Method for measuring quality control specimens and specimen analyzer

Abstract

To provide an accuracy control specimen measurement method and a specimen analyzer capable of normally acquiring a measurement result of the accuracy control specimen.SOLUTION: An accuracy control specimen measurement method includes the steps of: controlling a stirring mechanism so as to stir a container containing an accuracy control specimen which has been stored in a cooled state in a first operation mode (step S2); and controlling a measurement device so as to suck and measure the accuracy control specimen in the stirred container (step 3). The control of the stirring mechanism for stirring according to the first operation mode is different from the control of the stirring mechanism for stirring according to a second operation mode for stirring a subject specimen collected from subjects.SELECTED DRAWING: Figure 13

Description

Technical Field

[0001] The present invention relates to a precision control specimen measurement method and a specimen analysis apparatus.

Background Art

[0002] Conventionally, in a specimen analysis apparatus, a precision control specimen is measured periodically so as to obtain an appropriate measurement result. A precision control specimen is a specimen containing components with known concentrations. For example, it is blood artificially adjusted so that blood components such as red blood cells, white blood cells, and platelets have known concentrations. In internal precision control, which is one of the precision control methods, the same lot of precision control specimens is repeatedly measured, and the measurement accuracy of the specimen analysis apparatus is maintained by checking whether the variation in the measured values is within the allowable range.

[0003] The following Patent Document 1 describes a blood specimen transport analysis system in which a control specimen (precision control specimen) stored in a cold storage is transported to an analysis apparatus by a transport device and measured by the analysis apparatus.

Prior Art Documents

Patent Documents

[0004]

Patent Document 1

Summary of the Invention

Problems to be Solved by the Invention

[0005] Patent Document 1 does not describe the stirring of the precision control specimen for correctly obtaining the measurement result of the precision control specimen. If the precision control specimen stored in the cooling unit is measured without being appropriately stirred, it may be impossible to normally obtain the measurement result of the precision control specimen.

[0006] An object of the present invention is to provide a precision control specimen measurement method and a specimen analysis apparatus capable of normally obtaining the measurement result of the precision control specimen.

Means for Solving the Problems

[0007] The method for measuring quality control samples of the present invention includes the steps of: controlling a stirring mechanism (46, 48, 49, 410) to stir a container (110, T1) containing a quality control sample that has been stored under refrigeration in a first operating mode (step S2); and controlling a measuring device (10) to aspirate and measure the quality control sample in the stirred container (110, T1) (step S3). The control of the stirring mechanism (46, 48, 49, 410) for stirring in the first operating mode is the same as the control of the stirring mechanism (46, 48, 49, 410) for stirring a subject sample collected from a subject in a second operating mode. In comparison, (1) The number of stirring cycles is high. (2) The stirring angle is large, (3) The stirring speed is fast. (4) It differs in that it repeatedly applies impact to the container (110, T1), (5) It differs in that the container (110, T1) is rotated circumferentially during the stirring process. Satisfying at least one of the following conditions .

[0008] A quality control sample is a sample containing known components at known concentrations, and is used to control the accuracy of measurements taken from subject samples.

[0009] When quality control samples are agitated using the same method as test samples, the agitation of the quality control samples may be insufficient due to factors such as the influence of pseudo-components contained in the quality control samples or the effects of long-term storage at low temperatures. As a result, blood cell components may not be uniformly dispersed in the container during measurement. When blood cell components are not dispersed during measurement, for example, certain blood cell components may show falsely high values, and the measurement results for the quality control samples may not be obtained correctly. Therefore, the inventors have solved the above problem by agitating the quality control samples using a first operating mode, which is different from the second operating mode used for agitating test samples, and then performing the measurement. According to the quality control sample measurement method of the present invention, insufficient agitation of the quality control samples can be avoided, and the measurement results for the quality control samples can be obtained correctly.

[0010] The specimen analyzer (1a) of the present invention comprises a transport device (20) for transporting containers (110, T1, T2), and a measuring device (10) for transporting the specimens in the containers (110, T1, T2) by the transport device (20) using a stirring mechanism (410), and for aspirating and measuring the stirred specimens. The measuring device (10) controls the stirring mechanism (410) to transport the container (110, T1) in a first operating mode if the specimen contained in the container (110, T1) transported by the transport device (20) is a quality control specimen, and controls the stirring mechanism (410) to transport the container (110, T2) in a second operating mode if the specimen contained in the container (110, T2) transported by the transport device (20) is a subject specimen. The stirring in the first operating mode is equivalent to the stirring in the second operating mode. In comparison, (1) The number of stirring cycles is high. (2) The stirring angle is large, (3) The stirring speed is fast. (4) It differs in that it repeatedly applies impact to the container (110, T1), (5) It differs in that the container (110, T1) is rotated circumferentially during the stirring process. Satisfying at least one of the following conditions .

[0011] According to the sample analyzer of the present invention, similar to the above-described method for measuring quality control samples, poor mixing of quality control samples can be avoided, and measurement results for quality control samples can be obtained normally. [Effects of the Invention]

[0012] According to the present invention, poor mixing of quality control samples can be avoided, and measurement results of quality control samples can be obtained normally. [Brief explanation of the drawing]

[0013] [Figure 1] Figure 1 is a schematic diagram showing the configuration of a sample analysis system according to Embodiment 1. [Figure 2] Figure 2 is a perspective view showing the configuration of the rack and container according to Embodiment 1. [Figure 3] Figure 3 is a schematic diagram showing the interconnection relationships of each device in the sample analysis system according to Embodiment 1. [Figure 4] FIG. 4 is a plan view schematically showing a detailed configuration of a supply device according to Embodiment 1. [Figure 5] FIG. 5 is a plan view schematically showing a detailed configuration of a transport device according to Embodiment 1. [Figure 6] FIG. 6 is a plan view schematically showing an internal configuration of a measurement device according to Embodiment 1. [Figure 7] FIG. 7 is a side view schematically showing a detailed configuration of a stirring mechanism according to Embodiment 1. [Figure 8] FIG. 8 is a side view schematically showing a detailed configuration of a stirring mechanism according to Embodiment 1. [Figure 9] FIG. 9 is a side view schematically showing a tilting stirring performed on a container according to Embodiment 1. [Figure 10] FIG. 10 is a side view schematically showing a detailed configuration of a reading unit according to Embodiment 1. [Figure 11] FIG. 11 is a block diagram showing a configuration of a supply device according to Embodiment 1. [Figure 12] FIG. 12 is a block diagram showing a configuration of a measurement device according to Embodiment 1. [Figure 13] FIG. 13 is a flowchart explaining a flow of measurement of a precision control sample by a specimen analyzer according to Embodiment 1. [Figure 14] FIG. 14 is a diagram schematically showing that the posture of a container is changed when blood cell components remain at the bottom of the container according to Embodiment 1. [Figure 15] FIG. 15 is a diagram showing details of stirring in a first operation mode and stirring in a second operation mode according to Embodiment 1. [Figure 16] FIG. 16 is a flowchart showing a process of changing the posture of a container containing a precision control sample according to Embodiment 1. [Figure 17] FIG. 17 is a flowchart showing a specimen analysis process by a control device according to Modification 1 of Embodiment 1. [Figure 18]Figure 18 shows the details of stirring according to the first operation mode 1A, the first operation mode 1B, and the second operation mode, according to a modified example 2 of Embodiment 1. [Figure 19] Figure 19 is a flowchart showing the sample analysis process by the control device according to a modified example 2 of Embodiment 1. [Figure 20] Figure 20 is a flowchart showing the sample analysis process by the control device according to a modified example 3 of Embodiment 1. [Figure 21] Figure 21 is a flowchart showing the sample analysis process by the control device according to modification example 4 of Embodiment 1. [Figure 22] Figure 22 is a schematic graph showing the number of stirring cycles in modification example 4 of Embodiment 1. [Figure 23] Figure 23 is a flowchart showing the sample analysis process by the control device according to Modification Example 5 of Embodiment 1. [Figure 24] Figure 24 is a schematic graph showing the number of stirring cycles in modification example 5 of Embodiment 1. [Figure 25] Figure 25 shows the details of stirring by the first operating mode and stirring by the second operating mode according to Embodiment 2. [Figure 26] Figure 26 is a schematic plan view showing the detailed configuration of the supply device according to Embodiment 2. [Figure 27] Figure 27 is a schematic side view showing the detailed configuration of the rotating mechanism and stirring mechanism according to Embodiment 2. [Figure 28] Figure 28 is a flowchart showing the stirring and conveying process by the supply device according to Embodiment 2. [Figure 29] Figure 29 is a flowchart showing the process of changing the orientation of the container containing the quality control sample during pre-mixing, according to Embodiment 2. [Figure 30] Figure 30 is a schematic side view showing the detailed configuration of the support mechanism and stirring mechanism according to Modification Example 1 of Embodiment 2. [Figure 31] Figure 31 is a schematic side view showing the detailed configuration of the heating and stirring mechanism according to a modified example 2 of Embodiment 2. [Figure 32] Figure 32 is a schematic plan view showing the detailed configuration of the heating and stirring mechanism according to a modified example 2 of Embodiment 2. [Figure 33] Figure 33 is a flowchart showing the stirring and conveying process by the supply device according to a modified example 2 of Embodiment 2. [Figure 34] Figure 34 is a schematic diagram showing the configuration of the sample analysis system according to Embodiment 3. [Modes for carrying out the invention]

[0014] <Embodiment 1> Figure 1 is a schematic diagram showing the configuration of the sample analysis system 1.

[0015] Figure 1 shows a plan view configuration of the measuring device 10, conveying device 20, supply device 40, and retrieval device 50, with the up, down, left, and right directions indicated in the plan view. Figure 1 also shows communication cables for communication between the devices, indicated by dashed lines. Furthermore, Figure 1 shows the conveying direction of the rack 100 with arrows, where the downstream direction is to the left and the upstream direction is to the right.

[0016] The sample analysis system 1 comprises a sample analyzer 1a, a collection device 50, and a transport control device 60. The sample analyzer 1a comprises two sets, each containing two measuring devices 10, one transport device 20, and one control device 30. The sample analyzer 1a also includes a supply device 40. The sample analysis system 1 is communicated with an external host computer 2.

[0017] The sample analysis system 1 is a system that automatically measures subject samples and quality control samples collected from subjects and performs analysis and interpretation based on the measurement data. In embodiments 1 to 3, the subject sample is whole blood collected from the subject. A quality control sample is a sample containing known components at known concentrations and is used to control the measurement accuracy of the subject sample. More specifically, a quality control sample is a so-called control blood containing blood cell components contained in whole blood, such as red blood cells, white blood cells, and platelets, at known concentrations. An example of a quality control sample is XN-CHECK® (manufactured by Sysmex Corporation). The composition of a quality control sample is disclosed, for example, in U.S. Patent No. 6221668. Quality control samples are divided into three types according to the concentration levels of blood cell components they contain: Level 1 contains components at lower concentrations than those in samples collected from healthy individuals (healthy blood); Level 2 contains components at a similar level to healthy blood; and Level 3 contains components at higher concentrations than healthy blood. These three concentration levels correspond to quality control samples LV1 to LV3. In the following, when simply referred to as "sample," this concept includes both subject samples and quality control samples.

[0018] The measuring device 10 agitates the sample in the container 110 transported from the supply device 40 and measures the agitated sample. The measuring device 10 counts blood cells in the subject sample and counts particles in the quality control sample. The transport device 20 transports the rack 100, which holds the container 110 taken out of the storage cabinet 42 by the supply device 40, to the measuring device 10. The transport device 20 also transports the rack 100 that has been removed from the upstream device to the downstream device, and transports the rack 100 after measurement to either the downstream or upstream device. The control device 30 controls the two corresponding measuring devices 10 so that the sample is measured, and receives measurement data from the two corresponding measuring devices 10 to analyze the sample.

[0019] In Figure 1, two sets are shown, each containing two measuring devices 10, one transport device 20, and one control device 30. However, the sample analysis system 1 may contain only one such set, or three or more such sets. Also, in Figure 1, each set consisting of a measuring device 10, a transport device 20, and a control device 30 contains two measuring devices 10, but it may contain one measuring device 10, or three or more measuring devices 10.

[0020] Figure 2 is a perspective view showing the configuration of the rack 100 and the container 110.

[0021] The rack 100 comprises 10 holding sections 101 capable of holding containers 110 vertically, and a barcode label 102. The barcode label 102 is affixed to the rear surface of the rack 100. The barcode label 102 has a barcode printed on it that indicates the rack ID, which serves as identification information that allows for individual identification of the rack 100.

[0022] The container 110 comprises a body portion 111, a barcode label 112, and a lid portion 113. The body portion 111 is a tubular container with an open top, and contains quality control samples or subject samples. The barcode label 112 is affixed to the side of the body portion 111. The barcode label 112 has a barcode printed on it that indicates the sample ID, which is identification information that allows for individual identification of the quality control samples or subject samples contained inside. The lid portion 113 is configured so that a piercer 441, described later, can pass through it from top to bottom, and is installed at the top end of the body portion 111 to seal the inside of the body portion 111.

[0023] Returning to Figure 1, the rack 100 holds only one of the following: a container 110 for quality control samples (hereinafter referred to as "container T1") and a container 110 for subject samples (hereinafter referred to as "container T2"). For convenience, in Figure 1, container T1 is shown as a black circle and container T2 is shown as a double circle. Also, for convenience, Figure 1 shows a state in which four containers 110 are held in one rack 100.

[0024] The supply device 40 supplies quality control samples and subject samples to the measuring device 10 that measures the samples. The supply device 40 is installed adjacent to the rightmost transport device 20 on the upstream side. The supply device 40 comprises an unloading section 41, a storage section 42, a cooling section 43, and a heating section 44.

[0025] The unloading unit 41 transports the rack 100 within the supply device 40 and unloads the transported rack 100 to the adjacent transport device 20 downstream. The storage unit 42 cools and stores the container T1. Quality control samples are stored in the storage unit 42 in container T1. The storage unit 42 can store a predetermined number (for example, 9) of container T1. The cooling unit 43 cools the container T1 inside the storage unit 42. The heating unit 44 heats the container T1 after it has been removed from the storage unit 42. When measuring quality control samples, the container T1 is removed from the storage unit 42 and returned to room temperature in the heating unit 44.

