Sample analysis method and sample analysis system

Abstract

To provide a sample analysis method and a sample analysis system that can efficiently provide highly reliable analysis results using a plurality of testing devices that employ different measurement methods.SOLUTION: A sample analysis method for analyzing a sample using multiple testing devices (a urine qualitative testing device 10, a urinary sediment testing device 20, and an image capturing device 30) that use different measurement methods includes a step of measuring the sample using a first testing device, and a step of determining measurement conditions for a second testing device based on the first measurement results, which vary depending on the amount of the substance to be detected in the sample.SELECTED DRAWING: Figure 1

Description

[Technical Field]

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

[0002] Known urine analysis methods include qualitative urine testing, which examines chemical components such as sugar and protein in urine, and sediment testing, which analyzes formed elements in urine such as red blood cells, white blood cells, bacteria, etc. Furthermore, known methods for sediment testing include imaging and using a flow cytometer.

[0003] Conventionally, qualitative urine testing and urinary sediment testing have been combined to perform accurate urine analysis. Patent Document 1 below describes a urinary sediment testing device that includes a qualitative analysis unit and a urinary sediment analysis unit, analyzes a sample in the qualitative analysis unit, and automatically changes measurement conditions for analyzing the urinary sediment components of the sample liquid for each sample depending on whether the analysis result is positive or negative. As an example, it describes extending the measurement time in the sediment analysis unit when the qualitative analysis shows a positive result for protein. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] Japanese Patent Application Publication No. 6-138120 Summary of the Invention [Problem to be solved by the invention]

[0005] Urine tests are clinical tests used for health checkups and screening tests for outpatients and inpatients, and because a large number of samples must be processed, efficient processing by a testing device is required. However, in the processing by the testing device described in Patent Document 1, the urinary sediment measurement conditions are changed selectively depending on whether the analysis result by the qualitative analysis unit is positive or negative, making it difficult to efficiently measure urinary sediments.

[0006] The above-mentioned problems are not limited to urine analysis systems including urine qualitative tests and urinary sediment tests, but also exist in other analysis systems that are capable of multiple stages of analysis using different measurement methods, and that perform later-stage tests that involve more precise analysis depending on the results of earlier-stage tests, and these problems have been desired to be solved.

[0007] In view of the above, an object of the present invention is to provide a sample analysis method and a sample analysis system that can efficiently provide highly reliable analysis results using a plurality of testing devices that use different measurement methods. [Means for solving the problem]

[0008] The present invention relates to a sample analysis method for analyzing a sample using a plurality of testing devices (10, 20, 30) with different measurement methods. The sample analysis method of the present invention includes a step (S103) of measuring the sample using a first testing device (10, 20), and steps (S114 to S116) of determining measurement conditions for a second testing device (20, 30) based on the first measurement result, which varies depending on the amount of a substance to be detected in the sample.

[0009] According to the sample analysis method of the present invention, the measurement by the second testing device is performed under measurement conditions based on the first measurement result, which varies depending on the amount of the detection target substance in the sample, so that the second testing device can perform an appropriate measurement according to the condition of the sample and avoid excessive measurement, thereby efficiently providing highly reliable analysis results.

[0010] The present invention relates to a sample analysis system (1) including a plurality of testing devices (10, 20, 30) using different measurement methods, and a management device (40) that receives measurement results obtained by the plurality of testing devices (10, 20, 30). In the sample analysis system (1) of the present invention, the management device (40) determines measurement conditions for a second testing device (20, 30) based on a first measurement result of a first testing device (10, 20), which varies depending on the amount of a substance to be detected in a sample, and generates an order that specifies the measurement by the second testing device (20, 30).

[0011] According to the sample analysis system of the present invention, the second testing device performs measurement under measurement conditions based on the first measurement result, which varies depending on the amount of the detection target substance in the sample, so that the second testing device can perform appropriate measurement according to the condition of the sample and avoid excessive measurement, thereby efficiently providing highly reliable analysis results. [Effects of the Invention]

[0012] According to the present invention, highly reliable analytical results can be efficiently provided using a plurality of testing devices that use different measurement methods. [Brief explanation of the drawings]

[0013] [Figure 1] FIG. 1 is a front view schematically showing the configuration of a sample analysis system according to an embodiment. [Figure 2] FIG. 2 is a block diagram showing the functional configurations of a urine qualitative testing apparatus, a urinary sediment testing apparatus, and an imaging apparatus according to an embodiment. [Figure 3] FIG. 3 is a block diagram illustrating the functional configuration of a management device according to an embodiment. [Figure 4] FIG. 4 is a diagram schematically illustrating the configuration of an optical measurement unit according to an embodiment. [Figure 5] FIG. 5 is a diagram schematically illustrating the configuration of an imaging unit according to an embodiment. [Figure 6] FIG. 6 is a diagram showing measurement items of a urine qualitative testing apparatus, measurement items of a urinary sediment testing apparatus, and measurement items of an imaging apparatus according to an embodiment. [Figure 7] FIG. 7 is a diagram illustrating rules for additional measurements when the first testing device is a urine qualitative testing device and the second testing device is a urinary sediment testing device according to the embodiment. [Figure 8] FIG. 8 is a diagram illustrating rules for additional measurements when the first testing device is a urine qualitative testing device and the second testing device is an imaging device according to the embodiment. [Figure 9]FIG. 9 is a diagram illustrating rules for additional measurements when the first testing device is a urinary sediment testing device and the second testing device is an imaging device according to the embodiment. [Figure 10] FIG. 10 is a diagram schematically showing a rule list screen showing a list of rules for additional measurement according to the embodiment. [Figure 11] FIG. 11 is a diagram schematically showing a rule setting screen for setting rules for additional measurements according to the embodiment. [Figure 12] FIG. 12 is a diagram schematically showing an end condition setting screen for setting an end condition according to the embodiment. [Figure 13] FIG. 13 is a diagram showing a rule setting screen according to an embodiment, in which a rule for additional measurement has been set when the measurement item shown in FIG. 7 is protein. [Figure 14] FIG. 14 is a diagram schematically showing a termination condition setting screen according to the embodiment, in which the termination condition is set when the measurement item shown in FIG. 7 is protein. [Figure 15] FIG. 15 is a diagram schematically showing a rule setting screen in a state in which a rule for additional measurement has been set when the measurement item shown in FIG. 7 is specific gravity, according to the embodiment. [Figure 16] FIG. 16 is a diagram schematically showing a rule setting screen according to the embodiment, in which a rule for additional measurement has been set when the measurement item shown in FIG. 8 is bilirubin. [Figure 17] FIG. 17 is a diagram schematically showing a termination condition setting screen according to the embodiment, in which the termination condition is set when the measurement item shown in FIG. 8 is bilirubin. [Figure 18] FIG. 18 is a diagram schematically showing a rule setting screen according to an embodiment, in which a rule for additional measurement has been set when the measurement item shown in FIG. 9 is atypical cells. [Figure 19] FIG. 19 is a diagram schematically showing a termination condition setting screen according to an embodiment, in which a termination condition has been set when the measurement item shown in FIG. 9 is atypical cells. [Figure 20] FIG. 20 is a diagram schematically showing a result list screen that displays a list of measurement results according to the embodiment. [Figure 21] FIG. 21 is a diagram schematically showing a detailed result screen that displays detailed measurement results according to an embodiment. [Figure 22] FIG. 22 is a diagram schematically showing a detailed result screen that displays detailed measurement results according to the embodiment. [Figure 23] FIG. 23 is a diagram schematically showing a detailed result screen that displays detailed measurement results according to the embodiment. [Figure 24] FIG. 24 is a flowchart showing a process for setting rules for additional measurements according to an embodiment. [Figure 25] FIG. 25 is a flowchart showing the processing of the first inspection device and the management device according to the embodiment. [Figure 26] FIG. 26 is a diagram illustrating a schematic example of updating and registering an order for a second inspection device according to an embodiment. [Figure 27] FIG. 27 is a flowchart showing the processing of the second inspection device and the management device according to the embodiment. [Figure 28] FIG. 28 is a flowchart showing the measurement process of the urine qualitative testing apparatus, urinary sediment testing apparatus, and imaging apparatus according to the embodiment. [Figure 29] FIG. 29 is a flowchart showing the processing of the second inspection device and the management device according to the first modification. [Figure 30] FIG. 30 is a flowchart showing the process of the second inspection device according to the second modification. [Figure 31] FIG. 31 is a flowchart showing the process of the second inspection device according to the third modification. DETAILED DESCRIPTION OF THE INVENTION

[0014] Fig. 1 is a front view showing a schematic configuration of a sample analysis system 1. In Fig. 1, up, down, left and right directions are indicated.

[0015] The sample analysis system 1 is a system for analyzing urine samples. The urine samples to be analyzed include not only excreted urine but also urine collected from within a living body, such as urine in the bladder. The sample analysis system 1 includes a urine qualitative analysis apparatus 10, a urinary sediment analysis apparatus 20, an image capture apparatus 30, and a management apparatus 40.

[0016] The qualitative urine testing device 10 is a device for analyzing chemical components in a urine sample for multiple measurement items related to urine quality. The urinary sediment testing device 20 is a urine sediment analyzer for analyzing sediments in a urine sample for multiple measurement items related to urinary sediment using a flow cytometer. The imaging device 30 is a urine sediment analyzer for capturing images of the sediments contained in the urine sample and analyzing the sediments in the urine sample for multiple measurement items using the captured images. Note that the analysis by the imaging device 30 is sufficient as long as it obtains measurement results corresponding to at least the measurement items, and further analysis based on the measurement results (e.g., suggesting the possibility of disease) is not necessarily performed.

[0017] The urine qualitative analysis apparatus 10, the urinary sediment analysis apparatus 20, and the imaging apparatus 30 each have a transport device 10a, 20a, and 30a on the front side. The transport devices 10a, 20a, and 30a transport a sample rack 100 holding a plurality of sample containers 101, and are connected to each other so that the sample rack 100 can be transported to an adjacent transport device. The sample containers 101 contain samples collected from subjects.

[0018] The operator places a sample container 101 containing a sample to be tested in a sample rack 100 and sets the sample rack 100 in the right-end region of the transport device 10a. The transport devices 10a, 20a, and 30a sequentially transport the sample rack 100 to the urine qualitative analysis device 10, the urinary sediment analysis device 20, and the imaging device 30. The urine qualitative analysis device 10 reads the sample ID from the sample container 101, aspirates the sample from the sample container 101, performs a urine qualitative measurement on the aspirated sample, and generates a measurement result. The urinary sediment analysis device 20 reads the sample ID from the sample container 101, aspirates the sample from the sample container 101, and performs a urinary sediment measurement on the aspirated sample, and generates a measurement result. The imaging device 30 reads the sample ID from the sample container 101, aspirates the sample from the sample container 101, and generates a measurement result.

[0019] When the required measurement processing for all samples held in the sample rack 100 is completed by the urine qualitative analysis apparatus 10, the urinary sediment analysis apparatus 20, and the imaging apparatus 30, the sample rack 100 is transported to the left end region of the transport apparatus 30a. The operator removes the processed sample rack 100 from the transport apparatus 30a.

[0020] The management device 40 receives and stores the measurement results obtained by the urine qualitative testing device 10, the measurement results obtained by the urinary sediment testing device 20, and the measurement results obtained by the imaging device 30, and displays the measurement results on the display unit 43 in response to the operator's instructions.

[0021] FIG. 2 is a block diagram showing the functional configuration of the urine qualitative testing apparatus 10, the urinary sediment testing apparatus 20, and the imaging apparatus 30. As shown in FIG.

[0022] The urine qualitative testing device 10 comprises a control unit 11 , a storage unit 12 , a reading unit 13 , a dispensing unit 14 , a container measuring unit 15 , a color development measuring unit 16 , and a communication unit 17 .

[0023] The control unit 11 is configured with, for example, a CPU or FPGA. The control unit 11 performs measurement and analysis of a sample by executing a computer program stored in the storage unit 12. The storage unit 12 is configured with, for example, an SSD or HDD. The storage unit 12 stores measurement data acquired by the container measurement unit 15 and the color development measurement unit 16, and measurement results (analysis results) generated by analyzing the measurement data.

[0024] The reading unit 13 reads a sample ID for individually identifying the sample from the sample container 101. If a barcode label on which a barcode containing the sample ID information is printed is attached to the sample container 101, the reading unit 13 is configured, for example, by a barcode reader. The dispensing unit 14 inserts an aspirating tube from above the sample container 101 transported by the transport device 10a, and releases air from the tip of the aspirating tube to agitate the sample in the sample container 101. The dispensing unit 14 then aspirates the sample in the sample container 101 and supplies it to the container measurement unit 15 and the color development measurement unit 16.

