System

Abstract

To assess a disease status even when there is no definite diagnosis.SOLUTION: There is provided a system for monitoring a patient suspected of having a disease on the basis of a result of a test for assessing a condition of the patient, the system comprising: a disease determination section that analyzes a database of measurement data collected in association with information regarding a location of the patient and determines the patient suspected of having the disease, the measurement data acquired by a plurality of specimen measuring apparatuses used for the test on a specimen of the patient; and a status monitor section that monitors the status of the disease in an area determined on the basis of the information regarding the location.SELECTED DRAWING: Figure 44

Description

[Technical Field]

[0001] The present invention relates to a system for monitoring disease conditions. [Background technology]

[0002] Patent Document 1 discloses an infectious disease information disclosure system in which a server computer compiles information on infectious diseases of patients from each of multiple medical institutions, creates public infectious disease information on target infectious diseases, and transmits the public infectious disease information to the computers of medical institutions that have requested viewing and to the personal information terminals of surrounding residents. In this system, medical institution staff such as doctors and medical office workers input various information into the server computer. [Prior art documents] [Patent documents]

[0003] [Patent Document 1] Japanese Patent Application Laid-Open No. 2007-200107 Summary of the Invention [Problem to be solved by the invention]

[0004] However, the system in Patent Document 1 requires workers to input various information about the patient based on the results of the doctor's examination, and it is not possible to grasp the status of the target infectious disease without a definitive diagnosis such as the results of the doctor's examination.

[0005] The present invention aims to understand the state of a disease such as an infectious disease even when a definitive diagnosis has not been made. [Means for solving the problem]

[0006] A system according to one embodiment of the present invention is a system for monitoring patients suspected of having a disease based on the results of tests to determine the patient's condition, and includes a disease determination unit that analyzes a database in which measurement data obtained by multiple sample measurement devices used to test the patient's samples is collected in association with information about the patient's location, and determines whether the patient is suspected of having a disease, and a status monitoring unit that monitors the disease status in a defined area based on the information about the location. [Effects of the Invention]

[0007] According to the present invention, it is possible to grasp the state of a disease such as an infectious disease even in the absence of a definitive diagnosis. [Brief explanation of the drawings]

[0008] [Figure 1] FIG. 1 is a diagram showing components of a sample measurement system according to an embodiment of the present invention. [Figure 2] FIG. 1 illustrates an example of the configuration of a computer. [Figure 3] FIG. 1 is a diagram showing a first example configuration of a specimen measurement system according to an embodiment of the present invention. [Figure 4] FIG. 10 is a diagram showing a second configuration example of a specimen measurement system according to the present embodiment. [Figure 5] FIG. 10 is a diagram showing a third example configuration of a specimen measurement system according to the present embodiment. [Figure 6] FIG. 10 is a diagram showing a fourth configuration example of a specimen measurement system according to the present embodiment. [Figure 7] FIG. 5 is a diagram showing a fifth configuration example of a specimen measurement system according to the present embodiment. [Figure 8] FIG. 1 is a diagram illustrating an example of the configuration of a specimen measurement device. [Figure 9] FIG. 2 is a diagram illustrating an example of a hardware configuration of a control unit. [Figure 10] FIG. 2 is a diagram illustrating an example of the configuration of control software and data management software. [Figure 11] FIG. 10 is a diagram illustrating a modified example of the configuration of the control unit. [Figure 12]FIG. 2 is a diagram illustrating an example of the configuration of a measurement unit. [Figure 13] FIG. 10 is a diagram showing a configuration example in which the measurement unit is a blood cell analyzer. [Figure 14] FIG. 10 is a schematic diagram illustrating a specimen suction section and a sample preparation section when a measurement sample is supplied to an FCM detection section. [Figure 15] FIG. 10 is a schematic diagram illustrating a specimen suction section and a sample preparation section when a measurement sample is supplied to an RBC / PLT detection section. [Figure 16] 10 is a schematic diagram illustrating a specimen suction section and a sample preparation section when a measurement sample is supplied to an HGB detection section. FIG. [Figure 17] FIG. 10 is a diagram showing a configuration example in which the measurement unit is a urine sediment device. [Figure 18] FIG. 2 is a diagram illustrating an example of the configuration of a detection unit. [Figure 19] FIG. 10 is a diagram showing a configuration example in which the measurement unit is a blood coagulation analyzer. [Figure 20] FIG. 2 is a diagram illustrating a configuration example of a light irradiation unit of the detection unit. [Figure 21] FIG. 2 is a diagram illustrating an example of the configuration of an optical detection unit of the detection unit. [Figure 22] FIG. 10 is a diagram showing a configuration example in which the measurement unit is an immunoassay analyzer. [Figure 23] FIG. 10 is a diagram showing an example of a processing flow by a sample preparation unit. [Figure 24] FIG. 2 is a diagram illustrating an example of the configuration of an interface. [Figure 25] 10 is a flowchart showing an example of a processing flow (linkage method) by an interface of a sample measurement device. [Figure 26] FIG. 2 is a diagram illustrating an example of the configuration of an interface of a data management system. [Figure 27] FIG. 10 is a diagram showing an example of the data structure of an HTTP request body when updating lot information for quality control. [Figure 28] 10A and 10B are diagrams illustrating an example of a request for information about a sample measurement device and a response to the request. [Figure 29]10A and 10B are diagrams illustrating examples of requests for information regarding sample measurements and responses to the requests. [Figure 30] 10A and 10B are diagrams showing examples of requests for information regarding maintenance of a specimen measurement device and responses to the requests. [Figure 31] FIG. 10 is a diagram showing an example of a request related to the operation of the sample measurement device. [Figure 32] FIG. 10 is a diagram illustrating an example of the configuration of a push notification from a sample measurement device to a data management system. [Figure 33] 10A and 10B are diagrams illustrating an example of an event and an example of information corresponding to the event (information that is the target of a PUSH notification). [Figure 34] FIG. 10 illustrates an example of the configuration of an application. [Figure 35] FIG. 10 is a diagram illustrating a configuration example in which the application is a disease prediction application. [Figure 36] FIG. 10 is a diagram showing an example of providing disease predictions using a GUI. [Figure 37] FIG. 10 is a diagram illustrating an example of a configuration in which application functions are provided as Web services. [Figure 38] FIG. 10 is a diagram illustrating another example of a configuration in which application functions are provided as Web services. [Figure 39] FIG. 10 is a diagram illustrating yet another example configuration in which application functions are provided as Web services. [Figure 40] FIG. 2 is a diagram illustrating a configuration example of an application providing server that provides an application. [Figure 41] FIG. 1 is a diagram illustrating an example of a configuration for providing an application in a secure communication environment. [Figure 42] FIG. 10 is a diagram illustrating an example of a configuration in which an application is provided using MDM or MAM. [Figure 43] FIG. 10 is a diagram illustrating an example of a data structure when the database of the MDM / MAM system is a relational database. [Figure 44] FIG. 1 is a diagram illustrating components of a system according to an embodiment of the present invention. [Figure 45]1 is a diagram illustrating an example of the configuration of a data management system according to an embodiment of the present invention. [Figure 46] FIG. 2 is a diagram illustrating an example 1 of a data structure in a data storage according to the present embodiment. [Figure 47] FIG. 10 is a diagram showing a modified example of the first data structure example in the data storage according to the embodiment. [Figure 48] FIG. 10 is a diagram illustrating a second example of a data structure in the data storage according to the embodiment. [Figure 49] 1 is a flowchart showing an example of the processing flow by disease prediction software of the data management system according to this embodiment. DETAILED DESCRIPTION OF THE INVENTION

[0009] [System components] As shown in FIG. 44, the system according to this embodiment includes, as an example, multiple specimen measurement devices 11, a data management system 15, and a terminal device 101 as components. The multiple specimen measurement devices 11 and the data management system 15 are connected via a communication network, and the data management system 15 and the terminal device 101 are connected via the communication network. With this configuration, the system functions as a system for monitoring the occurrence of disease. For example, this system analyzes the measurement data of multiple patients acquired by each of the multiple specimen measurement devices 11, and monitors the occurrence of disease at a specific location based on the determination results of the likelihood that each of the multiple patients corresponding to each measurement data associated with location information is suffering from a disease. It is possible to detect the occurrence of disease at a specific location and issue an alert. Therefore, even if a doctor's examination result (definitive diagnosis) has not been registered, patients who may have a disease such as an infectious disease can be identified by analyzing the measurement data, and the disease status and the possibility of a disease epidemic can be grasped. Each of the multiple specimen measurement devices 11 is, for example, a specimen measurement device including a measurement unit 2, as described below. This system is equivalent to the specimen measurement system 1, described below. The system may also include, for example, other devices and other systems.

[0010] Specimen measurement device 11 measures an input specimen and acquires data corresponding to the measurement results. Examples of specimen measurement device 11 include a device that performs measurements for blood cell analysis, a device that performs measurements for blood coagulation analysis, a device that performs measurements for urine formed element analysis, and a device that performs measurements for immune analysis. Specimen measurement device 11 may be configured as an integrated device consisting of multiple types of devices, for example, a device that performs measurements for blood cell analysis and a device that performs measurements for C-reactive protein (CRP) analysis. Specimen measurement device 11 also analyzes the acquired data and acquires measurement data (test data) that is the test results. Specimen measurement device 11 is installed, for example, in medical institutions such as hospitals and testing centers. Specimen measurement device 11 is used, for example, in tests to determine the condition and pathology of patients visiting medical institutions, and doctors can determine the patient's condition and pathology from the measurement data that is the test results. Specimen measurement device 11 may also be used, for example, to determine the condition and pathology of subjects who are asymptomatic and have no clinical signs.

[0011] The specimen measurement device 11 described above may require certification by a certification body as a medical device, for example. Medical devices requiring certification include, for example, in vitro diagnostic medical devices. In this case, the specimen measurement device 11 provides, for example, a function corresponding to the intended use of the certified medical device. The intended use of the medical device is, for example, to measure a specimen and provide the measurement results. If the medical device is a blood cell analyzer, for example, it measures a blood specimen and provides measurement data related to blood cells (e.g., red blood cell count, white blood cell count, white blood cell differentiation, etc.).

[0012] [Data management system configuration example] 45 shows an example configuration of the data management system 15. The data management system 15 includes, for example, a control unit 17 and a data storage 18. The control unit 17 is equivalent to a processor 71, which will be described later. The control unit 17 includes, for example, data management software 4A and a communication control unit 16, which will be described later, and disease prediction software 170. The disease prediction software 170 includes, for example, a disease determination unit 171 and a condition monitoring unit 172.

[0013] Data management system 15 is located, for example, at a different location from specimen measurement device 11. In this case, the measurement data acquired by specimen measurement device 11 is collected, for example, in data storage 18 located at a different location from specimen measurement device 11. Data management system 15 is located, for example, at a different location from the medical facility (e.g., hospital) where the specimen to be measured by specimen measurement device 11 is collected from the patient. In this case, the measurement data acquired by specimen measurement device 11 is collected, for example, in data storage 18 located at a different location from the medical facility. As in the above example, when measurement data is collected in data storage 18 located at a different location from specimen measurement device 11 or the medical facility, disease prediction software 170 cannot monitor the disease status in an area such as a city or state unless each piece of collected measurement data is associated with information about the patient's location. As in the above example, when measurement data is collected in data storage 18 located at a different location from specimen measurement device 11 or the medical facility, by associating the measurement data with information about the location, disease prediction software 170 can monitor the disease status in an area such as a city or state based on the measurement data and information about the location. As in the above example, when measurement data is collected in data storage 18 located at a location different from the sample measurement device 11 or the medical facility, for example, measurement data transmitted to the data management system 15 via a communication network is collected in data storage 18.

[0014] The measurement data may be collected in a distributed manner in multiple data storages 18. In this case, the disease inference software 170 analyzes the measurement data collected in at least one of the multiple data storages 18. For example, each of the multiple data storages 18 corresponds to a predetermined region (e.g., a country or an association consisting of multiple member states), and each data storage 18 collects the measurement data for the corresponding region. In this example, multiple disease inference software 170 may be provided, for example, for each corresponding region, similar to the data storage 18. Each disease inference software 170 analyzes the measurement data collected in the data storage 18 for the corresponding region. Each data storage 18 may be configured to collect only the measurement data for the corresponding region. Each disease inference software 170 may be configured to analyze only the measurement data collected in the data storage 18 for the corresponding region.

