Automatic analysis device

Abstract

The automatic analyzer of the present invention comprises: an ISE measuring unit (32) for measuring the electrolyte concentration of a sample; a spectrophotometer (14) for measuring biochemical items of the sample; a pH measuring mechanism (34) for measuring the pH of the sample; a sample dispensing mechanism (21, 22) for dispensing a sample for measurement from a container containing the sample to the ISE measuring unit (32) or the spectrophotometer (14); and a transport mechanism (27) for transporting the container, wherein the transport mechanism (27), the sample dispensing mechanism (21, 22) and the pH measuring mechanism (34) are configured so that the sample for pH measurement by the pH measuring mechanism (34) is dispensed or the pH measurement is performed after the sample is dispensed by the sample dispensing mechanism (21, 22).

Description

Technical Field

[0001] The present invention relates to an automatic analyzer for analyzing the physical properties of components such as blood. Background Art

[0002] As an example of an automatic analyzer capable of performing analysis without compromising the freshness of a sample, Patent Document 1 describes the following: a sample identification device connected to a control device is provided between a sample collection introduction portion and a sample dispensing portion of a sample introduction device, and detects the types of multiple samples based on the physical or physicochemical properties of the clinical samples without deteriorating the clinical samples.

[0003] Prior art literature

[0004] Patent Literature

[0005] Patent Document 1: Japanese Patent Publication No. 6-54319 Summary of the Invention

[0006] Problems to be solved by the invention

[0007] An automatic analyzer is a device that performs qualitative and quantitative analysis of components contained in biological samples such as blood and urine by colorimetric analysis and ISE measurement.

[0008] Colorimetric analysis refers to qualitative or quantitative analysis by adding a reagent that specifically reacts with a specific component, allowing the reagent to react, and measuring the absorbance or luminescence of the reaction solution.

[0009] ISE measurement refers to the use of ion selective electrodes to measure the Na + , K + 、Cl - Quantitative analysis of electrolytes.

[0010] If a pH measurement unit is not provided in current automatic analyzers and one still wants to measure pH, it is necessary to use a separate dedicated device for measurement, which also requires an additional sample volume.

[0011] Patent Document 1 also describes a device that uses a pH meter installed between a sample introduction unit and a dispensing unit to discriminate between serum and urine based on pH differences. The device described in Patent Document 1 uses pH and colorimetric analysis as the measurement sequence.

[0012] The automatic analyzer described in Patent Document 1 has a problem in that it cannot provide a pH measurement unit when pH measurement is required in addition to colorimetry and ISE items in a mode different from a biological sample from a patient, such as dialysate.

[0013] In addition, Patent Document 1 provides a pH measurement unit, but the pH is measured before the colorimetric analysis. Here, the colorimetric analysis targets lipid, enzyme, and immunological items, and therefore requires higher measurement accuracy than pH.

[0014] However, as described in Patent Document 1, pH measurement is performed before colorimetric analysis. This poses problems such as sample concentration over time, raising concerns about the accuracy of colorimetric analysis and ISE analysis, and the risk of carryover due to immersion of the pH measurement unit in the sample.

[0015] An object of the present invention is to provide an automatic analyzer capable of performing pH measurement without affecting colorimetric analysis or ISE analysis and without reducing processing capacity.

[0016] Means for solving problems

[0017] The present invention includes multiple means for solving the above-mentioned problems. One example is an automatic analysis device that automatically performs sample analysis, characterized in that the automatic analysis device includes: an electrolyte measuring unit that measures the electrolyte concentration of the sample; a colorimetric measuring unit that measures the biochemical items of the sample; a pH measuring unit that measures the pH of the sample; a first dispensing unit that dispenses the sample for measurement in at least one of the electrolyte measuring unit and the colorimetric measuring unit from a container containing the sample; and a transport unit that transports the container, the transport unit, the first dispensing unit and the pH measuring unit being configured to dispense the sample for pH measurement by the pH measuring unit or to perform pH measurement after the sample is dispensed by the first dispensing unit.

[0018] In addition, as another example, an automatic analyzer that automatically performs analysis of a sample is provided, characterized in that it comprises: an electrolyte measuring unit that measures the electrolyte concentration of the sample; a colorimetric measuring unit that measures the biochemical items of the sample; a pH measuring unit that measures the pH of the sample; a first dispensing unit that dispenses the sample for measurement in at least one of the electrolyte measuring unit and the colorimetric measuring unit from a container containing the sample; a transport unit that transports the container; and a control unit that controls the operation of the mechanism of the automatic analyzer, the control unit controlling the transport unit so that the dispensing of the sample for pH measurement or the pH measurement performed by the pH measuring unit is performed after the sample dispensing performed by the first dispensing unit.

[0019] Effects of the Invention

[0020] According to the present invention, pH measurement can be performed without affecting colorimetric analysis or ISE analysis and without reducing processing capacity. Other problems, structures, and effects than those described above will become clear from the following examples. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Figure 1 It is a perspective view showing the structure of an automatic analyzer according to Example 1 of the present invention.

[0022] Figure 2 This is a diagram showing a schematic configuration of an ISE measurement unit of the automatic analyzer of Example 1.

[0023] Figure 3 This is a flowchart showing the operation of the automatic analyzer of Example 1.

[0024] Figure 4 This is a theoretical value input screen displayed on the display device of the automatic analyzer of Example 1.

[0025] Figure 5 This is the ISE calibration result screen displayed on the display device of the automatic analyzer of Example 1.

[0026] Figure 6 This is a colorimetric calibration result screen displayed on the display device of the automatic analyzer of Example 1.