[0025] The container measurement unit 15 includes a measurement container for containing the sample supplied by the dispensing unit 14. It measures the refractive index of the sample in the measurement container using a prism and measures the transmitted and scattered light obtained by irradiating the sample with light. The control unit 11 obtains measurement results for specific gravity, color tone, and turbidity based on the measurement data obtained by the container measurement unit 15. The color development measurement unit 16 retrieves a test strip from the test strip feeder and applies the sample supplied by the dispensing unit 14 to the test strip. The color development measurement unit 16 applies light to the test strip on which the sample has been applied and measures the color of the test strip with a color sensor. The control unit 11 obtains various measurement results based on the measurement data obtained by the color development measurement unit 16. The measurement items of the urine qualitative testing device 10 will be described later with reference to FIG. 6.

[0026] 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 a cable based on the Ethernet standard, and with the conveying device 10a via a cable based on a serial communication standard such as USB. The control unit 11 controls the conveying device 10a via the communication unit 17.

[0027] The specific configuration of the urine qualitative testing apparatus 10 is, for example, the configuration of the urine qualitative testing apparatus disclosed in U.S. Patent Application Publication No. 2016 / 0061851. The contents of this document are incorporated by reference as part of this specification.

[0028] The urinary sediment testing apparatus 20 includes a control unit 21 , a memory unit 22 , a reading unit 23 , a dispensing unit 24 , a sample preparing unit 25 , an optical measurement unit 26 , and a communication unit 27 .

[0029] The control unit 21 is configured with, for example, a CPU or FPGA. The control unit 21 performs measurement and analysis of the sample by executing a computer program stored in the storage unit 22. The storage unit 22 is configured with, for example, an SSD or HDD. The storage unit 22 stores the measurement data acquired by the optical measurement unit 26 and the measurement results (analysis results) generated by analyzing the measurement data.

[0030] The reading unit 23 reads the sample ID from the sample container 101. The reading unit 23 is configured by, for example, a barcode reader. The dispensing unit 24 inserts an aspirating tube from above the sample container 101 transported by the transport device 20a and releases air from the tip of the aspirating tube to agitate 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 sample preparation unit 25.

[0031] Sample preparation unit 25 includes a reaction vessel to which a specimen is supplied by dispensing unit 24, and prepares a measurement specimen by mixing the specimen with a reagent in the reaction vessel. Optical measurement unit 26 is a flow cytometer that measures the measurement specimen based on flow cytometry. Optical measurement unit 26 will be described later with reference to FIG. 4. Control unit 21 obtains various measurement results based on the measurement data obtained by optical measurement unit 26. Measurement items of urinary sediment testing apparatus 20 will be described later with reference to FIG. 6.

[0032] 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 a cable based on the Ethernet standard, and with the transport device 20a via a cable based on a serial communication standard such as USB. The control unit 21 controls the transport device 20a via the communication unit 27.

[0033] The specific configuration of the urinary sediment testing apparatus 20 may be the same as that of the urinary sediment testing apparatus disclosed in U.S. Patent Application Publication No. 2016 / 0061851, the contents of which are incorporated by reference as part of this specification.

[0034] The image capturing device 30 includes a control unit 31, a storage unit 32, a reading unit 33, a dispensing unit 34, an imaging unit 35, and a communication unit 36.

[0035] The control unit 31 is configured with, for example, a CPU or FPGA. The control unit 31 performs measurement (imaging) and analysis of the sample by executing a computer program stored in the storage unit 32. The storage unit 32 is configured with, for example, an SSD or 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).

[0036] The reading unit 33 reads the sample ID from the sample container 101. The reading unit 33 is configured by, for example, a barcode reader. The dispensing unit 34 inserts an aspirating tube from above the sample container 101 transported by the transport device 30a and releases air from the tip of the aspirating tube to agitate 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.

[0037] The imaging unit 35 includes a cell to which the sample is supplied by the dispensing unit 34, and captures an image of the formed elements in the sample contained in the cell. The imaging unit 35 will be described later with reference to FIG. 5. The control unit 31 acquires various measurement results based on the measurement data (images) acquired by the imaging unit 35. The measurement items of the image capturing device 30 will be described later with reference to FIG. 6.

[0038] 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 a cable based on the Ethernet standard, and with the transport device 30a via a cable based on a serial communication standard such as USB. The control unit 31 controls the transport device 30a via the communication unit 36.

[0039] The specific configuration of the image capturing device 30 may be the same as that of the image capturing device disclosed in U.S. Patent Application Publication No. 2018 / 0017480, the contents of which are incorporated by reference herein as part of this specification.

[0040] FIG. 3 is a block diagram showing the functional configuration of the management device 40. As shown in FIG.

[0041] 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 .

[0042] The control unit 41 is configured, for example, by a CPU. The control unit 41 performs various processes such as managing measurement results by executing computer programs stored in the storage unit 42. The storage unit 42 is configured, for example, by an SSD or HDD. The storage unit 42 stores the measurement results transmitted from the urine qualitative analysis apparatus 10, the urinary sediment analysis apparatus 20, and the imaging device 30.

[0043] The display unit 43 is configured, for example, by a liquid crystal display, an organic EL display, etc. The input unit 44 is configured, for example, by a mouse, a keyboard, etc. Note that the display unit 43 and the input unit 44 may be configured integrally, for example, as a touch panel display.

[0044] The communication unit 45 includes a connection terminal based on the Ethernet standard. The communication unit 45 communicates with the urine qualitative analysis apparatus 10, the urinary sediment analysis apparatus 20, and the imaging device 30 via cables based on the Ethernet standard. The control unit 41 transmits various instruction information to the urine qualitative analysis apparatus 10, the urinary sediment analysis apparatus 20, and the imaging device 30 via the communication unit 45, and receives measurement results from these devices.

[0045] The specific configuration of the management device 40 may be the same as that of the information processing device disclosed in U.S. Patent Application Publication No. 2017 / 0153221, the contents of which are incorporated by reference herein as part of this specification.

[0046] Fig. 4 is a diagram schematically showing the configuration of the optical measurement unit 26. For convenience, Fig. 4 shows X, Y, and Z axes that are orthogonal to each other.

[0047] 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 that has passed through the collimator lens 202 only in the Y-axis direction. The condenser lens 204 focuses the laser light that has passed 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 in the form of a thin beam that is elongated in the Y-axis direction onto the measurement sample flowing in the Z-axis direction inside the flow cell 205. When the laser light is irradiated onto the solid components in the measurement sample, forward scattered light is generated in front of the flow cell 205, and side scattered light and fluorescence are generated to the sides of the flow cell 205.

[0048] The condensing lens 206 condenses the forward scattered light at the position of the pinhole 208. Of the light emitted from the laser light source 201, the laser light that has passed through the flow cell 205 without being irradiated onto any formed components in the measurement sample is condensed by the condensing lens 206 and then blocked by a beam stopper 207 to prevent it from entering 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.

[0049] The condenser lens 210 converges 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.

[0050] 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. The spectral filter 213 transmits fluorescence of a predetermined wavelength out of the fluorescence that has passed through the dichroic mirror 211. The light receiving unit 214 receives the fluorescence that has passed through the spectral filter 213 and outputs a signal based on the intensity of the received fluorescence. The light receiving unit 214 is, for example, a photomultiplier.

[0051] The signals output from the light receiving units 209, 212, and 214 are subjected to predetermined processing and then stored in the storage unit 22 as measurement data.

[0052] Fig. 5 is a diagram schematically showing the configuration of the imaging unit 35. For convenience, mutually orthogonal X, Y, and Z axes are shown in Fig. 5. The Z axis direction is the vertical direction.

[0053] The light source 301 emits light of a predetermined wavelength. The light source 301 is formed, for example, by a light-emitting diode. The irradiation optical system 302 is formed by a plurality of lenses, converts the light from the light source 301 into parallel light, and irradiates the light onto an imaging area of the objective lens 311. The objective lens 311 forms an image of the light irradiated onto the imaging area on the light-receiving surface of the imaging element 312. The objective lens 311 is driven in the optical axis direction (Z-axis direction) for focus adjustment. The imaging element 312 is, for example, a CCD image sensor or a CMOS image sensor. The stage 320 includes a cell 321. The cell 321 is a rectangular parallelepiped container made of a transparent material.

[0054] During imaging, each specimen supplied from the dispensing unit 34 is introduced into the cell 321. The stage 320 is driven to move the cell 321 in the X-axis direction. During this time, the objective lens 311 is moved in the optical axis direction and focus adjustment is performed. The cell 321 is positioned in the imaging area of the objective lens 311, and while the cell 321 is being moved in the X-axis direction, the imaging element 312 images the specimen filled in the cell 321 multiple times. As a result, a predetermined number of images (for example, 40 images) are acquired for the specimen in the cell 321.

[0055] FIG. 6 is a diagram showing the measurement items of the urine qualitative analyzing apparatus 10, the measurement items of the urinary sediment analyzing apparatus 20, and the measurement items of the imaging apparatus 30.

[0056] As shown in FIG. 6, the urine qualitative testing apparatus 10, the urinary sediment testing apparatus 20, and the imaging apparatus 30 are all configured to be able to obtain measurement results for a plurality of measurement items.

[0057] When the control unit 11 of the urine qualitative testing apparatus 10 acquires the sample ID using the reading unit 13, it transmits order inquiry information including the sample ID to the management device 40. When the control unit 41 of the management device 40 receives the order inquiry information from the urine qualitative testing apparatus 10, it transmits an order for the urine qualitative testing apparatus 10 (a urine qualitative order) set for that sample ID to the urine qualitative testing apparatus 10. The urine qualitative order includes the sample ID of the target sample and information indicating for which measurement items of the urine qualitative test measurement results are to be obtained, as shown in the table on the left side of FIG. 6. When the control unit 11 of the urine qualitative testing apparatus 10 receives the urine qualitative order from the management device 40, it performs urine qualitative measurement on the target sample based on the received urine qualitative order and generates the measurement results specified in the urine qualitative order.

[0058] When the control unit 21 of the urinary sediment analysis apparatus 20 acquires the sample ID using the reading unit 23, it transmits order inquiry information including the sample ID to the management device 40. When the control unit 41 of the management device 40 receives the order inquiry information from the urinary sediment analysis apparatus 20, it transmits an order for the urinary sediment analysis apparatus 20 (a urinary sediment order) set corresponding to the sample ID to the urinary sediment analysis apparatus 20. The urinary sediment order includes the sample ID of the target sample and information indicating for which of the measurement items of the urinary sediment test measurement results are to be obtained, as shown in the table in the center of FIG. 6. When the control unit 21 of the urinary sediment analysis apparatus 20 receives the urinary sediment order from the management device 40, it performs urinary sediment measurement on the target sample based on the received urinary sediment order and generates the measurement results specified in the urinary sediment order.

[0059] When the control unit 31 of the imaging device 30 acquires the sample ID using the reading unit 33, it transmits order inquiry information including the sample ID to the management device 40. When the control unit 41 of the management device 40 receives the order inquiry information from the imaging device 30, it transmits to the imaging device 30 an order for the imaging device 30 (an order for imaging) set corresponding to the sample ID. The imaging order includes the sample ID of the target sample and information indicating for which of the measurement items of imaging to obtain measurement results, such as those shown in the table on the right side of FIG. 6 . When the control unit 31 of the imaging device 30 receives the imaging order from the management device 40, it performs imaging of the target sample based on the received imaging order and generates the measurement results specified in the imaging order.

[0060] Such orders for urine qualitative analysis, urinary sediment analysis, and imaging are set in advance by an operator or the like in accordance with the judgment of a doctor or the like based on patient information and the policies of the testing facility, and are stored in the memory unit 42 of the management device 40 or a host computer with which the management device 40 can communicate.

[0061] In an embodiment, in addition to the pre-set orders, additional orders may be automatically set in accordance with the sample measurement results.

[0062] For example, when a sample is transported sequentially to three testing devices (the urine qualitative testing device 10, the urinary sediment testing device 20, and the imaging device 30), it may be preferable to perform an additional measurement in a downstream testing device (hereinafter referred to as the "second testing device") based on a predetermined measurement result obtained in the upstream testing device (hereinafter referred to as the "first testing device"). In this case, even if an order for the second testing device has not been set in advance, an additional order for the second testing device is automatically set for the measurement item of the second testing device related to the predetermined measurement result of the first testing device, and a measurement (hereinafter referred to as the "additional measurement") in the second testing device based on this order is performed.

[0063] If an order for the second inspection device is set in advance, an additional order may be included in the pre-set order for the second inspection device, or the additional order may be set separately. For example, if the original order for the second inspection device specifies measurement of measurement item A and the measurement item to be added is B, the original order for the second inspection device may be changed to an additional order specifying measurement items A and B, or an additional order specifying measurement item B may be set separately from the original order for the second inspection device.