[0026] Container T1, which has been returned to room temperature in the heating unit 44, is transferred to the rack 100 in the discharge unit 41. Then, the rack 100 holding container T1 is discharged to the transport device 20 by the discharge unit 41. On the other hand, when measuring a subject's sample, the operator sets container T2 in the rack 100 in advance, and the rack 100 holding container T2 is placed in the discharge unit 41. Then, the rack 100 holding container T2 is discharged to the transport device 20 by the discharge unit 41.

[0027] The unloading unit 41, the two transport devices 20, and the retrieval device 50 are arranged side by side in the left-right direction to allow for the transfer of racks 100. Racks 100 unloaded from the unloading unit 41 are transported to the measuring device 10, which is the destination, according to instructions from the transport control device 60. The measuring device 10 measures the samples in the containers 110 held in the racks 100.

[0028] Once the measurement of the rack 100 holding container T1 is complete, the rack 100 is transported to the right by the transport device 20 and carried to the discharge section 41. The container T1 held in the rack 100 is then transferred back to the storage unit 42 and stored there under controlled conditions. Meanwhile, once the measurement of the rack 100 holding container T2 is complete, the rack 100 is transported to the left by the transport device 20 and carried to the retrieval device 50. Thus, the container T2 containing the measured subject sample is retrieved by the retrieval device 50.

[0029] The transport control device 60 is a device for controlling the transport of the racks 100, and determines the transport destinations of the rack 100 holding container T1 and the rack 100 holding container T2.

[0030] Figure 3 schematically shows the interconnection relationships of each device in the sample analysis system 1. For convenience, only one set consisting of two measuring devices 10, one transport device 20, and one control device 30 is illustrated in Figure 3.

[0031] The conveying device 20 consists of a first conveying mechanism 20a and a second conveying mechanism 20b. The first conveying mechanism 20a is controlled by a conveying control device 60, and the second conveying mechanism 20b is controlled by a control device 30. The configuration of the conveying device 20 will be described later with reference to Figure 5.

[0032] The control device 30 comprises a control unit 31 and a storage unit 32. The control unit 31 is composed of a processor such as a CPU or FPGA. The storage unit 32 is composed of an SSD, HDD, RAM, etc. The control device 30 is communicatively connected to two corresponding measuring devices 10 and one transport device 20. The configuration of the measuring device 10 will be described later with reference to Figures 6 and 12.

[0033] The supply device 40 comprises a control unit 201 and a storage unit 202. The control unit 201 is composed of, for example, a processor such as a CPU or FPGA. The storage unit 202 is composed of, for example, an SSD, HDD, RAM, etc. The configuration of the supply device 40 will be described later with reference to Figures 4 and 4.11.

[0034] The recovery device 50 comprises a control unit 51 and a storage unit 52. The control unit 51 is composed of, for example, a processor such as a CPU or FPGA. The storage unit 52 is composed of, for example, an SSD, HDD, RAM, etc.

[0035] The transport control device 60 comprises a control unit 61 and a storage unit 62. The control unit 61 is composed of a processor such as a CPU or FPGA. The storage unit 62 is composed of an SSD, HDD, RAM, etc. The control unit 61 of the transport control device 60 controls the transport of the rack 100 by communicating with the first transport mechanism 20a, the supply device 40 and the retrieval device 50 via the concentrator 70.

[0036] The concentrator 70 is comprised of, for example, a switching hub. The concentrator 70 is communicatively connected to the first transport mechanism 20a, the supply device 40, the retrieval device 50, and the transport control device 60. The control device 30 and the transport control device 60 are communicatively connected to the host computer 2 via a communication network.

[0037] Figure 4 is a schematic plan view showing the detailed configuration of the supply device 40.

[0038] The supply device 40 includes a discharge unit 41, a storage unit 42, a cooling unit 43, a heating unit 44, a transfer unit 210, a barcode unit 220, and a barcode reader 230.

[0039] The cooling unit 43 comprises a Peltier element, a heat sink connected to the Peltier element, and a heat conductive member 43a installed on the upper surface of the Peltier element. The heat conductive member 43a has a circular shape. Multiple holding portions 43b capable of holding the container T1 vertically are formed on the heat conductive member 43a in the circumferential direction. When the Peltier element is driven to cool the heat conductive member 43a, the quality control sample in the container T1 held by the holding portions 43b is cooled.

[0040] The heating unit 44 is equipped with an aluminum block heater 44a. The aluminum block heater 44a has multiple holding parts 44b formed in the front-to-back direction, which are capable of holding the container T1 vertically. When a Peltier element is driven to heat the aluminum block heater 44a, the quality control sample in the container T1 held by the holding parts 44b is heated.

[0041] The transfer unit 210 includes a gripping unit 211 for gripping the container T1. The transfer unit 210 also includes a mechanism for moving the gripping unit 211 in the front-rear, left-right, and up-down directions. When the container T1 in the storage unit 42 is to be measured, the transfer unit 210 transfers the container T1 in the storage unit 42 to the holding unit 44b of the heating unit 44.

[0042] Here, if the temperature of the location where the supply device 40 is installed is above room temperature, for example, a predetermined temperature (20°C to 25°C), the container T1 transferred from the storage cabinet 42 to the heating unit 44 is heated by being left in the holding unit 44b for a predetermined time with the Peltier element of the aluminum block heater 44a not driven. As a result, the temperature of the quality control sample inside the container T1 is raised to room temperature. On the other hand, if the temperature of the location where the supply device 40 is installed is lower than the predetermined temperature, the Peltier element of the aluminum block heater 44a is driven, and the container T1 transferred from the storage cabinet 42 to the heating unit 44 is heated by the heat of the heating unit 44 for a predetermined time. In this way, the temperature of the quality control sample inside the container T1 is raised to room temperature.

[0043] When the container T1 is brought to room temperature in the heating unit 44, the transfer unit 210 transfers the container T1 to the rack 100 located at the front position 233 of the first rack storage unit 231.

[0044] The unloading section 41 includes a first rack storage section 231, a transport arm 232, a first transport path 241, a rack feeding section 242, a second rack storage section 251, a rack unloading section 252, a second transport path 261, a third transport path 271, a rack feeding section 272, a third rack storage section 281, and a rack unloading section 282.

[0045] The first rack storage section 231 is made up of a plate member whose upper surface is parallel to the horizontal plane. The transport arm 232 pulls the rack 100 at the right end of the first transport path 241 into the first rack storage section 231 and also feeds the rack 100 on the first rack storage section 231 into the first transport path 241.

[0046] The first transport path 241 is composed of a conveyor belt that moves in the left-right direction and transports the racks 100 fed from the first rack storage section 231 and the third rack storage section 281 in the left-right direction. The rack feeding section 242 feeds the rack 100 at the left end of the first transport path 241 to the second rack storage section 251. The second rack storage section 251 is composed of a plate member whose upper surface is parallel to the horizontal plane. The rack delivery section 252 delivers the racks 100 on the second rack storage section 251 to the second transport path 261. The second transport path 261 is composed of a conveyor belt that moves in the left-right direction and transports the racks 100 delivered from the second rack storage section 251 to the first transport path 301 (see Figure 5) of the transport device 20 connected to the left of the supply device 40.

[0047] The third transport path 271 is composed of a conveyor belt that moves in the left-right direction and transports the racks 100 transported from the third transport path 341 (see Figure 5) of the transport device 20 connected to the left of the supply device 40 to the right. The rack feeding section 272 feeds the racks 100 at the right end of the third transport path 271 to the third rack storage section 281. The third rack storage section 281 is composed of plate members whose upper surface is parallel to the horizontal plane. The rack delivery section 282 delivers the racks 100 on the third rack storage section 281 to the first transport path 241.

[0048] The barcode unit 220 reads barcode labels 102 and 112 from the rack 100 located at the left end of the first transport path 241. The barcode unit 220 is equipped with two reading units 221 that move in the left-right direction. Each reading unit 221 includes a driving roller 221a that rotates the container 110 held in the rack 100 in the circumferential direction, two driven rollers 221b that rotatably hold the container 110 from the opposite side of the driving roller 221a, and a barcode reader 221c that reads the barcode label 112 of the container 110 sandwiched between the driving roller 221a and the driven rollers 221b. The left reading unit 221 also reads the barcode label 102 of the rack 100. The configuration of the reading unit 221 is substantially the same as that of the reading unit 430 provided in the measuring device 10, which will be described later.

[0049] The barcode reader 230 reads the barcode label 102 of the rack 100 which is being transported to the left by the second transport path 261.

[0050] Here, we will explain the transport operation of the rack 100 by the unloading unit 41.

[0051] After container T1 is transferred from the heating unit 44 to the holding unit 101 of rack 100 positioned at the front position 233 of the first rack storage unit 231, transport of rack 100 begins. As a result, rack 100 is sent to the right end of the first transport path 241 and transported in front of the barcode unit 220 by the first transport path 241. After barcode labels 102 and 112 are read by the barcode unit 220, rack 100 is sent to the second rack storage unit 251 by the rack feeding unit 242 and transported along the second rack storage unit 251 to the second transport path 261. Then, after barcode label 102 is read by the barcode reader 230, rack 100 is unloaded to the transport device 20 adjacent to the left.

[0052] Once the measurement operation is completed for the quality control sample in container T1 held in rack 100, rack 100 is transported from the transport device 20 adjacent to the left side of the supply device 40 to the third transport path 271. Rack 100 is transported to the right along the third transport path 271, fed into the third rack storage unit 281 by the rack feeding unit 272, and transported along the third rack storage unit 281 to the first transport path 241. Rack 100 is transported along the first transport path 241 to the front of the barcode unit 220, where the barcode labels 102 and 112 are read again. After that, rack 100 is transported to the right end of the first transport path 241 and positioned at the front position 233 of the first rack storage unit 231 by the transport arm 232.

[0053] Subsequently, when all containers T1 held in the rack 100 at the forward position 233 are transferred by the transfer unit 210 to the holding unit 43b of the storage unit 42, the empty rack 100 is sent to the rear of the first rack storage unit 231 by the transfer arm 232.

[0054] After the rack 100 holding the container T2 containing the subject sample is placed in the third rack storage unit 281 by the operator, transport is initiated. As a result, the rack 100 is transported to the transport device 20 adjacent to the left via the first transport path 241, the second rack storage unit 251, and the second transport path 261. At this time, similar to the rack 100 holding container T1, the barcode labels 102 and 112 are read by the barcode unit 220 and barcode reader 230. Once the measurement operation is completed for the subject sample in container T2 held in the rack 100, the rack 100 is transported to the left as described above and collected in the retrieval device 50 (see Figure 1).

[0055] Figure 5 is a schematic plan view showing the detailed configuration of the conveying device 20.

[0056] The conveying device 20 includes a first conveying path 301, a rack feeding unit 302, a rack conveying path 303, a first rack storage unit 311, a rack delivery unit 312, a second conveying path 321, a reading unit 322, a rack feeding unit 324, a second rack storage unit 331, a rack delivery unit 332, and a third conveying path 341.

[0057] The first transport mechanism 20a in Figure 3 includes a first transport path 301, a rack feeding unit 302, a rack transport path 303, a second rack storage unit 331, a rack delivery unit 332, and a third transport path 341. The second transport mechanism 20b in Figure 3 includes a first rack storage unit 311, a rack delivery unit 312, a second transport path 321, a reading unit 322, and a rack feeding unit 324.

[0058] The first transport path 301 consists of a conveyor belt that moves in the left-right direction and transports racks 100 discharged from the supply device 40 or transport device 20 adjacent to the right side in the leftward direction. The rack feeding section 302 feeds the rack 100 at the right end of the first transport path 301 to the first rack storage section 311. The first rack storage section 311 consists of plate members parallel to the horizontal plane. The rack delivery section 312 transports the racks 100 on the first rack storage section 311 to the second transport path 321.

[0059] The second transport path 321 is composed of two conveyor belts 321a and 321b that move independently in the left-right direction, and transports the racks 100 on the second transport path 321 in the left-right direction. The reading unit 322 comprises a driving roller 322a, two driven rollers 322b, and a barcode reader 322c. The configuration of the reading unit 322 is substantially the same as that of the reading unit 430 provided in the measuring device 10, which will be described later. The reading unit 322 reads the barcode labels 102 on the racks 100 and the barcode labels 112 on the containers 110 on the second transport path 321.

[0060] On the second transport path 321, there are two removal positions 323 where two measuring devices 10 each remove containers 110 from the rack 100. The measuring device 10 sequentially removes the containers 110 held in the holding section 101 of the rack 100 at the removal positions 323, takes the removed containers 110 into the measuring device 10, stirs and aspirates the sample inside the container 110, and measures the sample inside the container 110. Once aspiration is complete for the taken-in container 110, the measuring device 10 returns the container 110 to its original holding section 101 of the rack 100.

[0061] When measurement is no longer required for all containers 110 held in rack 100 by the two measuring devices 10 located behind the second transport path 321, rack 100 is transported to the left end of the second transport path 321 and sent to the second rack storage section 331 by the rack feeding section 272. The second rack storage section 331 is made up of plate members whose upper surface is parallel to the horizontal plane. The rack delivery section 332 transports the rack 100 on the second rack storage section 331 to the rack transport path 303 located to the left of the first transport path 301, or to the third transport path 341.

[0062] The rack transport path 303 is composed of a conveyor belt that moves in the left-right direction. If any of the containers 110 held in rack 100 require further measurement at the downstream measuring device 10, the rack transport path 303 transports this rack 100 to the transport device 20 adjacent to the left. Also, if no further measurement is required for any of the containers T2 held in rack 100, the rack transport path 303 transports this rack 100 to the transport device 20 or retrieval device 50 adjacent to the left.

[0063] The third transport path 341 consists of a conveyor belt that moves in the left-right direction. If no further measurement is required for all containers T1 held in the rack 100, the third transport path 341 receives the racks 100 holding the containers T1 from the second rack storage section 331 and the transport device 20 adjacent to the left, transports the received racks 100 to the right, and delivers them to the transport device 20 or supply device 40 adjacent to the right.

