Reagent cartridge

Abstract

To provide a reagent cartridge capable of reducing a risk of injection caused by workers touching a specimen, etc. while dispensing the specimen or handling the reagent cartridge, capable of improving work efficiency to shorten an inspection time, and capable of reliably analyzing the specimen.SOLUTION: A reagent cartridge used in an analyzer that analyzes a result based on a reaction between a specimen and a reagent, comprises a specimen housing part that houses the specimen. The specimen housing part comprises an injection part and a liquid absorption part.SELECTED DRAWING: Figure 2

Description

[Technical field]

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

[0002] 2. Description of the Related Art Various types of analyzers are known as conventional analyzers for analyzing a reaction between a specimen such as blood and a reagent. For example, an analyzer such as that shown in Patent Document 1 is known.The analytical device described in Patent Document 1 includes one or more test cartridges, each of which includes at least a sample cell for accommodating a sample, a reagent cell for accommodating a reagent, and a reaction cell in which the sample and the reagent are reacted, and in which the cells are linearly arranged; a device housing having an internal space for a predetermined set stage and 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, which linearly transports the test cartridge held by the cartridge holding means to the test stage and transports the test cartridge along a longitudinal direction along the arrangement direction of each cell of the test cartridge in the test stage that has been carried in, while linearly transporting the test cartridge after testing from the test stage to the set stage and returning it to the cartridge receiving portion of the cartridge holding means; and cartridge transport means provided in a portion of a transport path for the test cartridge in the test stage corresponding to a predetermined dispensing position, which transports the test cartridge held by the cartridge carrying means to the test stage and transports the test cartridge along a longitudinal direction along the arrangement direction of each cell of the test cartridge in the carried-in test stage, while linearly transporting the test cartridge from the test stage to the set stage and returning it to the cartridge receiving portion of the cartridge holding means. a specimen and reagent dispensing means for dispensing a specimen and a reagent of the specimen cartridge into a reaction cell of the specimen cartridge in a state where a dispensing target cell of the specimen cartridge in the inspection stage transported by the cartridge transporting means is transported to the measurement position and placed therein; a measuring means which is provided in a part of a transport path of the specimen cartridge in the inspection stage corresponding to a predetermined measurement position, and which measures a reaction between a specimen and a reagent in a reaction cell dispensed by the specimen and reagent dispensing means in a state where a reaction cell of the specimen cartridge in the inspection stage transported by the cartridge transporting means is transported to the measurement position and placed therein; a constant temperature bath which is heated by a heat source and keeps the liquid temperature in at least the reaction cell of the specimen cartridge in the inspection stage transported by the cartridge transporting means at a predetermined constant environmental temperature; and a constant temperature bath control means which has a temperature detector capable of detecting an internal environmental temperature of the inspection stage and controls a set temperature of the heat source of the constant temperature bath based on the internal environmental temperature detected by the temperature detector so that when the internal environmental temperature is lower than a predetermined threshold value, the set temperature of the heat source of the constant temperature bath is higher than when the temperature is equal to or higher than the threshold value.

[0003] According to such an analytical device, after the sample or reagent is dispensed into the reaction cell of the test cartridge, a constant temperature bath is provided which maintains the liquid temperature in the reaction cell of the test cartridge at a preset constant environmental temperature, thereby effectively preventing a decrease in measurement accuracy due to changes in the test cartridge and environmental temperature.

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

[0005] Such a reagent cartridge may be used as a single unit configured to contain all of the reagents and containers necessary to perform a sample preparation. [Prior art documents] [Patent documents]

[0006] [Patent Document 1] JP 2016-24054 A [Patent Document 2] JP 2013-150634 A Summary of the Invention [Problem to be solved by the invention]

[0007] However, the reagent cartridge described in Patent Document 1 has a problem in that there is a risk of infection or so-called contamination because there is a possibility that the sample may drip onto the top surface of the reagent cartridge or into other cells while the capillary is moving.

[0008] Furthermore, when the structure of the reagent cartridge described in Patent Document 2 is used in an analytical device that analyzes the reaction between a sample and a reagent described in Patent Document 1, the configuration involves dispensing a sample into a process tube (sample cell), which requires a process of inserting a blood collection tool into the opening of the sample cell to dispense the sample, and then removing the blood collection tool from the sample cell.This process poses the risk of infection if the sample adhering to the tip of the blood collection tool is scattered outside the sample cell, or the sample may get mixed into cells other than the sample cell and the reaction cell, resulting in contamination.

[0009] Therefore, the present invention has been made to solve such problems, and aims to provide a reagent cartridge that can reduce the risk of infection or contamination caused by an operator touching a sample, etc. while dispensing the sample or handling the reagent cartridge. [Means for solving the problem]

[0010] The reagent cartridge of 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 is characterized in that it has a sample storage section that stores the sample, and the sample storage section has an injection section and a liquid suction section. Moreover, one embodiment of the invention is a reagent cartridge used in an analytical device that analyzes results based on a reaction between a sample and a reagent, comprising a sample storage section that stores the sample, the sample storage section comprising an injection section and a liquid suction section, and a sample dilution liquid is stored in the sample storage section, and the sample dilution liquid is arranged so that when the sample is ejected into the injection section by a pipette tip, a droplet of the sample can reach the sample dilution liquid before leaving the tip of the pipette tip. Moreover, one embodiment of the invention is a reagent cartridge used in an analytical device that analyzes results based on a reaction between a sample and a reagent, comprising a sample storage section that stores the sample, the sample storage section comprising an injection section and a liquid suction section, and a sample dilution solution is stored in the sample storage section.