[0064] Note that, since the urinary sediment analyzing apparatus 20 can acquire measurement results for all measurement items of the urinary sediment analyzing apparatus 20 through a common measurement operation, all measurement items may be set as additional orders for the urinary sediment analyzing apparatus 20. Similarly, since the imaging apparatus 30 can acquire measurement results for all measurement items of the imaging apparatus 30 through a common measurement operation, all measurement items may be set as additional orders for the imaging apparatus 30.

[0065] As a specific example, when protein is detected by the urine qualitative testing apparatus 10, an additional order for urinary sediment analysis for that sample is automatically set. Specifically, the measurement item "casts (CAST)" of the urinary sediment testing apparatus 20, which is related to the measurement item "protein (PRO)" of the urine qualitative testing apparatus 10, is designated as the measurement item to be added, and an additional order including the designated measurement item is set. Then, the additional measurement is automatically performed by the urinary sediment testing apparatus 20, and the presence or absence of casts related to the detection of protein is examined.

[0066] In this case, if the amount of protein detected by the urine qualitative testing apparatus 10 is minute, it is expected that the amount of casts contained in the sample is small, and therefore, in the additional measurement by the urinary sediment testing apparatus 20, it is preferable to perform a predetermined number of measurements to reliably test for the presence or absence of casts. Therefore, in the embodiment, to increase the possibility of obtaining reliable measurement results, an order is set so that additional measurements are performed multiple times for a sample with the same sample ID. Additional measurements performed multiple times using the same measurement method are hereinafter referred to as "multiple measurements."

[0067] Furthermore, in the embodiment, when multiplex measurements are performed in the second testing device, if a predetermined measurement result is obtained in the second testing device, the multiplex measurements are terminated even if the multiplex measurements are in progress. The condition for terminating the multiplex measurements is hereinafter referred to as the "termination condition." By setting a termination condition for the additional order, it is possible to save reagents, samples, time, etc. compared to performing all of the predetermined number of measurements in the multiplex measurements.

[0068] 7 to 9 are diagrams illustrating examples of rules for additional measurements. Three, two, and five rules for additional measurements are shown in FIGS. 7 to 9, respectively. In FIGS. 7 to 9, each rule for additional measurements includes a condition for performing additional measurements by the second inspection device, the number of measurements by the second inspection device, and a termination condition for multiple measurements by the second inspection device. Each condition for performing additional measurements by the second inspection device includes a measurement item for the first inspection device and a criterion corresponding to the measurement result of the measurement item.

[0069] FIG. 7 is a diagram illustrating an example of rules for additional measurements when the first testing device is a urine qualitative testing device 10 and the second testing device is a urinary sediment testing device 20. In FIG.

[0070] When the measurement result of the measurement item "Protein (PRO)" of the urine qualitative testing apparatus 10 is "+-," "1+," "2+," "3+," or "4+," the urinary sediment testing apparatus 20 performs 3, 2, 1, 1, and 1 additional measurements, respectively, and an additional order is set to include the measurement items "Casts (CAST)," "Red Blood Cell Morphological Information (RBC-Info.)," and "Renal Tubular Epithelial Cells (RTEC)." In this case, if the measurement results of each additional measurement by the urinary sediment testing apparatus 20 show that the measurement result of the measurement item "Casts (CAST)" is equal to or greater than a predetermined value, the measurement result of the measurement item "Red Blood Cell Morphological Information (RBC-Info.)" shows the presence of dysmorphic red blood cells (Dysmorphic? or Mixed?), or the measurement result of the measurement item "Renal Tubular Epithelial Cells (RTEC)" is equal to or greater than a predetermined value, a termination condition is set to terminate the multiplex measurement. Note that the termination condition may also be set when the measurement results of two or three of these three formed elements are equal to or greater than a predetermined value.

[0071] If the measurement result of the measurement item "specific gravity (SG)" of the urine qualitative testing apparatus 10 is 1.010 or less, greater than 1.010 but less than 1.030, or greater than 1.030, two, one, and two additional measurements are performed in the urinary sediment testing apparatus 20, respectively, and an additional order is set to include all measurement items. In this case, the measurement result of the measurement item "specific gravity (SG)" of the urine qualitative testing apparatus 10 is related to all measurement items of the urinary sediment testing apparatus 20, no termination condition is set, and a set number of measurements are performed.

[0072] If the measurement result of the measurement item "pH" of the urine qualitative testing apparatus 10 is 5.0 or less, greater than 5.0 but less than 8.0, or greater than 8.0, two, one, and two additional measurements are performed in the urinary sediment testing apparatus 20, respectively, and an additional order is set to include all measurement items. In this case, the measurement result of the measurement item "pH" of the urine qualitative testing apparatus 10 is related to all measurement items of the urinary sediment testing apparatus 20, no termination condition is set, and a set number of measurements are performed.

[0073] FIG. 8 is a diagram illustrating an example of rules for additional measurements when the first testing device is a urine qualitative testing device 10 and the second testing device is an image capturing device 30. In FIG.

[0074] If the measurement result for the measurement item "bilirubin (BIL)" of the urine qualitative testing device 10 is "+", five additional measurements (imaging) are performed by the imaging device 30, and an additional order is set to include the measurement item "bilirubin crystals". In this case, if the measurement result for the measurement item "bilirubin crystals" in each additional measurement by the imaging device 30 is equal to or greater than a predetermined value, an end condition is set to end the multiplex measurement.

[0075] The measurement results for the measurement item "COLOR" of the urine qualitative testing device 10 include "OTHER," "L YELLOW," "STRAW," "YELLOW," "AMBER," "RED," and "DK BROWN." If the measurement result for the measurement item "COLOR" of the urine qualitative testing device 10 is "OTHER," five additional measurements (image capture) are performed by the imaging device 30, and an additional order is set to include the measurement item "drug crystals." In this case, if the measurement result for the measurement item "drug crystals" in each additional measurement by the imaging device 30 is equal to or greater than a predetermined value, a termination condition is set to terminate the multiplex measurement.

[0076] FIG. 9 is a diagram illustrating an example of rules for additional measurements when the first testing device is the urinary sediment testing device 20 and the second testing device is the imaging device 30.

[0077] The measurement result of the measurement item "atypical cells (Atyp. C)" of the urinary sediment analyzer 20 includes a measurement value indicating the number per unit volume and a positive flag determined based on the measurement value. If the measurement result of the measurement item "atypical cells (Atyp. C)" of the urinary sediment analyzer 20 is flagged as positive or is equal to or greater than the threshold, the imaging device 30 performs five additional measurements (image capture), and an additional order is set to include the measurement item "atypical cells." In this case, if the measurement result of the measurement item "atypical cells" of each additional measurement by the imaging device 30 is equal to or greater than a predetermined value, a termination condition is set to terminate the multiplex measurement.

[0078] The measurement results for the "fat droplet" measurement item of the urinary sediment analyzer 20 include a measurement value indicating the number per unit volume and a positive flag determined based on the measurement value. If the measurement result for the "fat droplet" measurement item of the urinary sediment analyzer 20 is flagged as positive or is above a threshold, the imaging device 30 performs five additional measurements (image capture), and an additional order is set to include the measurement items "oval fat bodies," "Mulberry bodies," and "fat droplets." In this case, a termination condition is set to terminate the multiplex measurement if, in the measurement results of each additional measurement by the imaging device 30, the measurement result for the "oval fat bodies" measurement item is equal to or greater than a predetermined value, the measurement result for the "Mulberry bodies" measurement item is equal to or greater than a predetermined value, or the measurement result for the "fat droplet" measurement item is equal to or greater than a predetermined value. Note that the termination condition may also be set when the measurement results for two or three of these three formed elements are equal to or greater than a predetermined value.

[0079] If the measurement result for the measurement item "casts (CAST)" of the urinary sediment testing apparatus 20 is equal to or greater than the threshold value, five additional measurements (image capture) are performed by the imaging device 30, and an additional order is set to include the measurement item "casts." In this case, if the measurement result for the measurement item "casts" in each additional measurement by the imaging device 30 is equal to or greater than a predetermined value, an end condition is set to end the multiple measurements.

[0080] If the measurement result of the measurement item "epithelial cells (EC)" of urinary sediment testing device 20 is equal to or greater than the threshold value, five additional measurements (image capture) are performed by imaging device 30, and an additional order is set to include the measurement item "epithelial cells." In this case, if the measurement result of the measurement item "epithelial cells" of each additional measurement by imaging device 30 is equal to or greater than a predetermined value, an end condition is set to end the multiplex measurement.

[0081] If the measurement result of the measurement item "sperm" by urinary sediment testing apparatus 20 is equal to or greater than the threshold value, five additional measurements (image capture) are performed by imaging device 30, and an additional order is set to include the measurement item "sperm." In this case, if the measurement result of the additional measurements by imaging device 30 for the measurement item "sperm" is equal to or greater than a predetermined value, an end condition is set to end the multiplex measurement.

[0082] As shown in Figures 7 to 9, the measurement item of the first testing device that serves as a condition for performing additional measurements using the second testing device and the measurement item that serves as a termination condition for multiplex measurements using the second testing device are related to each other. That is, the measurement result that serves as the termination condition for multiplex measurements using the second testing device can be used to infer a disease similar to the disease inferred from the measurement result of the first testing device used to determine whether additional measurements using the second testing device are necessary. For example, if the measurement result for the measurement item "protein (PRO)" using the urine qualitative testing device 10 (first testing device) is "+-," it is inferred that the subject is likely to be suffering from a kidney-related disease. In this case, if the measurement result for the measurement item "cast (CAST)" using the urinary sediment testing device 20 (second testing device) is greater than or equal to a predetermined value, it can be determined that the subject is likely to be suffering from a kidney-related disease.

[0083] In the embodiment, the measurement items of the first and second test devices are associated in the rule for additional measurement, and the termination condition for the multiplex measurement of the second test device includes obtaining a measurement result of the second test device suggested by the measurement result of the first test device used to determine whether or not to perform testing by the second test device. This increases the possibility of obtaining the measurement result of the second test device suggested by the measurement result of the first test device through multiplex measurement, and terminates the measurement of the second test device when the measurement result of the second test device is obtained, thereby saving reagent consumed by the second test device, samples supplied to the second test device, the time required to measure the samples, etc.

[0084] Next, a screen for setting rules for additional measurements will be described.

[0085] A rule list screen 400, a rule setting screen 500, and an end 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. When an operator of the management device 40 inputs an operation on these screens via the input unit 44, the control unit 41 of the management device 40 executes processing in accordance with the input operation.

[0086] FIG. 10 is a diagram that schematically shows a rule list screen 400 that displays a list of rules for additional measurements.

[0087] The list area 410 shows the rules for additional measurements on a line-by-line basis, and includes the following items: valid, rule name, first inspection device, second inspection device, multiple measurements, and termination condition.

[0088] The "Enabled" item includes a check box 411 that indicates whether the rule is enabled. By operating the check box 411, the operator can set the rule to be enabled (checked) or disabled (unchecked). The "Rule Name" item indicates the name given to the rule by the operator. The "First Inspection Device" item indicates the name of the upstream inspection device that determines the execution conditions for additional measurements, and the "Second Inspection Device" item indicates the name of the downstream inspection device that performs additional measurements. The "Multiple Measurements" item indicates the number of measurements by the second inspection device that are set for the rule. The "End Conditions" item indicates whether or not there are conditions for ending multiple measurements that are set for the rule.

[0089] When the operator creates a new rule, he operates the new creation button 401. As a result, a rule setting screen 500 (see FIG. 11 ) is displayed on the display unit 43. When the operator edits an existing rule, he operates the corresponding line in the list area 410. As a result, the rule setting screen 500 including the rule in the operated line is displayed on the display unit 43.

[0090] FIG. 11 is a diagram that schematically shows a rule setting screen 500 for setting rules for additional measurements.

[0091] The operator inputs a name that will enable identification of the rule in the text box 510. The operator operates the pull-down menu 521 to input either the urine qualitative analysis apparatus 10, the urinary sediment analysis apparatus 20, or the imaging apparatus 30 as the first testing apparatus, and operates the pull-down menu 522 to input either the urinary sediment analysis apparatus 20 or the imaging apparatus 30 as the second testing apparatus.

[0092] The operator operates pull-down menu 530 to input the measurement item of the first inspection device used to determine whether additional measurements are necessary, and enters the condition value of the measurement item of the first inspection device in text box 541. If there are multiple condition values, the operator operates add button 542 to display additional text boxes 541. The operator enters the number of measurements to be performed by the second inspection device in text box 543. If setting one measurement, the operator enters "1" in text box 543, and if setting multiple measurements, the operator enters a value of two or more in text box 543. In text box 544, the operator enters a comment to be displayed on detailed result screen 800 (see FIG. 21 ), which displays the measurement results, when the measurement results of the first inspection device satisfy the condition value. If the operator wants to add rules to the measurement item of the first inspection device, the operator operates add button 545. This adds another condition area 540.

