Analysis system and analysis method

Abstract

An analysis system (100) comprises: a terminal (1) that transmits, to an analysis device (2), an analysis request (51) including information on a specimen and information on an analyte; the analysis device (2) that measures an analysis value from the specimen; and a determination device (3) that determines the degree of deviation of the analysis value from a normal value. The determination device (3) transmits, to the analysis device (2), a determination result (53) including a determination alarm, which is outputted when the analysis value is determined to be deviating from the normal value as a result of the determination for the analysis value, which is included in a determination request (52) received from the analysis device (2). The analysis device (2) outputs the determination alarm in the determination result (53) received from the determination device (3) and an analysis alarm indicating an abnormality that has occurred in the process of the analysis device (2) measuring the analysis value from the specimen.

Description

Analysis system and analysis method

[0001] The present invention relates to an analysis system and an analysis method.

[0002] A clinical laboratory technician measures samples collected from patients using an automatic analyzer and performs an analytical process to determine whether the measurement data deviates from a regression line. Patent Document 1 describes a data analysis system in which an automatic analysis system in a laboratory acquires device information, reagent information, and reaction process data, and a comprehensive analysis server performs a comprehensive analysis based on the data transmitted from the automatic analysis system.

[0003] International Publication No. 2023 / 153032

[0004] When multiple devices work together to form a data analysis system, as in Patent Document 1, reducing the burden on clinical laboratory technicians who operate each device becomes an important issue for clinical laboratory technicians who are busy with testing work.

[0005] FIG. 11 is a schematic diagram of a conventional analysis system 100z. The analysis system 100z includes a terminal 1z, an analysis device 2z, and a determination device 3z. The terminal 1z transmits an analysis request 51z, including personal information about the patient, to the analysis device 2z. In response to the analysis request 51z, the analysis device 2z generates measurement data indicating the analytical reaction process from a sample collected from the patient. The analysis device 2z transmits a determination request 52z to the determination device 3z, requesting a deviation determination (determination of the degree of deviation from the normal range) for the analyzed measurement data. In response to the determination request 52z, the determination device 3z determines the degree of deviation of the measurement data from the normal range using an approximation formula.

[0006] Here, the clinical laboratory technician 9z performs the following tasks using the analysis system 100z: - Operates the terminal 1z to input an analysis request 51z for a new patient. - Visually checks the reaction process of the analysis device 2z and monitors whether the analysis has stopped. - Checks the measurement data of the analysis device 2z and determines whether reanalysis is necessary due to abnormal values. - Checks the degree of deviation of the measurement data on the display screen of the determination device 3z (reference symbol 53z) and determines whether reanalysis is necessary using the analysis device 2z. However, because there are a large number of specimens to be analyzed, the clinical laboratory technician 9z is burdened with performing each of the above tasks across multiple devices. As a result, there is a risk that the timing for determining whether reanalysis is necessary will be delayed.

[0007] An object of the present invention is to reduce the burden when performing inspection work across multiple devices.

[0008] In order to solve the above problems, the analytical system of the present invention has the following features: The present invention is an analytical system having an analytical device that measures an analytical value from a sample and a determination device that determines the degree of deviation between the analytical value and a normal value, wherein the determination device transmits to the analytical device a determination result including a determination alarm when the analytical value deviates from the normal value as a result of determining the analytical value included in a determination request received from the analytical device, and the analytical device outputs the determination alarm of the determination result received from the determination device and an analysis alarm that indicates an abnormality that occurred during the analytical device's measurement of the analytical value from the sample. Other features will be described below.

[0009] According to the present invention, it is possible to reduce the burden when performing inspection work across a plurality of devices.

[0010] 7 is a schematic diagram of an analysis system. A hardware configuration diagram of each device in the analysis system. A configuration diagram of the analysis system. A flowchart showing main processing of the analysis system. A table showing an example of an analysis DB. A screen diagram showing an example of a display screen of an analysis display unit. An explanatory diagram showing processing for determining the display priority of an alarm column in the display screen of Figure 6. A screen diagram showing a first example of an input screen for a deviation range accepted by a judgment setting unit. A screen diagram showing a second example of an input screen for a deviation range accepted by a judgment setting unit. A flowchart showing details of judgment execution processing. A schematic diagram of a conventional analysis system.