[0011] In one embodiment of the invention, the injection section and the liquid suction section are preferably an injection / liquid suction section that functions both as an injection section and a liquid suction section. In one embodiment of the invention, it is preferable that the injection part and the suction part extend vertically relative to each other, and that a slope is formed at the lower end of the injection part that slopes toward the suction part, and that the slope is continuous with the suction part via a side surface of the suction part.

[0012] In one embodiment of the invention, it is preferable that the injection section is formed with a guide surface that is inclined with respect to the vertical direction.

[0013] In one embodiment of the invention, the guide surface is preferably formed on a side wall facing the liquid suction portion.

[0014] In one embodiment of the invention, it is preferable to include a holding portion that is spaced a predetermined distance from the guide surface.

[0015] In one embodiment of the invention, the inclined surface is preferably inclined at an angle of 30° to 60° with respect to the vertical direction.

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

[0017] In one embodiment of the invention, it is preferable that the liquid level of the specimen dilution solution is located between the upper end and the lower end of the inclined surface.

[0018] In one embodiment of the invention, it is preferable to provide at least one of a reagent container that contains the reagent and an antibody container that contains the antibody.

[0019] In one embodiment of the invention, it is preferable that the liquid suction section and at least one of the reagent containing section and the antibody containing section are arranged substantially on an operating line of an analysis device.

[0020] Furthermore, in one embodiment of the invention, it is preferable that a first blocking section which blocks at least one of the reagent containing section and the antibody containing section and has an air vent hole formed at a position corresponding to at least one of the reagent containing section and the antibody containing section, and a second blocking section which blocks the air vent hole are stacked.

[0021] In one embodiment of the invention, it is preferable that the first closing part closes at least one of the liquid suction part and the injection part.

[0022] In one embodiment of the invention, it is preferable that the first blocking portion has a second air vent hole formed at a position corresponding to the liquid suction portion.

[0023] In one embodiment of the invention, it is preferable that the first blocking portion has a second air vent hole formed at a position corresponding to the injection portion.

[0024] Moreover, one embodiment of the invention is a reagent cartridge used in an analytical device that analyzes results based on a reaction between a sample and a reagent, comprising a sample storage section that stores the sample, the sample storage section comprising an injection section and a liquid suction section, the sample storage section stores a sample dilution solution, and the injection section is formed with a guide surface that is inclined with respect to the vertical direction. Effect of the Invention

[0025] According to the present invention, the specimen storage section is equipped with an injection section and an suction section, so that specimen injection and suction can be performed in separate locations. Therefore, after specimen injection, suction can be performed without removing the pipette tip at the end of the blood collection tool from the injection section, thereby reducing the risk of infection or contamination due to removing the blood collection tool. [Brief description of the drawings]

[0026] [Figure 1] 1 is a perspective view of an analyzer using a reagent cartridge according to a first embodiment of the present invention. [Diagram 2] FIG. 1 is a perspective view of a reagent cartridge according to a first embodiment of the present invention. [Diagram 3] Cross-sectional view taken along line AA in FIG. [Figure 4] FIG. 2 is a partially exploded view of the reagent cartridge according to the first embodiment of the present invention. [Diagram 5] FIG. 1 is a perspective view of a sample collecting pipette used when dispensing a sample into a reagent cartridge according to a first embodiment of the present invention. [Figure 6] FIG. 2 is a cross-sectional view showing a state in which a sample is dispensed into the reagent cartridge according to the first embodiment of the present invention. [Figure 7] FIG. 3 is a cross-sectional view showing a state in which an antibody or a reagent is being removed from the reagent cartridge according to the first embodiment of the present invention. [Figure 8] FIG. 11 is a cross-sectional view of a sample storage section of a reagent cartridge according to a second embodiment of the present invention. [Figure 9] FIG. 11 is a cross-sectional view showing a state in which a sample is dispensed into a reagent cartridge according to a second embodiment of the present invention. [Figure 10] FIG. 11 is a cross-sectional view of a sample storage portion of a reagent cartridge according to a third embodiment of the present invention. [Figure 11] FIG. 11 is a cross-sectional view showing a state in which a sample is dispensed into a reagent cartridge according to a third embodiment of the present invention. [Figure 12] FIG. 13 is a cross-sectional view taken along the center line M of a sample storage portion of a reagent cartridge according to a fourth embodiment of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

