Reagent cartridge

Abstract

This reagent cartridge reduces the risk of infection caused by workers touching specimens during sample dispensing or handling reagent cartridges, while also improving work efficiency, shortening testing time, and ensuring reliable sample analysis. [Solution] A reagent cartridge used in an analytical device for analyzing results based on a reaction between a sample and a reagent, comprising a sample storage section for storing the sample, a reagent storage section for storing the reagent, and an antibody storage section for storing the antibody, and comprising at least a sample tip for dispensing the sample, a reagent tip for dispensing the reagent, and an antibody tip for dispensing the antibody.

Description

Technical Field

[0001] The present invention relates to a reagent cartridge used in an analyzer that analyzes results based on the reaction between a specimen such as blood and a reagent.

Background Art

[0002] Conventionally, various forms of analytical devices have been known for analyzing the reaction between a sample such as blood and a reagent, such as the analytical device shown in Patent Document 1.The analytical apparatus described in Patent Document 1 comprises one or more test cartridges having a configuration in which at least a sample cell for containing a sample, a reagent cell for containing a reagent, and a reaction cell for reacting the sample and reagent, and in which each cell is arranged linearly; an apparatus housing having a predetermined set stage and a space for an adjacent test stage; cartridge holding means provided on the set stage and having a cartridge receiving portion for holding the one or more test cartridges; cartridge transport means provided on the test stage for linearly transporting the test cartridge held by the cartridge holding means into the test stage and transporting the test cartridge along the longitudinal direction along the arrangement direction of each cell of the test cartridge in the transported test stage, while linearly transporting the tested cartridge from the test stage to the set stage and returning it to the cartridge receiving portion of the cartridge holding means; and provided in a part of the transport path of the test cartridge in the test stage corresponding to a predetermined dispensing position, which is transported by the cartridge transport means. The system includes: a sample and reagent dispensing means for dispensing the sample and reagents of a test cartridge into reaction cells in a test stage after transporting and positioning the cells to be dispensed from the test cartridge within the test stage to the dispensing position; a measuring means provided in a part of the transport path of the test cartridge within the test stage corresponding to a predetermined measurement position, for measuring the reaction between the sample and reagent in the reaction cells dispensed by the sample and reagent dispensing means after transporting and positioning the reaction cells of the test cartridge within the test stage, which have been transported by the cartridge transport means, to the measurement position; a constant temperature bath heated by a heat source to maintain the liquid temperature in at least the reaction cells of the test cartridge within the test stage, which have been transported by the cartridge transport means, at a predetermined constant temperature ambient temperature; and a constant temperature bath control means having a temperature detector capable of detecting the internal ambient temperature of the test stage, and controlling the set temperature of the heat source of the constant temperature bath to be higher than when the temperature is above a predetermined threshold when the internal ambient temperature is lower than a predetermined threshold, based on the internal ambient temperature detected by the temperature detector.

[0003] With such an analytical device, after dispensing the sample or reagent into the reaction cell of the test cartridge, it is equipped with a constant temperature bath that maintains the liquid temperature in the reaction cell of the test cartridge at a preset constant ambient temperature. Therefore, it is possible to effectively prevent a decrease in measurement accuracy due to changes in the temperature of the test cartridge and the ambient temperature.

[0004] Furthermore, as a reagent cartridge for handling samples and reagents simultaneously, for example, the reagent cartridge described in Patent Document 2 is known, and the reagent holder is configured to include a process tube fixed by a connecting member and having a hole located in the connecting member, at least one socket arranged in the connecting member and configured to receive the tip of a disposable pipette, two or more reagent tubes provided at the lower part of the connecting member and each having an inlet hole located in the connecting member, and one or more containers provided in the connecting member, and each of the one or more containers is configured to receive a complementary container, such as a reagent tube, inserted from the receiving side of the connecting member.

[0005] Such reagent cartridges contain the reagents and ingredients necessary for performing sample preparation. It can be used as a single unit configured to accommodate all of the contents. [Prior art documents] [Patent Documents]

[0006] [Patent Document 1] Japanese Patent Publication No. 2016-24054 [Patent Document 2] Japanese Patent Publication No. 2013-150634 [Overview of the Initiative] [Problems that the invention aims to solve]

[0007] However, the reagent cartridge described in Patent Document 1 had a problem in that the sample could be dropped onto the top surface or into other cells of the reagent cartridge during the movement of the capillary, which posed a risk of infection or so-called contamination.

[0008] Furthermore, when the reagent cartridge structure described in Patent Document 2 is applied to the analytical apparatus described in Patent Document 1 for analyzing the reaction between a sample and a reagent, the configuration involves dispensing the sample into a process tube (sample cell). This requires inserting a blood collection tool into the opening of the sample cell to dispense the sample, followed by removing the blood collection tool from the sample cell. This process poses a risk of infection due to the sample adhering to the tip of the blood collection tool scattering outside the sample cell, or contamination may occur due to the sample mixing with cells other than the sample cell and reaction cell.

