Reagent cartridge

Abstract

To provide a reagent cartridge that can reduce the risk of infection occurring due to an operator touching a specimen during dispensation of the specimen or handling of the reagent cartridge, can improve working efficiency to reduce inspection time, and can reliably conduct analysis of the specimen.SOLUTION: A reagent cartridge is used for an analyzer that analyzes a result based on the reaction between a specimen and a reagent, and comprises a specimen storage unit that stores the specimen, a reagent storage unit that stores the reagent, and an antibody storage unit that stores an antibody, and comprises a tip storage unit that stores tips corresponding respectively to at least the specimen, the reagent, and the antibody. The specimen storage unit stores specimen diluent liquid.SELECTED DRAWING: Figure 2

Description

[Technical Field]

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

[0002] BACKGROUND ART Various types of analyzers for analyzing a reaction between a specimen such as blood and a reagent have been known in the past, and an analyzer such as that shown in Patent Document 1 is known, for example.The analyzer described in Patent Document 1 includes one or more test cartridges each including 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, the cells being linearly arranged; an apparatus 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 and configured to linearly transport the test cartridge held by the cartridge holding means onto the test stage and transport the test cartridge along a longitudinal direction that is in line with the arrangement direction of the cells of the test cartridge in the test stage that has been carried in, and to linearly transport the test cartridge from the test stage to the set stage after testing and return it to the cartridge receiving portion of the cartridge holding means; and cartridge transport means provided in a portion of the test cartridge transport path within the test stage corresponding to a predetermined dispensing position, the cartridge transported by the cartridge transport means. a specimen and reagent dispensing means for dispensing specimens and reagents from the specimen cartridge into reaction cells of the specimen cartridge in a state where a dispensing target cell of the specimen cartridge in the specimen stage is transported and placed at the dispensing position; a measuring means provided in a part of a transport path of the specimen cartridge in the specimen stage corresponding to a predetermined measurement position, and for measuring a reaction between the specimen and reagent in the reaction cell dispensed by the specimen and reagent dispensing means in a state where the reaction cell of the specimen cartridge in the specimen stage transported by the cartridge transporting means is transported and placed at the measurement position; a thermostatic bath heated by a heat source to maintain the temperature of at least the liquid in the reaction cell of the specimen cartridge in the specimen stage transported by the cartridge transporting means at a predetermined constant environmental temperature; and a thermostatic bath control means having a temperature detector capable of detecting an internal environmental temperature of the specimen stage, and for controlling the set temperature of the heat source of the thermostatic 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 thermostatic bath is higher than when the temperature is equal to or higher than the threshold value.

[0003] Such an analytical device 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 after dispensing the sample or reagent into the reaction cell of the test cartridge, thereby effectively preventing a decrease in measurement accuracy due to changes in the test cartridge and ambient temperature.

[0004] Furthermore, a known example of a reagent cartridge that simultaneously handles specimens and reagents is the reagent cartridge described in Patent Document 2, 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 disposed in the connecting member and configured to receive a disposable pipette tip, two or more reagent tubes provided in the lower part of the connecting member and each including an inlet hole located in the connecting member, and one or more containers provided in the connecting member, each configured to receive a complementary vessel, for example a reagent tube, inserted from the receiving side of the connecting member.

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

[0006] [Patent Document 1] Japanese Patent Application Laid-Open No. 2016-24054 [Patent Document 2] Japanese Patent Application Laid-Open No. 2013-150634 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 the sample may drip onto the top surface of the reagent cartridge or into other cells while the capillary is moving, which poses a risk of infection or so-called contamination.

[0008] Furthermore, when the structure of the reagent cartridge described in Patent Document 2 is applied to an analyzer that analyzes the reaction between a sample and a reagent described in Patent Document 1, the sample is dispensed into a process tube (sample cell), which requires a step 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 poses a problem in that the sample adhering to the tip of the blood collection tool may be scattered outside the sample cell, creating a risk of infection, or the sample may get mixed into cells other than the sample cell and 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-mentioned problems, is a reagent cartridge used in an analyzer that analyzes results based on the reaction between a sample and a reagent, and is characterized in that it comprises a sample storage section that stores the sample, a reagent storage section that stores the reagent, and an antibody storage section that stores an antibody, and also comprises chip storage sections that store chips corresponding to at least the sample, the reagent, and the antibody, respectively, and the sample storage section stores a sample dilution solution. Furthermore, 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 absorption section, and a sample dilution solution stored in the sample storage section, the sample dilution solution being 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 solution before leaving the tip of the pipette tip. Furthermore, one embodiment of the invention is a reagent cartridge used in an analyzer that analyzes results based on a reaction between a sample and a reagent, and is characterized in that it comprises a sample storage section that stores the sample, the sample storage section comprising an injection section and a liquid absorption section, and the sample storage section contains a sample dilution solution.