[0093] The operator operates check box 551 to set whether or not to enable the condition for terminating multiple measurements by the second inspection device. When check box 551 is checked, the condition for terminating multiple measurements is enabled. When the operator operates end condition setting button 552, end condition setting screen 600 (see FIG. 12) for setting the end condition is displayed on display unit 43.

[0094] When the OK button 501 is operated, the control unit 41 of the management device 40 stores the rules set on the rule setting screen 500 and the setting 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 operated, the control unit 41 discards the rules set on the rule setting screen 500 and closes the rule setting screen 500. When the delete button 503 is operated, the control unit 41 deletes the rules set on the rule setting screen 500 from the storage unit 42.

[0095] FIG. 12 is a diagram schematically showing an end condition setting screen 600 for setting an end condition.

[0096] The operator operates check box 610 to set whether or not to validate the condition for terminating multiple measurements by the second inspection device, i.e., the condition set on termination condition setting screen 600. When check box 610 is checked, the condition for terminating multiple measurements is validated. The state of check box 610 is linked to the state of check box 551 on rule setting screen 500.

[0097] The operator operates pull-down menu 621 to input the measurement item of the second inspection device used to determine the end of multiplex 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 operates add button 623 to display an additional text box 622. If the operator wants to increase the conditions for multiplex measurement, he operates add button 624. This adds another condition area 620. When multiple condition areas 620 are displayed, the operator can operate pull-down menu 630 to set whether the conditions set in the multiple condition areas 620 are to be determined using "and" or "or."

[0098] When the OK button 601 is operated, the control unit 41 of the management device 40 temporarily stores the termination conditions 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 operated, the control unit 41 discards the termination conditions set on the termination condition setting screen 600 and closes the termination condition setting screen 600.

[0099] FIG. 13 is a diagram that schematically shows the rule setting screen 500 in a state in which the rule for additional measurement when the measurement item shown in FIG. 7 is protein has been set.

[0100] 7, five conditions are set for the measurement item "protein (PRO)" of the first testing device (urine qualitative testing device 10), and therefore five condition areas 540 are displayed. When multiple condition areas 540 are displayed, a delete button 546 is provided for deleting each condition area 540.

[0101] FIG. 14 is a diagram that schematically shows the termination condition setting screen 600 in a state in which the termination condition for the measurement item shown in FIG. 7, which is protein, has been set.

[0102] 7, in this case, termination conditions are set for the measurement items "casts (CAST)," "red blood cell morphology information (RBC-Info.)," and "renal tubular epithelial cells (RTEC)" of the second testing device (urinary sediment testing device 20), and so three condition areas 620 are displayed. When multiple text boxes 622 for inputting condition values for the measurement items of the second testing device are displayed, a delete button 625 for deleting each text box 622 and a pull-down menu 626 for setting whether the condition value in each text box 622 is to be determined by "and" or "or" are provided. Furthermore, when multiple condition areas 620 are displayed, a delete button 627 for deleting each condition area 620 is provided.

[0103] FIG. 15 is a diagram that schematically shows rule setting screen 500 in a state in which rules for additional measurements when the measurement item shown in FIG. 7 is specific gravity have been set.

[0104] As shown in FIG. 7, three conditions are set for the measurement item "specific gravity (SG)" of the first testing device (urine qualitative testing device 10), and therefore three condition areas 540 are displayed. When multiple text boxes 541 for inputting condition values for the measurement items of the first testing device are displayed in the condition area 540, a delete button 547 for deleting each text box 541 and a pull-down menu 548 for setting whether the condition value of each text box 541 is to be determined by "and" or "or" are provided. In this case, as shown in FIG. 7, there is no condition for ending the measurement in the second testing device (urinary sediment testing device 20), and therefore check box 551 is set to the off state.

[0105] FIG. 16 is a diagram that schematically shows rule setting screen 500 in a state in which a rule for additional measurement has been set when the measurement item shown in FIG. 8 is bilirubin.

[0106] 8, one condition is set for the measurement item "bilirubin (BIL)" of the first testing device (urine qualitative testing device 10), and therefore one condition area 540 is displayed. In this case, the number of measurements (number of images taken) of the second testing device (image capturing device 30) is set to five.

[0107] FIG. 17 is a diagram that schematically shows the termination condition setting screen 600 in a state in which the termination condition for the measurement item shown in FIG. 8 when bilirubin is set.

[0108] 8, in this case, one termination condition has been set for the measurement item "bilirubin crystals" of the second testing device (imaging device 30), and therefore one condition area 620 is displayed. In this case, "+" has been entered in text box 622 indicating the condition value, and the termination condition is set to be that at least one bilirubin crystal is detected in the imaging device 30. Note that an inequality sign or the like may be entered in text box 622, and the termination condition may be set to be that a predetermined value or more of bilirubin crystals are detected.

[0109] FIG. 18 is a diagram that schematically shows the rule setting screen 500 in a state in which the rule for additional measurement when the measurement item shown in FIG. 9 is atypical cells has been set.

[0110] As shown in FIG. 9, one condition is set for the measurement item "atypical cells (Atyp. C)" of the first testing apparatus (urinary sediment testing apparatus 20), and therefore one condition area 540 is displayed.

[0111] FIG. 19 is a diagram that schematically shows the termination condition setting screen 600 in a state in which the termination condition shown in FIG. 9 is set when the measurement item is atypical cells.

[0112] As shown in FIG. 9, in this case, one termination condition is set for the measurement item "atypical cells" of the second testing device (imaging device 30), and therefore one condition area 620 is displayed.

[0113] Next, the screen for displaying the measurement results will be described.

[0114] A result list screen 700 and a 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 an operator of the management device 40 inputs an operation on these screens via the input unit 44, the control unit 41 of the management device 40 executes processing in accordance with the input operation.

[0115] FIG. 20 is a diagram that schematically shows a result list screen 700 that displays a list of measurement results.

[0116] The list area 710 shows measurement results associated with a specimen ID in rows, and includes items such as Measurement, Specimen ID, Qualitative, Sediment, Image, and multiple measurement items.

[0117] In the "Measurement" item, a mark 711 is displayed when an order is set for multiple additional measurements (multiple measurements) to be performed on a second testing device (either the urinary sediment testing device 20 or the imaging device 30). In the "Qualitative," "Sediment," and "Image" items, a check mark 712 is displayed when measurements are performed using the urinary qualitative testing device 10, the urinary sediment testing device 20, and the imaging device 30, respectively. The multiple measurement item item shows the measurement results of all measurement items that can be obtained using the urinary qualitative testing device 10, the urinary sediment testing device 20, and the imaging device 30.

[0118] When the operator wishes to refer to the detailed measurement results of the target sample, he or she operates the corresponding row in the list area 710. As a result, the detailed results screen 800 (see FIGS. 21 to 23) including the detailed measurement results associated with the sample ID of the operated row is displayed on the display unit 43.

[0119] FIG. 21 is a diagram that schematically shows a detailed result screen 800 that displays detailed measurement results when the tab 821 is operated.

[0120] The specimen information display area 810 displays the specimen ID, the specimen collection date, the name of the subject from whom the specimen was collected, etc. In addition, similar to the mark 711 shown in Fig. 20, the specimen information display area 810 displays a mark 811 when an order is set for multiple additional measurements (multiple measurements) to the second testing apparatus (either the urinary sediment testing apparatus 20 or the imaging apparatus 30).

[0121] Various measurement results are displayed in display area 820 in response to the operation of tabs 821 to 824. In display area 820 in Fig. 21, an example is shown in which, as a result of operating tab 821, measurement results are displayed in a list and comments are also displayed.

[0122] The operator operates the pull-down menu 831 to determine whether to display in the list area 832 the measurement results obtained by the urine qualitative testing device 10 (urine qualitative test results), the measurement results obtained by the urinary sediment testing device 20 (urinary sediment test results), or the measurement results obtained by the imaging device 30 (image test results).

[0123] If the target sample is measured multiple times using a device corresponding to pull-down menu 831, list area 832 displays the measurement results for each measurement in items such as "Result 1" and "Result 2," and displays an overall result value based on the measurement results for each measurement in the "Result" item. The overall result value is, for example, the average of the measurement results for each measurement. On the other hand, if the target sample is measured only once using a device corresponding to pull-down menu 831, list area 832 displays the measurement result for that single measurement in the "Result," and items such as "Result 1" and "Result 2" are omitted.

[0124] If the target specimen has been measured multiple times using an apparatus corresponding to the pull-down menu 831, a comment indicating this and the measurement items that were the basis for the multiple measurements are displayed in the review comment 833. For example, the review comment 833 in Fig. 21 indicates that multiple measurements were performed using the urinary sediment analyzer 20 based on the measurement results of protein (PRO) using the urine qualitative analyzer 10. The review comment 833 also displays the comment entered in the text box 544 (see Fig. 11) on the rule setting screen 500.

[0125] FIG. 22 is a diagram that schematically shows a detailed results screen 800 that displays detailed measurement results when the tab 824 is operated.

[0126] In display area 820 in FIG. 22, a tab 824 is operated to display a list of measurement results, and graphs such as scattergrams and histograms are also displayed.

[0127] The operator operates the pull-down menu 841 to determine whether to display the urine qualitative test results, the urinary sediment test results, or the image test results in the list area 842. Depending on the operation of the pull-down menu 841, the graph area 850 displays either a graph acquired by the urine qualitative testing apparatus 10, a graph acquired by the urinary sediment testing apparatus 20, or an image acquired by the imaging device 30. The graph area 850 in FIG. 22 displays two scattergrams 851 and 852 acquired by the urinary sediment testing apparatus 20, and displays a mark 853 indicating that these scattergrams 851 and 852 were acquired by multiple measurements.

[0128] Here, when multiple measurements are performed on one sample using one device, the graph obtained by the device is generated by overlaying the results of the multiple measurements. Generally, the number of formed elements detected by the urinary sediment analysis device 20 or the imaging device 30 is small, and therefore the number of formed elements plotted on the scattergram from one measurement is also small. In this case, it becomes difficult to fractionate the formed elements using the scattergram. In contrast, according to the embodiment, when multiple measurements are performed, the plots obtained from the multiple measurements are overlaid on the graph. This increases the number of formed elements plotted on the scattergram, making it easier to fractionate the formed elements using the scattergram.

[0129] In addition, for a scattergram generated by overlapping multiple measurement results, the scattergrams of the original measurement results may be displayed individually.

[0130] FIG. 23 is a diagram that schematically shows a detailed results screen 800 that displays detailed measurement results when the tab 822 is operated.

[0131] In the display area 820 of FIG. 23, an example is shown in which measurement results obtained by two devices are displayed side by side as a result of operating tab 822.

[0132] The operator operates pull-down menu 861 to determine whether to display the urine qualitative test results, the urinary sediment test results, or the image test results in list area 862. The operator operates pull-down menu 863 to determine whether to display the urine qualitative test results, the urinary sediment test results, or the image test results in list area 864.

[0133] When tab 823 is operated, the display area 820 displays the measurement results of each device's measurement items as research items, such as the measurement items of the urine sediment testing device 20, such as "urothelial cells (Tran.EC)," "renal tubular epithelial cells (RTEC)," "small round epithelial cells (SRC)," "atypical cells (Atyp.C)," and "red blood cell morphology information (RBC-Info.)."

[0134] Next, the processes performed by the management device 40, the first inspection device, and the second inspection device will be described with reference to flowcharts.

[0135] FIG. 24 is a flowchart showing the process of setting rules for additional measurements.

[0136] 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. As a result, the operator of the management device 40 inputs a rule for additional measurement into the rule setting screen 500 via the input unit 44. When the control unit 41 determines that the termination condition setting button 552 for displaying the termination condition setting screen 600 has been operated on the rule setting screen 500 as an instruction to set a termination condition (step S13: YES), the control unit 41 displays the termination condition setting screen 600 on the display unit 43 in step S14. As a result, the operator of the management device 40 inputs the termination condition into the termination condition setting screen 600 via the input unit 44.

[0137] When the control unit 41 determines that the OK button 601 or the cancel button 602 has been operated on the termination condition setting screen 600 as an instruction to end 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 operated on the termination condition setting screen 600, the control unit 41 temporarily stores the termination condition set on the termination condition setting screen 600.