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

[0028] The reagent cartridge provided by the present invention relates to a cartridge used in an analyzer for analyzing results based on a reaction between a sample such as blood and a reagent. The reagent cartridge provided by the present invention may be used in an analyzer for analyzing results based on a reaction between a sample such as blood and a reagent, and the subject of the analysis is not particularly limited. In one embodiment, the reagent cartridge provided by the present invention relates to a cartridge used in an allergy test (a test for confirming the presence or absence of a specific allergy). In another embodiment, the reagent cartridge provided by the present invention relates to a cartridge used in a blood test such as a blood hemoglobin A1c concentration measurement. In another embodiment, the reagent cartridge provided by the present invention relates to a cartridge used in a genetic test. In addition, the mode of analysis of results based on a reaction between a sample such as blood and a reagent in the present invention may be any mode that can perform analysis, and is not particularly limited. In one embodiment, the reagent cartridge used in an allergy test relates to an analysis for detecting the presence or absence of luminescence based on an antibody (hereinafter referred to as a labeled antibody) that has specific binding ability to the antibody and is labeled with a physiologically active substance having 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, for example, a luminescent substrate is dispensed to cause the substrate to emit light through a chemical reaction catalyzed by the labeled antibody (for example, an anti-IgE antibody labeled with an enzyme), thereby making the substrate visible. Furthermore, the visualization analysis relates to an analysis in which, for example, the chemical reaction is carried out for a predetermined period of time under predetermined environmental conditions, and the intensity of the luminescence is measured by a detection camera. Note that, in this specification, the term "reagent" refers to a reagent for a reaction required for detection, such as a labeled antibody or a luminescent substrate. The reagent may be any reagent required for the reaction, and is not particularly limited to these specific examples.

[0029] [First embodiment] FIG. 1 is a perspective view of an analytical device using a reagent cartridge according to a first embodiment of the present invention, FIG. 2 is a perspective view of the reagent cartridge according to the first embodiment of the present invention, FIG. 3 is a cross-sectional view taken along line AA in FIG. 2, FIG. 4 is a partially exploded view of the reagent cartridge according to the first embodiment of the present invention, FIG. 5 is a perspective view of a sample collection pipette used when dispensing a sample into the reagent cartridge according to the first embodiment of the present invention, FIG. 6 is a cross-sectional view showing the state in which a sample is dispensed into the reagent cartridge according to the first embodiment of the present invention, and FIG. 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] 1, the reagent cartridge according to this embodiment is inserted into an analyzer 1 to analyze the results based on the reaction between the sample dispensed into the reagent cartridge and the reagent. The analyzer 1 includes an operation panel 2 and a housing 4 having an installation door 3 that can be opened and closed to close an input section in which a reagent cartridge 10 and a reaction cell are installed.

[0031] In the analyzer 1, the reaction cell and the reagent cartridge 10 are set on a moving table (not shown) from an input section by opening a mounting door 3. Then, the tip 40 stored in the reagent cartridge 10 is fitted to the tip of the dispensing nozzle, and the specimen, reagent, etc. are aspirated from the reagent cartridge 10. The aspirated specimen, reagent, etc. are dispensed into the reaction cell.

[0032] After the dispensing process is completed, the moving table is reciprocated to stir and react the specimen, antibody (including an antibody having specific binding ability to the specimen, an antibody labeled with a physiologically active substance having enzyme activity, etc.) dispensed into the reaction cell. After stirring, the dispensed specimen and other liquids are drained, and the detection camera is brought into close contact with the reaction cell and shielded from external light from the outside of the reaction cell and the testing device. In this state, the presence or absence of luminescence from an antibody having specific binding ability to the specimen and labeled with a physiologically active substance having enzyme activity (hereinafter referred to as a labeled antibody) can be detected, for example, to detect the presence or absence of an allergic reaction. Specifically, the luminescence of the labeled antibody is visualized by dispensing a reagent (luminescent substrate) and causing the substrate to emit light through a chemical reaction catalyzed by the labeled antibody (in this embodiment, an anti-IgE antibody labeled with an enzyme), and this chemical reaction is carried out under a predetermined environmental condition for a predetermined time, and the intensity of this luminescence is measured by the detection camera.

[0033] In one embodiment, the specimen is discharged into the specimen storage section, and the labeled antibody is stored in the antibody storage section. In this case, for example, the aspirated specimen is dispensed and stirred into a reaction cell, and then the solution is drained after a washing process, and the labeled antibody is dispensed into the reaction cell, stirred to react, and then washed and drained.

[0034] In another embodiment different from the above embodiment, it is possible to omit the antibody storage section by storing a labeled antibody in the specimen storage section in advance. In this case, for example, the labeled antibody is stored in the specimen storage section in advance, and the specimen and the labeled antibody are reacted in the specimen storage section, which is then dispensed and stirred into a reaction cell, followed by washing and draining.

[0035] Here, the reaction cell may be any cell that allows a sample and a reagent to react with each other, and there are no particular limitations on the shape, structure, material, etc. The reaction cell may be configured to be contained in a so-called cassette.

[0036] Furthermore, the physiologically active substance having enzymatic activity to be labeled to the antibody capable of specifically binding to the analyte may be any of those known in the art, and may include, but is not limited to, the following enzymes: alkaline phosphatase, β-galactosidase, glucose oxidase, urease, creatine kinase, uricase, glucose-6-phosphate dehydrogenase, peroxidase, etc.

[0037] The luminescent substrate may be any of those known in the art, and may include, but is not limited to, the following substrates: acridinium salts, dioxetanes, luciferin, lucigenin, oxalyl chloride, etc.

