Sample analysis method and sample analysis system

Abstract

The invention provides a sample analysis method and a sample analysis system capable of efficiently providing highly reliable analysis results using a plurality of inspection devices having different measurement methods. A sample analysis method for analyzing a sample using a plurality of inspection devices having different measurement methods, the plurality of inspection devices including a urine qualitative inspection device (10), a urinary sediment inspection device (20), and an image capturing device (30), the sample analysis method comprising: a step for measuring the sample using a first inspection device; and a step for determining the measurement conditions of the second inspection device on the basis of a first measurement result that varies in accordance with the amount of the substance to be detected in the sample.

Description

Technical Field

[0001] The present invention relates to a sample analysis method and a sample analysis system. Background Art

[0002] Urinalysis includes qualitative urine analysis, which examines chemical components such as sugar and protein in urine, and urine sediment analysis, which analyzes visible elements such as red blood cells, white blood cells, and bacteria in urine. Furthermore, urine sediment analysis includes imaging and flow cytometry.

[0003] Currently, accurate urine analysis is performed by combining qualitative urine analysis with urine sediment analysis. Patent Document 1 below describes a urine sediment analysis device that incorporates both a qualitative analysis unit and a urine sediment analysis unit. The qualitative analysis unit analyzes the sample and, depending on whether the analysis is positive or negative, automatically changes the measurement conditions for analyzing urine sediment components in the sample liquid for each sample. For example, the device describes extending the measurement time of the sediment analysis unit if the qualitative analysis is positive for protein.

[0004] Prior art literature Patent Literature Patent Document 1: Japanese Patent Application Laid-Open No. 6-138120 Summary of the Invention Problems to be solved by the invention Urinalysis is a clinical examination used for physical examinations and screening of outpatients and inpatients. Because the number of samples processed is large, efficient processing is required from the examination device. However, in the processing performed by the examination device described in Patent Document 1, the urine sediment measurement conditions are selectively changed based on whether the analysis result of the qualitative analysis unit is positive or negative, making efficient urine sediment measurement difficult.

[0005] The above problem is not related to the urine analysis system that includes urine qualitative examination / urine sediment examination. The same problem also exists in other analysis systems that can perform multiple stages of analysis with different measurement methods, that is, analysis systems that perform the next stage of examination with more detailed analysis based on the results of the previous stage of examination. We hope that it can be solved.

[0006] In view of this problem, an object of the present invention is to provide a sample analysis method and a sample analysis system capable of efficiently providing highly reliable analysis results using a plurality of inspection apparatuses having different measurement methods.

[0007] Technical solutions to solve problems The present invention relates to a sample analysis method for analyzing a sample using multiple testing devices with different measurement methods. The method includes: performing a sample measurement using a first testing device; and determining measurement conditions for a second testing device based on the first measurement results, which vary depending on the amount of a test target substance in the sample.

[0008] According to the sample analysis method of the present invention, since the second inspection device performs measurements based on the first measurement results, which vary according to the amount of the target substance in the sample, the second inspection device can perform appropriate measurements corresponding to the sample conditions and avoid excessive measurements. Consequently, highly reliable analysis results can be efficiently provided.

[0009] The present invention relates to a sample analysis system comprising multiple testing devices using different measurement methods and a management device that receives measurement results obtained by the multiple testing devices. In the sample analysis system of the present invention, the management device determines measurement conditions for a second testing device based on a first measurement result obtained by the first testing device that varies depending on the amount of a test target substance in the sample, and generates an instruction specifying a measurement to be performed by the second testing device.

[0010] According to the sample analysis system of the present invention, since the second inspection device performs measurements under measurement conditions based on the first measurement results, which vary depending on the amount of the test target substance in the sample, the second inspection device can perform appropriate measurements corresponding to the sample conditions and avoid excessive measurements. Consequently, highly reliable analysis results can be efficiently provided.

[0011] Effects of the Invention According to the present invention, it is possible to efficiently provide highly reliable analysis results using a plurality of inspection apparatuses using different measurement methods. BRIEF DESCRIPTION OF THE DRAWINGS

[0012] Figure 1 It is a front view schematically showing the configuration of the sample analysis system according to the embodiment.

[0013] Figure 2 This is a block diagram showing the functional configuration of a urine qualitative testing device, a urine sediment testing device, and an imaging device according to an embodiment.

[0014] Figure 3 This is a block diagram showing the functional structure of the management device according to the embodiment.

[0015] Figure 4 It is a diagram schematically showing the configuration of an optical measurement unit according to an embodiment.

[0016] Figure 5 It is a diagram schematically showing the configuration of an imaging unit according to an embodiment.

[0017] Figure 6 It is a diagram showing measurement items of the urine qualitative testing device, measurement items of the urine sediment testing device, and measurement items of the imaging device according to the embodiment.

[0018] Figure 7 This is a diagram illustrating rules for additional measurement when the first inspection apparatus is a urine qualitative inspection apparatus and the second inspection apparatus is a urine sediment inspection apparatus according to the embodiment.

[0019] Figure 8 This is a diagram illustrating rules for additional measurement when the first inspection apparatus is a urine qualitative inspection apparatus and the second inspection apparatus is an image pickup apparatus according to an embodiment.

[0020] Figure 9 This is a diagram illustrating rules for additional measurement when the first inspection apparatus is a urine sediment inspection apparatus and the second inspection apparatus is an image pickup apparatus according to an embodiment.

[0021] Figure 10 This is a diagram schematically showing a rule list screen showing a list of rules for additional measurement according to the embodiment.

[0022] Figure 11 This is a diagram schematically showing a rule setting screen for setting a rule for additional measurement according to the embodiment.

[0023] Figure 12 It is a diagram schematically showing a termination condition setting screen for setting a termination condition according to the embodiment.

[0024] Figure 13 This is a schematic diagram showing the settings of the implementation method. Figure 7 The diagram shows a rule setting screen showing the status of the additional measurement rule when the measurement item is protein.

[0025] Figure 14 This is a schematic diagram showing the settings of the implementation method. Figure 7 The figure shows the end condition setting screen showing the state of the end condition when the measurement item is protein.

[0026] Figure 15 This is a schematic diagram showing the settings of the implementation method. Figure 7 The illustrated diagram is a diagram of a rule setting screen showing the state of the additional measurement rule when the measurement item is specific gravity.

[0027] Figure 16 This is a schematic diagram showing the settings of the implementation method. Figure 8 The illustrated diagram is a rule setting screen showing the status of the additional measurement rule when the measurement item is bilirubin.

[0028] Figure 17This is a schematic diagram showing the settings of the implementation method. Figure 8 The diagram shows the end condition setting screen in the state of the end condition when the measurement item is bilirubin.

[0029] Figure 18 This is a schematic diagram showing the settings of the implementation method. Figure 9 The diagram shows a rule setting screen showing the status of the additional measurement rule when the measurement item is atypical cells.

[0030] Figure 19 This is a schematic diagram showing the settings of the implementation method. Figure 9 The figure shows the end condition setting screen showing the state of the end condition when the measurement item is atypical cells.

[0031] Figure 20 It is a diagram schematically showing a result list screen displaying a list of measurement results according to the embodiment.

[0032] Figure 21 It is a diagram schematically showing a detailed result screen displaying detailed measurement results according to the embodiment.

[0033] Figure 22 It is a diagram schematically showing a detailed result screen displaying detailed measurement results according to the embodiment.

[0034] Figure 23 It is a diagram schematically showing a detailed result screen displaying detailed measurement results according to the embodiment.

[0035] Figure 24 This is a flowchart showing a process of setting a rule for additional measurement according to the embodiment.

[0036] Figure 25 This is a flowchart showing the processing of the first inspection device and the management device according to the embodiment.

[0037] Figure 26 This is a diagram schematically illustrating update and registration of a command by the second inspection device according to the embodiment.

[0038] Figure 27 This is a flowchart showing the processing of the second inspection device and the management device according to the embodiment.

[0039] Figure 28 This is a flowchart showing the measurement process of the urine qualitative testing device, the urine sediment testing device, and the imaging device according to the embodiment.

[0040] Figure 29 This is a flowchart showing the processing of the second inspection device and the management device in Modification Example 1.

[0041] Figure 30This is a flowchart showing the processing of the second inspection device in Modification Example 2.

[0042] Figure 31 This is a flowchart showing the processing of the second inspection device in Modification Example 3. DETAILED DESCRIPTION

[0043] Figure 1 It is a front view schematically showing the structure of the sample analysis system 1 . Figure 1 The up, down, left, and right directions are shown in FIG.

[0044] Sample analysis system 1 is a system for analyzing urine samples. In addition to excreted urine, urine samples analyzed also include urine collected from the body, such as bladder urine. Sample analysis system 1 includes a urine qualitative testing device 10, a urine sediment testing device 20, an imaging device 30, and a management device 40.

[0045] The urine qualitative testing device 10 is used to analyze the chemical components of a urine sample for multiple measurement items related to urine qualitative testing. The urine sediment testing device 20 is a urine formed element analysis device that uses flow cytometry to analyze the formed elements in a urine sample for multiple measurement items related to urine sediment. The image capture device 30 is a urine formed element analysis device that uses images obtained by capturing the formed elements contained in the urine sample to analyze the formed elements in the urine sample for multiple measurement items. It should be noted that the analysis performed by the image capture device 30 only requires obtaining at least the measurement results corresponding to the measurement items, and further analysis based on the measurement results (e.g., indication of a possible disease) is not required.

[0046] The urine qualitative testing device 10, urine sediment testing device 20, and imaging device 30 each include transport devices 10a, 20a, and 30a on their front sides. The transport devices 10a, 20a, and 30a transport sample racks 100 holding multiple sample containers 101 and are interconnected so that sample racks 100 can be transported to adjacent transport devices. Sample containers 101 contain samples collected from subjects.

[0047] The operator holds a sample container 101 containing a sample to be inspected in a sample rack 100 and places the sample rack 100 in the right end area of the transport device 10a. The transport devices 10a, 20a, and 30a sequentially transport the sample rack 100 to the urine qualitative testing device 10, the urine sediment testing device 20, and the image capture device 30. The urine qualitative testing device 10 reads the sample ID from the sample container 101, aspirates the sample within the sample container 101, performs a urine qualitative measurement on the aspirated sample, and generates a measurement result. The urine sediment testing device 20 reads the sample ID from the sample container 101, aspirates the sample within the sample container 101, performs a urine sediment measurement on the aspirated sample, and generates a measurement result. The image capture device 30 reads the sample ID from the sample container 101, aspirates the sample within the sample container 101, and captures an image of the aspirated sample to generate a measurement result.

[0048] When all the samples held in the sample rack 100 have been subjected to the required measurement processing by the urine qualitative testing device 10, the urine sediment testing device 20, and the imaging device 30, the sample rack 100 is transported to the left end area of the transport device 30a. The operator removes the processed sample rack 100 from the transport device 30a.

[0049] The management device 40 receives and stores the measurement results obtained by the urine qualitative testing device 10 , the urine sediment testing device 20 , and the imaging device 30 , and displays the measurement results on the display unit 43 in response to an operator's instruction.

[0050] Figure 2 1 is a block diagram showing the functional configuration of the urine qualitative testing device 10 , the urine sediment testing device 20 , and the imaging device 30 .

[0051] The urine qualitative test apparatus 10 includes a control unit 11 , a storage unit 12 , a reading unit 13 , a dispensing unit 14 , a container measuring unit 15 , a colorimetric measuring unit 16 , and a communication unit 17 .

[0052] The control unit 11 is comprised of, for example, a CPU or an FPGA. The control unit 11 performs sample measurement and analysis by executing a computer program stored in the storage unit 12. The storage unit 12 is comprised of, for example, an SSD or a HDD. The storage unit 12 stores measurement data acquired by the container measurement unit 15 and the colorimetric measurement unit 16, as well as measurement results (analysis results) generated by analyzing the measurement data.

[0053] The reader 13 reads the sample ID used to individually identify the sample from the sample container 101. If a barcode label printed with a barcode containing the sample ID is attached to the sample container 101, the reader 13 is comprised of, for example, a barcode reader. The dispensing unit 14 inserts a pipette from above the sample container 101 transported by the transport device 10a, releases air from the tip of the pipette, and stirs the sample within the sample container 101. The dispensing unit 14 then aspirates the sample within the sample container 101 and supplies it to the container measuring unit 15 and the colorimetric measuring unit 16.

[0054] The container measuring section 15 is provided with a measuring container for storing the sample supplied by the subpackaging section 14, and measures the refractive index of the sample in the measuring container using a prism, and measures the transmitted light and scattered light obtained by the irradiated light. The control section 11 obtains the measurement results of specific gravity, hue and turbidity based on the measurement data obtained by the container measuring section 15. The colorimetric measuring section 16 takes out the test paper from the test paper supplier, and places the sample supplied by the subpackaging section 14 on the test paper. The colorimetric measuring section 16 irradiates the test paper with the sample on it with light, and measures the color of the test paper using a color sensor. The control section 11 obtains various measurement results based on the measurement data obtained by the colorimetric measuring section 16. Thereafter, referring to Figure 6 The measurement items of the urine qualitative testing device 10 will be described.

[0055] The communication unit 17 includes a connection terminal based on the Ethernet standard and a connection terminal based on a serial communication standard such as USB. The communication unit 17 communicates with the management device 40 via an Ethernet cable and communicates with the transport device 10a via a USB cable. The control unit 11 controls the transport device 10a via the communication unit 17.

[0056] The specific structure of the urine qualitative testing device 10 is based on the structure of the urine qualitative testing device disclosed in, for example, U.S. Patent Application Publication No. 2016 / 0061851, the contents of which are incorporated by reference as part of this specification.

[0057] The urine sediment inspection device 20 includes a control unit 21 , a storage unit 22 , a reading unit 23 , a dispensing unit 24 , a sample preparation unit 25 , an optical measurement unit 26 , and a communication unit 27 .