[0015] The disease determination unit 171 analyzes each measurement data and determines the possibility that a patient corresponding to the measurement data has a disease. The disease determination unit 171 analyzes the measurement data based on, for example, a predetermined algorithm corresponding to the disease. For example, the disease determination unit 171 may analyze the measurement data based on multiple algorithms corresponding to multiple diseases, or may analyze the measurement data based on a single algorithm corresponding to multiple diseases. For example, if the disease determination unit 171 determines, as a result of the analysis, that a patient corresponding to the measurement data may have a disease, it associates a flag corresponding to the disease with the measurement data. Examples of diseases include dengue fever, COVID-19, malaria, microcytic anemia, influenza, and rubella. Examples of algorithms include an algorithm for determining the possibility of dengue fever, an algorithm for determining the possibility of COVID-19, an algorithm for determining the possibility of malaria, an algorithm for determining the possibility of microcytic anemia, an algorithm for determining the possibility of influenza, and an algorithm for determining the possibility of rubella. The flags may be, for example, a flag for dengue fever, a flag for COVID-19, a flag for malaria, a flag for microcytic anemia, a flag for influenza, a flag for rubella, etc.

[0016] The disease determination unit 171 further analyzes, for example, measurement data that is the result of a test to understand the patient's condition, and identifies patients suspected of having a disease. The disease determination unit 171 can identify a patient's condition (i.e., suspected disease) that is difficult to identify from the measurement data itself that is the result of the test. The disease determination unit 171 identifies suspected disease, for example, by analyzing and interpreting the measurement data using an algorithm corresponding to the disease. The algorithm for analyzing and interpreting the measurement data is determined, for example, based on clinical knowledge regarding the correlation between various test results (measurement data) and diseases. Examples of analysis and interpretation of measurement data by the disease determination unit 171 will be described later.

[0017] The status monitor unit 172 monitors the status of a disease based on the measurement data associated with a flag corresponding to the disease by the disease determination unit 171. The status monitor unit 172 identifies an area for monitoring the status of the disease. An area is, for example, a region (state, city, etc.) of a country. The status monitor unit 172 identifies measurement data belonging to the area based on location information associated with the measurement data. For example, if the identified area is Madhya Pradesh, India, the status monitor unit 172 refers to the location information and identifies measurement data acquired in the state. The status monitor unit 172 calculates, for example, the proportion of patients suspected of having a disease in the monitored area. The proportion of patients suspected of having a disease is expressed, for example, as the ratio of the number of measurement data assigned a disease flag (i.e., the number of patients suspected of having a disease in the area) to the total number of measurement data in the area (i.e., the total number of patients in the area) (number of measurement data assigned a disease flag in the area / total number of measurement data in the area). The status monitor unit 172, for example, monitors the proportion of patients suspected of having a disease over time, and generates an alert regarding the occurrence status of the disease (e.g., signs of a disease epidemic) based on changes in the proportion over time. For example, the status monitor unit 172 calculates the proportion of patients suspected of having a disease on a daily basis. For example, if the proportion of patients suspected of having a disease exceeds a threshold within a predetermined period (e.g., one week), the status monitor unit 172 generates an alert. The area specified by the status monitor unit 172 is, for example, a country, a state, a city, a county, or a facility (e.g., a hospital or a school). The status monitor unit 172 can change the scope of the area. For example, the status monitor unit 172 can change the area to be monitored, such as monitoring the status of a certain disease within a certain state or within a certain city within a state. The area may also be set in advance by the user, and may be, for example, a target region (e.g., multiple countries or states) or target facility (e.g., multiple specific hospitals) set in advance by the user. The status monitor unit 172 sends an alert or a notification to the notification destination corresponding to the identified area.For example, the destination of alerts and notifications is set according to an area (e.g., a state or city) in the disease prediction software 170, and the status monitor unit 172 identifies the destination of alerts and notifications according to the setting. The destination of alerts and notifications is, for example, a public health department in the area.

[0018] [Example of dengue fever analysis] The disease determination unit 171 of the disease prediction software 170 analyzes the measurement data of each of the multiple patients acquired by each of the multiple sample measurement devices 11 using an algorithm that compares the white blood cell count (also called WBC) with a predetermined threshold and the platelet count (also called PLT) with a predetermined threshold. Dengue fever analysis uses measurement data acquired as a result of a blood cell count test (hematology test), for example. For example, literature has shown that patients suffering from dengue fever tend to have a decreased white blood cell count and a decreased platelet count (Source: Shinohara Hiroshi et al., "Retrospective Study of Suspected Domestic Dengue Fever Cases," 2017, Journal of Infectious Diseases, Vol. 91, No. 6, pp. 930-935). Based on such knowledge, the disease determination unit 171 performs disease determination using an algorithm that determines that a patient whose white blood cell count has decreased to 3,500 / μL or less and whose platelet count has decreased to 100,000 / μL or less may be suffering from dengue fever. The disease determination unit 171, for example, analyzes each piece of measurement data and identifies measurement data in which the white blood cell count is 3,500 / μL or less and the platelet count is 100,000 / μL or less. The disease determination unit 171, for example, assigns a flag to measurement data of a patient suspected of having dengue fever. The status monitor unit 172 monitors the analysis results of the measurement data in chronological order. The status monitor unit 172, for example, identifies measurement data corresponding to an area to be monitored based on information regarding the location, and monitors the analysis results by the disease determination unit 171 for each area. The status monitor unit 172, for example, identifies information regarding the location corresponding to the area to be monitored. For example, if the monitored area is a city, the situation monitor unit 172 identifies information about multiple locations corresponding to the city (e.g., identifies information about locations corresponding to multiple medical institutions in the city) and identifies measurement data associated with the information about the identified locations. Based on the monitoring results, the situation monitor unit 172 generates an alert regarding a disease outbreak as necessary. For example, the situation monitor unit 172 calculates the proportion of patients suspected of having dengue fever in the monitored area on a daily basis and monitors changes in the proportion of dengue fever patients over a predetermined period of time.As a specific example, the situation monitor unit 172 monitors, for a predetermined period (e.g., one week), changes over time in the proportion of patients who may be suffering from dengue fever throughout the entire area of ​​Ahmedabad, a city in Gujarat state in western India. For example, if the proportion of patients suspected of having dengue fever during the predetermined period exceeds a threshold value (e.g., 3%), the situation monitor unit 172 infers that dengue fever is prevalent in the monitored area (e.g., the entire area of ​​Ahmedabad, a city in Gujarat state in western India), and generates an alert.

[0019] [Example of microcytic anemia analysis] An example of determining the possibility of a disease by the disease prediction software 170 is not limited to the above-mentioned example of dengue fever analysis. For example, an example of analyzing a predetermined disease state is an analysis example of therapeutic drug monitoring for microcytic anemia. It is said that patients with microcytic anemia tend to have a reduced mean corpuscular volume (MCV). The disease determination unit 171 analyzes, for example, measurement data acquired as a result of a blood cell count test (hematology test) and performs an analysis related to microcytic anemia. The disease determination unit 171 performs disease determination using an algorithm that determines, for example, that a patient with a mean corpuscular volume (MCV) of less than 75 fL is likely to be suffering from microcytic anemia. The disease determination unit 171, for example, analyzes each piece of measurement data and identifies measurement data with a mean corpuscular volume (MCV) of less than 75 fL. The disease determination unit 171, for example, assigns a flag to measurement data of a patient suspected of having microcytic anemia. The status monitor unit 172 monitors the analysis results of the measurement data in chronological order. For example, the status monitor unit 172 identifies the measurement data corresponding to the area being monitored based on information about the location, and monitors the analysis results by the disease determination unit 171 for each area. The status monitor unit 172 generates a notification regarding the status of microcytic anemia as necessary based on the monitoring results. For example, the status monitor unit 172 calculates the proportion of patients suspected of having microcytic anemia in the monitored area on a daily basis, and monitors the chronological change in the proportion of patients with microcytic anemia over a predetermined period (e.g., 1 to 3 months). When performing therapeutic drug monitoring for microcytic anemia, for example, the status of microcytic anemia in a patient group in an area (i.e., a monitored area) to which drugs such as iron preparations for drug therapy of microcytic anemia are supplied is monitored for a predetermined period (e.g., 1 to 3 months). In the time series change in the number of patients suffering from microcytic anemia, for example, if the proportion of patients suffering from microcytic anemia decreases by several percent (e.g., 1% to 3%) over a certain period (e.g., 1 to 3 months), it can be inferred that the supply of drugs such as iron supplements as a pharmacotherapy for microcytic anemia is effective.In this case, the condition monitor 172 generates a notification indicating that the drug delivery is effective.

[0020] [Data structure example 1 in data storage] 46 is a diagram showing an example of the data structure when data storage 18 is a relational database. As shown in the figure, information managed in data storage 18 includes, for example, an "apparatus ID" which is identification information for specimen measurement apparatus 11, an "ID related to measurement data" which is identification information for measurement data acquired by specimen measurement apparatus 11, a "timestamp" indicating the date and time the measurement data was acquired, the measurement data, a "flag" set by disease determination unit 171, and "location information" corresponding to the location of specimen measurement apparatus 11 which acquired the measurement data. The "ID related to measurement data" is associated with the "apparatus ID." The "timestamp," "measurement data," and "flag" are associated with the "ID related to measurement data." The "location information" is associated with the "apparatus ID."

[0021] Measurement data associated with an "device ID" is collected in data storage 18. For example, sample measurement device 11 transmits the measurement data and the "device ID" to data management system 15. As a result, data storage 18 collects the measurement data in association with the "device ID," which is identification information (e.g., the serial number of the device) of sample measurement device 11 that acquired the measurement data. Data storage 18 stores "location information" associated with the "device ID." The "location information" is, for example, information regarding the location where sample measurement device 11 corresponding to the "device ID" is installed. For example, the "location information" is location information (e.g., address or GPS information) and identification information (e.g., an ID used to identify the medical facility or testing facility in data management system 15) of the medical facility or testing facility where sample measurement device 11 is installed, or information indicating the country, state, city, etc. where sample measurement device 11 is installed (text information, an ID used to identify the country, state, city, etc. in data management system 15). The "location information" may be, for example, information corresponding to an area set by status monitor unit 172. For example, the "location information" may be hierarchically structured information (e.g., information structured to identify each country, state, and city corresponding to the "device ID") so that the status monitor unit 172 can variably set the area. Note that the hierarchical structure of the "location information" is not limited to this example and may be more detailed than this example. When the "location information" is configured, for example, in a hierarchy of countries, states, and cities, the status monitor unit 172 references the information at the hierarchy corresponding to the range of the area to be set. For example, when specifying the range of a state in a certain country as an area, the status monitor unit 172 references the information at the hierarchy corresponding to the state and identifies the measurement data corresponding to the area. The association between the "device ID" and the "location information" is set, for example, by the operator of the data management system 15 when the specimen measurement device 11 is installed. When the specimen measurement device 11 is installed in a medical facility or testing facility where patient tests are performed, the "device ID," which is the identification information of the specimen measurement device 11, indirectly indicates the location of the patient.Because the patient's measurement data is associated with the "device ID" and collected in data storage 18, and because "location information" corresponding to the location of sample measurement device 11 is associated with the "device ID," disease prediction software 170 can indirectly identify the patient's location. In other words, the condition monitor unit 172 of disease prediction software 170 can identify the measurement data associated with the "location information" corresponding to the area to be monitored, using the "device ID" associated with the measurement data as a key.

[0022] It is also possible that a sample is collected at a medical facility visited by a patient and then transported to a testing center located elsewhere for testing. In this case, since the sample measurement device 11 is installed at the testing center, it is expected that the relationship between the "device ID" and "location information" alone will result in a large discrepancy between the patient's actual location and the "location information" corresponding to the "device ID." (For example, if the city where the medical institution visited by the patient is located is different from the city where the testing center where the sample is transported and tested is located, the discrepancy between the patient's actual location and the "location information" corresponding to the "device ID" may be large.) By having the data structure illustrated in FIG. 47 in data storage 18, it is possible to identify the patient's location even if there is a discrepancy between the patient's location and the location where the test was performed. In the example data structure of FIG. 47, the "medical institution ID," which is the identification information of the medical institution where the patient's sample was collected for testing, is associated with the "ID related to measurement data." For example, when a testing center that receives a patient's sample from a medical institution transmits the test results, that is, measurement data, to the data management system 15, the measurement data is transmitted after associating the "device ID" and the "medical institution ID" corresponding to the medical institution that sent the sample to the testing center. Alternatively, for example, a medical institution receives the measurement data and the "device ID" from the testing center, associates the received measurement data and the "device ID" with the "medical institution ID," and transmits the data to the data management system 15. As a result, information in which the measurement data is associated with the "device ID" and the "medical institution ID" is collected in the data storage 18. As illustrated in FIG. 47, the "medical institution ID" is associated with "location information" corresponding to the medical institution (for example, set by the operator of the data management system 15). When the measurement data is associated with the "device ID" and the "medical institution ID," the status monitor unit 172 of the disease prediction software 170 uses the "medical institution ID" as a key, rather than the "device ID." to identify the measurement data corresponding to the area to be monitored. If the patient's location can be estimated from the "device ID" (for example, if the examination is performed at the medical institution visited by the patient), for example, "null" is set in the "medical institution ID."In this case, the status monitor unit 172 determines that the measurement data is not associated with a "medical institution ID," and uses the "device ID" as a key to identify the measurement data corresponding to the area to be monitored.