[0027] Figure 7 This is a pH measurement calibration result screen displayed on the display device of the automatic analyzer of Example 1.

[0028] Figure 8 This is a dialysate mode item request screen displayed on the display device of the automatic analyzer of Example 1.

[0029] Figure 9 This is a dialysate determination result screen displayed on the display device of the automatic analyzer of Example 1.

[0030] Figure 10 This is a diagram schematically showing the configuration of an automatic analyzer according to Example 3 of the present invention. DETAILED DESCRIPTION

[0031] The following describes an embodiment of the automatic analyzer of the present invention using the accompanying drawings. In the following embodiments, the constituent elements (including element steps, etc.) are not necessarily essential unless otherwise specified or clearly considered to be essential in principle.

[0032] In addition, the sample in the present invention that is the object of measurement by each analysis unit and analysis module described later includes not only biological samples such as serum and urine but also liquids other than biological samples such as dialysate.

[0033] <Example 1>

[0034] use Figures 1 to 9 , Example 1 of the automatic analysis device of the present invention is described.

[0035] First, use Figure 1 The overall configuration of the automatic analyzer of this embodiment will be described in outline. Figure 1 A perspective view showing the overall structure of an automatic analyzer according to one embodiment of the present invention is shown.

[0036] Figure 1 The automatic analyzer 100 shown is a device for automatically performing sample analysis, and mainly includes a conveying mechanism 27, a reaction disk 11, a reagent disk 19, sample dispensing mechanisms 21 and 22, reagent dispensing mechanisms 17 and 18, stirring mechanisms 15 and 16, a spectrophotometer 14, cleaning tanks 23, 24, 28, 29, and 31, a cleaning mechanism 13, an ISE measuring unit 32, a pH measuring mechanism 34, a cleaning tank 39, and a control device 40.

[0037] The transport mechanism 27 is provided near the reaction disk 11 and is a device that transports a sample holding container 26 loaded with a plurality of sample containers 25 containing samples, which is loaded from a sample rack loading portion (not shown), to the dispensing positions of the sample dispensing mechanisms 21 and 22 and the pH measurement position of the pH measuring mechanism 34, and delivers the sample holding container 26 after the measurement has been completed.

[0038] In addition, in this embodiment, an example is described in which a plurality of sample containers 25 are placed on the sample storage container 26. However, it is sufficient as long as one or more sample containers 25 can be placed on the sample storage container 26. Examples of the sample storage container 26 include a sample holder that holds one sample container 25 and a sample rack that holds a plurality of sample containers 25.

[0039] In the reaction disk 11 , a plurality of reaction containers 12 for reacting a sample such as blood or urine with a reagent are accommodated in a state separated from each other at predetermined intervals along the circumferential direction thereof.

[0040] The reagent tray 19 is a storage unit in which a plurality of reagent bottles 20 containing reagents are stored in a circular pattern. The reagent tray 19 is kept cold.

[0041] The sample dispensing mechanisms 21 and 22 are provided between the reaction disk 11 and the transport mechanism 27 and are configured to be rotatable in an arcuate shape and movable up and down. Sample probes 21 a and 22 a are provided at their respective tips.

[0042] The sample probes 21a and 22a move while describing an arc around the rotation axes of the sample dispensing mechanisms 21 and 22, performing various dispensing operations, such as sucking the measurement sample in the ISE measurement unit 32 from the sample container 25 and discharging the sample into the dilution reservoir 33 of the ISE measurement unit 32, and sucking the measurement sample in the spectrophotometer 14 from the sample container 25 or the reaction container 12 and discharging it into the reaction container 12.

[0043] The reagent dispensing mechanisms 17 and 18 are provided adjacent to the reaction disk 11 and the reagent disk 19 , are configured to be rotatable in an arcuate shape and movable up and down, and have reagent probes 17 a and 18 a provided at their distal ends.

[0044] The reagent probes 17 a and 18 a move while drawing an arc around the rotation axes of the reagent dispensing mechanisms 17 and 18 , and perform a dispensing operation of sucking the reagent from the reagent bottle 20 and discharging it into the reaction container 12 .

[0045] The stirring mechanisms 15 and 16 include, for example, stirring blades or spatula-like rods (not shown) provided at their tips, and stir the mixture of the sample and reagent, i.e., the reaction solution, by immersing the stirring blades or rods in the reaction container 12 and rotating them. The stirring mechanisms 15 and 16 are not limited to such mechanisms and may be ultrasonic-based mechanisms.

[0046] The spectrophotometer 14 is a device for measuring the reaction process and post-reaction optical properties of the reaction solution after the sample and reagent in the reaction container 12 react. It is arranged opposite to the light source 14 a arranged inside the reaction disk 11 with the reaction container 12 interposed therebetween.

[0047] The cleaning mechanism 13 is a device that cleans the reaction container 12 after the measurement is completed.

[0048] Between the reaction disk 11 and the reagent disk 19, cleaning tanks 28 and 29 are provided for cleaning the reagent probes 17a and 18a of the reagent dispensing mechanisms 17 and 18. Furthermore, between the reaction disk 11 and the transport mechanism 27, cleaning tanks 23 and 24 are provided for cleaning the sample probes 21a and 22a of the sample dispensing mechanisms 21 and 22. Furthermore, between the reaction disk 11 and the stirring mechanisms 15 and 16, a cleaning tank 31 is provided for cleaning the stirring blades or scraper-like rods of the stirring mechanisms 15 and 16 to prevent contamination.

[0049] Figure 2 This is a schematic diagram of the configuration of the ISE measurement unit 32 of the first embodiment.