[0011] In the reagent cartridge according to the present invention, it is preferable that the tip storage section is formed so as to be able to store the tips individually. In one embodiment of the invention, the injection section and the liquid suction section are preferably an injection / liquid suction section that serves as both 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, that the lower end of the injection part has a slope 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 the reagent cartridge according to the present invention, it is preferable that the tip storage portion is formed as a bottomed hole. In one embodiment of the invention, it is preferable that the injection section has a guide surface formed thereon that is inclined with respect to the vertical direction.

[0013] The reagent cartridge of the present invention is a reagent cartridge used in an analytical device that analyzes results based on the reaction between a sample and a reagent, and is characterized in that a sample container that contains the sample, a reagent container that contains the reagent, an antibody container that contains an antibody, a cleaning fluid container that contains a cleaning fluid, and a chip container that contains a chip are arranged in one direction, the cleaning fluid container is arranged on one end side of the one direction, and the chip container is arranged on the other end side of the one direction, and a sample dilution solution is stored in the sample container. In one embodiment of the invention, the guide surface is preferably formed on a side wall facing the liquid suction portion.

[0014] In the reagent cartridge according to the present invention, it is preferable that the specimen containing section, the reagent containing section, the antibody containing section, the washing liquid containing section, and the chip containing section are arranged on a straight line. 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 the reagent cartridge according to the present invention, it is preferable 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. In one embodiment of the invention, it is preferable that the inclined surface is inclined at an angle of 30° to 60° with respect to the vertical direction.

[0016] In the reagent cartridge according to the present invention, it is preferable that the specimen containing section, the reagent containing section, the antibody containing section, the cleaning solution containing section, and the chip containing section are formed in bottomed holes that open in the same plane, and that the straight line is arranged in the same plane. 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 storage section that stores the reagent and an antibody storage section that stores 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 the operating line of the analyzer.

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

[0024] Furthermore, one embodiment of the invention is a reagent cartridge used in an analyzer that analyzes results based on a reaction between a sample and a reagent, and is characterized in that it comprises a sample storage section that stores the sample, the sample storage section comprising an injection section and a liquid absorption section, the sample storage section stores a sample dilution solution, and the injection section is formed with a guide surface that is inclined relative to the vertical direction. [Effects 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 device from the injection section, thereby reducing the risk of infection or contamination due to removing the blood collection device. [Brief explanation of the drawings]