[0009] Therefore, the present invention has been made to solve these problems, and aims to provide a reagent cartridge that can reduce the risk of infection or contamination caused by workers coming into contact with specimens or other materials during specimen dispensing or handling of reagent cartridges. [Means for solving the problem]

[0010] The reagent cartridge according to the present invention, which solves the above problems, is a reagent cartridge used in an analytical device that analyzes results based on a reaction between a sample and a reagent, and comprises a sample storage section for storing the sample, a reagent storage section for storing the reagent, and an antibody storage section for storing an antibody, and is characterized by comprising at least a sample tip for dispensing the sample, a reagent tip for dispensing the reagent, and an antibody tip for dispensing the antibody. Furthermore, according to one embodiment of the invention, a reagent cartridge used in an analytical apparatus for analyzing results based on a reaction between a sample and a reagent is provided, comprising a sample storage section for storing the sample, the sample storage section comprising an injection section and a liquid absorption section, the sample storage section containing a sample diluent, and the sample diluent being arranged such that when the sample is dispensed into the injection section by a pipette tip, the droplet of the sample reaches the sample diluent before it leaves the tip of the pipette tip. Furthermore, according to one embodiment of the invention, a reagent cartridge used in an analytical device for analyzing results based on a reaction between a sample and a reagent is provided, comprising a sample storage section for storing the sample, the sample storage section comprising an injection section and a liquid absorption section, and the sample storage section containing a sample diluent.

[0011] In the reagent cartridge according to the present invention, the chip housing section is preferably formed to accommodate the chips individually. Furthermore, in the invention according to one embodiment, it is preferable that the injection unit and the liquid absorption unit be an injection and liquid absorption unit that serves both functions. Furthermore, in one embodiment of the invention, it is preferable that the injection portion and the liquid absorption portion extend vertically from each other, and that the lower end of the injection portion has a slope that inclines toward the liquid absorption portion, and that this slope is continuous with the liquid absorption portion via the side surface of the liquid absorption portion.

[0012] In the reagent cartridge according to the present invention, the tip housing portion is preferably formed as a bottomed hole. Furthermore, in the invention according to one embodiment, it is preferable that the injection portion has a guide surface that is inclined with respect to the vertical direction.

[0013] Furthermore, in the invention according to one embodiment, the guide surface is preferably formed on the side wall facing the liquid absorption portion.

[0014] Furthermore, in the invention according to one embodiment, it is preferable to provide a holding portion having a predetermined distance from the guide surface.

[0015] Also, in the invention according to one embodiment, it is preferable that the inclined surface is inclined at 30° to 60° with respect to the vertical direction.

[0016] Also, in the invention according to one embodiment, it is preferable that the inclined surface is formed continuously with the liquid reservoir portion so as to form a part of the liquid reservoir portion.

[0017] In the reagent cartridge according to the present invention, it is preferable that a sample diluent is accommodated in the sample accommodation portion. Also, in the invention according to one embodiment, it is preferable that the liquid level of the sample diluent is located between the upper end and the lower end of the inclined surface.

[0018] Also, in the invention according to one embodiment, it is preferable to include at least one of a reagent accommodation portion that accommodates the reagent and an antibody accommodation portion that accommodates the antibody.

[0019] Also, in the invention according to one embodiment, it is preferable that at least one of the liquid absorption portion, the reagent accommodation portion, and the antibody accommodation portion is arranged on a substantially operation line of the analyzer.

[0020] Also, in the invention according to one embodiment, a first closing portion that closes at least one of the reagent accommodation portion and the antibody accommodation portion and has a vent hole formed at a position corresponding to at least one of the reagent accommodation portion and the antibody accommodation portion, and a second closing portion that closes the vent hole are laminated.

[0021] Also, in the invention according to one embodiment, it is preferable that the first closing portion closes at least one of the liquid absorption portion and the injection portion.

[0022] Also, in the invention according to one embodiment, it is preferable that a second vent hole is formed in the first closing portion at a position corresponding to the liquid absorption portion.

[0023] Also, in the invention according to one embodiment, it is preferable that a second air vent hole is formed at a position corresponding to the injection part in the first blocking part.

[0024] Also, the invention according to one embodiment is a reagent cartridge used in an analyzer that analyzes the result based on the reaction between a sample and a reagent, comprising a sample storage part for storing the sample, the sample storage part comprising an injection part and a liquid suction part, the sample storage part storing a sample diluent, and the injection part being characterized in that a guide surface inclined with respect to the vertical direction is formed.

Advantages of the Invention

[0025] According to the present invention, since the sample storage part comprises an injection part and a liquid suction part, the injection and liquid suction of the sample can be performed at separate locations. Therefore, liquid suction can be performed without removing the pipette tip at the tip of the blood collection tool from the injection part after injecting the sample, and the risk of infection or contamination due to removing the blood collection tool can be reduced.

Brief Description of the Drawings

[0026] [Figure 1] Perspective view of an analyzer using the reagent cartridge according to the first embodiment of the present invention. [Figure 2] Perspective view of the reagent cartridge according to the first embodiment of the present invention. [Figure 3] Cross-sectional view taken along line A - A in FIG. 2. [Figure 4] Partial exploded view of the reagent cartridge according to the first embodiment of the present invention. [Figure 5] Perspective view of a pipette for sample collection used when dispensing a sample in the reagent cartridge according to the first embodiment of the present invention. [Figure 6] Cross-sectional view showing the state of dispensing a sample into the reagent cartridge according to the first embodiment of the present invention. [Figure 7] Cross-sectional view showing the state of taking out an antibody or a reagent from the reagent cartridge according to the first embodiment of the present invention. [Figure 8]A cross-sectional view of the sample storage section of a reagent cartridge according to a second embodiment of the present invention. [Figure 9] A cross-sectional view showing the state in which a sample is dispensed into a reagent cartridge according to a second embodiment of the present invention. [Figure 10] A cross-sectional view of the sample storage section of a reagent cartridge according to a third embodiment of the present invention. [Figure 11] A cross-sectional view showing the state in which a sample is dispensed into a reagent cartridge according to the third embodiment of the present invention. [Figure 12] A cross-sectional view of the sample storage section of a reagent cartridge according to a fourth embodiment of the present invention, with the center line M. [Modes for carrying out the invention]

[0027] The reagent cartridge according to the present invention will be described below with reference to the drawings. Note that the following embodiments are not intended to limit the invention as described in each claim, and not all combinations of features described in the embodiments are necessarily essential to the solution of the invention.