[0050] The ISE measurement unit 32 uses an ion selective electrode to measure electrolytes in the sample, such as Na + , K+ 、Cl + Ion concentration measurement unit, such as Figure 1 As shown, they are arranged around the reaction disk 11.

[0051] like Figure 2 As shown, the ISE measuring unit 32 includes a dilution tank 33, a diluent syringe 106, a diluent electromagnetic valve 107, an ISE transport syringe 108, a transport syringe electromagnetic valve 109, a pinch valve 110, and a Na + Select electrodes 111, K + Select electrode 112, Cl - A selection electrode 113 , a solenoid valve 115 for a comparative electrode solution, a comparative electrode 116 , a syringe 118 for an internal standard solution, and a solenoid valve 119 for an internal standard solution are provided.

[0052] The diluent bottle 105 contains a diluent for diluting a sample for ISE measurement. The diluent is fed to the dilution tank 33 by the operation of the dilution syringe 106 and the dilution solenoid valve 107 to dilute the sample in the dilution tank 33 .

[0053] The sample diluted in the dilution tank 33 is transferred to the Na by the operation of the ISE transport syringe 108, the electromagnetic valve 109 for the transport syringe, and the pinch valve 110. + Select electrodes 111, K + Select electrode 112 and Cl - The electrode 113 is selected for attraction.

[0054] The comparative electrode solution contained in the comparative electrode solution bottle 114 is drawn to the comparative electrode 116 by the operation of the comparative electrode solution solenoid valve 115, the transport syringe 108, and the transport syringe solenoid valve 109. The electromotive force between the comparative electrode 116 and the ion selective electrodes 111, 112, and 113 is measured.

[0055] In the measurement of the internal standard solution used to determine the sample concentration, the internal standard solution contained in the internal standard solution bottle 117 is sent to the dilution tank 33 from which the sample and diluent are removed by the operation of the internal standard solution syringe 118 and the internal standard solution solenoid valve 119 .

[0056] The internal standard solution in the dilution tank 33 is transferred to the Na + Select electrodes 111, K + Select electrode 112 and Cl - The electrode 113 is selected to attract and the electromotive force between the electrode 113 and the reference electrode 116 is measured.

[0057] Hereinafter, when simply referring to an electromotive force, the electromotive force between the reference electrode 116 is indicated.

[0058] Na + Select electrodes 111, K + Select electrode 112, Cl - The selection electrode 113 and the comparison electrode 116 are connected to the control device 40 and output the measurement results.

[0059] Return to Figure 1 A pH measuring mechanism 34 for measuring the pH of the sample is provided on the downstream side of the sample dispensing mechanisms 21 and 22 .

[0060] Therefore, the transport mechanism 27 , the sample dispensing mechanisms 21 , 22 , and the pH measuring mechanism 34 are arranged so that the pH measuring mechanism 34 performs the sample dispensing or pH measurement after the sample dispensing mechanisms 21 , 22 perform the sample dispensing.

[0061] In this case, the operation of the conveying mechanism 27 is preferably a one-way movement from the upstream to the downstream side.

[0062] Furthermore, the position at which the pH measurement sample is dispensed by the pH measurement mechanism 34 or the pH measurement position is different from the sample dispensing positions by the sample dispensing mechanisms 21 and 22 .

[0063] The pH measuring mechanism 34 is configured to rotate and move vertically. It includes a pH electrode 35 capable of measuring, for example, a 50 μL sample. The electrode is inserted into the sample container 25 to measure the pH of the sample. This allows pH measurement to be performed directly from the sample container 25, eliminating the need to prepare or add a separate sample for pH measurement. A temperature element (not shown) is built into the pH electrode 35.

[0064] The pH measuring mechanism 34 further includes a dedicated cleaning tank 39 , which can clean the pH electrode 35 with running water.

[0065] Furthermore, standard solution bottles 36 , 37 , and 38 dedicated to calibration are provided around the pH measurement mechanism 34 , and the pH electrode 35 is immersed therein for measurement.

[0066] The cleaning of the pH electrode 35 may be performed in common with the cleaning tanks 23 and 24 for the colorimetric or ISE sample probe.

[0067] The control device 40 is connected to each mechanism within the automatic analyzer 100 described above, and includes a CPU (control unit 44 ) that controls the overall operation of the automatic analyzer 100 .

[0068] The control device 40 is a computer having a control unit 44, a memory, etc., and controls various operations of the above-mentioned components and performs the operations according to the spectrophotometer 14 and the Na + Select electrodes 111, K + Select electrode 112, Cl - The detection results of the selection electrode 113 and the comparison electrode 116 are used for calculation processing to determine the concentration of a predetermined component in the sample.

[0069] The control device 40 controls the operation of each device based on various programs stored in the storage device 41. In addition to various programs for sample measurement, the storage device 41 also stores various parameters input via the input device 43, information on the sample to be measured (such as sample type information), and measurement results.

[0070] Furthermore, the control processing of the actions executed by the control device 40 may be integrated into one program, divided into multiple programs, or a combination of these programs. In addition, part or all of the program may be implemented by dedicated hardware or modularized.

[0071] In the control device 40 of this embodiment, it is particularly preferable to control the sample dispensing mechanisms 21 and 22 so that dispensing for measuring electrolyte concentration is performed before dispensing for measuring biochemical items.

[0072] The display device 42 is a display capable of displaying a setting screen for instructing measurement items to be measured for a sample being measured and a confirmation screen for confirming the measurement results. Based on the setting screen displayed on the display device 42, the user inputs various information by operating an input device 43 such as a keyboard for inputting various instructions.