[0138] When the control unit 41 determines that the OK button 501, the cancel button 502, or the delete button 503 on the rule setting screen 500 has been operated as an instruction to end the setting of the rule for the additional measurement (step S17: YES), in step S18, the control unit 41 stores the rule for the additional measurement entered on the rule setting screen 500 and the end condition entered on the end condition setting screen 600 in the storage unit 42. Here, if the cancel button 502 on the rule setting screen 500 has been operated, the control unit 41 omits the processing of step S18, and if the delete button 503 on the rule setting screen 500 has been operated, the control unit 41 deletes the rule for the additional measurement and the end condition that have already been stored from the storage unit 42. Then, in step S19, the control unit 41 closes the rule setting screen 500.

[0139] Next, the processing of the first inspection device, the second inspection device, and the management device 40 when measurements are performed in the first inspection device and the second inspection device in turn will be described with reference to a flowchart.

[0140] As described above, in the embodiment, there are three combinations of the first testing device and the second testing device. Specifically, the combinations are: (1) when the first testing device and the second testing device are the urine qualitative testing device 10 and the urinary sediment testing device 20, respectively; (2) when the first testing device and the second testing device are the urine qualitative testing device 10 and the imaging device 30, respectively; and (3) when the first testing device and the second testing device are the urinary sediment testing device 20 and the imaging device 30, respectively. In combinations (1) to (3), additional measurements are performed according to the rules shown in Figures 7, 8, and 9, respectively.

[0141] FIG. 25 is a flowchart showing the processing of the first inspection device and management device 40.

[0142] In step S101, the control unit of the first testing apparatus reads the sample ID from the sample container 101 using the reading unit of the first testing apparatus. In step S102, the control unit of the first testing apparatus transmits order inquiry information including the sample ID read in step S101 to the management apparatus 40. Upon receiving the order inquiry information from the first testing apparatus, the control unit 41 of the management apparatus 40 acquires the order of the first testing apparatus associated with the sample ID included in the received order inquiry information from the storage unit 42 of the management apparatus 40 or an external host computer. Then, in step S111, the control unit 41 of the management apparatus 40 transmits the acquired order to the first testing apparatus.

[0143] In step S103, the control unit of the first testing device performs measurement processing by the first testing device based on the order received from the management device 40, and acquires the measurement results of the first testing device (first measurement results). The measurement processing will be described later with reference to FIG. 28. In step S104, the control unit of the first testing device associates the first measurement results acquired in step S103 with the sample ID and transmits them to the management device 40. Thereafter, in step S105, the control unit of the first testing device transports the sample rack 100.

[0144] If the sample rack 100 holds samples that have not been processed by the first testing device, the control unit of the first testing device performs the processes of steps S101 to S105 on the other samples. When the measurement of all samples held in this sample rack 100 is completed, the control unit of the first testing device transports this sample rack 100 from the transport device of the first testing device to the transport device of the subsequent testing device.

[0145] 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 an additional measurement by the second testing device is necessary based on the rules for additional measurement for the received first measurement result. If the first testing device is the urine qualitative testing device 10, the determination of necessity is made based on the rules for additional measurement shown in Figures 7 and 8. If the first testing device is the urinary sediment testing device 20, the determination of necessity is made based on the rules for additional measurement shown in Figure 9.

[0146] If the control unit 41 determines in step S114 that additional measurement by the second testing device is necessary (step S115: YES), then in step S116 it updates or registers the order for the second testing device for the target sample.

[0147] FIG. 26 is a diagram illustrating a schematic example of updating and registering an order for the second inspection device.

[0148] As shown in the upper left of Figure 26, if an order for the second testing device for the target sample has been set in advance by an operator or the like, i.e., if an original order exists, as shown in the upper right of Figure 26, the control unit 41 updates the original order stored in the memory unit 42 or the host computer with the measurement details of the second testing device corresponding to the first measurement result of the first testing device that meets the conditions for performing an additional measurement, as shown in the upper right of Figure 26. In the upper left of Figure 26, the measurement item specified in the original order is "cast (CAST)." In this case, when the additional measurement rule in the first row of Figure 7 is applied, the original order is updated with the details of the additional measurement, as shown in the upper right of Figure 26. As a result, "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 a termination condition is added.

[0149] Even if a termination condition is set in the rule for additional measurement, all measurement items of the second inspection device may be set when updating the additional order. Also, when an original order exists as shown in the upper left of Fig. 26, an additional order as shown in the upper right of Fig. 26 may be registered separately.

[0150] On the other hand, as shown in the lower left of Fig. 26, if the original order for the target sample does not exist, the control unit 41 newly registers an order for the second testing device based on the rules for additional measurement and stores it in the storage unit 42 or the host computer, as shown in the lower right of Fig. 26. In this case, all measurement items for the second testing device may also be set when registering the additional order.

[0151] In addition, if 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 for the order of the second inspection device, and all termination conditions corresponding to each condition are set as the termination conditions for the order of the second inspection device.

[0152] 25, if the control unit 41 determines in step S114 that additional measurement by the second inspection device is not necessary (step S115: NO), it does not perform the process of step S116. If the determination in step S115 is NO, or if step S116 is executed, the process proceeds to step S131 in FIG.

[0153] FIG. 27 is a flowchart showing the processing of the second inspection device and management device 40.

[0154] In step S121, the control unit of the second testing apparatus reads the sample ID from the sample container 101 using the reading unit of the second testing apparatus. In step S122, the control unit of the second testing apparatus transmits order inquiry information including the sample ID read in step S121 to the management apparatus 40. Upon receiving the order inquiry information from the second testing apparatus, the control unit 41 of the management apparatus 40 acquires the order of the second testing apparatus associated with the sample ID included in the received order inquiry information from the storage unit 42 of the management apparatus 40 or an external host computer. Then, in step S131, the control unit 41 of the management apparatus 40 transmits the acquired order to the second testing apparatus.

[0155] If an order for the second testing device is not stored for the target sample, the control unit 41 of the management device 40 transmits information indicating that there is no order for the second testing device to the second testing device. In this case, the second testing device omits the processing of steps S123 to S127, which will be described later.

[0156] In step S123, the control unit of the second testing device performs measurement processing using the second testing device based on the order received from the management device 40, and acquires the measurement results of the second testing device (second measurement results). The processing of step S123 completes one measurement using the second testing device. Subsequently, in step S124, the control unit of the second testing device determines whether measurements have been performed on the target sample the number of times specified in the order of the second testing device. If measurements have been performed the number of times specified in the order of the second testing device (step S124: YES), in step S126, the control unit of the second testing device ends the measurements using the second testing device.

[0157] If the number of measurements specified in the order of the second inspection device has not been completed (step S124: NO), in step S125, the control unit of the second inspection device determines whether the second measurement result obtained in the measurement of the immediately preceding step S123 satisfies the termination condition specified in the order of the second inspection device. If the second measurement result satisfies the termination condition (step S125: YES), in step S126, the control unit of the second inspection device terminates the measurement by the second inspection device.

[0158] If the number of measurements specified in the order of the second inspection device has not been 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 device returns the process to step S123 and performs the measurement process again using the second inspection device.

[0159] As described above, the determination of the termination condition (step S125) is performed for each measurement process (step S123) of the second inspection device, and the measurement termination process (step S126) when the termination condition is satisfied is performed in response to the end of the measurement by the second inspection device for which the termination condition determination has been performed. In other words, the measurement termination process (step S126) when the termination condition is satisfied is performed at a timing when no measurement is being performed by the second inspection device. This ensures that the measurement for which the termination condition determination has been performed is performed to the end.

[0160] In step S127, the control unit of the second testing device transmits the number of times the measurement process of step S123 was performed and all of the second measurement results acquired in step S123 in association with the sample ID to the management device 40. Thereafter, in step S128, the control unit of the second testing device transports the sample rack 100.

[0161] In this case, if the sample rack 100 contains samples that have not been processed by the second testing apparatus, the control unit of the second testing apparatus performs steps S121 to S127 on the other samples. When measurement of all samples held in this sample rack 100 is completed, if the second testing apparatus is the urinary sediment testing apparatus 20, the control unit of the second testing apparatus transports this sample rack 100 to the transport device 30a of the downstream imaging apparatus 30, and if the second testing apparatus is the imaging apparatus 30, the control unit of the second testing apparatus stores this sample rack 100 at the left end of the transport device 30a.

[0162] When the control unit 41 of the management device 40 receives the second measurement result from the second inspection device (step S132: YES), in step S133, the control unit 41 stores the received second measurement result in the storage unit 42. Thereafter, in step S134, the control unit 41 outputs the measurement result in response to an instruction from the operator.

[0163] In the embodiment, the control unit 41 outputs the measurement results by displaying them on the display unit 43, but this is not limited to this, and the measurement results may be output, for example, by transmitting them to another device.

[0164] FIG. 28 is a flowchart showing the measurement processes of the urine qualitative analyzing apparatus 10, the urinary sediment analyzing apparatus 20, and the imaging apparatus 30, in this order from left to right.

[0165] As shown in the flowchart on the left side of Figure 28, in step S201, the control unit 11 of the urine qualitative testing apparatus 10 agitates 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, and in step S203, controls the container measurement unit 15 to measure the sample in the measurement container. In step S204, the control unit 11 controls the dispensing unit 14 to deposit the aspirated sample on a test strip, and in step S205, controls the color development measurement unit 16 to measure the color development of the test strip.

[0166] In step S206, the control unit 11 generates measurement results for the measurement items of specific gravity, color tone, and turbidity of the urine qualitative testing apparatus 10 shown in FIG. 6 based on the measurement data acquired in step S203, and generates measurement results for the other measurement items of the urine qualitative testing apparatus 10 shown in FIG. 6 based on the measurement data acquired in step S205.

[0167] All measurements performed by the urine qualitative testing apparatus 10 are performed under the same conditions, in other words, in the same sequence. That is, the time for stirring the sample in step S201, the amount of sample aspirated in step S201, the position of the tip of the aspirating tube when aspirating the sample in step S201, the amount of sample supplied to the measurement container in step S202, the time from supplying to the measurement container in step S202 to measurement in step S203, the amount of sample deposited in step S204, the time from deposition in step S204 to measurement in step S205, the wavelength and intensity of light during measurement in step S205, etc. are the same for all measurements.

[0168] As shown in the central flowchart of FIG. 28, in step S211, the control unit 21 of the urinary sediment analyzing apparatus 20 agitates 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 a reaction container (chamber), and in step S213, controls the sample preparing unit 25 to supply a reagent to the reaction container. This prepares a measurement sample 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.

[0169] In step S215, the control unit 21 generates measurement results for the measurement items of the urinary sediment examining apparatus 20 shown in FIG. 6 based on the measurement data acquired in step S214.

[0170] All measurements performed by urinary sediment analyzer 20 are performed under the same conditions, in other words, in the same sequence. That is, the time for stirring the sample in step S211, the amount of sample aspirated in step S211, the position of the tip of the aspirating tube when aspirating the sample 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 through flow cell 205, the wavelength and intensity of light during the measurement performed in step S214, etc. are the same for all measurements.

[0171] When the urinary sediment analyzing apparatus 20 is the second testing apparatus, each measurement process of the second testing apparatus performed in step S123 of FIG. 27 is performed under the same conditions as described above, according to the flowchart in the center of FIG.

[0172] As shown in the flowchart on the right side of Figure 28, in step S221, the control unit 31 of the image capturing device 30 controls the dispensing unit 34 to agitate the sample in the sample container 101 transported by the transport device 30a and aspirate the sample from the sample container 101. In step S222, the control unit 31 controls the dispensing unit 24 to supply the aspirated sample to a cell 321 (see Figure 5). In step S223, the control unit 31 controls the imaging unit 35 to capture images of the sample supplied to the cell and obtain a predetermined number of images.

[0173] In step S224, the control unit 31 generates measurement results for the measurement items of the image capturing device 30 shown in FIG. 6 based on the measurement data (image) acquired in step S223.

[0174] All measurements performed by the image capturing device 30 are performed under the same conditions, in other words, in the same sequence. That is, the time for stirring the sample in step S221, the amount of sample aspirated in step S221, the position of the tip of the aspirating tube when aspirating the sample in step S221, the amount of sample supplied to the cell 321 in step S222, the time from when the sample is supplied to the cell 321 to when imaging begins (the time for sedimentation of formed elements), the time for which the light source 301 is made to emit light, the light intensity of the light source 301, the transport speed of the cell 321, the imaging settings and number of images of the image capturing element 312, etc. are the same for all measurements.

[0175] When the image pickup device 30 is the second inspection device, each measurement process of the second inspection device performed in step S123 of FIG. 27 is performed under the same conditions as described above according to the flowchart on the right side of FIG.

