Automatic analysis device

Abstract

Provided is an automatic analysis device having an incubation function. An example of the automatic analysis device includes: a reaction vessel storage section where a reaction vessel storage container that stores reaction vessels is installed; and a dispensing mechanism that dispenses specimens or reagents into a reaction vessel which was removed from the reaction vessel storage container. The reaction vessel storage section has a temperature-controlled area where at least a portion of the storage section is adjusted to a prescribed temperature. The reaction vessel into which a specimen or a reagent is dispensed by the dispensing mechanism is placed in a reaction vessel storage container installed in the temperature-controlled area for a prescribed period.

Description

Technical Field

[0001] The present invention relates to an automatic analyzer for analyzing samples (specimens) such as blood and urine.

Background Art

[0002] In an automatic analyzer for analyzing biological samples such as blood and urine, the number of specimens analyzed per unit time and the number of tests that can be performed are important. Also, in the analysis cycle of an automatic analyzer, after holding a single specimen, a single reagent, a mixed solution of a plurality of specimens, or a mixed solution of a specimen and a reagent at a predetermined time and temperature, analysis is performed. However, depending on the type of analysis, it may be necessary to arbitrarily shorten or extend the holding time or temperature.

[0003] For this reason, Patent Document 1 discloses providing an incubation function for temperature holding in the apparatus and transferring a container that has passed a predetermined temperature control time to a detection position.

Prior Art Documents

Patent Documents

[0004]

Patent Document 1

Summary of the Invention

Problems to be Solved by the Invention

[0005] If an automatic analyzer is provided with an incubation function and a transfer mechanism therefor as in Patent Document 1, there is a risk that the apparatus will become larger or the processing capacity will decrease.

[0006] An object of the present invention is to provide a small automatic analyzer equipped with an incubation function.

Means for Solving the Problems

[0007] To solve the above problems, an automated analyzer according to one embodiment of the present invention includes a reaction vessel storage section in which a reaction vessel storage container for housing reaction vessels is installed, and a dispensing mechanism for dispensing samples or reagents into reaction vessels removed from the reaction vessel storage container. The reaction vessel storage section includes a temperature control region in which at least a part thereof is adjusted to a predetermined temperature, and the reaction vessels into which samples or reagents have been dispensed by the dispensing mechanism are placed in the reaction vessel storage container installed in the temperature control region for a predetermined period of time. [Effects of the Invention]

[0008] We provide an automated analyzer equipped with an incubation function. Other issues, configurations, and effects will be clarified by the following description of the embodiments. [Brief explanation of the drawing]

[0009] [Figure 1] This is a system block diagram showing the entire automated analyzer capable of measuring blood coagulation. [Figure 2] This is a schematic diagram of an automated analyzer capable of measuring blood coagulation and biochemistry. [Figure 3] This is an example of the operation sequence of a transfer device. [Figure 4A] This diagram shows the operation of the transfer device. [Figure 4B] This diagram shows the operation of the transfer device. [Figure 4C] This diagram shows the operation of the transfer device. [Figure 4D] This diagram shows the operation of the transfer device. [Figure 4E] This diagram shows the operation of the transfer device. [Figure 4F] This diagram shows the operation of the transfer device. [Figure 4G] This diagram shows the operation of the transfer device. [Figure 4H] This diagram shows the operation of the transfer device. [Figure 4I] This diagram shows the operation of the transfer device. [Figure 5A] This diagram shows the lid mechanism for the reaction vessel housing. [Figure 5B] It is a diagram showing the lid mechanism of the reaction vessel storage section. [Figure 6] It is a diagram showing the lid mechanism of the reaction vessel storage section. [Figure 7] It is a diagram showing the lid mechanism of the reaction vessel storage section. [Figure 8] It is a diagram showing a state of preventing evaporation of a specimen in a reaction vessel using the reaction vessel. [Figure 9A] It is a diagram showing an operation of preventing a decrease in heat retention efficiency of the temperature control mechanism of the reaction vessel storage section. [Figure 9B] It is a diagram showing an operation of preventing a decrease in heat retention efficiency of the temperature control mechanism of the reaction vessel storage section. [Figure 10] It is a diagram showing the temperature control mechanism of the reaction vessel storage section. [Figure 11] It is a diagram showing the temperature control mechanism of the reaction vessel storage section. [Figure 12] It is a diagram showing the temperature control mechanism of the reaction vessel storage section. [Figure 13] It is a diagram showing a sample disk. [Figure 14] It is a diagram showing a sample disk and a sample dispensing mechanism [Figure 15] It is a diagram showing the temperature control mechanism of a sample disk. [Figure 16] It is a diagram showing the temperature control mechanism of a sample disk. [Figure 17] It is a diagram showing the temperature control mechanism of a sample disk. [Figure 18] It is a diagram showing an example of a temperature control region provided on a sample disk. [Figure 19] It is an example of a measurement flow when the reaction vessel storage section has a temperature control mechanism. [Figure 20] It is an example of a measurement flow when the sample disk has a temperature control mechanism. [Figure 21] It is an example of a temperature control setting screen. [Figure 22] It is an example of a temperature log screen.

Embodiments for Carrying Out the Invention

[0010] Hereinafter, embodiments of the present invention will be described based on the drawings. [Examples]

[0011] Figure 1 is a system block diagram showing the entirety of an automated analyzer capable of measuring blood coagulation, which is one embodiment of the present invention. As shown in Figure 1, the automated analyzer 1 mainly comprises a sample dispensing mechanism 10, a sample disk 11, a coagulation reagent dispensing mechanism 20, a reagent disk 21, a reaction vessel storage unit 30, a transfer device 32, a coagulation time measurement unit 40, and a computer (control unit) 52.

[0012] The transfer device 32 is equipped with an arm capable of gripping the reaction vessel 31. The transfer device 32 can move between the reaction vessel storage section 30, the coagulation sample dispensing section 43, and the coagulation time measurement section 40, and can transport and place the reaction vessel 31 in a predetermined location. The reaction vessel 31 is a container for mixing the sample and reagents and for reacting the mixed solution.