[0038] In addition, the reagent cartridge according to the present embodiment has been described as being in a form in which luminescence is measured using a labeled antibody labeled with a physiologically active substance having enzymatic activity and a luminescent substrate, but the reagent cartridge according to the present embodiment can also be used for other measurements. For example, the reagent cartridge according to the present embodiment can also be used for measuring fluorescence by using a labeled antibody in which the substance labeled to the labeled antibody is a fluorescent substrate (fluorophore) instead of a physiologically active substance having enzymatic activity.

[0039] Specifically, the specimen is discharged into the specimen storage section, and the labeled antibody is stored in the antibody storage section, or the specimen is discharged into the specimen storage section in which the labeled antibody has been stored beforehand, and can be used for measuring fluorescence. In this case, if the substance to label the antibody is a fluorescent substrate (fluorophore), the reagent storage section can be omitted. Furthermore, by storing the labeled antibody in advance in the specimen storage section, the antibody storage section can also be omitted. For example, the aspirated specimen is dispensed and stirred into a reaction cell, and after a washing process and draining, the labeled antibody is dispensed into the reaction cell, stirred to cause a reaction, and washed and drained. Alternatively, the labeled antibody is stored in the specimen storage section beforehand, and the specimen and the labeled antibody reacted in the specimen storage section are dispensed and stirred into the reaction cell, washed and drained. After that, an excitation antigen, a spectrometer, a fluorescence detector, or the like is used instead of a detection camera to block external light from entering the reaction cell, and detection is performed by applying light having a wavelength that excites the fluorescent substrate to cause fluorescence.

[0040] Next, the reagent cartridge 10 according to this embodiment will be described. As shown in Fig. 2, the reagent cartridge 10 according to this embodiment includes a specimen storage section 11 that dispenses and stores a specimen, an antibody storage section 12 that stores an antibody, a reagent storage section 13 that stores a reagent, a cleaning liquid storage section 14 that stores a cleaning liquid, and a chip storage section 15 that stores a plurality of chips. The reagent cartridge 10 is preferably configured as a molded product from a synthetic resin such as polypropylene or polyethylene, and in this case, it is preferably configured such that the specimen storage section 11, the antibody storage section 12, the reagent storage section 13, the cleaning liquid storage section 14, and the chip storage section 15 are integrally configured.

[0041] The cleaning solution storage section 14, the specimen storage section 11, the antibody storage section 12, the reagent storage section 13, and the chip storage section 15 are arranged along the longitudinal direction on the approximately rectangular top surface section 17. At this time, it is preferable that the cleaning solution storage section 14, the specimen storage section 11, the antibody storage section 12, the reagent storage section 13, and the chip storage section 15 are arranged approximately on the same straight line along the approximate center line M in the width direction of the top surface section 17 so as to follow the operation line along which the moving table reciprocates. Also, the cleaning solution storage section 14, the specimen storage section 11, the antibody storage section 12, the reagent storage section 13, and the chip storage section 15 are each formed in a bottomed cylindrical tube shape extending vertically from the top surface section 17.

[0042] The specimen storage section 11 includes a liquid suction section 11a disposed on a center line M (approximately the operating line of the analyzer) and an injection section 11b disposed adjacent to the liquid suction section 11a. The liquid suction section 11a and the injection section 11b are continuous with each other in any direction in the vertical direction, and in the reagent cartridge 10 of this embodiment, they are disposed so as to overlap each other, so that the liquid suction section 11a and the injection section 11b extend in a continuous manner along the vertical direction, and an opening formed in the top surface section 17 is formed into an approximately gourd shape (an external shape resembling the figure eight).

[0043] 3, the specimen storage section 11 is formed with an absorbing section 11a and an injecting section 11b each extending in the vertical direction. The absorbing section 11a is formed longer than the injecting section 11b, and a substantially hemispherical reservoir section 16 is formed at the bottom of the absorbing section 11a.

[0044] Injection section 11b extends vertically along suction section 11a, and has a slope 11c at its lower end that is continuous with the side surface of suction section 11a. Slope 11c may have any shape as long as the specimen dispensed into injection section 11b flows smoothly into reservoir section 16, but is preferably formed with an arc-shaped or linear cross section. Slope 11c is more preferably linear, and when slope 11c is formed linearly, it is preferably formed obliquely toward reservoir section 16, with the inclination angle being preferably 30° to 60°, and a preferred angle being approximately 45°. Furthermore, slope 11c is more preferably formed linearly in continuity with reservoir section 16 so as to form a part of reservoir section 16. In this case, slope 11c may be formed from approximately the lower end of reservoir section 16. It is preferred that specimen dilution solution is stored in specimen storage section 11 beforehand. By diluting the specimen, the amount of specimen used can be reduced. Furthermore, in the case of a specimen having a certain degree of viscosity such as blood, it can be used to spread the specimen evenly over the reaction cell, and can be used to ensure that the reaction between the specimen and a substance on the reaction cell such as an antigen occurs without unevenness. Here, the specimen dilution liquid may be any liquid capable of diluting the specimen, and any conventional technology may be used. Therefore, although not particularly limited, for example, physiological saline, a buffer having a buffer capacity of pH 6 to 9, or a so-called Good's buffer may be used. Furthermore, the specimen dilution liquid may contain heparin or the like.

