JPWO2017115775A1 - Analysis device, analysis method, and analysis system - Google Patents

Abstract

In a urine test, the number of samples to be retested is reduced.
When the analysis result of at least one kind of formed component is out of the reference range, if there is a request from the user, the analyzer displays an image of the sample. The user of the analysis apparatus looks at the image and determines whether or not the sample needs to be retested. When the user confirms that the reexamination of the sample is unnecessary by confirming the image, the user inputs information indicating that to the analyzer. When the information is input, the analyzer outputs an analysis result based on the sample image as an analysis result of the formed component.
[Selection] Figure 1

Description

  The present disclosure relates to an analysis apparatus, an analysis method, and an analysis system, and more particularly, to an analysis apparatus, an analysis method, and an analysis system for analyzing a formed component of a urine sample.

  Conventionally, an apparatus for analyzing a component of a specimen in a urine test has been proposed. For example, Japanese Patent Laid-Open No. 2006-98219 (Patent Document 1) mutually checks a measurement result obtained with a urine qualitative analyzer and a measurement result obtained with a urine sediment analyzer using a flow cytometry method. And the measurement result check apparatus which evaluates the reliability of these measurement results is disclosed.

JP 2006-98219 A

  When a device such as that disclosed in Patent Document 1 is used in a urine test, if the test result cannot be determined based on the value acquired by the device, the sample is subjected to retesting. As re-inspection, manual inspection is often performed. In manual inspection, an inspector manually prepares a specimen from a specimen and observes the specimen with a microscope.

  For this reason, in the urinalysis using a conventional analyzer, it has been required to reduce the number of samples to be retested as much as possible.

  The present disclosure has been devised in view of such circumstances, and an object thereof is to reduce the number of samples to be retested in a urine test using an analyzer.

  According to an aspect of the present disclosure, an analyzer for analyzing a tangible component of a urine sample is provided. The analyzer includes an image acquisition unit for acquiring an image of the specimen, an information processing unit configured to identify each of one or more types of formed components in the image acquired by the image acquisition unit, A storage means for storing a reference range is provided for each of the formed components of the type or more. The information processing unit outputs the specified result as the analysis result of the sample when the result specified by the information processing unit is within the reference range for all of the one or more formed components, and outputs one or more types When at least one type of the formed portion is out of the reference range, information for prompting confirmation of the sample image is output when the result specified by the information processing means is out of the reference range.

  Preferably, the storage unit stores a condition for outputting the result specified by the information processing unit as the analysis result of the sample. If the sample satisfies the condition, the information processing means may process the information even if the result specified by the information processing means is out of the reference range for at least one of the one or more formed components. The result specified by the means is output as the analysis result of the specimen.

  Preferably, the information processing unit accepts input of information indicating that the sample reexamination is necessary or unnecessary as a result of the sample image confirmation, and the sample reexamination is not required as the result of the sample image confirmation. When the information indicating that the sample is input is input, at least a part of the image of the specimen is stored in the storage unit in association with the type of the formed component whose result is out of the reference range. The condition includes that the feature of the specimen image matches the feature of the previous specimen image stored in the storage means.

  Preferably, the analyzer further includes an input unit configured to accept an input of a measurement result of another device for the sample. The information processing means relates to the first type of formed component in the measurement result of another device when the result specified by the information processing unit is outside the reference range for the first type of formed component. Based on the result of the item to be determined, it is configured to determine whether or not to output information for prompting confirmation of the sample image.

  Preferably, the input means receives an input of a result of qualitative analysis. The information processing means, when the result of the item related to the first type of tangible component in the result of the qualitative analysis conflicts with the result specified by the information processing means, information for prompting confirmation of the sample image If the result of the item related to the first type of tangible component in the result of the qualitative analysis matches the result specified by the information processing means, the specified result is analyzed for the sample. It is configured to output as a result.

  Preferably, the input means receives an input of a flow cytometry result. The information processing means outputs information that prompts confirmation of the image of the specimen when the measurement result of the first type of formed component in the flow cytometry conflicts with the result specified by the information processing means, When the measurement result of the first type of formed component in flow cytometry matches the result specified by the information processing means, the specified result is output as the analysis result of the sample. ing.

  Preferably, the condition includes an attribute of the subject corresponding to the specimen.

  According to another aspect of the present disclosure, an analysis method for analyzing a tangible component of a urine sample is provided. The analysis method includes a step of acquiring an image of a specimen, a step of identifying each of one or more formed components in the sample using the acquired image, and all types of one or more formed components A step of outputting the specified result as the analysis result of the sample when the result specified in the image of the image is within a predetermined reference range for each type, and at least one of the one or more types of formed components Outputting information for prompting confirmation of the sample image when the result specified in the image for one type is outside the reference range.

  According to yet another aspect of the present disclosure, an analysis system for analyzing a urine sample is provided. The analysis system includes a first analyzer that outputs an analysis result of the sample using an image of the sample, and a second analyzer that outputs a measurement result of the sample. The first analyzer includes an image acquisition unit for acquiring an image of a specimen, and an information processing unit configured to identify each of one or more types of formed components in the image acquired by the image acquisition unit And a storage means for storing a reference range for each of the one or more formed components, and an input means for receiving an input of a measurement result of the sample by the second analyzer. The information processing means relates to the first type of formed component in the measurement result of another device when the result specified by the information processing unit is outside the reference range for the first type of formed component. Based on the result of the item to be determined, it is configured to determine whether or not to output information for prompting confirmation of the sample image.

  According to an aspect of the present disclosure, in the analysis of the formed component of the sample using the analyzer, if the analysis result of at least one type of formed component falls outside the reference range set for the formed component, Confirmation of the image is prompted. As a result, the user of the analyzer may determine that the reexamination of the sample is unnecessary by checking the image of the sample. Therefore, it is possible to reduce the number of samples to be retested.

  According to another aspect of the present disclosure, even when the analysis results of the samples analyzed by the plurality of types of analyzers conflict, the user of the analyzer can visually recognize the image of the sample. There may be cases where it can be determined that no re-examination is necessary. Therefore, it is possible to reduce the number of samples to be retested.

It is a figure for demonstrating the outline | summary of the formation analysis using the analyzer of 1st Embodiment. It is a figure for demonstrating the outline | summary of the formation analysis using the comparative example of the analyzer of 1st Embodiment. It is a figure which shows the whole structure of the analysis system of 1st Embodiment. It is a figure for demonstrating the hardware constitutions of the analysis system of 1st Embodiment. 4 is a flowchart of processing executed for analyzing a formed component of a sample in the analyzer according to the first embodiment. It is a figure which shows an example of the screen displayed in the confirmation of the image by an analyzer. It is a figure which shows an example of the screen which displays the image of a sample. It is an example of a screen displayed when a user inputs a determination result indicating that reexamination of a specimen is unnecessary by confirming an image. It is a flowchart of the process for an analyzer to register the characteristic of a sample, after the result of the visual recognition of the image by a user is input. It is a flowchart of the process performed in the analyzer of 2nd Embodiment for the analysis of the formed part of a sample. It is a figure for demonstrating the outline | summary of the analysis of the sample in the analysis system of 3rd Embodiment. It is a figure which shows the whole structure of the analysis system of 3rd Embodiment. It is a figure for demonstrating the hardware constitutions of the analysis system of 3rd Embodiment. It is a flowchart of the process performed in the analyzer of 3rd Embodiment for the analysis of the formed part of a sample. It is a figure for demonstrating the content of a cross check. It is a figure for demonstrating the outline | summary of the analysis of the sample in the analysis system of 4th Embodiment. It is a figure which shows the whole structure of the analysis system of 4th Embodiment. It is a figure for demonstrating the hardware constitutions of the analysis system of 4th Embodiment. It is a flowchart of the process performed in the analyzer of 4th Embodiment for the analysis of the formed part of a sample. It is a figure for demonstrating the outline | summary of the analysis of the sample in the analysis system of 5th Embodiment. It is a figure which shows the whole structure of the analysis system of 5th Embodiment. It is a figure for demonstrating the hardware constitutions of the analysis system of 5th Embodiment. It is a flowchart of the process performed in the analyzer of 6th Embodiment for the analysis of the formed part of a sample.

  Embodiments of an analysis apparatus and an analysis system will be described below with reference to the drawings. In the following description, the same parts and components are denoted by the same reference numerals. Their names and functions are also the same. Therefore, these descriptions will not be repeated.