[0023] [Data structure example 2 in data storage] The data structure of data storage 18 may directly associate measurement data with "location information," as illustrated in FIG. 48. For example, if sample measurement device 11 has the function of associating measurement data with "location information" and transmitting the data to data management system 15, information structured in such a way that measurement data and "location information" are directly associated can be collected in data storage 18, as illustrated in FIG. 48. For example, sample measurement device 11 is configured with "location information" corresponding to the device, and when transmitting measurement data to data management system 15, sample measurement device 11 associates the set "location information" with the measurement data and transmits it. For example, when sample measurement device 11 is installed in a medical institution or testing facility, a maintenance worker sets the "location information" in sample measurement device 11. It is also possible that a sample is collected at a medical facility visited by a patient and then transported to a testing center located elsewhere to undergo testing. In this case, a "medical institution ID" may be associated with the measurement data, as in the example of FIG. 47 above.

[0024] [Processing flow by disease prediction software in the data management system] 49 is a flowchart showing an example of the processing flow (disease inference) by the disease inference software 170 of the data management system 15. The data management system 15 collects measurement data from a plurality of specimen measurement devices 11 (S11). The data management system 15 collects the measurement data in association with information relating to the location.

[0025] The disease prediction software 170 analyzes each measurement data and determines the possibility that the patient corresponding to each measurement data is suffering from the disease (S22).

[0026] Based on the location information, the disease prediction software 170 identifies measurement data corresponding to areas set as areas to be monitored for the disease (S33).

[0027] The disease prediction software 170 monitors the state of the disease based on the identified measurement data and the analysis results of the measurement data in S22 (S44). For example, the disease prediction software 170 monitors the time series change in the proportion of measurement data determined to be suspected of being a disease among the identified measurement data.

[0028] [Components of the sample measurement system] As shown in Figure 1, the specimen measurement system 1 according to this embodiment includes, as an example, a measurement unit 2, control software 3, data management software 4, and an interface 5 as components. Note that the control software 3 and data management software 4 may be configured as an integrated unit. The specimen measurement system 1 is, for example, a specimen measurement device including the measurement unit 2, control software 3, data management software 4, and interface 5. The specimen measurement system 1 is, for example, a system including a specimen measurement device including the measurement unit 2, control software 3, data management software 4, and interface 5, as well as other devices and other software.

[0029] The measurement unit 2 measures a sample input into the measurement unit 2 and acquires data corresponding to the measurement results. Examples of the measurement unit 2 include a unit that performs measurements for blood cell analysis, a unit that performs measurements for blood coagulation analysis, a unit that performs measurements for urine formed element analysis, and a unit that performs measurements for immune analysis. The measurement unit 2 operates under the control of the control software 3. The measurement unit 2 provides the acquired data to the data management software 4 via the control software 3.

[0030] The control software 3 controls the operation of the measurement unit 2 in cooperation with the data management software 4. The control software 3 commands the measurement unit 2 to perform a measurement operation corresponding to a measurement order for a sample input into the measurement unit 2. The control software 3 analyzes the data acquired by the measurement unit 2 and acquires measurement data, which is the measurement result.

[0031] The data management software 4 manages data related to the measurement unit 2. The data management software 4 has a function (e.g., a UI: User Interface) that provides the operator with measurement results acquired by the control software 3. The data management software 4 has functions related to device operations such as registering and acquiring measurement orders, and a function that provides information related to measurement orders to the control software 3. The data management software 4 may manage data related to the measurement unit 2 based on classification according to the type of data. For example, the data management software 4 may classify and manage the data according to the type of measurement unit 2 it associates with. Types of measurement unit 2 include, for example, a unit that performs measurements for blood cell analysis, a unit that performs measurements for blood coagulation analysis, a unit that performs measurements for urine formed element analysis, and a unit that performs measurements for immune analysis. The control software 3 and the data management software 4 may be independent software. Software having equivalent functions to the control software 3 and the data management software 4 may control the measurement unit 2 and manage data related to the measurement unit 2.

[0032] The measurement unit 2, control software 3, and data management software 4 described above may require certification by a certification body as a medical device. Medical devices requiring certification include, for example, in vitro diagnostic medical devices. In this case, the measurement unit 2, control software 3, and data management software 4 provide functions corresponding to the intended use of the certified medical device. The intended use of the medical device is, for example, to measure a sample and provide measurement results. If the medical device is a hematology analyzer, for example, it is to measure a blood sample and provide measurement results related to blood cells (e.g., red blood cell count, white blood cell count, white blood cell differentiation, etc.).

[0033] When changing the disease to be determined in the measurement data acquired by the specimen measurement device, it may be necessary to analyze the measurement data based on an algorithm corresponding to the type of disease, such as dengue fever, COVID-19, malaria, or microcytic anemia. However, when adding an algorithm corresponding to such a type of disease to expand functionality, software modifications may be required. Furthermore, if the software has been certified by a certification body as a component of a medical device, it may be necessary to obtain certification again in response to software modifications. Due to these circumstances, functional expansion has traditionally been difficult to implement. On the other hand, in this embodiment, the system's functionality can be easily expanded, for example, by using a configuration such as that described below.

[0034] The application software (hereinafter simply referred to as "application") 6 is software independent of the control software 3 and the data management software 4. The application 6 has, for example, a function that was incorporated into prior art software related to a device for measuring a specimen. In other words, the application 6 has a function that is separate from prior art software related to a device for measuring a specimen. The application 6 may have, for example, a new function that was not incorporated into prior art software related to a device for measuring a specimen, and a disease diagnosis algorithm is implemented as the application 6. The application 6 provides, for example, a function different from the function corresponding to the "intended use" of a medical device. Examples of the application 6 are software for healthcare purposes other than medical care (hereinafter referred to as "non-medical device software") and software not for healthcare purposes (hereinafter referred to as "non-health software"). Non-medical device software and non-health software are software that do not require or require limited certification as a medical device. Note that the application 6 may also be an application that requires certification as a medical device.

[0035] The application 6 can be added to the sample measurement system 1. In other words, the application 6 can be added to the sample measurement system 1. The application 6 added to the sample measurement system 1 becomes a component of the sample measurement system 1. The application 6 added to the sample measurement system 1 provides, for example, a function that uses information managed by the data management software 4 (data related to the measurement unit 2) and a function that uses the functions of the data management software 4. The functions provided by the application 6 are, for example, functions that the data management software 4 does not have and functions that extend the functions that the data management software 4 has. The functions provided by the application 6 are, for example, new functions that are different from functions that correspond to the intended use as a medical device ("Intended Use"). In this way, the application 6 added to the sample measurement system 1 provides functions to extend the sample measurement system 1. In other words, the application 6 added to the sample measurement system 1 can be said to provide functions that complement the data management software 4.

[0036] Because the application 6 is separated from the data management software 4 and the control software 3, the application 6 can be easily added to the specimen measurement system 1 without modifying the data management software 4 and the control software 3. Furthermore, if the application 6 is non-medical device software or non-health software that does not require certification as a medical device, for example, there is no need to obtain certification from a certification body when adding the application 6. Similarly, when deleting the application 6 from the specimen measurement system 1, there is no need to modify the data management software 4 and the control software 3.

[0037] The application 6 separated from the data management software 4 can cooperate with the data management software 4 via an interface 5. The interface 5 is, for example, a software interface. The interface 5 is, for example, an API (Application Programming Interface). The interface 5 allows the application 6 to use information managed by the data management software 4 (for example, data related to the measurement unit 2, such as measurement data) and the functions of the data management software 4. Specifically, the interface 5 accepts requests from the application 6 and sends a response corresponding to the request to the application 6, thereby allowing the application 6 to use, for example, data corresponding to the request or a function corresponding to the request. A request from the application 6 is, for example, a request to use data managed by the data management software 4 or a request to use a function of the data management software 4. A response to the application 6 is, for example, providing data corresponding to the request or providing a function corresponding to the request.

[0038] The application 6 interacts with the interface 5 in accordance with a predetermined rule (hereinafter referred to as "rule R"). The interface 5 allows the application 6 to use information and functions related to the data management software 4 based on rule R. If the interface 5 is configured as a Web API, for example, rule R is defined as a combination of a uniform resource identifier (URI) for specifying a processing target using a predetermined syntax and a predetermined hypertext transfer protocol (HTTP) method indicating an operation on the processing target. Based on rule R, the application 6 creates a request to the interface 5 that combines a URI and an HTTP method that specifically identifies the processing target and the operation on the processing target. Below, this request is also referred to as "command C." The application 6 sends command C created based on rule R to the interface 5. The interface 5 provides the application 6 with a response corresponding to command C sent from the application 6. For example, based on a command C sent from the application 6, the interface 5 causes the application 6 to use at least one of data related to the measurement unit 2, data related to the measurement operation by the measurement unit 2, data related to the maintenance of the measurement unit 2, and data related to the operation of the measurement unit 2. Furthermore, based on a command C sent from the application 6, the interface 5 causes the application 6 to perform at least one of acquiring data related to the measurement unit 2, registering the data, updating the data, and deleting the data. For example, multiple types of rules R may be used depending on the type of specimen measurement device 11. For example, the information management style of the data management software 4 and the data management system 15 may differ depending on the type of specimen measurement device 11. In such a case, for example, the interface 5 / 5A and the application 6 cooperate based on multiple types of rules R according to the information management style, thereby enabling the application 6 to use multiple types of information, each with a different information management style.

[0039] The interface 5 may allow multiple types of applications 6 to use data related to the measurement unit 2 based on a rule R that is commonly defined for multiple types of applications 6 that provide different functions. The interface 5 may allow multiple types of applications 6 to use data related to the measurement unit 2 based on a rule R that is commonly defined for multiple types of applications 6 that are each created for multiple types of operating systems.

[0040] The interface 5 may be incorporated into the data management software 4, or may be incorporated into a software program separate from the data management software 4. The interface 5 may be software independent of the data management software 4, the control software 3, and other software programs. Furthermore, the data management software 4 may be composed of a single piece of software (e.g., a single executable file), or may be composed of multiple pieces of software (e.g., multiple executable files). For example, the software responsible for the interface 5 and the software responsible for the data management software 4 may be composed of multiple different executable files.

[0041] [Example of software operating environment] The control software 3, data management software 4, interface 5, and applications 6 are executed, for example, on one or more computers 900. The computers 900 are, for example, smartphones (iPhone, Android devices), tablets (iPad, Android tablets, Windows tablets), Windows PCs with the Windows OS installed, or Macs with the Mac OS installed (iPhone, iPad, Android, Windows, and Mac OS are registered trademarks). Note that the applications 6 may be created for, for example, multiple types of operating systems. For example, a certain application 6 may be created for both the Windows OS and iOS.

[0042] 2 shows an example of the configuration of a computer 900. The computer 900 includes, for example, a processor 71, a memory 72, a bus 73, a storage unit 74, a display unit 75, an interface 751, an operation unit 76, an interface 761, and a communication unit 78. The terminal device 101 and a control unit 7, which will be described later, have the same configuration as the computer 900 shown in FIG.

[0043] The storage unit 74 is a non-volatile memory such as a solid state drive (SSD), a flash memory, a hard disk drive (HDD), or a combination of these. The storage unit 74 stores various programs including, for example, control software 3, data management software 4, an interface 5, and an application 6, as well as various data.

[0044] The processor 71 is, for example, an infrastructure processing unit (IPU), a central processing unit (CPU), a graphic processing unit (GPU), a digital signal processor (DSP), a micro processing unit (MPU), or a combination of these. The processor 71 may be realized by, for example, a logic circuit. The processor 71 reads various programs from the storage unit 74, loads them into the memory 72, and executes them. The memory 72 is, for example, a volatile memory such as a random access memory (RAM) or a dynamic random access memory (DRAM).

[0045] The interface 751 connects the bus 73 to a display unit 75 such as a display. The interface 761 connects the bus 73 to an operation unit 76 such as a keyboard and a mouse. The communication unit 78 is responsible for communication with external devices.