[0176] The measurement process of the urine qualitative testing apparatus 10, urinary sediment testing apparatus 20, and imaging apparatus 30 shown in Figure 28 all begins with stirring and aspirating the sample and ends with the generation of a measurement result. Therefore, each measurement performed for each sample based on a regular order in each apparatus begins with stirring and aspirating the sample and ends with the generation of a measurement result. Similarly, each measurement performed based on an additional order in the second testing apparatus also begins with stirring and aspirating the sample and ends with the generation of a measurement result.

[0177] <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 testing device and the second testing device. Specifically, the combinations are: (1) when the first testing device and the second testing device are the urine qualitative testing device 10 and the urinary sediment testing device 20, respectively; (2) when the first testing device and the second testing device are the urine qualitative testing device 10 and the imaging device 30, respectively; and (3) when the first testing device and the second testing device are the urinary sediment testing device 20 and the imaging device 30, respectively. In all of the combinations (1) to (3), the measurement methods of the first testing device and the second testing device are different from each other.

[0178] As shown in FIG. 25, the sample analysis method of the embodiment includes a step of measuring the sample using a first testing device (step S103), and a step of determining measurement conditions for a second testing device based on the first measurement result, which varies depending on the amount of the substance to be detected in the sample (steps S114 to S116).

[0179] When the first testing device is a urine qualitative testing device 10, as described with reference to Figures 7 and 8, the measurement results for the measurement item "protein (PRO)" such as "+-," "1+," "2+," "3+," "4+," etc., the measurement results for the measurement items "specific gravity (SG)" and "pH," and the measurement results for the measurement item "color (COLOR)" such as "OTHER," "L YELLOW," "STRAW," "YELLOW," "AMBER," "RED," "DK BROWN," etc. are all first measurement results that fluctuate depending on the amount of the substance to be detected in the sample. When the first testing device is a urinary sediment testing device 20, as described with reference to Figure 9, the measurement results for the measurement items "atypical cells (Atyp. C)," "fat droplets," "casts (CAST)," "epithelial cells (EC)," and "sperm (SPERM)" are all first measurement results that fluctuate depending on the amount of the substance to be detected in the sample.

[0180] According to this method, the second testing device performs measurement under measurement conditions based on the first measurement result, which varies depending on the amount of the detection target substance in the sample, so that the second testing device can perform appropriate measurement according to the condition of the sample and avoid excessive measurement, thereby efficiently providing highly reliable analysis results.

[0181] As shown in FIG. 25, the step of determining the measurement conditions includes a step (step S114) of determining whether or not multiple measurements by the second inspection device are required based on the first measurement result.

[0182] According to this method, measurements are performed multiple times in the second testing device as needed, so that highly reliable analysis results can be obtained in the second testing device.

[0183] As shown in Figures 25 and 27, the sample analysis method of the embodiment includes a step (step S126) of terminating the measurement by the second testing device based on the fact that the second measurement result obtained during the measurement period (steps S123 to S125) by the second testing device in accordance with the step (step S114) of determining whether or not it is necessary satisfies a predetermined termination condition (step S125: YES).

[0184] This method provides highly reliable analysis results because measurements are performed by a first testing device and a subsequent second testing device. Furthermore, the measurement by the subsequent second testing device is terminated when the second measurement result satisfies a predetermined termination condition. This saves reagents consumed by the second testing device, samples supplied to the second testing device, and the time required to measure the samples.

[0185] As shown in FIG. 27, a determination of a predetermined termination condition (step S125) is made for each measurement by the second inspection device (step S123), and the measurement by the second inspection device is terminated (step S126) upon completion of the measurement by the second inspection device for which it has been determined that the termination condition has been met (step S125: YES).

[0186] According to this method, the measurement by the second testing device for which the termination condition has been determined can be reliably carried out to the end, and the measurement by the second testing device is not started after it is determined that the second measurement result satisfies the termination condition. This makes it possible to reliably obtain the second measurement result from the measurement for which the termination condition has been determined, and also saves the reagent consumed by the second testing device, the sample supplied to the second testing device, the time required to measure the sample, etc.

[0187] As shown in Figures 7 to 9, the termination conditions for terminating the measurement by the second inspection device include obtaining the second measurement result suggested by the first measurement result used to determine whether or not to perform inspection by the second inspection device.

[0188] According to this method, multiple measurements using the second testing device increase the possibility of obtaining a second measurement result of the second testing device that is suggested by the first measurement result of the first testing device, and if the second measurement result is obtained, it is possible to save reagents consumed by the second testing device, the sample supplied to the second testing device, the time required to measure the sample, etc. Furthermore, if the second measurement result is obtained, it can be determined that there is an extremely high possibility that the subject from whom the sample was collected is suffering from, for example, a disease or the like predicted from the first measurement result.

[0189] As shown in FIG. 25, when it is determined that measurement by a second inspection device is necessary based on the first measurement result of the first inspection device (step S115: YES), a step of generating an order specifying measurement by the second inspection device (step S116) is executed.

[0190] According to this method, when measurement by the second inspection device is required, an order specifying the measurement by the second inspection device is generated, so that the second inspection device can smoothly perform the measurement based on the generated order.

[0191] As shown in FIG. 27, if the second measurement result obtained during the measurement period (steps S123 to S125) of the second inspection device performed according to the order satisfies a predetermined termination condition (step S125: YES), the measurement by the second inspection device ends (step S126).

[0192] According to this method, even during the measurement period according to the order, if the second measurement result satisfies a predetermined termination condition, the measurement by the second testing device is terminated. This allows obtaining the necessary second measurement result while saving reagents, specimens, time, etc.

[0193] As shown in FIG. 27, if the second measurement result obtained during the measurement period (steps S123 to S125) of the second inspection device performed according to the order does not satisfy the predetermined termination condition (step S125: NO), and the number of measurements by the second inspection device has reached the number of measurements specified by the order (step S124: YES), the measurement by the second inspection device ends (step S126).

[0194] According to this method, even if the termination condition is not satisfied, the measurement by the second inspection device will terminate if the number of measurements by the second inspection device reaches the number of measurements specified by the order, thereby enabling the measurement by the second inspection device to be terminated smoothly.

[0195] As shown in FIG. 26, the order for the second inspection device includes the number of measurements.

[0196] According to this configuration, the second inspection device can smoothly perform measurements according to orders.

[0197] The order for the second testing device may include, in addition to the number of measurements, the measurement items, the sample aspirate volume, the sample volume to be measured, and the measurement time. In this case, too, the second testing device can smoothly perform measurements according to the order.

[0198] When the order for the second inspection device includes a plurality of measurements, the measurements by the second inspection device are performed under the same conditions.

[0199] This method can prevent deviations in the second measurement results of the second inspection device due to different measurement conditions in the second inspection device. Also, by performing measurements under the same conditions, it is possible to prevent the control of the second inspection device from becoming complicated.

[0200] When the order for the second testing device includes a plurality of measurements, the second testing device aspirates the sample from the sample container 101 containing the sample for each of the plurality of measurements.

[0201] The above-described method of aspirating a sample for each measurement has the following advantages over aspirating the required amount of sample for multiple measurements at once. Specifically, because multiple measurements are performed separately, it is easy to terminate the multiple measurements when one measurement is completed. This shortens the time required for the measurement and reduces the amount of sample consumed. Furthermore, because the same amount of sample is always used in each measurement, there is no need to set multiple measurement modes to measure different amounts of sample, simplifying measurement control. Furthermore, because the device only needs to store the amount of sample required for one measurement, the capacity of containers such as measurement containers, reaction containers, and cells can be reduced. This allows the device to be made more compact.

[0202] When the order for the second testing device includes a plurality of measurements, the sample is agitated before being aspirated for each of the plurality of measurements by the second testing device.

[0203] If the sample is not stirred before aspirating, the sediment elements in the sample contained in the sample container 101 may precipitate, resulting in an insufficient amount of sediment in the aspirated sample. In contrast, if the sample is stirred before aspirating as described above, the sample containing sufficient sediment elements is aspirated, allowing a sufficient number of sediment elements to be detected in the device that aspirated the sample. Furthermore, when multiple measurements are performed in the second testing device, the likelihood of detecting the target sediment elements can be increased. Furthermore, if a termination condition is set, the likelihood of obtaining the target measurement results with fewer measurements can be increased, thereby shortening the time required for measurement and reducing the amount of sample used in the measurement.

[0204] The order for the second inspection device is generated based on the first measurement result of the first inspection device when it is determined that measurement by the second inspection device is necessary based on the first measurement result of the first inspection device.

[0205] According to this method, for example, as shown in Figure 7, the number of measurements by the second testing device is determined for each of five different first measurement results for the measurement item "protein (PRO)" by the first testing device, and an order for the second testing device is generated based on the determined number of measurements by the second testing device. In other words, the order for the second testing device is generated based on the first measurement result that is the basis for determining that measurement by the second testing device is necessary. This allows the order for the second testing device to be generated appropriately based on the first measurement result of the first testing device.

[0206] The sample analysis method of the embodiment further includes a step (steps S12 to S18 in Figure 24) of setting conditions for determining whether measurement by the second testing device is necessary, the contents of an order specifying the measurement by the second testing device that is generated when it is determined that measurement by the second testing device is necessary based on the results of the first measurement, and a predetermined termination condition for terminating the measurement by the second testing device.

[0207] According to this method, the operator can make the above-mentioned various settings for the second inspection device in accordance with the operation of the facility or the like.

[0208] As shown in FIGS. 7 to 9, in the setting step, the conditions for determining necessity, the order contents, and the predetermined termination conditions are set for each measurement item of the first testing device.

[0209] According to this method, detailed settings can be made for each measurement item of the first inspection device.

[0210] In the step of determining necessity (step S114 in FIG. 25), it is determined whether measurement by at least one of the plurality of types of second testing devices is necessary based on the first measurement result. For example, as shown in FIG. 7, if the first measurement result for the measurement item "protein (PRO)" is "+-", it is determined that measurement by urinary sediment testing device 20 is necessary, and as shown in FIG. 8, if the first measurement result for the measurement item "color (COLOR)" is "OHTER", it is determined that measurement by imaging device 30 is necessary.

[0211] According to this method, when multiple types of second inspection devices are provided, it is possible to determine whether measurement is necessary and to determine which of the multiple types of second inspection devices requires measurement, thereby ensuring that the necessary measurement is performed using the appropriate type of second inspection device.

[0212] The sample to be measured is a urine sample.

[0213] In the case of urine samples, not only the measurement results based on the first testing device but also the measurement results based on the second testing device are often required, so the second testing device is operated frequently. Therefore, the savings in reagents, samples, time, etc., in the second testing device as described above are particularly effective for urine samples.

[0214] The first testing device is a urine qualitative testing device 10, and the second testing device is a urinary sediment testing device 20 that uses a flow cytometer, or an image capturing device 30.

[0215] According to this configuration, it is possible to perform measurements on a large number of urine samples using the urine qualitative testing apparatus 10 (first testing apparatus), while performing detailed measurements using the urinary sediment testing apparatus 20 or the imaging apparatus 30 (second testing apparatus).

[0216] When the first testing apparatus is a urine qualitative testing apparatus 10, the second testing apparatus is a urinary sediment testing apparatus 20 that uses a flow cytometer, and measurements are performed multiple times by the second testing apparatus, the multiple measurements by the second testing apparatus are performed under the same conditions. Measurement conditions in the urinary sediment testing apparatus 20 include, for example, the amount of specimen aspirated in step S211, the amount of specimen 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 specimen and reagent in the reaction vessel, the speed at which the measurement sample is flowed through the flow cell 205, and the wavelength and intensity of light during the measurement performed in step S214.

[0217] This method can prevent discrepancies between second measurement results due to different measurement conditions in the urinary sediment analyzer 20 (second testing device). Furthermore, by performing measurements under the same conditions, it is possible to prevent the control of the urinary sediment analyzer 20 (second testing device) from becoming too complicated.

[0218] When the first testing device is the urine qualitative testing device 10, the second testing device is the image capturing device 30, and measurements are performed multiple times by the second testing device, a predetermined number of images are captured of the cell 321 filled with the sample under the same conditions in the multiple measurements by the second testing device. The imaging conditions in the image capturing device 30 include, for example, the amount of sample aspirated in step S221, the amount of sample supplied to the cell 321 in step S222, the time from when the sample is supplied to the cell 321 to when imaging begins (the time for forming elements to settle), the time for which the light source 301 is made to emit light, the light intensity of the light source 301, the transport speed of the cell 321, the imaging settings of the image capturing element 312, and the number of images captured.

[0219] This method can prevent deviations in the second measurement results generated based on images caused by different imaging conditions in the image capturing device 30 (second inspection device). Also, since the images are captured under the same conditions, it is possible to prevent the control of the image capturing device 30 (second inspection device) from becoming complicated.