[0028] Furthermore, the reagent cartridge provided by the present invention relates to one used in an analytical device that analyzes results based on the reaction between a sample such as blood and a reagent. The reagent cartridge provided by the present invention is not particularly limited to the object of analysis, as long as it is used in an analytical device that analyzes results based on the reaction between a sample such as blood and a reagent. However, as one embodiment, the reagent cartridge provided by the present invention relates to one used in allergy testing (tests to confirm the presence or absence of specific allergies). Another embodiment relates to one used in blood tests such as measuring blood hemoglobin A1c concentration. Yet another embodiment relates to one used in genetic testing. Furthermore, the method of analyzing the results based on the reaction between a sample such as blood and a reagent in the present invention is not particularly limited, as long as it is an analytical method that can perform the analysis. However, as one embodiment, in the case of a reagent cartridge used in allergy testing, the present invention relates to an analysis that detects the presence or absence of luminescence based on an antibody (hereinafter referred to as a labeled antibody) that has specific binding ability to a specific allergen (antigen) and has enzymatic activity, in order to detect the presence or absence of an antibody that specifically binds to a specific allergen (antigen) in a sample such as blood. Furthermore, the luminescence of the labeled antibody relates to an analysis in which the luminescence of the substrate is made visible by dispensing a luminescent substrate and causing a chemical reaction catalyzed by the labeled antibody (e.g., an enzyme-labeled anti-IgE antibody) to luminescently emit light. Furthermore, the analysis of this visualization relates to an analysis in which this chemical reaction is carried out for a predetermined time under predetermined environmental conditions and the intensity of the luminescence is measured by a detection camera. In this specification, "reagent" refers to a reagent for the reaction necessary for detection, such as a labeled antibody or a luminescent substrate. The reagent can be any reagent necessary for the reaction and is not limited to these specific examples.

[0029] [First Embodiment] Figure 1 is a perspective view of an analyzer using a reagent cartridge according to the first embodiment of the present invention, Figure 2 is a perspective view of a reagent cartridge according to the first embodiment of the present invention, Figure 3 is a cross-sectional view of AA in Figure 2, Figure 4 is a partially exploded view of a reagent cartridge according to the first embodiment of the present invention, Figure 5 is a perspective view of a sample collection pipette used when dispensing a sample from the reagent cartridge according to the first embodiment of the present invention, and Figure 6 is the first embodiment of the present invention Figure 7 is a cross-sectional view showing the state in which a sample is dispensed into the reagent cartridge according to the embodiment, and Figure 7 is a cross-sectional view showing the state in which antibodies and reagents are removed from the reagent cartridge according to the first embodiment of the present invention.

[0030] As shown in Figure 1, the reagent cartridge according to this embodiment is loaded into the analyzer 1 to analyze the results based on the reaction between the sample dispensed into the reagent cartridge and the reagent. The analyzer 1 comprises a housing 4 having an operation panel 2 and a loading door 3 that can be opened and closed to close the loading section for mounting the reagent cartridge 10 and reaction cell.

[0031] The analyzer 1 places the reaction cell and reagent cartridge 10 on a movable table (not shown), opens the door 3, and sets them in from the input section. Then, the tip 40 stored in the reagent cartridge 10 is fitted onto the tip of the dispensing nozzle, and samples and reagents are aspirated from the reagent cartridge 10. The aspirated samples and reagents are then dispensed into the reaction cell.

[0032] Once the dispensing process is complete, the moving table is moved back and forth to allow the dispensed sample, antibody (such as an antibody with specific binding ability to the sample, or an antibody labeled with a physiologically active substance having enzymatic activity), reagent, and washing solution to react in a timely manner. After mixing, the dispensed sample and other materials are drained, and the detection camera is placed in close contact with the reaction cell, shielding it from external light from entering the reaction cell and the inspection device. In this state, the presence or absence of luminescence from an antibody labeled with a physiologically active substance having specific binding ability to the sample and having enzymatic activity (hereinafter referred to as "labeled antibody") can be detected, for example, to determine the presence or absence of an allergic reaction. Specifically, the luminescence of the labeled antibody is visualized by dispensing a reagent (luminescent substrate), which causes a chemical reaction catalyzed by the labeled antibody (in this embodiment, an enzyme-labeled anti-IgE antibody) to emit light from the substrate. This chemical reaction is carried out for a predetermined time under predetermined environmental conditions, and the intensity of this luminescence is measured by the detection camera.

[0033] In one embodiment, the sample is dispensed into the sample container and the labeled antibody is stored in the antibody container. In this case, for example, the aspirated sample is dispensed and mixed into the reaction cell, washed and drained, then the labeled antibody is dispensed into the reaction cell, mixed and reacted, and then washed and drained.