[0013] The sample disc 11 is capable of intermittent rotation clockwise and counterclockwise, and has multiple sample containers 12 on which biological samples such as blood are stored. A sample dispensing mechanism 10 is located near the sample disc 11. The sample dispensing mechanism 10 can rotate clockwise and counterclockwise between the sample disc 11 and the coagulation sample dispensing unit 43. The sample dispensing mechanism 10 uses a probe attached to the tip of the sample dispensing mechanism 10 to aspirate the sample (specimen) from the sample container 12 and dispenses the sample into the reaction vessel 31 on the coagulation sample dispensing unit 43.

[0014] Multiple reagent containers 22 corresponding to the analysis items of the automated analyzer 1 are placed on the reagent disk 21. The coagulation reagent dispensing mechanism 20 aspirates the reagents from the reagent containers 22 and dispenses them into the reaction vessel 31. The coagulation reagent dispensing mechanism 20 has a built-in reagent heating mechanism 23, and the reagents aspirated by the coagulation reagent dispensing mechanism 20 are heated to a predetermined temperature (optimal temperature) by the reagent heating mechanism 23.

[0015] The reaction vessel storage section 30 is equipped with one or more reaction vessel storage containers 30a for housing the reaction vessel 31. The reaction vessel storage containers 30a are provided with numerous through holes (reaction vessel storage positions), into which the reaction vessel 31 is inserted.

[0016] The coagulation sample dispensing section 43 is provided with a recess for placing the reaction vessel 31, into which the reaction vessel 31 is inserted.

[0017] The solidification time measurement unit 40 includes a solidification time detection unit 41 with a recess for placing the reaction vessel 31. The light source 42 irradiates light onto the reaction vessel 31 placed on the solidification time detection unit 41. The light irradiated from the light source 42 is scattered within the reaction vessel 31, and this scattered light is received by a photodiode provided in the solidification time detection unit 41. The measured analog signal of the scattered light is input to the A / D converter 56. Based on the digital signal output from the A / D converter, the solidification time is measured. In this way, the solidification time of the mixed liquid in the reaction vessel 31 placed on the solidification time measurement unit 40 can be measured.

[0018] Next, the control system and signal processing system in the automated analyzer 1 shown in Figure 1 will be briefly explained. The computer (control unit) 52 is connected to the sample dispensing control unit 57, the coagulation reagent dispensing control unit 58, the transfer device control unit 59, and the A / D converter 56 via the interface 50. The computer 52 sends commands to each of these control units and controls their respective operations. In other words, the computer 52 can control the transfer device, dispensing mechanism, etc., via the control units of each mechanism.

[0019] Interface 50 is connected to a printer 53 for printing, a memory 55 for storage, a keyboard 51 for inputting operation commands, and a display device 54 for screen display, such as a CRT display or LCD display. The memory 55 is composed of, for example, hard disk memory or external memory. Information such as analysis parameters, analysis item requests, calibration results, and analysis results is stored in the memory 55.

[0020] Next, we will explain blood coagulation measurement. When the operator requests analysis from the computer 52, the transfer device 32 transfers the reaction vessel 31, which is stored in the reaction vessel storage unit 30, to the coagulation sample dispensing unit 43 and places it there. Subsequently, the sample dispensing mechanism 10 aspirates the sample to be used for analysis from the sample container 12 on the sample disk 11 and dispenses the sample into the reaction vessel 31 on the coagulation sample dispensing unit 43. The reaction vessel 31, into which the sample has been dispensed, is then transferred and placed on the coagulation time detection unit 41 by the transfer device 32. After that, when the reagent is dispensed into the reaction vessel 31 on the coagulation time detection unit 41 by the coagulation reagent dispensing mechanism 20, the sample and reagent are mixed and the blood coagulation reaction begins.

[0021] Light from the light source 42 is shone onto the reaction vessel 31 on the solidification time detection unit 41. The solidification time measurement unit 40 receives this scattered light, and the A / D converted measurement value is input to the computer 52 through the interface 50. The measurement result is output by the printer 53 or display device 54.

[0022] Figure 2 is a schematic diagram of an automated analyzer 1b, which is an embodiment of the present invention and is equipped with a blood coagulation measurement unit and an absorbance measurement unit capable of biochemical measurement. Note that the control system and signal processing system are omitted in Figure 2. Mechanisms equivalent to those shown in Figure 1 are given the same reference numerals and redundant explanations are omitted. The automated analyzer 1b is equipped with a reaction disk 60 with multiple reaction cells (second reaction vessels) 62 used for biochemical measurement, and reagent dispensing mechanisms 61a, 61b, and the sample dispensing mechanism 10 is shared for blood coagulation testing and biochemical testing. In the configuration of Figure 2, the coagulation time measurement unit 40 is equipped with multiple (six in this example) coagulation time detection units 41. In this configuration, reagents for blood coagulation testing can be drawn from the reagent disks 21a, 21b through the reaction cells 62 to the coagulation reagent dispensing mechanism 20, and the reagents can be efficiently heated before being dispensed into the reaction vessel 31. This is because the reaction cells 62 are kept warm at approximately 37 degrees Celsius in a constant temperature bath.

[0023] The reaction vessel storage section 30 of the automated analyzer 1b is equipped with a temperature control area in which its temperature is adjusted to a predetermined temperature, and two reaction vessel storage containers are installed. The configuration of the reaction vessel storage section 30 will be described later, but the temperature control area may be the entire reaction vessel storage section 30 or only a part of it. The reaction vessel storage containers are equipped with numerous through holes (reaction vessel storage positions) into which reaction vessels 31 are inserted, and empty reaction vessels 31 used for blood coagulation measurement are placed in advance. Furthermore, the reaction vessel storage containers are detachable from the reaction vessel storage section 30. For example, when a reaction vessel storage container becomes empty, the operator removes the empty reaction vessel storage container from the reaction vessel storage section 30 and installs a new reaction vessel storage container with a reaction vessel 31 already installed.

[0024] Here, we will describe the operation sequence of the transfer device 32 when measuring blood coagulation time, which involves applying a predetermined temperature control to the sample, according to one embodiment of the present invention.