[0045] As shown in FIG. 2, the antibody storage section 12 and the reagent storage section 13 are tubular sections with an oval cross section extending vertically, and their vertical lengths can be changed as appropriate depending on the amount of antibody or reagent to be stored, but are generally formed shorter than the specimen storage section 11, the washing solution storage section 14, and the chip storage section 15.

[0046] The washing solution containing section 14 is a tubular member having an elliptical cross section that extends vertically, similar to the antibody containing section 12 and the reagent containing section 13, but its volume is configured to be larger than those of the antibody containing section 12 and the reagent containing section 13.

[0047] The chip storage section 15 is formed so as to be capable of storing a plurality of chips 40 shown in Fig. 7, and is configured so as to be able to store the required number of chips 40. The lower ends of all the chip storage sections 15 are connected to each other by a connecting plate 15a. Furthermore, the connecting plate 15a and the bottom 14a of the cleaning liquid storage section 14 are configured horizontally so as to be positioned on the same plane, and when the reagent cartridge 10 is placed on a workbench such as a desk, the reagent cartridge 10 can be prevented from falling over and the reagent cartridge 10 can be held so as to be able to stand on its own.

[0048] As shown in FIG. 4, the reagent cartridge 10 according to this embodiment has an antibody, a reagent, and a cleaning solution stored in advance in the antibody storage section 12, the reagent storage section 13, and the cleaning solution storage section 14, respectively, and a blocking section 20 is attached to the top surface 17 to prevent leakage of the antibody, the reagent, and the cleaning solution during transportation, etc.

[0049] The blocking portion 20 is attached to the top surface portion 17 and includes a first blocking portion 21 having an air vent hole 23 formed at a position corresponding to the antibody containing portion 12 and the reagent containing portion 13, and a second blocking portion 22 laminated on the first blocking portion 21 so as to block the air vent hole 23 of the first blocking portion 21. The first blocking portion 21 and the second blocking portion 22 are preferably made of a membranous film material, and are attached to each other with an adhesive or the like.

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

[0051] The specimen collecting pipette 30 includes a pipette tip 31 that sucks, discharges and holds the specimen, and a nipple 32 made of an elastic material such as rubber that sucks in the specimen when absorbing it. The specimen is sucked into the pipette tip 31 by capillary action, for example, and is collected and held in the pipette tip 31.

[0052] The sample thus collected is dispensed into the sample storage section 11 by inserting the pipette tip 31 into the injection section 11b while breaking the first blocking section 21 after peeling off the second blocking section 22 of the reagent cartridge 10, as shown in FIG. 6. At this time, the sample held in the pipette tip 31 flows out into the injection section 11b by pressing the nipple 32. The injection section 11b is formed shorter than the liquid suction section 11a, and a slope 11c is formed at the lower end, so that the entire amount of the sample that flows out from the pipette tip 31 is collected in the liquid storage section 16 along the slope 11c. Although the case where the injection section 11b is sealed in the first blocking section 21 has been shown, the injection section 11b may be opened in advance in the first blocking section 21 as shown in FIG. 4. This allows the operator to more easily discharge the collected sample into the sample storage section 11.

[0053] At this time, when the specimen held in the pipette tip 31 is discharged into the injection section 11b, the specimen is dropped as shown in Fig. 6, but if a specimen dilution liquid is previously stored in the specimen storage section 11, the droplets of the specimen can reach the specimen dilution liquid before leaving the tip of the pipette tip 31, and the specimen can be reliably discharged into the specimen storage section 11. Alternatively, the droplets of the specimen can reach a slope that slopes toward the liquid suction section 11a formed at the lower end of the injection section 11b before leaving the tip of the pipette tip 31, and the droplets can be reliably discharged into the specimen storage section 11 via the specimen dilution liquid. Thereafter, the specimen and the specimen dilution liquid can be agitated, for example, by shaking the cartridge itself.

[0054] It is also preferable to keep a distance between the surface of the specimen dilution liquid and the tip of the pipette tip 31. Specifically, the distance is preferably such that the risk of the specimen dilution liquid flowing back into the pipette tip 31 due to the tip of the pipette tip 31 reaching the specimen dilution liquid can be reduced, and the discharged specimen (droplets) can reach the specimen dilution liquid and the specimen can be normally mixed in the specimen dilution liquid. For example, the allowable range of the distance 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 in the reagent cartridge 10 should be long enough to prevent the sample from scattering when the sample is ejected or when the sample and the sample dilution solution are mixed.

[0056] Furthermore, the amount of specimen dilution liquid contained in specimen storage section 11 may be such that it can be spread evenly over the reaction cell when the specimen has a certain degree of viscosity, such as blood. Furthermore, when reagent cartridge 10 is left standing in the vertical direction, the liquid level of the specimen dilution liquid is preferably between the upper end and the lower end of a slope that slopes toward liquid suction section 11a formed at the lower end of injection section 11b.

[0057] In addition, the sample-collecting pipette 30 can be left in the injection section 11b even after the sample has been ejected, but if the main body including the nipple 32 and the tip section, which is the pipette tip 31, can be detached (separated), then only the pipette tip 31 can be left in the injection section 11b, as shown in Figure 6.