[0058] The control unit 21 is comprised of, for example, a CPU or FPGA. The control unit 21 performs sample measurement and analysis by executing a computer program stored in the storage unit 22. The storage unit 22 is comprised of, for example, an SSD or HDD. The storage unit 22 stores measurement data acquired by the optical measurement unit 26 and measurement results (analysis results) generated by analyzing the measurement data.

[0059] The reader 23 reads the sample ID from the sample container 101. The reader 23 is comprised of, for example, a barcode reader. The dispensing unit 24 inserts a pipette from above the sample container 101 transported by the transport device 20a, releases air from the tip of the pipette, and stirs the sample in the sample container 101. The dispensing unit 24 then aspirates the sample in the sample container 101 and supplies it to the specimen preparation unit 25.

[0060] The sample preparation unit 25 includes a reaction container to which the sample is supplied by the dispensing unit 24, and mixes the sample and the reagent in the reaction container to prepare the measurement sample. The optical measurement unit 26 is a flow cytometer that measures the measurement sample based on the flow cytometric quantitative method. Figure 4 The optical measuring unit 26 will be described. The control unit 21 obtains various measurement results based on the measurement data obtained by the optical measuring unit 26. Figure 6 The measurement items of the urine sediment inspection device 20 will be described.

[0061] The communication unit 27 includes a connection terminal based on the Ethernet standard and a connection terminal based on a serial communication standard such as USB. The communication unit 27 communicates with the management device 40 via an Ethernet cable and communicates with the transport device 20a via a USB cable. The control unit 21 controls the transport device 20a via the communication unit 27.

[0062] The specific structure of the urine sediment inspection device 20 is based on the structure of the urine formed component inspection device disclosed in, for example, US Patent Application Publication No. 2016 / 0061851, the contents of which are incorporated by reference as part of this specification.

[0063] The image capturing device 30 includes a control unit 31 , a storage unit 32 , a reading unit 33 , a packaging unit 34 , an imaging unit 35 , and a communication unit 36 .

[0064] The control unit 31 is comprised of, for example, a CPU or an FPGA. The control unit 31 performs sample measurement (imaging) and analysis by executing a computer program stored in the storage unit 32. The storage unit 32 is comprised of, for example, an SSD or a HDD. The storage unit 32 stores measurement data (images) acquired by the imaging unit 35 and measurement results (analysis results) generated by analyzing the measurement data (images).

[0065] The reader 33 reads the sample ID from the sample container 101. The reader 33 is comprised of, for example, a barcode reader. The dispensing unit 34 inserts a pipette from above the sample container 101 transported by the transport device 30a, releases air from the tip of the pipette, and stirs the sample in the sample container 101. The dispensing unit 34 then aspirates the sample in the sample container 101 and supplies it to the imaging unit 35.

[0066] The imaging unit 35 includes a chamber to which the sample is supplied by the dispensing unit 34, and images the formed components in the sample stored in the chamber. Figure 5 The imaging unit 35 will be described. The control unit 31 acquires various measurement results based on the measurement data (image) acquired by the imaging unit 35. Figure 6 The measurement items of the image pickup device 30 will be described.

[0067] The communication unit 36 includes a connection terminal based on the Ethernet standard and a connection terminal based on a serial communication standard such as USB. The communication unit 36 communicates with the management device 40 via an Ethernet cable and communicates with the transport device 30a via a USB cable. The control unit 31 controls the transport device 30a via the communication unit 36.

[0068] It should be noted that the specific structure of the image capture device 30 is, for example, based on the structure of the image capture device disclosed in U.S. Patent Application Publication No. 2018 / 0017480, the contents of which are incorporated by reference as part of this specification.

[0069] Figure 3 It is a block diagram showing the functional structure of the management device 40.

[0070] The management device 40 includes a control unit 41 , a storage unit 42 , a display unit 43 , an input unit 44 , and a communication unit 45 .

[0071] The control unit 41 is comprised of, for example, a CPU. The control unit 41 executes computer programs stored in the storage unit 42 to perform various processes, such as managing measurement results. The storage unit 42 is comprised of, for example, an SSD or HDD. The storage unit 42 stores measurement results transmitted from the urine qualitative testing device 10, the urine sediment testing device 20, and the imaging device 30.

[0072] The display unit 43 is composed of, for example, a liquid crystal display or an organic EL display, etc. The input unit 44 is composed of, for example, a mouse or a keyboard, etc. It should be noted that the display unit 43 and the input unit 44 may be integrally formed, for example, like a touch panel display.

[0073] The communication unit 45 includes a connection terminal compliant with the Ethernet standard. The communication unit 45 communicates with the urine qualitative testing device 10, the urine sediment testing device 20, and the imaging device 30 via Ethernet cables. The control unit 41 transmits various instruction information to the urine qualitative testing device 10, the urine sediment testing device 20, and the imaging device 30 via the communication unit 45, and receives measurement results from these devices.

[0074] It should be noted that the specific structure of the management device 40 is, for example, based on the structure of the information processing device disclosed in U.S. Patent Application Publication No. 2017 / 0153221, the contents of which are incorporated by reference as part of this specification.

[0075] Figure 4 It is a diagram schematically showing the structure of the optical measurement unit 26 . Figure 4 For convenience, mutually orthogonal X, Y, and Z axes are recorded.

[0076] The laser light source 201 emits laser light of a predetermined wavelength in the X-axis direction. The collimator lens 202 converts the laser light emitted from the laser light source 201 into parallel light. The cylindrical lens 203 converges the laser light transmitted through the collimator lens 202 only in the Y-axis direction. The condenser lens 204 converges the laser light transmitted through the cylindrical lens 203 in the Y-axis and Z-axis directions. As a result, the laser light emitted from the laser light source 201 is irradiated onto the measurement sample flowing in the Z-axis direction within the flow cell 205 in a beam shape elongated in the Y-axis direction. Irradiation of the formed components in the measurement sample with the laser light generates forward scattered light in front of the flow cell 205 and side scattered light and fluorescence to the sides of the flow cell 205.

[0077] The condenser lens 206 focuses the forward scattered light at the position of the pinhole 208. The laser light emitted from the laser light source 201 that has not irradiated the formed components in the measurement sample and has passed through the flow cell 205 is condensed by the condenser lens 206 and then blocked by the semitransparent mirror 207 so as not to enter the light receiving unit 209. The light receiving unit 209 receives the forward scattered light that has passed through the pinhole 208 and outputs a signal based on the intensity of the received forward scattered light. The light receiving unit 209 is, for example, a photodiode.

[0078] The condenser lens 210 condenses the side scattered light and the fluorescence. The dichroic mirror 211 reflects the side scattered light that has passed through the condenser lens 210 and transmits the fluorescence that has passed through the condenser lens 210.

[0079] The light receiving unit 212 receives the side scattered light reflected by the dichroic mirror 211 and outputs a signal based on the intensity of the received side scattered light. The light receiving unit 212 is, for example, a photomultiplier tube. The spectroscopic filter 213 transmits fluorescence of a predetermined wavelength from the fluorescence transmitted through the dichroic mirror 211. The light receiving unit 214 receives the fluorescence transmitted through the spectroscopic filter 213 and outputs a signal based on the intensity of the received fluorescence. The light receiving unit 214 is, for example, a photomultiplier tube.

[0080] The signals outputted from the light receiving units 209 , 212 , and 214 are subjected to predetermined processing and are then stored in the storage unit 22 as measurement data.

[0081] Figure 5 It is a diagram schematically showing the configuration of the imaging unit 35 . Figure 5 For convenience, mutually orthogonal X, Y, and Z axes are shown. The Z axis is the vertical direction.

[0082] The light source 301 emits light of a predetermined wavelength. The light source 301 is, for example, a light-emitting diode. The illumination optical system 302 is composed of a plurality of lenses, converting the light from the light source 301 into parallel light and illuminating the imaging area of the objective lens 311. The objective lens 311 forms an image of the light irradiated on the imaging area onto the light-receiving surface of the imaging element 312. The objective lens 311 is driven along the optical axis (Z-axis direction) for focus adjustment. The imaging element 312 is, for example, a CCD image sensor or a CMOS image sensor. The workbench 320 includes a chamber 321. The chamber 321 is a rectangular parallelepiped container made of a transparent material.

[0083] During imaging, each sample supplied from the dispensing unit 34 is introduced into the chamber 321. The chamber 321 is moved along the X-axis by driving the workbench 320. During this time, the objective lens 311 is moved along the optical axis to perform focus adjustment. The chamber 321 is positioned within the imaging area of the objective lens 311. While the chamber 321 is being moved along the X-axis, the imaging element 312 captures the sample filled in the chamber 321 multiple times. Thus, a predetermined number (e.g., 40 images) of the sample in the chamber 321 are acquired.

[0084] Figure 6 It is a diagram showing measurement items of the urine qualitative testing device 10 , measurement items of the urine sediment testing device 20 , and measurement items of the imaging device 30 .

[0085] like Figure 6 As shown, the urine qualitative testing device 10, the urine sediment testing device 20, and the imaging device 30 are each configured to be able to acquire measurement results regarding a plurality of measurement items.

[0086] When the control unit 11 of the urine qualitative testing device 10 acquires the sample ID using the reading unit 13, it transmits command inquiry information including the sample ID to the management device 40. When the control unit 41 of the management device 40 receives the command inquiry information from the urine qualitative testing device 10, it transmits a command (urine qualitative command) of the urine qualitative testing device 10 set for the sample ID to the urine qualitative testing device 10. The urine qualitative command includes the sample ID of the target sample, an indication of the target sample ID, and a command indicating the target sample ID. Figure 6 The control unit 11 of the urine qualitative testing device 10 receives a urine qualitative test command from the management device 40, performs a urine qualitative test on the target sample based on the received urine qualitative test command, and generates the measurement result specified by the urine qualitative test command.

[0087] When the control unit 21 of the urine sediment examination device 20 acquires the sample ID using the reading unit 23, it transmits a command inquiry message including the sample ID to the management device 40. When the control unit 41 of the management device 40 receives the command inquiry message from the urine sediment examination device 20, it transmits a command (urine sediment command) of the urine sediment examination device 20 set corresponding to the sample ID to the urine sediment examination device 20. The urine sediment command includes the sample ID of the target sample, an instruction indicating the target sample ID, and a command indicating the target sample ID. Figure 6 The control unit 21 of the urine sediment examination device 20 receives a urine sediment instruction from the management device 40, performs urine sediment measurement on the target sample based on the received urine sediment instruction, and generates the measurement result specified by the urine sediment instruction.

[0088] When the control unit 31 of the image capture device 30 acquires the sample ID using the reading unit 33, it transmits a command inquiry message including the sample ID to the management device 40. When the control unit 41 of the management device 40 receives the command inquiry message from the image capture device 30, it transmits a command (image capture command) of the image capture device 30 set corresponding to the sample ID to the image capture device 30. The image capture command includes the sample ID of the target sample, an indication of the target sample ID, and a command indicating the target sample ID. Figure 6 The control unit 31 of the image capturing device 30, upon receiving an image capturing instruction from the management device 40, captures an image of the target sample based on the received image capturing instruction and generates the measurement result specified by the image capturing instruction.

[0089] Such urine qualitative instructions, urine sediment instructions, and image capture instructions are set in advance by an operator based on a doctor's judgment based on patient information or the policy of an examination facility, and are stored in the storage unit 42 of the management device 40 or a host with which the management device 40 can communicate.

[0090] In the embodiment, in addition to the commands set in advance, additional commands may be automatically set based on the measurement results of the sample.

[0091] For example, when samples are sequentially conveyed to three testing devices (the urine qualitative testing device 10, the urine sediment testing device 20, and the imaging device 30), it may be desirable to perform additional measurements at a downstream testing device (hereinafter referred to as the "second testing device") based on predetermined measurement results obtained by the upstream testing device (hereinafter referred to as the "first testing device"). In this case, even if no commands for the second testing device have been pre-set, additional commands for the second testing device are automatically set for the measurement items of the second testing device associated with the predetermined measurement results of the first testing device, and measurements are performed by the second testing device based on these commands (hereinafter referred to as "additional measurements").

[0092] If the second inspection apparatus instructions are pre-set, the pre-set second inspection apparatus instructions may include additional instructions, or additional instructions may be set separately. For example, if the original second inspection apparatus instructions specify measurement item A, and the additional measurement item to be added is B, the original second inspection apparatus instructions may be modified to additional instructions specifying both measurement items A and B, or additional instructions specifying measurement item B may be set separately from the original second inspection apparatus instructions.

[0093] It should be noted that, because the urine sediment inspection device 20 can obtain measurement results for all measurement items of the urine sediment inspection device 20 through a common measurement operation, all measurement items can also be set as additional instructions for the urine sediment inspection device 20. Similarly, because the image capture device 30 can obtain measurement results for all measurement items of the image capture device 30 through a common measurement operation, all measurement items can also be set as additional instructions for the image capture device 30.

[0094] As a specific example, if protein is detected by the urine qualitative testing device 10, an additional command is automatically set for the urine sediment of the sample. Specifically, the measurement item "casts (CAST)" of the urine sediment testing device 20, which is associated with the measurement item "protein (PRO)" of the urine qualitative testing device 10, is designated as an additional measurement item, and an additional command including the designated measurement item is set. The urine sediment testing device 20 then automatically performs an additional measurement to check for the presence of casts, which are associated with protein detection.

[0095] In this case, if the amount of protein detected by the urine qualitative testing device 10 is trace, it is assumed that the amount of casts contained in the sample is small. Therefore, it is preferable to perform a predetermined number of additional measurements in the urine sediment testing device 20 to reliably detect the presence of casts. Therefore, in the embodiment, to increase the likelihood of obtaining reliable measurement results, instructions are set to perform multiple additional measurements on samples with the same sample ID. Hereinafter, performing multiple measurements using the same measurement method in additional measurements is referred to as "multiple measurements."