[0064] Figure 6 is a schematic plan view showing the internal configuration of the measuring device 10. For convenience, the second transport path 321 of the transport device 20 is also shown in Figure 6.

[0065] The measuring device 10 comprises a stirring mechanism 410, a forward / backward transfer unit 420, a reading unit 430, a piercer 441, and a piercer drive unit 442.

[0066] The stirring mechanism 410 includes a pair of gripping parts 514 that grip the container 110 from the front and rear directions. With the container 110 positioned at the removal position 323, the stirring mechanism 410 grips the pair of gripping parts 514, moves the pair of gripping parts 514 upward by the vertical drive mechanism 411 (see Figure 7), and rotates the container 110 so that it tilts by the rotation mechanism 413 (see Figure 7). This stirs the sample inside the container 110.

[0067] The forward / backward transfer unit 420 includes a holding unit 421 capable of holding the container 110 vertically, a plate member 422 that supports the holding unit 421 and extends in the forward / backward direction, and a mechanism for moving the plate member 422 in the forward / backward direction. When the stirring operation by the stirring mechanism 410 is completed, the plate member 422 is moved forward so that the holding unit 421 aligns with the removal position 323 in a plan view. In this state, the stirring mechanism 410 moves a pair of gripping units 514 downward and sets the gripped container 110 into the holding unit 421. Subsequently, the holding unit 421 is moved backward and positioned at the reading position 433 of the reading unit 430.

[0068] The reading unit 430 comprises a rotating mechanism 431 and a barcode reader 432. The rotating mechanism 431 includes a driving roller 431a for rotating the container 110 at the reading position 433, and a pair of driven rollers 431b for holding the container 110 at the reading position 433 between the driving roller 431a and the rotating mechanism 431b. When the container 110 is positioned at the reading position 433, the container 110 is rotated by the rotating mechanism 431, and the barcode label 112 on the container 110 is read by the barcode reader 432.

[0069] Subsequently, the holding unit 421 is moved further rearward, and the container 110 held by the holding unit 421 is positioned directly below the piercer 441. The piercer 441 is a rigid suction tube that extends vertically. The piercer drive unit 442 moves the piercer 441 vertically. Once the container 110 is positioned directly below the piercer 441, the piercer 441 is moved downward so that its lower end penetrates the lid 113 of the container 110. The tip of the piercer 441 is lowered to near the bottom of the container 110. Then, the sample inside the container 110 is aspirated through the piercer 441.

[0070] Once the sample has been aspirated into container 110, container 110 is transported forward by the forward / backward transport unit 420 to a position that coincides with the removal position 323 in a plan view, and at this position it is grasped by the stirring mechanism 410 and lifted upward. Then the holding unit 421 and the plate member 422 are transported backward, and the stirring mechanism 410 returns container 110 to its original holding unit 101 on the rack 100.

[0071] Figures 7 and 8 are schematic side views illustrating the detailed configuration of the stirring mechanism 410.

[0072] As shown in Figure 7, the stirring mechanism 410 comprises a vertical drive mechanism 411, a gripping mechanism 412, and a rotating mechanism 413. The rotating mechanism 413 is installed in a position that does not come into contact with the gripping mechanism 412.

[0073] The vertical drive mechanism 411 moves the gripping mechanism 412 in the vertical direction. The vertical drive mechanism 411 comprises a motor 501, pulleys 502 and 503, a belt 504, and a rail 505.

[0074] Motor 501 is a stepping motor. Pulley 502 is mounted on a shaft extending in the front-rear direction of motor 501. Pulley 503 is mounted below pulley 502. Belt 504 is connected to pulleys 502 and 503 and moves up and down in response to the drive of motor 501. Rail 505 extends in the vertical direction.

[0075] The gripping mechanism 412 comprises a connecting member 511, a base plate 512, a shaft 513, a pair of gripping parts 514, a spring 515, a cylinder 516, a plate member 517, a transmissive sensor 518, a magnet 519, and a metal member 520.

[0076] The left end of the connecting member 511 is fixed to the belt 504. As the belt 504 moves vertically, the connecting member 511 moves vertically along the rail 505 while being supported by the rail 505. The connecting member 511 is fixed to the base plate 512.

[0077] The shaft 513 extends in the front-rear direction and is fixed to the base plate 512. A pair of gripping parts 514 are mounted on the shaft 513 so as to be rotatable about the shaft 513. The rear gripping part 514 is mounted on the shaft 513 so as not to move in the front-rear direction, while the front gripping part 514 is mounted on the shaft 513 so as to move in the front-rear direction. Both ends of the spring 515 are mounted on the two faces of the pair of gripping parts 514. The spring 515 applies force to the pair of gripping parts 514 in a direction that moves them away from each other.

[0078] The cylinder 516 drives the rod 516a in the forward and backward directions. The plate member 517 is fixed to the left end of the rod 516a and the upper end of the front gripping portion 514. When the rod 516a moves backward from the state shown in Figure 7, the front gripping portion 514 moves backward, and the container 110 held in the rack 100 is gripped by the pair of gripping portions 514. On the other hand, when the rod 516a moves forward from the state in which the container 110 is gripped, the front gripping portion 514 moves forward, and the gripping state of the container 110 by the pair of gripping portions 514 is released, as shown in Figure 7.

[0079] When the rod 516a moves in the front-rear direction, the upper end of the plate member 517 also moves in the front-rear direction. If the container 110 is not between the pair of gripping parts 514, when the above gripping operation is performed, the upper end of the plate member 517 is positioned between the transmissive sensors 518. This allows detection that the container 110 was not gripped by the pair of gripping parts 514.

[0080] The magnet 519 is installed at the lower end of the substrate 512. The metal member 520 is a material attracted to the magnet 519 and is made of, for example, iron. The metal member 520 is installed on the left side of the rear gripping portion 514 (see Figure 9). As shown in Figure 7, in the normal state in which the pair of gripping portions 514 extend vertically, the magnet 519 and the metal member 520 are in contact.

[0081] With the container 110 being held by the pair of gripping parts 514, the motor 501 is driven and the gripping mechanism 412 is moved upward, and as shown in Figure 8, the container 110 is removed from the rack 100.

[0082] As shown in Figure 8, the rotating mechanism 413 comprises a motor 521 and a contact member 522. The motor 521 is a stepping motor. The shaft 521a of the motor 521 extends in the front-rear direction and is located on the extension of the shaft 513 of the gripping mechanism 412. The contact member 522 is fixed to the shaft 521a of the motor 521. When the motor 521 is driven, the contact member 522 rotates about the shaft 521a.

[0083] When the container 110 is to be stirred, as shown in Figure 8, the container 110 is moved upward while being gripped by a pair of gripping parts 514. At this time, the contact member 522 is positioned to the left of the container 110. Then, in the state shown in Figure 8, when the motor 521 is driven, the body 111 of the container 110 is pushed by the contact member 522, causing the container 110 to tip over around the axis 513, and the sample inside the container 110 is stirred.

[0084] Figure 9 is a schematic side view showing the inversion stirring process performed on container 110.

[0085] Hereinafter, the position of the contact member 522 when it contacts the left side of the container 110 in a vertical state will be referred to as the "initial position". The state of the container 110 when its longitudinal direction is oriented vertically will be referred to as the "vertical state". The state in which the container 110 has rotated around the axis 513 from the vertical state will be referred to as the "overturned state".

[0086] When the container 110 is in a vertical position, if the contact member 522 rotates around the axis 513 from its initial position, the metal member 520 moves away from the magnet 519, and the body 111 is pushed by the contact member 522. As a result, the container 110 rotates around the axis 513 and changes from a vertical position to an inverted position.

[0087] Furthermore, when the container 110 is in an inverted position, if the contact member 522 rotates around the axis 513 toward its initial position, the container 110 rotates around the axis 513 toward a vertical position while being supported by the contact member 522. When the container 110 is returned to a vertical position, the metal member 520 comes into contact with the magnet 519 due to the magnetic force of the magnet 519. At this time, the metal member 520 is attracted to the magnet 519 and collides with it forcefully, so an impact is applied to the container 110 via the grip 514.

[0088] Here, the angle of the container 110 with respect to the vertical state will be referred to as the "inversion angle." During the agitation of the sample in the container 110, the container 110 is repeatedly rotated between a state where the inversion angle of the container 110 is θ1 and a state where the inversion angle of the container 110 is θ2. The inversion angles θ1 and θ2 differ depending on whether the sample contained in the container 110 is a quality control sample or a subject sample. The inversion angles θ1 and θ2 will be explained later with reference to Figure 15.

[0089] Figure 10 is a schematic side view illustrating the detailed configuration of the reading unit 430.

[0090] As described above, the reading unit 430 includes a rotating mechanism 431 and a barcode reader 432. The rotating mechanism 431 includes a driving roller 431a, a pair of driven rollers 431b, a motor 601, pulleys 602 and 603, a belt 604, a shaft 605, a motor 611, pulleys 612 and 613, a belt 614, a base plate 615, and a shaft 616.

[0091] Motor 601 is a stepping motor. Pulley 602 is mounted on a shaft that extends vertically from motor 601. Pulley 603 is mounted to the right of pulley 602. Belt 604 is connected to pulleys 602 and 603. Shaft 605 extends vertically and is connected to pulley 603. A drive roller 431a is fixed to the lower end of shaft 605. When motor 601 is driven, belt 604 moves from side to side, and pulley 603, shaft 605, and drive roller 431a rotate with the vertical direction as the axis of rotation.

[0092] Motor 611 is a stepping motor. Pulley 612 is mounted on a shaft extending vertically from motor 611. Pulley 613 is mounted to the right of pulley 612. Belt 614 is connected to pulleys 612 and 613. Circuit board 615 is fixed to belt 614. Shaft 616 is mounted at the lower end of circuit board 615 so that it can rotate with its axis of rotation in the vertical direction. Driven roller 431b is mounted on shaft 616. When motor 611 is driven, belt 614 moves from side to side, and driven roller 431b moves from side to side.

[0093] When the container 110, held by the holding unit 421, is positioned at the reading position 433 (see Figure 6), the motor 611 is driven, and the pair of driven rollers 431b move to the right toward the container 110. As a result, the body 111 of the container 110 is clamped between the driving roller 431a and the pair of driven rollers 431b. In this state, when the motor 601 is driven, the driving roller 431a rotates. As a result, the container 110 rotates circumferentially while being held by the holding unit 421. Then, the barcode reader 432 reads the barcode label 112 of the container 110.

[0094] As the container 110 rotates circumferentially in this manner, the barcode label 112 is positioned directly in front of the barcode reader 432, allowing the barcode reader 432 to reliably read the barcode label 112.

[0095] Figure 11 is a block diagram showing the configuration of the supply device 40.

[0096] The supply device 40 includes a control unit 201, a storage unit 202, a discharge unit 41, a cooling unit 43, a heating unit 44, a transfer unit 210, a barcode unit 220, a barcode reader 230, and a communication unit 203.

[0097] The unloading unit 41 includes a stepping motor and the like for a mechanism to transport the rack 100 within the unloading unit 41. The communication unit 203 is connected to the concentrator 70, for example, by Ethernet.

[0098] The control unit 201 is composed of, for example, a CPU. The control unit 201 controls each part of the hardware by executing a computer program stored in the memory unit 202. The memory unit 202 stores a schedule for automatically performing quality control measurements. The schedule can be registered, for example, by specifying a time for each day of the week, or by specifying a specific date and time. The schedule further includes specifying the type of quality control sample to be measured by the measuring device 10.

[0099] The control unit 201 controls each part to supply quality control samples to the measuring device 10 so that quality control measurements are automatically started at a specified date and time according to a schedule registered in the storage unit 202. Specifically, when a predetermined time (for example, 30 minutes) before the specified date and time registered as a schedule, the control unit 201 controls the transfer unit 210 to have the transfer unit 210 retrieve the container T1 of the specified type of quality control sample from the container T1 stored in the cooling unit 43. Under the control of the control unit 201, the transfer unit 210 sets the retrieved container T1 in the heating unit 44, raises the temperature for a predetermined time, and then sets it in the rack 100. Under the control of the control unit 201, the unloading unit 41 transports the rack 100 toward the measuring device 10. The rack 100 is transported to the measuring device 10 by the transport device 20 under the control of the transport control device 60, and the quality control samples set in the rack 100 are measured. In this way, automatic measurement of quality control samples is performed.

[0100] Figure 12 is a block diagram showing the configuration of the measuring device 10.

[0101] The measuring device 10 includes a stirring mechanism 410, a forward / backward transfer unit 420, a reading unit 430, a liquid transfer unit 401, a sample preparation unit 402, a measuring unit 403, and a communication unit 404.

[0102] The liquid transfer unit 401 includes a pump and valves for applying pressure to the flow path and transferring the liquid within the flow path within the measuring device 10. The liquid transfer unit 401 aspirates the sample through a piercer 441 inserted into the container 110 and transfers the aspirated sample to the sample preparation unit 402. The sample preparation unit 402 includes a chamber for mixing the sample and reagents. The liquid transfer unit 401 sends the measurement sample obtained by mixing the sample and reagents in the sample preparation unit 402 to the measuring unit 403.

[0103] The measurement unit 403 includes an electrical resistance detection unit, a hemoglobin detection unit, and an optical detection unit. The electrical resistance detection unit measures blood cells using the sheath flow DC detection method. The hemoglobin detection unit measures hemoglobin using the SLS-hemoglobin method. The optical detection unit measures blood cells using the flow cytometry method. The measurement unit 403 measures the sample to be measured and acquires measurement data.

[0104] The communication unit 404 is configured, for example, by a USB interface and is connected to the corresponding control device 30. Measurement data obtained by the measurement unit 403 is transmitted to the control device 30 via the communication unit 404.

[0105] As described above, the sample in container 110 is stirred by the stirring mechanism 410 before being aspirated in the measuring device 10. As described above, container 110 (container T1) containing the quality control sample is stored in a refrigerated state in the storage chamber 42 of the supply device 40, so blood cell components may aggregate and precipitate in container T1. In particular, in quality control samples containing pseudoplatelets, such as those disclosed in U.S. Patent No. 6221668, the pseudoplatelets are more prone to aggregation and more difficult to break apart than natural platelets. If the quality control sample is stirred in the same way as the subject sample, the stirring of the quality control sample may be insufficient, and if the quality control sample is aspirated from this container T1 and measured, there is a risk that the measurement results of the quality control sample will not be obtained properly.