[0026] [Figure 1] 1 is a perspective view of an analyzer that uses a reagent cartridge according to a first embodiment of the present invention. [Figure 2] FIG. 1 is a perspective view of a reagent cartridge according to a first embodiment of the present invention. [Figure 3] Cross section AA in Figure 2. [Figure 4] FIG. 2 is a partially exploded view of the reagent cartridge according to the first embodiment of the present invention. [Figure 5] 1 is a perspective view of a sample collection pipette used when dispensing a sample into a reagent cartridge according to a first embodiment of the present invention. FIG. [Figure 6] FIG. 2 is a cross-sectional view showing a state in which a sample is being 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 antibodies and reagents are being removed from the reagent cartridge according to the first embodiment of the present invention. [Figure 8] FIG. 10 is a cross-sectional view of a specimen storage section of a reagent cartridge according to a second embodiment of the present invention. [Figure 9] FIG. 10 is a cross-sectional view showing a state in which a sample is being dispensed into a reagent cartridge according to a second embodiment of the present invention. [Figure 10] FIG. 10 is a cross-sectional view of a specimen storage section of a reagent cartridge according to a third embodiment of the present invention. [Figure 11] FIG. 10 is a cross-sectional view showing a state in which a sample is being dispensed into a reagent cartridge according to a third embodiment of the present invention. [Figure 12] FIG. 10 is a cross-sectional view taken along the center line M of a sample storage section of a reagent cartridge according to a fourth embodiment of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0027] The following describes a reagent cartridge according to the present invention with reference to the drawings. Note that the following embodiments do not limit the invention according to the claims, and not all of the combinations of features described in the embodiments are 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 that analyzes 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 that analyzes results based on a reaction between a sample, such as blood, and a reagent, and the target of analysis is not particularly limited. In one embodiment, the reagent cartridge provided by the present invention relates to a cartridge used in allergy testing (a test to confirm 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 blood testing, such as measuring blood hemoglobin A1c concentration. In another embodiment, the reagent cartridge provided by the present invention relates to a cartridge used in genetic testing. 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 allows analysis, and is not particularly limited. In one embodiment, the reagent cartridge used in allergy testing detects the presence or absence of an antibody that specifically binds to a specific allergen (antigen) in a sample, such as blood, by detecting the presence or absence of luminescence based on an antibody (hereinafter referred to as a labeled antibody) that is labeled with a physiologically active substance having enzymatic activity and that specifically binds to the antibody. Furthermore, the luminescence of the labeled antibody relates to an analysis in which, for example, a luminescent substrate is dispensed, causing the substrate to emit light through a chemical reaction catalyzed by the labeled antibody (e.g., an enzyme-labeled anti-IgE antibody), thereby visualizing the luminescence. Furthermore, the visualization analysis relates to an analysis in which, for example, this chemical reaction is carried out for a predetermined period of time under predetermined environmental conditions, and the intensity of this luminescence is measured using a detection camera. Note that, in this specification, the term "reagent" refers to a reagent for the 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 analyzer 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 being 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 an antibody or reagent is being removed from the reagent cartridge according to the first embodiment of the present invention.

[0030] 1, the reagent cartridge according to this embodiment is loaded 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 the reagent cartridge 10 and the reaction cell are installed.

[0031] In the analyzer 1, the reaction cell and reagent cartridge 10 are set on a moving table (not shown) through an input section by opening a 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 then dispensed into the reaction cell.

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

[0033] In one embodiment, the sample is discharged into the sample storage section, and the labeled antibody is stored in the antibody storage section. In this case, for example, the aspirated sample is dispensed into a reaction cell, stirred, and then drained after a washing step. Then, 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, the antibody containing section can be omitted by pre-accommodating a labeled antibody in the specimen containing section. In this case, for example, the labeled antibody is pre-accommodated in the specimen containing section, and the specimen and the labeled antibody are reacted in the specimen containing section, which is then dispensed into reaction cells, stirred, and washed and drained.

[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 also be configured to be housed in a so-called cassette.

[0036] Furthermore, the physiologically active substance having enzymatic activity that is labeled onto the antibody capable of specifically binding to the analyte can be any conventional substance, and is not particularly limited, including the following enzymes: alkaline phosphatase, β-galactosidase, glucose oxidase, urease, creatine kinase, uricase, glucose-6-phosphate dehydrogenase, peroxidase, etc.

[0037] Furthermore, the luminescent substrate may be any conventional substrate, and is not particularly limited, including, for example, acridinium salts, dioxetanes, luciferin, lucigenin, oxalyl chloride, etc.

[0038] Furthermore, although the reagent cartridge according to this embodiment has been described as being configured to measure luminescence using a labeled antibody labeled with a physiologically active substance having enzymatic activity and a luminescent substrate, the reagent cartridge according to this embodiment can also be used for other measurements. For example, the reagent cartridge according to this embodiment can also be used to measure fluorescence by using a labeled antibody in which the substance labeled to the labeled antibody is a fluorescent substrate (fluorophore molecule) rather than a physiologically active substance having enzymatic activity.

[0039] Specifically, the sample can be discharged into the sample container and the labeled antibody can be contained in the antibody container. Alternatively, the sample can be discharged into a sample container that already contains the labeled antibody, allowing for fluorescence measurement. In this case, if a fluorescent substrate (fluorophore) is used as the antibody label, the reagent container can be omitted. Furthermore, if the labeled antibody is already contained in the sample container, the antibody container can also be omitted. For example, the aspirated sample can be dispensed and stirred into a reaction cell, washed, and then drained. After that, the labeled antibody can be dispensed into the reaction cell, stirred, and reacted, followed by washing and draining. Alternatively, the labeled antibody can be pre-filled into the sample container, and the sample and labeled antibody reacted in the sample container can be dispensed and stirred into the reaction cell, followed by washing and draining. Then, instead of a detection camera, an excitation light source, a spectrometer, a fluorescence detector, or the like can be used to shield the reaction cell from external light, and then irradiate the reaction cell with light having a wavelength that excites the fluorescent substrate, causing it to fluoresce.