  [First Embodiment]

  <1. Overview>

  FIG. 1 is a diagram for explaining an outline of the formation analysis using the analysis apparatus according to the first embodiment. In FIG. 1, the automatic inspection process by the analyzer is shown in a frame AT. The process of manual inspection with a microscope by an inspector is shown in a frame MT.

  More specifically, in the automatic inspection process by the analyzer, the analyzer captures an image of the sample and performs a formation analysis based on the image. The formed component is, for example, at least one component in red blood cells, white blood cells, epithelial cells, and a cylinder. For example, the analyzer captures an image of the specimen at a magnification of about 20 times, identifies each formed component in the image, and counts the number of formed components included in one field of view of the image. The number of each formed component per visual field is an example of the result of the formed component analysis of the specimen.

  Next, the analyzer checks the analysis result of the formed component. In the analyzer, a reference range is set in advance for the analysis results of each formed component. In the analysis result check, the analyzer determines, for example, whether or not the analysis result of at least one kind of formed component is within a warning range. The analysis result of the formed component is a result of specifying the formed component in the specimen, and is, for example, “number per visual field” or “concentration” of at least one type of formed component. An example of “being within the warning range” is “being outside the reference range”.

  If the analysis results of all the formed components are within the reference range, the analyzer determines the results of the formed component analysis. In other words, the analyzer displays the analysis result of the formed component based on the sample image as the sample analysis result.

If the analysis result of at least one kind of formed component is outside the reference range, the analyzer displays information that prompts confirmation of the sample image. Thereafter, the analyzer displays an image of the sample. The analyzer may display a sample image together with a display for prompting confirmation of the image, or may display a sample image in response to a request from a user of the analyzer. The user looks at the image and determines whether or not the specimen needs to be reexamined (“image determination” in FIG. 1).
When judging by the number per field of view, for example, when the number of cylinders detected in one field of view of the sample exceeds the reference range, the user confirms the image of the sample taken by the analyzer. To do. When judging based on the concentration, for example, when the cylinder concentration in the sample exceeds the reference range, the user checks the image of the sample taken by the analyzer.

  When the user determines that reexamination of the sample is unnecessary by confirming the image, the user inputs information indicating that to the analyzer (or a computer that handles the analysis result displayed by the analyzer) ( “Determination” in FIG. For example, when the user confirms that the image is determined to be a cylinder by the analyzer in the image, it is not an original cylinder (a protein condensed), but a contaminant such as dust. Judge that re-examination is unnecessary.

  On the other hand, when the user determines that the sample needs to be re-examined by checking the image, information indicating that is input to the analyzer (or a computer that handles the analysis results displayed by the analyzer). ("Determination not possible" in FIG. 1). For example, if the user cannot identify what the analyzer has determined to be a cylinder, or the original cylinder (the protein has condensed), or what the analyzer has determined to be a cylinder, It is determined that manual analysis of the sample is necessary.

  When information indicating that the reexamination of the sample is not necessary is input (“determination” in FIG. 1), the analysis apparatus displays the analysis result based on the sample image as the analysis result for the formed component.

  When information indicating that the sample needs to be retested is input, the analyzer displays that the information has been input (“determination impossible” in FIG. 1). As a result, the specimen is subjected to retesting. An example of re-examination is manual inspection. In the manual examination, as shown in the frame MT, a specimen sample is prepared and the specimen is observed with a microscope. The person who performs the manual examination may be the same as or different from the person who determined that manual analysis of the sample is necessary. In addition, manual testing is not essential for samples that are determined to require retesting. There may be a case where a result indicating that “re-examination is necessary” is simply displayed without performing the manual inspection.

  FIG. 2 is a diagram for explaining the outline of the formation analysis using the comparative example of the analyzer according to the first embodiment. In the apparatus of FIG. 2, even when it is determined that the analysis result of the formed component is out of the reference range, the analysis apparatus does not display information that prompts confirmation of the image. In the system shown in FIG. 2, a sample that has been determined that the measurement result of at least one kind of component is outside the reference range as a result of the component analysis is reexamined without confirming the image. (Typically manual inspection).

  <2. Configuration of analysis system>

  FIG. 3 is a diagram illustrating an overall configuration of the analysis system according to the first embodiment.

  As shown in FIG. 3, the analysis system 1 includes an analysis device 20 and an information processing device 40. The analysis device 20 and the information processing device 40 can communicate with each other. The analysis device 20 displays the analysis result for the formed component on the information processing device 40. The information processing device 40 displays the analysis result displayed from the analysis device 20. The analysis device 20 and the information processing device 40 may be integrated.

  The analyzer 20 includes a main body 20A and a transport unit 20B. The main body 20A houses a control unit 210, a sample preparation unit 222, and the like which will be described later.

  The transport unit 20B transports a container (for example, Spitz) that stores a specimen. More specifically, in the analysis system 1, each specimen is accommodated in the container 4. The rack 7 accommodates one or more containers 4. The conveyance unit 20 </ b> B includes a groove 250. In the transport unit 20 </ b> B, one or more containers 4 are transported while being accommodated in the rack 7.

  A bar code reader 224 may be provided in the main body 20A. Each container 4 may have a barcode for identifying each sample. The analyzer 20 reads each barcode of the container 4 with the barcode reader 224 to identify each specimen to be examined.

  The conveyance mode of the container 4 described with reference to FIG. 3 is merely an example. In the analyzer 20, the container 4 may be transported alone without being accommodated in the rack 7.

  <3. Hardware configuration>

  FIG. 4 is a diagram for explaining a hardware configuration of the analysis system 1 according to the first embodiment.

  First, an example of the hardware configuration of the analyzer 20 will be described.

  The analyzer 20 includes a control unit 210, a communication unit 221, a sample preparation unit 222, an imaging unit 223, and a barcode reader 224. The control unit 210 includes a CPU (Central Processing Unit) 211 and a storage unit 212. The CPU 211 executes the computer program stored in the storage unit 212 and controls each unit of the analyzer 20. The storage unit 212 includes a storage device such as a ROM, a RAM, and a hard disk.

  The communication unit 221 transmits data from the control unit 210 to other devices, and inputs information from other devices to the control unit 210. The communication unit 221 is realized by a network interface card, for example.

  The sample preparation unit 222 prepares a sample necessary for analysis by mixing and stirring the specimen in the container 4 and a reagent necessary for measurement.

  The imaging unit 223 captures an image of the sample prepared by the sample preparation unit 222. The photographing unit 223 has an automatic focusing mechanism. Thereby, the sample adjusted by the sample preparation unit 222 is automatically photographed by the photographing unit 223. The photographing unit 223 displays the photographed image on the control unit 210.

  The barcode reader 224 reads the barcode attached to the container 4 and displays the read information on the control unit 210.

  Next, an example of the hardware configuration of the information processing apparatus 40 will be described.

  The information processing apparatus 40 includes a control unit 410 and a communication unit 420. The control unit 410 is realized by, for example, a general-purpose computer, and includes a CPU 411, a storage unit 412, a keyboard 413, a mouse 414, and a monitor 415. The CPU 411 communicates with an external device such as the analysis device 20 via the communication unit 420. The communication unit 420 is composed of a network interface card, for example.

  The CPU 411 executes a computer program stored in the storage unit 412, receives information input from the keyboard 413 and the mouse 414, and displays the information on the monitor 415. For example, the CPU 411 can display data input from the analysis device 20 on the monitor 415.

  <5. Flow of processing>

  FIG. 5 is a flowchart of processing executed for analyzing the formed portion of the sample in the analyzer 20 according to the first embodiment. As shown in FIG. 5, in step S10, the CPU 211 acquires an image of the sample. The image of the specimen is acquired by photographing the sample image prepared by the sample preparation unit 222 (see FIG. 4) by the photographing unit 223 (see FIG. 4). Thereafter, the control proceeds to step S20.

  In step S <b> 20, the CPU 211 specifies the number of one or more predetermined formations per visual field in the specimen using the acquired image. The identification of the number of each of the one or more kinds of formed components determined in advance per one visual field can be made using a known method of forming analysis, and thus detailed description thereof is omitted here. Thereafter, the CPU 211 determines whether or not there is an abnormal value in the number (measurement result) of one or more formed portions per visual field.