[0106] One example of how poor mixing can reduce the accuracy of measurement results is that, for instance, in quality control samples containing pseudo-platelets as described above, if the pseudo-platelets remain aggregated during measurement, they may be detected as other cells larger than normal platelets, such as red blood cells, resulting in a low platelet count. Another example of how poor mixing can reduce the accuracy of measurement results is that if the quality control sample is aspirated and measured while the concentration of the quality control sample in container T1 is not uniform, the measurement result of the quality control sample may deviate from the indicated value.

[0107] The measuring device 10 lowers the tip of the piercer 441 to near the bottom of container T1 before aspirating the quality control sample. If the concentration in container T1 is non-uniform, the concentration of blood cell components will be higher at the bottom of container T1 and lower at the liquid surface. Therefore, if the piercer 441 is positioned near the bottom when aspirating, the concentration of blood cell components will be higher than the displayed value, and an accurate measurement result will not be obtained.

[0108] Therefore, in Embodiment 1, the quality control sample is agitated using a first operating mode that is different from the second operating mode used for agitating the subject sample. As the first operating mode for agitating the quality control sample, conditions can be set to ensure that the quality control sample, which is more difficult to mix than the subject sample, is sufficiently mixed. More specifically, in Embodiment 1, the agitation in the first operating mode is enhanced compared to the second operating mode. Enhancement means, for example, that when two quality control samples from the same lot are prepared and agitated using the first operating mode and the second operating mode respectively, the mixture agitated using the first operating mode results in a more uniform concentration of components in the container after agitation compared to the mixture agitated using the second operating mode. As a result, the quality control sample can be sufficiently agitated, and the measurement results of the quality control sample can be obtained normally. The first and second operating modes will be explained later with reference to Figure 15.

[0109] The following describes the process of measuring quality control samples by agitating them using the first operating mode, which is different from the second operating mode used to agitate the subject samples.

[0110] Figure 13 is a flowchart illustrating the measurement process of quality control samples using the sample analyzer 1a of Embodiment 1.

[0111] In step S1, the transport device 20 receives the rack 100 holding the container T1 of the quality control sample. Specifically, when the supply device 40 sends the rack 100, on which the container T1 of the quality control sample is set, to the transport device 20 via the first transport path 301, the transport device 20 receives the rack 100 into the first rack storage section 311.

[0112] In step S2, the measuring device 10 agitates the container T1 containing the quality control sample in the first operating mode. Specifically, the rack 100 received in the first rack storage section 311 is transported by the transport device 20, and the container T1 containing the quality control sample is positioned at the removal position 323. The measuring device 10 drives the agitation mechanism 410 to remove the container T1 from the rack 100 at the removal position 323. The measuring device 10 drives the agitation mechanism 410 to agitate the removed container T1 in the first operating mode.

[0113] In step S3, the measuring device 10 aspirates the quality control sample, which has been stirred in the first operating mode, using the piercer 441 and measures it. Specifically, the measuring device 10 drives the liquid transfer unit 401 to mix the aspirated quality control sample with a predetermined reagent to prepare a measurement sample. The measuring device 10 drives the measuring unit 403 to measure the prepared measurement sample. Then, the control device 30 analyzes the measurement data.

[0114] <Agitation parameters> The first operating mode for agitating container T1 containing quality control samples is configured with parameters that enhance agitation compared to the second operating mode for agitating container T2 containing subject samples. The agitation parameters include five elements: (1) number of agitation cycles, (2) inversion speed, (3) inversion angle, (4) whether or not repeated impacts are applied, and (5) whether or not the container's orientation is changed.

[0115] (1) Number of stirring cycles The number of agitation cycles refers to the number of times the container 110 is inverted and agitated by the agitation mechanism 410. One agitation cycle is defined as the inversion motion from the inversion angle rising from θ1 to θ2 and then returning to θ1. When the container 110 rotates to the inverted position of θ2, the sample inside the container 110 moves from the bottom towards the lid 113. Generally, when a blood sample is left standing, the blood cell components (red blood cells, white blood cells, platelets) settle, separating the blood cell components from the liquid component (plasma) in the vertical direction. By inverting and agitating, the settled blood cell components are mixed with the plasma, and the concentration of blood cell components in the sample is made uniform. In the first operating mode, the number of agitation cycles can be increased compared to the second operating mode. A higher number of agitation cycles causes the liquid component to repeatedly push over the blood cell components that have settled at the bottom, making it easier for the blood cell components to detach from the bottom and promoting the mixing of the liquid component and the blood cell components. Furthermore, because external force is repeatedly applied to the blood cell components mixed with the liquid components, the aggregated blood cell components break down, promoting mixing. Therefore, in the first operating mode, by increasing the number of stirring cycles, even quality control samples can be properly mixed. Preferably, the number of stirring cycles in the second operating mode for stirring the subject sample is 10 times or less (preferably 6 to 10 times), while the number of stirring cycles in the first operating mode is at least twice, more preferably three times or more, and even more preferably five times or more, the number of stirring cycles in the second operating mode.

[0116] (2) Falling speed The tipping speed refers to the rotational speed at which the container 110 rotates due to the stirring mechanism 410. The speed may be the maximum speed between θ1 and θ2, or the average speed. The tipping speed is controlled by the rotational speed of the shaft 521a of the motor 521. The tipping speed may be set to different speeds when the container 110 is rising, i.e., when the container 110 is rotated in the direction that increases the tipping angle, and when the container 110 is descending, i.e., when the container 110 is rotated in the direction that decreases the tipping angle. In the first operating mode, the tipping speed can be higher than in the second operating mode. A higher tipping speed increases the speed at which the liquid component moves within the container 110, making it easier for the liquid component to push down the blood cell component that has settled at the bottom. In addition, the shaking of the liquid surface makes it easier for aggregated blood cell component to dissolve. Preferably, the inversion speed in the first operating mode is at least 1.2 times, and more preferably at least 1.4 times, the inversion speed in the second operating mode for agitating the subject sample.

[0117] (3) Angle of fall The inversion angle refers to the highest angle θ1 and the lowest angle θ2 when the container 110 is rotated by the stirring mechanism 410. In the first operating mode, the amplitude of oscillation can be increased by making θ2 lower than in the second operating mode. A larger amplitude increases the amount of liquid components moved within the container, promoting mixing. Preferably, the inversion angle in the first operating mode is at least 1.2 times, and more preferably 1.4 times, the inversion angle in the second operating mode. In the example described later, the inversion angle in the second operating mode is 97.2° (θ1=47.8°, θ2=145°), while the inversion angle in the first operating mode is 140° (θ1=0°, θ2=145°).

[0118] (4) Repeated application of impact Applying impact means lowering the container 110 to a vertical position, thereby bringing the magnet 519 and the metal member 520 into contact and applying impact to the container 110. Applying impact to the container 110 makes it easier for the blood cell components that have settled at the bottom to detach. Also, applying impact makes it easier for aggregated blood cell components to loosen. Preferably, in the first operating mode, impact is repeatedly applied to the container 110, and in the second operating mode, impact is not repeatedly applied.

[0119] Specifically, in the second operating mode, during the final cycle of the eight inversion and agitation cycles, the magnet 519 and the metal member 520 are brought into contact with the container 110 when it is returned to a vertical position, thereby impacting the container 110. This dislodges any blood adhering to the inside of the lid 113 and prevents blood from splashing out when the piercer 441 punctures the lid 113. On the other hand, in the first operating mode, the magnet 519 and the metal member 520 are repeatedly brought into contact with the container 110 by returning it to a vertical position during all 50 inversion and agitation cycles. This detaches blood cell components that have settled at the bottom and loosens aggregated blood cell components. The number of impacts in the first operating mode is not limited; at least multiple impacts are sufficient. Furthermore, impacts in the second operating mode are not mandatory.

[0120] (5) Change of posture A change in orientation refers to rotating the container 110 circumferentially during the stirring process. The first operating mode includes rotating the container 110 circumferentially during stirring, while the second operating mode does not include rotating the container 110 circumferentially during stirring. In the inversion stirring method shown in Figure 9, as schematically shown in Figure 14, blood cell components in the area below the bottom of the container 110 when it is lifted may remain unmixed. Therefore, by rotating the container 110 circumferentially by 180° during the stirring process, the blood cell components that were located below the bottom of the container 110 before the change in orientation can be moved to the area above the bottom of the container 110, as shown in Figure 14. By performing inversion stirring again after the change in orientation, it is possible to suppress the aggregation and sedimentation of components of the quality control sample in an uneven position around the axis within the container 110. Note that the angle of rotation does not have to be 180°; it may be arbitrarily determined within the range of 90° to 270°.

[0121] Figure 15 is a table showing a first example of the stirring parameters for the first and second operating modes. The stirring parameters for the first operating mode (quality control sample) and the second operating mode (subject sample) are as follows:

[0122] (1) Number of stirring cycles • First operating mode (quality control sample): 50 times • Second operating mode (subject sample): 8 times (2) Falling speed • First operating mode (quality control sample): 105 rpm during upward and downward movement. • Second operating mode (subject sample): 73.5 rpm during ascent and descent. (3) Angle of fall • First operating mode (quality control sample): θ1=0°, θ2=145° • Second operating mode (subject sample): θ1 = 47.8°, θ2 = 145° (4) Repeated application of impact • First operating mode (quality control sample): Yes • Second operating mode (subject sample): None (5) Change of posture • First operating mode (quality control sample): Yes • Second operating mode (subject sample): None

[0123] In the example shown in Figure 15, the parameters for (1) number of stirring cycles, (2) tipping speed, (3) tipping angle, (4) presence or absence of impact, and (5) presence or absence of posture change are set so that the stirring force is stronger in the first operating mode than in the second operating mode. By setting the operating modes in this way, even quality control samples, which are more difficult to mix than subject samples, can be properly mixed. Here, the parameters for all items (1) to (5) are set so that the stirring force is stronger in the first operating mode than in the second operating mode, but one or more of the items (1) to (5) may be strengthened in the first operating mode. For example, the tipping speed and tipping angle may be the same in the first and second operating modes. In this case, the stirring force may be compensated for by strengthening other parameters. For example, the number of stirring cycles may be increased from 50.

[0124] Figure 16 is a flowchart showing the stirring process in the first operating mode of step S2 in Figure 13. Here, we will explain the case where the quality control sample is stirred with the stirring parameters in Figure 15 set as the first operating mode.

[0125] In step S101, the control unit 31 controls the stirring mechanism 410 so that the container T1 is inverted and stirred 25 times. First, the control unit 31 controls the motor 521 of the rotation mechanism 413 so that the vertical container T1 rotates to 145° at a speed of 105 rpm. As the bottom of the container T1 comes higher than the lid 113 (top), the liquid components flow from the bottom towards the lid 113. Next, the control unit 31 controls the motor 521 of the rotation mechanism 413 so that the container T1 rotates in the reverse direction to 0° at a speed of 105 rpm. As the bottom of the container T1 comes lower than the lid 113 again, the liquid components that flowed towards the lid 113 flow back towards the bottom. This inversion completes one stirring cycle. The control unit 31 repeats this inversion stirring control 25 times.

[0126] Next, in step S102, the control unit 31 controls the rotation mechanism 431 (see Figure 6, 10) so that the orientation of the container T1 is changed.

[0127] Specifically, referring to Figure 6, the control unit 31 controls the forward / backward transfer unit 420 so that the holding unit 421 is positioned at the removal position 323. Next, referring to Figure 7, the control unit 31 controls the motor 501 of the stirring mechanism 410 so that the container T1 gripped by the gripping unit 514 descends and the container T1 is set in the holding unit 421. The control unit 31 controls the cylinder 516 so that the two gripping units 514 separate. This releases the grip on the container T1. The control unit 31 controls the motor 501 so that the gripping units 514 retract upward.

[0128] The control unit 31 controls the forward / backward transfer unit 420 so that the holding unit 421, which holds the container T1, is positioned at the reading position 433. The control unit 31 controls the motor 611 of the rotation mechanism 431 so that the driven roller 431b moves toward the container T1 and the body 111 of the container T1 is sandwiched between the driving roller 431a and the driven roller 431b. In this state, the control unit 31 controls the motor 601 so that the driving roller 431a rotates and the container T1 rotates circumferentially, that is, around the longitudinal axis of the container T1. The circumferential rotation angle is, for example, 180°. Once the rotation is complete, the control unit 31 controls the motor 611 so that the driven roller 431b moves away from the container T1.

[0129] In step S103, the control unit 31 controls the remaining 25 inversions and agitations of the container T1. Specifically, the control unit 31 controls the forward and backward transfer unit 420 so that the holding unit 421, which holds the container T1, is positioned at the removal position 323. At this time, the container T1 held in the holding unit 421 is rotated 180° from the orientation it was in when it was set in the holding unit 421 in step S102. The control unit 31 grasps the container T1 held in the holding unit 421 and pulls it upward, and controls the agitation mechanism 410 so that the container T1 is inverted and agitated 25 times. Due to the 180° rotation in step S102, the container T1 is agitated with its orientation rotated 180° around its axis from the state in step S101. The operation of the agitation mechanism 410 grasping the container T1 and the operation of the inversion and agitation are as described above. Once the agitation is complete, the control unit 31 returns the process to the main routine shown in Figure 13.

[0130] <Example of modification 1 of Embodiment 1> Figure 17 is a flowchart showing the processing in modified example 1 of Embodiment 1. Unlike the example in Figure 13, in the example in Figure 17, the type of container 110 held in the rack 100 is determined based on the sample ID, and the stirring operation mode is switched according to the type. Specifically, based on the sample ID, if it is determined that container 110 is container T1 containing a quality control sample, container T1 is stirred using the first operation mode, and if it is determined that container 110 is container T2 containing a subject sample, container T2 is stirred using the second operation mode. The flowchart in Figure 17 is realized by the control unit 31 of the control device 30 controlling the measuring device 10 and the second transport mechanism 20b by executing a computer program stored in the storage unit 32.