[0096] Furthermore, in the embodiment, when performing multiplex measurements using a second inspection device, if a predetermined measurement result is obtained by the second inspection device, the multiplex measurement is terminated even in the middle of the multiplex measurement. Hereinafter, the condition for terminating the multiplex measurement is referred to as the "termination condition." By setting the termination condition in the additional instruction, it is possible to save reagents, samples, and time, compared to performing all predetermined measurements in the multiplex measurement.

[0097] Figures 7-9 This is a diagram illustrating the rules for additional measurement. Figures 7-9 The rules for three, two, and five additional measurements are shown respectively. Figures 7-9 In the present invention, each rule for additional measurement includes a condition for performing additional measurement by a second inspection device, the number of additional measurements by the second inspection device, and a condition for terminating multiple measurements by the second inspection device. Each condition for performing additional measurement by a second inspection device includes a measurement item by the first inspection device and a benchmark corresponding to the measurement result of the measurement item.

[0098] Figure 7 This is a diagram illustrating rules for additional measurement when the first inspection apparatus is the urine qualitative inspection apparatus 10 and the second inspection apparatus is the urine sediment inspection apparatus 20 .

[0099] When the measurement results for the "Protein (PRO)" measurement item in the urine qualitative testing device 10 are "+-," "1+," "2+," "3+," or "4+," the urine sediment testing device 20 performs additional measurements three, two, one, one, and one times, respectively, and sets additional commands to include the measurement items "Cases (CAST)," "Red Blood Cell Morphology Information (RBC-Info.)," and "Renal Tubular Epithelial Cells (RTEC)." In this case, in each of the additional measurement results in the urine sediment testing device 20, if the measurement result for the "Cases (CAST)" measurement item exceeds a specified value, if the measurement result for the "Red Blood Cell Morphology Information (RBC-Info.)" measurement item indicates the presence of deformed red blood cells (Dysmorphic? or Mixed?), or if the measurement result for the "Renal Tubular Epithelial Cells (RTEC)" measurement item exceeds a specified value, an end condition is set to terminate the multiplex measurement. It should be noted that the termination condition may be set when the measurement results of two or three of the three tangible components are equal to or greater than a predetermined value.

[0100] If the measurement result of the "specific gravity (SG)" measurement item in the urine qualitative testing device 10 is 1.010 or less, greater than 1.010 and less than 1.030, or greater than 1.030, the urine sediment testing device 20 performs two, one, and two additional measurements, respectively, and an additional command is set to include all measurement items. In this case, the measurement result of the "specific gravity (SG)" measurement item in the urine qualitative testing device 10 is associated with all measurement items in the urine sediment testing device 20, and no termination condition is set, but the specified number of measurements is performed.

[0101] If the measurement result of the "pH" measurement item in the urine qualitative testing device 10 is 5.0 or less, greater than 5.0 and less than 8.0, or 8.0 or greater, the urine sediment testing device 20 performs two, one, and two additional measurements, respectively, and an additional instruction is set to include all measurement items. In this case, the measurement result of the "pH" measurement item in the urine qualitative testing device 10 is associated with all measurement items in the urine sediment testing device 20, and no termination condition is set, but the specified number of measurements is performed.

[0102] Figure 8 This is a diagram illustrating rules for additional measurement when the first inspection apparatus is the urine qualitative inspection apparatus 10 and the second inspection apparatus is the imaging apparatus 30 .

[0103] If the urine qualitative testing device 10's measurement result for the measurement item "Bilirubin (BIL)" is "+," the imaging device 30 performs five additional measurements (images) and sets an additional command to include the measurement item "Bilirubin crystals." In this case, if the measurement result for the measurement item "Bilirubin crystals" in each of the additional measurements performed by the imaging device 30 exceeds a predetermined value, an end condition is set to terminate the multiplex measurement.

[0104] The urine qualitative testing device 10's measurement results for the "color" measurement item include "OTHER," "LYELLOW," "STRAW," "YELLOW," "AMBER," "RED," and "DK BROWN." If the urine qualitative testing device 10's measurement result for the "color" measurement item is "OTHER," the imaging device 30 performs five additional measurements (images) and sets an additional command to include the "drug crystals" measurement item. In this case, if the measurement result for the "drug crystals" measurement item in each of the additional measurements performed by the imaging device 30 exceeds a specified value, an end condition is set to terminate the multiplex measurement.

[0105] Figure 9 This is a diagram illustrating rules for additional measurement when the first inspection apparatus is the urine sediment inspection apparatus 20 and the second inspection apparatus is the imaging apparatus 30 .

[0106] The measurement result for the "Atypical Cells (Atyp. C)" measurement item in the urine sediment inspection device 20 includes a measurement value indicating the number of cells per unit volume and a positive flag determined based on the measurement value. If the measurement result for the "Atypical Cells (Atyp. C)" measurement item in the urine sediment inspection device 20 indicates the presence of a positive flag or a value above a threshold, the imaging device 30 performs five additional measurements (images) and sets an additional command to include the "Atypical Cells" measurement item. In this case, if the measurement result for the "Atypical Cells" measurement item in each of the additional measurements performed by the imaging device 30 exceeds a predetermined value, an end condition is set to terminate the multiplex measurement.

[0107] The measurement results for the "fat droplets" measurement item in the urine sediment examination device 20 include a measurement value indicating the number of fat droplets per unit volume and a positive flag determined based on the measurement value. If the measurement result for the "fat droplets" measurement item in the urine sediment examination device 20 indicates the presence of a positive flag or a value above a threshold, the imaging device 30 performs five additional measurements (images), and an additional instruction is set to include the measurement items "oval fat bodies," "Mallory bodies," and "fat droplets." In this case, an end condition is set to terminate the multiplex measurement if, in each of the additional measurement results of the imaging device 30, the measurement result for the "oval fat bodies" measurement item is above a specified value, the measurement result for the "Mallory bodies" measurement item is above a specified value, or the measurement result for the "fat droplets" measurement item is above a specified value. It should be noted that an end condition can also be set when the measurement results for two or three of these three formed components are above a specified value.

[0108] If the measurement result for the "cast (CAST)" measurement item in the urine sediment examination device 20 exceeds the threshold, the imaging device 30 performs five additional measurements (images), and an additional instruction is set to include the "cast" measurement item. In this case, an end condition is set to terminate the multiplex measurement if the measurement result for the "cast" measurement item in each of the additional measurements performed by the imaging device 30 exceeds a predetermined value.

[0109] If the measurement result of the measurement item "epithelial cells (EC)" by the urine sediment inspection device 20 is greater than a threshold value, the image capture device 30 performs five additional measurements (image capture) and sets an additional instruction to include the measurement item "epithelial cells." In this case, if the measurement result of the measurement item "epithelial cells" in each of the additional measurements by the image capture device 30 is greater than a predetermined value, an end condition is set to terminate the multiplex measurement.

[0110] If the measurement result of the "Sperm" measurement item in the urine sediment examination device 20 exceeds a threshold, the image capture device 30 performs five additional measurements (image capture) and sets an additional command to include the "Sperm" measurement item. In this case, if the measurement result of the "Sperm" measurement item in the additional measurements performed by the image capture device 30 exceeds a predetermined value, an end condition is set to terminate the multiplex measurement.

[0111] like Figures 7-9As shown, the measurement items of the first testing device that serve as conditions for performing additional measurements with the second testing device and the measurement items that serve as termination conditions for multiplexed measurements with the second testing device are associated with each other. That is, based on the measurement results that serve as termination conditions for multiplexed measurements with the second testing device, it is possible to infer the same disease as the disease inferred from the measurement results of the first testing device used to determine whether additional measurements with the second testing device are necessary. For example, if the measurement result for the measurement item "Protein (PRO)" by the urine qualitative testing device 10 (first testing device) is "+-", it is inferred that the subject may have a kidney disease. In this case, if the measurement result for the measurement item "Cases (CAST)" by the urine sediment testing device 20 (second testing device) is above a specified value, it can be determined that the subject is highly likely to have a kidney disease.

[0112] In this embodiment, based on the association of measurement items between the first and second inspection devices in the additional measurement rule, the termination condition for the multiplex measurement by the second inspection device includes obtaining a measurement result from the second inspection device that is indicated by the measurement result from the first inspection device, which is used to determine whether to perform the inspection by the second inspection device. This increases the likelihood of obtaining a measurement result from the second inspection device indicated by the measurement result from the first inspection device, and terminates the measurement by the second inspection device if the measurement result from the second inspection device is available. This reduces reagent consumption by the second inspection device, sample supply to the second inspection device, and the time required for sample measurement.

[0113] Next, the screen for setting the additional measurement rule will be described.

[0114] The rule list screen 400, rule setting screen 500, and termination condition setting screen 600 shown below are displayed on the display unit 43 of the management device 40 by the control unit 41 of the management device 40. Furthermore, when the operator of the management device 40 inputs an operation to these screens via the input unit 44, the control unit 41 of the management device 40 executes a process based on the input operation.

[0115] Figure 10 1 is a diagram schematically showing a rule list screen 400 showing a list of rules for additional measurement.

[0116] The list area 410 displays the additional measurement rules in rows, including items such as valid, rule name, first inspection device, second inspection device, multiple measurements, and end condition.

[0117] The "Effective" item includes a checkbox 411 indicating whether the rule is valid. By operating checkbox 411, the operator can set the rule to be valid (checked) or invalid (unchecked). The "Rule Name" item indicates the name assigned to the rule by the operator. The "First Inspection Device" item indicates the name of the upstream inspection device used to determine the execution conditions for the additional measurement, and the "Second Inspection Device" item indicates the name of the downstream inspection device for performing the additional measurement. The "Multiple Measurements" item indicates the number of measurements performed by the second inspection device set for the rule. The "End Condition" item indicates whether there is a condition for ending the multiple measurements set for the rule.

[0118] When creating a new rule, the operator operates the new button 401. As a result, the rule setting screen 500 (see Figure 11 ). When editing an existing rule, the operator operates the corresponding row in the list area 410. As a result, the display unit 43 displays the rule setting screen 500 including the rule of the operated row.

[0119] Figure 11 1 is a diagram schematically showing a rule setting screen 500 for setting a rule for additional measurement.

[0120] The operator enters a name that identifies the rule in text box 510. The operator operates pull-down menu 521 to enter any one of the urine qualitative testing device 10, urine sediment testing device 20, and image capturing device 30 as the first testing device, and operates pull-down menu 522 to enter any one of the urine sediment testing device 20 and image capturing device 30 as the second testing device.

[0121] The operator operates the pull-down menu 530 to input the measurement item of the first inspection device for determining whether additional measurement is required, and enters the condition value of the measurement item of the first inspection device in the text box 541. When there are multiple condition values, the operator can operate the add button 542 to additionally display the text box 541. The operator enters the number of measurements performed using the second inspection device in the text box 543. When setting a single measurement, the operator enters "1" in the text box 543. When setting multiple measurements, the operator enters a value of 2 or more in the text box 543. When the measurement result of the first inspection device meets the condition value, the operator enters the detailed result screen 800 (refer to the text box 544) that displays the measurement result. Figure 21 ) When adding a rule to the measurement item setting for the first inspection device, the operator operates the add button 545. As a result, a condition area 540 is further added.

[0122] The operator operates the check box 551 to set whether or not to enable the condition for terminating the multiple measurements performed by the second inspection apparatus. If the check box 551 is checked, the condition for terminating the multiple measurements is enabled. If the operator operates the end condition setting button 552, an end condition setting screen 600 (see FIG. 4 ) for setting the end condition is displayed on the display unit 43. Figure 12 ).

[0123] When the OK button 501 is pressed, the control unit 41 of the management device 40 stores the rules set on the rule setting screen 500 and the set conditions temporarily stored on the termination condition setting screen 600 (described later) in the storage unit 42, and closes the rule setting screen 500. When the Cancel button 502 is pressed, the control unit 41 cancels the rules set on the rule setting screen 500 and closes the rule setting screen 500. When the Delete button 503 is pressed, the control unit 41 deletes the rules set on the rule setting screen 500 from the storage unit 42.

[0124] Figure 12 FIG. 6 is a diagram schematically showing an end condition setting screen 600 for setting an end condition.

[0125] The operator operates checkbox 610 to determine whether the conditions for terminating multiple measurements by the second inspection device, that is, the conditions set on the termination condition setting screen 600, are valid. If checkbox 610 is checked, the conditions for terminating multiple measurements are valid. The status of checkbox 610 is linked to the status of checkbox 551 on the rule setting screen 500.

[0126] The operator operates pull-down menu 621 to enter the measurement item of the second inspection device used to determine the completion of the multiplexed measurement by the second inspection device, and enters the condition value of the measurement item of the second inspection device in text box 622. If there are multiple condition values, the operator can operate add button 623 to display an additional text box 622. To add a condition for multiplexed measurement, the operator operates add button 624. This adds another condition area 620. If multiple condition areas 620 are displayed, the operator operates pull-down menu 630 to select whether to use "and" or "or" to determine the conditions set in the multiple condition areas 620.

[0127] When the OK button 601 is pressed, the control unit 41 of the management device 40 temporarily stores the termination condition set on the termination condition setting screen 600 in the storage unit 42 and closes the termination condition setting screen 600. When the Cancel button 602 is pressed, the control unit 41 cancels the termination condition set on the termination condition setting screen 600 and closes the termination condition setting screen 600.

[0128] Figure 13 This is a schematic representation of the setting Figure 7 The diagram shows a rule setting screen 500 showing the status of the additional measurement rule when the measurement item is protein.

[0129] like Figure 7 As shown, since five conditions are set for the measurement item "Protein (PRO)" of the first test apparatus (urine qualitative test apparatus 10), five condition areas 540 are displayed. If multiple condition areas 540 are displayed, a delete button 546 for deleting each condition area 540 is provided.