[0034] Furthermore, in another embodiment different from the above embodiment, the antibody storage unit can be omitted by pre-storing the labeled antibody in the sample storage unit. In this case, for example, the labeled antibody is pre-stored in the sample storage unit, the sample and the labeled antibody are reacted in the sample storage unit, the mixture is dispensed and stirred into the reaction cell, and then washing and draining are performed.

[0035] Here, the reaction cell can be anything that allows the sample and reagent to react, and its shape, structure, materials, etc., are not particularly limited. Furthermore, the reaction cell may be housed in a so-called cassette.

[0036] Furthermore, the physiologically active substance having enzymatic activity to label antibodies that have specific binding ability to the sample can be one of those used in the prior art and is not particularly limited, but the enzymes listed below can be used. For example, alkaline phosphatase, β-galactosidase, glucose oxidase, urease, creatine kinase, uricase, glucose-6-phosphate dehydrogenase, peroxidase, etc.

[0037] Furthermore, while conventional luminescent substrates can be used and are not particularly limited, the following substrates can be used. For example, acridinium salts, dioxetanes, luciferin, lucigenin, oxalil chloride, etc.

[0038] Furthermore, although the reagent cartridge according to this embodiment was described in a form in which luminescence is measured using a labeled antibody labeled with a physiologically active substance having enzyme activity and a luminescent substrate, the reagent cartridge according to this embodiment can also be used for other measurements. For example, the labeled antibody can also be used to measure fluorescence by using a labeled antibody in which the substance labeled is a fluorescent substrate (fluorescent dye molecule) instead of a physiologically active substance having enzyme activity.

[0039] Specifically, the device can be used for fluorescence measurement by dispensing the sample into the sample container and storing the labeled antibody in the antibody container, or by dispensing the sample into a sample container that already contains the labeled antibody. If a fluorescent substrate (fluorescent dye molecule) is used to label the antibody, the reagent container can be omitted. Furthermore, by pre-packaging the labeled antibody in the sample container, the antibody container can also be omitted. For example, the aspirated sample is dispensed and mixed into the reaction cell, washed and drained, then the labeled antibody is dispensed into the reaction cell, mixed and reacted, followed by washing and draining. Alternatively, the labeled antibody is pre-packaged in the sample container, the sample and labeled antibody are reacted in the sample container, and the mixture is dispensed and mixed into the reaction cell, followed by washing and draining. Afterward, instead of a detection camera, an excitation antigen, spectrometer, fluorescence detector, etc., are used to detect fluorescence by irradiating the reaction cell with light of a wavelength that excites the fluorescent substrate, while shielding the reaction cell from ambient light.

[0040] Next, the reagent cartridge 10 according to this embodiment will be described. As shown in Figure 2, the reagent cartridge 10 according to this embodiment includes a sample storage section 11 for dispensing and storing a sample, an antibody storage section 12 for storing antibodies, a reagent storage section 13 for storing reagents, a washing solution storage section 14 for storing washing solution, and a tip storage section 15 for storing multiple tips. The reagent cartridge 10 is preferably constructed as a molded product from a synthetic resin such as polypropylene or polyethylene, and in this case, it is preferable that the sample storage section 11, antibody storage section 12, reagent storage section 13, washing solution storage section 14, and tip storage section 15 are integrally constructed.

[0041] The washing solution container 14, sample container 11, antibody container 12, reagent container 13, and tip container 15 are arranged along the longitudinal direction on a roughly rectangular top surface 17. In this case, it is preferable that the washing solution container 14, sample container 11, antibody container 12, reagent container 13, and tip container 15 are arranged along the approximate operating line of the analyzer. In this embodiment, they are arranged on a roughly straight line along the approximate centerline M in the width direction of the top surface 17 so as to follow the operating line of the moving table as it reciprocates. Furthermore, the washing solution container 14, sample container 11, antibody container 12, reagent container 13, and tip container 15 are each formed as bottomed cylindrical tubes extending vertically from the top surface 17.

[0042] The sample storage section 11 comprises an absorption section 11a positioned on the center line M (approximately the operating line of the analyzer) and an injection section 11b positioned adjacent to the absorption section 11a. The absorption section 11a and the injection section 11b are continuous with each other in either the vertical direction, and in the reagent cartridge 10 of this embodiment, they are arranged to overlap each other, so that the absorption section 11a and the injection section 11b extend continuously with each other along the vertical direction, and the opening formed in the top surface 17 is formed in a roughly gourd shape (the outer shape of a figure eight).

[0043] Furthermore, as shown in Figure 3, the sample storage section 11 is formed with an absorption section 11a and an injection section 11b, both extending vertically. The absorption section 11a is longer than the injection section 11b, and the bottom of the absorption section 11a has a roughly hemispherical liquid reservoir section 16.