More specifically, the CPU 211 determines whether or not the measurement result of each formed component is within a reference range that is predetermined for each. An example of a formed component is a white blood cell. An example of the reference range is 3 / field (“/ field” indicates the number per field. The same applies hereinafter) for leukocytes. Another example of a formed component is red blood cells. Other examples of reference ranges are 1 / field (male) or 5 / field (female) for red blood cells.
In step S20, the CPU 211 may determine the presence or absence of an abnormal value in the concentration of the formed component in the sample. In this case, in step S20, the CPU 211 specifies the concentrations of one or more predetermined formed components in the sample. Since the known component analysis method can be used to specify the concentration of the component in the specimen, a detailed description thereof is omitted here. Thereafter, the CPU 211 determines whether or not there is an abnormal value in the specified density of each formed component. More specifically, the CPU 211 determines whether or not the density of each formed component is within a reference range predetermined for each.
An example of a formed component is a white blood cell. An example of the reference range is 3.5 to 9.7 × 10 3 / μl for leukocytes.
Another example of a formed component is red blood cells. Other examples of reference ranges are 4.38-5.77 × 10 6 / μl (male) or 3.76-5.16 × 10 6 / μl (female) for red blood cells.

  When CPU 211 determines that the measurement results for all the formed components are within the reference range (YES in step S20), control proceeds to step S60. On the other hand, when CPU 211 determines that the measurement result of at least one kind of formed component is outside the reference range (abnormal value) (NO in step S20), the control proceeds to step S30.

In step S30, the CPU 211 displays a message requesting confirmation of the image. The message is an example of information for prompting confirmation of an image, and is transmitted from the analysis device 20 to the information processing device 40, for example. The information processing apparatus 40 displays the message on the monitor 415 (see FIG. 4). Thereafter, the control proceeds to step S40.
The display mode of the message requesting confirmation of the image may be changed according to the degree to which the analysis result of the formed component deviates from the reference range. For example, the higher the degree of divergence, the higher the warning level. In one example, as the degree of deviation is higher, the message is displayed in a darker color and / or larger size so as to include content with a higher degree of warning.
The display mode of the message may be changed based on the type of formed component whose analysis result is outside the reference range. For example, priorities are given to two or more types of formed components. When the type of a component with an analysis result outside the reference range includes a type with a high priority, the type of a component with an analysis result outside the reference range does not include a type with a high priority. The message is displayed in a mode with a high warning level. In one example, the message is darker in color so that it contains more warning content if the analysis result of the high-priority types of constituents exceeds the reference range than if it did not exceed the reference range. / Or large and displayed.
The display mode of the message may be based on the number of types of formed components whose analysis results are outside the reference range. For example, the message is displayed in a mode with a higher degree of warning as the number of types of formed components whose analysis results are out of the reference range increases. In one example, the message is displayed in a darker color and / or larger so as to include content with a higher warning degree as the number of types of formed components whose analysis results are out of the reference range increases.

  In step S40, the CPU 211 determines whether display of the image acquired in step S10 has been requested. The message included in the request in step S30 may include a link of the image acquired in step S10. The user of the analysis device 20 requests display of an image by operating a link with the mouse 414 of the information processing device 40, for example. In the first embodiment, the image is displayed (in the information processing apparatus 40) for confirmation of the image prompted in step S30. In this sense, visual recognition of the image by the user is an example of image confirmation.

  The CPU 211 stops control at step S40 until image display is requested (NO at step S40). When CPU 211 determines that display of an image has been requested, control proceeds to step S42.

  In step S42, the CPU 211 displays the image acquired in step S10. For example, the CPU 211 transmits the image to the information processing apparatus 40. In response to this, the information processing apparatus 40 displays the image on the monitor 415. Thereafter, the control proceeds to step S50.

  The user visually determines the necessity of reexamination (typically a manual inspection) of the specimen that is the object of the component analysis of the analyzer 20 by visually recognizing the image acquired in step S10. The determination result is input to the information processing apparatus 40. The information processing apparatus 40 transmits the input determination result to the analysis apparatus 20.

  In step S50, the CPU 211 determines whether or not the determination result of the user indicates that re-examination is unnecessary. If the user's determination result indicates that re-examination is unnecessary (YES in step S50), CPU 211 advances the control to step S60. On the other hand, if the determination result of the user indicates that reexamination is necessary (NO in step S50), the CPU 211 advances the control to step S70.

  In step S <b> 60, the CPU 211 displays the analysis result of the formed object using the image acquired in step S <b> 10 (number of one or more formed objects per visual field) as the analysis result.

  In step S70, the CPU 211 displays information indicating that reexamination (typically manual inspection) is necessary.

  <5. Display example>

  A specific example of screen display in the analysis system 1 will be described with reference to FIGS. FIG. 6 is a diagram illustrating an example of a screen displayed for the analysis apparatus 20 to request confirmation of an image in step S30.

  The screen 900 of FIG. 6 includes a table 901 that shows the analysis results for each of the plurality of specimens. The table displays data of a plurality of items for each sample in each row. The plurality of items can include a formal item, an analysis item, and an item representing a situation. The formal items are, for example, a specimen ID, a sequence number (Seq. No.), a position (Pos) in the rack 7, a reception number, a patient name, a specimen type, and / or a sex. The analysis item indicates, for example, each measurement result of red blood cells, white blood cells, epithelial cells, cylinders, and / or bacteria.

  The item representing the status indicates the progress of analysis of each sample. The information displayed as the item representing the situation includes, for example, “automatic confirmation”, “confirmation required”, and “confirmation [corrected]”. The “automatic confirmation” is displayed for the sample for which it is determined in step S20 in FIG. 5 that the measurement results of all the formed components are within the reference range. “Confirmation required” is displayed for the sample for which confirmation is requested in step S30 of FIG. “Confirm [corrected]” is displayed for the sample that is determined to be unnecessary for reexamination as a result of confirmation by the user in step S42 of FIG.

  In the screen 900 of FIG. 6, for example, the sample ID “0004” is displayed when confirmation of the image is requested. The user who views the screen 900 performs a click operation on the row 902 in the table 901 that displays data on the sample ID “0004”. In response to this, the image of the sample ID is requested from the information processing device 40 to the analyzer 20 (YES in step S40 in FIG. 5). In response to this, the analysis apparatus 20 transmits an image of the sample ID to the information processing apparatus 40. The transmitted image is displayed on the information processing apparatus 40.

  FIG. 7 is a diagram illustrating an example of a screen that displays an image of a specimen.

A screen 910 in FIG. 7 includes an image 911. The image 911 is an image acquired in step S10 (FIG. 5) for the sample with the sample ID “0004”. The screen 910 further includes a display field 919 for displaying an analysis result of one or more kinds of formed components. The display column 919 indicates conditions, measurement results (number per field of view (/ HPF)), and presence / absence of check for each formed component (“item” in the display column 919). The condition is a condition for displaying an attention to the measurement result of each formed component.
For example, the analysis result “red blood cells” shown in the display column 919 has a condition of “5 / HPF or higher” and a measurement result of “10-19 / HPF”. That is, the measurement result of red blood cells satisfies the above conditions. Therefore, the check result is “Yes” for red blood cells.

  The user who visually recognizes the screen 910 evaluates the reliability of the data displayed in the display field 919 by comparing the image 911 and the data in the display field 919.

  The image displayed on the information processing apparatus 40 may be attached with information indicating which portion of the image corresponds to which formed portion. As a result, the user can enlarge and display the portion of the sample image that includes the formed component in which the measurement result is determined to be out of the reference range. The attached information is generated by the CPU 211, for example. More specifically, the CPU 211 identifies each formed component such as a white blood cell, a red blood cell, and a cylinder from the image acquired for the sample by pattern recognition using the image pattern registered as the formed component. To do. The CPU 211 sends the image data acquired for the sample to the information processing apparatus 40 with information indicating a portion specified as a formed portion in the image.

  For example, when it is determined that the measurement result of the cylinder exceeds the reference range, the monitor 415 displays an enlarged image of a portion including the cylinder in the sample image. When the user visually confirms the enlarged image and confirms that the substance determined to be a cylinder is not an original cylinder (condensed protein) but a contaminant such as dust, It can be judged that manual analysis is unnecessary. The user inputs the determination result to the information processing apparatus 40. The input determination result is transmitted to the analyzer 20.