[0130] Figure 14 This is a schematic representation of the setting Figure 7 The diagram shows the end condition setting screen 600 showing the state of the end condition when the measurement item is protein.

[0131] like Figure 7 As shown, in this case, three condition areas 620 are displayed because end conditions related to the measurement items "casts (CAST)," "red blood cell morphology information (RBC-Info.)," and "renal tubular epithelial cells (RTEC)" of the second testing device (urine sediment testing device 20) have been set. When multiple text boxes 622 are displayed for inputting condition values for the measurement items of the second testing device, a delete button 625 for deleting each text box 622 and a pull-down menu 626 for selecting whether to use "and" or "or" to determine the condition value of each text box 622 are provided. Furthermore, when multiple condition areas 620 are displayed, a delete button 627 for deleting each condition area 620 is provided.

[0132] Figure 15 This is a schematic representation of the setting Figure 7 The illustrated diagram is a rule setting screen 500 showing a state of an additional measurement rule when the measurement item is specific gravity.

[0133] like Figure 7As shown in FIG, three conditions are set for the measurement item "Specific Gravity (SG)" of the first test device (urine qualitative test device 10), so three condition areas 540 are displayed. When the condition area 540 displays multiple text boxes 541 for inputting the condition values of the measurement items of the first test device, a delete button 547 for deleting each text box 541 and a pull-down menu 548 for selecting whether to determine the condition value of each text box 541 by "and" or "or" are provided. In this case, as shown in FIG. Figure 7 As shown, since there is no end condition for the measurement in the second inspection apparatus (urine sediment inspection apparatus 20 ), the check box 551 is set to an unchecked state.

[0134] Figure 16 This is a schematic representation of the setting Figure 8 The illustrated diagram is a rule setting screen 500 showing the status of the additional measurement rule when the measurement item is bilirubin.

[0135] like Figure 8 As shown, because one condition is set for the measurement item "Bilirubin (BIL)" by the first inspection device (urine qualitative inspection device 10), one condition area 540 is displayed. In this case, the number of measurements (number of images) by the second inspection device (image capture device 30) is set to five.

[0136] Figure 17 This is a schematic representation of the setting Figure 8 The diagram shows the end condition setting screen 600 in the state of the end condition when the measurement item is bilirubin.

[0137] like Figure 8 As shown, in this case, a single end condition has been set for the measurement item "bilirubin crystals" for the second inspection device (image capture device 30), so a single condition area 620 is displayed. In this case, "+" is entered in the text box 622 representing the condition value to set the detection of one bilirubin crystal in the image capture device 30 as the end condition. Note that an inequality sign, for example, can also be entered in text box 622 to set the detection of a predetermined value or more of bilirubin crystals as the end condition.

[0138] Figure 18 This is a schematic representation of the setting Figure 9 The diagram shows a rule setting screen 500 showing the status of the additional measurement rule when the measurement item is atypical cells.

[0139] like Figure 9 As shown, since one condition is set for the measurement item “Atypical cells (Atyp. C)” of the first inspection device (urine sediment inspection device 20 ), one condition area 540 is displayed.

[0140] Figure 19 This is a schematic representation of the setting Figure 9 The diagram shows the end condition setting screen 600 showing the state of the end condition when the measurement item is atypical cells.

[0141] like Figure 9 As shown, in this case, since one end condition related to the measurement item “abnormal cells” of the second inspection device (image capturing device 30 ) is set, one condition area 620 is displayed.

[0142] Next, the screen for displaying the measurement results will be described.

[0143] The result list screen 700 and detailed result screen 800 shown below are also displayed on the display unit 43 of the management device 40 by the control unit 41 of the management device 40. When the operator of the management device 40 inputs an operation to these screens via the input unit 44, the control unit 41 of the management device 40 executes a process according to the input operation.

[0144] Figure 20 FIG. 7 is a diagram schematically showing a result list screen 700 displaying a list of measurement results.

[0145] The list area 710 displays the measurement results associated with the sample ID in rows, including items such as measurement, sample ID, qualitative analysis, sediment, image, and a plurality of measurement items.

[0146] In the "Measurement" item, a check mark 711 is displayed when a command to perform multiple additional measurements (multiple measurements) has been set for the second testing device (either the urine sediment testing device 20 or the image capturing device 30). In the "Qualitative," "Sediment," and "Image" items, a check mark 712 is displayed when measurements are performed using the urine qualitative testing device 10, the urine sediment testing device 20, and the image capturing device 30, respectively. The "Multiple Measurement Items" item indicates the measurement results of all measurement items that can be acquired using the urine qualitative testing device 10, the urine sediment testing device 20, and the image capturing device 30.

[0147] When the operator refers to the detailed measurement results of the target sample, he operates the corresponding row in the list area 710. As a result, the detailed result screen 800 (see FIG. 1 ) including the detailed measurement results corresponding to the sample ID of the operated row is displayed on the display unit 43. Figures 21-23 ).

[0148] Figure 21 1 is a diagram schematically showing a detailed result screen 800 displaying detailed measurement results when a tab 821 is operated.

[0149] The sample information display area 810 displays the sample ID, the date of sample collection, the name of the subject who collected the sample, etc. Figure 20 Similar to the symbol 711 shown, a symbol 811 is displayed when a command to perform a plurality of additional measurements (multiple measurements) is set to the second inspection apparatus (either the urine sediment inspection apparatus 20 or the imaging apparatus 30 ).

[0150] In the display area 820, various measurement results are displayed according to the operation of the tabs 821 to 824. Figure 21 The display area 820 displays the measurement results at a glance by operating the tab 821 and also displays the status of the annotations.

[0151] The operator operates the pull-down menu 831 to determine which of the measurement results obtained by the urine qualitative testing device 10 (urine qualitative testing results), the measurement results obtained by the urine sediment testing device 20 (urine sediment testing results), and the measurement results obtained by the image capturing device 30 (image testing results) is to be displayed in the list area 832.

[0152] If the target sample has been measured multiple times by the device corresponding to pull-down menu 831, the results of each measurement are displayed in items such as "Result 1" or "Result 2" in list area 832, and a comprehensive result value based on each measurement result is displayed in the "Result" item. The comprehensive result value is, for example, the average of the measurement results. On the other hand, if the target sample has been measured only once by the device corresponding to pull-down menu 831, the result of that single measurement is displayed in the "Result" item in list area 832, and items such as "Result 1" or "Result 2" are omitted.

[0153] In the review note 833, when the target sample has been measured multiple times in the device corresponding to the pull-down menu 831, a note indicating this and the measurement items that served as the basis for the multiple measurements are displayed. Figure 21 The review note 833 shows that the measurement results of protein (PRO) in the urine qualitative test device 10 are performed multiple times in the urine sediment test device 20. In addition, the text box 544 (refer to Figure 11 ) in the comments.

[0154] Figure 22 1 is a diagram schematically showing a detailed result screen 800 displaying detailed measurement results when the tab 824 is operated.

[0155] Example in Figure 22The display area 820 displays the measurement results at a glance by operating the tab 824 , and displays a state of a graph such as a scattergram or a histogram.

[0156] The operator operates the pull-down menu 841 to determine which of the urine qualitative test results, urine sediment test results, and image test results is to be displayed in the list area 842. According to the operation of the pull-down menu 841, the chart obtained by the urine qualitative test device 10, the chart obtained by the urine sediment test device 20, and the image obtained by the image capture device 30 are displayed in the chart area 850. Figure 22 The graph area 850 displays two scattergrams 851 and 852 obtained by the urine sediment inspection apparatus 20 , and displays a mark 853 indicating that these scattergrams 851 and 852 are obtained through a plurality of measurements.

[0157] Here, when a single device performs multiple measurements on a single sample, the graph obtained using the device is generated by superimposing the multiple measurement results. Typically, because the number of visible components detected by the urine sediment examination device 20 or the imaging device 30 is small, the number of visible components plotted on the scatter plot from a single measurement is also small. In this case, it is difficult to classify visible components using a scatter plot. In contrast, according to an embodiment, when multiple measurements are performed, the plots obtained from these multiple measurements are superimposed on the graph. This makes it easier to classify visible components using a scatter plot because the number of visible components plotted on the scatter plot increases.

[0158] Note that, the scattergrams of the original measurement results may be displayed separately from the scattergram generated by superimposing a plurality of measurement results.

[0159] Figure 23 1 is a diagram schematically showing a detailed result screen 800 displaying detailed measurement results when the tab 822 is operated.

[0160] Example in Figure 23 The display area 820 displays the measurement results obtained by the two devices in parallel horizontally by operating the tab 822.

[0161] The operator operates pull-down menu 861 to determine which of the urine qualitative test results, urine sediment test results, and image test results is to be displayed in list area 862. The operator operates pull-down menu 863 to determine which of the urine qualitative test results, urine sediment test results, and image test results is to be displayed in list area 864.

[0162] It should be noted that if the tab 823 is operated, the display area 820 displays measurement results of, for example, the urine sediment examination device 20's measurement items "urothelial cells (Tran.EC)", "renal tubular epithelial cells (RTEC)", "small round epithelial cells (SRC)", "atypia cells (Atyp.C)", "red blood cell morphology information (RBC-Info.)" as research items among the measurement items of each device.

[0163] Next, the processing performed by the management device 40, the first inspection device, and the second inspection device will be described with reference to a flowchart.

[0164] Figure 24 This is a flowchart showing the process of setting a rule for additional measurement.

[0165] When the control unit 41 of the management device 40 determines that an instruction to display the rule setting screen 500 has been input via the input unit 44 (step S11: YES), the control unit 41 displays the rule setting screen 500 on the display unit 43 in step S12. The operator of the management device 40 thereby inputs a rule for additional measurement on the rule setting screen 500 via the input unit 44. When the control unit 41 determines that the end condition setting button 552 for displaying the end condition setting screen 600 has been pressed on the rule setting screen 500 as an instruction to set an end condition (step S13: YES), the control unit 41 displays the end condition setting screen 600 on the display unit 43 in step S14. The operator of the management device 40 thereby inputs an end condition on the end condition setting screen 600 via the input unit 44.

[0166] When the control unit 41 determines that the OK button 601 or the Cancel button 602 on the termination condition setting screen 600 has been pressed as an instruction to terminate the setting of the termination condition (step S15: YES), the control unit 41 closes the termination condition setting screen 600 in step S16 and returns the process to step S12. Here, when the OK button 601 has been pressed on the termination condition setting screen 600, the control unit 41 temporarily stores the termination condition set on the termination condition setting screen 600.

[0167] When the control unit 41 determines that the OK button 501, Cancel button 502, or Delete button 503 on the rule setting screen 500 has been pressed as an instruction to terminate the setting of the additional measurement rule (step S17: YES), the control unit 41 stores the additional measurement rule entered on the rule setting screen 500 and the termination condition entered on the termination condition setting screen 600 in the storage unit 42 in step S18. If the Cancel button 502 on the rule setting screen 500 has been pressed, the control unit 41 skips the processing of step S18. If the Delete button 503 on the rule setting screen 500 has been pressed, the control unit 41 deletes the stored additional measurement rule and termination condition from the storage unit 42. Then, in step S19, the control unit 41 closes the rule setting screen 500.

[0168] Next, the processing of the first inspection apparatus, the second inspection apparatus, and the management apparatus 40 when the first inspection apparatus and the second inspection apparatus sequentially perform measurement will be described with reference to a flowchart.

[0169] As described above, in the embodiment, there are three types of combinations of the first inspection device and the second inspection device. Specifically, as combinations, there are the following cases: (1) the first inspection device and the second inspection device are respectively a urine qualitative inspection device 10 and a urine sediment inspection device 20; (2) the first inspection device and the second inspection device are respectively a urine qualitative inspection device 10 and an image pickup device 30; (3) the first inspection device and the second inspection device are respectively a urine sediment inspection device 20 and an image pickup device 30. In the combinations (1) to (3), respectively according to Figure 7 、 8 , and perform additional measurements according to the rules shown in 9.

[0170] Figure 25 This is a flowchart showing the processing of the first inspection device and the management device 40.

[0171] In step S101, the control unit of the first inspection device uses the reading unit of the first inspection device to read the sample ID from the sample container 101. In step S102, the control unit of the first inspection device sends query information containing a command for the sample ID read in step S101 to the management device 40. Upon receiving the command query information from the first inspection device, the control unit 41 of the management device 40 retrieves the command for the first inspection device corresponding to the sample ID contained in the received command query information from the storage unit 42 of the management device 40 or an external host. Then, in step S111, the control unit 41 of the management device 40 transmits the retrieved command to the first inspection device.

[0172] In step S103, the control unit of the first inspection device performs measurement processing using the first inspection device based on the instruction received from the management device 40, and obtains the measurement result (first measurement result) of the first inspection device. Figure 28 The measurement process will be described. In step S104 , the control unit of the first inspection apparatus associates the first measurement result acquired in step S103 with the sample ID and transmits it to the management apparatus 40 . Thereafter, in step S105 , the control unit of the first inspection apparatus transports the sample rack 100 .

[0173] If the sample rack 100 contains samples that have not been processed by the first inspection apparatus, the control unit of the first inspection apparatus performs steps S101 to S105 on the remaining samples. When the measurement of all samples held in the sample rack 100 is completed, the control unit of the first inspection apparatus transfers the sample rack 100 from the transport device of the first inspection apparatus to the transport device of a subsequent inspection apparatus.

[0174] When the control unit 41 of the management device 40 receives the first measurement result from the first testing device (step S112: YES), in step S113, the control unit 41 stores the received first measurement result in the storage unit 42. In step S114, the control unit 41 determines whether the received first measurement result needs to be additionally measured by the second testing device based on the additional measurement rule. If the first testing device is the urine qualitative testing device 10, the determination of whether the second testing device needs to be additionally measured is based on the additional measurement rule. Figure 7 、 8 In the case where the first inspection device is a urine sediment inspection device 20, the determination of whether or not it is necessary is based on Figure 9 The additional measurement was performed according to the rules shown.