[0044] Furthermore, the injection section 11b extends vertically along the absorption section 11a, and a sloped surface 11c is formed at its lower end, which is continuous with the side surface of the absorption section 11a. The sloped surface 11c can have any shape as long as the sample dispensed into the injection section 11b flows smoothly into the accumulation section 16, but it is preferable that it be formed in a circular arc shape or a straight line shape in cross-section. It is even more preferable that the sloped surface 11c be straight, Furthermore, when the inclined surface 11c is formed in a straight line, it is preferable that it is formed at an angle toward the liquid accumulation section 16, and the angle of inclination is preferably 30° to 60°, with a preferred angle being approximately 45°. Moreover, it is even more preferable that the inclined surface 11c is formed in a straight line continuous with the liquid accumulation section 16 so as to form a part of the liquid accumulation section 16. In this case, the inclined surface 11c may be formed from approximately the lower end of the liquid accumulation section 16. It is preferable that the sample collection section 11 is pre-filled with a sample diluent. Diluting the sample reduces the amount of sample used. Also, in the case of a sample with a certain viscosity, such as blood, it helps to spread it evenly on the reaction cell, and helps to carry out a uniform reaction between the sample and substances on the reaction cell, such as antigens. Here, the sample diluent only needs to be able to dilute the sample, and conventional techniques can be used. Therefore, it is not particularly limited, but for example, physiological saline, a buffer with a buffering capacity of pH 6 to 9, or so-called Good's buffer can be used. The sample diluent may also contain heparin, etc.

[0045] As shown in Figure 2, the antibody storage section 12 and the reagent storage section 13 are tubular sections with an oval cross-section extending vertically. Their vertical length can be appropriately changed depending on the amount of antibody or reagent to be stored, but they are generally shorter than the sample storage section 11, the washing solution storage section 14, and the tip storage section 15.

[0046] The washing solution storage section 14 is a tubular member with an oval cross-section that extends vertically, similar to the antibody storage section 12 and the reagent storage section 13, but its volume is larger than that of the antibody storage section 12 and the reagent storage section 13.

[0047] The chip storage section 15 is formed to accommodate multiple chips 40 as shown in Figure 7, and is configured to accommodate the required number of chips 40. Furthermore, the lower ends of all the chip storage sections 15 are connected by a connecting plate 15a. In addition, the connecting plate 15a and the bottom 14a of the washing solution storage section 14 are horizontally positioned on the same plane, so that when the reagent cartridge 10 is placed on a workbench such as a desk, the reagent cartridge 10 does not tip over and can be held upright.

[0048] Furthermore, as shown in Figure 4, the reagent cartridge 10 according to this embodiment has the antibody, reagent, and washing solution pre-stored in the antibody storage section 12, reagent storage section 13, and washing solution storage section 14, respectively, and a closure section 20 is attached to the top surface 17 to prevent leakage of the antibody, reagent, and washing solution during transport.

[0049] The occlusion section 20 is attached to the top surface section 17 and comprises a first occlusion section 21 having vent holes 23 formed in positions corresponding to the antibody storage section 12 and the reagent storage section 13, and a second occlusion section 22 which is laminated on the first occlusion section 21 so as to close the vent holes 23 of the first occlusion section 21. The first occlusion section 21 and the second occlusion section 22 are preferably made of a film-like material and are attached to each other with an adhesive or the like.

[0050] Next, the method for dispensing the sample into the reagent cartridge 10 and the method for aspirating the sample, antibody, and reagent will be explained with reference to Figures 5-7. For dispensing the sample into the reagent cartridge 10, a sample collection pipette 30 as shown in Figure 5 is preferably used. Examples of such pipettes include those in Japanese Patent No. 5909470 and Japanese Patent No. 5730695.

[0051] The sample collection pipette 30 comprises a pipette tip 31 for aspirating, dispensing, and holding the sample, and a nipple 32 made of an elastic material such as rubber for suction during sample collection. The sample is collected by being aspirated from the pipette tip 31, for example, by capillary action, and held within the pipette tip 31.

[0052] As shown in Figure 6, the sample collected in this manner is dispensed into the sample storage section 11 by removing the second closure portion 22 of the reagent cartridge 10 and inserting the pipette tip 31 into the injection portion 11b while piercing the first closure portion 21. At this time, pressing the nipple 32 causes the sample held in the pipette tip 31 to flow out into the injection portion 11b. The injection portion 11b is formed to be shorter than the absorption portion 11a, and a slope 11c is formed at its lower end, so the entire amount of sample that flows out from the pipette tip 31 is collected in the accumulation portion 16 along the slope 11c. In addition, although the case in which the injection portion 11b is sealed in the first closure portion 21 is shown, as shown in Figure 4, the injection portion 11b may be open in advance in the first closure portion 21. This makes it easier for the operator to dispense the collected sample into the sample storage section 11.

[0053] At this time, when the sample held in the pipette tip 31 is dispensed into the injection section 11b, as shown in Figure 6, the sample is dispensed dropwise. However, if the sample diluent is already contained in the sample storage section 11, the sample droplet can reach the sample diluent before leaving the tip of the pipette tip 31, ensuring that the sample is dispensed into the sample storage section 11. Alternatively, the sample droplet can reach the slope that inclines toward the absorption section 11a formed at the lower end of the injection section 11b before leaving the tip of the pipette tip 31, ensuring that the droplet is dispensed into the sample storage section 11 via the sample diluent. After that, the sample and sample diluent can be agitated, for example, by shaking the cartridge itself.

[0054] Furthermore, it is preferable to maintain a distance between the liquid surface of the sample diluent and the tip of the pipette tip 31. Specifically, this distance reduces the risk of the sample diluent flowing back into the pipette tip 31 when the tip of the pipette tip 31 reaches the sample diluent, and allows the dispensed sample (droplet) to reach the sample diluent. A distance that allows for proper stirring is preferred. For example, the acceptable range of the spacing is 5.8 to 9.8 mm, the preferred range is 6.8 to 8.8 mm, and the more preferred length is 7.6 to 8.0 mm.