[0046] Hereinafter, in order to simplify the explanation of the operation of the control software 3, data management software 4, interface 5, or application 6, the components corresponding to the processor 71, storage unit 74, and memory 72 used to execute these may be omitted.

[0047] The computer 900 may further include a communication interface for communicating with other devices, and an input / output interface for connecting input / output devices such as a keyboard, a mouse, a display, and a printer.

[0048] [Example of sample measurement system configuration] [Configuration example 1] Figure 3 shows an example configuration of a specimen measurement system 1. In the example configuration shown in the figure, specimen measurement system 1 is configured as a specimen measurement device 11 including a measurement unit 2, control software 3, data management software 4, an interface 5, and a control unit 7 that executes an application 6. In this example configuration, application 6 is executed by specimen measurement device 11, and uses the information managed by data management software 4 and the functions of data management software 4 via interface 5.

[0049] [Configuration example 2] Terminal device 101 equipped with application 6 may be used in a location different from the facility where sample measurement device 11 is installed (for example, outside the laboratory, or in a different room in the same facility as the laboratory). In the configuration example shown in FIG. 4, sample measurement system 1 includes sample measurement device 11 installed in the laboratory, and terminal device 101 used in a facility different from the laboratory and connected to sample measurement device 11 via communication network 202. Communication network 202 is, for example, the Internet or an intranet. Sample measurement device 11 includes measurement unit 2 and control unit 7 that executes control software 3, data management software 4, and interface 5. Terminal device 101 is equipped with application 6 and executes application 6.

[0050] In this configuration example, application 6 executed on terminal device 101 accesses interface 5 of specimen measurement device 11 via communication network 202. Interface 5 allows application 6 of terminal device 101 to use information managed by data management software 4 and functions of data management software 4 via communication network 202. With this configuration, application 6 can acquire measurement data from multiple specimen measurement devices 11.

[0051] [Configuration Example 3] The information (e.g., measurement data, etc.) managed by the data management software 4 may be managed by a device different from the specimen measurement device 11. In the configuration example shown in FIG. 5, the specimen measurement system 1 includes the specimen measurement device 11 and a data management system 15 connected to the specimen measurement device 11 via a communication network 204. The communication network 204 is, for example, an intranetwork or the Internet. The information (e.g., measurement data, etc.) managed by the data management software 4 may be managed by both the specimen measurement device 11 and the data management system 15. For example, a copy of all or part of the information managed by the data management software 4 of the specimen measurement device 11 may be managed by the data management system 15.

[0052] The specimen measurement device 11 includes a measurement unit 2, control software 3, data management software 4, an interface 5, and a control unit 7 that executes an application 6. The specimen measurement device 11 has a function for providing information managed by the data management software 4 to the data management system 15. As will be described in detail later, one example of this function is for the interface 5 to provide information corresponding to a predetermined event (such as measurement data) to the data management system 15 by a push notification via the communication network 204 in response to the event. The push notification may be executed by a device other than the interface 5 (for example, the data management software 4 or other software installed in the control unit 7). Instead of a push notification, the specimen measurement device 11 may provide information managed by the data management software 4 to the data management system 15 in response to an inquiry from the data management system 15. The provision of information to the data management system 15 is similar to configuration examples 4 and 5 described below.

[0053] The data management system 15 includes, for example, a control unit 17 that executes data management software 4A, an interface 5A, and a communication control unit 16. The control unit 17 is equivalent to the processor 71 shown in FIG. 2. The data management system 15 includes a data storage 18 that is a storage device. The data management software 4A accumulates and manages information received via push notification from the sample measurement device 11 in the data storage 18. The communication control unit 16 has a function of controlling communication related to push notifications from the sample measurement device 11.

[0054] The application 6 can cooperate with the data management software 4A via the interface 5A. The data management software 4A retrieves data corresponding to a request from the application 6 received by the interface 5A from the data storage 18 and provides it to the requesting application 6. The interface 5A has the function of allowing the application 6 executed on the sample measurement device 11 to use information managed in the data storage 18 via the data management software 4A. The interface 5A is equivalent to the interface 5 and is, for example, a software interface, typically an API. The interface 5A allows the application 6 to use the information managed by the data management software 4A. The application 6 cooperates with the interface 5A based on the rule R, and the interface 5A allows the application 6 to use information and functions related to the data management software 4A based on the rule R.

[0055] In this configuration example, application 6 executed on sample measurement device 11 accesses interface 5A of data management system 15 via communication network 204 and requests the use of information stored in data storage 18 of data management system 15. Data management system 15 may be installed in a laboratory or medical facility, in which case application 6 of sample measurement device 11 accesses interface 5A via communication network 204, for example as an intranet.

[0056] [Configuration Example 4] The information stored in data storage 18 of data management system 15 may be used by application 6 executed on terminal device 101. In the configuration example shown in Figure 6, sample measurement system 1 is configured by connecting sample measurement device 11, data management system 15, and terminal device 101 via communication network 204. In this configuration example, for example, measurement data acquired by sample measurement device 11 may be associated with information about its location by using setting information for sample measurement device 11 (e.g., location information about the facility where sample measurement device 11 is installed or location information about the area where sample measurement device 11 is installed), and the measurement data may be provided from sample measurement device 11 to data management system 15 via communication network 204.

[0057] In this configuration example, the application 6 executed on the terminal device 101 accesses the interface 5A of the data management system 15 via the communication network 204 and requests the use of information stored in the data storage 18 of the data management system 15. The application 6 executed on the terminal device 101 cooperates with the interface 5A based on the rule R.

[0058] [Configuration Example 5] As a variation of configuration example 4, the specimen measurement device 11 does not have to include the data management software 4 and the interface 5. The configuration example shown in Figure 7 is the same as configuration example 4, except that the specimen measurement device 11 does not have the data management software 4 and the interface 5.

[0059] In this configuration example, information such as measurement data acquired by the control software 3 controlling the measurement unit 2 is transmitted to the data management system 15 via the communication network 204 and stored in the data storage 18 via the data management software 4A of the data management system 15. As in configuration example 6, the application 6 executed on the terminal device 101 accesses the interface 5A of the data management system 15 via the communication network 204 and requests the use of the information stored in the data storage 18 of the data management system 15.

[0060] In the configuration examples shown in FIGS. 3 to 7, for simplicity, only one specimen measurement device 11 is shown, but one specimen measurement system 1 may be equipped with multiple specimen measurement devices 11.

[0061] [Configuration example of a specimen measurement device] As described above, the specimen measurement device 11 includes, for example, a control unit 7 and a measurement unit 2, as shown in FIG.

[0062] [Control unit] The control unit 7 is, for example, a computer. An example hardware configuration of the control unit 7 is shown in Fig. 9. The control unit 7 includes, for example, a processor 71, a memory 72, a bus 73, a storage unit 74, a display unit 75, an interface 751, an operation unit 76, an interface 761, an interface 77, and a communication unit 78.

[0063] The processor 71 is a control unit that controls the overall functions of the control unit 7. The processor 71 is equivalent to the processor 71 shown in FIG. 2. The processor 71 reads, for example, the control software 3 and the data management software 4 from the storage unit 74, loads them into the memory 72, and executes them. The storage unit 74 is equivalent to the storage unit 74 shown in FIG. 2. The memory 72 is equivalent to the memory 72 shown in FIG. 2.

[0064] The interface 751 connects the bus 73 to a display unit 75 such as a display. The interface 761 connects the bus 73 to an operation unit 76 such as a keyboard or mouse. The interface 77 connects the bus 73 to the measurement unit 2. The communication unit 78 is responsible for communication with external devices.

[0065] [Example of control software and data management software configuration] 10 shows an example configuration of the control software 3 and data management software 4 executed by the control unit 7. The control software 3 includes, for example, a unit control unit 31 and an analysis unit 32. The unit control unit 31 commands the measurement unit 2 to perform an operation corresponding to a measurement order for a sample to be measured. The analysis unit 32 analyzes data acquired by the measurement unit 2 that has operated in accordance with the commands of the unit control unit 31, generates measurement data as the measurement results, and stores the generated measurement data in the memory unit 74.

[0066] The data management software 4 includes, for example, a result providing unit 41 and an operation unit 42. The result providing unit 41 has a function (e.g., a GUI (Graphical User Interface)) for acquiring measurement data generated by the analysis unit 32 from the storage unit 74 and providing the acquired measurement data to the operator. The operation unit 42 has operation functions such as a function (UI) for the operator to register measurement orders / specimen information, a function for acquiring measurement orders and specimen information from a laboratory information system (LIS) and / or a hospital information system (HIS), a function for registering measurement instructions based on measurement orders, various settings related to the device and system, and registration of reagent information and consumable information. The information set and registered by the operation unit 42 is stored in the storage unit 74. The operation functions provided by the data management software 4 are, for example, functions required for the intended use of the specimen measurement device 11 approved as a medical device (e.g., the minimum functions for measuring specimens and providing measurement results specified for the intended use). The operation functions of the data management software 4 are, for example, functions required for the intended use of the specimen measurement device 11 approved as a medical device, and additional functions for improving user convenience. The operation functions of the data management software 4 can be expanded, for example, by adding applications 6.

[0067] As a modified example, as shown in FIG. 11, the control unit 7 may not include the data management software 4. The control unit 7 illustrated in FIG. 11 is used, for example, in the system illustrated in FIG. 7. In this example, the unit control unit 31 commands the measurement unit 2 to perform an operation corresponding to a measurement order obtained from, for example, the LIS / HIS. The analysis unit 32 analyzes the data obtained by the measurement unit 2 that operated according to the command of the unit control unit 31, generates measurement data as the measurement result, and transmits the generated measurement data to the data management system 15 via, for example, the communication unit 78.

[0068] [Measurement unit] An example configuration of the measurement unit 2 is shown in FIG. 12. The measurement unit 2 includes, as an example, a specimen processing unit 21 and a detection unit 22. The specimen processing unit 21 prepares a measurement sample based on a specimen and a reagent. The detection unit 22 measures the measurement sample prepared by the specimen processing unit 21. The unit control unit 31 of the control software 3 controls the operation of the specimen processing unit 21 and the detection unit 22 in cooperation with the operation unit 42 of the data management software 4 (in accordance with instructions from the operation unit 42). The unit control unit 31 controls, for example, the operation of the mechanisms and fluid circuits that make up the specimen processing unit 21 and the detection unit 22. This operation control may include, for example, at least one of control of the aspirating operation of a liquid containing at least one of a specimen and a reagent, control of mixing the specimen and the reagent to prepare a measurement specimen, control of detecting the measurement specimen by the detection unit 22, and control of detecting at least one of optical information and an electrical signal related to the measurement specimen by the detection unit 22 and analyzing the measurement results based on the detected detection results.

[0069] [Hematology analyzer] 13 shows a configuration example in which the measurement unit 2 is a blood cell analyzer. In this case, the specimen processing unit 21 includes, for example, a specimen aspirating unit 211 and a sample preparing unit 212, and the detection unit 22 includes, for example, an FCM detection unit 221, an RBC / PLT detection unit 222, and an HGB detection unit 223.

[0070] 14 is a schematic diagram illustrating the specimen aspirating unit 211 and specimen preparing unit 212 when supplying a measurement sample to the FCM detection unit 221. The specimen aspirating unit 211 includes a nozzle 2111 for aspirating a blood specimen (whole blood) from a blood collection tube T, and a pump 2112 for applying negative / positive pressure to the nozzle. The nozzle 2111 is inserted into the blood collection tube T by being moved up and down by a device mechanism (not shown). When the pump 2112 applies negative pressure while the nozzle 2111 is inserted into the blood collection tube T, the blood specimen is aspirated through the nozzle 2111. The device mechanism may also include a hand member for inverting and stirring the blood collection tube T before aspirating blood from it.

[0071] The sample preparation unit 212 includes five reaction chambers 212a to 212e. The reaction chambers 212a to 212e are used in the measurement channels (also referred to as measurement systems) for DIFF, RET, WPC, PLT-F, and WNR, respectively. A hemolytic agent container containing a hemolytic agent and a staining solution container containing a staining solution, which are reagents corresponding to each measurement channel, are connected to each reaction chamber via a flow path. A measurement channel is made up of one reaction chamber and the reagents (hemolytic agent and staining solution) connected to it. For example, the DIFF measurement channel corresponds to the measurement item of classifying white blood cells into multiple subpopulations (five-partition white blood cell classification), and is made up of a DIFF hemolytic agent and a DIFF staining solution, which are DIFF measurement reagents, and a DIFF reaction chamber. The RET measurement channel corresponds to measurement items related to reticulocyte measurement, the WPC measurement channel corresponds to measurement items related to abnormal white blood cells, the PLT-F measurement channel corresponds to measurement items related to optical measurement of platelets, and the WNR measurement channel corresponds to measurement items related to white blood cells and nucleated red blood cells. These measurement channels are configured in the same way as the DIFF measurement channel.