[0175] When the control unit 41 determines in step S114 that additional measurement is required by the second inspection apparatus (step S115 : YES), in step S116 , the control unit 41 updates or registers the command of the second inspection apparatus for the target sample.

[0176] Figure 26 This is a diagram schematically illustrating the updating and registration of the command of the second inspection device.

[0177] like Figure 26 As shown in the upper left side of FIG, in the case where the instruction of the second inspection device of the target sample is set in advance by the operator, that is, in the case where there is an original instruction, as shown in FIG. Figure 26 As shown in the upper right section of , the control unit 41 updates the original instruction stored in the storage unit 42 or the host according to the measurement content of the second inspection device corresponding to the first measurement result of the first inspection device in accordance with the conditions for performing additional measurement. Figure 26In the upper left section of the table, the measurement item specified by the original command is "Cast (CAST)". In this case, if Figure 7 The rules for appending the first line are as follows Figure 26 As shown in the upper right section of the , the original command is updated to reflect the contents of the additional measurement. Thus, "Red Blood Cell Morphology Information (RBC-Info.)" and "Renal Tubular Epithelial Cells (RTEC)" are added to the measurement items, the number of measurements is set to three, and an end condition is added.

[0178] It should be noted that, when the end condition is set in the additional measurement rule, all the measurement items of the second inspection device can also be set in the update of the additional instruction. Figure 26 If there is an original instruction as shown on the left side of the upper paragraph, it can also be registered separately Figure 26 The additional instructions shown on the right side of the upper section.

[0179] On the other hand, Figure 26 As shown in the lower left side of , when there is no original instruction of the target sample, as shown in Figure 26 As shown in the lower right side of FIG, the control unit 41 re-registers the command of the second inspection device based on the additional measurement rule and stores it in the storage unit 42 or the host. In this case, all measurement items of the second inspection device can also be set in the registration of the additional command.

[0180] It should be noted that when the first measurement result satisfies multiple conditions for performing additional measurements, for example, the largest number of additional measurements corresponding to each condition is set as the number of additional measurements instructed by the second inspection device, and all end conditions corresponding to each condition are set as the end conditions of the instructions of the second inspection device.

[0181] return Figure 25 If the control unit 41 determines in step S114 that additional measurement is not required using the second inspection device (step S115: NO), the process of step S116 is not performed. If the determination in step S115 is NO or step S116 has been executed, the process proceeds to Figure 27 Step S131.

[0182] Figure 27 This is a flowchart showing the processing of the second inspection device and the management device 40.

[0183] In step S121, the control unit of the second inspection device uses the reading unit of the second inspection device to read the sample ID from the sample container 101. In step S122, the control unit of the second inspection device sends query information containing a command for the sample ID read in step S121 to the management device 40. Upon receiving the command query information from the second inspection device, the control unit 41 of the management device 40 retrieves the command for the second inspection device corresponding to the sample ID contained in the received command query information from the storage unit 42 of the management device 40 or an external host. Then, in step S131, the control unit 41 of the management device 40 transmits the retrieved command to the second inspection device.

[0184] If no instructions for the second inspection apparatus are stored for the target sample, the control unit 41 of the management device 40 transmits information to the second inspection apparatus indicating that no instructions for the second inspection apparatus exist. In this case, the processing of steps S123 to S127, described below, is omitted in the second inspection apparatus.

[0185] In step S123, the control unit of the second inspection device performs measurement processing using the second inspection device based on the command received from the management device 40, and obtains the measurement results of the second inspection device (second measurement results). The processing of step S123 completes one measurement by the second inspection device. Next, in step S124, the control unit of the second inspection device determines whether the target sample has been measured the number of times specified in the command from the second inspection device. If the number of measurements specified in the command from the second inspection device has been completed (step S124: YES), the control unit of the second inspection device completes the measurement by the second inspection device in step S126.

[0186] If the number of measurements specified by the command from the second inspection apparatus has not been completed (step S124: NO), in step S125, the control unit of the second inspection apparatus determines whether the second measurement result obtained in the previous step S123 satisfies the termination condition specified by the command from the second inspection apparatus. If the second measurement result satisfies the termination condition (step S125: YES), in step S126, the control unit of the second inspection apparatus terminates the measurement by the second inspection apparatus.

[0187] If the number of measurements specified by the command from the second inspection apparatus is not completed (step S124: NO) and the second measurement result does not satisfy the termination condition (step S125: NO), the control unit of the second inspection apparatus returns the process to step S123 and performs the measurement process by the second inspection apparatus again.

[0188] As described above, the determination of the end condition (step S125) is performed each time the second inspection device performs a measurement (step S123). The termination process (step S126) of the measurement when the end condition is satisfied is executed upon completion of the measurement by the second inspection device for which the termination condition has been determined. In other words, the termination process (step S126) of the measurement when the end condition is satisfied is executed at a time when no measurement by the second inspection device is in progress. This ensures that measurements for which the termination condition has been determined can be reliably executed to the end.

[0189] In step S127, the control unit of the second inspection apparatus transmits the number of times the measurement process of step S123 was performed and all second measurement results acquired in step S123 in association with the sample ID to the management apparatus 40. Thereafter, in step S128, the control unit of the second inspection apparatus transports the sample rack 100.

[0190] In this case, if the sample rack 100 holds samples that have not been processed by the second inspection apparatus, the control unit of the second inspection apparatus performs steps S121 to S127 on the remaining samples. When the measurement of all samples held in the sample rack 100 is completed, if the second inspection apparatus is the urine sediment inspection apparatus 20, the control unit of the second inspection apparatus transports the sample rack 100 to the transport device 30a of the subsequent imaging apparatus 30. If the second inspection apparatus is the imaging apparatus 30, the control unit of the second inspection apparatus deposits the sample rack 100 at the left end of the transport device 30a.

[0191] Upon receiving the second measurement result from the second inspection apparatus (step S132: YES), the control unit 41 of the management device 40 stores the received second measurement result in the storage unit 42 in step S133. Thereafter, in step S134, the control unit 41 outputs the measurement result according to the operator's instruction.

[0192] In the embodiment, the control unit 41 outputs the measurement results by displaying the measurement results on the display unit 43 , but the present invention is not limited thereto. For example, the measurement results may be output by transmitting them to another device.

[0193] Figure 28 This is a flowchart showing the measurement processing of the urine qualitative testing device 10 , the urine sediment testing device 20 , and the imaging device 30 in order from left to right.

[0194] like Figure 28As shown in the flowchart on the left of FIG, in step S201, the control unit 11 of the urine qualitative testing apparatus 10 stirs the sample in the sample container 101 transported by the transport device 10a and controls the dispensing unit 14 to aspirate the sample from the sample container 101. In step S202, the control unit 11 controls the dispensing unit 14 to supply the aspirated sample to a measurement container. In step S203, the control unit 11 controls the container measuring unit 15 to measure the sample in the measurement container. In step S204, the control unit 11 controls the dispensing unit 14 to apply the aspirated sample to a test strip. In step S205, the control unit 11 controls the colorimetric unit 16 to measure the colorimetric value of the test strip.

[0195] In step S206, the control unit 11 generates a Figure 6 The urine qualitative test device 10 shown in FIG. 10 is used to obtain the measurement results of the measurement items of specific gravity, color tone, and turbidity, and generates a corresponding measurement result based on the measurement data obtained in step S205. Figure 6 The measurement results related to other measurement items of the urine qualitative testing device 10 are shown.

[0196] Measurements performed using the urine qualitative testing apparatus 10 are performed under identical conditions, or in other words, the same procedure. Specifically, the following items are common to all measurements: the time the sample is stirred in step S201; the amount of sample aspirated in step S201; the position of the pipette tip during aspiration in step S201; the amount of sample supplied to the measurement container in step S202; the time from supply to the measurement container in step S202 to measurement in step S203; the amount of sample at the midpoint in step S204; the time from the midpoint in step S204 to measurement in step S205; and the wavelength and intensity of light used during measurement in step S205.

[0197] like Figure 28 As shown in the center flowchart of FIG, in step S211, the control unit 21 of the urine sediment examination apparatus 20 stirs the sample in the sample container 101 transported by the transport device 20a and controls the dispensing unit 24 to aspirate the sample from the sample container 101. In step S212, the control unit 21 controls the dispensing unit 24 to supply the aspirated sample to the reaction container (chamber). In step S213, the control unit 21 controls the sample preparation unit 25 to supply a reagent to the reaction container. Thus, a measurement sample is prepared in the reaction container. In step S214, the control unit 21 controls the optical measurement unit 26 to measure the measurement sample prepared in the reaction container.

[0198] In step S215, the control unit 21 generates the same Figure 6 The measurement results related to the measurement items of the urine sediment inspection device 20 are shown.

[0199] Measurements performed using the urine sediment examination apparatus 20 are performed under identical conditions, or in other words, the same procedure. Specifically, the following items are common to all measurements: the time the sample is stirred in step S211; the amount of sample aspirated in step S211; the position of the pipette tip during aspiration in step S211; the amount of sample supplied to the reaction vessel in step S212; the amount of reagent supplied to the reaction vessel in step S213; the reaction time between the sample and reagent in the reaction vessel; the speed at which the measurement sample is flowed into the flow cell 205; and the wavelength and intensity of light used during the measurement in step S214.

[0200] When the urine sediment inspection device 20 is the second inspection device, Figure 27 The measurement processing of each time by the second inspection device in step S123 is performed according to Figure 28 The central flow chart is performed under the same conditions as above.

[0201] like Figure 28 As shown in the flowchart on the right side of FIG, in step S221, the control unit 31 of the image capture device 30 stirs the sample in the sample container 101 transported by the transport device 30a, and controls the dispensing unit 34 to aspirate the sample from the sample container 101. In step S222, the control unit 31 controls the dispensing unit 24 to move the sample to the chamber 321 (refer to FIG. Figure 5 In step S223, the control unit 31 images the sample supplied into the chamber and controls the imaging unit 35 to acquire a predetermined number of images.

[0202] In step S224, the control unit 31 generates the same image as the image based on the measurement data (image) acquired in step S223. Figure 6 The measurement results related to the measurement items of the imaging device 30 are shown.

[0203] Measurements performed using the image capture device 30 are performed under identical conditions, or in other words, the same procedure. Specifically, the following items are common to all measurements: the time the sample is stirred in step S221; the amount of sample aspirated in step S221; the position of the pipette tip during aspiration in step S221; the amount of sample supplied to the chamber 321 in step S222; the time from sample supply to the chamber 321 to the start of imaging (time for the formed components to settle); the time the light source 301 is illuminated; the light intensity of the light source 301; the speed at which the chamber 321 is transported; and the imaging settings and number of images captured by the imaging element 312.

[0204] When the image capturing device 30 is the second inspection device, Figure 27 The measurement processing of each time by the second inspection device in step S123 is performed according to Figure 28The flowchart on the right side of is performed under the same conditions as described above.

[0205] Figure 28 The measurement processes of the urine qualitative testing device 10, urine sediment testing device 20, and imaging device 30 shown above all begin with sample stirring and pipetting and are completed by generating a measurement result. Therefore, each measurement performed on each sample in each device based on standard commands begins with sample stirring and pipetting and is completed by generating a measurement result. Furthermore, each measurement performed in the second testing device based on additional commands also begins with sample stirring and pipetting and is completed by generating a measurement result.

[0206] <Effects of the Sample Analysis Method and Sample Analysis System According to the Embodiment> In the above embodiment, there are three combinations of the first and second inspection devices. Specifically, the combinations include: (1) the first and second inspection devices are the urine qualitative inspection device 10 and the urine sediment inspection device 20, respectively; (2) the first and second inspection devices are the urine qualitative inspection device 10 and the image capture device 30, respectively; and (3) the first and second inspection devices are the urine sediment inspection device 20 and the image capture device 30, respectively. In any of the combinations (1) to (3), the measurement method of the first and second inspection devices is also different.

[0207] like Figure 25 As shown, the sample analysis method of the embodiment includes: a step of measuring the sample using a first inspection device (step S103); and a step of determining measurement conditions of a second inspection device based on the first measurement result that varies according to the amount of the detection target substance in the sample (steps S114 to S116).

[0208] In the case where the first inspection device is a urine qualitative inspection device 10, as shown in FIG. Figure 7 、 8 As described above, the measurement results of the measurement item "Protein (PRO)", i.e., "+-", "1+", "2+", "3+", "4+", etc., the measurement results of the measurement items "Specific Gravity (SG)" and "pH", i.e., the measurement values (numerical values), and the measurement results of the measurement item "Hue (COLOR)", i.e., "OTHER", "L YELLOW", "STRAW", "YELLOW", "AMBER", "RED", "DK BROWN", etc., are all first measurement results that vary depending on the amount of the detection target substance in the sample. In the case where the first inspection device is the urine sediment inspection device 20, as shown in FIG. Figure 9As described above, the measurement results of the measurement items "Atypical cells (Atyp.C)", "Lipid droplets", "Cases (CAST)", "Epithelial cells (EC)", and "Sperm (SPERM)", i.e., the measurement values (numerical values) are all first measurement results that vary depending on the amount of the detection target substance in the sample.

[0209] According to this method, since the second inspection device performs measurements under measurement conditions based on the first measurement results, which vary depending on the amount of the target substance in the sample, the second inspection device can perform appropriate measurements appropriate to the sample's condition and avoid excessive measurements. Consequently, highly reliable analysis results can be efficiently provided.

[0210] like Figure 25 As shown, the step of determining the measurement conditions includes a step of determining whether a plurality of measurements are required using the second inspection apparatus based on the first measurement result (step S114 ).