[0025] Figure 3 shows the operation sequence of the transfer device 32 when the operator registers a request for blood coagulation analysis and the analysis is started. The operation of the transfer device 32 at each step is shown in accordance with Figures 4A to 4I.

[0026] The transfer device 32 is stopped with the upper left of the reaction vessel storage section 30 as its initial position (S01, Figure 4A). When the analysis starts, the transfer device 32 grasps the empty reaction vessel 31 placed in the reaction vessel storage section 30 (S02, Figure 4B) and transfers it to the coagulation sample dispensing section 43 and places it there (S03, Figure 4C). Next, the transfer device 32 moves back to its initial position, and the sample dispensing mechanism 10 dispenses one or more samples into the reaction vessel 31 on the coagulation sample dispensing section 43 (S04, Figure 4D).

[0027] Subsequently, the transfer device 32 grasps the reaction vessel 35 containing the sample on the coagulation sample dispensing unit 43 (S05, Figure 4E), and transfers and places the reaction vessel 35 containing the sample into the temperature-controlled reaction vessel storage unit 30 (for example, assuming the left reaction vessel storage unit is temperature-controlled) (S06, Figure 4F). After that, the transfer device 32 moves to its initial position (S07, Figure 4G). The reaction vessel 35 containing the sample is placed in the temperature-controlled reaction vessel storage unit 30 and maintained at a predetermined temperature for a predetermined period (incubation). After the predetermined temperature-controlled period has elapsed for the reaction vessel 35 containing the sample before analysis, the transfer device 32 grasps the reaction vessel 35 containing the sample placed in the reaction vessel storage unit 30 and transfers and places the reaction vessel 35 containing the sample into the coagulation time detection unit 41 (S08, Figure 4H). After the transfer device 32 moves to its initial position (S09, Figure 4I), the coagulation reagent dispensing mechanism 20 dispenses the reagent into the reaction vessel 31 on the coagulation time detection unit 41, and the coagulation reaction begins. After the coagulation reaction is complete, the transfer device 32 grasps the reaction vessel 31 after the photometric measurement is complete and discards the reaction vessel after measurement in the reaction vessel disposal unit 34.

[0028] The operation of the transfer device 32 described above is controlled by the transfer device control unit 59 via the interface 50 from the computer 52.

[0029] The operation sequence in Figure 3 shows an example where the incubation target is a sample or a mixed sample, but the incubation target may also be a reagent dispensed into the reaction vessel 31 or a mixture of the reagent and the sample. In this case as well, after dispensing the reagent or sample, the reaction vessel containing the reagent or the mixture of the reagent and the sample is transferred to and placed in the temperature-controlled reaction vessel storage unit 30, and allowed to elapse for a predetermined temperature control period. In the configuration of Figure 1, the reagent is dispensed into the reaction vessel 31 placed on the coagulation time measurement unit 40 by the coagulation reagent dispensing mechanism 20. In the configuration of Figure 2, there may be multiple dispensing methods. The coagulation reagent dispensing mechanism 20 aspirates reagent from the reagent disk 21a and discharges it into the reaction vessel 31 placed on the coagulation time measurement unit 40. In addition, the reagent dispensing mechanism 61a (61b) dispenses reagent from the reagent disk 21a (21b) into the reaction cell 62 on the reaction disk 60, and further dispenses reagent from the reaction cell 62 into the reaction vessel 31 placed on the coagulation time measurement unit 40 by the coagulation reagent dispensing mechanism 20, or dispenses reagent from the reaction cell 62 into the reaction vessel 31 placed on the coagulation sample dispensing unit 43 by the sample dispensing mechanism 10.

[0030] The configuration of the reaction vessel storage section 30 will be described below. During incubation in the reaction vessel storage section 30, the temperature at which the sample is held is higher than room temperature, and there is a risk that the sample may evaporate from the reaction vessel, causing the sample concentration to increase. For this reason, the reaction vessel storage section 30 is provided with a lid mechanism to prevent the evaporation of the sample. It is also conceivable to provide a lid to prevent evaporation for each reaction vessel, but in order to keep the configuration as simple as possible, in this embodiment, the reaction vessel storage section 30 is provided with a lid mechanism that covers at least the area used for incubation (incubation area) in the reaction vessel storage section 30.

[0031] The storage compartment lid 70 moves between the lid standby position and the incubation area of ​​the reaction vessel storage compartment 30 via a slide rail 71, which is connected to the automatic analyzer on one end and to the storage compartment lid 70 on the other. Figure 5A shows the storage compartment lid 70 in the lid standby position, and Figure 5B shows the storage compartment lid 70 covering the incubation area. Here, an example is shown in which the left two rows of reaction vessel storage containers 30a1, which are installed on the left side of the storage compartment, are set as the incubation area. The reaction vessel 35 containing the sample, which has been transferred to the incubation area of ​​the reaction vessel storage compartment 30 by the transfer device 32, is covered by the storage compartment lid 70, thereby preventing evaporation of the liquid contained in the reaction vessel 35.

[0032] The storage compartment lid 70 is driven by a motor 72. Transfer device 32 When the empty reaction vessel 31 is grasped on the reaction vessel storage section 30, or when the transfer device 32 places the reaction vessel 35 containing the sample on the reaction vessel storage section 30, or when the transfer device 32 grasps the reaction vessel 35 containing the sample on the reaction vessel storage section 30, the motor 72 drives the storage section lid 70 to be retracted to the lid standby position. When the transfer device 32 moves away from the reaction vessel storage section 30, the motor 72 drives the storage section lid 70 to cover the incubation area.

[0033] Furthermore, it is undesirable for condensation to occur on the storage compartment lid 70 during the incubation of the reaction vessel 35 containing the sample. For this reason, it is advisable to provide an insulating material on the surface of the storage compartment lid 70 that faces the incubation area of ​​the reaction vessel storage compartment 30, or to provide a heating mechanism that heats the storage compartment lid 70 to the same temperature as the temperature control area of ​​the reaction vessel storage compartment 30.

[0034] Furthermore, the drive mechanism for the storage compartment lid 70 is not limited to a motor; it may also be driven by a cylinder 73 as shown in Figure 6. Alternatively, as shown in Figure 7, instead of providing a dedicated drive mechanism for the storage compartment lid 70, a knob 74 on the storage compartment lid 70 may be gripped by a transfer device 32, and the lid may be moved using the power of the transfer device 32.