[0072] After aspirating the blood sample, nozzle 2111 accesses from above one of reaction chambers 212a-212e that corresponds to the measurement channel corresponding to the order by horizontal and vertical movement of the device mechanism, and dispenses the aspirated blood sample. Sample preparation unit 212 supplies the corresponding hemolytic agent and staining solution to the reaction chamber into which the blood sample has been dispensed, and prepares a measurement sample by mixing the blood sample, hemolytic agent, and staining solution in the reaction chamber. The prepared measurement sample is supplied from the reaction chamber via a flow channel to FCM detection unit 221, where cells are measured by flow cytometry.

[0073] FIG. 15 is a schematic diagram illustrating the specimen aspirating unit 211 and specimen preparing unit 212 when a measurement specimen is supplied to the RBC / PLT detecting unit 222. The specimen aspirating unit 211 is the same as the specimen aspirating unit 211 shown in FIG. 14. The specimen preparing unit 212 includes a reaction chamber 212f. A diluent container containing a diluent corresponding to the RBC / PLT is connected to the reaction chamber 212f via a flow path. A measurement specimen is prepared by mixing the blood specimen and the diluent in the reaction chamber 212f. The prepared measurement specimen is supplied from the reaction chamber to the RBC / PLT detecting unit 222 via the flow path.

[0074] FIG. 16 is a schematic diagram illustrating the specimen aspirating unit 211 and specimen preparing unit 212 when supplying a measurement specimen to the HGB detection unit 223. The specimen aspirating unit 211 is similar to the specimen aspirating unit 211 shown in FIG. 14. The specimen preparing unit 212 includes a reaction chamber 212g. A hemolytic agent container containing a hemolytic agent, which is a reagent corresponding to HGB, is connected to the reaction chamber 212g via a flow path. A measurement specimen is prepared by mixing the blood specimen and the hemolytic agent in the reaction chamber 212g. The prepared measurement specimen is supplied from the reaction chamber to the HGB detection unit 223 via the flow path.

[0075] [Urine formed component device] An example configuration in which the measurement unit 2 is a urine formed element apparatus is shown in Fig. 17. In this case, the specimen processing unit 21 includes, for example, a specimen aspirating unit 213 and a sample preparing unit 214, and the detection unit 22 includes, for example, a light irradiating unit 224 and an optical detection unit 225.

[0076] The sample preparation unit 214 aspirates a urine sample from a sample container using the sample aspirator 213. The sample aspirator 213 is made up of a pipe-shaped aspirator tube. The sample preparation unit 214 prepares a measurement sample by mixing a reagent with the urine sample aspirated by the sample aspirator 213. The reagent mixed with the urine sample is a dilution solution or a staining solution containing a pigment that stains formed elements in the urine sample.

[0077] The detection unit 22 measures the measurement sample prepared by the sample preparation unit 214. An example configuration of the detection unit 22 is shown in FIG. 18. The detection unit 22 includes a flow cell 2250, a light irradiation unit 224, an optical system 2240, and optical detection units 225 (225A, 225B, 225C). The flow cell 2250 allows the measurement sample to flow in one direction while being surrounded by sheath fluid. The light irradiation unit 224 is formed, for example, by a laser diode and emits light of a predetermined wavelength. The optical system 2240 irradiates the light emitted from the light irradiation unit 224 onto the sample flow in the flow cell 2250. The optical system 2240 guides forward scattered light generated from the solid components in the flow cell 2250 to the optical detection unit 225A. The optical system 2240 guides side scattered light and side fluorescent light generated from the solid components to the optical detection units 225B and 225C, respectively.

[0078] The optical system 2240 includes a collimator lens 2241 , a cylindrical lens 2242 , a condenser lens 2243 , a condenser lens 2244 , a beam stopper 2245 , a pinhole 2246 , a condenser lens 2247 , a dichroic mirror 2248 , and an optical filter 2249 .

[0079] Collimator lens 2241 converts the light emitted from light irradiation unit 224 into parallel light. Cylindrical lens 2242 and condenser lens 2243 shape the light that has passed through collimator lens 2241 into a shape that is wide in the direction perpendicular to the flow of the measurement sample, and irradiate the sample flow in flow cell 2250. As a result, forward scattered light is generated in front of the particles flowing through flow cell 2250, and side scattered light and fluorescence are generated to the sides of the particles flowing through flow cell 2250.

[0080] Condenser lens 2244 condenses the forward scattered light at the position of pinhole 2246. Beam stopper 2245 blocks light that has passed through flow cell 2250 without being irradiated on particles in the measurement sample. Optical detection unit 225A receives the forward scattered light that has passed through pinhole 2246. Optical detection unit 225A includes, for example, a photodiode. Optical detection unit 225A amplifies the detection signal with an amplifier to generate a forward scattered light signal based on the forward scattered light, and outputs the generated forward scattered light signal.

[0081] The condenser lens 2247 converges the side scattered light and the fluorescent light. The dichroic mirror 2248 reflects the side scattered light that has passed through the condenser lens 2247. The optical detection unit 225B receives the side scattered light reflected by the dichroic mirror 2248. The optical detection unit 225B includes, for example, a photodiode or a photomultiplier tube. The optical detection unit 225B amplifies the detection signal with an amplifier to generate a side scattered light signal based on the side scattered light, and outputs the generated side scattered light signal.

[0082] The dichroic mirror 2248 transmits the fluorescence that has passed through the condenser lens 2247. The optical filter 2249 removes light in a wavelength band that becomes noise from the fluorescence that has passed through the dichroic mirror 2248. The optical detection unit 225C receives the fluorescence that has passed through the optical filter 2249. The optical detection unit 225C includes, for example, a photomultiplier. The optical detection unit 225C amplifies the detection signal with an amplifier to generate a fluorescence signal based on the fluorescence, and outputs the generated fluorescence signal.

[0083] The optical detection units 225 (225A, 225B, 225C) can switch the light receiving sensitivity between low and high by switching the drive voltage during photoelectric conversion or by using an amplifier. The optical detection units 225 (225A, 225B, 225C) each generate and output a signal of each light when the light receiving sensitivity is low and a signal of each light when the light receiving sensitivity is high while the measurement sample flows through the flow cell 2250.

[0084] [Blood coagulation analyzer] An example configuration in which the measurement unit 2 is a blood coagulation analyzer is shown in Fig. 19. In this case, the specimen processing unit 21 includes, for example, a specimen aspirating unit 215 and a sample preparing unit 216, and the detection unit 22 includes, for example, a light irradiating unit 226 and an optical detection unit 227.

[0085] The specimen aspirator 215 aspirates the specimen from the specimen container. The specimen preparation unit 216 mixes the specimen aspirated by the specimen aspirator 215 with a reagent to prepare a measurement specimen.

[0086] The detection unit 22 measures the measurement sample prepared by the sample preparation unit 216. An example configuration of the light irradiation unit 226 of the detection unit 22 is shown in Fig. 20. The light irradiation unit 226 includes five light sources 2260, five optical fiber units 2261 provided corresponding to the five light sources 2260, and one holding member 2263 for holding each light source 2260 and the incident end 2262 of each optical fiber unit 2261. The light sources 2260, the optical fiber units 2261, and the holding member 2263 are housed in a housing 2264 made of, for example, metal.

[0087] Each of the plurality of optical fiber portions 2261 includes a plurality of optical fibers 2265. The plurality of optical fiber portions 2261 are mixed and bundled at the output end 2266 so that the plurality of optical fiber portions 2261 corresponding to each light source 2260 are distributed approximately uniformly. The five optical fiber portions 2261 are twisted together midway to form an integrated unit, and are configured to have two output ends 2266. The two output ends 2266 are provided to correspond to the optical detection unit 227. The light irradiation unit 226 includes a light distribution member 2267 for distributing light from the bundled output ends 2266.

[0088] 21 shows an example of the configuration of the optical detection unit 227 of the detection unit 22. The optical detection unit 227 includes a container installation section 2271 as a hole extending in the vertical direction, and an exit end 2268 of a light distribution member 2267 is disposed in a hole 2272 extending laterally from the container installation section 2271. A condenser lens 2273 is disposed inside the hole 2272. The light receiving unit 2274 is provided at the end of a hole 2275 formed to face the hole 2272 across the container installation section 2271. As a result, the exit end 2268 of the light distribution member 2267, the condenser lens 2273, the container installation section 2271, and the light receiving unit 2274 are disposed in a linear arrangement. The light emitted from the emission end 2268 passes through the condenser lens 2273 , passes through the container C containing the measurement sample in the container installation section 2271 and the measurement sample in the container C, and is detected by the light receiving section 2274 .

[0089] [Immunology analyzer] 22 shows a configuration example in which the measurement unit 2 is an immunoassay device. In this case, the sample processing unit 21 includes, for example, a sample aspirating unit 217 and a sample preparing unit 218, and the detection unit 22 includes, for example, an optical detection unit 228.

[0090] The specimen aspirator 217 aspirates a specimen from a specimen container. The specimen preparation unit 218 includes, for example, a primary reaction unit 2181, a primary BF (Bound Free) separation unit 2182, a secondary reaction unit 2183, and a secondary BF separation unit 2184. An example of the processing flow by the specimen preparation unit 218 will be described with reference to FIG. 23. In the primary reaction unit 2181, magnetic particles (R2 reagent) are bound to a capture antibody (R1 reagent) that has bound to an antigen contained in the specimen aspirated by the specimen aspirator 217, and then the bound (bound) antigen, capture antibody, and magnetic particles are attracted to the magnet of the primary BF separation unit 2182, thereby removing the R1 reagent containing unreacted (free) capture antibody. Then, in the secondary reaction unit 2183, the antigen bound to the magnetic particles is bound to the labeled antibody (R3 reagent), and then the bound magnetic particles, antigen, and labeled antibody are attracted to the magnet of the secondary BF separation unit 2184, thereby removing the R3 reagent containing the unreacted (free) labeled antibody. Furthermore, in the secondary reaction unit 2183, a dispersion liquid (R4 reagent) is added, and then a luminescent substrate (R5 reagent) that emits light in the reaction process with the labeled antibody is added, and then the amount of luminescence (proportional to the number of photons) generated in the reaction process between the labeled antibody of the R3 reagent and the luminescent substrate of the R5 reagent is acquired by a photomultiplier tube in the optical detection unit 228.

[0091] [Interface configuration example] The interface 5 receives requests from the application 6, cooperates with the data management software 4 (result providing unit 41 and operation unit 42), and sends a response corresponding to the request to the application 6. FIG. 24 shows an example configuration of the interface 5. The interface 5 includes, as an example, a request receiving unit 51, a linking unit 52, and a response unit 53. The request receiving unit 51 receives a request from the application 6. The request receiving unit 51 analyzes the content of the request based on rule R, and based on the analyzed request, instructs the linking unit 52 to cooperate with the data management software 4 to obtain a response to the request. The linking unit 52 cooperates with the data management software 4 in accordance with the instruction and obtains a response corresponding to the request. The response unit 53 provides the response obtained by the linking unit 52 to the application 6.

[0092] FIG. 25 is a flowchart showing an example of the processing flow (linkage method) by the interface 5 of the sample measurement device 11. First, the interface 5 waits for a request from the application 6 (S1). In response to receiving a request from the application 6 (Yes in S1), the interface 5 analyzes the contents of the request based on rule R (S2). The interface 5 instructs the data management software 4 to perform processing corresponding to the analyzed request (S3). The data management software 4 executes processing according to the instruction. For example, when the application 6 requests information about the measurement results (e.g., measurement data measured by the measurement unit 2 of a specific sample measurement device 11, or measurement results of quality control materials for a period specified in the request (e.g., daily, weekly, or monthly)), the result providing unit 41 of the data management software 4 identifies the data corresponding to the request and provides the information to the application 6 via the interface 5. For example, in response to a measurement order registration request from the application 6, the operation unit 42 of the data management software 4 registers the measurement order and provides the application 6 with a response indicating that the registration has been completed via the interface 5. The interface 5 returns a response to the application 6 in response to the processing being executed by the data management software 4 (S4). In response to this, the interface 5 allows the application 6 to use the data and functions corresponding to the request.