[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 containing section 11 that dispenses and contains a specimen, an antibody containing section 12 that contains an antibody, a reagent containing section 13 that contains a reagent, a cleaning liquid containing section 14 that contains a cleaning liquid, and a chip containing section 15 that contains a plurality of chips. The reagent cartridge 10 is preferably formed as a molded product from a synthetic resin such as polypropylene or polyethylene. In this case, it is preferable that the specimen containing section 11, the antibody containing section 12, the reagent containing section 13, the cleaning liquid containing section 14, and the chip containing section 15 are integrally formed.

[0041] The cleaning solution containing section 14, the specimen containing section 11, the antibody containing section 12, the reagent containing section 13, and the chip containing section 15 are arranged along the longitudinal direction on the generally rectangular top surface 17. In this case, it is preferable that the cleaning solution containing section 14, the specimen containing section 11, the antibody containing section 12, the reagent containing section 13, and the chip containing section 15 are arranged approximately on the same line of motion of the analyzer, and in this embodiment, they are arranged approximately on the same line of motion along the approximate center line M in the width direction of the top surface 17 so as to follow the line of motion along which the movable table reciprocates. Furthermore, the cleaning solution containing section 14, the specimen containing section 11, the antibody containing section 12, the reagent containing section 13, and the chip containing section 15 are each formed in the shape of a cylindrical tube with a bottom extending vertically from the top surface 17.

[0042] The specimen storage section 11 includes a liquid suction section 11a disposed on the 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 arranged so as to overlap each other, so that the liquid suction section 11a and the injection section 11b extend continuously with each other in the vertical direction, and the opening formed in the top surface section 17 is formed in a substantially gourd shape (an external shape resembling a figure eight).

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

[0044] Injection section 11b extends vertically along absorbing section 11a, and has a slope 11c at its lower end that is continuous with the side surface of absorbing section 11a. While slope 11c may have any shape as long as the sample dispensed into injection section 11b flows smoothly into reservoir section 16, it is preferable for it to be arcuate or linear in cross section. It is more preferable for slope 11c to be linear. If slope 11c is linear, it is preferable for it to be obliquely formed toward reservoir section 16, with the inclination angle preferably being 30° to 60°, and more preferably approximately 45°. It is more preferable for slope 11c to be linearly continuous with reservoir section 16 so as to form part of reservoir section 16. In this case, slope 11c may be formed from approximately the lower end of reservoir section 16. It is preferable for a sample dilution solution to be stored in specimen storage section 11 in advance. By diluting the specimen, the amount of specimen used can be reduced. Furthermore, in the case of a sample with a certain degree of viscosity, such as blood, this can help spread the sample evenly over the reaction cell, thereby helping to ensure a uniform reaction between the sample and a substance in the reaction cell, such as an antigen. Here, the sample dilution liquid can be any liquid capable of diluting the sample, and conventional techniques can be used. Therefore, while not particularly limited, examples that can be used include physiological saline, a buffer with a buffer capacity of pH 6 to 9, or a so-called Good's buffer. The sample dilution liquid 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 that extend 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 to be shorter than the specimen storage section 11, the cleaning solution storage section 14, and the chip storage section 15.

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

[0047] The chip storage section 15 is formed so as to be able to store a plurality of chips 40 shown in Fig. 7, and is configured to be able to store the required number of chips 40. The lower ends of all of the chip storage sections 15 are connected 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 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 is configured such that the antibody, reagent, and cleaning solution are 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, reagent, and cleaning solution during transportation, etc.

[0049] The blocking section 20 is attached to the top surface section 17 and includes a first blocking section 21 having an air vent hole 23 formed at a position corresponding to the antibody containing section 12 and the reagent containing section 13, and a second blocking section 22 laminated on the first blocking section 21 so as to block the air vent hole 23 of the first blocking section 21. The first blocking section 21 and the second blocking section 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 to dispense a sample into the reagent cartridge 10. Examples of such pipettes include those disclosed in Japanese Patent Nos. 5909470 and 5730695.