[0073] When a sample different from the biological sample is measured, the display device 42 displays a comparison result between a theoretical value and a measured value of the measurement result of the different sample.

[0074] use Figure 3 The details of these devices will be described in the following figures.

[0075] The above is the overall structure of the automatic analyzer 100 .

[0076] The analysis process of a sample by the automatic analyzer 100 as described above is generally performed according to the following procedure.

[0077] First, the sample storage container 26 is placed in a loading portion or the like, and is loaded into a sample collection position of the automatic analyzer 100 by the transport mechanism 27 .

[0078] When the measurement item is a biochemical item, the sample dispensing mechanisms 21 and 22 discharge the sucked sample into the reaction container 12 located on the reaction disk 11, and the reagent sucked from the reagent bottle 20 on the reagent disk 19 is further added to the reaction container 12 through the reagent dispensing mechanisms 17 and 18, and the sample and reagent in the reaction container 12 are mixed and stirred through the stirring mechanisms 15 and 16.

[0079] Thereafter, the spectrophotometer 14 measures the optical properties of the light from the light source 14 a that has passed through the reaction solution held in the reaction container 12 , and the measurement results are transmitted to the control device 40 .

[0080] In contrast, when the requested measurement item is an electrolyte item, the sample dispensing mechanisms 21 and 22 discharge the aspirated sample into the dilution tank 33 of the ISE measurement unit 32, measure the electromotive force using the ion selective electrodes 111, 112, and 113, and transmit the measurement results to the control device 40. However, in the case of electrolyte item measurements, the electromotive force of an internal standard solution of known concentration is measured before dispensing the sample.

[0081] Furthermore, when the requested measurement item is a pH item, the sample holding container 26 is transported by the transport mechanism 27 to a position close to the pH electrode 35 of the pH measuring mechanism 34 on the downstream side of the dispensing position of the sample dispensing mechanisms 21 and 22, the pH is measured by the pH measuring mechanism 34, and the measurement result is sent to the control device 40.

[0082] The control unit 44 of the control device 40 calculates the concentration of the specific component in the sample based on the transmitted measurement results through calculation processing, notifies the user of the analysis results via the display device 42 , and records them in the storage device 41 .

[0083] Next, use Figures 3 to 9 The following describes the operation of the automatic analyzer 100 during analysis and an example of a screen displayed on the display device 42. The operation described below is executed by the control unit 44 of the control device 40 for each analysis cycle.

[0084] Figure 3 This is a flowchart showing the operation of the automatic analyzer according to the first embodiment. Figure 4 Yes Figure 3 FIG. 1 is a diagram showing an example of a screen of step S406, Figure 5 Yes Figure 3 FIG. 1 is a diagram showing an example of an ISE calibration result screen of step S401 or step S407, Figure 6 Yes Figure 3 FIG. 1 is a diagram showing an example of a colorimetric calibration result screen of step S401 or step S407, Figure 7 Yes Figure 3FIG. 1 is a diagram showing an example of a pH measurement calibration result screen of step S401 or step S407, Figure 8 Yes Figure 3 The figure of an example of the dialysate sample in the screen of step S408 is shown. Figure 9 Yes Figure 3 FIG. 1 is a diagram showing an example of a screen of step S413.

[0085] In this embodiment, dialysate is used as an example of a sample other than a biological sample.

[0086] First, the control unit 44 determines whether the sample to be analyzed input by the user is a biological sample or dialysate (step S400). If it is determined to be a biological sample, the process proceeds to step S401. If it is determined to be dialysate, the process proceeds to step S406.

[0087] When it is determined in step S400 that the sample is a biological sample, the control unit 44 first performs calibration of the scheduled measurement items as necessary (step S401 ).

[0088] Thereafter, the control unit 44 determines the items to be measured for each sample input by the user (step S402 ), and starts the biological sample measurement operation (step S403 ).

[0089] First, a sample is dispensed into the reaction container 12 or the dilution tank 33 (step S404 ), and when the measurement is completed, the measurement result is output (step S405 ).

[0090] The dialysate used for dialysis treatment is prepared by diluting and mixing dialysate sold by a pharmaceutical company on-site, i.e., before use. The dialysate used is in liquid or powder form, and the adjusted component concentrations of the dialysate are listed in the appendix as theoretical values. The dialysate mode here refers to the measurement of only the Na in the dialysate. + , K + 、Cl - 、HCO3 - , pH and other pre-set items. You can also entrust the above items individually or in combination.

[0091] When measuring the dialysate, Figure 4 In the screen shown, the theoretical value and judgment standard of each measurement item are input before the analysis starts (step S406). This step S406 is an optional step and can be omitted.

[0092] like Figure 4As shown, in this step, for items with theoretical values, if the user wishes to automatically determine the measured value, the user can enter the item to be determined, the theoretical value, and the determination criteria. The user can select an item from those pre-registered in the automatic analyzer 100 and manually enter the theoretical value and determination criteria. Multiple dialysate types can be registered.

[0093] Here, the composition and properties of dialysate differ from those of biological samples, and therefore their reactivity in ISE and colorimetric parameters is different. Therefore, separate calibration is required, with a calibration curve for dialysate and a calibration curve for biological samples being prepared.

[0094] Therefore, the control unit 44 performs calibration separately for the measurement items for the dialysate and the biological sample items as necessary (step S407 ).

[0095] The pH measurement in step S407 is calibrated using, for example, a neutral phosphate standard solution at pH 6.86 at 25°C, an acidic acid salt standard solution at pH 4.01 at 25°C or an acidic oxalate standard solution at pH 1.68 at 25°C, and an alkaline borate standard solution at pH 9.18 at 25°C. Figure 1 The standard liquid bottles 36, 37, and 38 are arranged in the setting position.