[0058] Next, the sample is absorbed by the dispensing nozzle of the analyzer 1 taking out the tip 40 from the tip storage section 15 of the reagent cartridge 10, fitting it to the tip of the dispensing nozzle, and inserting it into the liquid suction section 11a so as to break through the first blocking section 21, thereby moving the tip of the tip 40 to a position where the sample stored in the liquid reservoir section 16 can be absorbed. At this time, the bottom of the liquid reservoir section 16 is formed in a hemispherical or conical shape, so that the sample in the liquid reservoir section 16 can be efficiently absorbed.

[0059] Next, a method for extracting antibodies and reagents will be described with reference to Fig. 7. The method for extracting antibodies and reagents is performed by fitting a tip 40 to the dispensing nozzle of the analysis device 1, similar to the above-mentioned method for extracting specimens. At this time, separate tips 40 are used for extracting the antibodies and the reagents, respectively. For this reason, the necessary number of tips 40 required for extracting the specimens, antibodies and reagents are stored in the tip storage section 15. After extraction, the specimens, antibodies and reagents are dispensed into the analysis device 1 (reaction cells), and the used tips 40 are stored again in the tip storage section 15 and are discarded at the same time as the reagent cartridge 10 is discarded.

[0060] The antibody and the reagent are accommodated in the reagent cartridge 10 in advance and sealed by the blocking portion 20. However, when the tip 40 is inserted through the blocking portion to extract the antibody and the reagent, the internal pressure of the antibody containing section 12 and the reagent containing section 13 increases due to the sealing action of the blocking portion 20, which may hinder the absorption of the antibody and the reagent. To prevent this, the reagent cartridge 10 according to this embodiment has a first blocking portion 21 having an air vent hole 23 formed in a corresponding position of the antibody containing section 12 and the reagent containing section 13 attached thereto. Even if the tip 40 breaks through the first blocking portion 21 and is inserted into the antibody containing section 12 and the reagent containing section 13, the air vent hole 23 can suppress the increase in the internal pressure of the antibody containing section 12 and the reagent containing section 13, so that the antibody and the reagent can be smoothly absorbed. The air vent hole 23 may be provided in a corresponding position of the suction section 11a. Providing the air vent hole 23 in the liquid suction section 11a can contribute to smooth discharge of the specimen from the specimen collecting pipette 30. The second blocking section 22 is attached to prevent leakage of the antibody or reagent from the air vent hole 23 during transportation or handling of the reagent cartridge 10, and is removed beforehand at the time of injection of the specimen, as described above. In addition, in the present embodiment, the blocking section 20 is described as being formed by stacking the first blocking section 21 and the second blocking section 22, but the blocking section 20 may be formed as a single layer instead of being stacked.

[0061] According to the reagent cartridge 10, in an allergy test, the risk of infection caused by an operator touching a sample while dispensing the sample or handling the reagent cartridge can be reduced. In addition, the sample can be dispensed from the liquid suction section 11a while the pipette tip 31 for dispensing the sample is inserted in the injection section 11b, and the used tip 40 can be stored in the tip storage section 15. When the reagent cartridge 10 is disposed of after the analysis by the analyzer 1 is completed, the pipette tip 31 and the tip 40 can be disposed of at the same time, so that the risk of infection caused by touching them can also be reduced. In addition, by configuring the reagent cartridge 10 so that a removable cover member that covers the top surface section 17 of the reagent cartridge 10 can be attached when the reagent cartridge 10 is disposed of, the risk of infection can be further prevented.

[0062] [Second embodiment] In the above-described reagent cartridge 10 according to the first embodiment, the pipette tip 31 is inserted along the extension direction of the injection section 11b during dispensing. The reagent cartridge according to the second embodiment described below will be described with reference to an example of a specimen storage section 11A having a different form from that of the first embodiment. Note that the same reference numerals are used to designate the same or similar members as those in the first embodiment, and description thereof will be omitted.

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

[0064] As shown in Fig. 8, the specimen storage section 11A according to this embodiment is characterized by the shape of the injection section 11b. As with the reagent cartridge 10 according to the first embodiment described above, the specimen storage section 11A according to this embodiment has the liquid suction section 11a and the injection section 11b formed to extend vertically from each other, but the injection section 11b has a guide surface 50 formed therein that extends obliquely from a side wall facing the liquid suction section 11a. In addition, a holder 51 is formed at a predetermined distance from the guide surface 50, and a pipette tip insertion path 52 is formed between the guide surface 50 and the holder 51.

[0065] The lower end of injection section 11b has inclined surface 11c inclined at approximately 45° with respect to the vertical direction. Since inclined surface 11c at the lower end of injection section 11b is inclined at approximately 45°, the reagent cartridge according to this embodiment can more optimally mix the sample and the sample dilution solution when the reagent cartridge is stirred after the sample is discharged. Inclined surface 11c may be formed at an angle, but the inclination angle is preferably 30° to 60°, and the most suitable angle is approximately 45°.

[0066] The specimen storage section 11A of the reagent cartridge according to this embodiment formed in this manner can eject a specimen collected in the pipette tip 31 into the specimen storage section 11A by inserting the pipette tip 31 into the pipette tip insertion path 52 formed between the guide surface 50 and the holding section 51, as shown in FIG. 9.