[0011] Hereinafter, one embodiment of the present invention will be described with reference to the drawings.

[0012] FIG. 1 is a schematic diagram of an analysis system 100. The analysis system 100 includes a terminal 1 that transmits an analysis request 51, including information on the sample and the items to be analyzed, to an analysis device 2; the analysis device 2 that measures an analytical value from the sample; and a determination device 3 that determines the degree of deviation between the analytical value and a normal value. The terminal 1 transmits the analysis request 51, including personal information about the patient, to the analysis device 2. In response to the analysis request 51, the analysis device 2 generates measurement data indicating the analytical reaction process from the sample collected from the patient. The analysis device 2 transmits a determination request 52 to the determination device 3, requesting a deviation determination (determination of the degree of deviation from the normal range) for the analyzed measurement data. In response to the determination request 52, the determination device 3 determines the degree of deviation of the measurement data from the normal range using an approximation formula.

[0013] The main difference between Figure 11 and Figure 1 is that the analysis system 100 in Figure 1 has added notification messages of the determination result 53 and the analysis result 54. The determination device 3 determines the analysis value included in the determination request 52 received from the analysis device 2, and transmits the determination result 53, including a determination alarm if the analysis value deviates from the normal value, to the analysis device 2. The analysis device 2 outputs a determination alarm for the determination result 53 received from the determination device 3, and an analysis alarm indicating an abnormality that occurred in the process of the analysis device 2 measuring the analysis value from the sample. The determination alarm is an alarm that notifies that the numerical value of the reaction process data has deviated from the normal range. The analysis alarm is an alarm that notifies that an abnormality has occurred in the numerical value of the reaction process data during the analysis stage.

[0014] The determination result 53 is a message transmitted from the determination device 3 to the analysis device 2, and stores various data that was originally displayed on the display screen of the determination device 3 as a result of the determination process of the determination device 3 in response to the determination request 52. By referring to the determination result 53 displayed by the analysis device 2, the clinical laboratory technician 9 can reduce the effort of directly operating the determination device 3 or directly viewing the display screen of the determination device 3.

[0015] The terminal 1 outputs the determination alarm and analysis alarm received as the analysis result 54 from the determination device 3. The analysis result 54 is a message sent from the analyzer 2 to the terminal 1, and stores the results of the analysis processing by the analyzer 2 in response to the analysis request 51 and the determination result 53. By referring to the analysis result 54 displayed on the terminal 1, the clinical laboratory technician 9 can reduce the effort of directly operating the analyzer 2 and the determination device 3 or directly viewing the display screens of the analyzer 2 and the determination device 3. In other words, the clinical laboratory technician 9 does not need to move close to the determination device 3, and can immediately identify samples that require reanalysis. The output form from each device (terminal 1, analyzer 2, determination device 3) described above may be a display screen, or may be printed or output to a file.

[0016] FIG. 2 is a hardware configuration diagram of each device in the analysis system 100. Each device (terminal 1, analysis device 2, and determination device 3) in the analysis system 100 is configured as a computer 900 having a CPU 901, RAM 902, ROM 903, HDD 904, communication I / F 905, input / output I / F 906, and media I / F 907. The communication I / F 905 is connected to an external communication device 915. The input / output I / F 906 is connected to an input / output device 916. The media I / F 907 reads and writes data from a recording medium 917. Furthermore, the CPU 901 controls each processing unit by executing a program (also called an application or an app for short) loaded into the RAM 902. This program can also be distributed via a communication line or recorded on a recording medium 917 such as a CD-ROM.