[0096] Here, the pH electrode 35 is immersed in neutral, acidic, and alkaline solutions in this order, and the temperature is adjusted to a value corresponding to the pH standard solution. Each time a standard solution is measured, the pH electrode 35 is rinsed with running water in a cleaning tank 39 to prevent the previous solution from being carried over into the next standard solution or sample. Alternatively, calibration can be performed by placing these standard solutions in a sample container 25 and immersing the pH electrode 35 while the sample container 26 is placed near the pH measurement mechanism. This is a user-selectable option.

[0097] In step S407, in the ISE measurement unit 32, if different calibrations are performed for the dialysate item and the biological sample item, Figure 5 As shown, the difference shows the result of this calibration.

[0098] In addition, if the spectrophotometer 14 is calibrated differently for the dialysate item and the biological sample item, the same Figure 6 The results are displayed separately as shown.

[0099] And, as Figure 7 As shown, the electromotive force and temperature measured by the automatic analyzer 100 are displayed in parallel with the display values ​​of each standard solution input in advance.

[0100] Then, the control unit 44 passes Figure 8The screen displayed confirms the items that the user inputs to be measured for each sample (step S408 ), and the dialysate measurement operation starts (step S409 ).

[0101] To enter step S409, the user selects and registers Figure 8 Measured items in the dialysate sample are shown.

[0102] The item keys arranged in the center of each screen are pre-assigned with items registered in the automatic analyzer. First, select the item from the sample type drop-down list. Figure 4 When the dialysate A is registered in the Figure 4 Only items registered in the dialysate A can be selected. In this case, items registered as items for biological samples cannot be selected.

[0103] As a measurement operation, first, for the ISE item and the colorimetric item, sample dispensing is performed into the dilution tank 33 or the reaction container 12 (step S410). In step S410 or the above-mentioned step S404, the dispensing for the ISE analysis item is preferably performed before the dispensing for the colorimetric analysis item.

[0104] After the dispensing of the ISE items etc. is completed, the control unit 44 determines whether the measurement items input in step S408 include pH measurement (step S410A). If it is determined that pH measurement is included, the process proceeds to step S411. If it is determined that pH measurement is not included, the process proceeds to step S414.

[0105] Next, when pH measurement is included in the requested items, pH measurement is performed by the pH measuring mechanism 34 (step S411 ), and the control unit 44 is caused to output the measurement result (step S412 ).

[0106] In addition, when the theoretical value and the judgment standard are input in step S406, Na is automatically calculated. + , K + 、Cl - 、HCO3 - , the accuracy of the pH measurement result relative to the theoretical value, and the determination result of whether the reference is met is obtained, and the display device 42 displays Figure 9 The screen shown (step S413).

[0107] like Figure 9 As shown, in this step, the measurement result for one dialysate sample is displayed, and the determination result for the theoretical value and determination criterion registered in step S406 is also displayed.

[0108] On the other hand, if the requested items do not include pH measurement, the measurement results of the ISE and colorimetric items are output to the control unit 44 (step S414). Then, similar to step S413, the accuracy and judgment of the measurement results relative to the theoretical value are automatically calculated in step S413, and the judgment result of whether the standard is met is obtained (step S415).

[0109] After step S413 or step S415, the control unit 44 determines whether the determination result of whether the standard is satisfied includes an NG determination (step 416). If it is determined that an NG determination is included, the process proceeds to step S417 and an alarm is output (step S417). On the other hand, if it is determined that an NG determination is not included, the process ends.

[0110] Here, when step S406 is omitted as described above, steps S413 , S415 , S416 , and S417 can be omitted, and the process can be terminated with step S412 or step S414 .

[0111] In addition, if the user does not wish, the user can choose not to set steps S413 and S415.

[0112] Next, the effects of this embodiment will be described.

[0113] The automatic analyzer 100 of the first embodiment of the present invention described above comprises: an ISE measuring unit 32 for measuring the electrolyte concentration of a sample; a spectrophotometer 14 for measuring the biochemical items of the sample; a pH measuring mechanism 34 for measuring the pH of the sample; sample dispensing mechanisms 21 and 22 for dispensing the sample for measurement in the ISE measuring unit 32 or the spectrophotometer 14 from a container containing the sample; and a transport mechanism 27 for transporting the container. The automatic analyzer 100 is configured with the transport mechanism 27, the sample dispensing mechanisms 21 and 22, and the pH measuring mechanism 34, so that the dispensing of the sample for pH measurement or the pH measurement performed by the pH measuring mechanism 34 is performed after the sample dispensing performed by the sample dispensing mechanisms 21 and 22.

[0114] It is speculated that the pH electrode 35 has a larger contact area with the sample than the sample probes 21a and 22a, making it more susceptible to carryover. Therefore, by configuring the various mechanisms so that dispensing for ISE and colorimetric analysis, which are susceptible to cross-contamination, is performed first, followed by pH measurement and dispensing, it is possible to perform all ISE analysis, colorimetric analysis, and pH measurement within a single automated analyzer while continuously measuring samples undergoing pH measurement and samples not undergoing pH measurement, without reducing processing capacity and while suppressing the effects of cross-contamination and sample concentration.

[0115] This configuration structure is particularly suitable for medium-sized and small-sized automatic analysis devices.

[0116] In addition, the position for dispensing the sample for pH measurement by the pH measuring mechanism 34 or the pH measurement position is different from the sample dispensing position by the sample dispensing mechanisms 21 and 22, so pH measurement can be performed without reducing the processing capacity of ISE and colorimetry, and the analysis processing capacity can be improved more reliably.