[0211] According to this method, since the second inspection apparatus performs a plurality of measurements as needed, a highly reliable analysis result can be obtained in the second inspection apparatus.

[0212] like Figure 25 、 27 As shown, the sample analysis method of the embodiment includes a step (step S126) of ending the measurement performed by the second inspection device based on the second measurement result satisfying a prescribed end condition (step S125: YES), wherein the second measurement result is obtained within the measurement period (steps S123 to S125) using the second inspection device corresponding to the step of determining whether the measurement is necessary (step S114).

[0213] This method provides highly reliable analytical results because measurements are performed using a first testing device and then a subsequent second testing device. Furthermore, during the subsequent second testing device's measurement, the second testing device's measurement is terminated based on the second measurement result satisfying a predetermined termination condition. This reduces reagent consumption by the second testing device, sample supply to the second testing device, and the time required for sample measurement.

[0214] like Figure 27 As shown, the determination of the prescribed end condition (step S125) is performed each time the second inspection device performs a measurement (step S123), and the end of the measurement of the second inspection device (step S126) is executed based on the end of the measurement performed by the second inspection device that determines that the end condition is satisfied (step S125: YES).

[0215] This method allows for reliable execution of measurements by the second inspection device for which termination conditions have been determined, without starting measurements by the second inspection device after the second measurement result has been determined to satisfy the termination conditions. This method allows reliable acquisition of second measurement results through measurements for which termination conditions have been determined, while also reducing reagent consumption by the second inspection device, sample supply to the second inspection device, and the time required for sample measurement.

[0216] like Figures 7-9 As shown, the termination condition for terminating the measurement by the second inspection device includes obtaining the second measurement result indicated by the first measurement result for determining whether to perform the inspection by the second inspection device.

[0217] According to this method, by performing multiple measurements using the second testing device, the likelihood of obtaining a second measurement result from the second testing device, as indicated by the first measurement result from the first testing device, is increased. Furthermore, if this second measurement result is obtained, it is possible to reduce reagent consumption by the second testing device, sample supply to the second testing device, and the time required for sample measurement. Furthermore, if this second measurement result is obtained, it can be determined that the subject from whom the sample was collected is highly likely to suffer from, for example, a disease estimated based on the first measurement result.

[0218] like Figure 25 As shown, when it is determined based on the first measurement result of the first inspection apparatus that measurement by the second inspection apparatus is necessary (step S115 : YES), a step of generating a command specifying measurement by the second inspection apparatus is executed (step S116 ).

[0219] According to this method, when measurement by the second inspection apparatus is required, a command stipulating measurement by the second inspection apparatus is generated. Therefore, the second inspection apparatus can smoothly perform measurement based on the generated command.

[0220] like Figure 27 As shown, when the second measurement result obtained during the measurement period (steps S123 to S125 ) of the second inspection device according to the instruction meets the predetermined end condition (step S125 : YES), the measurement by the second inspection device ends (step S126 ).

[0221] According to this method, if the second measurement result satisfies the predetermined termination condition even within the instructed measurement period, the measurement by the second inspection device is terminated. This allows obtaining the desired second measurement result while saving reagents, samples, time, etc.

[0222] like Figure 27As shown, when the second measurement result obtained during the measurement period of the second inspection device performed in accordance with the instruction (steps S123 to S125) does not meet the specified end condition (step S125: NO), if the number of measurements by the second inspection device reaches the number of measurements specified by the instruction (step S124: YES), the measurement performed by the second inspection device ends (step S126).

[0223] According to this method, even if the termination condition is not satisfied, the measurement by the second inspection device ends when the number of measurements by the second inspection device reaches the number of measurements specified by the command.

[0224] like Figure 26 As shown, the instruction of the second inspection device includes the number of measurements.

[0225] According to this configuration, the second inspection device can smoothly perform measurement according to instructions.

[0226] It should be noted that, in addition to the number of measurements, the instruction to the second inspection device may also include the measurement item, the sample aspiration amount, the sample volume to be measured, and the measurement time. In this case, the second inspection device can also smoothly perform the measurement according to the instruction.

[0227] When the number of measurements included in the command to the second inspection apparatus is a plurality of times, the plurality of measurements by the second inspection apparatus are performed under the same conditions.

[0228] This method can prevent variations in the second measurement results of each second inspection apparatus due to differences in measurement conditions in the second inspection apparatus. Furthermore, by performing measurements under the same conditions, it is possible to suppress complication in the control of the second inspection apparatus.

[0229] When the number of measurements included in the command to the second inspection apparatus is a plurality of times, the sample is aspirated from the sample container 101 containing the sample during each of the plurality of measurements performed by the second inspection apparatus.

[0230] Compared to a single aspiration of the sample required for multiple measurements and performing the measurements, a single aspiration of the sample for each measurement, as in the above method, has the following advantages. Specifically, because multiple measurements are performed as individual measurements, it is easier to complete the multiple measurements at the moment a particular measurement ends. This shortens the time required for the measurement and reduces sample consumption. Furthermore, because the sample volume used for the measurement is always the same, there is no need to set multiple measurement modes for different sample volumes, simplifying measurement control. Furthermore, because the device only needs to store the sample volume required for a single measurement, the storage capacity of containers such as measurement vessels, reaction vessels, and chambers can be reduced. This allows the device to be miniaturized.

[0231] When the number of measurements included in the command to the second inspection apparatus is a plurality of times, the sample is stirred before aspirating in each of the plurality of measurements performed by the second inspection apparatus.

[0232] If the sample is not stirred before being aspirated, the following situation may occur: the formed components in the sample stored in the sample container 101 will precipitate, and the aspirated sample will not contain sufficient formed components. In contrast, if the sample is stirred before being aspirated as described above, the sample will be aspirated in a state that contains sufficient formed components. Therefore, a sufficient number of formed components can be detected in the device after the sample is aspirated. In addition, when multiple measurements are performed using the second inspection device, the possibility of detecting the target formed components can be increased. Moreover, when the end condition is set, the possibility of obtaining the target measurement result with a fewer number of measurements can be increased, thereby shortening the time required for the measurement and reducing the amount of sample used in the measurement.

[0233] When it is determined that measurement by the second inspection apparatus is necessary based on the first measurement result of the first inspection apparatus, a command for the second inspection apparatus is generated.

[0234] According to this method, for example, Figure 7 As shown, for the measurement item "Protein (PRO)" of the first testing device, the number of measurements to be performed by the second testing device is determined based on each of the five first measurement results. In other words, the instructions to the second testing device are generated based on the first measurement results that serve as the basis for determining the need for measurement by the second testing device. This allows for the appropriate generation of instructions for the second testing device based on the first measurement results of the first testing device.

[0235] The sample analysis method of the embodiment further includes the steps of setting a condition for determining whether measurement by the second inspection device is necessary, the content of an instruction specifying measurement by the second inspection device, which is generated when it is determined based on the first measurement result that measurement by the second inspection device is necessary, and a predetermined termination condition for terminating the measurement by the second inspection device ( Figure 24 Steps S12 to S18).

[0236] According to this method, the operator can perform the above-mentioned various settings related to the second inspection device according to the operation of the facility or the like.

[0237] like Figures 7-9 As shown, in the above-mentioned setting process, the conditions for determining necessity, the contents of the instruction, and the predetermined end conditions are set for each measurement item of the first inspection device.

[0238] According to this method, detailed settings can be made for each measurement item of the first inspection device.

[0239] In the process of determining whether it is necessary ( Figure 25 In step S114), it is determined whether it is necessary to use at least one of the plurality of second inspection devices for measurement based on the first measurement result. Figure 7 As shown, when the first measurement result of the measurement item "Protein (PRO)" is "+-", it is determined that the urine sediment inspection device 20 needs to be used for measurement, as shown in FIG. Figure 8 As shown, when the first measurement result of the measurement item “hue (COLOR)” is “OHTER”, it is determined that measurement by the image capturing device 30 is necessary.

[0240] According to this method, when multiple types of second inspection devices are installed, it is possible to determine whether measurement is necessary and identify the second inspection device that needs to perform measurement among the multiple types of second inspection devices. Therefore, the required measurement can be reliably performed by the appropriate type of second inspection device.

[0241] The sample to be measured is a urine sample.

[0242] In the case of urine samples, measurement results from not only the first testing device but also the second testing device are often required, so the second testing device is frequently operated. Therefore, saving reagents, samples, and time in the second testing device as described above is particularly effective for urine samples.

[0243] The first inspection device is a urine qualitative inspection device 10 , and the second inspection device is a urine sediment inspection device 20 or an image capturing device 30 using a flow cytometer.

[0244] According to this configuration, a large number of urine samples can be measured by the urine qualitative testing apparatus 10 (first testing apparatus) while detailed measurements can be performed by the urine sediment testing apparatus 20 or the imaging apparatus 30 (second testing apparatus).

[0245] The first inspection device is a urine qualitative inspection device 10, and the second inspection device is a urine sediment inspection device 20 using a flow cytometer. When multiple measurements are performed using the second inspection device, the multiple measurements by the second inspection device are performed under the same conditions. The measurement conditions in the urine sediment inspection device 20 include, for example, the amount of sample aspirated in step S211, the amount of sample supplied to the reaction vessel in step S212, the amount of reagent supplied to the reaction vessel in step S213, the reaction time of the sample and reagent in the reaction vessel, the speed at which the measurement sample is flowed into the flow cell 205, and the wavelength or intensity of the light used during the measurement in step S214.

[0246] This method can prevent variations in the second measurement results caused by different measurement conditions in the urine sediment inspection device 20 (second inspection device). Furthermore, by performing measurements under the same conditions, it is possible to minimize complication in the control of the urine sediment inspection device 20 (second inspection device).

[0247] The first inspection device is the urine qualitative inspection device 10, and the second inspection device is the image capture device 30. When multiple measurements are performed using the second inspection device, a predetermined number of images of the chamber 321 filled with the sample are captured under the same conditions during the multiple measurements. The imaging conditions used by the image capture device 30 include, for example, the amount of sample aspirated in step S221, the amount of sample supplied to the chamber 321 in step S222, the time from sample supply to the chamber 321 to the start of imaging (time for formed components to settle), the duration of light source 301 illumination, the light intensity of light source 301, the transfer speed of chamber 321, and the imaging settings and number of images captured by the imaging element 312.

[0248] This method prevents variations in the second measurement results generated from images due to differences in imaging conditions in the imaging device 30 (second inspection device). Furthermore, by performing imaging under the same conditions, it reduces the complexity of control in the imaging device 30 (second inspection device).

[0249] The first inspection device is a urine sediment inspection device 20 using a flow cytometer, and the second inspection device is an image capturing device 30 .

[0250] According to this configuration, detailed measurement can be performed by the urine sediment inspection device 20 (first inspection device), and further detailed measurement can be performed by the imaging device 30 (second inspection device) at the same time.

[0251] The sample analysis method of the embodiment further includes a step of outputting the first measurement result and the second measurement result ( Figure 27 Step S134). Thus, for example, Figures 20-23 The result list screen 700 and the detailed result screen 800 shown are displayed on the display unit 43 of the management device 40 .

[0252] According to this method, the operator can smoothly confirm the first measurement result and the second measurement result.

[0253] like Figure 1 As shown, the sample analysis system 1 includes a plurality of inspection devices having different measurement methods and a management device 40 that receives measurement results obtained by the plurality of inspection devices. Figure 25 As shown, the management device 40 determines the measurement conditions of the second inspection device based on the first measurement result of the first inspection device that varies according to the amount of the detection target substance in the sample (steps S114 to S116), and generates a command that specifies the measurement to be performed by the second inspection device (step S116).

[0254] With this configuration, since the second inspection device performs measurements under measurement conditions based on the first measurement results, which vary depending on the amount of the target substance in the sample, the second inspection device can perform appropriate measurements appropriate to the sample's condition and avoid excessive measurements. Consequently, highly reliable analysis results can be efficiently provided.

[0255] <Change Example 1> In the above embodiment, it is determined whether the second measurement result satisfies the predetermined end condition ( Figure 27 Step S125) is performed by the second inspection device, but is not limited thereto and may also be performed by the management device 40.

[0256] Figure 29 This is a flowchart showing the processing of the second inspection device and the management device 40 according to Modification Example 1.

[0257] and Figure 27 Compared with the embodiment shown in FIG, in the process of the second inspection device of Modification Example 1, steps S124 to S126 are omitted, and steps S301 to S303 are added between steps S127 and S128. Figure 27 Compared with the embodiment shown in FIG. 1 , in the process of the management device 40 of the modification example 1, steps S311 to S314 are added between step S133 and step S134. Figure 29 For the sake of convenience, some parts are omitted. Figure 27 Same steps.

[0258] In the first modification, the management device 40 manages and controls the number of measurements and the end condition in the second inspection device as shown below. Therefore, in the first modification, the command sent from the management device 40 to the second inspection device may not include Figure 26 The number of measurements and the end conditions are shown.

[0259] When the control unit of the second inspection apparatus performs measurement processing in step S123 and generates the second measurement result, in step S127 the second measurement result is transmitted to the management device 40. Thereafter, the control unit of the second inspection apparatus waits until receiving an end instruction or an additional measurement instruction from the management device 40.

[0260] Upon receiving the second measurement result from the second inspection apparatus (step S132: YES), the control unit 41 of the management device 40 stores the second measurement result in the storage unit 42 in step S133. Next, in step S311, the control unit 41 determines whether the second measurement result received in the previous step S132 satisfies the termination condition specified in the instruction from the second inspection apparatus related to the target sample. Furthermore, in step S312, the control unit 41 determines whether the number of measurements specified in the instruction from the second inspection apparatus related to the target sample has been performed.