[0017] FIG. 3 is a configuration diagram of analysis system 100. Analysis system 100 is configured such that terminal 1 and analysis device 2 are connected via a network, and analysis device 2 and determination device 3 are also connected via a network. Terminal 1 has a terminal input unit 11, a memory unit 12, a terminal transmission unit 13, a terminal reception unit 14, and a terminal display unit 15. Analysis device 2 has a first analysis transmission unit 21, an analysis unit 22, an analysis reception unit 23, an analysis DB 24, a second analysis transmission unit 25, and an analysis display unit 26. Analysis device 2 has a determination device 3, a determination reception unit 31, a determination transmission unit 32, a determination unit 33, and a determination setting unit 34. Details of each component of analysis system 100 will be explained below with reference to the flowchart in FIG. 4.

[0018] 4 is a flowchart showing the main processing of the analysis system 100. The terminal input unit 11 accepts input of information such as information about the sample collected from the patient and the analysis items to be analyzed by the analysis device 2 for the sample, and stores the input information in the memory unit 12 (S11). The terminal transmission unit 13 transmits an analysis request 51 including the input information of S11 to the analysis receiving unit 23 of the analysis device 2 (S12). The analysis unit 22 analyzes predetermined items related to the sample based on the reaction between the sample and the reagent in accordance with the analysis request 51 (S13), and creates a judgment request 52 for the measurement data, which is reaction process data resulting from the analysis. The first analysis transmission unit 21 transmits the judgment request 52 of S13 to the judgment receiving unit 31 of the judgment device 3 (S14).

[0019] The judgment unit 33 executes judgment of the judgment request 52 based on the setting data previously set by the judgment setting unit 34 (details in FIGS. 8 and 9) (S15, details in FIG. 10). The judgment sending unit 32 returns the judgment result 53 of S15 to the analysis receiving unit 23 (S16). The judgment result 53 includes a judgment alarm. The analysis receiving unit 23 associates the analysis result of the analysis unit 22 (S13) with the judgment result 53 of the judgment device 3 (S16) and stores them in the analysis DB 24. The analysis result of the analysis unit 22 (S13) includes an analysis alarm. The analysis display unit 26 displays the result data stored in the analysis DB 24 by the analysis receiving unit 23 from the analysis device 2 (S17, details in FIG. 6). The display content of S17 includes the analysis alarm and the judgment alarm.

[0020] The second analysis transmission unit 25 generates an analysis result 54 including the analysis result of the analysis unit 22 (S13) and the judgment result of the judgment device 3 (S16), and returns the analysis result 54 to the terminal receiving unit 14 of the terminal 1 (S18). The terminal display unit 15 displays the analysis result 54 received in S18 on the terminal 1 (S19). The display content of S19 also includes an analysis alarm and a judgment alarm. The clinical laboratory technician 9 determines whether retesting is necessary (S20) by referring to the display from the analysis device 2 (S17) or the display from the terminal 1 (S19). If the terminal 1 receives input from the clinical laboratory technician 9 indicating that retesting (such as recollection of the sample or reanalysis of the sample) is necessary (Yes in S20), the process returns to S11.

[0021] FIG. 5 is a table showing an example of the analysis DB 24. For each data number (No.) of a record indicating a determination request 52 and a determination result 53, the analysis DB 24 associates the specimen name, such as the patient name, the test item name, the analysis value for each item name output by the analysis unit 22, an alarm for the analysis value, the determination date and time when the determination device 3 determined the analysis value, and the determination result. The alarms in the analysis DB 24 are alarms (analysis alarms, determination alarms) that notify of abnormalities in the analysis values. For example, patient A submitted three analysis requests 51: a blood test, a urine test, and a stool test. The determination results 53, which were registered in the analysis DB 24, indicated that the urine test analysis value = 40 resulted in an analysis alarm (insufficient sample) and the stool test analysis value = 20 resulted in a determination alarm (major deviation).

[0022] FIG. 6 is a screen diagram showing an example of the display screen 26P of the analysis display unit 26. The display screen 26P is in table format, similar to the analysis DB 24 in FIG. 5. In addition to the items in the analysis DB 24, the display screen 26P also associates the ID of the rack where the sample to be analyzed by the analyzer 2 is brought in and the date and time the sample was brought into the rack (sample introduction date and time) with each record data number (No.). Therefore, the analysis request 51 includes the rack ID and the sample introduction date and time. For ease of explanation, the alarm field in FIGS. 5 and 6 has been described as storing a string such as "Sample Insufficiency." However, to reduce the data volume in the alarm field, a different alarm ID (alarm number) may be stored for each alarm content.