[0117] Furthermore, since ISE measurement takes more time than colorimetric measurement, the control device 40 can reliably shorten the time until the final sample analysis result is obtained by controlling the sample dispensing mechanisms 21 and 22 so that the dispensing for measuring electrolyte concentration is performed before the dispensing for measuring biochemical items.

[0118] In addition, the ISE measurement unit 32, spectrophotometer 14, and pH measurement mechanism 34 can measure a sample different from the biological sample as a sample, especially when the different sample is dialysate. This allows the measurement of various items determined as standardized items for dialysate to be completed within a single device, significantly reducing the burden on the user.

[0119] In addition, there is also a display device 42 that can display the measurement results of the sample. When a sample different from the biological sample is measured, the comparison result between the theoretical value and the measured value of the measurement result of the different sample is displayed on the display device 42. This allows the user to easily grasp the analysis results of samples other than the biological sample, which can further improve the convenience for the user.

[0120] <Example 2>

[0121] An automatic analyzer according to Example 2 of the present invention will be described. The same components as those in Example 1 are denoted by the same reference numerals, and their description will be omitted. This also applies to the following examples.

[0122] In the automatic analyzer of the first embodiment described above, pH measurement is performed by immersing the pH electrode 35 in the sample container 25. However, in the automatic analyzer of the second embodiment of the present invention, the pH measuring mechanism 34 is arranged at a position that can access the reaction container 12 containing the reaction solution in which the sample and the reagent are mixed and reacted for colorimetric measurement in addition to the sample container 25. For example, the pH measuring mechanism 34 is arranged at Figure 1 The position of the sample dispensing mechanism 22.

[0123] With this configuration, the standard solution bottles 36 , 37 , and 38 dedicated to calibration of the pH measurement mechanism 34 can be arranged in the reagent disk 19 .

[0124] In this case, the standard solution is dispensed into the reaction container 12 by the reagent dispensing mechanisms 17 and 18, and calibration is performed there. In addition, pH measurement can be performed by dispensing the sample on the sample storage container 26 into the reaction container 12.

[0125] Furthermore, it is more preferable that the user can select whether to perform calibration and measurement of pH measurement in the reaction container 12 or in the sample container 25 (or in the dedicated standard solution bottles 36 , 37 , 38 in the case of calibration).

[0126] Here, the reaction container 12 is heated to approximately 37°C, while the sample container 25 is at room temperature. Furthermore, since pH changes with temperature, it is preferable to input or store this change in the device, and convert the pH measurement results to a pH value at a constant temperature, such as 37°C or 25°C, based on the temperature during calibration and measurement, and output it.

[0127] The remaining configuration and operation are substantially the same as those of the automatic analyzer of the first embodiment, and detailed description thereof will be omitted.

[0128] The automatic analyzer according to the second embodiment of the present invention can also achieve substantially the same effects as those of the automatic analyzer according to the first embodiment described above.

[0129] Furthermore, the pH measurement mechanism 34 is positioned so that it can be close to the reaction vessel containing the reaction solution obtained by mixing and reacting the sample and reagent for colorimetric measurement. This allows pH measurement to be performed without directly inserting the pH electrode 35 into the sample container 25. Consequently, compared to the automatic analyzer of Example 1, the concern of cross-contamination when retesting the sample after pH measurement can be further reduced. Furthermore, the structure is simplified compared to the automatic analyzer of Example 1, resulting in the ability to provide an inexpensive analyzer.

[0130] <Example 3>

[0131] use Figure 10 An automatic analyzer according to Example 3 of the present invention will be described. Figure 10 This is a schematic diagram of the overall structure of the automatic analyzer of this embodiment 3.

[0132] Figure 10 The automatic analyzer 200 of the present embodiment shown includes an input unit 1, an ID reader 2, a transport mechanism 217, an ISE measurement module 32A, a colorimetric measurement module 100A, a pH measurement module 34A, a standby unit 5 for placing a sample container 26 on standby, a delivery unit 6 for delivering the sample container 26, and an overall management computer 221.

[0133] The loading unit 1 is a portion that loads one or more sample storage containers 26 carrying sample containers 25 into the automatic analyzer 200 .

[0134] A label, barcode, or the like recording a sample ID indicating attribute information (such as acceptance number, patient name, requested analysis items, etc.) related to a test sample (such as blood) is attached to the sample container 25 held by the sample container 26. Furthermore, a label indicating a rack ID indicating rack identification information such as a rack number is attached to the sample container 26 itself.

[0135] The sample container 26 placed in the loading unit 1 is transported by the transport mechanism 217. At this time, the ID reader 2 reads information related to the sample ID and the sample rack ID and transmits it to the overall management computer 221.

[0136] The transport mechanism 217 transports the sample holding container 26 introduced from the input section 1 to the target ISE measurement module 32A, colorimetric measurement module 100A, or pH measurement module 34A in response to an analysis request from a user such as a laboratory technician or physician. Furthermore, the transport mechanism 217 transports sample holding containers 26 whose analysis has been completed in the ISE measurement module 32A, colorimetric measurement module 100A, or pH measurement module 34A, or sample holding containers 26 for which no analysis request has been made, to the standby section 5 or the delivery section 6.

[0137] The transport mechanism 217 is configured to recognize sample holding containers 26 of different shapes, differentiate transport operations according to the shapes of the sample holding containers 26 , and transport the sample to the ISE measurement module 32A, the colorimetric measurement module 100A, and the pH measurement module 34A.