[0035] As a simpler mechanism to prevent the evaporation of the sample during incubation, the transfer device 32 can also grasp the empty reaction vessel 31 placed in the reaction vessel storage container 30a and place it on top of the reaction vessel 35 containing the sample, thereby preventing the evaporation of the sample during incubation. The reaction vessel 31 used as a temporary lid may develop condensation on its outer wall, and to prevent contamination, it should be discarded after use.

[0036] Next, the temperature control mechanism of the reaction vessel housing section 30 will be described. The temperature control mechanism shown in Figure 10 extends the flow path of the constant temperature bath 80, which is used to control the temperature of the reaction cells 62 on the reaction disk 60, as the heat source for the temperature control mechanism. In order to maintain a constant water temperature (approximately 37°C) in the constant temperature bath 80, the system water of the constant temperature bath 80 is heated and circulated through a flow path equipped with a heater 81, a filtration filter 82, a circulation pump 83, etc. The configuration in Figure 10 extends this flow path to the temperature control area of ​​the reaction vessel housing section 30, using the system water in the flow path as the heat source. As a result, the heat source and temperature control for the constant temperature bath 80 can be reused, making it possible to easily implement a temperature control function.

[0037] The temperature control mechanism for the reaction vessel housing 30 may be provided independently of the constant temperature bath 80. In this case, the reaction vessel housing 30 can be temperature-controlled to a temperature different from that of the constant temperature bath 80. Furthermore, when heating of the reaction vessel is not required, i.e., when incubation is not being performed, temperature control can be disabled. In addition, an independent temperature control mechanism may be provided instead of the temperature control mechanism shown in Figure 10, or an independent temperature control mechanism may be provided as an auxiliary measure in addition to the temperature control mechanism shown in Figure 10.

[0038] Figure 11 shows a first example in which hot air is used as the heat source. Air heated by the heater 84 is blown by the blower 85 into the temperature-controlled area of ​​the reaction vessel housing 30. A temperature sensor 86 is provided in the temperature-controlled area, and the heater control unit 87 controls the temperature of the heater 84 according to the temperature of the temperature-controlled area measured by the temperature sensor 86. Figure 12 shows a second example in which an electric heater 88 is provided in the temperature-controlled area of ​​the reaction vessel housing 30. The electric heater 88 is provided with a temperature sensor 89 such as a thermistor, and the heater control unit 90 controls the temperature of the electric heater 88 according to the temperature detected by the temperature sensor 89. Figure 12 shows an example in which the electric heater 88 is placed on the side of the reaction vessel housing container 30a1, but it may also be placed on the bottom side, or on both the side and bottom sides. Control by the heater control unit can also be performed by a computer (control unit) 52.

[0039] As mentioned above, the reaction vessel storage container 30a is provided with through-holes that serve as storage locations for the reaction vessels. Therefore, when a portion of the reaction vessel storage section 30 is temperature-controlled, even if the temperature-controlled area is heated, the heated air inside the reaction vessel storage container 30a escapes through the through-holes, reducing the heat retention efficiency. Figure 9A shows an example where reaction vessel storage containers 30a1 and 30a2 are placed in the reaction vessel storage section 30, with the reaction vessel storage container 30a1 on the left side being designated as the temperature-controlled area. In this example, the three rightmost columns of reaction vessel storage container 30a1 contain used reaction vessels, and the inside and outside of reaction vessel storage container 30a1 are connected by the through-holes where the reaction vessels are installed, causing heated air to leak out from the side of reaction vessel storage container 30a1. Therefore, as shown in Figure 9B, the transfer device 32 grasps the empty reaction vessel 31 placed in the reaction vessel storage container 30a2 outside the temperature-controlled area of ​​the reaction vessel storage section 30, moves it to the empty reaction vessel storage position in the temperature-controlled reaction vessel storage container 30a1, and places the reaction vessel 31 there, thereby sealing the through-hole and maintaining heat retention efficiency. [Examples]

[0040] In this embodiment, a temperature-controlled area is provided on the sample disk. Except for the location of the temperature-controlled area, the configuration is the same as in Embodiment 1, and the same reference numerals are used for components similar to those in Embodiment 1, and redundant explanations are omitted. Furthermore, the configuration of the automated analyzer may be the configuration of automated analyzer 1, which is capable of performing blood coagulation measurements as described in Figure 1, or the configuration of automated analyzer 1b, which is equipped with a blood coagulation measurement unit and an absorbance measurement unit capable of biochemical measurements, as described in Figure 2.

[0041] The structure of the sample disc is the same as in Example 1. As shown in Figure 13, the sample disc 11 can rotate intermittently clockwise and counterclockwise, and multiple sample containers 12 for containing biological samples such as blood are placed on it. In addition, as shown in Figure 14, a sample dispensing mechanism 10 is located near the sample disc 11.

[0042] The sample dispensing mechanism 10 uses a probe attached to its tip to aspirate the sample (specimen) from the sample container 12 placed on the sample disc 11 and dispenses it into another empty sample container 12 on the sample disc 11. The sample dispensing mechanism 10 also uses a probe attached to its tip to aspirate the sample (specimen) from the sample container 12 placed on the sample disc 11 and dispenses it into a reaction cell 62 provided on the reaction disc 60 or into a reaction vessel 31 on the coagulation sample dispensing section 43.

[0043] The sample disk 11 of the automated analyzer 1(1b) is equipped with a temperature control region in which the temperature of the sample disk 11 is adjusted to a predetermined temperature. The configuration of the sample disk 11 equipped with the temperature control region will be described later, but the temperature control region may be provided over the entire sample disk 11 or in a part of the sample disk 11.

[0044] The targets of incubation on the sample disk 11 are the sample or mixed sample in the sample container 12 placed on the sample disk 11, or the sample or mixed sample dispensed by the sample dispensing mechanism 10. Alternatively, the reagent or a mixture of the reagent and the sample may be the target of incubation. In this case as well, after dispensing the reagent or sample, the sample container 12 containing the reagent or the mixture of the reagent and the sample should be left on the temperature-controlled sample disk 11 for a predetermined temperature control period.