[0023] By referring to the alarm field on the display screen 26P, the clinical laboratory technician 9 can confirm the analysis abnormality of the analyzer 2 from the analysis alarm and the judgment abnormality of the judgment device 3 from the judgment alarm. In other words, the clinical laboratory technician 9 can reduce the effort of having to go close to the judgment device 3 to check the display information (judgment alarm) of the judgment device 3. This improves the daily work efficiency of the clinical laboratory technician and enables the prompt communication of information to patients. Note that the alarm field may contain not only a character string indicating the abnormality content, but also information that distinguishes whether the abnormality content is an analysis alarm or a judgment alarm (for example, by using different display colors for the text). In other words, the analyzer 2 outputs judgment alarms and analysis alarms in a manner that allows them to be distinguished.

[0024] Furthermore, an analysis alarm and a judgment alarm may occur simultaneously for a single item. In such cases, both the analysis alarm and the judgment alarm may be displayed in the alarm column, but doing so would result in too much information being inserted into the narrow alarm column, making it difficult to view. Therefore, FIG. 7 illustrates a method for selecting an alarm to be displayed with the highest priority in the alarm column for a single item value. In this case, multiple levels are set for the judgment alarm and the analysis alarm. The analysis device 2 then references priority setting data that specifies the output priority for combinations of multiple levels of judgment alarms and multiple levels of analysis alarms. For an item in which a judgment alarm and an analysis alarm simultaneously occurred, the analysis device 2 determines which alarm and which level have the highest priority, and outputs only the identified alarm to the alarm column for the item.

[0025] FIG. 7 is an explanatory diagram showing the process for determining the display priority of the alarm column on the display screen of FIG. 6 . Table 201 associates the deviation range output by the determination device 3 with the range ID corresponding to that deviation range. The larger the range ID, the greater the degree of abnormality of the analysis value, and a determination alarm is issued. Table 202 associates the output level of the analysis value output by the analyzer 2, information on whether output is possible according to that output level, and the analysis result according to that output level. The larger the output level, the higher the reliability of the analysis value. Furthermore, the analysis result "insufficient sample" with output level = 1 indicates that there is an insufficient sample of the specimen, and although the analysis value was measured, its reliability is low, and output to a display screen, etc. is not permitted (indicating that it is not recommended for use as diagnostic material).

[0026] Table 203 associates the display priority (the smaller the number, the higher the priority) when a determination alarm in table 201 and an analysis alarm in table 202 are combined, with the range ID in table 201 and the output level in table 202. The first display priority is the analysis alarm (output level = 1, sample shortage). Sample shortage indicates that a reliable analysis value could not be measured due to an insufficient amount of sample, such as a small amount of urine in a urinalysis. The second display priority is the determination alarm (range ID = 2, major deviation range). The third display priority is the analysis alarm (output level = 2, technical limit (abnormal output value)). The technical limit indicates that an analysis value that theoretically should not be measured from a human sample has been detected due to a malfunction of the analyzer 2, etc. The fourth display priority is the determination alarm (range ID = 1, minor deviation range).

[0027] For example, suppose that a judgment alarm (critical deviation range with range ID = 2) and an analysis alarm (technical limit (abnormal output value) with output level = 2) occur simultaneously for a certain item value A. The analysis display unit 26 displays only the second-ranked judgment alarm (critical deviation range with range ID = 2) in the alarm column for item value A in accordance with the display priority listed in table 203. On the other hand, suppose that a judgment alarm (critical deviation range with range ID = 2) and an analysis alarm (insufficient sample with output level = 1) occur simultaneously for another item value B. The analysis display unit 26 displays only the first-ranked analysis alarm (insufficient sample with output level = 1) in the alarm column for item value B in accordance with the display priority listed in table 203.