[0131] When the rack 100 is fed to the transport device 20 via the first transport path 301, in step S11, the control unit 31 controls the transport device 20 so that the rack 100 is received by the first rack storage unit 311. In step S12, the control unit 31 controls the transport device 20 so that the rack 100 is transported on the first rack storage unit 311 and the second transport path 321, and controls the reader unit 322 so that the barcode label 102 on the rack 100 and the barcode label 112 on the container 110 held in the rack 100 are read in sequence. As a result, the control unit 31 obtains the rack ID from the barcode label 102 and the sample ID from the barcode label 112.

[0132] Next, the control unit performs steps S13 to S21 sequentially on all containers 110 held in the rack 100.

[0133] In step S13, the control unit 31 determines the type of container 110 based on the sample ID obtained in step S12. That is, the control unit 31 determines, based on the sample ID, whether the target container 110 is container T1 containing quality control samples or container T2 containing subject samples. Note that the control unit 31 is not limited to determining the type of container 110 based solely on the sample ID; it may also determine that the container 110 is either container T1 or T2 if the type of rack 100 based on the rack ID matches the type of container 110 based on the sample ID.

[0134] If the target container 110 is the container 110 (container T1) that contains quality control samples, in step S14, the control unit 31 controls the stirring mechanism 410 so that the target container T1 is removed from the rack 100 at the removal position 323. Then, in step S15, the control unit 31 controls the stirring mechanism 410 so that stirring is performed on the removed container T1 in the first operating mode.

[0135] On the other hand, if the target container 110 is a container 110 (container T2) that contains a subject sample, in step S16, the control unit 31 controls the stirring mechanism 410 so that the target container T2 is removed from the rack 100 at the removal position 323. Then, in step S17, the control unit 31 controls the stirring mechanism 410 so that stirring is performed on the removed container T2 in the second operating mode.

[0136] In steps S15 and S17, when stirring by the stirring mechanism 410 is completed, the control unit 31 controls the forward / backward transfer unit 420 so that the stirred container 110 is moved to directly below the piercer 441. Then, in step S18, the control unit 31 controls the piercer drive unit 442 and the liquid transfer unit 401 so that the sample in the container 110 is aspirated.

[0137] In step S19, the control unit 31 controls the forward / backward transfer unit 420 and the stirring mechanism 410 so that the container 110, which was suctioned in step S18, is returned to the original holding unit 101 of the original rack 100.

[0138] Next, in step S20, the control unit 31 controls the liquid transfer unit 401 so that the sample aspirated in step S18 is mixed with a predetermined reagent to prepare a measurement sample. Also in step S20, the control unit 31 controls the measurement unit 403 so that the prepared measurement sample is measured and analyzes the measurement data obtained from the measurement. Then, in step S21, the control unit 31 transmits the results of the analysis performed in step S20 to the host computer 2. The host computer 2 transmits the analysis results to the display terminal in response to a request from the display terminal. The display terminal displays the analysis results of the quality control samples on a list screen and the analysis results of the subject samples on a list screen.

[0139] In step S22, once the processing in steps S13 to S19 is completed for all containers 110 held in the rack 100, the control unit 31 controls the transport device 20 so that the rack 100 is transported to the left end of the second transport path 321 and sent to the second rack storage unit 331. In this way, the processing by the control unit 31 for one rack 100 is completed.

[0140] Furthermore, if the processing described above is completed for the right-hand measuring device 10 of the two adjacent measuring devices 10 in the second transport path 321, the control unit 31 determines whether it is necessary to perform measurement with the left-hand measuring device 10. If the control unit 31 determines that it is necessary to perform measurement with the left-hand measuring device 10, it performs the processing described in steps S13 to S19 with the left-hand measuring device 10.

[0141] The rack 100, once sent to the second rack storage unit 331, is transported to the adjacent transport device 20 if further measurement by the measuring device 10 is required. If measurement by the measuring device 10 is not required, and the rack 100 is a rack holding quality control samples, it is transported to the right to the adjacent transport device 20 or supply device 40. If the rack 100 is a rack holding subject samples, it is transported to the left and collected by the recovery device 50.

[0142] <Example 2 of modification to Embodiment 1> Figure 18 is a table showing a second example of stirring parameters according to modification example 2. In the second example of settings, unlike the first example of settings shown in embodiment 1 above, different stirring parameters are set depending on the type of quality control sample. Specifically, in the second example of settings, the first operating mode includes first operating mode 1A, which is applied to level 1 quality control samples, and first operating mode 1B, which is set for level 2 and level 3 quality control samples. First operating mode 1A and first operating mode 1B include the following parameters.

[0143] (1) Number of stirring cycles • Operation mode 1A, Operation mode 1B: 50 times (2) Falling speed • Operating mode 1A: 105 rpm when rising, 120 rpm when descending • Operating mode 1B: 105 rpm during ascent and descent (3) Angle of fall • Operating mode 1A: θ1=0°, θ2=145° • Operating mode 1B: θ1=5°, θ2=145° (4) Repeated application of impact • Operation mode 1A: Yes • Operation mode 1B: None (5) Change of posture • Operating modes 1A and 1B: Available

[0144] As mentioned above, there are three types of quality control samples depending on the concentration level, and the ease with which the quality control samples mix by agitation differs depending on the concentration level, so it is preferable to set the optimal agitation parameters according to the type of quality control sample. The inventors found that the Level 1 quality control sample, which has the lowest concentration level, is the most difficult to mix. Therefore, in the second setting example, for the Level 1 quality control sample, the downward speed of the inversion speed is increased from 105 rpm to 120 rpm to increase the agitation force by applying a more rapid force. In addition, in the second setting example, impact is applied to the Level 1 quality control sample as in Figure 15, while no impact is applied to the Level 2 and Level 3 quality control samples. Applying impact is particularly effective in strengthening the agitation of the Level 1 quality control sample, which is prone to platelet aggregation, but there is a problem that metal fatigue may accumulate due to repeated collisions between the magnet 519 and the metal member 520. Therefore, by applying impact only to Level 1 quality control samples, which are particularly difficult to mix, it is possible to properly agitate multiple types of quality control samples with different concentration levels while avoiding mechanical fatigue.

[0145] Figure 19 is a flowchart showing the sample analysis process by the control device 30 according to modification example 2. Compared to Figure 17, steps S31 and S32 have been added between steps S13 and S18 in Figure 19, showing the process when the container T1 of container 110 contains quality control samples of level 1, and steps S33 and S34 have been added, showing the process when the container T1 of container 110 contains quality control samples of levels 2 and 3. Steps S31 to S34 will be explained below.

[0146] In step S13, the control unit 31 determines that the target container 110 is container T1 containing a level 1 quality control sample, and in step S31, controls the stirring mechanism 410 so that the target container T1 is removed from the rack 100. Then, in step S32, the control unit 31 controls the stirring mechanism 410 so that the removed container T1 is stirred in the operation mode 1A shown in Figure 18. At this time, the control unit 31 controls the forward / backward transfer unit 420 and the rotation mechanism 431 so that the orientation is changed during stirring.

[0147] In step S13, if the control unit 31 determines that the target container 110 is a container T1 containing a level 2 or level 3 quality control sample, in step S33, it controls the stirring mechanism 410 so that the target container T1 is removed from the rack 100. Then, in step S34, the control unit 31 controls the stirring mechanism 410 so that the removed container T1 is stirred in the operation mode 1B shown in Figure 18. In this case as well, the control unit 31 controls the forward / backward transfer unit 420 and the rotation mechanism 431 so that the orientation is changed during stirring.

[0148] <Example 3 of modifications to Embodiment 1> In the above embodiment 1, the container T1 taken out of the storage compartment 42 of the supply device 40 may be supplied sequentially to a plurality of measuring devices 10, and the quality control sample may be measured in each measuring device 10. In this case, according to the above embodiment 1, the quality control sample is always stirred in the first operating mode. However, this is not limited to this, and after the quality control sample is taken out of the storage compartment 42, stirring may be performed in the first operating mode in the first measuring device 10 that is transported, and stirring may be performed in the second operating mode in the measuring devices 10 that are transported afterward.

[0149] Figure 20 is a flowchart showing the sample analysis process by the control device 30 according to modification example 3 of Embodiment 1. In Figure 20, steps S111 to S113 are added in place of step S15 compared to Figure 17. This part will be explained below.

[0150] In step S111, the control unit 31 determines whether the current agitation of the target container T1 is the first agitation since it was removed from the storage unit 42. Specifically, based on the target sample ID read in step S12 (see Figure 17), the control unit 31 queries the transport control device 60 for the number of times the agitation process has been performed on the target container T1 since it was removed from the storage unit 42 (hereinafter referred to as the "agitation count value"). The query to the transport control device 60 is made via the first transport mechanism 20a and the concentrator 70.

[0151] The transport control device 60 maintains location information indicating the transport path for container T1 in the sample analysis system 1, as well as the number of times it has been stirred by the measuring device 10 after being removed from the storage unit 42. When step S15 (see Figure 17) is performed on one measuring device 10 for container T1, the transport control device 60 increments the stirring count value for this container T1 by 1. Furthermore, when container T1 is returned to the storage unit 42, the transport control device 60 sets the stirring count value for this container T1 to 0.

[0152] In step S111, the control unit 31 determines that if the stirring count value of the target container T1 is 0, this stirring is the first stirring since it was removed from the storage unit 42. Also in step S111, the control unit 31 determines that if the stirring count value of the target container T1 is 1 or more, this stirring is not the first stirring since it was removed from the storage unit 42.

[0153] If this is the first stirring, in step S112, the control unit 31 controls the stirring mechanism 410 so that stirring is performed in the first operating mode on the container T1, similar to step S15 in Figure 17. On the other hand, if this is not the first stirring, in step S113, the control unit 31 controls the stirring mechanism 410 so that stirring is performed in the second operating mode on the container T1.

[0154] Note that stirring in the second operating mode in step S113 is just one example and is not limited thereto. The stirring in step S113 does not have to be the same as the stirring parameters in the second operating mode; it just needs to be weaker than the stirring parameters in the first operating mode.

[0155] According to the modified example 3 of Embodiment 1, when the measuring device 10 stirs a quality control sample that has been stirred in the first operating mode again before measurement, it stirs the quality control sample with a weaker stirring than the stirring in the first operating mode (for example, stirring in the second operating mode). With this configuration, it is possible to avoid excessive damage to the quality control sample due to continuous stirring in the first operating mode. In addition, the quality control sample can be sufficiently stirred while increasing processing efficiency. For example, when stirring is performed in the second operating mode as weak stirring, the number of stirrings, stirring speed, and stirring angle are smaller and the posture is not changed compared to stirring in the first operating mode. Therefore, by performing stirring from the second time onward with a weaker stirring than stirring in the first operating mode, the time required for stirring can be shortened compared to the first operating mode, and the quality control sample can be sufficiently stirred in combination with the stirring based on the first operating mode performed the first time.

[0156] <Example 4 of the modification of Embodiment 1> In the modified example 3 of Embodiment 1 described above, if the current stirring is not the first stirring of the target container T1, stirring is performed in step S113 according to fixed parameters weaker than those of the first operating mode. However, the parameters may be changed according to the elapsed time since the stirring in the first operating mode if the current stirring is not the first stirring.

[0157] Figure 21 is a flowchart showing the sample analysis process by the control device 30 according to modification example 4 of Embodiment 1. In Figure 21, steps S121 and S122 are added in place of step S113 compared to Figure 20. This part will be explained below.

[0158] If this stirring is not the first stirring, in step S121, the control unit 31 obtains the elapsed time since the stirring performed in the first operating mode in step S112, and determines parameters according to the obtained elapsed time.

[0159] Specifically, the control unit 31 inquires with the transport control device 60 about the elapsed time since stirring in the first operating mode, based on the target sample ID read in step S12 (see Figure 17). The transport control device 60 maintains the elapsed time since container T1 in the sample analysis system 1 was removed from the storage cabinet 42, as well as the timing at which stirring was performed by the measuring device 10. The timing at which stirring was performed by the measuring device 10 is the timing at which the barcode label 112 of the target container T1 was read by the reading unit 322 (see Figure 5) immediately before measurement by the measuring device 10. The measuring device 10 transmits the timing at which the barcode label 112 was read to the transport control device 60 one by one.

[0160] When the transport control device 60 receives an inquiry about the elapsed time from the control unit 31, it calculates the time from the timing of the stirring in the first operation mode (the timing of the first stirring performed after being taken out of the storage unit 42) to the timing of the current stirring (the timing when the barcode label 112 was read by the reading unit 322 immediately before) and transmits it to the control unit 31. In step S121, the control unit 31 determines the stirring parameters according to the acquired elapsed time. In this case, the stirring parameters are changed compared to the second operation mode described above, for example, as shown in Figure 22, by changing the number of stirring cycles.

[0161] Figure 22 is a schematic graph showing the number of stirring cycles determined in step S121.

[0162] During the period from the start of stirring in the first operating mode until a predetermined time Tth has elapsed, the number of stirring cycles is set to N1. N1 is, for example, 8, the same as the number of stirring cycles in the second operating mode for the subject sample. Once the predetermined time Tth has elapsed since stirring in the first operating mode, the number of stirring cycles determined according to the elapsed time increases.

[0163] Returning to Figure 21, once the control unit 31 determines the stirring parameters in step S121, in step S122 it controls the stirring mechanism 410 so that the quality control sample in container T1 is stirred according to the determined stirring parameters.

[0164] According to the modified example 4 of Embodiment 1, when the measuring device 10 stirs a quality control sample that has been stirred in the first operating mode again before measurement, it stirs the quality control sample with stirring parameters corresponding to the elapsed time since stirring in the first operating mode. The quality control sample in container T1 settles as time passes after stirring. Therefore, by lowering the stirring intensity when the elapsed time is short and increasing the stirring intensity when the elapsed time is long, the stirring of the quality control sample immediately before measurement can be performed efficiently, and excessive damage to the quality control sample can be avoided.

[0165] In step S121, the stirring parameters determined according to the elapsed time were determined under conditions in which only the number of stirring cycles was changed compared to the parameters of the second operating mode described above. However, the parameters are not limited to this, and at least one of the following parameters may be changed: the number of stirring cycles, stirring speed, stirring angle, application of impact, and change of posture.

