JPH01107157A - Test film cassette for biochemical analysis - Google Patents

Abstract

PURPOSE:To keep the unused part of test film at the desired low-temperature, low-humidity state until the time of use, by providing a reversible temperature display label and/or a humidity display label on the outer surface of a test film cassette. CONSTITUTION:The tip part of long test film 10 for biochemical analysis is fixed or held to or with a reel 21 in an unused film cassette part 20. The film is wound in a roll state and accommodated in the unused cassette part 20. The other end of the film 10 is taken out through a film output port 22, brought into a used film cassette part 30 through a film input port 32 and fixed to a reel 31. A reversible temperature display label 40 and a humidity display label 41 are stuck to the outer surface of the cassette part 20. Thus the present temperature and/or humidity of an environment in which the cassette is exposed can be readily recognized under the state the test film cassette is set in a refrigerator when the test film cassette is handled in storage, movement and the like.

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 problems] In current medical care, biological body fluids (whole blood, plasma, serum, urine, saliva, etc.) are used for 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.
There is a need for 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 "colorimetric 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 is quantitatively analyzed by causing a color reaction between the target component in the test liquid and the reagent in the colorimetric analysis slide, and measuring the color density spectrophotometrically.

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 the long test film is housed in the apparatus, it is necessary to place the unused portion of the long test film under predetermined temperature and humidity conditions.

Therefore, in addition to making sure that the long test film is not touched when it is put into the device or taken out from the device, the unused portion of the long test film should be kept under the specified temperature and humidity conditions. The test film cassette is suitably accommodated in a test film cassette comprising an unused film cassette section for storing unused test film strips for biochemical analysis and a used film cassette section for storing used test films. (See Japanese Patent Application No. 62-176566 filed by the applicant of the present application, etc.).

By the way, as mentioned above, in order to obtain accurate and stable analysis results, an unused test film must be kept in an environment at a predetermined temperature or lower until it is used for analysis. This also applies during storage before the test film cassette is loaded into the device and put into use; therefore, during storage, transport or storage of the test film cassette in a storage room (container).
If the test film cassette is exposed to an environment with a temperature and/or humidity above the specified temperature and/or humidity while being transferred from The deterioration suffered cannot be recovered, and it is difficult to expect to obtain accurate and stable analytical results when using the test film that has undergone such a history. Since the test film does not change in appearance even if exposed to an environment with a predetermined temperature and/or humidity, it is possible to determine from the test film what temperature and humidity conditions the test film is currently exposed to. It is impossible to recognize. If incorrect analysis results are obtained by using the test film that has been exposed to an environment higher than the specified temperature and/or humidity, it should be avoided at all costs, especially in clinical tests, as it may be life-threatening. be. Therefore, it is absolutely necessary to be able to easily recognize and confirm the temperature and humidity conditions to which the test film is currently exposed. In addition, when changing analysis items, the test film cassette may be replaced midway through.
Even in such a case, the cassette may be exposed to an atmosphere with a temperature and/or humidity higher than a predetermined value, so
It is also necessary to recognize the situation.

[Object of the Invention] The object of the present invention is to perform biochemical analysis in which an unused portion of a test film can be maintained at a desired low temperature and low humidity state until the point of use, thereby stably obtaining accurate analytical results. To provide test film cassettes for

Another object of the present invention is to provide a test film cassette for biochemical analysis that allows easy recognition and confirmation of the current temperature and/or humidity of the environment to which the unused portion of the test film is exposed. be.

[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. A test film cassette for biochemical analysis characterized in that the cassette is provided with a reversible temperature display label and/or humidity display label on its outer surface.

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

FIG. 1 is a perspective view showing one embodiment of a 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 clamped 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 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. has been done. 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.

A reversible temperature display label 4 is provided on the outer surface of the cassette section 20.
0 and a reversible humidity display label 41 are attached.