[0138] The specific structure of the conveying mechanism 217 is not particularly limited, and various conveying mechanisms or a combination of conveying mechanisms such as belt conveying, conveying by a conveying robot, and conveying using electromagnetic force can be adopted.

[0139] The ISE measurement module 32A, the colorimetric measurement module 100A, and the pH measurement module 34A are modules for analyzing the sample in the sample container 25 held in the sample storage container 26 transported via the transport mechanism 217 . They are arranged along the transport mechanism 217 and are detachably connected to the transport mechanism 217 .

[0140] The general configurations of the ISE measurement module 32A and the pH measurement module 34A are substantially the same as the ISE measurement unit 32 and the pH measurement mechanism 34 described in Example 1, respectively, and therefore detailed descriptions thereof are omitted. Furthermore, the colorimetric measurement module 100A has a substantially similar configuration to the automatic analyzer 100 described in Example 1, excluding the ISE measurement unit 32 and the pH measurement mechanism 34, and therefore detailed descriptions thereof are omitted.

[0141] The ISE measurement module 32A, the colorimetric measurement module 100A, and the pH measurement module 34A are respectively provided with: a sample dispensing mechanism 21b, which dispenses the sample for measurement in the ISE measurement module 32A from the sample container 25; a sample dispensing mechanism 21c, which dispenses the sample for measurement in the spectrophotometer 14 of the colorimetric measurement module 100A from the sample container 25; and a sample dispensing mechanism 34b, which dispenses the sample for measurement in the pH measurement module 34A from the sample container 25.

[0142] Furthermore, as in the first embodiment, either or both of the ISE measurement unit 32 and the pH measurement mechanism 34 can be incorporated into the colorimetric measurement module 100A.

[0143] The number of ISE measurement modules 32A, colorimetric measurement modules 100A, and pH measurement modules 34A can be arbitrarily set as long as at least one is provided. In this embodiment, a case where the total number of modules is three is shown.

[0144] The overall management computer 221 is connected to each mechanism within the automatic analyzer 200 described above, and includes a CPU (control unit 223 ) that controls the overall operation of the automatic analyzer 200 .

[0145] The overall management computer 221 is a computer including a control unit 223, a memory, etc., and controls the various operations of the above-mentioned components and performs calculations to determine the concentration of a predetermined component in the sample based on the detection results of the ISE measurement module 32A, the colorimetric measurement module 100A, and the pH measurement module 34A.

[0146] For example, the overall management computer 221 determines which of the ISE measurement module 32A, the colorimetric measurement module 100A, and the pH measurement module 34A is to be performed according to the requested analysis item based on the attribute information read by the ID reader 2 .

[0147] In particular, the control unit 223 of this embodiment controls the transport mechanism 217 so that the sample dispensing for pH measurement or pH measurement performed by the pH measurement module 34A is performed after the sample dispensing mechanism 21b of the ISE measurement module 32A and the sample dispensing mechanism 21c of the colorimetric measurement module 100A.

[0148] Furthermore, it is preferable that the control unit 223 controls the transport mechanism 217 so that the dispensing for measuring the electrolyte concentration is performed before the dispensing for measuring the biochemical items.

[0149] The overall management computer 221 is also connected to an input unit 225 consisting of a keyboard and a mouse for inputting necessary information, a display device 224 for displaying various information such as analysis results and analysis instructions, a storage device 222, and a printer for printing the information displayed on the display device 224. Figure 4 A printing unit (not shown) for various information including a display screen, etc.

[0150] The storage device 222 is a recording medium such as a semiconductor memory such as a flash memory or a magnetic disk such as an HDD, which records the sample introduced into the automatic analyzer 200, detection information of the sample holding container 26, and measurement status and request information of the ISE measurement module 32A, the colorimetric measurement module 100A, and the pH measurement module 34A. The storage device 222 also stores various computer programs for controlling the operation of each device within the automatic analyzer 200 and executing various display processing operations.

[0151] The remaining configuration and operation are substantially the same as those of the automatic analyzer 100 of the first embodiment, and detailed description thereof will be omitted.

[0152] As in Example 3 of the present invention, in the automatic analyzer 200 that controls the conveying mechanism 217, an effect roughly the same as that of the automatic analyzer 100 of the above-mentioned Example 1 can also be obtained, wherein the conveying mechanism 217 enables the dispensing of the sample for pH measurement by the pH measurement module 34A or the pH measurement to be performed after the sample dispensing by the sample dispensing mechanisms 21b and 21c.

[0153] Such an automatic analyzer is particularly effective in a large-scale analyzer including one or more dedicated modules for analyzing each measurement item and a transport module.

[0154] Furthermore, the control unit 223 can reliably shorten the time until the final analysis result of the sample is obtained by controlling the transport mechanism 217 so that the dispensing for measuring the electrolyte concentration is performed before the dispensing for measuring the biochemical items.

[0155] <Other>

[0156] The present invention is not limited to the above-described embodiments, but includes various modifications. The above-described embodiments are described in detail to explain the present invention in an easily understandable manner, and are not limited to necessarily having all the described configurations.

[0157] Furthermore, a portion of the structure of one embodiment may be replaced with a structure of another embodiment, or a structure of another embodiment may be added to a structure of one embodiment. In addition, a portion of the structure of each embodiment may be added, deleted, or replaced with another structure.