[0261] If the second measurement result does not meet the termination conditions specified in the command and the number of measurements specified in the command has not been completed (step S311: NO, step S312: NO), the control unit 41 sends an additional measurement instruction to the second inspection device in step S313. The control unit 41 then returns the process to step S132 and waits until the second second measurement result is received. On the other hand, if the second measurement result meets the termination conditions specified in the command (step S311: YES) or the number of measurements specified in the command has been completed (step S312: YES), the control unit 41 sends an termination instruction to the second inspection device in step S314.

[0262] If the control unit of the second inspection device receives an end instruction from the management device 40 (step S301: YES), the measurement performed by the second inspection device is terminated in step S303. On the other hand, if the control unit of the second inspection device receives an additional measurement instruction from the management device 40 (step S301: NO, step S302: YES), the process returns to step S123 and the measurement process performed by the second inspection device is repeated.

[0263] In Modification 1, the end condition determination (step S311) is performed each time the second inspection device performs a measurement (step S123). The end condition determination (step S303) is executed upon completion of the measurement performed by the second inspection device for which the end condition determination has been made. In other words, the end condition determination (step S303) is executed when the second inspection device is not performing a measurement. This ensures that measurements for which the end condition determination has been made are reliably executed to the end.

[0264] According to Modification Example 1, if Figure 29 As shown, the management device 40 determines whether the second measurement result obtained during the measurement period using the second inspection device (steps S123, S127, S301, and S302) satisfies a predetermined termination condition (step S311). Based on the second measurement result satisfying the termination condition (step S311: YES), the management device 40 terminates the measurement performed by the second inspection device (steps S314 and S303). This achieves the same effects as the aforementioned embodiment. Specifically, by terminating the measurement by the second inspection device based on the second measurement result satisfying the predetermined termination condition, it is possible to reduce reagent consumption by the second inspection device, sample supply to the second inspection device, and the time required for sample measurement.

[0265] <Change Example 2> In the above embodiment, the end processing of the measurement when the end condition is satisfied is executed at a timing when the measurement by the second inspection device is not being performed. However, the present invention is not limited thereto and the end processing of the measurement when the end condition is satisfied may be executed during the measurement operation by the second inspection device.

[0266] Figure 30 This is a flowchart showing the processing of the second inspection device in Modification Example 2.

[0267] The second inspection device of Modification Example 2 is an image capturing device 30. Figure 27 Compared with the embodiment shown in FIG. 1 , in the process of the second inspection device in the modification example 2, steps S401 to S403 are added to replace step S123. Figure 30 For the sake of convenience, some parts are omitted. Figure 27 Same steps.

[0268] The control unit of the second inspection device starts the measurement process in step S401. The operation period P1 of the measurement started in step S401 is steps S401 to S403. During the operation period P1, the measurement started in step S401 is continued. If the measurement is started in step S401, the measurement is started. Figure 28 According to the measurement processing of the image pickup device 30 shown in the flowchart on the right side of FIG, a predetermined number of images (for example, 40 images) are sequentially acquired.

[0269] In Modification 2, unlike the above-described embodiment, the control unit of the second inspection apparatus analyzes the images acquired through the measurement process initiated in step S401 and sequentially generates second measurement results. Then, in step S402, the control unit of the second inspection apparatus determines whether the measurement results sequentially obtained during the measurement process initiated in step S401 meet the termination condition.

[0270] If the measurement result satisfies the termination condition (step S402: YES), in step S126, the control unit of the second inspection device suspends the ongoing measurement and ends the measurement performed by the second inspection device. In other words, the termination process in step S126, based on the determination in step S402, is executed based on the determination that the termination condition has been met during the measurement operation. On the other hand, if the measurement result does not satisfy the termination condition (step S402: NO), in step S403, the control unit of the second inspection device determines whether the measurement started in step S401 (the current measurement) has ended. If the current measurement has not ended (step S403: NO), the control unit of the second inspection device returns to step S402 and repeats the termination condition determination until the current measurement ends.

[0271] If the current measurement is complete (step S403: YES), the control unit of the second inspection device performs steps S124 to S126, similar to the embodiment. Specifically, if the number of measurements specified by the command from the second inspection device is complete (step S124: YES) or the current second measurement result meets the termination condition (step S125: YES), the control unit of the second inspection device ends the measurement by the second inspection device in step S126. On the other hand, if the number of measurements specified by the command from the second inspection device is not complete and the current second measurement result does not meet the termination condition (step S124: NO, step S125: NO), the control unit of the second inspection device returns to step S401 and begins the next measurement.

[0272] According to Modification Example 2, if Figure 30As shown, the second inspection device determines whether the second measurement result obtained during the measurement period using the second inspection device (steps S401-S403, S124, and S125) satisfies a predetermined termination condition (steps S402 and S125). Based on the second measurement result satisfying the termination condition (step S402: YES, step S125: YES), the measurement performed by the second inspection device is terminated (step S126). This achieves the same advantages as the aforementioned embodiment. Specifically, by terminating the measurement by the second inspection device based on the second measurement result satisfying the predetermined termination condition, it is possible to reduce reagent consumption by the second inspection device, sample supply to the second inspection device, and the time required for sample measurement.

[0273] Furthermore, according to Modification 2, the termination condition of step S402 is determined during each measurement performed by the second inspection device (operation period P1). Furthermore, the termination process of step S126 is executed upon determining that the termination condition has been satisfied (step S402: YES). According to this method, if the second measurement result is determined to satisfy the termination condition, the measurement performed by the second inspection device is terminated even if the measurement is in progress. This can reduce the time required for sample measurement by the second inspection device.

[0274] <Change Example 3> In the above-mentioned modification example 1, the end processing of the measurement when the end condition is satisfied is executed at a timing when the measurement by the second inspection device is not being performed. However, the present invention is not limited to this. The end processing of the measurement when the end condition is satisfied may also be executed during the measurement operation by the second inspection device.

[0275] Figure 31 This is a flowchart showing the processing of the second inspection device in Modification Example 3.

[0276] The second inspection device of Modification Example 3 is an image capturing device 30. Figure 29 Compared with the modified example 1 shown, in the processing of the second inspection apparatus of the modified example 3, steps S501 to S504 are added instead of steps S123 and S127.

[0277] In step S501, the control unit of the second inspection device starts the measurement process. The operation period P1 of the measurement started in step S501 is steps S501 to S503. During the operation period P1, the measurement started in step S501 is continued. If the measurement is started in step S501, the measurement process is started. Figure 28 According to the measurement processing of the image pickup device 30 shown in the flowchart on the right side of FIG, a predetermined number of images (for example, 40 images) are sequentially acquired.

[0278] In step S501, the control unit of the second inspection device analyzes the image acquired by the started measurement process, generates second measurement results in sequence, and transmits the second measurement results obtained in sequence in the started measurement operation to the management device 40. Figure 29 As shown, when the received second measurement result meets the end condition ( Figure 29 In step S311: YES), the management device 40 sends an end instruction.

[0279] If the control unit of the second inspection device receives a termination instruction from the management device 40 (step S502: YES), it terminates the ongoing measurement in step S303, ending the measurement performed by the second inspection device. Specifically, the termination process in this case is executed based on whether the termination conditions are satisfied during the measurement operation. On the other hand, if the control unit of the second inspection device does not receive a termination instruction from the management device 40 (step S502: NO), the control unit of the second inspection device determines in step S503 whether the measurement started in step S501 (the current measurement) has ended. If the current measurement has not ended (step S503: NO), the control unit of the second inspection device returns to step S502 and continues to determine whether a termination instruction has been received until the current measurement ends.

[0280] If the current measurement is completed (step S503: YES), in step S504, the control unit of the second inspection device sends a notification of the completion of the current measurement to the management device 40. As a result, the management device 40 increments the counter value of the measurement performed by the second inspection device by 1. Figure 29 In step S312, the count value is used to determine whether all measurements have been completed. Figure 29 The process of steps S301 to S303 is performed in the same manner as in the first modification shown.

[0281] According to Modification Example 3, if Figure 29 、 31 As shown, the management device 40 determines whether the second measurement result obtained during the measurement period using the second inspection device (steps S501-S504, S301, and S302) satisfies a predetermined termination condition (step S311). Based on the second measurement result satisfying the termination condition (step S311: YES), the management device 40 terminates the measurement performed by the second inspection device (steps S314 and S303). This achieves the same advantages as the aforementioned embodiment. Specifically, by terminating the measurement by the second inspection device based on the second measurement result satisfying the predetermined termination condition, it is possible to reduce reagent consumption by the second inspection device, sample supply to the second inspection device, and the time required for sample measurement.

[0282] Furthermore, according to Modification 3, during each measurement performed by the second inspection device, the termination condition of step S502 is determined during the measurement operation (operation period P1). Furthermore, the termination process of step S303 is executed upon determining that the termination condition has been satisfied (step S502: YES). According to this method, if the second measurement result is determined to satisfy the termination condition, the measurement performed by the second inspection device is terminated even if the measurement is in progress. This can reduce the time required for sample measurement by the second inspection device.

[0283] <Other Changes> In the above embodiment, the sample analysis system 1 is a system for analyzing urine samples, but is not limited to this and may also be a system for analyzing samples other than urine samples. For example, the sample analysis system 1 may also be a system for analyzing blood samples. In addition to the management device 40 that is the same as the above embodiment, the sample analysis system 1 in this case further includes, for example, a blood test device, an image capture device, and a general flow cytometer test device that are sequentially arranged from upstream to downstream. The blood cell test device measures a measurement sample prepared from a blood sample based on a flow cytometer quantitative method and counts the blood cells in the blood sample. The image capture device is configured similarly to the above-mentioned image capture device 30 and captures an image of the blood cells in the blood sample. The general flow cytometer test device measures a measurement sample prepared from a blood sample based on a flow cytometer quantitative method and counts the blood cells in the blood sample.

[0284] In this case, based on the first measurement result obtained by the first inspection device (blood inspection device, image capture device) on the upstream side, it is determined whether multiple measurements are required by the second inspection device (image capture device, general flow cytometer inspection device) on the downstream side. In addition, based on the second measurement result obtained during the measurement period using the second inspection device (image capture device, general flow cytometer inspection device) corresponding to the process for which the necessity is determined, the measurement by the second inspection device (image capture device, general flow cytometer inspection device) is terminated. In this case, the determination of the need for multiple measurements is also predetermined. Figure 9 The same additional measurement rule determines whether additional measurement is necessary based on the additional measurement rule and generates an instruction.

[0285] For example, the management device 40 determines whether additional measurements are necessary using the second testing device (image capture device) based on the measurement results of the "blast" measurement item obtained by the first testing device (blood test device). If the measurement result of the "blast" measurement item exceeds a specified value, the management device 40 generates a command specifying the number of measurements to be performed by the image capture device and the termination conditions. The termination conditions include, for example, that the measurement result of the "blast" measurement item by the image capture device exceeds a specified value.

[0286] Furthermore, for example, the management device 40 determines whether additional measurements are necessary using a second testing device (a general-purpose flow cytometer) based on predetermined measurement results obtained by a first testing device (a blood test device, an imaging device). If it is determined that additional measurements are necessary, the management device 40 generates a command specifying the number of measurements to be performed by the general-purpose flow cytometer and termination conditions. Termination conditions include, for example, that the measurement results of blood cells expressing a predetermined surface antigen are above a predetermined value. This allows the identification of diseases such as leukemia based on the measurement results of blood cells expressing the predetermined surface antigen.

[0287] In this modified example, similar to the embodiment, measurements by the second testing device are performed under measurement conditions based on the first measurement result, which vary depending on the amount of the target substance in the sample. Therefore, the second testing device can perform appropriate measurements appropriate to the sample's condition and avoid excessive measurements. Consequently, highly reliable analysis results can be provided efficiently. Furthermore, since measurements are performed by the first testing device (blood test device, image capture device) and by the subsequent second testing device (image capture device, general flow cytometer), highly reliable analysis results can be provided. Furthermore, during the subsequent measurement by the second testing device, the measurement by the second testing device is terminated based on the second measurement result satisfying a predetermined termination condition. This reduces reagent consumption by the second testing device, sample supply to the second testing device, and the time required for sample measurement.

[0288] In the above embodiment, the measurement results of the urine qualitative testing device 10, the urine sediment testing device 20, and the imaging device 30 are stored in the management device 40 of the sample analysis system 1. However, this is not limiting and the results may also be stored in an external host computer. In this case, for example, the sample analysis system 1 includes a display terminal for displaying the measurement results. This display terminal communicates with the host computer in response to operator operations and displays the measurement results on the display unit of the display terminal.

[0289] In the above embodiment, the urine qualitative testing device 10 is arranged on the most upstream side, but the present invention is not limited thereto. Alternatively, the urine sediment testing device 20 or the imaging device 30 may be arranged on the most upstream side, and the urine qualitative testing device 10 may operate as a second testing device.

[0290] In the above embodiment, based on the additional measurement rule, the command for the second inspection device is generated based on the measurement results of one first inspection device. However, the command for the downstream second inspection device may be generated based on the measurement results of two upstream first inspection devices.

[0291] For example, if the urine qualitative testing device 10's measurement result for the "occult blood (BLD (Hb))" or "occult blood (BLD (RBC))" measurement item is positive (+), and the urine sediment testing device 20's measurement result for the "red blood cell morphology information (RBC-Info.)" measurement item is Dysmorphic® or Mixed®, an additional command for the imaging device 30 is generated. This command, for example, sets the termination conditions to include performing multiple measurements (multiple measurements) using the imaging device 30 and setting the termination condition to include the presence of a positive marker or a threshold value for the measurement item "atypical cells" by the imaging device 30. Note that this command could also include performing multiple additional measurements (multiple measurements) using the imaging device 30 and setting the termination condition to include the measurement result for the "cast" measurement item by the imaging device 30 to include a predetermined value or above.