[0055] Furthermore, when the pipette tip 31 is inserted into the injection section 11b, the length of the pipette tip 31 inside the reagent cartridge 10 should be such that the sample does not scatter when the sample is dispensed or when the sample and sample diluent are mixed.

[0056] Furthermore, the amount of sample diluent contained in the sample storage section 11 should be sufficient to spread it evenly over the reaction cell if the sample has a certain viscosity, such as blood. Preferably, the liquid level of the sample diluent should be between the upper and lower ends of the slope that inclines toward the absorbent section 11a formed at the lower end of the injection section 11b, when the reagent cartridge 10 is placed upright.

[0057] Furthermore, while the sample collection pipette 30 can be left in the injection section 11b even after the sample has been dispensed, if the main body including the nipple 32 and the pipette tip 31 can be detached (separated), then, as shown in Figure 6, only the pipette tip 31 can be left in the injection section 11b.

[0058] Next, to absorb the sample, the dispensing nozzle of the analyzer 1 removes the tip 40 from the tip housing section 15 of the reagent cartridge 10, fits it onto the tip of the dispensing nozzle, and inserts it into the absorption section 11a so as to break through the first occlusion section 21, thereby moving the tip of the tip 40 to a position where it can absorb the sample accumulated in the reservoir section 16, and then absorbs the sample. At this time, since the bottom of the reservoir section 16 is formed in a hemispherical or conical shape, it is possible to efficiently absorb the sample in the reservoir section 16.

[0059] Next, the extraction method for antibodies and reagents will be explained with reference to Figure 7. The extraction method is the same as the sample extraction method described above, by fitting the tip 40 onto the dispensing nozzle of the analyzer 1. At this time, separate tips 40 are used for the extraction of antibodies and reagents. For this reason, the tip storage section 15 contains the necessary number of tips 40 required for the extraction of samples, antibodies, and reagents. After extraction, when the samples, antibodies, and reagents are dispensed into the analyzer 1 (reaction cell), the used tips 40 are put back into the tip storage section 15 and discarded at the same time as the reagent cartridge 10 is disposed of.

[0060] The antibody and reagent are pre-filled in the reagent cartridge 10 and sealed by the occlusion section 20. However, when the antibody and reagent are extracted, if the tip 40 is inserted and absorbed by piercing the occlusion section, the sealing action of the occlusion section 20 may increase the internal pressure in the antibody-containing section 12 and the reagent-containing section 13, potentially hindering the absorption of the antibody and reagent. To prevent this, the reagent cartridge 10 according to this embodiment has a first occlusion section 21 attached to the antibody-containing section 12 and the reagent-containing section 13 at corresponding positions. Even if the tip 40 pierces the first occlusion section 21 and is inserted into the antibody-containing section 12 and the reagent-containing section 13, the occlusion section 23 can suppress the increase in internal pressure in the antibody-containing section 12 and the reagent-containing section 13, thus enabling smooth absorption of the antibody and reagent. The occlusion section 23 may also be provided at a corresponding position on the absorption section 11a. By providing a vent hole 23 in the absorption section 11a, it is possible to facilitate the smooth dispensing of the sample from the sample collection pipette 30. The second occlusion section 22 is attached to prevent antibodies and reagents from leaking out of the vent hole 23 during transport and handling of the reagent cartridge 10, and is removed in advance when injecting the sample, as described above. In this embodiment, the case in which the occlusion section 20 is formed by stacking the first occlusion section 21 and the second occlusion section 22 has been described, but the occlusion section 20 may be formed as a single layer instead of being stacked.

[0061] With this reagent cartridge 10, the risk of infection from workers touching samples or other materials during allergy testing, such as when dispensing samples or handling reagent cartridges, can be reduced. Furthermore, since the sample can be dispensed from the absorption section 11a while the pipette tip 31 for dispensing samples remains inserted in the injection section 11b, and the used tip 40 can be stored in the tip storage section 15, the pipette tip 31 and tip 40 can be disposed of simultaneously when the reagent cartridge 10 is discarded after the analysis by the analyzer 1 is completed, thereby reducing the risk of infection from touching them. In addition, by configuring the reagent cartridge 10 so that a removable lid member can be attached to cover the top surface 17 of the reagent cartridge 10 when it is discarded, further prevention of infection risk is possible.

[0062] [Second Embodiment] In the reagent cartridge 10 according to the first embodiment described above, the case in which the pipette tip 31 is inserted along the extending direction of the injection section 11b during dispensing was described. The reagent cartridge of the second embodiment described next describes an embodiment of the sample storage section 11A which has a different configuration from the first embodiment. In addition, components that are the same as or similar to those in the first embodiment described above are denoted by the same reference numerals and their description is omitted.

[0063] Figure 8 is a cross-sectional view of the sample storage section of a reagent cartridge according to a second embodiment of the present invention, and Figure 9 is a cross-sectional view showing the state in which a sample is dispensed into the reagent cartridge according to the second embodiment of the present invention.

[0064] As shown in Figure 8, the sample storage section 11A according to this embodiment is characterized by the shape of the injection section 11b. Similar to the reagent cartridge 10 according to the first embodiment described above, the sample storage section 11A according to this embodiment is formed with the liquid absorption section 11a and the injection section 11b extending vertically from each other, but the injection section 11b has a guide extending obliquely from the side wall facing the liquid absorption section 11a. A guide surface 50 is formed. A retaining portion 51 is formed at a predetermined distance from the guide surface 50, and a pipette tip insertion passage 52 is formed between the guide surface 50 and the retaining portion 51.