[0028] This allows the clinical laboratory technician 9 to accurately determine whether or not a retest is necessary by checking the alarm column for one important alarm that will affect the decision on whether or not a retest is necessary. Furthermore, since only one important alarm is selected and displayed in the alarm column, the analysis display unit 26 can display a display screen 26P with excellent overview, displaying many item values ​​on a single screen. Furthermore, since the judgment alarm of the judgment device 3 and the analysis alarm of the analyzer 2 are displayed together on a single screen, the clinical laboratory technician 9 can avoid the trouble of checking the display screens of multiple devices.

[0029] 8 is a screen diagram showing a first example of an input screen for the deviation range accepted by the judgment setting unit 34. For the item "test-A," the clinical laboratory technician 9 inputs a combination of a positive deviation range (+50 to +150) and a negative deviation range (-150 to -50) via the judgment setting unit 34. For example, assume that the normal value for the item "test-A" is 100. If the analysis value for the item "test-A" of a certain patient is 110, the difference value (110-100=+10) is outside the deviation range (+50 to +150), and therefore the judgment unit 33 judges it to be within the normal range (not deviating from the normal value). - If the analysis value for the item "test-A" of another patient is 40, the difference value (40-100=-60) is within the deviation range (-150 to -50), so the judgment unit 33 judges that it is within the deviation range (deviation from the normal value).

[0030] FIG. 9 is a screen diagram showing a second example of an input screen for deviation ranges accepted by the judgment setting unit 34. In FIG. 9, the deviation ranges in FIG. 8 are divided into a minor deviation range, which indicates a small deviation from the normal value, and a major deviation range, which indicates a large deviation from the normal value. For the item "test-A," the clinical laboratory technician 9 is prompted to input a combination of a positive deviation range (+50 to +100) and a negative deviation range (-100 to -50) as the minor deviation range via the judgment setting unit 34. Furthermore, for the item "test-A," the clinical laboratory technician 9 is prompted to input a combination of a positive deviation range (+101 to +150) and a negative deviation range (-150 to -101) as the major deviation range via the judgment setting unit 34.

[0031] For example, suppose the normal value for item "test-A" is 100. If the analysis value for item "test-A" of a certain patient is 160, the judgment unit 33 judges that the difference value (160-100=+60) is within the slight deviation range (+50 to +150). If the analysis value for item "test-A" of another patient is 220, the judgment unit 33 judges that the difference value (220-100=+120) is within the serious deviation range (+101 to +150). In this way, the judgment device 3 accepts input of both the first range (serious deviation range) and the second range (slight deviation range), and the judgment alarm includes information indicating whether the result falls within the first range or the second range. By dividing the deviation range into a minor deviation range and a major deviation range, the clinical laboratory technician 9 can be assisted in making decisions such as "retest only the item values ​​in the major deviation range."

[0032] 10 is a flowchart showing the details of the judgment execution process (S15). The judgment unit 33 judges whether the analysis value of the analyzer 2 included in the judgment request 52 is within the serious deviation range (S151). If the answer is Yes in S151, the judgment unit 33 judges that the analysis value is within the serious deviation range (S153). If the answer is No in S151, the judgment unit 33 judges whether the analysis value is within the minor deviation range (S152). If the answer is Yes in S152, the judgment unit 33 judges that the analysis value is within the minor deviation range (S154). If the answer is No in S152, the judgment unit 33 judges that the analysis value is within the normal range (S155).

[0033] In the analysis system 100 described above, information from the determination device 3 (determination alarm) is notified to the analyzer 2 via the determination result 53, and is displayed on the display screen of the analyzer 2. Furthermore, information from the determination device 3 (determination alarm) and information from the analyzer 2 (analysis alarm) are notified to the terminal 1 via the analysis result 54, and are displayed on the display screen of the terminal 1. This provides the following advantages: The clinical laboratory technician 9 is saved the trouble of separately monitoring the display screens of the terminal 1, the analyzer 2, and the determination device 3. The clinical laboratory technician 9 can check the most serious alarm for each item based on the display priority of the alarm column shown in FIG. 7. The clinical laboratory technician 9 can distinguish whether the abnormality is an analysis alarm or a determination alarm from the alarms displayed in the alarm column.