[0166] Furthermore, in Figure 22, after a predetermined time Tth has elapsed since stirring in the first operating mode, the number of stirring cycles determined according to the elapsed time gradually increases. However, after a predetermined time Tth has elapsed, the number of stirring cycles N2 may be set to a predetermined number greater than N1.

[0167] <Example 5 of modifications to Embodiment 1> In the modified example 4 of Embodiment 1 described above, the stirring parameters were changed according to the elapsed time since stirring in the first operating mode. However, the stirring parameters may also be changed according to the remaining amount of quality control sample in container T1.

[0168] Figure 23 is a flowchart showing the sample analysis process by the control device 30 according to modification example 5 of Embodiment 1. In Figure 23, step S131 is added in place of step S121 compared to Figure 21. This part will be explained below.

[0169] If this stirring is not the first stirring, in step S131, the control unit 31 obtains the remaining amount of quality control sample in the target container T1 and determines stirring parameters according to the obtained remaining amount. Specifically, the control unit 31 inquires with the transport control device 60 about the remaining amount of this container T1 based on the target sample ID read in step S12 (see Figure 17). The transport control device 60 has previously obtained the remaining amount of container T1 transported from the supply device 40, and upon receiving the inquiry about the remaining amount from the control unit 31, transmits the corresponding remaining amount of container T1 to the control unit 31.

[0170] In step S131, the control unit 31 determines stirring parameters according to the acquired remaining amount. In this case, the stirring parameters are changed compared to the stirring parameters of the second operation mode described above, for example, as shown in Figure 24, by changing the number of stirring cycles.

[0171] Figure 24 is a schematic graph showing the number of stirring cycles determined in step S131.

[0172] As long as the remaining volume is above the threshold R1, the number of stirring cycles determined decreases in proportion to the decrease in the remaining volume. When the remaining volume falls below the threshold R1, the number of stirring cycles is set to a constant N1. N1 is, for example, 8, the same as the number of stirring cycles in the second operating mode for the subject sample.

[0173] According to Modification Example 5 of Embodiment 1, when the measuring device 10 stirs a quality control sample that has been stirred in the first operating mode again before measurement, it stirs the quality control sample with stirring parameters corresponding to the remaining amount of the quality control sample in container T1. As the amount of quality control sample remaining in container T1 decreases, stirring progresses even with the same stirring parameters. Therefore, by lowering the stirring intensity when the remaining amount is small and increasing the stirring intensity when the remaining amount is large, the stirring of the quality control sample performed immediately beforehand can be performed efficiently, and excessive damage to the quality control sample can be avoided.

[0174] In step S131, the stirring parameters determined according to the remaining amount were changed only in terms of the number of stirring cycles compared to the stirring parameters of the second operating mode described above. However, the parameters are not limited to this, and at least one of the following parameters may be changed: the number of stirring cycles, stirring speed, stirring angle, application of impact, and change of posture.

[0175] Furthermore, the remaining amount of quality control sample in container T1 is not limited to the actual volume or weight of the quality control sample remaining in container T1, but may also be the number of remaining tests indicating how many more measurements are possible. In addition, in step S131, the stirring parameters may be determined based on the amount used or the number of tests already performed, instead of the remaining amount.

[0176] Furthermore, in Figure 24, while the remaining amount is above the threshold R1, the number of stirring cycles determined by the decrease in the remaining amount gradually decreases. However, while the remaining amount is above a predetermined threshold R1, a predetermined number of stirring cycles N2, which is greater than N1, may be set.

[0177] In modified examples 4 and 5 of Embodiment 1, the number of stirring cycles was changed according to the elapsed time and remaining amount, but the number of stirring cycles may also be changed according to the temperature of the location where the measuring device 10 is installed, i.e., the external temperature of the measuring device 10. When the external temperature is low, it is expected that the quality control sample in container T1 will aggregate and settle. Therefore, when the external temperature is low, the number of stirring cycles to be determined may be increased, and when the external temperature is high, the number of stirring cycles to be determined may be decreased. This makes it possible to efficiently stir the quality control sample immediately beforehand and avoid excessive damage to the quality control sample. In addition, at least one of the stirring parameters determined according to the external temperature, such as the number of stirring cycles, stirring speed, stirring angle, application of impact, and change of posture, may also be changed.

[0178] <Embodiment 2> In Embodiment 1, stirring of the quality control sample based on the first operating mode was performed only in the measuring device 10. In contrast, in Embodiment 2, in addition to stirring of the quality control sample in the measuring device 10, stirring of the quality control sample is also performed in the supply device 40. Other controls and configurations in Embodiment 2 are the same as in Embodiment 1.

[0179] Figure 25 is a diagram showing in detail the first and second operating modes according to Embodiment 2.

[0180] The initial stirring performed after the material is taken out of the storage compartment 42 of the supply device 40 will be referred to as "preliminary stirring." In Embodiment 2, preliminary stirring is performed in the supply device 40. The stirring in the first operating mode of Embodiment 2 includes preliminary stirring and stirring performed in the measuring device 10 immediately before measurement after the preliminary stirring. The parameters of the preliminary stirring by the supply device 40 included in the first operating mode are the same as the stirring parameters in the first operating mode of Embodiment 1, and the parameters of the stirring by the measuring device 10 included in the first operating mode are the same as the stirring parameters in the second operating mode of Embodiment 1. In other words, the first and second operating modes of Embodiment 2 differ in the presence or absence of preliminary stirring.

[0181] After container T1 is removed from the supply device 40, if the quality control sample in container T1 is to be measured by two or more measuring devices 10, stirring is performed in the second operating mode in each of the measuring devices 10. As a result, both the measuring device 10 that first measured the quality control sample and the measuring device 10 that subsequently measured the quality control sample will perform preliminary stirring as well as stirring immediately before measurement in the measuring device 10, ensuring that the quality control sample is thoroughly stirred.

[0182] Figure 26 is a plan view showing the detailed configuration of the supply device 40 according to Embodiment 2.

[0183] Compared to the configuration shown in Figure 4, the supply device 40 of Embodiment 2 is further equipped with a rotating mechanism 45 and a stirring mechanism 46.

[0184] The rotating mechanism 45 rotates the container T1 in the circumferential direction during stirring by the stirring mechanism 46. The rotating mechanism 45 comprises a holding part 45a capable of holding the container T1 vertically, a driving roller 45b, and a pair of driven rollers 45c. The rotating mechanism 45 has substantially the same configuration as the rotating mechanism 431 shown in Figure 10. The stirring mechanism 46 stirs the quality control sample in the container T1 that has been removed from the storage cabinet 42. The stirring mechanism 46 comprises a pair of gripping parts 46a. The configurations of the rotating mechanism 45 and the stirring mechanism 46 will be described later with reference to Figure 27.

[0185] When a container T1 in the storage unit 42 is to be measured, the transfer unit 210 transfers the container T1 from the storage unit 42 to the holding unit 44b of the heating unit 44, where the container T1 is returned to room temperature. Subsequently, the transfer unit 210 sets the container T1 in the holding unit 45a of the rotating mechanism 45. The stirring mechanism 46 grasps and lifts the container T1 set in the holding unit 45a and performs inversion stirring as in Figure 9. The stirring mechanism 46 sets the container T1 in the holding unit 45a during stirring. The rotating mechanism 45 rotates the container T1 in the circumferential direction using the driving roller 45b and the driven roller 45c, changing the circumferential orientation of the container T1. After that, the stirring mechanism 46 grasps and lifts the container T1 set in the holding unit 45a, performs inversion stirring again, and sets it in the holding unit 45a. The transfer unit 210 transfers the container T1 held in the holding unit 45a to the rack 100 positioned at the forward position 233.

[0186] Figure 27 is a schematic side view showing the detailed configuration of the rotating mechanism 45 and the stirring mechanism 46.

[0187] The rotating mechanism 45 comprises a motor 701, a driving roller 45b, a motor 711, pulleys 712 and 713, a belt 714, a base plate 715, and a pair of driven rollers 45c.

[0188] When motor 701 is driven, the driving roller 45b connected to the shaft of motor 701 rotates with the vertical direction as its axis of rotation. When motor 711 is driven, the belt 714 and the substrate 715 move from side to side, and the pair of driven rollers 45c move from side to side. With the container T1 held in the holding part 45a, the pair of driven rollers 45c move to the left, causing the body 111 of the container 110 to be sandwiched between the driving roller 45b and the pair of driven rollers 45c. In this state, the driving roller 45b rotates, causing the container T1 to rotate in the circumferential direction.

[0189] The stirring mechanism 46 comprises an up-and-down drive unit 721, a left-and-right drive unit 722, and a stirring unit 730.

[0190] The vertical drive unit 721 is a mechanism for moving the horizontal drive unit 722 in the vertical direction. The horizontal drive unit 722 is a mechanism for moving the stirring unit 730 in the horizontal direction.

[0191] The stirring unit 730 comprises a substrate 731, a motor 732, a shaft 733, a gripping mechanism 734, a magnet 735, a metal member 736, and a pair of gripping parts 46a. The motor 732 is a stepping motor and is mounted on the substrate 731. The shaft 733 extends in the front-rear direction and rotates integrally with the shaft of the motor 732. The gripping mechanism 734 is mounted on the shaft 733. The gripping mechanism 734 moves the right gripping part 46a in the left-right direction with a configuration similar to the gripping mechanism 412 in Figures 7 and 8. This changes the distance between the pair of gripping parts 46a, and the container T1 is gripped by the pair of gripping parts 46a.

[0192] The magnet 735 and the metal member 736 have the same configuration as the magnet 519 and metal member 520 in Figure 7, respectively. The magnet 735 is installed on the substrate 731, and the metal member 736 is installed on the left-side gripping portion 46a. The magnet 735 and the metal member 736 come into contact when the pair of gripping portions 46a hold the container T1 vertically.

[0193] When the motor 732 is driven, the gripping mechanism 734 rotates around the shaft 733, and the container T1, gripped by the pair of gripping parts 46a, rotates around the shaft 733. This stirs the container T1, similar to the stirring mechanism 410 in Figures 7 and 8. Alternatively, a rotating mechanism 413 similar to that in Figures 7 and 8 may be provided instead of the motor 732.

[0194] Figure 28 is a flowchart showing the stirring and conveying process of container T1 by the supply device 40.

[0195] In step S201, the control unit 201 of the supply device 40 controls the transfer unit 210 so that the container T1 containing the quality control sample is taken out of the storage cabinet 42 and set in the heating unit 44. In step S202, if the installation temperature of the supply device 40 is room temperature, the control unit 201 maintains the state in which the container T1 is held in the holding unit 44b of the heating unit 44 for a certain period of time without performing heating by the heating unit 44. Also in step S202, if the installation temperature of the supply device 40 is lower than room temperature, the control unit 201 controls the heating unit 44 so that the container T1 is heated to room temperature. In this way, the temperature of the quality control sample in the container T1 is brought to room temperature.

[0196] In step S203, the control unit 201 controls the transfer unit 210 so that the container T1 is transferred from the heating unit 44 to the rotating mechanism 45, and controls the rotating mechanism 45 and the stirring mechanism 46 so that the quality control sample in the container T1 is stirred. The stirring in step S203 is the preliminary stirring described with reference to Figure 25.

[0197] In step S204, the control unit 201 controls the transfer unit 210 so that the containers T1 whose stirring has been completed are set in the holding unit 101 of the rack 100 positioned at the front position 233. After all the containers T1 to be set in the rack 100 have been set, in step S205, the control unit 201 controls the discharge unit 41 so that the rack 100 at the front position 233 is discharged into the first transport path 301 of the transport device 20 adjacent to the left side of the supply device 40. When the rack 100 is transported within the discharge unit 41, as described in Embodiment 1, the rack ID of the rack 100 and the sample ID of the containers T1 are read by the barcode unit 220, and the rack ID of the rack 100 is read by the barcode reader 230.

[0198] Figure 29 is a flowchart showing the process of changing the orientation of container 110 (container T1) containing the quality control sample during the preliminary stirring performed in step S203. During the preliminary stirring, 50 inversions are performed as shown in Figure 25.

[0199] In step S211, the control unit 201 controls the stirring mechanism 46 so that the container T1 is inverted and stirred 25 times. Subsequently, in step S212, the control unit 201 controls the rotation mechanism 45 so that the orientation of the container T1 is changed. This changes the circumferential position of the container T1. Subsequently, in step S213, the control unit 201 controls the stirring mechanism 46 so that the remaining 25 inverted and stirred cycles of the container T1 are performed.

[0200] <Example 1 of modification to Embodiment 2> In Embodiment 2, the quality control sample was pre-mixed by inverting and stirring the container T1 in the supply device 40. However, the pre-mixing of the quality control sample may also be performed by applying vortex vibration to the container T1 in the supply device 40.

[0201] Figure 30 is a schematic side view showing the detailed configuration of the support mechanism 47 and the stirring mechanism 48 according to modification example 1 of embodiment 2.

[0202] In the modified example 1 of Embodiment 2, the supply device 40 is equipped with a support mechanism 47 and a stirring mechanism 48 instead of the rotating mechanism 45 and stirring mechanism 46 shown in Figure 26. A holding part 831 is provided to hold the container T1 in a vertical position in order to transfer the container T1 between the transfer part 210 and the support mechanism 47.

[0203] The support mechanism 47 includes an up-and-down drive unit 801, a left-and-right drive unit 802, a base plate 811, a shaft 812, a base plate 813, a shaft 814, a gripping mechanism 821, and a pair of gripping parts 822.

[0204] The vertical drive unit 801 is a mechanism for moving the horizontal drive unit 802 in the vertical direction. The horizontal drive unit 802 is a mechanism for moving the substrate 811 in the horizontal direction. The shaft 812 extends in the horizontal direction and is held on the substrate 811 so that it can rotate with the horizontal direction as its center of rotation. The substrate 813 is fixed to the shaft 812. The shaft 814 extends in the front-rear direction and is held on the substrate 813 so that it can rotate with the front-rear direction as its center of rotation. The gripping mechanism 821 is fixed to the shaft 814. The gripping mechanism 821 grips the container T1 by changing the distance between a pair of gripping parts 822, with a configuration similar to the gripping mechanism 412 in Figures 7 and 8.