[0045] Next, the temperature control mechanism for the sample disk 11 will be described. The temperature control mechanism shown in Figure 15 extends the flow path of the constant temperature bath 80, which is used to control the temperature of the reaction cells 62 on the reaction disk 60, as the heat source for the temperature control mechanism. In order to maintain a constant water temperature (approximately 37°C) in the constant temperature bath 80, the system water of the constant temperature bath 80 is heated and circulated through a flow path equipped with a heater 81, a filtration filter 82, a circulation pump 83, etc. The configuration in Figure 15 extends this flow path to the temperature control area of ​​the sample disk 11, using the system water in the flow path as the heat source. As a result, the heat source and temperature control for the constant temperature bath 80 can be reused, making it possible to easily implement a temperature control function.

[0046] The temperature control mechanism for the sample disk 11 may be provided independently of the constant temperature chamber 80. In Example 2, an independent temperature control mechanism may be provided instead of the temperature control mechanism shown in Figure 15, or an auxiliary independent temperature control mechanism may be provided in addition to the temperature control mechanism shown in Figure 15.

[0047] Figure 16 shows the first example, in which hot air is used as the heat source. Air heated by the heater 161 is blown into the temperature-controlled area of ​​the sample disk 11 by the blower 162. A temperature sensor 163 is provided in the temperature-controlled area, and the heater control unit 164 controls the temperature of the heater 161 based on the temperature of the temperature-controlled area measured by the temperature sensor 163.

[0048] Figure 17 shows a second example, in which an electric heater 171 is installed in the temperature-controlled area of ​​the sample disk 11. The electric heater 171 is equipped with a temperature sensor 172 such as a thermistor, and the heater control unit 173 controls the temperature of the electric heater 171 according to the temperature detected by the temperature sensor 172. Control by the heater control unit 173 can also be performed by a computer (control unit) 52. In Figure 17, a heater control unit 173 is provided for each temperature-controlled area, but multiple electric heaters 171 and multiple temperature sensors 172 installed in multiple temperature-controlled areas may be controlled by a single heater control unit 173. When one or more electric heaters 171 are wired to the main body at the rotating part of the sample disk 11, they may be wired using slip rings.

[0049] By providing this independent temperature control mechanism, the sample disc 11 can be heated to a temperature different from that of the constant temperature bath 80. Furthermore, when heating of the sample container 12 is not required, i.e., when incubation is not being performed, temperature control can be disabled.

[0050] The temperature-controlled area may be located in a part of the sample disk 11 or throughout the entire disk. Furthermore, one or more temperature-controlled areas may be provided within the sample disk 11, and if multiple areas are provided, the size of each area may be varied. Also, if multiple temperature-controlled areas are provided, the temperature may be varied for each area.

[0051] The sample disk 11 shown in Figure 17 is an example in which four temperature-controlled regions, A to D, are provided on a part of the sample disk 11. A temperature sensor 172 is provided on the electric heater 171 of each temperature-controlled region, and control is performed by the heater control unit 173. Furthermore, while temperature control is performed by the electric heater 171 in temperature-controlled regions A to C, a Peltier element 174 is used as the heat source in temperature-controlled region D. By using a Peltier element, it is possible to not only heat but also cool the sample, making it possible to use a part of the reagent disk as a refrigerator for storing samples. When used as a refrigerator, for example, it is possible to store quality control samples or calibrators used for calibration. In this case, calibration for quality control can be automatically performed at any time during the analysis operation, and high-temperature incubation is also possible at the same time. In addition, although not shown in the figure, it is preferable to form a closed space for each temperature-controlled region in order to control the temperature in each region, and to provide insulating material to surround the space.

[0052] The above describes a method for controlling the temperature of all or part of the sample disk 11 using Figures 15 to 17. However, regardless of the temperature control method, a temperature control area may be provided on the inner circumference of the sample disk 11 as shown in Figure 18.

[0053] Next, we will explain the flow from sample dispensing to measurement in the coagulation time measurement unit 40 when a temperature control mechanism is provided in the reaction vessel storage unit 30 of Example 1, and the flow from sample dispensing to measurement in the coagulation time measurement unit 40 when a temperature control mechanism is provided in the sample disk 11 of Example 2, using a cross-mixing test that requires sample incubation as an example. The cross-mixing test is a method for differentiating the cause of prolonged blood coagulation time due to the addition of normal plasma. In the cross-mixing test, normal plasma is added to the test plasma, which is the sample, and mixed plasma is prepared by mixing so that the proportion of normal plasma is in multiple patterns (0, 10, 20, 50, 80, 90, 100%). The degree of correction of the blood coagulation time of the test plasma due to the addition of normal plasma is determined by creating a graph that plots the relationship between the measurement result (blood coagulation time) and the proportion of normal plasma. In the deficiency type, APTT prolongation is corrected by the addition of normal plasma, showing a downward convex pattern. On the other hand, in the inhibitor type, APTT prolongation is difficult to correct even with the addition of normal plasma, and an upward convex pattern is observed. However, since the inhibitor's reaction to factor VIII is time and temperature dependent, the reaction immediately after mixing (hereinafter referred to as the immediate reaction) may not clearly show an upward convex shape, but may become apparent in the reaction after incubation at 37°C for a certain period of time (hereinafter referred to as the delayed reaction). Therefore, it is recommended to measure both the immediate and delayed reactions in the cross-mixing test.

[0054] Using the flowchart in Figure 19, the flow from sample dispensing to measurement in the coagulation time measurement unit 40 in the case where a temperature control mechanism is provided in the reaction vessel housing unit 30 (Example 1) will be explained.