[0065] Furthermore, the lower end of the injection section 11b has a sloped surface 11c that is inclined at approximately 45° with respect to the vertical. In this way, the sloped surface 11c at the lower end of the injection section 11b is inclined at approximately 45°, so that the reagent cartridge according to this embodiment can more optimally mix the sample and the sample diluent when the reagent cartridge is stirred after the sample is dispensed. Note that the sloped surface 11c does not need to be formed at an angle, but the angle of inclination is preferably between 30° and 60°, with a preferred angle being approximately 45°.

[0066] As shown in Figure 9, the sample storage section 11A of the reagent cartridge according to this embodiment, formed in this manner, allows the pipette tip 31 to be inserted into the pipette tip insertion passage 52 formed between the guide surface 50 and the holding section 51, and the sample collected on the pipette tip 31 can be discharged into the sample storage section 11A.

[0067] Furthermore, in the sample storage section 11A of the reagent cartridge according to this embodiment, by inserting the pipette tip 31 along the guide surface 50, the distance between the tip of the pipette tip 31 from which the sample is dispensed and the inner wall 53 of the sample storage section 11A can be secured. This prevents the phenomenon in which the sample to be dispensed cannot be dispensed into the sample storage section 11A due to capillary action drawing the sample into the gap between the tip of the pipette tip 31 and the inner wall 53 of the sample storage section 11A when the distance between the tip of the pipette tip 31 and the inner wall 53 of the sample storage section 11A is narrow, and ensures that the sample is dispensed into the sample storage section 11A reliably.

[0068] In addition, as shown in Figure 9, it is preferable that the tip of the pipette tip 31 is inserted so that the distance between the tip of the droplet and the liquid surface of the sample diluent pre-contained in the sample container 11A is approximately equal to the liquid surface a of the sample diluent. However, even if the droplet does not reach the liquid surface b of the sample diluent, it is still possible to dispense the sample sufficiently.

[0069] Furthermore, the sample storage section 11A of the reagent cartridge according to this embodiment can hold the pipette tip 31 with the guide surface 50 and the holding section 51, so that the pipette tip 31 can be retained in the reagent cartridge after the sample has been dispensed.

[0070] [Third Embodiment] In the second embodiment of the reagent cartridge 10 described above, the case where the sample storage section 11A has a holding section 51 that is at a predetermined distance from the guide surface 50 was described. The reagent cartridge of the third embodiment described next will describe an embodiment of the sample storage section 11B which has a different configuration from the second embodiment. Note that components that are the same or similar as those in the first and second embodiments described above will be denoted by the same reference numerals and their description will be omitted.

[0071] Figure 10 is a cross-sectional view of the sample storage section of a reagent cartridge according to a third embodiment of the present invention, and Figure 11 is a cross-sectional view showing the state in which a sample is dispensed into the reagent cartridge according to the third embodiment of the present invention.

[0072] As shown in Figure 10, in this embodiment, the sample storage section 11B of the reagent cartridge has a closure section 20A attached to the upper opening of the sample storage section 11B to prevent leakage of the sample diluent stored in the sample storage section 11B during transport or other purposes.

[0073] The occlusion portion 20A is attached to the opening of the sample storage portion 11B, and the second vent hole 24 of the first occlusion portion 21A is formed at a position corresponding to the injection portion 11b. The device includes a second closing portion 22 which is laminated onto the first closing portion 21A so as to close the hole 24. The first closing portion 21A and the second closing portion 22 are preferably made of a film-like material and are attached to each other with an adhesive or the like.

[0074] Furthermore, the sample storage section 11B of the reagent cartridge according to this embodiment does not have a holding section 51 that is positioned at a predetermined distance from the guide surface 50 formed in the sample storage section 11A of the reagent cartridge according to the second embodiment, and the opening of the storage section 11b is large.

[0075] By not forming the holding portion 51 in this way, the structure of the mold used when manufacturing the reagent cartridge can be simplified, making it possible to easily and inexpensively manufacture the reagent cartridge according to this embodiment by resin molding.

[0076] Furthermore, when dispensing a sample into the sample storage section 11B of the reagent cartridge according to this embodiment, as shown in Figure 11, the pipette tip 31 can be held in the injection section 11b by first peeling off the second occlusion section 22 and inserting the pipette tip 31 along the guide surface 50 so as to pierce the first occlusion section 21A. In addition, a mark (for example, an arrow or a circle) may be provided in the first occlusion section 21A to indicate the part where the pipette tip 31 pierces (for example, the position corresponding to the insertion path 52 in the second embodiment).

[0077] In this case, since the second vent hole 24 is formed in the first occlusion section 21A at a position corresponding to the injection section 11b, the sample can be easily dispensed from the pipette tip 31. Furthermore, although the case in this embodiment was described in which the occlusion section 20A is formed by stacking the first occlusion section 21A and the second occlusion section 22, the occlusion section may be formed as a single layer instead of being stacked.

[0078] [Fourth Embodiment] In the reagent cartridges according to the first to third embodiments described above, the cases in which the sample storage sections 11, 11A, and 11B are formed with an absorption section 11a and an injection section 11b have been described. The reagent cartridge of the fourth embodiment, which will be described next, will describe an embodiment in which the sample storage section 11' has a different configuration from that of the first to third embodiments. Note that components that are the same or similar as those in the first to third embodiments described above will be denoted by the same reference numerals and their descriptions will be omitted.