[0051] The specimen collection pipette 30 includes a pipette tip 31 that absorbs, dispenses, and holds the specimen, and a nipple 32 made of an elastic material such as rubber that absorbs the specimen. The specimen is collected by being sucked into the pipette tip 31 by capillary action, for example, and is held in the pipette tip 31.

[0052] As shown in FIG. 6, the sample collected in this manner is dispensed into the sample storage unit 11 by peeling off the second closing portion 22 of the reagent cartridge 10 and then inserting the pipette tip 31 into the injection portion 11b while breaking through the first closing portion 21. At this time, by pressing the nipple 32, the sample held in the pipette tip 31 flows into the injection portion 11b. The injection portion 11b is formed shorter than the liquid-absorbing portion 11a, and a slope 11c is formed at its lower end. Therefore, the entire amount of the sample flowing out from the pipette tip 31 flows along the slope 11c and is collected in the reservoir 16. While the case where the injection portion 11b is sealed in the first closing portion 21 has been shown, the injection portion 11b may be opened in advance in the first closing portion 21, as shown in FIG. 4. This allows the operator to more easily dispense the collected sample into the sample storage unit 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. However, if a specimen dilution solution is previously stored in the specimen storage section 11, the specimen droplets can reach the specimen dilution solution before leaving the tip of the pipette tip 31, ensuring that the specimen can be reliably discharged into the specimen storage section 11. Alternatively, the specimen droplets can reach a slope that slopes toward the liquid absorbing section 11a formed at the bottom end of the injection section 11b before leaving the tip of the pipette tip 31, ensuring that the specimen droplets are reliably discharged into the specimen storage section 11 via the specimen dilution solution. Thereafter, the specimen and specimen dilution solution can be agitated, for example, by shaking the cartridge itself.

[0054] It is also preferable to maintain a distance between the liquid surface of the specimen dilution solution and the tip of the pipette tip 31. Specifically, the distance is preferably such that the risk of the specimen dilution solution flowing back into the pipette tip 31 due to the tip of the pipette tip 31 reaching the specimen dilution solution is reduced, and the ejected specimen (droplets) can reach the specimen dilution solution and be properly mixed with the specimen dilution solution. For example, the allowable range for the distance is 5.8 to 9.8 mm, with a preferred range being 6.8 to 8.8 mm and a more preferred range being 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, when the sample has a certain degree of viscosity, such as blood, the amount of specimen dilution solution contained in specimen storage section 11 may be sufficient to spread the solution evenly over the reaction cell. Furthermore, when reagent cartridge 10 is left standing in the vertical direction, the liquid level of the specimen dilution solution is preferably between the upper and lower ends of the slope that slopes toward liquid absorption section 11a formed at the lower end of injection section 11b.

[0057] Furthermore, the specimen collection pipette 30 can be left in the injection section 11b even after the specimen has been ejected, but if the main body including the nipple 32 and the tip section, i.e., 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 absorbing 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 16 can be absorbed. At this time, the bottom of the liquid reservoir 16 is formed in a hemispherical or conical shape, so that the sample in the liquid reservoir 16 can be efficiently absorbed.

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

[0060] The antibodies and reagents are pre-stored in the reagent cartridge 10 and sealed by the closure 20. However, if the tip 40 is inserted through the closure to extract the antibodies and reagents, the sealing action of the closure 20 increases the internal pressure of the antibody containing section 12 and the reagent containing section 13, potentially hindering the absorption of the antibodies and reagents. To prevent this, the reagent cartridge 10 according to this embodiment has a first closure 21 with an air vent hole 23 formed in a position corresponding to the antibody containing section 12 and the reagent containing section 13. Even if the tip 40 breaks through the first closure 21 and is inserted into the antibody containing section 12 and the reagent containing section 13, the air vent hole 23 can suppress an increase in internal pressure in the antibody containing section 12 and the reagent containing section 13, thereby enabling smooth absorption of the antibodies and reagents. The air vent hole 23 may also be provided in a position corresponding to the liquid absorbing section 11a. Providing the air vent hole 23 in the liquid suction section 11a can contribute to smooth discharge of the sample from the sample-collecting pipette 30. The second blocking section 22 is attached to prevent leakage of antibodies and reagents from the air vent hole 23 during transportation and handling of the reagent cartridge 10, and is removed beforehand when injecting the sample, as described above. In addition, in this embodiment, the blocking section 20 has been described as being formed by stacking the first blocking section 21 and the second blocking section 22, but the blocking section 20 may also be formed as a single layer rather than being stacked.