[0055] The automated analyzer 1(1b) accepts a request for a cross-mixing test (S11). First, it performs sample preparation and analysis for immediate-type measurements to measure immediate reactions (S12-S14). First, the sample dispensing mechanism 10 draws normal plasma from the sample container 12 containing normal plasma placed on the sample disc 11 and discharges the normal plasma into the empty reaction container 31 transferred from the reaction container storage container to the coagulation sample dispensing unit 43. At this time, the required amount of mixed plasma and normal plasma are discharged (S12). Next, the sample dispensing mechanism 10 draws the test plasma from the sample container 12 containing the test plasma placed on the sample disc 11 and discharges the test plasma into the reaction container 31 from which normal plasma was discharged in step S12, so that each component forms a mixed plasma with a predetermined proportion of test plasma (S13). Next, the reaction vessel 31 containing the mixed plasma is transferred to the coagulation time measurement unit 40 by the transfer device 32. The reaction vessel 31 containing the mixed plasma prepared for immediate measurement is then irradiated with light from the light source 42, and the light scattered within the reaction vessel 31 is detected by the coagulation time detection unit 41 (S14).

[0056] Next, sample preparation and analysis for delayed-type measurements are performed to measure the delayed reaction (S15-S18). Similar to immediate-type measurements, normal plasma is aspirated from the sample container 12, which contains normal plasma placed on the sample disc 11, by the sample dispensing mechanism 10, and the normal plasma is transferred from the reaction vessel storage container to the empty reaction vessel 31, which is then placed in the coagulation sample dispensing unit 43. of Discharge. At this time, the required amount of mixed plasma and normal plasma are discharged (S15). Next, the sample dispensing mechanism 10 draws the test plasma from the sample container 12 containing the test plasma placed on the sample disc 11 and discharges the test plasma into the reaction vessel 31 from which the normal plasma was discharged in step S15, so that each component forms a mixed plasma with a predetermined proportion of test plasma (S16). In the case of delayed-type measurement, the mixed plasma is incubated at 37°C for a certain period of time. For this purpose, the reaction vessel 31 in which the mixed plasma has been prepared is transferred to the reaction vessel storage unit 30 equipped with a temperature control mechanism by the transfer device 32, and the reaction vessel 31 is placed in the reaction vessel storage unit. This allows the mixed plasma in the reaction vessel 31 to be incubated (S17).

[0057] After a certain period of time has elapsed since the reaction vessel 31 was transferred to the reaction vessel storage unit 30, and the incubation of the mixed plasma is complete, a delayed measurement is performed. The control unit 52 detects that incubation has been performed for a certain period of time, making it possible to perform a delayed measurement automatically after incubation without requiring any user intervention. Alternatively, although user intervention is required, the delayed measurement may be triggered by a user instruction. In this case, the control unit 52 may notify the user that the required incubation time has elapsed. The reaction vessel 31, in which incubation is complete, is transferred from the reaction vessel storage unit 30 to the coagulation time measurement unit 40 by the transfer device 32. Light is then shone from the light source 42 onto the reaction vessel 31 containing the mixed plasma that has been prepared for delayed measurement and whose incubation is complete, and the light scattered within the reaction vessel 31 is detected by the coagulation time detection unit 41 (S18).

[0058] This flowchart illustrates an example where the mixed plasma for immediate measurement is prepared and the immediate reaction is measured, followed by the preparation of the mixed plasma for delayed measurement. However, it is not limited to this example; the mixed plasma for delayed measurement may be prepared at the same time as the mixed plasma for immediate measurement.

[0059] In contrast, the flowchart in Figure 20 will explain the process from sample dispensing to measurement in the coagulation time measurement unit 40 when a temperature control mechanism is provided on the sample disk 11 (Example 2).

[0060] The automated analyzer 1(1b) accepts a request for a cross-mixing test (S21). When incubation is performed on the sample disc 11, the mixed plasma for immediate and delayed measurements is prepared in the same container. Normal plasma is aspirated from the sample container 12 containing the normal plasma placed on the sample disc 11 by the sample dispensing mechanism 10 and placed in the empty sample container 12 placed on the sample disc 11. Immediate typeNormal plasma for measurement and delayed measurement is dispensed. At this time, the required amount of mixed plasma is dispensed into empty sample containers 12 (S22). Next, the sample dispensing mechanism 10 draws the test plasma from the sample container 12 containing the test plasma placed on the sample disc 11 and dispenses the test plasma into the sample container 12 from which the normal plasma was dispensed in step S22, so that each container contains mixed plasma in a predetermined proportion of test plasma (S23). The mixed plasma prepared in the sample container 12 is drawn from the sample container 12 by the sample dispensing mechanism 10 and dispensed into an empty reaction container 31 that has been transferred from the reaction container storage container to the coagulation sample dispensing unit 43 (S24). Next, the reaction container 31 from which the mixed plasma has been dispensed is transferred to the coagulation time measurement unit 40 by the transfer device 32, the reaction container 31 is irradiated with light by the light source 42, and the light scattered within the reaction container 31 is detected by the coagulation time detection unit 41 (S25).

[0061] The remaining mixed plasma used for immediate measurement is used for delayed measurement. Therefore, the sample container 12 containing the remaining mixed plasma is temperature-controlled on the sample disk 11 to incubate the mixed plasma in the sample container 12 (S26). Temperature control on the sample disk 11 can be initiated at the timing of temperature control for the mixed plasma for delayed measurement, or the sample container 12 can be placed in a temperature-controlled area that has been pre-temperature-controlled to 37°C using the transfer mechanism or manually by the user. Once the incubation of the mixed plasma is complete, the incubated mixed plasma is aspirated from the sample container 12 by the sample dispensing mechanism 10 and discharged from the reaction vessel storage container 30a into the empty reaction vessel 31 which has been transferred to the coagulation sample dispensing unit 43 in order to perform the measurement (S27). Step S27 can be performed automatically after incubation without user intervention by the control unit 52 detecting that incubation has been performed for a certain period of time. Alternatively, although user intervention is required, step S27 may be triggered by user instructions. In this case, the control unit 52 may notify that the incubation period has elapsed.

[0062] Next, the reaction vessel 31 from which the mixed plasma has been discharged is transferred to the coagulation time measurement unit 40 by the transfer device 32. The reaction vessel 31 containing the mixed plasma for delayed-type measurement is then irradiated with light from the light source 42, and the light scattered within the reaction vessel 31 is detected by the coagulation time detection unit 41 (S28).