[0079] Figure 12 is a cross-sectional view of the sample storage section of a reagent cartridge according to a fourth embodiment of the present invention, along the center line M.

[0080] The sample storage section 11' according to this embodiment includes an injection and absorption section that serves as both an injection section and an absorption section extending in the vertical direction, and a venting section that extends in connection with the injection and absorption section. The shape of the injection and absorption section is substantially the same as that of the absorption section 11a according to the first to third embodiments described above, and the shape of the venting section is substantially the same as that of the injection section 11b.

[0081] As shown in Figure 12, it is preferable that a recess 11d is formed on the inner edge of the upper end of the sample collection section 11', and in this case, the diameter of the recess 11d is formed to be smaller than the outer circumference of the body of the sample collection pipette 30, so that the sample collection pipette 30 is not inserted into the sample collection section 11' more than necessary during dispensing. Furthermore, it is preferable that the recess 11d is formed so that the tip of the body of the sample collection pipette 30 engages with it and is held in place so that it can be easily attached and detached.

[0082] Furthermore, since the venting port is connected to the injection and absorption port, the sample can be collected from the sample collection pipette 30. When dispensing, the internal pressure of the sample container 11' is released to ensure proper dispensing.

[0083] In this embodiment, the sample storage section 11' has an injection and absorption section that serves both for injecting and aspirating the sample. Therefore, after dispensing is complete, the sample collection pipette 30, which is engaged with the recess 11d, is removed from the sample storage section 11'. Alternatively, after injecting the sample, the pipette tip 31 of the pipette 30 can be moved to insert it into the venting section, and the pipette tip 31 can be separated from the pipette 30 while remaining in the venting section. Analysis can then be performed with the pipette tip 31 still placed in the sample storage section 11'.

[0084] Furthermore, the method of forming the slope 11c described in the first embodiment can be appropriately applied in the second to fourth embodiments as well. Also, the angle of the slope 11c described in the first and second embodiments can be appropriately applied in the third and fourth embodiments as well.

[0085] Furthermore, the distance between the tip of the pipette tip 31 and the liquid surface of the sample diluent pre-contained in the sample container 11A, as described in the second embodiment, can also be applied in the third embodiment.

[0086] Furthermore, the distance between the tip of the pipette tip 31 and the liquid surface of the sample diluent pre-contained in the sample container 11, as described in the first embodiment, can also be applied in the fourth embodiment.

[0087] Furthermore, the mark indicating the point where the pipette tip 31 is pierced, as described in the third embodiment, can also be applied in the first, second, and fourth embodiments.

[0088] Furthermore, the occluding portion 20A described in the third embodiment can also be applied in the second embodiment. Also, when the occluding portion 20A is applied to the third embodiment, the second vent hole 24 may be formed at a position corresponding to the injection portion 11b or at a position corresponding to both the injection portion 11b and the liquid absorption portion 11a. Furthermore, the occluding portion 20 described in the first embodiment can also be applied in the fourth embodiment.

[0089] In the first to fourth embodiments, the case where the inclined surface 11c is present has been described, but the inclined surface 11c may be omitted during formation. If it is necessary to form the reagent cartridge with a narrower width in the short direction according to the second or third embodiment, the guide surface 50 can be provided by appropriately narrowing the width of the reagent cartridge in the short direction of the absorption section 11a and the injection section 11b. In addition, in the second and third embodiments, the case where the guide surface 50 extends in a direction substantially perpendicular to the center line M has been described, but the extension direction of the guide surface 50 may be formed at an angle with respect to the center line M.

[0090] In addition, the reagent cartridge 10 according to the present embodiment described above is configured to accommodate three chips 40 in the chip housing section 15, but the number is not limited to this and can be increased or decreased as appropriate. It is clear from the claims that such modified or improved forms may also be included within the technical scope of the present invention. [Explanation of symbols]

[0091] 1 Analytical device, 2 Control panel, 3 Installation door, 4 Housing, 10 Reagent cartridge, 11,11A,11B,11' Sample storage section, 11a Absorption section, 11b Injection section, 11c Slope, 11d Recess, 12 Antibody storage section, 13 Reagent storage section, 14 Washing solution storage section, 15 Tip storage section, 15a Connecting plate, 16 Accumulation section, 17 Top surface, 20,20A Closure section, 21,21 A First occlusion, 22 Second occlusion, 23 Ventilation hole, 24 Second venting hole, 30 Pipette for sample collection, 31 Pipette tip, 32 Nipple, 40 Tip, 50 Guide surface, 51 Retaining part, 52 Pipette tip insertion path, 53 Inner wall.

Claims

1. A reagent cartridge used in an analytical instrument that analyzes results based on the reaction between a sample and a reagent, The system comprises a sample storage section for storing the sample, a reagent storage section for storing the reagent, and an antibody storage section for storing the antibody. A reagent cartridge characterized by comprising at least a sample tip for dispensing the sample, a reagent tip for dispensing the reagent, and a tip for dispensing the antibody, with a tip housing section for housing these.

2. In the reagent cartridge described in claim 1, The reagent cartridge is characterized in that the chip housing section is formed to accommodate the chips individually.

3. In the reagent cartridge described in claim 1, The reagent cartridge is characterized in that the chip housing portion is formed in a bottomed hole.

4. In the reagent cartridge described in claim 1, A reagent cartridge characterized in that the sample storage section contains a sample diluent.

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