[0205] The stirring mechanism 48 comprises a motor 841, a gear 842, a shaft 843, a plurality of rollers 844, and a rubber plate 845.

[0206] Motor 841 is a stepping motor. The shaft of motor 841 extends vertically and is connected to the center of the circular gear 842 in a plan view. The lower end of shaft 843 is connected to the upper surface of gear 842 at a position offset from the center of gear 842 in a plan view. The upper end of shaft 843 is connected to the lower surface of the circular rubber plate 845 at a position offset from the center of the rubber plate 845 in a plan view. Thus, the shaft of motor 841 and shaft 843 are connected at different positions in a plan view. Multiple rollers 844 are arranged along the outer edge of the rubber plate 845 and support the lower surface of the rubber plate 845.

[0207] In the modified example 1 of Embodiment 2, although the specific stirring process in step S203 in Figure 28 is different, the stirring and conveying process to the container T1 by the supply device 40 is performed in the same way as in Figure 28. The stirring process in step S203 will be described below.

[0208] In step S203, the control unit 201 controls the transfer unit 210 so that the container T1 is transferred from the heating unit 44 to the holding unit 831. The control unit 201 controls the support mechanism 47 so that the container T1 held in the holding unit 831 is gripped and pulled upward, and as shown in Figure 30, the lower end of the body portion 111 of the container T1 makes contact with the upper surface of the rubber plate 845 of the stirring mechanism 48. In this state, the control unit 201 drives the motor 841 of the stirring mechanism 48.

[0209] At this time, the shaft 843 connects the gear 842 and the rubber plate 845 at a position offset from the axis of the motor 841 in a plan view, causing the rubber plate 845 to rotate eccentrically. As a result, the container T1 placed on the upper surface of the rubber plate 845 vibrates horizontally in accordance with the movement of the rubber plate 845, generating a vortex inside the container T1. The vortex generated inside the container T1 agitates the quality control sample inside the container T1.

[0210] According to Modification Example 1 of Embodiment 2, similar to Embodiment 2, the quality control sample is pre-mixed by the stirring mechanism 48, so that the quality control sample can be sufficiently mixed by stirring in the measuring device 10 before measurement. Also, unlike Embodiment 2, the quality control sample is mixed by generating a vortex in the container T1, so the space required for mixing can be reduced compared to Embodiment 2.

[0211] <Example of modification 2 of Embodiment 2> In the modified example 1 of Embodiment 2, the quality control sample was pre-mixed by applying vortex vibration to the container T1 in the supply device 40. However, the method is not limited to this, and the quality control sample may also be pre-mixed by applying centrifugal force to the container T1 in the supply device 40.

[0212] Figures 31 and 32 are schematic side and plan views, respectively, showing the detailed configuration of the heating and stirring mechanism 49 according to a modified example 2 of Embodiment 2. For convenience, the inside of the rotating member 910 is shown in the side view of Figure 31.

[0213] In the second modification of Embodiment 2, a heating and stirring mechanism 49 is provided in the supply device 40, instead of the heating unit 44, rotating mechanism 45, and stirring mechanism 46 shown in Figure 26.

[0214] The heating and stirring mechanism 49 comprises a substrate 901, a motor 902, pulleys 903 and 904, a belt 905, a shaft 906, a gear 907, a shaft 908, a gear 909, a rotating member 910, and a plurality of Peltier elements 921.

[0215] Motor 902 is a stepping motor and is mounted on circuit board 901. The shaft 902a of motor 902 is connected to pulley 903. Belt 905 is connected to pulleys 903 and 904. Pulley 904 is connected to shaft 906.

[0216] Axles 906 and 908 are connected to the substrate 901 so that they can rotate about the vertical axis. Gears 907 and 909 are fixed to axles 906 and 908, respectively, and are connected to each other. The rotating member 910 has a cylindrical shape and is installed on the upper surface of the gear 909. Multiple holding portions 911 are formed on the upper surface of the rotating member 910. The multiple holding portions 911 are provided along the circumferential direction of the rotating member 910. The holding portions 911 are recesses provided on the upper surface of the rotating member 910 and hold the container T1 in a vertical position. The Peltier element 921 is provided on the inner surface of the holding portion 911 and heats the container T1 held by the holding portion 911.

[0217] Figure 33 is a flowchart showing the stirring and conveying process of the container T1 by the supply device 40, according to a modified example 2 of Embodiment 2.

[0218] In Figure 33, compared to Figure 28, steps S203 and S204 are replaced with a single step, S221, which combines steps S203 and S204. The processing of step S221 will be explained below.

[0219] In step S221, the control unit 201 of the supply device 40 controls the transfer unit 210 so that the container T1 containing the quality control sample is taken out of the storage unit 42 and set in the holding unit 911 of the heating and stirring mechanism 49. The control unit 201 then controls the motor 902 so that the rotating member 910 rotates with shafts 908 as the axis of rotation, as shafts 902a, 906, and 908 rotate in conjunction. This stirs the quality control sample in the container T1 set in the holding unit 911. Simultaneously with the rotation of the rotating member 910, the control unit 201 controls the Peltier element 921 so that the quality control sample in the container T1 set in the holding unit 911 is heated.

[0220] Similar to the heating unit 44 described above, heating of the quality control sample by the Peltier element 921 is performed only when the installation temperature of the supply device 40 is lower than room temperature. When the installation temperature of the supply device 40 is room temperature, heating by the Peltier element 921 is not performed, and the container T1 is held in the holding unit 911 for a predetermined time while stirring is performed by the rotation of the rotating member 910.

[0221] According to the modified example 2 of Embodiment 2, similar to Embodiment 2, the quality control sample is pre-mixed by the heating and stirring mechanism 49, so that the quality control sample can be sufficiently mixed by stirring in the measuring device 10 before measurement. Furthermore, since the quality control sample is mixed by applying centrifugal force to the container T1 without tipping the container T1 as in Embodiment 2, the space required for mixing can be reduced compared to Embodiment 2. In addition, since the quality control sample in the container T1 can be mixed while returning to room temperature, heating and mixing of the quality control sample can be performed efficiently.

[0222] <Embodiment 3> In Embodiment 2, the initial preliminary stirring of the container T1 containing the quality control sample taken from the storage unit 42 was performed by the supply device 40. In contrast, in Embodiment 3, the preliminary stirring is performed by a stirring device 80 located between the supply device 40 and the measuring device 10. Other controls and configurations in Embodiment 3 are the same as in Embodiment 2.

[0223] Figure 34 is a schematic diagram showing the configuration of the sample analysis system 1 according to Embodiment 3.

[0224] In Embodiment 3, compared to Embodiment 1 in Figure 1, the supply device 40 is positioned between the conveying device 20. In Figure 34, for convenience, only one set of measuring device 10, conveying device 20, and control device 30 is provided, but as in Embodiment 1, two or more such sets may be provided.

[0225] The stirring device 80 comprises a conveying section 81, a stirring mechanism 82, and a rotating mechanism 83. The conveying section 81 includes conveying paths 81a and 81b. Conveying path 81a conveys racks 100 discharged from the supply device 40 to the left and discharges them to the adjacent conveying device 20 on the left. Conveying path 81b conveys racks 100 discharged from the adjacent conveying device 20 on the left to the right and discharges them to the supply device 40. The stirring mechanism 82 and the rotating mechanism 83 are configured similarly to the stirring mechanism 46 and the rotating mechanism 45 of Embodiment 2 shown in Figure 26, respectively.

[0226] The rack 100, removed from the storage unit 42 and transported from the supply device 40 to the transport path 81a, is positioned in front of the stirring mechanism 82. The stirring mechanism 82 removes a container T1 from the rack 100 and performs inversion stirring on the container T1. During the stirring by the stirring mechanism 82, the container T1 is set in the rotating mechanism 83 and rotated circumferentially by the rotating mechanism 83. The stirring mechanism 82 removes the container T1 held by the rotating mechanism 83 and resumes inversion stirring. The stirring mechanism 82 returns the container T1, which has finished stirring, to its original holding part 101 on the rack 100 on the transport path 81a. Once preliminary stirring is complete for all containers T1 held in the rack 100, the rack 100 is transported to the adjacent transport device 20 on the left.

[0227] <Effects of the Embodiment> According to Embodiments 1 to 3, the quality control sample is agitated in a first operating mode different from the second operating mode used for agitating the subject sample, and the agitated quality control sample is measured.

[0228] According to embodiments 1 to 3, problems such as poor mixing due to differences in components or the effects of long-term storage of quality control samples, which occur when quality control samples are mixed in the same way as test samples, can be avoided, and measurement results for quality control samples can be obtained normally.

[0229] Container T1 containing the quality control sample is automatically retrieved from storage unit 42, and the retrieved container T1 is transported to measuring device 10. This reduces the effort required from the operator and allows for smooth measurement of quality control samples.

[0230] The storage unit 42 cools and stores the container T1 containing the quality control sample, and the heating unit 44 or heating and stirring mechanism 49 raises the temperature of the container T1 after it is removed from the storage unit 42. This allows for accurate storage of the quality control sample and enables smooth return of the quality control sample to room temperature during measurement.

[0231] The stirring operation performed in Embodiments 1 to 3 includes shaking the container 110 containing the quality control sample or subject sample in an inverted direction between a first angle where the bottom of the container is lower than the top and a second angle where the bottom is higher than the top. This stirring method ensures that blood cell components that have settled at the bottom of the container 110 are reliably detached from the bottom.

[0232] The stirring in the first operating mode and the stirring in the second operating mode differ in the angle at which the container 110 is shaken (stirring angle). The shaking angle of the container 110 in the first operating mode is greater than the shaking angle of the container 110 in the second operating mode. A larger shaking angle increases the amount of liquid components moved within the container 110, promoting mixing.

[0233] The stirring in the first operating mode and the stirring in the second operating mode differ in the speed at which the container 110 is shaken (stirring speed). The shaking speed of the container 110 in the first operating mode is faster than the shaking speed of the container 110 in the second operating mode. A higher inversion speed increases the speed at which the liquid component moves within the container 110, making it easier for the liquid component to push down the blood cell component that has settled at the bottom. In addition, the movement of the liquid component's surface makes it easier for aggregated blood cell component to break apart.

[0234] The stirring in the first operating mode and the stirring in the second operating mode differ in the number of stirring cycles, with the number of stirring cycles in the first operating mode being greater than that in the second operating mode. A higher number of stirring cycles causes the liquid component to repeatedly push and wash away the blood cell component that has settled at the bottom of the container 110, making it easier for the blood cell component to detach from the bottom and promoting the mixing of the liquid component and the blood cell component. Furthermore, repeated external force is applied to the blood cell component mixed with the liquid component, causing the aggregated blood cell component to break down and promoting mixing.

[0235] The stirring in the first operating mode and the stirring in the second operating mode differ in whether or not repeated impacts are applied. The first operating mode includes repeatedly applying impacts to the container 110, while the second operating mode does not include repeatedly applying impacts to the container 110. By repeatedly applying impacts, the dispersion of aggregated blood cell components contained in the quality control sample is promoted.

[0236] The stirring in the first operating mode and the stirring in the second operating mode differ in whether or not the orientation is changed. The first operating mode includes rotating the container 110 in the circumferential direction during stirring, while the second operating mode does not include rotating the container 110 in the circumferential direction during stirring. This prevents the components of the quality control sample from agglomerating and settling in an uneven position around the axis within the container 110. Therefore, the quality control sample can be properly stirred.

[0237] In Embodiment 2, the first operating mode for agitating the quality control sample and the second operating mode for agitating the subject sample differ in whether or not pre-agitation is performed, as shown in Figure 25. The first operating mode includes pre-agitation, while the second operating mode does not. As a result, the quality control sample is pre-agitated prior to the agitation performed in the second operating mode for the subject sample, ensuring that even quality control samples that are difficult to mix are thoroughly agitated. Therefore, the quality control sample can be measured appropriately.

[0238] Specifically, for quality control samples, pre-mixing is performed by the stirring mechanism 46, and then mixing is performed in the measuring device 10 in the same manner as the second operating mode. On the other hand, for subject samples, mixing is performed in the measuring device 10 in the second operating mode. By performing pre-mixing on the quality control samples in this way, the quality control samples can be supplied to the measuring device 10 in a thoroughly mixed state. Therefore, the measuring device 10 does not need to perform any special pre-treatment for mixing the quality control samples.

[0239] According to embodiments 1 to 3, the measuring device 10 includes a stirring mechanism 410 that grasps and shakes the container 110. This allows the hand mechanism for removing the container 110 from the rack 100 and the stirring mechanism to be shared, thereby simplifying the device.

[0240] According to embodiments 1 to 3, the rotating mechanism 431 is included in the reading unit 430 that reads identification information printed on the barcode label 112 attached to the side of the container 110. In this case, the rotating mechanism 431 is used for both reading the identification information and stirring the container 110. As a result, there is no need to provide separate rotating mechanisms for reading the identification information and stirring the container 110, and the sample analyzer 1a can be configured simply.

[0241] According to Embodiments 1 to 3, the sample analyzer 1a includes a supply device 40 equipped with a storage cabinet 42 for storing a container T1 containing quality control samples. The measuring device 10 agitates the quality control samples in container T1, which have been transported by the transport device 20, in a first operating mode. As described above, the quality control samples removed from the storage cabinet 42 may have aggregated and settled in container T1. With the above configuration, since the unagitated quality control samples are agitated in the first operating mode, the unagitated quality control samples can be sufficiently agitated.

[0242] According to Embodiments 1 to 3, the transport device 20 transports the container T1 containing the quality control sample measured by the measuring device 10 to the supply device 40, and the supply device 40 stores the container T1 transported from the measuring device 10 by the transport device 20 in the storage cabinet 42. With this configuration, not only the transport of the container T1 but also the storage of the container T1 is automated, further improving the convenience of the sample analyzer 1a and the sample analysis system 1.

[0243] According to embodiments 1 to 3, the supply device 40 includes a cooling unit 43 for cooling the container T1 in the storage unit 42. This makes it possible to maintain the quality of the quality control samples in the container T1.