[0061] This reagent cartridge 10 reduces the risk of infection during allergy testing due to an operator touching a sample while dispensing the sample or handling the reagent cartridge. Furthermore, the sample can be dispensed from the suction portion 11a while the pipette tip 31 for dispensing the sample remains inserted in the injection portion 11b. By storing the used tip 40 in the tip storage portion 15, the pipette tip 31 and tip 40 can be disposed of simultaneously when the reagent cartridge 10 is disposed of after the analysis by the analyzer 1 is completed, thereby reducing the risk of infection due to contact with these items. Furthermore, by configuring the reagent cartridge 10 so that a removable cover member can be attached to cover the top surface 17 of the reagent cartridge 10 when it is disposed of, the risk of infection can be further prevented.

[0062] [Second embodiment] In the reagent cartridge 10 according to the first embodiment described above, 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, which will be described next, will be described as an example of a specimen storage section 11A having a different configuration from that of the first embodiment. Note that components that are the same as or similar to those in the first embodiment described above will be assigned the same reference numerals and will not be described again.

[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 being dispensed into the reagent cartridge according to the second embodiment of the present invention.

[0064] 8, the specimen 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, the specimen storage section 11A according to this embodiment is formed with the liquid suction section 11a and the injection section 11b extending vertically to each other, but the injection section 11b has a guide extending obliquely from the side wall opposite the liquid suction section 11a. A guide surface 50 is formed on the pipette tip holder 1. A holding portion 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 holding portion 51.

[0065] Furthermore, 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 sample dilution solution when the reagent cartridge is stirred after sample ejection. Inclined surface 11c may be formed at an angle, but the inclination angle is preferably between 30° and 60°, with approximately 45° being the most suitable angle.

[0066] As shown in FIG. 9, 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 holder 51.

[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 sufficient 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 the specimen from being 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, as 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, thereby enabling 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 liquid surface of the specimen dilution liquid previously contained in the specimen storage section 11A is approximately equal to the tip of the droplet and the liquid surface a of the specimen dilution liquid, as shown in Figure 9. However, even if the droplet does not reach the liquid surface b of the specimen dilution liquid, it is possible to eject the specimen sufficiently.

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

[0070] [Third embodiment] The specimen storage section 11A of the reagent cartridge 10 according to the second embodiment has been described above as having a holding section 51 spaced a predetermined distance from the guide surface 50. The reagent cartridge according to the third embodiment, which will be described next, will be described as an example of a specimen storage section 11B having a different configuration from that of the second embodiment. Note that components that are the same as or similar to those in the first and second embodiments described above will be assigned the same reference numerals and will not be described again.

[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 a state in which a sample is being 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 closing section 20A is attached to the opening of the specimen storage section 11B and includes a first closing section 21A having a second air vent hole 24 formed at a position corresponding to the injection section 11b, and a second closing section 22 laminated on the first closing section 21A so as to close the second air vent hole 24 of the first closing section 21. The first closing section 21A and the second closing section 22 are preferably made of a membrane-like film material and are attached to each other with an adhesive or the like.

[0074] Furthermore, the specimen 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 specimen storage section 11A of the reagent cartridge according to the second embodiment, and the opening of the receiving section 11b is wide open.

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

[0076] When discharging a sample into the sample storage section 11B of the reagent cartridge according to this embodiment, the second closing 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 closing section 21A, thereby allowing the pipette tip 31 to be held in the injection section 11b, as shown in Fig. 11. Furthermore, a mark (such as an arrow or a circle) may be provided on the first closing section 21A to indicate the position where the pipette tip 31 breaks through (for example, a 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 closure part 21A at a position corresponding to the injection part 11b, the sample can be easily ejected from the pipette tip 31. Furthermore, in this embodiment, the case where the closure part 20A is formed by stacking the first closure part 21A and the second closure part 22 has been described, but the closure part may be formed in a single layer rather than being stacked.