[0220] The first testing device is a urinary sediment testing device 20 that uses a flow cytometer, and the second testing device is an image capturing device 30.

[0221] According to this configuration, while detailed measurements are performed by the urinary sediment testing apparatus 20 (first testing apparatus), even more detailed measurements can be performed by the image capturing apparatus 30 (second testing apparatus).

[0222] The sample analysis method of the embodiment further includes a step of outputting the first measurement result and the second measurement result (step S134 in FIG. 27). As a result, for example, the result list screen 700 and detailed result screen 800 shown in FIGS. 20 to 23 are displayed on the display unit 43 of the management device 40.

[0223] According to this method, the operator can smoothly check the first measurement result and the second measurement result.

[0224] As shown in Fig. 1, the sample analysis system 1 includes a plurality of testing devices that use different measurement methods, and a management device 40 that receives the measurement results obtained by the plurality of testing devices. As shown in Fig. 25, the management device 40 determines the measurement conditions for the second testing device based on the first measurement result of the first testing device, which varies depending on the amount of the detection target substance in the sample (steps S114 to S116), and generates an order that specifies the measurement by the second testing device (step S116).

[0225] With this configuration, the second testing device performs measurement under measurement conditions based on the first measurement result, which varies depending on the amount of the detection target substance in the sample, so the second testing device can perform appropriate measurement according to the condition of the sample and avoid excessive measurement, thereby efficiently providing highly reliable analysis results.

[0226] <Change example 1> In the above embodiment, the determination of whether the second measurement result satisfies the predetermined termination condition (step S125 in FIG. 27) is performed by the second inspection device, but this is not limiting and the determination may also be performed by the management device 40.

[0227] FIG. 29 is a flowchart showing the processing of the second inspection device and the management device 40 according to the first modification.

[0228] In the processing by 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, compared to the embodiment shown in Fig. 27. In the processing by management device 40 of Modification Example 1, steps S311 to S314 are added between steps S133 and S134, compared to the embodiment shown in Fig. 27. Note that in Fig. 29, for convenience, some steps similar to those in Fig. 27 are omitted.

[0229] In Modification 1, the number of measurements and the termination condition in the second inspection device are managed and controlled by the management device 40 as described below. Therefore, in Modification 1, the order sent from the management device 40 to the second inspection device does not need to include the number of measurements and the termination condition as shown in FIG.

[0230] In step S123, the control unit of the second inspection device performs measurement processing to generate second measurement results, and then in step S127 transmits the second measurement results to the management device 40. Thereafter, the control unit of the second inspection device puts the processing on hold until it receives an end instruction or an additional measurement instruction from the management device 40.

[0231] When the control unit 41 of the management device 40 receives the second measurement result from the second testing device (step S132: YES), in step S133 the control unit 41 stores the second measurement result in the memory unit 42. Next, in step S311, the control unit 41 determines whether the second measurement result received in the immediately preceding step S132 satisfies the termination condition specified in the order of the second testing device for the target sample. Furthermore, in step S312, the control unit 41 determines whether the number of measurements specified in the order of the second testing device for the target sample have been performed.

[0232] If the second measurement result does not satisfy the termination condition specified in the order and the number of measurements specified in the order has not been completed (step S311: NO, step S312: NO), the control unit 41 sends an instruction to perform additional measurement to the second testing device in step S313.The control unit 41 then returns the process to step S132 and waits until the second measurement result is received again.On the other hand, if the second measurement result satisfies the termination condition specified in the order (step S311: YES) or the number of measurements specified in the order has been completed (step S312: YES), the control unit 41 sends an instruction to terminate to the second testing device in step S314.

[0233] When the control unit of the second inspection device receives an end instruction from the management device 40 (step S301: YES), the control unit of the second inspection device ends the measurement by the second inspection device in step S303. On the other hand, when 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 by the second inspection device is performed again.

[0234] In the first modification, too, the determination of the termination condition (step S311) is performed for each measurement process (step S123) of the second inspection device, and the measurement termination process (step S303) when the termination condition is satisfied is executed in response to the end of the measurement by the second inspection device for which the termination condition determination has been performed. In other words, the measurement termination process (step S303) when the termination condition is satisfied is executed at a timing when no measurement is being performed by the second inspection device. This ensures that the measurement for which the termination condition determination has been performed can be performed to the end.

[0235] 29, according to the first modification, the management device 40 determines whether the second measurement result obtained during the measurement period by the second testing device (steps S123, S127, S301, S302) satisfies a predetermined termination condition (step S311), and terminates the measurement by the second testing device (steps S314, S303) based on the second measurement result satisfying the termination condition (step S311: YES). This achieves the same effect as the above embodiment. That is, because the measurement by the second testing device is terminated based on the second measurement result satisfying the predetermined termination condition, it is possible to save the reagent consumed by the second testing device, the sample supplied to the second testing device, the time required to measure the sample, and the like.

[0236] <Change example 2> In the above embodiment, the measurement termination process when the termination conditions are met is performed at a timing when measurement is not being performed by the second inspection device, but this is not limited to this, and the measurement termination process when the termination conditions are met may be performed during measurement operation by the second inspection device.

[0237] FIG. 30 is a flowchart showing the process of the second inspection device according to the second modification.

[0238] The second inspection device of the second modification is the image capturing device 30. In the processing of the second inspection device of the second modification, steps S401 to S403 are added instead of step S123, compared to the embodiment shown in Fig. 27. Note that in Fig. 30, some of the steps similar to those in Fig. 27 are omitted for convenience.

[0239] The control unit of the second inspection device starts the measurement process in step S401. An operation period P1 of the measurement started in step S401 includes steps S401 to S403, and the measurement started in step S401 continues during operation period P1. When the measurement starts in step S401, the measurement process of the image capturing device 30 shown in the flowchart on the right side of Fig. 28 starts, and a predetermined number of images (for example, 40) are sequentially acquired.

[0240] In Modification 2, unlike the above embodiment, the control unit of the second inspection device sequentially generates second measurement results while analyzing images acquired by the measurement process started in step S401. Then, in step S402, the control unit of the second inspection device determines whether the measurement results sequentially acquired during the measurement operation started in step S401 satisfy a termination condition.

[0241] If the measurement result satisfies the termination condition (step S402: YES), in step S126, the control unit of the second inspection device stops the measurement in progress and terminates the measurement by the second inspection device. That is, the termination process of step S126 based on the determination of step S402 is executed in response to a determination that the termination condition is satisfied 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 the process to step S402 and continues to determine whether the termination condition exists until the current measurement has ended.

[0242] If the current measurement has been completed (step S403: YES), the control unit of the second inspection device performs the processes of steps S124 to S126, as in the embodiment. That is, if the number of measurements specified in the order of the second inspection device has been completed (step S124: YES), or if the current second measurement result satisfies the termination condition (step S125: YES), the control unit of the second inspection device terminates the measurement by the second inspection device in step S126. On the other hand, if the number of measurements specified in the order of the second inspection device has not been completed and the current second measurement result does not satisfy the termination condition (step S124: NO, step S125: NO), the control unit of the second inspection device returns the process to step S401 and starts the next measurement.

[0243] 30, the second testing device determines whether the second measurement result obtained during the measurement period by the second testing device (steps S401 to S403, S124, S125) satisfies a predetermined termination condition (steps S402, S125), and terminates the measurement by the second testing device (step S126) based on the second measurement result satisfying the termination condition (step S402: YES, step S125: YES). This achieves the same effect as the above embodiment. That is, because the measurement by the second testing device is terminated based on the second measurement result satisfying the predetermined termination condition, it is possible to save the reagent consumed by the second testing device, the sample supplied to the second testing device, the time required to measure the sample, and the like.

[0244] Furthermore, according to the second modification, the determination of the termination condition in step S402 is performed during the measurement operation (operation period P1) for each measurement by the second testing device. Furthermore, the termination process in step S126 is executed in response to a determination that the termination condition is satisfied (step S402: YES). According to this method, if it is determined that the second measurement result satisfies the termination condition, the measurement by the second testing device is terminated even if the measurement by the second testing device is in progress. This makes it possible to save the time required for measuring the sample in the second testing device.

[0245] <Change example 3> In the above modification example 1, the measurement termination process when the termination condition is met is executed at a timing when measurement is not being performed by the second inspection device, but this is not limited to this, and the measurement termination process when the termination condition is met may be executed during the measurement operation by the second inspection device.

[0246] FIG. 31 is a flowchart showing the process of the second inspection device according to the third modification.

[0247] The second inspection device in the third modification is the image capturing device 30. In the processing of the second inspection device in the third modification, steps S501 to S504 are added instead of steps S123 and S127, as compared with the first modification shown in FIG.

[0248] In step S501, the control unit of the second inspection apparatus starts the measurement process. An operation period P1 of the measurement started in step S501 includes steps S501 to S503, and during operation period P1, the measurement started in step S501 continues. When the measurement starts in step S501, the measurement process of the image capturing device 30 shown in the flowchart on the right side of Fig. 28 starts, and a predetermined number of images (for example, 40) are sequentially acquired.

[0249] Also, in step S501, the control unit of the second inspection device sequentially generates second measurement results while analyzing the images acquired by the started measurement process, and transmits the sequentially obtained second measurement results during the started measurement operation to the management device 40. As shown in Fig. 29, if the received second measurement results satisfy the termination condition (step S311 in Fig. 29: YES), the management device 40 transmits a termination instruction.

[0250] If the control unit of the second inspection device receives an end instruction from the management device 40 (step S502: YES), in step S303, the control unit of the second inspection device stops the measurement in progress and terminates the measurement by the second inspection device. That is, the termination process in this case is executed in response to a determination that the termination condition has been met during the measurement operation. On the other hand, if the control unit of the second inspection device has not received an end instruction from the management device 40 (step S502: NO), in step S503, the control unit of the second inspection device determines 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 the process to step S502 and continues to determine whether an end instruction has been received until the current measurement has ended.

[0251] If the current measurement has been completed (step S503: YES), in step S504 the control unit of the second inspection device transmits a message to the management device 40 indicating that the current measurement has been completed. As a result, the management device 40 increments the count value of the measurements performed by the second inspection device by 1, and determines whether all measurements have been completed using this count value in step S312 of Fig. 29. Thereafter, the control unit of the second inspection device performs the processes of steps S301 to S303, similar to modification example 1 shown in Fig. 29.

[0252] 29 and 31, according to the third modification, the management device 40 determines whether the second measurement result obtained during the measurement period by the second testing device (steps S501 to S504, S301, S302) satisfies a predetermined termination condition (step S311), and terminates the measurement by the second testing device (steps S314, S303) based on the second measurement result satisfying the termination condition (step S311: YES). This achieves the same effect as the above embodiment. That is, because the measurement by the second testing device is terminated based on the second measurement result satisfying the predetermined termination condition, it is possible to save the reagent consumed by the second testing device, the sample supplied to the second testing device, the time required to measure the sample, and the like.

[0253] Furthermore, according to Modification Example 3, the determination of the termination condition in step S502 is performed during the measurement operation (operation period P1) for each measurement by the second testing device. Furthermore, the termination process in step S303 is executed in response to a determination that the termination condition is satisfied (step S502: YES). According to this method, if it is determined that the second measurement result satisfies the termination condition, the measurement by the second testing device is terminated even if the measurement by the second testing device is in progress. This can save the time required for measuring the sample in the second testing device.

[0254] <Other change examples> In the above embodiment, the sample analysis system 1 is a system for analyzing urine samples. However, this is not limiting and the system may be a system for analyzing samples other than urine samples. For example, the sample analysis system 1 may be a system for analyzing blood samples. In this case, the sample analysis system 1 includes a management device 40 similar to that in the above embodiment, as well as a blood testing device, an imaging device, and a general-purpose flow cytometer testing device, arranged in this order from upstream to downstream. The blood cell testing device measures a measurement sample prepared from the blood sample using flow cytometry and counts the blood cells in the blood sample. The imaging device is configured similarly to the imaging device 30 and captures images of the blood cells in the blood sample. The general-purpose flow cytometer testing device measures a measurement sample prepared from the blood sample using flow cytometry and counts the blood cells in the blood sample.

[0255] In this case, too, the necessity of multiple measurements by a downstream second testing device (imaging device, general-purpose flow cytometer testing device) is determined based on the first measurement result obtained by the upstream first testing device (blood testing device, imaging device). Also, the measurement by the second testing device (imaging device, general-purpose flow cytometer testing device) is terminated based on the fact that the second measurement result obtained during the measurement period by the second testing device (imaging device, general-purpose flow cytometer testing device) corresponding to the step for determining necessity satisfies a predetermined termination condition. In this case, too, the rules for additional measurements similar to those in FIG. 9 are determined in advance, and the necessity of additional measurements is determined based on the rules for additional measurements, and an order is generated.