The temperature display label 40 is a label having a display section 42 that displays the current temperature of the environment to which it is exposed.
Any label can be used. For example, labels that have multiple labels that develop color at above and below certain temperatures, labels that develop different hues at each specific temperature range (such as liquid crystal labels), Different symbols can be used, such as labels with numbers displayed. Such changes in the label need to occur reversibly, and preferably change as quickly as possible following changes in the temperature of the environment. Only one such label may be used, or two or more labels with different display methods may be used in combination.

Further, as for the humidity display label 41, any label can be used as long as it has a display section 43 that displays the current humidity of the environment to which it is exposed. Its use is the same as that of a temperature display label, except that the humidity is recognized through the display window 43.

These display labels 40 and 41 are known per se, and can be arbitrarily selected from among them in the present invention. Further, the display labels 40 and 41 may be provided anywhere on the outer surface of the cassette portion 20, and may be provided by themselves, by being attached using adhesive tape, or by being engaged with each other. .

An example of a test film according to the invention is a colorimetric test film having a multilayer analytical element as shown in Figure 2a. In FIG. 2a, 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, the target component to be analyzed moves to the reagent layer 12, and the reagent contained in the reagent layer 12 is removed. The color density change produced by the reaction is measured by reflection photometry from the support 11 side, and the component to be analyzed in the test liquid is analyzed by the principle of colorimetry. The colorimetric test film 10 further includes a reflective layer, a light shielding layer, a filtration layer, and a registration layer, if necessary.
) 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 analytical element as shown in FIG. 2a 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 μm,
In particular, it is preferably within the range of 80 to 200 μm,
Also, its width is conveniently within the 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 spreading layer 13 is made of paper such as filter paper, woven fabric, nonwoven fabric, etc. made from natural fibers, synthetic fibers, etc. Further, the spreading layer 13 may be made of a porous material made of fine particles of polymer.

The development layer 13 further contains a cellulose conductor, a hydrophilic polymer such as polyvinylpyrrolidone, polyvinyl alcohol, and polyacrylamide, and a nonionic, cationic, anionic, or amphoteric surfactant to control the development 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. 2b, the reagent layer 12, development layer 13, etc. may be divided into each analysis area 14. Further, as shown in FIG. 2C, 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, the test film may have an ion-selective electrode for measuring the ionic activity of the test liquid.

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, since it is undesirable to wind the test film 10 with a radius of curvature that is too small, as this may cause 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, high-impact 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.

In the test film cassette for biochemical analysis of the present invention, when the unused film cassette part and the used film cassette part are made separately, the unused film cassette part and the used film cassette section are either connected together so that the test film is not twisted and can be easily removed, or are packaged in the same container in such a way that the double force setting section does not move significantly. It is preferable that

The joining form is not particularly limited as long as it satisfies the above conditions, and may be in various forms. For example, you can fix the double-force setting part with adhesive tape, provide a convex part on the side of the negative cassette part and a concave part on the other cassette part, and connect them by engaging them. Engaging the double-force setting part with a member, fitting the end of the locking member into the rotating shaft hole of the double-force setting part, or connecting the double-force setting part with minute parts and molding them into one piece. , etc. 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. 3 is a cross-sectional view of an example of a colorimetric analysis apparatus using a colorimetric test film cassette according to one embodiment of the present invention.

In FIG. 3, a test liquid spotting means 51 is provided at the upper part of the colorimetric analyzer 50, and a spotting nozzle 52 connected to the test liquid spotting means 51 is installed at the center of the colorimetric analyzer 50. The opening is provided directly above the analysis area 53 provided in the.

The analysis area 53 is provided with a shutter 54, an incubator 55, and a photometer 56. A cold storage 57 is provided in the lower half of the colorimetric analyzer 50, and the cold storage 57 is maintained at a predetermined low temperature and low humidity by a cooling/dehumidifying device 58 and a fan 59.