[0067] Furthermore, by inserting the pipette tip 31 along the guide surface 50, the specimen storage section 11A of the reagent cartridge according to this embodiment can ensure a distance between the tip of the pipette tip 31 from which the specimen is ejected and the inner wall 53 of the specimen storage section 11A. This prevents a phenomenon in which the specimen cannot be ejected into the specimen storage section 11A when the distance between the tip of the pipette tip 31 and the inner wall 53 of the specimen storage section 11A is narrow, because the specimen to be ejected is sucked up by capillary action into the gap between the tip of the pipette tip 31 and the inner wall 53 of the specimen storage section 11A, and enables the specimen to be ejected reliably into the specimen storage section 11A.

[0068] It is preferable that the tip of the pipette tip 31 is inserted so that the distance from the tip of the droplet to the liquid level of the specimen dilution liquid pre-contained in the specimen storage section 11A is approximately equal to the liquid level a of the specimen dilution liquid, as shown in Figure 9. However, even if the droplet does not reach the liquid level b of the specimen dilution liquid, it is possible to eject the specimen sufficiently.

[0069] In addition, the sample storage section 11A of the reagent cartridge in this embodiment can hold the pipette tip 31 by the guide surface 50 and the holding section 51, making it possible to hold the pipette tip 31 in the reagent cartridge after sample ejection.

[0070] [Third embodiment] The above description has been given of the specimen storage section 11A of the reagent cartridge 10 according to the second embodiment, which has the holder 51 spaced a predetermined distance from the guide surface 50. The next description will be given of a reagent cartridge according to a third embodiment, which has a specimen storage section 11B having a different configuration from that of the second embodiment. Note that the same reference numerals are used to designate members that are the same as or similar to those in the first and second embodiments, and descriptions thereof will be omitted.

[0071] FIG. 10 is a cross-sectional view of a sample storage section of a reagent cartridge according to a third embodiment of the present invention, and FIG. 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 FIG. 10, the specimen storage section 11B of the reagent cartridge according to this embodiment has a blocking section 20A attached to the upper opening of the specimen storage section 11B to prevent leakage of the specimen dilution solution stored in the specimen storage section 11B during transportation, etc.

[0073] The blocking portion 20A is attached to the opening of the specimen storage portion 11B and includes a first blocking portion 21A having a second air vent hole 24 formed at a position corresponding to the injection portion 11b, and a second blocking portion 22 laminated on the first blocking portion 21A so as to block the second air vent hole 24 of the first blocking portion 21. The first blocking portion 21A and the second blocking portion 22 are preferably made of a membranous film material and are attached to each other with an adhesive or the like.

[0074] In addition, the sample storage section 11B of the reagent cartridge according to this embodiment does not have a holding section 51 arranged 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 receiving section 11b is opened wide.

[0075] In this manner, by not forming the holding portion 51, 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] When discharging a sample into the sample storage section 11B of the reagent cartridge according to this embodiment, the second blocking section 22 is peeled off in advance, and the pipette tip 31 is inserted along the guide surface 50 so as to break through the first blocking section 21A, so that the pipette tip 31 can be held in the injection section 11b, as shown in Fig. 11. Also, a mark (e.g., an arrow or a circle) indicating the portion where the pipette tip 31 breaks through the first blocking section 21A (e.g., a position corresponding to the insertion path 52 in the second embodiment) may be provided on the first blocking section 21A.

[0077] In this case, since the second vent hole 24 is formed in the first blocking portion 21A at a position corresponding to the injection portion 11b, the sample can be easily discharged from the pipette tip 31. In addition, in the present embodiment, the blocking portion 20A is formed by stacking the first blocking portion 21A and the second blocking portion 22, but the blocking portion may be formed in a single layer instead of being stacked.

[0078] [Fourth embodiment] The reagent cartridges according to the first to third embodiments described above have been described with reference to the case where the liquid suction section 11a and the injection section 11b are formed in the specimen storage sections 11, 11A, and 11B. The reagent cartridge according to the fourth embodiment described next will be described with reference to an example of a specimen storage section 11' having a different form from those of the first to third embodiments. Note that the same reference numerals are used to designate the same or similar members as those in the first to third embodiments described above, and descriptions thereof will be omitted.

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

[0080] The specimen storage section 11' according to this embodiment includes an injection and aspiration section that functions both as an injection section and an aspiration section extending in the vertical direction, and an air removal section that extends in connection with the injection and aspiration section. The shape of the injection and aspiration section is approximately the same as that of the aspiration section 11a according to the first to third embodiments described above, and the shape of the air removal section is approximately the same as that of the injection section 11b.

[0081] 12, the inner edge of the upper end of the specimen storage section 11' is preferably formed with a recess 11d, the diameter of which is smaller than the outer circumferential shape of the body of the specimen-collecting pipette 30 so that the specimen-collecting pipette 30 is not inserted into the specimen storage section 11' more than necessary during dispensing. Also, the recess 11d is preferably formed so that the tip of the body of the specimen-collecting pipette 30 can be engaged therewith and held in an easily detachable manner.