  FIG. 8 shows a screen that is displayed when the user inputs a determination result indicating that it is not necessary to reexamine a specimen for which the measurement result of the formed component is determined to be out of the reference range by checking the image. It is an example.

  A screen 990 in FIG. 8 includes a table 901 as in the screen 900 in FIG. In the table 901 of FIG. 8, the analysis status of the row 902 is “confirmed (corrected)” as compared to the table 901 of FIG. The analysis status means that the determination result is corrected by checking the user's image.

That is, conventionally, it has been determined that retesting of the specimen is necessary on the condition that the analysis result of at least one kind of formed component is out of the reference range. On the other hand, in the analyzer 20 of the first embodiment, when the analysis result of at least one kind of formed component is out of the reference range, it is used before it is determined that the sample needs to be retested. The person can visually recognize the image of the sample. The visually recognized image is an image with a magnification of about 20 taken by the analyzer 20. When the user determines that reexamination of the sample is unnecessary by visually recognizing the image, the analysis result of the formed component of the sample is determined based on the result acquired by the analyzer 20. That is, the test result of the sample is fixed without performing a retest.
In the first embodiment, whether or not the analysis result of the formed component is out of the reference range is based on the “number of formed components per field of view” of the specimen, or “ Based on the "concentration of". That is, an example of the analysis result of the formed component is the number of the formed component per visual field of the specimen image. Another example of the formed component is the concentration of the formed component in the specimen.

  [Second Embodiment]

  The analysis device 20 according to the second embodiment has a learning function. After determining that the measurement result of the formed component is out of the reference range, the CPU 211 stores the characteristics of the sample in the storage unit 212 for the sample that is determined not to be reexamined by visual recognition of the user's image. Further, for the specimen that is determined to be reexamined by visual recognition of the user's image, the characteristics of the specimen are registered in the storage unit 212. Thereafter, the CPU 211 can use the registered features for the analysis of the formed component.

  FIG. 9 is a flowchart of a process for the analysis apparatus 20 to register the characteristics of the specimen after the result of visual recognition of the image by the user is input. As shown in FIG. 9, in step SA10, the CPU 211 confirms the result input from the user in step S50 (FIG. 5). If it is determined that the input result indicates that re-examination is unnecessary, the control proceeds to step SA20. On the other hand, if the input result indicates that reexamination is necessary, the CPU 211 advances the control to step SA30.

  In step SA20, the CPU 211 registers the feature of the image transmitted to the information processing device 40 in the storage unit 212 for “display analysis result” in association with the formed component determined to be out of the reference range. . An example of the feature is an image pattern. For example, when it is determined that the measurement result of the cylinder is out of the reference range, the CPU 211 determines the image pattern of the portion identified as the cylinder in the image transmitted to the information processing device 40 in step SA20. Register it in association with the formation "cylinder".

  Another example of image characteristics is the subject attributes (age, gender, etc.) of the specimen to which the image corresponds. Yet another example of image characteristics is the image itself.

  In step SA30, the CPU 211 registers the feature of the image transmitted to the information processing apparatus 40 in the storage unit 212 for “re-examination required” in association with the formed component determined to be out of the reference range. For example, when it is determined that the measurement result of the cylinder is out of the reference range, the CPU 211 determines the image pattern of the portion identified as the cylinder in the image transmitted to the information processing device 40 in step SA30. Register it in association with the formation "cylinder".

  FIG. 10 is a flowchart of a process executed for analyzing the formed portion of the sample in the analyzer 20 according to the second embodiment. The flowchart of FIG. 10 further includes step S22 and step S24 with respect to the flowchart of FIG.

  More specifically, in the second embodiment, when the CPU 211 determines in step S20 that the measurement result of at least one kind of formed component in the sample is out of the reference range, the control proceeds to step S22.

  In step S22, the CPU 211 checks the specimen image using the feature registered in step SA20 or step SA30 (see FIG. 9). Thereafter, the control proceeds to step S24.

  In step S22, for example, when it is determined in step S20 that the measurement result of the formed portion “column” is out of the reference range, in step S22, the CPU 211 associates with the formed portion “column” and registers it. At least one of the feature for “display analysis result” and the feature for “re-examination required” is called from the storage unit 212. The CPU 211 compares the called feature with the sample image.

  In step S24, the CPU 211 determines whether or not the sample needs to be retested based on the comparison result in step S22. For example, the CPU 211 determines that reexamination is not necessary when the specimen image matches the feature for “display analysis result” by a certain degree or more, and the specimen image is for “retest required”. If the feature matches a certain degree or more, it is determined that reexamination is necessary. The CPU 211 preferably determines that reexamination is necessary when the specimen image matches both the “analysis result display” feature and the “retest required” feature to a certain degree or more. .

  If it is determined that re-examination is unnecessary (YES in step S24), CPU 211 advances the control to step S60. When determining that re-examination is necessary (NO in step S24), the CPU 211 advances the control to step S30.

  In the second embodiment described above, the analysis apparatus 20 has a learning function for determining whether or not a retest is necessary, using a determination result of whether or not a retest is necessary for a past sample by the user. . In the second embodiment, even if the measurement result of the formed component exceeds the reference range, if it is determined that reexamination is unnecessary based on the past history (YES in step S24), The user confirms the analysis result of the analyzer 20 without confirming the sample image (step S60). Thereby, a user's labor can be reduced.

  [Third Embodiment]

  <1. Overview>

  The analysis system according to the third embodiment performs a qualitative analysis in addition to the analysis of a specimen component. FIG. 11 is a diagram for explaining an outline of sample analysis in the analysis system according to the third embodiment.

  As shown in FIG. 11, in the analysis system of the third embodiment, the result of the qualitative analysis of the sample is input to the analysis device that analyzes the formed component of the sample. The analysis device determines whether to request confirmation of the image of the sample using the analysis result of the formed component and the analysis result of the qualitative analysis in the analysis device (“check” in FIG. 11). When the analysis apparatus determines to request confirmation of the image, the analysis apparatus requests confirmation of the image from the user. When determining that the confirmation of the image is not requested, the analysis device displays the analysis result based on the image acquired in the analysis device as the analysis result of the formed component.

  <2. Configuration of analysis system>

  FIG. 12 is a diagram illustrating an overall configuration of an analysis system according to the third embodiment. The analysis system 1 according to the third embodiment includes an analysis apparatus 10 that performs a qualitative analysis of a specimen in addition to an analysis apparatus 20 that analyzes a formed component using an image.

  More specifically, the analysis system 1 in FIG. 12 includes an analysis device 10, an analysis device 20, an information processing device 40, and a transport device 50. The analyzer 10 performs a qualitative analysis of the specimen. The analysis apparatus 20 performs the formation analysis of the sample using the sample image. The information processing device 40 displays an image displayed from the analysis device 20 and accepts input of information from the user. The transport device 50 transports the sample from the analyzer 10 to the analyzer 20.

  The transport device 50 includes a groove 500 for transporting the rack 7 (see FIG. 3). The analyzer 10 includes a barcode reader 124 for reading a barcode attached to each sample. The analysis device 10, the analysis device 20, the information processing device 40, and the transport device 50 may be partially or entirely integrated.

  <3. Hardware configuration>

  FIG. 13 is a diagram for explaining a hardware configuration of the analysis system 1 according to the third embodiment.

  As shown in FIG. 13, the analysis system 1 of the third embodiment is further compared with the hardware configuration of the first embodiment shown in FIG. including.

  The analysis apparatus 10 includes a control unit 110, a communication unit 121, a first detection unit 122, a second detection unit 123, and a barcode reader 124. The control unit 110 includes a CPU 111 and a storage unit 112. The CPU 111 executes the computer program stored in the storage unit 112 and controls each unit of the analysis apparatus 10. The storage unit 112 includes a storage device such as a ROM, a RAM, and a hard disk.

  The communication unit 121 transmits data from the control unit 110 to another device, and inputs information from the other device to the control unit 110. The communication unit 121 is realized by a network interface card, for example.

  The first detection unit 122 immerses a test paper corresponding to each measurement item (occult blood concentration, protein concentration, leukocyte concentration (leukocyte esterase reaction), nitrite concentration, and glucose concentration) in the specimen, and each test paper. Measure each measurement item from the degree of discoloration. The first detection unit 122 starts measurement in response to an instruction from the CPU 111 of the control unit 110. The first detection unit 122 calculates the occult blood concentration, protein concentration, leukocyte concentration, nitrite concentration, and glucose concentration, for example, the degree of discoloration of each test paper (−), (±), (+), (2+ ), (3+),..., (7+) are automatically classified and displayed on the control unit 110 as inspection results for each item.

