to the shape of the double force setting part.

FIG. 9 is a sectional view of an example of a colorimetric analyzer using the test film cassette of the present invention. In Figure 9,
A test liquid spotting means 51 is provided on the upper part of the colorimetric analyzer 50, and a spotting nozzle 52 connected to the test liquid spotting means 51 is provided at the center of the colorimetric analyzer 50. It is provided with an opening just above the area 53. The analysis area 53 includes a shutter 54, an incubator 55, and a photometer 5.
6 is provided. In the lower half of the colorimetric analyzer 50,
A cold storage 57 is provided, and the cold storage 5 is equipped with a cooling and dehumidifying device 5.
8 and a fan 59 to maintain a predetermined low temperature and low humidity.

In the test film cassette of the present invention, the unused film cassette part 20 is stored in the cold storage 57 at the film outlet part 22.
is aligned with the cold storage film outlet 60 and the reel 21 is attached so as to be rotatable, the used film cassette part 30 is in the winding chamber 61, and the film inlet part 32 is in the winding chamber film population 62. The reel 31 is attached to the colorimetric analyzer 50 so as to be rotated by a drive shaft (not shown), and the test film 1O is placed in the cold storage film outlet 60, in the incubator 55, and in the winding chamber. The film is attached to the colorimetric analyzer 50 so as to pass through the mouth 62.

When analyzing a test liquid using the colorimetric analyzer shown in FIG. is spotted on the analysis area of the test film 10, and then the incubator 55 is closed by the shutter 54, and the inside of the incubator is heated to a predetermined temperature (for example, 37° C.) and incubated for a predetermined time. During or after this incubation, the optical density of the analysis area 14 of the test film 10 is measured by the photometer 56. The component to be analyzed in the test liquid can be quantitatively analyzed from this optical density.

The same can be done for test films with ion-selective electrode slides.

[Effects of the Invention] In the test film cassette for biochemical analysis of the present invention, the test film accommodating portion of the unused film cassette portion is formed into a substantially disk shape that is slightly larger than the test film roll, and the amount of air that the unused test film comes into contact with is reduced. Even if a test film cassette, which has been stored at low temperature and low humidity until the point of use, is handled in normal air while being loaded into the cooler of the analyzer, the handling time is relatively short, so it is not necessary to The unused portion of the film in the used film cassette is maintained at a low temperature and low humidity condition that can substantially prevent moisture absorption, and it is possible to obtain accurate and stable analysis results without deteriorating the test film. It has the desired effect.

[Brief explanation of the drawing]

FIG. 1 is a perspective view showing an embodiment of the test film cassette for biochemical analysis of the present invention with the unused film force setting part and the used film cassette part separated; Figures 3a, 3b and 3c are perspective views showing examples of the test film according to the present invention; 4, 5, 6, 7, and 8 are enlarged sectional views showing the film exit portion of the unused film cassette portion of the test film cassette of the present invention; FIG. 9; 1 is a sectional view of an example of a colorimetric analysis device using the test film cassette for biochemical analysis of the present invention. 10: long test film for biochemical analysis, 11: support, 12: reagent layer, 13: development layer, 14: analysis area,
15: Barrier section, 20: Unused film cassette section, 21: Reel, 22: Film outlet section, 24: Film passage, 25: Partition plate, 2C gap, 27: Test film storage section, 28: Filler , 30: Used film cassette section, 31: Reel, 32: Film inlet section, 221: Film exit hole, 222: Plate member, 223: Film passing hole, 224: Channel, 225 Ni guide roller, 226:
Closing member, 226A: Elastic member, 227: Raised material, 2
28: Soft foam, 50: Colorimetric analyzer, 51: Test liquid spotting means, 52: Spotting nozzle, 53: Analysis area, 54: Shutter, 55: Incubator,
56: Photometric device, 57: Cold storage, 58: Cooling and dehumidification device, 59: Fan, 60: Cold storage film exit, 6
1: Winding room, 62: Winding room film population. Patent applicant: Fuji Photo Film Co., Ltd. Agent
Patent Attorney Yasushi Yanagawa M1 Diagram 2! Figure 4 Figure 5! Figure 6 Figure 7

Claims (1)

[Claims] 1. An unused film cassette part that stores unused long test films for biochemical analysis in roll form, and a used film cassette part that stores used film used for analysis rolled up in roll form. A test film cassette for biochemical analysis, in which the leading end of the film is fixed to a reel in a used film cassette part, and the test film storage part of the unused film cassette part is connected to the unused biochemical analysis test film cassette. A test film cassette for biochemical analysis, characterized in that it has a substantially disk shape that is slightly larger than the size of the entire roll of long test film for analysis. 2. The biochemical method according to claim 1, wherein the long test film for biochemical analysis is a test film having a multilayer analysis element including at least a developing layer, a reagent layer, and a light-transmitting support. Test film cassette for analysis. 3. The product according to claim 1, wherein the unused film cassette section has the test film outlet section having a structure that substantially prevents natural mixing of air inside the cassette section and air outside the cassette section. Test film cassette for chemical analysis. 4. 4. The test film cassette for biochemical analysis according to claim 3, wherein the test film exit portion has a channel structure.