[0078] [Fourth embodiment] The reagent cartridges according to the first to third embodiments described above have been described as having the liquid suction section 11a and the injection section 11b formed in the specimen storage sections 11, 11A, and 11B. The reagent cartridge according to the fourth embodiment, which will be described next, will be described as an example of a specimen storage section 11' having a different configuration from those of the first to third embodiments. Note that components that are the same as or similar to those in the first to third embodiments described above will be assigned the same reference numerals and will not be described again.

[0079] FIG. 12 is a cross-sectional view taken along the center line M of the sample storage section of the reagent cartridge according to the 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 communication with the injection and aspiration section. The shape of the injection and aspiration section is generally 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 generally the same as that of the injection section 11b.

[0081] 12, a recess 11d is preferably formed on the inner edge of the upper end of the specimen storage section 11', and the diameter of the recess 11d is smaller than the outer periphery of the body of the specimen collection pipette 30 so that the specimen collection pipette 30 is not inserted further into the specimen storage section 11' than necessary during dispensing. In addition, the recess 11d is preferably formed so that the tip of the body of the specimen collection pipette 30 can be engaged therewith and held in an easily detachable manner.

[0082] Furthermore, since the air removal section is connected to the injection and suction section, when dispensing a specimen from the specimen collection pipette 30, the internal pressure of the specimen storage section 11' can be released and the specimen can be dispensed reliably.

[0083] In the specimen storage section 11' according to this embodiment, the injecting / absorption section serves both to inject and absorb the specimen, so that after dispensing is completed, the specimen collection 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 release section, and then the pipette tip 31 can be separated from the pipette 30 while remaining in the air release section, and analysis can be performed with the pipette tip 31 left in the specimen storage section 11'.

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

[0085] Furthermore, the distance between the tip of the pipette tip 31 and the liquid surface of the diluted specimen solution stored in advance in the specimen storage section 11A, which has been described in the second embodiment, can also be applied to the third embodiment.

[0086] Furthermore, the distance between the tip of the pipette tip 31 and the liquid surface of the specimen dilution liquid previously contained in the specimen containing portion 11 described in the first embodiment can also be applied to the fourth embodiment.

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

[0088] The closing section 20A described in the third embodiment can also be applied to the second embodiment. When the closing section 20A is applied to the third embodiment, the second vent hole 24 may be formed at a position corresponding to the injection section 11b or at positions corresponding to both the injection section 11b and the liquid suction section 11a. The closing section 20 described in the first embodiment can also be applied to the fourth embodiment.

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

[0090] Although the reagent cartridge 10 according to the present embodiment described above is configured so that three tips 40 can be accommodated in the tip accommodating 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 embodiments are also included within the technical scope of the present invention. [Explanation of symbols]

[0091] 1 analyzer, 2 operation unit, 3 installation door, 4 housing, 10 reagent cartridge, 11, 11A, 11B, 11' sample 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, 21 A first occluding portion, 22 second occluding portion, 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 portion, 52 pipette tip insertion path, 53 inner wall.

Claims

1. A reagent cartridge used in an analyzer for analyzing results based on a reaction between a sample and a reagent, a specimen storage section for storing the specimen, a reagent storage section for storing the reagent, and an antibody storage section for storing the antibody, a chip storage unit for storing chips corresponding to at least the specimen, the reagent, and the antibody, A reagent cartridge characterized in that the specimen storage section stores a specimen dilution solution.

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

3. 2. 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 used in an analyzer for analyzing results based on a reaction between a sample and a reagent, a specimen storage section for storing the specimen, a reagent storage section for storing the reagent, an antibody storage section for storing the antibody, a cleaning solution storage section for storing the cleaning solution, and a tip storage section for storing the tip are arranged in one direction; the cleaning liquid storage section is disposed on one end side in the one direction, the chip accommodating portion is disposed on the other end side in the one direction, A reagent cartridge characterized in that the specimen storage section stores a specimen dilution solution.

5. 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 washing liquid containing section, and the chip containing section are arranged in a straight line.

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

7. 6. 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 that open to the same plane, The reagent cartridge is characterized in that the straight lines are arranged on the same plane.

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