  The second detection unit 123 detects the refractive index of the specimen and measures the specific gravity of the specimen from the refractive index. The second detection unit 123 starts measurement in response to an instruction from the CPU 111 of the control unit 110. The second detection unit 123 displays the specific gravity that is the detection result on the control unit 110.

  The barcode reader 124 reads the barcode attached to the container 4 and displays the read information on the control unit 210.

  The transport device 50 includes a control unit 510 and a communication unit 520. Control unit 510 includes a CPU 511, a storage unit 512, a drive unit 513, and a sensor 514.

  The driving unit 513 drives a motor that rotates to convey the rack 7.

  The CPU 511 controls the operation of the drive unit 513.

  The storage unit 512 stores a program executed by the CPU 511 and data used for executing the program.

  The sensor 514 detects the presence / absence of an object in the groove 500. The sensor 514 displays the detection result on the CPU 511. Based on the detection result input from the sensor 514, the CPU 511 specifies, for example, where the rack 7 is located in the groove 500.

  The CPU 211 controls the transport device 50 to transport the sample that has been subjected to qualitative analysis in the analyzer 10 to the analyzer 20.

  In the example illustrated in FIG. 13, the analysis device 10, the analysis device 20, and the information processing device 40 can communicate with each other. The transport device 50 can communicate with the information processing device 40. This communication mode is merely an example. The analysis device 20 may communicate with the analysis device 10 only via the information processing device 40. Communication between apparatuses may be wired or wireless.

  <4. Flow of processing>

  FIG. 14 is a flowchart of processing executed for analyzing the formed portion of the sample in the analyzer 20 according to the third embodiment. The flowchart of FIG. 14 further includes step S10A, step S22A, and step S24A with respect to the flowchart of FIG.

  More specifically, after acquiring the sample image in step S10, the CPU 211 advances the control to step S10A.

  In step S10A, the CPU 211 acquires the result of the qualitative analysis of the specimen whose image has been acquired in step S10. For example, the CPU 211 acquires the ID of the sample from the barcode of the sample before acquiring the sample image. Thereafter, the result of the qualitative analysis of the sample with the ID is requested to the analyzer 10. In response to the request, the analyzer 10 transmits the result of the qualitative analysis of the sample to the analyzer 20.

  After acquiring the result of the qualitative analysis in step S10A, the CPU 211 advances the control to step S20. Note that the order of step S10 and step S10A may be interchanged.

  If it is determined in step S20 that the measurement result of at least one kind of formed component is outside the reference range, the CPU 211 advances the control to step S22A.

  In step S <b> 22 </ b> A, the CPU 211 cross-checks the result of the qualitative analysis and the analysis result of the formed component based on the image acquired in the analysis device 20. The contents of the cross check will be described later with reference to FIG. Thereafter, the control proceeds to step S24A.

  In step S24A, the CPU 211 determines whether or not the result of the cross check in step S22A indicates that image confirmation is required. FIG. 15 is a diagram for explaining the contents of the cross check.

  Referring to FIG. 15, in step S220, CPU 211 determines whether or not the measurement result of the formed component “red blood cells” exceeds the reference range in the formed component analysis. When CPU 211 determines that the measurement result of “red blood cells” exceeds the reference range (YES in step S220), control proceeds to step S224. On the other hand, when CPU 211 determines that the measurement result of “red blood cells” is within the reference range or below the reference range (NO in step S220), control proceeds to step S222.

  In step S <b> 222, the CPU 211 determines whether or not the item “occult blood” is “−” in the result of the qualitative analysis acquired from the analyzer 10. When determining that the result of the item “occult blood” is “−” (YES in step S222), the CPU 211 advances the control to step S230. On the other hand, when determining that the result of the item “occult blood” is not “−” (NO in step S222), the CPU 211 advances the control to step S232.

  In step S230, the CPU 211 sets the result of the cross check as “confirmation of the image is unnecessary”.

  In step S232, the CPU 211 sets the result of the cross check as “confirmation of image is necessary”.

  The control in step S222 is an example of determining whether or not the analysis result of a specific material component matches the result of the qualitative analysis item associated with the specific material component. More specifically, the item “occult blood” in the qualitative analysis is an example of an item related to the formed component “red blood cell” in the formed component analysis. In the process of FIG. 15, when determining that the result of occult blood is “−” in step S <b> 222, the CPU 211 determines that confirmation of an image is unnecessary. A occult blood result of “−” means that the amount of occult blood detected in a qualitative analysis is less than or equal to a minute amount. That is, the result that the measurement result of red blood cells is not more than the reference range in the formed component analysis (NO in step S220) matches the result that the detected amount of occult blood is not more than a minute amount in the qualitative analysis. In such a case, the CPU 211 determines that the image confirmation is unnecessary.

  On the other hand, in the process of FIG. 15, the CPU 211 determines that the result of the occult blood in the qualitative analysis is not “−” (“±” to “7+”) even though the measurement result of the red blood cells is less than the reference range in the component analysis. ”), It is determined that image confirmation is necessary. This is because the result of the component analysis is in conflict with the result of the qualitative analysis.

  In step S224, the CPU 211 determines whether or not the item of occult blood is “+” or more (“+” to “7+”) in the result of the qualitative analysis. When CPU 211 determines that the item of occult blood is “+” (YES in step S224), the control proceeds to step S226, and the item of occult blood is not “+” (“±” or “−”). If determined (NO in step S224), the control proceeds to step S228.

  In step S226, the CPU 211 determines whether the sex of the subject of the sample to be processed is female. If CPU 211 determines that the subject is a woman (YES in step S226), the control proceeds to step S230. If CPU 211 determines that the subject is not a woman (NO in step S226), control proceeds to step S232.

  In step S228, the CPU 211 determines whether or not the sex of the subject of the sample to be processed is male. If CPU 211 determines that the subject is a male (YES in step S228), the control proceeds to step S232, and if it is determined that the subject is not a male (NO in step S228), the control proceeds to step S230.

  In the process of FIG. 15, when the number of red blood cells in urine per visual field is larger than the reference range in the component analysis, and the occult blood is “±” or “−” in the qualitative analysis, the subject is a female. If so (YES in step S226), it is determined that image confirmation is unnecessary. The relatively large number of red blood cells per visual field in the component analysis is likely to be menstrual blood even if it does not match the results of occult blood in the qualitative analysis, and the number per visual field is relatively large. This is because it is not necessary for the user to check the image.

  On the other hand, when the number of red blood cells in the urine is relatively large in the component analysis and the occult blood is “±” or “−” in the qualitative analysis, the subject is not a woman (step NO in S226), it is determined that image confirmation is necessary. Since the test subject is not a woman, the reason why the relatively high number of red blood cells per visual field in the component analysis is relatively large is not menstrual blood and requires careful confirmation.

  In the process of FIG. 15, if the number of red blood cells in urine is relatively large in the component analysis, the occult blood is “+” or more in the qualitative analysis, and the sex of the subject is female (step NO in S228), it is determined that image confirmation is unnecessary. This is because it is predicted that the cause of both the relatively large number of red blood cells per visual field and the result of occult blood is menstrual blood, and thus further confirmation is considered unnecessary.

  On the other hand, if the number of red blood cells in the urine is relatively large in the component analysis, the occult blood is "+" or more in the qualitative analysis, and the sex of the subject is male (YES in step S228). It is determined that the confirmation of the image is necessary. This is because the cause of both the relatively large number of red blood cells per visual field and the result of occult blood is not menstrual blood, and it is considered that further confirmation is necessary.

  Returning to FIG. 14, in step S <b> 24 </ b> A, the CPU 211 determines whether or not the result of the cross check described with reference to FIG. 15 is “image confirmation is required”. If the result of the cross check is “image confirmation is necessary” (YES in step S24A), the CPU 211 requests image confirmation in step S30. If the result of the cross check is “no image confirmation is required” (NO in step S24A), the CPU 211 displays the result of the formation based on the image acquired in step S10 as the analysis result in step S60. The CPU 211 may display the result of the qualitative analysis together with the result of the formation analysis.