[0093] FIG. 26 shows an example configuration of the interface 5A of the data management system 15. The interface 5A includes, for example, a request receiving unit 51A, a linking unit 52A, and a response unit 53A. The request receiving unit 51A receives a request from the application 6 via the communication network 204. The request receiving unit 51A analyzes the contents of the request and, based on the analyzed request, instructs the linking unit 52A to link with the data management software 4A to obtain a response to the request. The linking unit 52A links with the data management software 4A in accordance with the instruction and obtains a response corresponding to the request. The response unit 53A provides the response obtained by the linking unit 52A to the application 6 via the communication network 204.

[0094] When the interfaces 5 and 5A are configured as WebAPIs, the application 6 accesses the interfaces 5 and 5A using a URI defined in rule R. An example of the syntax of the URI defined in rule R is shown in Expression 1.

[0095] http: / / [server address] / [interface ID] / [device ID]{ / [resource] / [query parameters]} (Formula 1)

[0096] The "server address" in Expression 1 is a communication address corresponding to the interface 5, 5A. The server address is specified by, for example, an IP address and a port number.

[0097] The interfaces 5 and 5A may be set, for example, according to the type of sample measurement device 11. In this case, an "interface ID" in formula 1 is specified to identify the interfaces 5 and 5A. The interface ID is, for example, an ID corresponding to the type of sample measurement device 11. Specifying the "interface ID" in formula 1 is not essential, and if it is not specified, a wildcard (blank, *, etc.) is used, for example. The interface ID corresponds, for example, to the type of rule R. For example, there are multiple types of rule R depending on the type of sample measurement device 11. In other words, the interface ID corresponds, for example, to the type of sample measurement device 11. For example, the information management style of the data management software 4 and the data management system 15 may differ depending on the type of sample measurement device 11. In such a case, for example, the interface 5 / 5A and the application 6 cooperate based on multiple types of rule R corresponding to the information management style, allowing the application 6 to use multiple types of information, each with a different information management style.

[0098] The "device ID" in formula 1 is the ID of the sample measurement device 11 for which the information and functions are to be used. The device ID is, for example, the serial number of the sample measurement device 11. It is not necessary to specify the "device ID" in formula 1, and if it is not to be specified, for example, a wildcard (blank, *, etc.) can be used.

[0099] The "resource" in Expression 1 is the resource of the API endpoint. For example, the resource is a directory on a database that corresponds to the information to be used.

[0100] The "query parameter" in Expression 1 is a query for uniquely identifying multiple data and control targets when they exist on a resource. For example, it is used to identify measurement data among multiple measurement data that meets the conditions specified in the query parameter (a specific period, a specific sample, measurement data with a measurement abnormality). Specifying a "resource" in Expression 1 is not required; if it is not specified, a wildcard (e.g., a space, *) is used. The specification format for the "resource" and "query parameter" may differ, for example, depending on the type of specimen measurement device 11. For example, when acquiring "measurement data," the specification format for the "resource" and / or "query parameter" for acquiring "measurement data" from a blood cell analyzer may differ from the specification format for the "resource" and / or "query parameter" for acquiring "measurement data" from an immunological analyzer. Even for the same type of "measurement data," the resource as an API endpoint may differ depending on the type of specimen measurement device 11, or specific query parameters may be required for each type of specimen measurement device 11. In such cases, the specification format for the "resource" and "query parameter" may differ, for example, depending on the type of specimen measurement device 11. The specification format of the "resources" and "query parameters" is part of rule R, so in other words, the "resources" and / or "query parameters" may be set based on multiple types of rule R depending on the type of sample measurement device 11.

[0101] An operation on a resource specified by a URI is specified, for example, by an HTTP method. Examples of HTTP methods include "GET," "PUT," "DELETE," and "POST." By using "GET," you can obtain the information specified by the "resource" and "query parameters" of the URI.

[0102] Using "PUT" updates or edits information specified by the "resource" and "query parameters" of the URI. In this case, the new data (the content of the resource to be updated or edited) is included in the HTTP request body. An example of the data structure of the HTTP request body when updating quality control lot information is shown in Figure 27. This example is written in JSON (JavaScript Object Notation) format (JavaScript is a registered trademark). For example, URI = "http: / / 127.0.0.1:8080 / qcdata / qcLotsInfo?lotNumber=QC22421101" specifies the "server address" = "127.0.0.1" of the control unit 7 that is the target of the "PUT" process (update). The QC (Quality Control) data held by the control unit 7 with "server address" = "127.0.0.1" is specified by "resource" = "qcdata". Among the QC data held by the control unit 7 with a "server address" of "127.0.0.1," a "PUT" operation (update) is specified for the QC lot information with a "query parameter" of "QC22421101" (QC lot number). The HTTP request body ("{"Limits":[{"parameter":"WBC","lowerLimit":10.0,"upperLimit":100.0},{"parameter":"RBC","lowerLimit":20.0,"upperLimit":200.0},{"parameter":"HGB","lowerLimit":30.0,"upperLimit":300.0},]}" specifies the target and content of the "PUT" operation (update) for the specified QC lot information. This combination of URI and HTTP request body updates the specified QC lot information as follows: WBC (white blood cell count) lower limit = 10.0 / upper limit = 100.0, RBC (red blood cell count) lower limit = 20.0 / upper limit = 200.0, and HGB (hemoglobin concentration) lower limit = 30.0 / upper limit = 300.0.By updating the lower and upper limits for WBC (white blood cell count), RBC (red blood cell count), and HGB (hemoglobin concentration), QC can be performed using the updated lower and upper limits. These lower and upper limits are also called control values ​​and are set to ensure the accuracy of measurement results and to verify the validity of the measurement method and its control method from the measurement result records. In addition, if the measurement result falls outside the lower or upper limit, it can also be used as an indicator that the measurement result is abnormal or that the measurement was not performed correctly.

[0103] By using "DELETE", the information specified by the "resource" and "query parameters" of the URI is deleted.

[0104] To register or create new information, use "POST" without specifying a "resource" or "query parameters." In this case, include the new data (the content of the resource to be registered or created) in the HTTP request body.

[0105] The request receiving unit 51 of the interface 5 receives, for example, a URI and an HTTP method received from the application 6. The linking unit 52 of the interface 5 links with the data management software 4, for example, based on the URI and HTTP method received by the request receiving unit 51. For example, in response to a request to obtain the measurement results (HTTP method "GET") of the sample measurement device 11 specified by the "device ID" in the URI, the linking unit 52 links with the result providing unit 41 to obtain the corresponding measurement results. The response unit 53 of the interface 5 sends a response to the application 6 according to the received URI and HTTP method.

[0106] Similarly, request receiving unit 51A of interface 5A receives, for example, a URI and HTTP method received from application 6. Linking unit 52A of interface 5A links with data management software 4A, for example, based on the URI and HTTP method received by request receiving unit 51A. For example, linking unit 52A links with data management software 4A in response to a request (HTTP method "GET") to obtain measurement results from sample measurement device 11 specified by the "device ID" in the URI, and obtains the corresponding measurement results. Response unit 53A of interface 5A sends a response to application 6 in accordance with the received URI and HTTP method.

[0107] Examples of requests and responses to interfaces 5, 5A are shown in Figures 28 to 31. Figure 28 shows an example of a request for information about sample measurement device 11 / a response to the request. Figure 28 shows examples of, for example, (1) a request and response for information specific to sample measurement device 11 or a system including sample measurement device 11, (2) a request and response for information about the status of sample measurement device 11, and (3) a request and response for information about the operation of sample measurement device 11. Examples of various information corresponding to requests and responses are shown in the table in Figure 28, but the various information corresponding to requests and responses is not limited to the examples shown in the table. Interface 5 can, for example, provide application 6 with information about multiple sample measurement devices 11 (e.g., serial numbers of multiple sample measurement devices 11 installed in a laboratory, error statuses of multiple sample measurement devices 11 installed in a laboratory, etc.). Figure 29 shows an example of a request for information about sample measurement / a response to the request. FIG. 29 shows, for example, examples of (1) a request and response for information regarding measurement results, (2) a request and response regarding quality control measurements, and (3) a request and response for information regarding measurement orders. Examples of various information corresponding to requests and responses are shown in the table of FIG. 29, but the various information corresponding to requests and responses is not limited to the examples shown in the table. The interface 5 can, for example, provide to the application 6 information regarding multiple specimen measurement devices 11 (e.g., the results of specimen measurements performed by multiple specimen measurement devices 11 installed in a laboratory during a specified period, the results of measurements of quality control specimens performed by multiple specimen measurement devices 11 installed in a laboratory during a specified period, etc.). FIG. 30 shows examples of a request for information regarding maintenance of the specimen measurement device 11 / a response to the request. FIG. 30 shows, for example, examples of (1) a request and response for information regarding reagents, and (2) a request and response for information regarding maintenance. Examples of various information corresponding to requests and responses are shown in the table of FIG. 30, but the various information corresponding to requests and responses is not limited to the examples shown in the table. The "consumables" shown in FIG. 30 are, for example, cuvettes used in measurements, cleaning solutions for cleaning the flow paths in the device, pipette tips, and the like.The interface 5 can, for example, collectively provide information relating to multiple specimen measurement devices 11 (e.g., information on the remaining amount of reagents in multiple specimen measurement devices 11 installed in a laboratory, maintenance schedule information for multiple specimen measurement devices 11 installed in a laboratory, etc.) to the application 6. Figure 31 shows examples of requests related to the operation of the specimen measurement device 11. Figure 31 shows examples of, for example, (1) a request and response for an operation related to specimen measurement, (2) a request and response for an operation related to maintenance, and (3) a request and response for the operation of the specimen measurement device 11. Examples of various information corresponding to the requests and responses are shown in the table in Figure 31, but the various information corresponding to the requests and responses is not limited to the examples shown in the table. The interface 5 can, for example, collectively cause the application 6 to execute operations on multiple specimen measurement devices 11 (e.g., registering rerun / reflex rules for multiple specimen measurement devices 11 installed in a laboratory, requesting startup / shutdown of multiple specimen measurement devices 11 installed in a laboratory, etc.). In the example of FIG. 31, the response to the operation request includes, for example, information indicating whether the operation has been completed (for example, an ACK corresponding to completion of the operation, and a NACK corresponding to incomplete operation (for example, an error)).

[0108] [PUSH notification] FIG. 32 shows an example of the configuration of a push notification from the data management software 4 of the sample measurement device 11 to the data management system 15. The interface 5 may include a notification unit 54 that has the function of sending a push notification. For example, when a predetermined event occurs, the notification unit 54 provides information corresponding to the event to the data management system 15 via the communication network 204 by a push notification. FIG. 33 shows an example of an event and an example of information corresponding to the event (information that is the subject of a push notification). For example, when the sample measurement device 11 acquires a sample measurement result, the notification unit 54 provides the measurement result to the data management system 15. For example, when a predetermined operation (e.g., reagent replacement, maintenance, information setting, etc.) is performed on the sample measurement device 11, the notification unit 54 provides information related to the operation to the data management system 15. For example, when the status of the sample measurement device 11 changes (e.g., an error occurs, the error is cleared, etc.), the notification unit 54 provides information related to the status change (e.g., error information, an operation history related to the error, etc.) to the data management system 15.

[0109] The notification unit 54 may be provided in the data management software 4 instead of the interface 5. The notification unit 54 may also be provided in the control unit 7 as software independent of the interface 5 and the data management software 4.

[0110] 〔application〕 34 shows an example of the configuration of the application 6. The application 6 includes, for example, a function providing unit 61, a request unit 62, and a response receiving unit 63.

[0111] The function providing unit 61 provides functions for expanding the sample measurement system 1. The function providing unit 61 provides functions according to the type of application 6. For example, depending on the type of application 6, it provides functions such as providing QC results (QC charts, etc.), managing reagents installed in the sample measurement device 11, managing errors that occur in the sample measurement device 11, maintaining the sample measurement device 11, and managing the operation of the sample measurement device 11.

[0112] The function providing unit 61 may have a function of allowing a user to log in using an account of a service provider of a service provided by the application 6. In this case, the application 6 provides the service provided by the function providing unit 61 only when the user logs in using the account of the service provider.