[0063] Using the results measured in the flow shown in Figure 19 or Figure 20, graphs of immediate and delayed measurements are created, and the user determines the cause of the delay from the created graphs.

[0064] As explained in Figure 19, when incubation of the mixed plasma for delayed-type measurement is performed in the reaction vessel storage section 30, the mixed plasma for immediate-type measurement and the mixed plasma for delayed-type measurement are prepared in separate containers. On the other hand, as explained in Figure 20, when incubation of the mixed plasma for delayed-type measurement is performed in the sample disk 11 (Example 2), the mixed plasma for immediate-type measurement and the mixed plasma for delayed-type measurement can be prepared together in a single sample container 12. Therefore, the same sample can be used for both immediate-type and delayed-type measurements. In other words, because it is not affected by the dispensing error of the sample dispensing mechanism 10, it is possible to compare the measurement results of immediate-type and delayed-type measurements more accurately. Note that the above effect cannot be obtained in the automated analyzer of Example 2, Immediate type It is possible to prepare mixed plasma for measurement and mixed plasma for delayed measurement in separate sample containers 12 and perform the measurements.

[0065] In contrast, when incubation of mixed plasma for delayed-type measurement is performed in the reaction vessel storage unit 30, the mixed plasma is prepared directly in the reaction vessel 31. On the other hand, when incubation of mixed plasma for delayed-type measurement is performed in the sample disc 11, the mixed plasma is first prepared in the sample container 12, and then the prepared mixed plasma is dispensed into the reaction vessel 31. Therefore, when temperature control is performed in the sample disc 11, one more dispensing operation is required compared to when temperature control is performed in the reaction vessel storage unit 30, resulting in a larger sample volume. In other words, when the reaction vessel storage unit 30 is equipped with a temperature control mechanism (Example 1), cross-mixing analysis can be performed with a smaller sample volume compared to when temperature control is performed in the sample disc 11.

[0066] The temperature control of the sample disk 11 may be set arbitrarily by the user. An example of the temperature control setting screen displayed on the display device 54 is shown in Figure 21. The setting screen has a schematic diagram of the sample disk divided into areas 211, a temperature setting unit 212 for inputting the set temperature for each area, and a control setting unit 213 for setting how long the temperature control will be performed at the temperature set in the temperature setting unit 212. The temperature control period and set temperature can be set arbitrarily for each area, making it possible to set according to the user's usage of the automatic analyzer 1(1b). In addition, the temperature control position, temperature, or incubation elapsed time can be checked from this screen.

[0067] To clarify the correspondence between area names A to H in the schematic diagram of the sample disc 211 and the sample disc 11 of the automated analyzer 1(1b), it is desirable that the area numbers in the schematic diagram of the sample disc 211 be displayed on the sample disc 11, and that the position numbers of the sample container 12 displayed on the sample disc 11 also be displayed in the schematic diagram of the sample disc 211.

[0068] Furthermore, clicking on the area name in the schematic diagram of the sample disk in Figure 21 will take you to the temperature log screen shown in Figure 22, where you can view the temperature log for the selected area. Figure 22 is an example of the display screen when area B is selected. Since the temperature log may be used as evidence of experimental results, you can output the temperature log data by pressing the CSV output button 221. Also, by clicking the area selection button 222, you can switch and display the temperature log data for each area without returning to the settings screen (Figure 21).

[0069] Note that Figure 21 shows an example of the settings screen when a temperature control area is set for the entire sample disc, but the settings screen should be displayed according to the actual temperature control area. For example, if the temperature of the entire sample disc is controlled by a single temperature control area, only area A will be shown, and the temperature setting unit 212 and control setting unit 213 will only correspond to area A. Also, if the temperature control area is set for only a part of the sample disc, the area will be set in the schematic diagram of the sample disc 211 for the area where the temperature control area is set, and the temperature setting unit 212 and control setting unit 213 corresponding to the set area will be displayed. Furthermore, as shown in Figure 15, if the flow path of the constant temperature bath 80 is extended to control the temperature of the sample disc, the set temperature and control method cannot be changed, so only the temperature log in Figure 22 may be displayed.

[0070] The present invention is not limited to the embodiments described above, and includes various modifications. For example, the embodiments and modifications described above are explained in detail to make the present invention easier to understand, and are not necessarily limited to those having all the configurations described. Furthermore, it is possible to replace parts of the configuration of one embodiment or modification with the configuration of another embodiment or modification, and it is also possible to add the configuration of another embodiment or modification to the configuration of one embodiment or modification. In addition, it is possible to add, delete, or replace parts of the configuration of each embodiment or modification with other configurations. [Explanation of Symbols]

[0071] 1,1b...Automatic analyzer, 10...Sample dispensing mechanism, 11...Sample disk, 12...Sample container, 20...Coagulation reagent dispensing mechanism, 21...Reagent disk, 22...Reagent container, 23...Reagent heating mechanism, 30...Reaction vessel storage section, 30a...Reaction vessel storage container, 31...Reaction vessel, 32...Transfer device, 34...Reaction vessel disposal section, 35...Reaction vessel with sample, 40...Coagulation time measurement section, 41...Coagulation time detection section, 42...Light source, 43...Coagulation sample dispensing section, 50...Interface, 51...Keyboard, 52...Computer (control unit), 53...Printer, 54...Display device, 55...Memory, 56...A / D converter, 57...Sample dispensing control unit, 58...Coagulation reagent dispensing control unit, 59...Transfer device control unit, 60...Reaction disk, 61 ...Reagent dispensing mechanism, 62...Reaction cell (second reaction vessel), 70...Storage compartment lid, 71...Slide rail, 72...Motor, 73...Cylinder, 74...Knob, 80...Constant temperature bath, 81...Heater, 82...Filtration filter, 83...Circulation pump, 84,161...Heater, 85,162...Blower, 86,163...Temperature sensor, 87,164...Heater control unit, 88,171a,171b,171c...Electric heater, 89,172a,172b,172c,172d...Temperature sensor, 90,173a,173b,173c,173d...Heater control unit, 174...Peltier element, 211:Schematic diagram of sample disc, 212:Temperature setting unit, 213:Control setting unit, 221:CSV output button, 222:Area selection button.