  <5. Modification>

  The analysis apparatus 20 of the third embodiment may have a learning function.

  For example, when the result of confirmation by the user determined in step S50 indicates that reexamination is necessary or unnecessary, the CPU 211 combines the result of the tangible analysis and the result of the qualitative analysis for the sample at that time. Remember. In the subsequent step S22A, the CPU 211 may perform a cross check using the stored combination.

In one example, the tendency of the user's judgment when the “number of red blood cells per field of view” exceeds the reference range in the component analysis is stored in the storage unit 212. Specific examples of stored tendencies are used when the number of red blood cells per visual field exceeds the reference range, and the qualitative analysis occult blood results are “+” or more (“+1” to “+7”). The person determines that reexamination is necessary, and when the number of red blood cells per field exceeds the reference range and the qualitative analysis occult blood is "±" or less ("±" or "-"), The user decides that re-examination is unnecessary.
Thereafter, the CPU 211 uses the tendency in step S22A.

  That is, even if the number of red blood cells per visual field exceeds the reference range, if the result of the qualitative analysis occult blood is “+” or more (“+1” to “+7”), in step S22A, the CPU 211 By referring to the tendency, it is determined that confirmation of the image is unnecessary. In such a case, according to the above tendency, it is considered that the user will determine that re-examination is necessary. When the number of red blood cells per visual field exceeds the reference range and the result of qualitative analysis occult blood is “±” or less, in step S22A, the CPU 211 refers to the above-described tendency to display an image. It is judged that confirmation is necessary. In such a case, according to the above tendency, the user may determine that re-examination is unnecessary.

In another example, the tendency of the user's judgment when the “concentration” of red blood cells in the sample exceeds the reference range in the component analysis is stored in the storage unit 212. A specific example of the stored tendency is that when the concentration of red blood cells exceeds the reference range, and the result of qualitative analysis occult blood is “+” or more (“+1” to “+7”), the user reexamines If the concentration of red blood cells exceeds the reference range and the occult blood of qualitative analysis is “±” or less (“±” or “−”), the user does not need to retest It is to judge.
Thereafter, the CPU 211 uses the tendency in step S22A.

  That is, even if the concentration of red blood cells exceeds the reference range, if the result of the qualitative analysis occult blood is “+” or more (“+1” to “+7”), the CPU 211 refers to the above-described tendency in step S22A. Therefore, it is determined that the confirmation of the image is unnecessary. In such a case, according to the above tendency, it is considered that the user will determine that re-examination is necessary. In step S22A, when the concentration of red blood cells exceeds the reference range, if the qualitative analysis occult blood result is “±” or less, the CPU 211 needs to confirm the image by referring to the above tendency. Judge. In such a case, according to the above tendency, the user may determine that re-examination is unnecessary.

  [Fourth Embodiment]

  <1. Overview>

  The analysis system according to the fourth embodiment executes the formation analysis by flow cytometry in addition to the formation analysis by image. FIG. 16 is a diagram for explaining an outline of sample analysis in the analysis system according to the fourth embodiment.

  As shown in FIG. 16, in the fourth embodiment, it is possible to determine whether or not to perform the component analysis based on the image based on the result of the component analysis by the flow cytometry. An analyzer (analyzer 30 to be described later) that performs the formation analysis by flow cytometry confirms the result of the analysis (the upper of the two “checks” in FIG. 16), and all the formations If it is determined that the measurement result of the minute is within the reference range, the analysis result by the flow cytometry is displayed as the analysis result of the formed component, and the execution of the analysis of the formed component based on the image can be omitted. When it is determined in the analysis by flow cytometry that the measurement result of one or more types of formed components is outside the reference range, the formed components based on the image is analyzed.

  The result of the component analysis by flow cytometry is input to the analyzer that analyzes the component based on the image. The analyzer that analyzes the formed component based on the image determines whether the analysis result of the formed component in the analyzer is consistent with the analyzed result of the formed component by flow cytometry (2 in FIG. 16). Of the two “checks”). The determination of whether these two analysis results contradict each other will be described later as a cross check in step S22B of FIG. After that, when these are consistent, the analysis apparatus displays the analysis result based on the image as the analysis result of the formed component (“determined by the result of the formed component analysis” in FIG. 16). On the other hand, if these contradict each other, the analyzer displays an image of the sample (“image display” in FIG. 16) and requests confirmation of the image.

  As a result of the image confirmation, an input specifying whether or not reexamination is necessary is received from the user. When an input designating that reexamination is necessary is received, information indicating that the reexamination of the sample is necessary is displayed. When an input designating that re-examination is unnecessary is received, the analysis result based on the image is displayed as the analysis result of the formed component (“determined by the result of the formed component analysis” in FIG. 16).

In the fourth embodiment, according to conditions other than whether or not the measurement result by flow cytometry is within the reference range, that is, for example, the measurement result by flow cytometry is inconsistent with information such as the sex of the subject. The formation analysis using the image by the analysis device 20 may be executed on the condition that the occurrence of the above occurs.
In the analysis device 20, the analysis of the formed component based on the image may be executed regardless of the result of the analysis by flow cytometry.

  <2. Configuration of analysis system>

  FIG. 17 is a diagram illustrating an overall configuration of an analysis system according to the fourth embodiment. The analysis system 1 according to the fourth embodiment includes an analysis device 30 that performs the formation analysis of the specimen by flow cytometry, in addition to the analysis device 20 that analyzes the formation using the image.

  More specifically, the analysis system 1 in FIG. 17 includes an analysis device 20, an analysis device 30, an information processing device 40, and a transport device 50. The information processing device 40 displays an image displayed from the analysis device 20 and accepts input of information from the user. The transport device 50 transports the sample from the analyzer 30 to the analyzer 20. The transport device 50 includes a groove 500 for transporting the rack 7 (see FIG. 3). The analyzer 30 includes a barcode reader 323 for reading a barcode attached to each sample.

  <3. Hardware configuration>

  FIG. 18 is a diagram for explaining a hardware configuration of the analysis system 1 according to the fourth embodiment.

  As shown in FIG. 18, the analysis system 1 of the fourth embodiment is further compared with the hardware configuration of the first embodiment shown in FIG. including.

  The analysis device 30 includes a control unit 310, a communication unit 321, a measurement unit 322, and a barcode reader 323. The control unit 310 includes a CPU 311 and a storage unit 312. The CPU 311 executes the computer program stored in the storage unit 312 and controls each unit of the analyzer 30. The storage unit 312 includes a storage device such as a ROM, a RAM, and a hard disk.

  The communication unit 321 transmits data from the control unit 310 to another device and inputs information from the other device to the control unit 310. The communication unit 321 is realized by a network interface card, for example.

  The measuring unit 322 performs the formation analysis of the specimen according to the flow cytometry. A known method can be adopted as the method for analyzing the formed component according to the flow cytometry, and thus a detailed description thereof is omitted here.

  The barcode reader 323 reads the barcode attached to the container 4 and displays the read information on the control unit 310.

  The transport device 50 includes a control unit 510 and a communication unit 520. Control unit 510 includes a CPU 511, a storage unit 512, a drive unit 513, and a sensor 514.

  The driving unit 513 drives a motor that rotates to convey the rack 7.

  The CPU 511 controls the operation of the drive unit 513.

  The storage unit 512 stores a program executed by the CPU 511 and data used for executing the program.

  The sensor 514 detects the presence / absence of an object in the groove 500. The sensor 514 displays the detection result on the CPU 511. Based on the detection result input from the sensor 514, the CPU 511 specifies, for example, where the rack 7 is located in the groove 500.

  The CPU 411 of the information processing device 40 controls the transport device 50 to transport the sample that is the object of the formation analysis by flow cytometry in the analysis device 30 to the analysis device 20.

  The CPU 411 instructs the analyzer 30 to analyze the sample. The analysis device 30 notifies the CPU 411 which sample analysis (or acquisition of a sample for analysis) has been completed. The CPU 411 instructs the analyzer 20 to analyze the sample that is the analysis target in the analyzer 30. The CPU 411 may parallelize the analysis in the analysis device 20 and the analysis in the analysis device 30. When the analysis result for a certain sample in the analysis device 30 indicates that the measurement results for all the formed components are within the reference range, the CPU 411 executes the test of the sample for the analysis device 20. You do not have to give instructions.