[0034] Furthermore, the present invention is not limited to the above-described embodiments, and various other applications and modifications are possible without departing from the spirit of the present invention as defined in the claims. For example, the above-described embodiments have described the configuration of the analysis system 100 in detail and specifically in order to clearly explain the present invention, and the present invention is not necessarily limited to systems that include all of the components described. Furthermore, it is possible to replace part of the configuration of one embodiment with a component of another embodiment. It is also possible to add a component of another embodiment to the configuration of one embodiment. It is also possible to add, replace, or delete other components from part of the configuration of each embodiment.

[0035] Furthermore, some or all of the above-described configurations, functions, processing units, etc. may be implemented in hardware, for example, by designing them as integrated circuits. Broad processor devices such as FPGAs (Field Programmable Gate Arrays) and ASICs (Application Specific Integrated Circuits) may also be used as hardware. Furthermore, each component of the analysis system 100 according to the above-described embodiment may be implemented in any hardware as long as the respective hardware can transmit and receive information to and from each other via a network. Furthermore, the processing performed by a certain processing unit may be implemented by a single piece of hardware, or may be implemented by distributed processing using multiple pieces of hardware.

[0036] 1 Terminal 2 Analysis device 3 Determination device 9 Clinical laboratory technician 51 Analysis request 52 Determination request 53 Determination result 54 Analysis result 100 Analysis system

Claims

1. An analytical system having an analytical device that measures an analytical value from a specimen, and a determination device that determines the degree of deviation between the analytical value and a normal value, wherein the determination device determines the analytical value included in a determination request received from the analytical device, and transmits a determination result to the analytical device including a determination alarm if the analytical value deviates from the normal value, and the analytical device outputs the determination alarm of the determination result received from the determination device and an analysis alarm that indicates an abnormality that occurred in the process of the analytical device measuring the analytical value from the specimen.

2. The analysis system according to claim 1, further comprising a terminal that transmits an analysis request to the analysis device, including information on the sample and the items to be analyzed, and the terminal outputs the judgment alarm and analysis alarm received from the judgment device as the analysis results.

3. The analytical system according to claim 1, wherein the analytical device outputs the judgment alarm and the analysis alarm in a manner that allows them to be distinguished from each other.

4. The analysis system according to claim 1, wherein the judgment alarm and the analysis alarm are each set to a plurality of stages, and the analysis device refers to priority setting data that specifies the output priority for combinations of the plurality of stages of the judgment alarm and the plurality of stages of the analysis alarm, identifies which alarm and which stage has the highest priority for an item in which the judgment alarm and the analysis alarm have occurred simultaneously, and outputs only the identified alarm to the alarm column of the item.

5. The analytical system according to claim 4, wherein the analytical device references, as the priority setting data, data indicating that the analysis alarm indicates a shortage of specimen samples as a first priority, that the judgment alarm indicates that the difference between the analysis value and the normal value falls within a first range as a second priority, that the analysis alarm indicates that the analysis value of the specimen is an abnormal value as a third priority, and that the judgment alarm indicates that the difference between the analysis value and the normal value falls within a second range that is smaller than the first range as a fourth priority.

6. The analytical system described in claim 5, wherein the determination device accepts input of the first range and the second range, and the determination alarm includes information indicating whether the result falls within the first range or the second range.

7. An analytical method performed by an analytical system having an analytical device that measures an analytical value from a specimen and a judgment device that judges the degree of deviation between the analytical value and a normal value, wherein the judgment device judges the analytical value included in the judgment request received from the analytical device and transmits a judgment result to the analytical device including a judgment alarm if the analytical value deviates from the normal value, and the analytical device outputs the judgment alarm of the judgment result received from the judgment device and an analysis alarm that indicates an abnormality that occurred in the process of the analytical device measuring the analytical value from the specimen.

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