Claims

1. A reaction vessel storage section is installed in which a reaction vessel storage container for housing the reaction vessel is located, A dispensing mechanism for dispensing a sample or reagent into a reaction vessel removed from the reaction vessel storage container, The measurement unit performs biochemical measurements, A reaction disk on which a plurality of reaction cells used for the biochemical measurement are installed, A constant temperature bath for adjusting the multiple reaction cells to a predetermined temperature, It has a channel for heating and circulating the system water in the constant temperature bath, The reaction vessel housing section includes a temperature control region in which at least a portion thereof is adjusted to a predetermined temperature. The reaction vessel from which the sample or reagent has been dispensed by the dispensing mechanism is placed in the reaction vessel storage container installed in the temperature-controlled area for a predetermined period of time. The temperature-controlled region is heated by the system water in the flow path of the automated analyzer.

2. In claim 1, Dispensing location for dispensing samples and reagents into reaction vessel, It has a transfer device that grips and transports the reaction vessel, The aforementioned dispensing mechanism is a sample dispensing mechanism for dispensing samples, The transfer device transfers an empty reaction vessel from the reaction vessel storage container to the dispensing position. After the sample has been dispensed into the reaction vessel transferred to the dispensing position by the sample dispensing mechanism, the transfer device is an automated analyzer that transfers the reaction vessel at the dispensing position to a reaction vessel storage container installed in the temperature-controlled area.

3. In claim 2, The transfer device is an automatic analyzer that, when an empty reaction vessel becomes available in the reaction vessel storage position of the reaction vessel storage container installed in the temperature control area, transfers an empty reaction vessel to the empty reaction vessel storage position.

4. In claim 3, In the reaction vessel housing section, a first reaction vessel housing is installed in the temperature control area, and a second reaction vessel housing is installed outside the temperature control area. The transfer device is an automated analyzer that, when an empty reaction vessel becomes available in the reaction vessel storage position of the first reaction vessel storage container, transfers an empty reaction vessel from the second reaction vessel storage container to the empty reaction vessel storage position of the first reaction vessel storage container.

5. In claim 2, A coagulation time detection unit that measures blood coagulation, It comprises a coagulation reagent dispensing mechanism equipped with a reagent heating mechanism, After the predetermined period has elapsed, the transfer device transfers the reaction vessel, which is placed in the reaction vessel storage container installed in the temperature control area, to the solidification time detection unit. The aforementioned coagulation reagent dispensing mechanism is an automated analyzer that dispenses a heated reagent into a reaction vessel transferred to the coagulation time detection unit.

6. In claim 1, A heater for heating the aforementioned temperature control region, A temperature sensor for measuring the temperature of the temperature-controlled area, An automatic analyzer having a heater control unit that controls the temperature of the heater based on the temperature measured by the temperature sensor.

7. In claim 6, The heater control unit is an automatic analyzer that stops heating by the heater when heating of the reaction vessel is not required.

8. In claim 2, The reaction vessel housing section has a lid that covers at least a portion of the temperature control area. The reaction vessel at the dispensing position is transferred to the reaction vessel storage position, which is covered by the lid of the reaction vessel storage container installed in the temperature control area, by an automated analyzer.

9. In claim 8, The lid is heated to the temperature of the temperature-controlled region, or an insulating material is provided on the surface facing the reaction vessel housing container of the automated analyzer.

10. In claim 8, The reaction vessel housing section is an automatic analyzer having a drive mechanism for moving the lid between a standby position and the temperature-controlled area.

11. In claim 8, The transfer device is an automatic analyzer that moves the lid between the standby position and the temperature-controlled area.

12. In claim 2, The transfer device is an automated analyzer that transfers empty reaction vessels so as to overlap them with reaction vessels that have been transferred from the dispensing position to a reaction vessel storage container installed in the temperature-controlled area.

13. A reaction vessel storage section in which a reaction vessel storage container for storing a reaction vessel is installed, A sample dispensing mechanism for dispensing a sample into a reaction vessel removed from the reaction vessel storage container, Dispensing location for dispensing samples and reagents into reaction vessel, It has a transfer device that grips and transports the reaction vessel, The reaction vessel housing section includes a temperature-controlled area in which at least a portion thereof is adjusted to a predetermined temperature, a first reaction vessel housing container is installed in the temperature-controlled area, and a second reaction vessel housing container is installed outside the temperature-controlled area. The transfer device transfers an empty reaction vessel from the reaction vessel storage container to the dispensing position. After the sample has been dispensed into the reaction vessel transferred to the dispensing position by the sample dispensing mechanism, the transfer device transfers the reaction vessel at the dispensing position to the first reaction vessel storage container. The reaction vessels from which the samples have been dispensed by the sample dispensing mechanism are placed in the first reaction vessel storage container for a predetermined period of time. The transfer device is an automated analyzer that, when an empty reaction vessel becomes available in the reaction vessel storage position of the first reaction vessel storage container, transfers an empty reaction vessel from the second reaction vessel storage container to the empty reaction vessel storage position of the first reaction vessel storage container.

14. A reaction vessel storage section in which a reaction vessel storage container for storing a reaction vessel is installed, A sample dispensing mechanism for dispensing a sample into a reaction vessel removed from the reaction vessel storage container, Dispensing location for dispensing samples and reagents into reaction vessel, It has a transfer device that grips and transports the reaction vessel, The reaction vessel housing section includes a temperature control region in which at least a portion thereof is adjusted to a predetermined temperature. The transfer device transfers an empty reaction vessel from the reaction vessel storage container to the dispensing position. After the sample has been dispensed into the reaction vessel transferred to the dispensing position by the sample dispensing mechanism, the transfer device transfers the reaction vessel from the dispensing position to the reaction vessel storage container installed in the temperature control area. The transfer device transfers an empty reaction vessel so as to overlap it with the reaction vessel that has been transferred from the dispensing position to the reaction vessel storage container installed in the temperature-controlled area. An automated analyzer in which the reaction vessels from which the samples have been dispensed by the sample dispensing mechanism are placed in a reaction vessel storage container located in the temperature-controlled area for a predetermined period of time.

Images