  In the example shown in FIG. 18, the analysis device 20, the analysis device 30, and the information processing device 40 can communicate with each other. The transport device 50 can communicate with the information processing device 40. This communication mode is merely an example. The analysis device 20 may communicate with the analysis device 30 only via the information processing device 40. Communication between apparatuses may be wired or wireless.

  <4. Flow of processing>

  FIG. 19 is a flowchart of processing executed for analyzing the formed portion of the specimen in the analyzer 20 according to the fourth embodiment. The flowchart in FIG. 19 further includes step S10B, step S22B, and step S24B with respect to the flowchart in FIG.

  In step S <b> 10 </ b> B, the CPU 211 acquires the analysis result by flow cytometry from the analysis device 30. Thereafter, the control proceeds to step S20.

  In step S <b> 20, the CPU 211 checks the measurement result of each formed component in the analysis result using the image in the analyzer 20. If the measurement result of at least one kind of formed component is out of the reference range, the CPU 211 advances the control to step S22B.

  In step S <b> 22 </ b> B, the CPU 211 cross-checks the result of the component analysis of the analyzer 20 and the result of the component analysis of the analyzer 30. Thereafter, the control proceeds to step S24B.

  In step S24B, the CPU 211 determines whether it is necessary to check the image based on the result of the cross check in step S22B. For example, the CPU 211 determines that the image needs to be confirmed when the result of the component analysis of the analyzer 20 contradicts the result of the component analysis of the analyzer 30.

  An example of the “contradiction” in the cross check in step S22B is that the formed component whose measurement result is determined to be out of the reference range in the analysis result of the analysis device 20 is within the reference range in the analysis result of the analysis device 30. It is judged. Another example of “contradiction” is that the formed component whose measurement result is determined to be within the reference range in the analysis result of the analyzer 20 is determined to be outside the reference range in the analysis result of the analyzer 30. It is.

  The CPU 211 needs to check the image when the result of the component analysis of the analyzer 20 is consistent with the result of the component analysis of the analyzer 30 (when the former result matches the latter result). Judge.

  An example of “no contradiction” in the cross check in step S22B is that the measurement result of the formed component determined by the analysis result of the analysis device 20 to be within the reference range is the reference range of the analysis result of the analysis device 30. It is determined that it is within. Another example of “no contradiction” is that, for the formed component for which the analysis result of the analysis device 20 is determined to exceed the reference range, the analysis result of the analysis device 30 is also determined to exceed the reference range. Still another example of “no contradiction” is that the formed component determined to be below the reference range in the analysis result of the analysis device 20 is determined to be below the reference range also in the analysis result of the analysis device 30.

  If CPU 211 determines in step S24B that image confirmation is necessary (YES in step S24B), control proceeds to step S30. On the other hand, when CPU 211 determines that image confirmation is unnecessary (NO in step S24B), control proceeds to step S60.

  <5. Modification of processing>

  Also in the fourth embodiment, the CPU 211 may have a learning function. For example, if the result input in step S60 indicates that the user has determined that reexamination is necessary, the CPU 211 stores the scattergram of the sample in the storage unit 212 as data for reexamination required. May be. When the result input in step S60 indicates that the user has determined that reexamination is not necessary, the CPU 211 may store the scattergram of the sample in the storage unit 212 as data for determining the result. .

  The CPU 211 may determine the necessity of image confirmation using the scattergram stored in the storage unit 212 as described above, instead of the cross check in step S24B. In this case, the CPU 211 obtains a scattergram of the sample from the analyzer 30 in step S10B. Thereafter, in step S24B, the CPU 211 determines that image confirmation is necessary when the acquired scattergram feature is close to the scattergram feature stored as data for reexamination required. This is because it is considered that there is a high possibility that it is necessary to carefully check because the specimen to be judged has characteristics close to those of specimens judged to require reexamination. In step S <b> 24 </ b> B, the CPU 211 determines that image confirmation is unnecessary when the acquired scattergram feature is close to the scattergram feature stored as result determination data. This is because it is considered that there is a high possibility that careful confirmation is unnecessary because the specimen to be judged has characteristics close to those of specimens that are judged not to be retested.

  <6. Possible changes in flow cytometry analyzers>

  In the analyzer 30, various changes may be added in order to improve the accuracy of the formation analysis. For example, a reagent that specifically stains a nucleic acid may be added to the specimen. Thus, various urinary components including fungi and human cells can be separated from each other in the cells depending on the presence or absence of nucleic acids or the amount of nucleic acids. Epithelial cells that cannot be classified by nucleic acid content can be classified by using waveform feature parameters. Components such as red blood cells, cylinders, etc. that do not have nucleic acids can be distinguished using depolarized side scattered light and / or waveform feature parameters. Furthermore, by using fluorescent staining, more of the formed component can be distinguished.

  In the analyzer 30, a substance that causes irregular reflection such as mucus or salt may adhere to the formed component. In such a case, the scattered light due to the formed component is disturbed, and thereby an error included in the analysis result of the formed component can be increased. In order to further reduce the error, it is preferable to acquire the scattergram data of the attached substance as described above. The CPU 311 may detect the formed component after subtracting the scattergram of the attached substance from the scattergram displayed by the measurement unit 322.

  [Fifth Embodiment]

  <1. Overview>

  The analysis system according to the fifth embodiment executes qualitative analysis and flow cytometry-based component analysis in addition to image formation analysis. FIG. 20 is a diagram for explaining an outline of sample analysis in the analysis system according to the fifth embodiment.

  As shown in FIG. 20, the analysis system of the fifth embodiment uses the analysis result of the formed component by flow cytometry and the analysis result of the qualitative analysis, and these analysis results match or contradict each other. Is judged. The determination of whether the analysis result of the formed component and the analysis result of the qualitative analysis match or contradicts (contradicts) is realized, for example, according to the contents described with reference to FIG.

  The analysis result of the formed component by flow cytometry is compared with the analysis result of the qualitative analysis (“check” in the upper part of FIG. 20), and if these two results match, the analysis result by the flow cytometry is formed. Displayed as minute analysis results. In this case, the analysis of the formed component by the image can be omitted.

  If the analysis result of the formed component by flow cytometry and the analysis result of the qualitative analysis contradict each other, the analysis of the formed component by the image is executed. Thereafter, it is determined whether the analysis result of the formed component by flow cytometry and the analysis result of the formed component by the image are inconsistent. The determination as to whether or not the analysis result of the formed component by flow cytometry and the analysis result of the formed component by the image contradict each other is realized according to the contents of the cross check in step S22B of FIG.

  <2. Configuration of analysis system>

  FIG. 21 is a diagram illustrating an overall configuration of an analysis system according to the fifth embodiment. In the analysis system 1 of the fifth embodiment, in addition to the analyzer 20 that analyzes the formed component using the image, the analyzer 10 that performs the qualitative analysis and the component analyzed of the sample by the flow cytometry. And an analysis device 30 to be executed.

  More specifically, the analysis system 1 of FIG. 21 includes an analysis device 10, an analysis device 20, an analysis device 30, an information processing device 40, and a transport device 50. The information processing device 40 displays an image displayed from the analysis device 20 and accepts input of information from the user. The transport device 50 transports the sample from the analyzer 10 to the analyzer 30 and further transports the sample from the analyzer 30 to the analyzer 20.

  <3. Hardware configuration>

  FIG. 22 is a diagram for explaining a hardware configuration of the analysis system 1 according to the fifth embodiment.

  As shown in FIG. 22, the analysis system 1 of the fifth embodiment is further compared with the hardware configuration of the first embodiment shown in FIG. And a transfer device 50.

  The CPU 411 of the information processing device 40 controls the transport device 50 to transport the sample that has been subjected to qualitative analysis in the analysis device 10 to the analysis device 30, and then to the analysis device 20.

  The CPU 411 instructs the analyzer 10 to perform qualitative analysis of the sample. The analysis apparatus 10 notifies the CPU 411 which sample analysis (or acquisition of a sample for analysis) has been completed. The CPU 411 instructs the analysis apparatus 30 to analyze the sample that is the analysis target in the analysis apparatus 10.

  The analysis device 30 notifies the CPU 411 which sample analysis (or acquisition of a sample for analysis) has been completed. The CPU 411 instructs the analyzer 20 to analyze the sample that is the analysis target in the analyzer 30. When the analysis result for a certain sample in the analysis device 30 indicates that the measurement results for all the formed components are within the reference range, the CPU 411 executes the test of the sample for the analysis device 20. You do not have to give instructions.