[0113] For example, when information about the sample measurement device 11 is required, the function providing unit 61 requests the request unit 62 to obtain the information. In response to the request from the function providing unit 61, the request unit 62 requests information from the interface 5 / 5A. The request unit 62 requests the information, for example, using a command C defined by a combination of a URI and an HTTP method, as described above. Furthermore, when control of the sample measurement device 11 (for example, registration and change of setting information for the sample measurement device 11) is required in response to the operation of the function providing unit 61, the function providing unit 61 makes a request for the control to the request unit 62 (for example, a request for registration and change of setting information). The request unit 62 makes a request for the control to the interface 5 / 5A. For example, the request unit 62 makes a request for the control using a command C defined by a combination of a URI and an HTTP method, as described above. The request unit 62 generates a command C including a URI based on the information provided by the function providing unit 61, and sends the request to the interface 5 / 5A. For example, when requesting information about the sample measurement device 11, the function providing unit 61 notifies the requesting unit 62 of an instruction regarding the requested information (e.g., measurement results obtained by a sample measurement device 11 with a specific ID during a predetermined period). The requesting unit 62 generates a command C based on the notified instruction. The instruction from the function providing unit 61 to the requesting unit 62 is notified, for example, based on an operation by a user of the application 6. For example, when a user requests measurement results obtained by a sample measurement device 11 with a specific ID on a specific day, the function providing unit 61 notifies the requesting unit 62 of an instruction corresponding to the request. When generating command C, the requesting unit 62 references, for example, setting information regarding the creation of a URI (e.g., the IP address of the server to which the request is made) and generates command C. The setting information may be the IP address of the server to which the request is made, or the URL (Uniform Resource Locator) of the server. The IP address of the server to which the request is made is, for example, the IP address of the control unit 7 of the sample measurement device 11 set in the laboratory or the IP address of the data management system 15.When the address of the requested server is set by a URL, the request unit 62 queries a Domain Name System (DNS) for an IP address based on the domain name included in the URL, for example. The request unit 62 generates a URI based on the IP address notified by the DNS. The IP address or URL may be input by the user via the GUI of the application 6. The generation of the URI and command C by the request unit 62 is similar in the application examples described below.

[0114] The response receiving unit 63 receives a response corresponding to the request made by the request unit 62 from the interface 5, 5A, and passes the response content to the function providing unit 61.

[0115] [Application example] 35 shows a configuration example when application 6 is a disease prediction application. The disease prediction application provides functions for, for example, analyzing each measurement data acquired from each of multiple sample measurement devices 11 and managing information regarding the possibility that each of multiple patients corresponding to each measurement data has a disease (e.g., information on the determination of the possibility of having a disease, information on grouping all samples including samples determined to have a possibility of having a disease based on the locations where tests were performed, and information on monitoring the disease status at locations corresponding to the groups based on the grouping information). The function providing unit 61 of application 6 in this configuration example includes, for example, a disease determination unit 171, a status monitor unit 172, and an alarm notification unit 173.

[0116] The disease determination unit 171 requests the request unit 62 to acquire information about each of the multiple specimen measurement devices 11 to be managed. For example, the disease determination unit 171 requests the request unit 62 to acquire information about each of the multiple specimen measurement devices 11 to acquire measurement data to be managed. For example, the disease determination unit 171 requests the request unit 62 to acquire information about each of the multiple specimen measurement devices 11 (e.g., the device ID of the specimen measurement device 11, the name of the specimen measurement device 11, the measurement data of the patient acquired by the specimen measurement device 11, information about the location of the specimen measurement device 11, etc.). The disease determination unit 171 may request the request unit 62 to acquire information about a specific type of specimen measurement device 11 out of the multiple types of specimen measurement devices 11 (e.g., information about the type of specimen measurement device 11, the device ID of the specimen measurement device 11, the name of the specimen measurement device 11, the measurement data of the patient acquired by the specimen measurement device 11, information about the location of the specimen measurement device 11, etc.). The request unit 62 generates a URI based on the request from the disease determination unit 171, for example, and requests the interface 5, 5A to obtain information using a command C generated by combining the generated URI with the HTTP method "GET." The URI generated by the request unit 62 is, for example, "http: / / 127.0.0.1:8080 / XR / / XXXX." In this URI example, the "server address" is specified as "127.0.0.1:8080," the "interface ID" is specified as "XR," the "device ID" is not specified, the "resource" is specified as "XXXX," and no "query parameters" are specified. "XXXX" is an API endpoint corresponding to information about the specimen measurement device 11 (for example, information about the type of specimen measurement device 11, the device ID of the specimen measurement device 11, the name of the specimen measurement device 11, the patient's measurement data obtained by the specimen measurement device 11, etc.). The "server address" "127.0.0.1:8080" is, for example, an address corresponding to the interface 5A of the data management system 15 that manages information about multiple sample measurement devices 11. If there are multiple "server addresses," multiple URIs (each corresponding to multiple addresses) may be generated.The "interface ID" "XR" is set, for example, according to the type of sample measurement device 11 from which information is to be acquired. Multiple URIs may be generated according to the type of information requested. The response receiving unit 63 receives a response corresponding to the request of the request unit 62 and passes the received information to the disease determination unit 171. For example, the request unit 62 generates a URI in response to the request, and requests information acquisition from the interface 5, 5A using command C generated by combining the generated URI with the HTTP method "GET".

[0117] The condition monitor unit 172 monitors the occurrence condition of a disease based on the determination result of the possibility of the patient suffering from the disease acquired and analyzed by the disease determination unit 171.

[0118] The alarm notification unit 173 notifies the terminal device 101 of an alarm based on the occurrence status of a disease at a predetermined location monitored by the status monitor unit 172. The alarm notification unit 173 provides information related to disease prediction using, for example, a GUI. FIG. 36 is an example of providing disease epidemic prediction using a GUI. FIG. 36 shows an example of a predicted dengue fever epidemic period. In the example of FIG. 36, for example, the predicted start of the dengue fever epidemic period is indicated by an arrow 360. The GUI of FIG. 36 makes it possible to provide, for example, information on the predicted dengue fever epidemic period, such as a time-series change in the number of patients who may have contracted dengue fever, the predicted start of the dengue fever epidemic period, and information on the predicted arrow 360.

[0119] [Configuration example for providing application functions as web services] The functions of the application 6 do not necessarily have to be provided as standalone software executed by the terminal device 101 and the specimen measurement device 11, but may also be provided as a web service.

[0120] 37 shows an example configuration in which the functions of application 6 are provided as a web service. In the example configuration shown in the figure, sample measurement system 1 includes sample measurement device 11 equipped with web browser 8, and web service system 301 connected to sample measurement device 11 via communication network 205. Communication network 205 is, for example, the Internet. Sample measurement device 11 includes measurement unit 2, control software 3, data management software 4, interface 5, and control unit 7 having processor 71 that executes web browser 8.

[0121] The Web service system 301 includes a control unit 302 having a processor that executes a service function providing unit 6A that functions as a Web service. The service function providing unit 6A has functions equivalent to those of the application 6. The service function providing unit 6A includes, for example, a function providing unit 61A, a request unit 62A, and a response receiving unit 63A. The function providing unit 61A, the request unit 62A, and the response receiving unit 63A have functions equivalent to those of the function providing unit 61, the request unit 62, and the response receiving unit 63, respectively.

[0122] In this configuration example, by accessing the service function providing unit 6A, which functions as a web service, using the web browser 8 of the sample measurement device 11, information and functions can be used via the interface 5 of the sample measurement device 11.

[0123] 38 shows another example configuration in which the functions of application 6 are provided as a web service. In the example configuration shown in the figure, sample measurement system 1 is configured by connecting sample measurement device 11, web service system 301, data management system 15, and terminal device 101 equipped with web browser 8 via communication network 205.

[0124] In this configuration example, by accessing the service function providing unit 6A, which functions as a web service, using the web browser 8 of the terminal device 101, it is possible to use the information managed in the data storage 18 via the interface 5A of the data management system 15.

[0125] 39 shows yet another example configuration in which the functions of application 6 are provided as a web service. In the example configuration shown in the figure, sample measurement system 1 is configured by connecting sample measurement device 11, web service system 301, and terminal device 101 equipped with web browser 8 via communication network 205.

[0126] In this configuration example, by accessing the service function providing unit 6A, which functions as a web service, using the web browser 8 of the terminal device 101, information and functions can be used via the interface 5 of the specimen measurement device 11.

[0127] [Application delivery format] The manner in which the application 6 is provided will now be described. FIG. 40 shows a configuration example of an application providing server 401 that provides the application 6. The application providing server 401 is located, for example, on the cloud, and is communicatively connected to the terminal device 101 and the control unit 7 via a communication network. The terminal device 101 and the control unit 7 are, for example, a smartphone (iPhone, Android device), a tablet (iPad, Android tablet, Windows tablet), a Windows PC with the Windows OS installed, or a Mac with the Mac OS installed. The application providing server 401 includes a control unit 402 having a processor that executes a download request receiving unit 403 and an application providing unit 404, and an application storage 405 that stores the application 6.

[0128] The operator of the terminal device 101 and the control unit 7 logs in to a specific download application (e.g., App Store, Google Play Store, Windows Store) using, for example, an account ID managed by an application provider (e.g., Apple ID, Google account, Microsoft account, etc.), and requests the application providing server 401 to download the desired application 6 via the download application.

[0129] The download request receiving unit 403 notifies, for example, the application providing unit 404 of information related to the requested application 6. The application providing unit 404 searches for and acquires the notified application 6 from the application storage 405, and transmits it to the request source (the terminal device 101 or the control unit 7). The application providing unit 404 may also transmit, for example, an installer for the application 6 to the request source (the terminal device 101 or the control unit 7). Having received the installer, the terminal device 101 or the control unit 7 installs the application 6 based on the installer.

[0130] The application providing server 401 may be compatible with multiple platforms (for example, Windows, MacOS, iOS, and Android). Furthermore, there may be a plurality of application providing servers 401 depending on the type of platform. For example, there may be an application providing server 401 (for example, App Store) that provides applications 6 for iOS, an application providing server 401 (for example, Google Play) that provides applications 6 for Android, and an application providing server 401 (for example, Microsoft Store) that provides applications 6 for Windows. In this case, the terminal device 101 and the control unit 7 request the provision of the application 6 in a manner appropriate for the platform.

[0131] For example, the terminal device 101 and control unit 7 equipped with iOS request the application provider server 401, which provides applications 6 for iOS, to download a desired application 6 found in a predetermined download application (for example, the App Store). Also, the terminal device 101 and control unit 7 equipped with Android OS request the application provider server 401, which provides applications 6 for Android, to download a desired application 6 found in a predetermined download application (for example, the Google Play Store). Also, the terminal device 101 and control unit 7 equipped with Windows OS request the application provider server 401, which provides applications 6 for Windows, to download a desired application 6 found in a predetermined download application (for example, the Microsoft Store).

[0132] Depending on the medical facility, examination room, etc., it is conceivable that the terminal device 101 and the control unit 7 may not be connected to the Internet, etc. In such a case, for example, a maintenance person may copy the installer for the application 6 from a medium (e.g., a CD / DVD / USB memory / external HDD / SDD) on which the installer is stored to the terminal device 101 and the control unit 7, and then install the application 6 in the terminal device 101 and the control unit 7.

[0133] Depending on the medical facility or examination room, the terminal device 101 and the control unit 7 may be permitted to communicate with the outside world only via a secure communication network (e.g., a Virtual Private Network (VPN)). In this case, for example, the application 6 may be distributed from a server that can set up a secure communication network with the terminal device 101 and the control unit 7. FIG. 41 shows an example of a configuration in which the application 6 is provided in a secure communication environment. Note that the secure communication environment includes an environment in which a file distribution server 501 is installed within the facility's intranet and is accessible from the terminal device 101 and the control unit 7 via the intranet.

[0134] The file distribution server 501 includes a processor that executes a communication unit 502 and an information providing unit 503, and a storage 504 that stores data necessary for installing the application 6 (for example, an installer and a setting file for the application 6). The communication unit 502 has, for example, a VPN server function. The information providing unit 503 has, for example, a Web server function.

[0135] The terminal device 101 and the control unit 7 have processors that execute a communication client unit 91 and an information acquisition unit 92. The communication client unit 91 has, for example, a VPN client function, and sets up a secure communication network 206 with the communication unit 502. The information acquisition unit 92 is, for example, a web browser.

[0136] The information acquisition unit 92 of the terminal device 101 and the control unit 7 accesses the information provision unit 503 of the file distribution server 501 via the secure communication network 206. The information provision unit 503 provides the information acquisition unit 92 with, for example, data that can be downloaded by the terminal device 101 and the control unit 7. The information acquisition unit 92 presents the data on a Web page. When the operators of the terminal device 101 and the control unit 7 select the data they wish to download from the Web page, the information provision unit 503 acquires the corresponding data from the storage 504 and transmits it to the information acquisition unit 92. The information acquisition unit 92 installs the application 6 based on the acquired data.