[0082] Furthermore, since the air removal section communicates with the injection and suction section, when dispensing a specimen from the specimen-collecting pipette 30, the internal pressure of the specimen storage section 11' can be released to ensure reliable dispensing.

[0083] In the specimen storage section 11' according to this embodiment, the injection / absorption section serves both to inject and absorb the specimen, so that after dispensing is completed, the specimen collecting pipette 30 engaged with the recess 11d is removed from the specimen storage section 11'. After injecting the specimen, the pipette tip 31 of the pipette 30 can be moved so as to be inserted into the air removal section, and the pipette tip 31 can be separated from the pipette 30 while remaining in the air removal section, and analysis can be performed with the pipette tip 31 remaining in the specimen storage section 11'.

[0084] The form of the inclined surface 11c described in the first embodiment can be appropriately applied to the second to fourth embodiments. The angle of the inclined surface 11c described in the first and second embodiments can be appropriately applied to the third and fourth embodiments.

[0085] Furthermore, the distance between the tip of pipette tip 31 and the liquid surface of the specimen dilution liquid contained in specimen containing portion 11A in advance, which has been described in the second embodiment, can also be applied to the third embodiment.

[0086] Furthermore, the distance between the tip of pipette tip 31 and the liquid surface of the specimen dilution liquid contained in advance in specimen container 11, which has been described in the first embodiment, can also be applied to the fourth embodiment.

[0087] Moreover, the mark indicating the portion for piercing the pipette tip 31 described in the third embodiment can also be applied to the first, second and fourth embodiments.

[0088] The blocking portion 20A described in the third embodiment can also be applied to the second embodiment. When the blocking 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 positions corresponding to both the injection portion 11b and the liquid suction portion 11a. The blocking portion 20 described in the first embodiment can also be applied to the fourth embodiment.

[0089] In the first to fourth embodiments, the case where the inclined surface 11c is provided has been described, but the inclined surface 11c may be omitted. When it is necessary to narrow the width of the short side direction of the reagent cartridge according to the second or third embodiment, the guide surface 50 can be provided by appropriately narrowing the width of the short side direction of the reagent cartridge of the liquid suction section 11a and the injection section 11b. In the second and third embodiments, the guide surface 50 is described as extending in a direction substantially perpendicular to the center line M, but the extension direction of the guide surface 50 may be formed at a predetermined angle obliquely with respect to the center line M.

[0090] Although the reagent cartridge 10 according to the present embodiment described above is configured to be able to accommodate three tips 40 in the tip accommodation section 15, 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 are also included within the technical scope of the present invention. [Explanation of symbols]

[0091] 1 analyzer, 2 operation section, 3 installation door, 4 housing, 10 reagent cartridge, 11, 11A, 11B, 11' specimen storage section, 11a suction section, 11b injection section, 11c inclined surface, 11d recess, 12 antibody storage section, 13 reagent storage section, 14 cleaning solution storage section, 15 tip storage section, 15a connecting plate, 16 reservoir section, 17 top surface, 20, 20A blocking section, 21, 21A first blocking section, 22 second blocking section, 23 air vent hole, 24 second air vent hole, 30 specimen collection pipette, 31 pipette tip, 32 nipple, 40 tip, 50 guide surface, 51 holding section, 52 Pipette tip insertion passage, 53 inner wall.

Claims

1. A reagent cartridge for use in an analyzer for analyzing a result based on a reaction between a sample and a reagent, comprising: The apparatus includes a specimen container that contains the specimen, a reagent container that contains the reagent, and an antibody container that contains an antibody, A reagent cartridge comprising: a chip storage section for storing chips corresponding to at least the specimen, the reagent, and the antibody.

2. The reagent cartridge according to claim 1, The reagent cartridge, wherein the chip storage section is formed so as to be able to store the chips individually.

3. The reagent cartridge according to claim 1, The reagent cartridge is characterized in that the chip storage portion is formed as a bottomed hole.

4. A reagent cartridge for use in an analyzer for analyzing results based on a reaction between a sample and a reagent, comprising: a specimen container for accommodating the specimen, a reagent container for accommodating the reagent, an antibody container for accommodating an antibody, a cleaning solution container for accommodating a cleaning solution, and a tip container for accommodating a tip are arranged in one direction; The cleaning liquid storage unit is disposed on one end side in the one direction, The reagent cartridge is characterized in that the chip storage section is disposed on the other end side in the one direction.

5. The reagent cartridge according to claim 4, A reagent cartridge, characterized in that the specimen containing section, the reagent containing section, the antibody containing section, the cleaning solution containing section and the chip containing section are arranged on a straight line.

6. The reagent cartridge according to claim 5, A reagent cartridge characterized in that the cleaning liquid containing section, the specimen containing section, the antibody containing section, the reagent containing section, and the chip containing section are arranged in this order from one end side to the other end side in the one direction.

7. The reagent cartridge according to claim 5, the specimen storage section, the reagent storage section, the antibody storage section, the cleaning solution storage section, and the chip storage section are formed as bottomed holes each opening on the same plane, The straight lines are disposed on the same plane.

8. The reagent cartridge according to claim 1 or 4, A reagent cartridge, wherein the specimen storage section stores a specimen dilution solution.

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