[0158] Description of Reference Numerals

[0159] 1…Input Department

[0160] 2…ID reading unit

[0161] 5…Standby unit

[0162] 6…Sending Department

[0163] 11…Reaction plate

[0164] 12…Reaction vessel

[0165] 13…Cleaning mechanism

[0166] 14…Spectrophotometer (colorimetric unit)

[0167] 14a…Light source

[0168] 15, 16… stirring mechanism

[0169] 17, 18…reagent dispensing mechanism

[0170] 17a, 18a…reagent probe

[0171] 19…reagent tray

[0172] 20…reagent bottles

[0173] 21, 21b, 21c, 22...Sample dispensing mechanism (first dispensing section)

[0174] 21a, 22a…sample probe

[0175] 23, 24, 28, 29, 31... cleaning tank

[0176] 25…Sample container

[0177] 26…Sample container

[0178] 27…Conveying mechanism (conveying unit)

[0179] 32…ISE measurement unit (electrolyte measurement unit)

[0180] 32A…ISE measurement module (electrolyte measurement unit)

[0181] 33…Dilution tank

[0182] 34…pH measuring mechanism (pH measuring unit)

[0183] 34A…pH measurement module (pH measurement unit)

[0184] 34b…Sample dispensing mechanism

[0185] 35…pH electrode

[0186] 36, 37, 38…pH electrode dedicated standard solution bottle

[0187] 39…pH electrode cleaning tank

[0188] 40…Control device

[0189] 41…Storage device

[0190] 42…Display device

[0191] 43…Input device

[0192] 44…Control Department

[0193] 100, 200...Automatic analyzer

[0194] 100A...Colorimetric Measurement Module

[0195] 105… diluent bottle

[0196] 106…Dilution syringe

[0197] 107…Solenoid valve for diluent

[0198] 108…ISE delivery syringe

[0199] 109…Solenoid valve for transporting syringes

[0200] 110…Pinch valve

[0201] 111…Na+ selective electrode

[0202] 112…K+ selective electrode

[0203] 113…Cl - Selecting electrodes

[0204] 114…Comparison electrode solution bottle

[0205] 115…Solenoid valve for comparison electrode solution

[0206] 116…Comparison electrode

[0207] 117…Internal standard solution bottle

[0208] 118…Syringe for internal standard solution

[0209] 119…Solenoid valve for internal standard solution

[0210] 217…Conveying mechanism (conveying unit)

[0211] 221…Computer for overall management

[0212] 222…Storage device

[0213] 223…Control Department

[0214] 224…Display device

[0215] 225…Input unit.

Claims

1. An automatic analysis device that automatically analyzes a sample, characterized in that: The automatic analysis device comprises: an electrolyte measuring unit for measuring the electrolyte concentration of the sample; a colorimetric measurement unit for measuring biochemical parameters of the sample; A pH measuring unit for measuring the pH of the sample; a first dispensing unit for dispensing the sample for measurement in at least one of the electrolyte measurement unit and the colorimetric measurement unit from a sample container containing the sample; a conveying portion that conveys the container; and a control unit that controls the operation of the mechanism of the automatic analysis device, The transport unit, the first dispensing unit, and the pH measuring unit are configured so that the pH measuring unit dispenses the sample for pH measurement or performs pH measurement after the sample is dispensed by the first dispensing unit. The control unit controls the first dispensing unit so that the dispensing for measuring the electrolyte concentration is performed before the dispensing for measuring the biochemical item. The pH measuring section is disposed at a position accessible to a reaction container containing a reaction solution obtained by mixing and reacting the sample and a reagent for colorimetric measurement by the colorimetric measuring section. The user can select whether to perform the pH measurement in the reaction vessel or in the sample vessel. A standard solution bottle dedicated to calibration of the pH measuring unit is arranged around the pH measuring unit or in a reagent tray storing a plurality of reagent bottles for containing the reagents.

2. The automatic analysis device according to claim 1, characterized in that The position where the sample for pH measurement is dispensed by the pH measuring unit or the pH measurement position is different from the sample dispensing position by the first dispensing unit.

3. An automatic analysis device that automatically analyzes a sample, characterized in that: The automatic analysis device comprises: an electrolyte measuring unit for measuring the electrolyte concentration of the sample; a colorimetric measurement unit for measuring biochemical parameters of the sample; A pH measuring unit for measuring the pH of the sample; a first dispensing unit for dispensing the sample for measurement in at least one of the electrolyte measurement unit and the colorimetric measurement unit from a sample container containing the sample; a conveying portion that conveys the container; and a control unit that controls the operation of the mechanism of the automatic analysis device, The control unit controls the transport unit so that the pH measurement unit performs the dispensing of the sample for pH measurement or the pH measurement after the sample is dispensed by the first dispensing unit. The control unit controls the transport unit so that the dispensing for measuring the electrolyte concentration is performed before the dispensing for measuring the biochemical item. The pH measuring section is disposed at a position accessible to a reaction container containing a reaction solution obtained by mixing and reacting the sample and a reagent for colorimetric measurement by the colorimetric measuring section. The user can select whether to perform the pH measurement in the reaction vessel or in the sample vessel. A standard solution bottle dedicated to calibration of the pH measuring unit is arranged around the pH measuring unit or in a reagent tray storing a plurality of reagent bottles for containing the reagents.

4. The automatic analyzer according to claim 1 or 3, characterized in that The electrolyte measuring unit, the colorimetric measuring unit, and the pH measuring unit can measure a sample different from a biological sample as the sample.

5. The automatic analysis device according to claim 4, characterized in that The automatic analyzer further includes a display unit capable of displaying the measurement result of the sample. When a sample different from the biological sample is measured, a comparison result between a theoretical value and a measured value of the measurement result of the different sample is displayed on the display unit.

6. The automatic analysis device according to claim 4, characterized in that The different sample is dialysate.

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