The colorimetric test film cassette of the present invention is arranged such that the unused film cassette part 20 is aligned in the cold storage 57, the film outlet part 22 is aligned with the cold storage film outlet 60, and the reel 21 is rotatable. installed, the used film cassette part 30 is aligned in the take-up chamber 61, the film inlet part 32 is aligned with the take-up chamber film opening 62,
The reel 31 is mounted to be rotated by a drive shaft (not shown) of the colorimetric analyzer 50, and the test film 10 passes through the cold storage film outlet 60, into the incubator 55 and through the winding chamber film outlet 62. like,
It is attached to the colorimetric analyzer 50.

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.

In the above description, an example has been described in which the unused film cassette section and the used film cassette section are made separately, but these two force setting sections may be made integrally to match the analyzer. However, it is preferable to make the double-force setting part separately from the viewpoint of handling and keeping it cool within the analyzer. Further, in the case of integrally manufacturing, it is preferable that the unused film cassette part and the used film cassette part are spatially separated.

[Effects of the Invention] The test film cassette for biochemical analysis of the present invention is provided with a reversible temperature display label and/or humidity display label on the outer surface of the unused film cassette portion, so that the test film cassette for biochemical analysis of the present invention can be used for the biochemical analysis test. When handling film cassettes for storage, transportation, analysis, etc., the current temperature and/or humidity of the environment to which the cassettes are exposed when set in a cold storage can be easily recognized visually or by a color sensor. Therefore, it is possible to quickly take measures to appropriately change the conditions of the environment, and also to reduce the risk of incorrect use of the test film cassette for biochemical analysis, which may deteriorate and give inaccurate analysis results. This has the effect of being able to prevent this from happening.

[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 cassette section and the used film cassette section separated; FIG. 2a, FIG. 2b, and FIG. FIG. 2c is a perspective view showing an example of a test film according to the present invention, and FIG. 3 is a sectional view of an example of a colorimetric analysis apparatus using the test film cassette for biochemical analysis according to 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 exit section, 30: Used film cassette section, 31: Reel, 32: Film inlet section, 40: Temperature display label, 41: Humidity Display label, 42.43: Display window, 50: Colorimetric analyzer, 51: Test liquid spotting means, 52: Spotting nozzle, 53: Analysis area,
54: Shutter, 55: Incubator, 56: Photometer, 57: Cooling box, 58: Cooling and dehumidifying device, 59
: Fan, 60: Cooler film outlet, 61: @ Take-up room, 62: Film population in the take-up room.

Claims (1)

[Scope of Claims] 1. An unused film cassette section for storing an unused long test film for biochemical analysis in the form of a roll, and a part for storing the used film used for analysis in the form of a roll. A test film cassette for biochemical analysis consisting of a used film cassette part and a leading end of the film fixed to a reel in the used film cassette part, the test film cassette having a reversible temperature label and/or a reversible temperature label on the outer surface. A test film cassette for biochemical analysis characterized by being provided with a humidity display label. 2. 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 biochemical analysis. 3. The test film cassette for biochemical analysis according to claim 1, wherein the unused film cassette part and the used film cassette part are each made separately. 4. The temperature display label and/or humidity display label:
The test film cassette for biochemical analysis according to any one of claims 1 to 3, wherein the test film cassette is provided on the outer surface of the unused film cassette portion. 5. The test film cassette for biochemical analysis according to claim 1, wherein the temperature display label is a label that displays the current temperature using a distinguished color. 6. Claim 1, wherein the temperature display label is a label that indicates the current temperature with a symbol.
Test film cassette for biochemical analysis as described in section. 7. The test film cassette for biochemical analysis according to claim 1, wherein the humidity display label is a label that displays the current humidity using a distinguished color. 8. Claim 1, characterized in that the humidity display label is a label that indicates the current humidity with a symbol.
Test film cassette for biochemical analysis as described in section. 9. The test film cassette for biochemical analysis according to claim 1, wherein at least one of the temperature display label and the humidity display label is a combination of two or more labels with different display methods. .