[0137] The terminal device 101 and the control unit 7 may download an installer for the application 6 via the Internet and install the application 6 using the installer.

[0138] [Web Clip] The function of application 6 may be provided to terminal device 101 and control unit 7 as a Web clip (a shortcut to a Web site). For example, the service provider notifies terminal device 101 and control unit 7 of a URL (Uniform Resource Locator) to be accessed by the Web clip. An operator of terminal device 101 and control unit 7, for example, bookmarks the notified URL as a Web clip on the home screen or desktop of terminal device 101 and control unit 7. For example, the operator of terminal device 101 and control unit 7 may access the service provider's Web site using a Web browser installed in terminal device 101 and control unit 7, access a menu that provides a desired service from the Web site, and bookmark the site in the menu as a Web clip.

[0139] System configuration examples for using the functions of application 6 using a Web clip are similar to those shown in Figures 37 to 39. In the configuration example shown in Figure 37, by using the Web browser 8 of the control unit 7 to access service function provider 6A, which functions as a Web service for a URL specified in the Web clip, information and functions can be used via the interface 5 of the specimen measurement device 11. Similarly, in the configuration example shown in Figure 38, by using the Web browser 8 of the terminal device 101 to access service function provider 6A, which functions as a Web service for a URL specified in the Web clip, information managed in data storage 18 can be used via the interface 5A of the data management system 15. Similarly, in the configuration example shown in Figure 39, by using the Web browser 8 of the terminal device 101 to access service function provider 6A, which functions as a Web service for a URL specified in the Web clip, information and functions can be used via the interface 5 of the specimen measurement device 11.

[0140] [Providing applications via MDM / MAM] The application 6 may be provided without going through a predetermined application provider (for example, Apple Store, Google Play Store, or Microsoft Store). For example, the application 6 may be provided to the terminal device 101 and the control unit 7 without going through a predetermined application provider by using a mechanism of MDM (Mobile Device Management) or MAM (Mobile Application Management).

[0141] 42 shows an example of a configuration in which an application 6 is provided using MDM or MAM. The terminal device 101 and the control unit 7 are communicatively connected to an MDM / MAM system 601 via a communication network 207. The terminal device 101 and the control unit 7 are registered in the MDM / MAM system 601 and managed by the MDM / MAM system 601 in accordance with a management policy. In order to manage the terminal device 101 and the control unit 7 with the MDM / MAM system 601, for example, a management profile is installed in the terminal device 101 and the control unit 7. For example, information for installing the management profile (for example, a URL for downloading an installer) is notified to the terminal device 101 and the control unit 7 (for example, by email, etc.).

[0142] When the management profile is installed in the terminal device 101 and the control unit 7, the terminal device 101 and the control unit 7 are registered in the MDM / MAM system 601, and information about the terminal device 101 and the control unit 7 is registered in the database 604 of the MDM / MAM system 601.

[0143] The MDM / MAM execution unit 603 acquires information about the application 6 installed in the terminal device 101 and the control unit 7, and registers it in the application list of the database 604. The MDM / MAM execution unit 603 can distribute the application 6 to the terminal device 101 and the control unit 7. The terminal device 101 and the control unit 7 install the distributed application 6. This makes it possible to provide the application 6 without going through a predetermined application provider (such as the App Store).

[0144] The management function providing unit 602 provides the MDM / MAM management terminal 701 with management functions for the terminal device 101 and the control unit 7. For example, the management function providing unit 602 provides the MDM / MAM management terminal 701 with a website for managing the terminal device 101 and the control unit 7. Via the website, the operator of the MDM / MAM management terminal 701 can, for example, register and change management policies for the terminal device 101 and the control unit 7, distribute applications 6 to the terminal device 101 and the control unit 7, and manage the applications 6 installed on the terminal device 101 and the control unit 7.

[0145] 43 is a diagram showing an example of the data structure of the database 604 when the database 604 is a relational database. As shown in the figure, information managed by the database 604 includes, for example, user identification information, affiliated organization, device type, device identification information, policy, and application list.

[0146] The user identification information is information for identifying the user of the terminal device 101 and the control unit 7. For example, it is an ID assigned to the user by the MDM / MAM system 601, the user's name, a combination thereof, or the like.

[0147] The organization is identification information of the organization to which the terminal device 101 and the control unit 7 belong. For example, it is an ID assigned to the organization by the MDM / MAM system 601, the organization name, a combination thereof, or the like.

[0148] The device type is information for identifying the platform of the device, such as iOS, Android, Windows, or Mac.

[0149] The device identification information is identification information unique to the terminal device 101 and the control unit 7 that are to be managed by the MDM / MAM system 601. For example, it is an IMEI (International Mobile Equipment Identifier), a serial number, a SIM (Subscriber Identity Module) card number, a telephone number, a MAC (Media Access Control) address, a combination thereof, or the like.

[0150] The policy is a management policy by the MDM / MAM system 601. For example, it is setting information of the management policy.

[0151] The application list is information about the applications 6 installed in the terminal device 101 and control unit 7 corresponding to the user identification information. For example, it is a list that describes the identification information of the applications 6 (application name, application ID) and the application versions.

[0152] The present invention is not limited to the above-described embodiments, and various modifications are possible within the scope of the claims. Embodiments obtained by appropriately combining the technical means disclosed in different embodiments are also included in the technical scope of the present invention. [Explanation of symbols]

[0153] 1. Sample measurement system 2 Measurement Unit 3 Control software 4. 4A Data Management Software 5, 5A interface 6 Application Software 11. Sample measurement device 15 Data Management System 16 Communication control section 17 Control Unit 18 Data Storage 21 Sample processing section 22 Detection unit 61 Function provision department 62 Request part 63 Response Reception Department 101 Terminal equipment 170 Disease Prediction Software 171 Disease Evaluation Department 172 Situation Monitor Section C Commands R Prescribed rules

Claims

1. 1. A system for monitoring a patient suspected of having a disease based on a result of a test for understanding the patient's condition, comprising: a disease determination unit that analyzes a database in which measurement data acquired by a plurality of specimen measurement devices used in the test on the patient specimen is associated with information about the patient's location, and determines whether the patient is suspected of having the disease; a condition monitor unit that monitors the condition of the disease in an area determined based on the information about the location, system.

2. the disease determination unit determines whether the patient is suspected of having the disease based on the measurement data collected in the database located at a location different from the specimen measurement device. The system of claim 1.

3. the disease determination unit determines whether the patient is suspected of having the disease based on the measurement data collected in the database located at a location different from the medical facility where the specimen for the test was collected from the patient. The system of claim 1.

4. the disease determination unit determines whether the patient is suspected of having the disease based on the measurement data collected in the database via a communication network. The system of claim 1.

5. the condition monitoring unit identifies measurement data corresponding to the area based on information about the plurality of positions, and monitors the condition of the disease in the area. The system of claim 1.

6. the condition monitor unit is capable of changing the range of the area to be monitored for the condition of the disease. The system of claim 1.

7. the disease determination unit analyzes the measurement data indicating the results of the test for understanding the condition of the patient, and determines whether the patient is suspected of having the disease. The system of claim 1.

8. the disease determination unit analyzes information on a portion of the results indicated by the measurement data and determines whether the patient is suspected of having the disease. The system of claim 1.

9. the disease determination unit analyzes part of information correlated with the disease among the results indicated by the measurement data, and determines whether the patient is suspected of having the disease. The system of claim 1.

10. the disease determination unit analyzes data stored in at least one of the plurality of databases that collect the measurement data, and determines whether the patient is suspected of having the disease. The system of claim 1.

11. the disease determination unit determines whether the patient is suspected of having the disease by analyzing data stored in at least one of the plurality of databases that collect the measurement data; Each of the plurality of databases collects the measurement data acquired in a predetermined area corresponding to the respective database. The system of claim 1.

12. control software for controlling a measurement unit included in the sample measurement device; data management software that manages data related to the measurement unit that operates under the control of the control software; application software having the disease determination unit and the condition monitoring unit; an interface for allowing the application software that can be added to the system to use the data; The application software added to the system extends the functionality of the system. The system of claim 1 .

13. the interface allows the application software to use the data based on predetermined rules; The system of claim 12.

14. the interface allows the plurality of types of application software to use the data based on a predetermined rule that is common to the plurality of types of application software providing different functions; The system of claim 12.

15. the interface responds to a request from the application software by providing the application software with a response corresponding to the request; The system of claim 12.

16. the interface allows the application software to use the data based on a command created by the application software in accordance with a predetermined rule; The system of claim 12.

17. the interface causes the application software to use at least one of the data related to the measurement unit, the data related to the measurement operation by the measurement unit, the data related to the maintenance of the measurement unit, and the data related to the operation of the measurement unit, based on a command created by the application software in accordance with a predetermined rule; The system of claim 12.

18. the interface causes the application software to perform at least one of acquiring the data, registering the data, updating the data, and deleting the data, based on a command created by the application software in accordance with a predetermined rule; The system of claim 12.

19. the interface allows the plurality of types of application software to use the data based on a predetermined rule that is common to the plurality of types of application software that run on the plurality of types of operating systems; The system of claim 12.

20. the data management software manages the data based on classification according to the type of data. The system of claim 12.

21. The interface allows the application software to use the data based on predetermined rules; the data management software manages the data based on classifications corresponding to the predetermined rules. The system of claim 12.

22. the system includes an analyte measurement device including the measurement unit, the control software, and the data management software; The interface causes the application software to use the data based on a plurality of predetermined rules each corresponding to a type of the specimen measurement device. The system of claim 12.

23. the system includes an analyte measurement device including the measurement unit, the control software, and the data management software; The specimen measurement device is certified as a medical device. The system of claim 12.

24. the interface allows the application software, which is a non-medical device, to utilize the data; The system of claim 12.

25. the control software and the data management software are software independent of the application software; The system of claim 12.

26. the measurement unit includes a specimen processing section for preparing a measurement sample based on the specimen and a reagent, and a detection section for measuring the prepared measurement sample; the control software controls the operations of the sample processing unit and the detection unit in cooperation with the data management software; the data management software manages the data including the measurement results obtained by the operations of the sample processing unit and the detection unit. The system of claim 12.

27. the measurement unit includes a specimen processing section for preparing a measurement sample based on the specimen and a reagent, and a detection section for measuring the prepared measurement sample; the control software controls the operations of the sample processing unit and the detection unit in cooperation with the data management software; the data management software manages the data including the measurement results obtained by the operations of the sample processing unit and the detection unit; the control software and the data management software are software independent of the application software; The system of claim 12.

28. the measurement unit includes a specimen processing section for preparing a measurement sample based on the specimen and a reagent, and a detection section for measuring the prepared measurement sample; the control software controls the operations of the sample processing unit and the detection unit in cooperation with the data management software; the data management software manages the data including the measurement results obtained by the operations of the sample processing unit and the detection unit; the control software and the data management software are software independent of the application software; the data management software is capable of cooperating with the application software via the interface; The system of claim 12.

29. the system includes an analyte measurement device including the measurement unit, the control software, and the data management software; the measurement unit includes a specimen processing section for preparing a measurement sample based on the specimen and a reagent, and a detection section for measuring the prepared measurement sample; the control software controls the operations of the sample processing unit and the detection unit in cooperation with the data management software; the data management software manages the data including the measurement results obtained by the operations of the sample processing unit and the detection unit; the data management software is capable of cooperating with the application software via the interface; the measurement unit, the control software, and the data management software are components of a certified medical device; the control software and the data management software are software independent of the application software; The system of claim 12.

30. the system includes an analyte measurement device including the measurement unit, the control software, and the data management software; the measurement unit includes a specimen processing section for preparing a measurement sample based on the specimen and a reagent, and a detection section for measuring the prepared measurement sample; the control software controls the operations of the sample processing unit and the detection unit in cooperation with the data management software; the data management software manages the data including the measurement results obtained by the operations of the sample processing unit and the detection unit; the data management software is capable of cooperating with the application software via the interface; The measurement unit, the control software, and at least a portion of the data management software provide functions corresponding to the intended use of the specimen measurement device certified as a medical device, The functionality of the system is extended by the application software capable of providing functions different from those corresponding to the intended use. The system of claim 12.

31. The control software controls the operation of the sample processing unit and the detection unit by: Controlling the aspirating operation of the liquid containing at least one of the sample and the reagent; Control of preparing a measurement sample by mixing the specimen and the reagent; Controlling detection of the measurement sample by a detection unit; and a control for detecting at least one of optical information and electrical signals related to the measurement sample by the detection unit, and analyzing the measurement results based on the detected detection results; at least one of A system according to any one of claims 26 to 30.

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