  In the example illustrated in FIG. 22, the analysis device 10, the analysis device 20, the analysis device 30, and the information processing device 40 can communicate with each other. The transport device 50 can communicate with the information processing device 40. This communication mode is merely an example. Communication between apparatuses may be wired or wireless.

  <4. Flow of processing>

The CPU 211 of the fifth embodiment can execute the same processing as the CPU 211 of the fourth embodiment shown in FIG. That is, in step S22B, the analysis result of the analysis device 20 and the analysis result of the analysis device 30 are cross-checked. If it is determined that there is a contradiction in these two analysis results, the CPU 211 requests confirmation of the image acquired in step S10 in step S30. If it is determined that there is no contradiction in these two analysis results, the CPU 211 displays the analysis result of the analysis device 20 as the analysis result of the formed component in step S60.
[Sixth Embodiment]
The analysis system according to the sixth embodiment may have the same hardware configuration as the analysis system according to the fourth or fifth embodiment. In the analysis system of the sixth embodiment, if there is no abnormal value in all the formed components in the inspection result by flow cytometry output from the analyzing device 30, the analyzing device 20 analyzes the formed components based on the sample image. Do not execute. In this case, the analyzer 20 displays the analysis result of the formed component output from the analyzer 30 as the analysis result of the sample. Below, the process performed in the analyzer 20 of 6th Embodiment is demonstrated in detail.
FIG. 23 is a flowchart of processing executed by the CPU 211 of the sixth embodiment. The processing in FIG. 23 differs from the processing shown in FIG. 19 in the execution order of step S10, step S10B, and step S20.
More specifically, in the process shown in FIG. 19, the CPU 211 acquires the analysis result by flow cytometry from the analysis device 30 in step S <b> 10 </ b> B. Thereafter, the control proceeds to step S20.
In step S20, the CPU 211 determines whether or not the measurement result of at least one kind of formed component is an abnormal value (out of the reference range) in the result of analysis by flow cytometry. When the CPU 211 determines that the measurement results of all the formed components are normal values (within the reference range), the control proceeds to step S60. In step S60, the CPU 211 determines the result of analysis by flow cytometry as the analysis result of the sample. That is, the CPU 211 displays the analysis result by flow cytometry as the analysis result of the formed component. In this case, the CPU 211 does not capture an image of the sample in the analyzer 20.
On the other hand, if it is determined in step S20 that the measurement result of at least one kind of formed component is an abnormal value in the analysis result by flow cytometry, the CPU 211 advances the control to step S10. In step S10, the CPU 211 captures an image of the specimen for the formation analysis. In the process of FIG. 23, when the control of step S60 is executed after the control of step S10, the analysis result displayed in step S60 may be an inspection result based on the image taken in step S10. In addition, the result obtained from the analysis device 30 (by flow cytometry) may be used.
In the sixth embodiment described above, the component analysis using the image in the analyzer 20 is performed on one or more types of component in the component analysis by flow cytometry input from the analyzer 30. It is executed on condition that the measurement result is out of the reference range. In other words, if the measurement result of all the formed components is within the reference range in the formed component analysis by flow cytometry, the formed component analysis using the image in the analyzer 20 is not executed.
When the analysis system 1 includes the analysis device 10 that performs urine qualitative analysis in addition to the analysis device 30 and the analysis device 20, the analysis device 20 may change the conditions for performing the tangible component analysis using the image. Good. That is, the analysis device 20 may perform the formation analysis when the result of at least one kind of formation is inconsistent with the result of the qualitative analysis by the analysis device 10 in the formation analysis by the analysis device 30. Good.

  In this case, the analyzer 20 does not execute the component analysis if the measurement result of all the components in the component analysis by the analyzer 30 matches the result of the qualitative analysis by the analyzer 10. The CPU 211 displays the result of the component analysis by the analyzer 30 as the result of the component analysis.

  Each embodiment disclosed this time must be considered as illustrative in all points and not restrictive. The scope of the present invention is defined by the terms of the claims, rather than the description above, and is intended to include any modifications within the scope and meaning equivalent to the terms of the claims. In addition, the invention described in the embodiment and each modification is intended to be carried out independently or in combination as much as possible.

DESCRIPTION OF SYMBOLS 1 Analysis system, 4 containers, 7 racks, 10, 20, 30 Analysis apparatus, 20A main body, 20B Conveyance part, 40 Information processing apparatus, 50 Conveyance apparatus, 111, 211, 311, 411 CPU.

Claims (9)

An analyzer for analyzing a formed component of a urine sample,
Image acquisition means for acquiring an image of the specimen;
Information processing means configured to identify each of one or more formed components in the image obtained by the image obtaining means;
A storage means for storing a reference range for each of the one or more types of formed components;
The information processing means includes
When the result specified by the information processing means is within the reference range for all of one or more formed components, the specified result is output as the analysis result of the sample,
For at least one of the one or more types of formed components, information that prompts confirmation of the image of the sample is output when the result specified by the information processing means is outside the reference range. Analytical device. The storage means stores a condition for outputting a result specified by the information processing means as an analysis result of the sample,
The information processing means is a case where the result specified by the information processing means is out of the reference range for at least one of the one or more formed components when the sample satisfies the condition. However, the analyzer according to claim 1, wherein the analyzer is configured to output a result specified by the information processing means as an analysis result of the sample. The information processing means includes
As a result of confirming the image of the sample, accepting input of information indicating that retesting of the sample is necessary or unnecessary,
When information indicating that retesting of the sample is unnecessary is input as a result of checking the sample image, at least a part of the sample image is stored in the storage unit, and the result is the reference range. It is configured to store in association with the type of formation that is outside,
The analyzer according to claim 2, wherein the condition includes that the feature of the image of the specimen matches the feature of the image of the previous specimen stored in the storage unit. The sample further comprises an input means configured to accept an input of a measurement result of another device,
When the result specified by the information processing unit is out of the reference range for the first type of formed component, the information processing unit 4. The apparatus according to claim 1, wherein it is configured to determine whether or not to output information that prompts confirmation of the image of the specimen based on a result of an item related to the formed component. 5. The analyzer described in 1. The input means receives an input of a result of qualitative analysis,
The information processing means includes
In the result of the qualitative analysis, when the result of the item related to the first type of tangible component is in conflict with the result specified by the information processing means, information prompting confirmation of the image of the sample is displayed. Output,
In the result of the qualitative analysis, when the result of the item related to the first type of tangible component matches the result specified by the information processing means, the specified result is analyzed for the specimen. The analyzer according to claim 4, wherein the analyzer is configured to output as a result. The input means accepts input of flow cytometry results;
The information processing means includes
If the measurement result of the first type of tangible component in the flow cytometry conflicts with the result specified by the information processing means, the information for prompting the confirmation of the image of the sample is output,
If the measurement result of the first type of formed component in the flow cytometry matches the result specified by the information processing means, the specified result is output as the analysis result of the sample. The analyzer according to claim 4 or 5, which is configured as described above.   The analyzer according to claim 2 or 3, wherein the condition includes an attribute of a subject corresponding to the specimen. An analysis method for analyzing a formed component of a urine sample,
Obtaining a sample image;
Identifying each of one or more formed components in the specimen using the acquired image; and
When the result specified in the image for all types of one or more formed components is within a predetermined reference range for each type, the specified result is output as the analysis result of the sample. And steps to
And a step of outputting information for prompting confirmation of the image of the specimen when a result specified in the image of at least one of the one or more kinds of formed components is outside the reference range. . An analysis system for analyzing a urine sample,
A first analyzer for outputting an analysis result of the sample using an image of the sample;
A second analyzer that outputs a measurement result of the sample,
The first analyzer is
Image acquisition means for acquiring an image of the specimen;
Information processing means configured to identify each of one or more formed components in the image obtained by the image obtaining means;
Storage means for storing a reference range for each of the one or more formed components;
Input means for receiving an input of the measurement result of the sample by the second analyzer,
When the result specified by the information processing unit is out of the reference range for the first type of formed component, the information processing unit An analysis system configured to determine whether or not to output information that prompts confirmation of an image of the specimen based on a result of an item related to the formed component.

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