[0256] For example, the management device 40 determines whether or not additional measurement by a second testing device (imaging device) is necessary based on the measurement result of the measurement item "blast cells (Blast)" obtained by measurement by a first testing device (blood testing device). If the measurement result of the measurement item "blast cells (Blast)" is equal to or greater than a predetermined value, the management device 40 generates an order that specifies the number of measurements to be made by the imaging device, termination conditions, etc. Termination conditions include, for example, the measurement result of the measurement item "blast cells (Blast)" by the imaging device being equal to or greater than a predetermined value.

[0257] Furthermore, for example, the management device 40 determines whether additional measurements are required by a second testing device (general-purpose flow cytometer testing device) based on predetermined measurement results obtained by measurements by a first testing device (blood testing device, image capturing device). If the management device 40 determines that additional measurements are required, it generates an order that specifies the number of measurements to be performed by the general-purpose flow cytometer testing device, termination conditions, etc. Termination conditions include, for example, that the measurement results of blood cells expressing predetermined surface antigens are equal to or greater than a predetermined value. This makes it possible to identify diseases such as leukemia based on the measurement results of blood cells expressing predetermined surface antigens.

[0258] In this modified example, as in the embodiment, the measurement by the second testing device is performed under measurement conditions based on the first measurement result, which varies depending on the amount of the detection target substance in the sample. This allows the second testing device to perform an appropriate measurement according to the condition of the sample and avoid excessive measurement. Therefore, highly reliable analysis results can be provided efficiently. Furthermore, since measurements are performed by the first testing device (blood testing device, imaging device) and the subsequent second testing device (imaging device, general-purpose flow cytometer testing device), highly reliable analysis results can be provided. Furthermore, in the measurement by the subsequent second testing device, the measurement by the second testing device is terminated when the second measurement result satisfies a predetermined termination condition. This allows for savings in reagents consumed by the second testing device, samples supplied to the second testing device, and the time required to measure the samples.

[0259] In the above embodiment, the measurement results of the urine qualitative testing apparatus 10, urinary sediment testing apparatus 20, and imaging apparatus 30 are stored in the management device 40 of the sample analysis system 1, but 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 is provided with a display terminal for displaying the measurement results, etc., and the display terminal communicates with the host computer in response to an operator's operation to display the measurement results on the display unit of the display terminal.

[0260] In the above embodiment, the urine qualitative testing device 10 is placed at the most upstream side, but this is not limited thereto; the urinary sediment testing device 20 or the image capturing device 30 may be placed at the most upstream side, and the urine qualitative testing device 10 may operate as the second testing device.

[0261] In the above embodiment, an order for a second inspection device is generated based on the measurement results of one first inspection device, based on the rules for additional measurements, but an order for a downstream second inspection device may also be generated based on the measurement results of two upstream first inspection devices.

[0262] For example, if the measurement result of the measurement item "occult blood (BLD(Hb))" or "occult blood (BLD(RBC))" by the urine qualitative testing apparatus 10 is positive (+) and the measurement result of the measurement item "red blood cell morphology information (RBC-Info.)" by the urinary sediment testing apparatus 20 is dysmorphic red blood cells (Dysmorphic?) or a mixture of uniform and dysmorphic red blood cells (Mixed?), an additional order is generated by the imaging device 30. In this case, the order may be set to perform multiple measurements (multiple measurements) by the imaging device 30, and the end condition may be set to be that the measurement result of the measurement item "atypical cells" by the imaging device 30 is flagged as positive or is equal to or greater than a threshold. Note that the order may be set to perform multiple additional measurements (multiple measurements) by the imaging device 30, and the end condition may be set to be that the measurement result of the measurement item "casts" by the imaging device 30 is equal to or greater than a predetermined value.

[0263] In the above embodiment, one condition for performing an additional measurement by the second testing device includes only one measurement item of the first testing device, but this is not limited to this and may include multiple measurement items of the first testing device. For example, one condition may include the measurement items "protein" and "specific gravity" shown in Figure 7, and an additional measurement may be set when the measurement results of both measurement items meet the corresponding condition.

[0264] In the above embodiment, when the first testing apparatus is the urinary sediment testing apparatus 20, the conditions for performing additional measurements by the second testing apparatus may include multiple criteria. For example, the conditions for the measurement result (measurement value) of the measurement item "atypical cells (Atyp. C)" of the urinary sediment testing apparatus 20 may include multiple criteria for determining which of multiple numerical ranges the result falls within. In this case, the measurement conditions for the second testing apparatus are determined depending on which of the multiple numerical ranges the first measurement result of the urinary sediment testing apparatus 20 falls within. This allows the second testing apparatus to perform appropriate measurements according to the condition of the sample, as in the above embodiment, and avoids excessive measurements. Therefore, highly reliable analysis results can be provided efficiently.

[0265] In the above embodiment, the rules for additional measurements were set on the rule setting screen 500 and the termination condition setting screen 600 shown in Figures 11 to 19, but this is not limited to this. The operator may input the settings in program formation, and the control unit 41 of the management device 40 may generate an additional order based on this input.

[0266] In the above embodiment, when an order for the second testing device (urinary sediment testing device 20 and imaging device 30) includes multiple measurements, the multiple measurements by the second testing device are performed under the same conditions, but this is not limited to this and the conditions may be different from each other.

[0267] Specifically, in the above embodiment, the position of the tip of the aspirating tube when aspirating the sample from the sample container 101 in each measurement of the multiplex measurement was the same, but it may be different from each other. For example, if the sedimentation rate of formed components in the sample differs depending on the type of formed component, the position (height and horizontal position) of the tip of the aspirating tube when aspirating the sample in each measurement can be made different from each other, thereby increasing the possibility that the formed components in the sample will be sufficiently aspirated in the multiplex measurement.

[0268] Similarly, in the above embodiment, the measurement time may be different for each multiplex measurement, and the amount of sample aspirated may be different for each multiplex measurement. For example, if the measurement result for the measurement item "protein (PRO)" of the urine qualitative testing apparatus 10 is "+-", the measurement time may be set longer and the amount of sample aspirated larger for each multiplex measurement performed by the urinary sediment testing apparatus 20.

[0269] In the above embodiment, even if the measurement result of the second inspection device satisfies the termination condition, the measurement by the second inspection device may not be terminated, and measurements by the second inspection device may be performed the number of times indicated by the order. In this case, for example, a check box for temporarily disabling the condition may be provided for each condition area 540 on the rule setting screen 500 shown in FIG. 11. If this check box is set to on, the termination condition may be ignored, and measurements by the second inspection device may be performed the number of times indicated by the order.

[0270] The embodiments of the present invention can be modified in various ways as appropriate within the scope of the technical idea defined in the claims. [Explanation of symbols]

[0271] 1. Sample analysis system 10. Qualitative urine testing device (testing device, first testing device, second testing device) 20 Urinary sediment testing device (testing device, first testing device, second testing device) 26 Optical measurement unit (flow cytometer) 30 Image capturing device (inspection device, first inspection device, second inspection device) 40 Management device 101 Sample container 321 cells

Claims

1. A sample analysis method for analyzing a sample using a plurality of testing devices that use different measurement methods, comprising: measuring the sample using a first testing device; determining measurement conditions for the second testing device based on the first measurement result, which varies depending on the amount of the detection target substance in the sample; Sample analysis methods.

2. The sample is a urine sample. The sample analysis method according to claim 1 .

3. the first testing device is a urine qualitative testing device, the second testing device is a urinary sediment testing device using a flow cytometer or an imaging device; The sample analysis method according to claim 1 .

4. the first testing device is a urinary sediment testing device using a flow cytometer, the second inspection device is an image capturing device; The sample analysis method according to claim 1 .

5. further comprising outputting the first measurement result and the second measurement result obtained by the second inspection device. The sample analysis method according to claim 1 .

6. the step of determining the measurement conditions includes a step of determining whether or not multiple measurements by the second inspection device are necessary based on the first measurement result. The sample analysis method according to any one of claims 1 to 5.

7. and a step of terminating the measurement by the second inspection device based on a second measurement result obtained during a measurement period by the second inspection device corresponding to the step of determining whether or not the measurement is necessary satisfying a predetermined termination condition. The sample analysis method according to claim 6.

8. the determination of the predetermined termination condition is performed for each measurement by the second inspection device, The measurement by the second inspection device is terminated in response to the measurement by the second inspection device being determined to satisfy the termination condition. The sample analysis method according to claim 7.

9. the termination condition includes that the second measurement result suggested by the first measurement result used to determine whether or not to perform the inspection by the second inspection device has been obtained. The sample analysis method according to claim 7.

10. and generating an order specifying the measurement by the second inspection device when it is determined that the measurement by the second inspection device is necessary based on the first measurement result. The sample analysis method according to claim 7.

11. When the second measurement result obtained during the measurement period of the second inspection device performed according to the order satisfies the predetermined termination condition, the measurement by the second inspection device is terminated. The sample analysis method according to claim 10.

12. When the second measurement result obtained during the measurement period of the second inspection device performed in accordance with the order does not satisfy the predetermined termination condition, if the number of measurements by the second inspection device has reached the number of measurements specified by the order, the measurement by the second inspection device is terminated. The sample analysis method according to claim 11.

13. The order includes at least one of a measurement item, a number of measurements, a sample aspirate amount, a sample amount to be measured, and a measurement time. The sample analysis method according to claim 10.

14. When the order includes a plurality of measurements, the plurality of measurements are performed by the second inspection device under the same conditions. The sample analysis method according to claim 13.

15. When the number of measurements included in the order is multiple, the sample is aspirated from a sample container containing the sample for each of the multiple measurements performed by the second testing device. The sample analysis method according to claim 10.

16. If the order includes a plurality of measurements, the sample is stirred before being aspirated for each of the measurements by the second testing device. The sample analysis method according to claim 10.

17. When the order includes a plurality of measurements, the position of the tip of the aspirating tube when aspirating the sample from the sample container differs for each of the measurements performed by the second testing device. The sample analysis method according to claim 10.

18. the order is generated based on the first measurement result when it is determined based on the first measurement result that measurement by the second testing device is necessary; The sample analysis method according to claim 10.

19. The termination condition is: when the first measurement result related to protein is within a predetermined range, it is determined that at least one type of cells, such as casts, dysmorphic red blood cells, and renal tubular epithelial cells, has been detected based on the second measurement result; When the first measurement result regarding color tone is within a predetermined range, it is determined that drug crystals are detected based on the second measurement result; determining that atypical cells have been detected based on the second measurement results when the first measurement results regarding atypical cells are within a predetermined range; When the first measurement result regarding lipid droplets is within a predetermined range, it is determined that at least one type of oval fat bodies, Mulberry bodies, and lipid droplets has been detected based on the second measurement result; determining that a cylinder has been detected based on the second measurement result when the first measurement result regarding a cylinder is within a predetermined range; determining that epithelial cells have been detected based on the second measurement results when the first measurement results regarding epithelial cells are within a predetermined range; When the first measurement result regarding sperm is within a predetermined range, it is determined that sperm have been detected based on the second measurement result. at least one of The sample analysis method according to claim 7.

20. The method further includes a step of setting a condition for determining whether or not measurement by the second inspection device is necessary, the content of the order, and the predetermined termination condition. The sample analysis method according to claim 7.

21. In the setting step, the conditions for determining whether or not the order is necessary, the contents of the order, and the predetermined termination conditions are set for each measurement item of the first inspection device. The sample analysis method according to claim 20.

22. In the step of determining whether or not it is necessary, based on the first measurement result, it is determined whether or not measurement by at least one of the plurality of types of second inspection devices is necessary. The sample analysis method according to claim 7.

23. the determination of the predetermined termination condition is performed during the measurement operation for each measurement by the second inspection device; The measurement by the second inspection device is terminated in response to a determination that the termination condition is satisfied. The sample analysis method according to claim 7.

24. the first testing device is a urine qualitative testing device, the second testing device is a urinary sediment testing device using a flow cytometer, When the measurement by the second inspection device is performed multiple times, the measurements by the second inspection device are performed multiple times under the same conditions. The sample analysis method according to claim 6.

25. the first testing device is a urine qualitative testing device, the second inspection device is an image capturing device, When the measurement by the second inspection device is performed a plurality of times, a predetermined number of images are taken of the cell filled with the sample under the same conditions in the plurality of measurements by the second inspection device. The sample analysis method according to claim 6.

26. A sample analysis system comprising a plurality of testing devices each having a different measurement method, and a management device that receives measurement results obtained by the plurality of testing devices, the management device determines measurement conditions for the second testing device based on the first measurement result of the first testing device, which varies depending on the amount of the detection target substance in the sample, and generates an order that specifies the measurement by the second testing device. Sample analysis system.

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