[0244] According to embodiments 1 to 3, the supply device 40 includes a heating unit 44 that heats the container T1 taken out of the storage unit 42. In this way, when the container T1 is kept cool in the storage unit 42 and the ambient temperature is lower than the temperature suitable for stirring, heating the container T1 allows the temperature of the quality control sample inside the container T1 to be quickly raised to a temperature suitable for stirring.

[0245] According to Embodiment 3, similar to Embodiment 2, preliminary stirring is performed in the container T1 containing the quality control sample in the first operating mode. In this case as well, since the quality control sample is stirred in advance, the stirring performed by the measuring device 10 before measurement can bring the quality control sample to a sufficiently stirred state. Therefore, the measurement results of the quality control sample can be properly obtained.

[0246] Note that instead of the stirring mechanism 82 and the rotating mechanism 83, the support mechanism 47 and the stirring mechanism 48 of FIG. 30 may be provided, or the heating and stirring mechanism 49 of FIG. 31 may be provided. When a stirring mechanism similar to the heating and stirring mechanism 49 is provided, the Peltier element 921 is omitted. Further, instead of the mechanism for stirring the specimen for each container T1 as described above, at least one of grasping and shaking the rack 100, applying vibration to the rack 100, and applying centrifugal force to the rack 100 may be used to stir the specimen in the container 110 held by the rack 100.

[0247] <Other modification examples> In Embodiment 1, the first operation mode and the second operation mode differed in all parameters such as the stirring frequency, the stirring angle, the stirring speed, the presence or absence of posture change, and the presence or absence of repeated application of impact. However, if the parameters of the first operation mode are set so that the precision control specimen can be properly stirred, the parameters of the first operation mode and the parameters of the second operation mode may differ in one or a combination of predetermined items in FIG. 15. That is, the first operation mode may differ from the second operation mode in at least one item in FIG. 15. Further, the items of the first operation mode and the second operation mode are not limited to the items shown in FIG. 15, and may be one or a combination of a plurality of these items.

[0248] In Embodiment 2, the parameters of the preliminary stirring in the first operation mode and the parameters of the second operation mode were different in all items of the number of stirrings, the stirring angle, the stirring speed, the presence or absence of posture change, and the presence or absence of repeated application of impact. However, if the parameters of the first operation mode are set so that the accuracy control specimen can be properly stirred, the parameters of the preliminary stirring in the first operation mode and the parameters of the second operation mode may be different or the same in one or a predetermined combination of items in FIG. 25. Further, although the parameters of the stirring by the measuring device 10 in the first operation mode and the parameters of the stirring in the second operation mode were the same, if the parameters of the first operation mode are set so that the accuracy control specimen can be properly stirred, the operation mode of the stirring by the measuring device 10 in the first operation mode and the second operation mode may be different in one or a predetermined combination of the parameters in FIG. 25. Further, the items of the first operation mode and the second operation mode are not limited to the items shown in FIG. 25, and may be one or a combination of a plurality of these items.

[0249] In Embodiment 2, as shown in FIG. 25, the intensity by the preliminary stirring performed by the supply device 40 in the first operation mode was set to be stronger than the intensity by the stirring performed by the measuring device 10 in the first operation mode. However, the present invention is not limited to this. If the stirring in the first operation mode for stirring the accuracy control specimen is stronger than the stirring in the second operation mode for stirring the subject specimen, the intensity by the preliminary stirring in the first operation mode and the intensity by the stirring of the measuring device 10 in the first operation mode may be equal, or the intensity by the preliminary stirring in the first operation mode may be weaker than the intensity by the stirring of the measuring device 10 in the first operation mode. Further, if the above conditions are satisfied, the intensity of each stirring in the first operation mode may be weaker or stronger than the intensity of the stirring in the second operation mode for stirring the subject specimen.

[0250] In the above embodiment, the stirring by the first operating mode was stronger than the stirring by the second operating mode. However, the stirring by the first operating mode only needs to differ from the stirring by the second operating mode, as long as it can properly stir the quality control sample. For example, in order to properly stir the quality control sample by stirring by the first operating mode, the stirring parameters of the first operating mode and the stirring parameters of the second operating mode may be the same, and the waiting time from one inversion to the next stirring may be set longer in the first operating mode than in the second operating mode. Also, in order to prevent the destruction of blood cell components of the quality control sample during stirring, the stirring by the first operating mode may be set weaker than the stirring by the second operating mode.

[0251] In Embodiment 2, as shown in Figure 25, the first operating mode consisted of two stirrings: a preliminary stirring performed in the supply device 40 and stirring performed in the measuring device 10. However, the stirring in the first operating mode may consist of three or more stirrings. For example, the first operating mode may consist of a preliminary stirring performed in the supply device 40, a first stirring performed in the measuring device 10, and a second and subsequent stirring performed in the measuring device 10.

[0252] In Embodiment 2, the parameters of the pre-stirring performed by the supply device 40 may change depending on the time the quality control sample has been stored in the storage cabinet 42. For example, if the quality control sample has been stored in the storage cabinet 42 for 0 minutes, it is assumed that precipitation has not progressed much in container T1, so the parameters of the pre-stirring are set in the same way as the second operating mode for the subject sample in Figure 25. On the other hand, if the quality control sample has been stored in the storage cabinet 42 for a longer period of time and a predetermined amount of time has elapsed, it is assumed that precipitation is complete, so the pre-stirring is set to gradually increase in strength until the predetermined amount of time has elapsed, and then the pre-stirring is set to the same strength as in Figure 25.

[0253] In Embodiment 1, Modified Example 2 of Embodiment 1, and Embodiment 2, as shown in Figures 15, 18, and 25, the inversion angles θ1 in the first and second operating modes were set to be less than 90°, and the inversion angles θ2 in the first and second operating modes were set to be greater than 90°. That is, according to the first and second operating modes, the container 110 was shaken between a position where the bottom of the container 110 was lower than the top and a position where the bottom of the container 110 was higher than the top. However, if the stirring by the first operating mode for stirring quality control samples is stronger than the stirring by the second operating mode for stirring subject samples, then depending on the type of sample, the inversion angles θ1 and θ2 may both be less than 90°, or the inversion angles θ1 and θ2 may both be greater than 90°. However, when θ1 < 90° and θ2 > 90° as described above, the sample in the container 110 can be effectively stirred.

[0254] The stirring mechanism 410 in Figure 7 and the stirring mechanism 46 in Figure 27 agitated the sample inside the container 110 by shaking the container 110 in an inverted direction. However, the agitation by the stirring mechanisms 410 and 46 is not limited to inverted agitation. For example, the stirring mechanisms 410 and 46 may agitate the sample by moving the container 110 in the longitudinal direction (vertical direction), by moving the container 110 in the short direction (horizontal direction), or by rotating the container 110 around a longitudinal (vertical) axis passing through the center of the container 110. Furthermore, these agitations may be combined.

[0255] The stirring mechanism 410 in Figure 7 rotates the container 110 around the axis 513, and the stirring mechanism 46 in Figure 27 rotates the container 110 around the axis 733. In other words, the stirring mechanisms 410 and 46 rotate the container 110 around only one axis. However, the stirring mechanisms 410 and 46 are not limited to this and may be configured to rotate the container 110 around two or more axes. For example, the stirring mechanisms 410 and 46 may be configured to perform a first stirring, which shakes the container 110 in a first direction, and a second stirring, which shakes it in a second direction different from the first direction. In this case, it is not necessary to transfer the container 110 from the stirring mechanism to the rotating mechanism and rotate the container 110 circumferentially by the rotating mechanism during stirring.

[0256] In Embodiment 1, the sample analyzer 1a (see Figure 1) does not necessarily have to be equipped with a supply device 40. For example, the operator may manually set a rack 100 holding container T1 or a rack 100 holding container T2 onto the transport device 20. In this case, the operator takes container T1 containing the quality control sample from a separately installed storage unit, sets the retrieved container T1 onto the rack 100, and then manually sets the rack 100 onto the transport device 20.

[0257] In step S13 of Figure 17, the control unit 31 determined whether the container 110 to be stirred was container T1 or T2 based on the sample ID read by the barcode reader 322c of the reading unit 322. However, the control unit 31 may also read the sample ID with the barcode reader 432 of the reading unit 430 after removing the container 110 from the rack 100 and before starting stirring by the stirring mechanism 410, and determine the type of container 110 based on the read ID. Alternatively, the control unit 31 may obtain the type of container 110 to be stirred by querying the transport control device 60.

[0258] The rack 100 holding the containers T1 containing quality control samples was transported to the right and collected by the supply device 40 after processing of all containers T1 held in the rack 100 was completed. However, the rack 100 may also be transported to the left and collected by the collection device 50, similar to the rack 100 holding the subject samples, if the use of containers T1 is completed in a single transport, after processing of all containers T1 is completed.

[0259] The cooling section 43 is equipped with a Peltier element for cooling, but it may also be a vapor compression type cooling device equipped with a compressor. The heating section 44 is equipped with a Peltier element for heating, but it may also be equipped with a heater instead. The heating and stirring mechanism 49 is equipped with a Peltier element 921 for heating, but it may also be equipped with a heater instead.

[0260] As shown in Figure 6, the stirring mechanism 410, which removes the container 110 from the removal position 323 and stirs the container 110, is installed in a different position from the reading unit 430. However, this is not the only option; the mechanism for removing the container 110 from the removal position 323 and the mechanism for stirring the container 110 may be provided separately, with the stirring mechanism located at the position of the reading unit 430. In this case, since the stirring mechanism and the rotation mechanism 431 are located in the same position, it is possible to quickly switch between stirring and rotating the container 110.

[0261] A rack 100 may have an RFID tag storing the rack ID attached instead of a barcode label 102, and a container 110 may have an RFID tag storing the sample ID attached instead of a barcode label 112. In this case, an antenna for reading the RFID is provided instead of a barcode reader.

[0262] The specimen analyzer 1a was a device for measuring and analyzing whole blood collected from a subject as a subject specimen, but it may also be a device for measuring and analyzing other specimens collected from a subject. Examples of other specimens include plasma, cerebrospinal fluid, tissue fluid, and urine. In this case as well, the measurement accuracy of the subject specimens described above is controlled using quality control specimens.

[0263] Embodiments of the present invention can be modified in various ways as appropriate within the scope of the technical idea set forth in the claims. [Explanation of Symbols]

[0264] 1a Sample analyzer 10 Measuring device 20 Conveying device 40 Feeding device 42 Storage 43 Cooling section 44 Heating section 46, 48 Stirring mechanism 49 Heating stirring mechanism (heating section, stirring mechanism) 110, T1, T2 containers 410 Stirring mechanism 430 Reading Unit 431 Rotation mechanism

Claims

1. A step of controlling the stirring mechanism to stir a container containing quality control samples that have been stored under cooling in a first operating mode, The process includes controlling the measuring device to aspirate and measure the quality control sample in the stirred container, The control of the stirring mechanism for stirring in the first operating mode is compared to the control of the stirring mechanism for stirring in the second operating mode for stirring a subject sample collected from a subject, (1) The number of stirring cycles is high. (2) The stirring angle is large, (3) The stirring speed is fast. (4) It differs in that it repeatedly applies impact to the container, (5) It differs in that the container is rotated in the circumferential direction during the stirring process. A method for measuring quality control samples that satisfies at least one of the following conditions.

2. A step of automatically removing the container containing the quality control sample from a storage cabinet where the container is stored, The method for measuring a quality control sample according to claim 1, further comprising the step of transporting the removed container to a measuring device.

3. The storage unit cools and stores the containers containing the quality control samples. The method for measuring a quality control sample according to claim 2, further comprising the step of raising the temperature of the container removed from the storage cabinet.

4. A conveying device for transporting containers, The measuring device comprises a device that stirs the sample in the container, which has been transported by the transport device, using a stirring mechanism, and then aspirates and measures the stirred sample. The measuring device is, If the sample contained in the container transported by the transport device is a quality control sample, the stirring mechanism is controlled to agitate the container in the first operating mode. If the specimen contained in the container transported by the transport device is a subject specimen, the stirring mechanism is controlled to agitate the container in a second operating mode. The stirring performed in the first operating mode is, compared to the stirring performed in the second operating mode, (1) The number of stirring cycles is high. (2) The stirring angle is large, (3) The stirring speed is fast. (4) It differs in that it repeatedly applies impact to the container, (5) It differs in that the container is rotated in the circumferential direction during the stirring process. A sample analyzer that satisfies at least one of the following conditions.

5. The sample analyzer according to claim 4, wherein the measuring device includes a stirring mechanism for grasping and shaking the container.

6. The measuring device comprises a rotating mechanism for rotating the container in the circumferential direction, The sample analyzer according to claim 5, wherein the rotation mechanism rotates the container circumferentially during the stirring of the quality control sample based on the first operating mode.

7. The sample analyzer according to claim 6, wherein the rotating mechanism is included in a reading unit for reading identification information attached to the side of the container.

8. The sample analyzer according to any one of claims 4 to 7, wherein when the quality control sample that has been stirred in the first operating mode is stirred again before measurement, the quality control sample is stirred with a weaker agitation than that performed in the first operating mode.

9. The sample analyzer according to any one of claims 4 to 8, wherein, when the quality control sample that has been stirred in the first operating mode is stirred again before measurement, the quality control sample is stirred with a strength corresponding to the elapsed time since stirring in the first operating mode.

10. The supply device further includes a storage unit for storing the containers containing the quality control samples, The conveying device conveys the containers removed from the storage unit by the supplying device to the measuring device. The sample analyzer according to any one of claims 4 to 9, wherein the measuring device agitates the quality control sample in the container transported from the supply device in the first operating mode.

11. The transport device transports the container containing the quality control sample that has been measured by the measuring device to the supply device. The sample analyzer according to claim 10, wherein the supply device stores the containers transported from the measuring device by the transport device in the storage cabinet.

12. The sample analyzer according to claim 10 or 11, wherein the supply device includes a cooling unit for cooling the container in the storage cabinet.

13. The sample analyzer according to any one of claims 10 to 12, wherein the supply device comprises a heating unit for heating the container taken out of the storage cabinet.

Images