[0292] In the above embodiment, one condition for performing additional measurement using the second inspection device only includes one measurement item of the first inspection device, but the present invention is not limited thereto and may also include multiple measurement items of the first inspection device. For example, one condition includes Figure 7 The measurement items "protein" and "specific gravity" shown can also be set to be subjected to additional measurement when the measurement results of these two measurement items satisfy the corresponding conditions.

[0293] In the above embodiment, when the first testing device is a urine sediment testing device 20, the conditions for the additional measurement performed by the second testing device may also include multiple criteria. For example, multiple criteria may be included to determine whether the condition related to the measurement result (measurement value) of the measurement item "Atyp. C" performed by the urine sediment testing device 20 falls within any of multiple numerical ranges. In this case, the measurement conditions of the second testing device are determined based on which of the multiple numerical ranges the first measurement result of the urine sediment testing device 20 falls within. This allows, as in the above embodiment, the second testing device to perform appropriate measurements appropriate to the sample's condition and avoid excessive measurements. Consequently, highly reliable analysis results can be efficiently provided.

[0294] In the above embodiment, Figures 11-19 The rule setting screen 500 and the end condition setting screen 600 shown have additional measurement rules set, but the present invention is not limited thereto. An operator may input settings by creating a program, and the control unit 41 of the management device 40 may generate an additional instruction based on the input.

[0295] In the above embodiment, when the number of measurements included in the command of the second inspection device (urine sediment inspection device 20 and imaging device 30) is multiple, the multiple measurements performed by the second inspection device are performed under the same conditions, but the present invention is not limited to this and the measurements may be performed under different conditions.

[0296] Specifically, in the above-described embodiment, the position of the pipette tip when aspirating the sample from the sample container 101 is the same for each measurement in a multiplex measurement. However, this position may also be different. For example, if the sedimentation rate of a formed component in a sample differs depending on the type of formed component, by varying the position of the pipette tip (in both the vertical and horizontal directions) when aspirating the sample in each measurement, the likelihood of sufficient aspiration of the formed component in the sample can be increased in multiplex measurements.

[0297] Similarly, in the above embodiment, the measurement time can be set to be different for each multiplex measurement, and the amount of sample aspirated can also be set to be different for each multiplex measurement. For example, if the measurement result of the measurement item "Protein (PRO)" by the urine qualitative testing device 10 is "+-", the measurement time can be set to be longer and the amount of sample aspirated can be set to be larger in each multiplex measurement performed by the urine sediment testing device 20.

[0298] In the above embodiment, even if the measurement result of the second inspection device satisfies the termination condition, the measurement of the second inspection device may not be terminated but the second inspection device may be continued for the number of times indicated by the instruction. Figure 11 A check box for temporarily disabling the condition is provided in each condition area 540 of the rule setting screen 500. When the check box is checked, the end condition may be ignored and the second inspection device may perform the measurement the number of times instructed.

[0299] The urine qualitative testing device 10 will be further described. The color of the test paper changes depending on the amount of the target substance being measured by the urine qualitative testing device 10. The urine qualitative testing device 10 uses a color sensor to measure the color of the test paper on which the sample has been dropped. Based on the color of the test paper, the device obtains a measurement result that is expressed in three or more stages, depending on the amount of the target substance. These three or more stages consist of a first stage (e.g., "-") indicating a normal amount of the target substance, and multiple second stages (e.g., "+-," "1+," "2+," "3+," and "4+") indicating a higher amount of the target substance than the first stage. Among these multiple second stages, the lowest stage (e.g., "+-") indicates the lowest amount of the target substance, while the highest stage (e.g., "4+") indicates the highest amount of the target substance.

[0300] The type of the detection target substance to be measured by the urine qualitative test apparatus 10 is different from the type of the detection target substance to be measured by the urine qualitative test apparatus 10. Figure 6 Corresponding to the measurement items described. For example, if the measurement item is occult blood (BLD(Hb)), the target substance is hemoglobin, and the gradation indicating the measurement result consists of, for example, a first gradation ("-") and multiple second gradations ("+-," "1+," "2+," "3+"). For example, if the measurement item is protein (PRO), the target substance is protein, and the gradation indicating the measurement result consists of, for example, a first gradation ("-") and multiple second gradations ("+-," "1+," "2+," "3+," "4+"). For example, if the measurement item is leukocytes (LEU), the target substance is leukocytes, and the gradation indicating the measurement result consists of, for example, a first gradation ("-") and multiple second gradations ("1+," "2+," "3+"). For the above measurement items, if the measurement result is the first gradation, the target substance is not present in the sample, or, if present, is only in trace amounts.

[0301] If used Figure 7As described, in the rule of additional measurement, for example, when the object of measurement, i.e., the detection target substance, measured by the urine qualitative test device 10 is protein, when the measurement result of the urine qualitative test device 10 is "+-", "1+", "2+", "3+", or "4+", the number of measurements by the urine sediment test device 20 can be set to 3, 2, 1, 1, and 1 times, respectively. That is, when the measurement result of the urine qualitative test device 10 is the lowest level ("+-") among multiple second levels, the number of measurements by the urine sediment test device 20 can be set to be greater than the number of measurements when the measurement result is the highest level ("4+") among multiple second levels. The number of measurements can be set, for example, via Figure 11 The rule setting screen 500 described in is used. The same applies to the case where the urine qualitative testing device 10 is measuring another detection target substance, such as hemoglobin or leukocytes. When the measurement result of the urine qualitative testing device 10 is the lowest of the multiple second levels, the number of measurements by the urine sediment testing device 20 can be set to be greater than the number of measurements when the measurement result is the highest of the multiple second levels.

[0302] It should be noted that in the above embodiment, the number of measurements performed by the urine sediment testing device 20 when the measurement result of the urine qualitative testing device 10 is the lowest of the multiple second levels can be set to be greater than the number of measurements performed when the measurement result of the urine qualitative testing device 10 is the highest of the multiple second levels. However, instead of setting the number of measurements, the time for the urine sediment testing device 20 to perform sample measurements can be set. In other words, the management device 40 can simply determine the amount (total amount) of sample used in the urine sediment testing device 20 based on the measurement result of the urine qualitative testing device 10. The number of measurements can be determined based on the sample amount, and the measurement time can also be set. It should be noted that the time for the measurement sample to flow through the flow cell 205 of the urine sediment testing device 20 can also be used as the measurement time.

[0303] The type of detection target substance measured by the urine sediment testing apparatus 20 may also be determined based on the type of detection target substance measured by the urine qualitative testing apparatus 10. For example, the detection target substance measured by the urine qualitative testing apparatus 10 and the detection target substance measured by the urine sediment testing apparatus 20 may be the same. For example, if the detection target substance measured by the urine qualitative testing apparatus 10 is leukocytes, the management apparatus may determine the amount of urine sample used in the measurement by the urine sediment testing apparatus 20 based on the level indicated by the measurement results of the urine qualitative testing apparatus 10. The urine sediment testing apparatus 20 may then measure the determined amount of urine sample and count the leukocytes.

[0304] The target substance, i.e., the substance to be detected, measured by the urine qualitative testing device 10, and the target substance, i.e., the substance to be detected, measured by the urine sediment testing device 20 may be different. For example, if the target substance, i.e., the substance to be detected, measured by the urine qualitative testing device 10 is protein, the management device may determine the amount of urine sample to be used in the measurement by the urine sediment testing device 20 based on the level indicated by the measurement results of the urine qualitative testing device 10. The sediment testing device 20 may measure the determined amount of urine sample and count at least one of casts and renal tubular epithelial cells. In this case, the urine sediment testing device 20 may also determine the presence or absence of deformed red blood cells. Furthermore, if the target substance, i.e., the substance to be detected, measured by the urine qualitative testing device 10 is hemoglobin, the management device may determine the amount of urine sample to be used in the measurement by the urine sediment testing device 20 based on the level indicated by the measurement results of the urine qualitative testing device 10. The urine sediment testing device 20 may measure the determined amount of urine sample and count red blood cells.

[0305] In the above embodiment, the urine sediment inspection device 20 is a device that uses a flow cytometer to count particles in a urine sample. However, the present invention is not limited to this. The urine sediment inspection device 20 may also be a device that images a urine sample flowing through or stored in a chamber and counts particles in the urine sample based on the resulting image. In this case, the image capture device 30 may be omitted from the sample analysis system 1. In this case, the amount of urine sample used for imaging is determined as the sample amount.

[0306] In the above embodiment, the management device 40 is provided separately from the urine qualitative testing device 10 and the urine sediment testing device 20. However, the present invention is not limited to this, and the management device 40 may be incorporated into the urine qualitative testing device 10 or the urine sediment testing device 20. In this case, the functions of the control unit 41, storage unit 42, display unit 43, and input unit 44 may be shared by the management device 40 and the urine qualitative testing device 10 or the urine sediment testing device 20.

[0307] The embodiments of the present invention can be modified in various ways as appropriate within the scope of the technical concept shown in the claims.

[0308] Description of Reference Numerals 1. Sample analysis system 10 Urine qualitative testing device (testing device, first testing device, second testing device) 20 Urine sediment inspection device (inspection device, first inspection device, second inspection device) 26 Optical measurement unit (flow cytometer) 30 Image capture device (inspection device, first inspection device, second inspection device) 40 Management Device 101 Sample Container Room 321

Claims

1. A sample analysis system comprising the following devices: a plurality of inspection devices, wherein the inspection devices include a first inspection device and a second inspection device, in, The first and second inspection devices use different measurement methods, the first inspection device measures the urine sample using a test strip whose color changes depending on the amount of a detection target substance in the urine sample, and obtains a first measurement result represented by three or more levels depending on the amount of the detection target substance based on the color of the test strip. wherein the levels include a first level indicating that the amount of the detection target substance is normal, and a plurality of second levels indicating that the amount of the detection target substance is higher than the first level; a management device that acquires the first measurement result and determines the amount of the urine sample used in the measurement of the second inspection device based on the first measurement result; The amount of the urine sample corresponding to the lowest level among the plurality of second levels can be set to be larger than the amount of the urine sample corresponding to the highest level among the plurality of second levels. The second inspection device measures the amount of the urine sample determined by the management device to obtain a second measurement result of the urine sample.

2. The sample analysis system according to claim 1, wherein: The first inspection device is a urine qualitative inspection device, and the second inspection device is a urine sediment inspection device.

3. The sample analysis system according to claim 1, wherein: The management device acquires the second measurement result, and outputs the first measurement result and the second measurement result in association with the identification information of the urine sample.

4. The sample analysis system according to claim 1, wherein: The amount of the urine sample is determined based on the number of times the second testing device measures the urine sample.

5. The sample analysis system according to claim 4, wherein: When the number of measurements is a plurality of times, the second inspection device acquires the second measurement result based on a plurality of measurement results of the urine sample obtained by each measurement. The sample analysis system according to claim 4 , wherein: When the number of measurements is a plurality of times, the second inspection apparatus aspirates the urine sample from the sample container containing the urine sample in each measurement and performs the measurement.

7. The sample analysis system according to claim 6, wherein: When the number of measurements is a plurality of times, if a predetermined end condition is satisfied before the final aspiration of the plurality of times is performed, the second inspection apparatus cancels aspiration and measurement of the urine sample after the predetermined end condition is satisfied.

8. The sample analysis system according to claim 7, wherein: The predetermined termination condition is that at least one of the plurality of measurement results obtained by the respective measurements performed by the second inspection device satisfies a predetermined detection condition.

9. The sample analysis system according to claim 8, wherein: The predetermined detection condition is to detect a predetermined detection target substance.

10. The sample analysis system according to claim 7, wherein: The management device receives the setting of the predetermined termination condition.

11. The sample analysis system according to claim 6, wherein: When the number of measurements is a plurality of times, the second inspection apparatus stirs the urine sample contained in the sample container before each aspiration.

12. The sample analysis system according to claim 6, wherein: When the number of measurements is a plurality of times, the second inspection device performs the measurements in the same order.

13. The sample analysis system according to claim 6, wherein: When the number of measurements is a plurality of times, the second inspection apparatus performs each aspiration with the same sample aspiration volume.

14. The sample analysis system according to claim 1, wherein: The sample analysis system further includes a transport device configured to transport the sample container to the first inspection device and the second inspection device.

15. The sample analysis system according to claim 1, wherein: The first measurement result and the second measurement result are results related to the same detection target substance.

16. The sample analysis system according to claim 15, wherein: The detection target substance is leukocytes.

17. The sample analysis system according to claim 1, wherein: The first measurement result is a result related to the amount of a first detection target substance as the detection target substance, and the second measurement result is a result related to the amount of a second detection target substance different from the first detection target substance.

18. The sample analysis system according to claim 17, wherein: The first detection target substance is a protein, and the second detection target substance is at least one of casts, deformed erythrocytes, and renal tubular epithelial cells.

19. The sample analysis system according to claim 17, wherein: The first detection target substance is hemoglobin, and the second detection target substance is red blood cells.

20. The sample analysis system according to claim 1, wherein: The second inspection device is a urine sediment inspection device, The amount of the urine sample is determined according to the measurement time of the urine sample.

21. A sample analysis method is performed by a plurality of inspection devices including a first inspection device and a second inspection device, wherein: The first inspection device and the second inspection device have different measurement methods, and the sample analysis method includes: Using the first inspection device, measuring a urine sample using a test paper whose color changes according to the amount of a detection target substance in the urine sample, and obtaining a first measurement result represented by three or more levels according to the amount of the detection target substance based on the color of the test paper, wherein the levels include a first level indicating that the amount of the detection target substance is normal and a plurality of second levels higher than the first level; and The first measurement result is acquired by a management device, and based on the first measurement result, an amount of a urine sample to be used in a measurement by the second inspection device is determined, wherein the amount of the urine sample corresponding to the lowest level among the plurality of second levels can be set to be larger than the amount of the urine sample corresponding to the highest level among the plurality of second levels. The second inspection device measures the amount of the urine sample determined by the management device to obtain a second measurement result of the urine sample.

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