JP7586790B2 - Method for checking operation of specimen characteristic discriminating device, and specimen characteristic discriminating device - Google Patents

Description

The present invention relates to a method for checking the operation of a sample characteristic discrimination device, and a sample characteristic discrimination device.

In general, before analyzing a sample such as serum, plasma, or urine, the presence or absence of abnormal samples is confirmed and removed. For example, an operator visually checks whether the sample contains foreign matter such as clots or fibrin, and removes samples that contain foreign matter as abnormal samples. However, this method increases the burden on the operator. To address this issue, it is possible to automatically identify abnormal samples by using a sample property discrimination device that discriminates the properties of the sample. For example, a sample property discrimination device generates an image representing the sample by capturing an image of the sample, and automatically discriminates abnormal samples by performing discrimination processing on the image using image processing or artificial intelligence (AI).

Patent document 1 describes an apparatus that sets the brightness of a backlight based on a sample image, photographs a container that contains a sample to obtain an image, and determines the properties of the sample based on the sample image contained in the image.

JP 2021-4782 A

However, there are many different types of abnormal specimens, and the condition of these specimens (e.g., the shape and color of foreign matter) is unstable. For example, the shape and color of foreign matter contained in a specimen may vary and change from moment to moment depending on the patient from whom the specimen was collected and the management conditions. Therefore, even if such a specimen is introduced into a specimen property discrimination device and an abnormal specimen discrimination process is performed, it is difficult to confirm whether the specimen property discrimination device is operating normally based on the discrimination results, evaluate the performance of the specimen property discrimination device, and determine whether adjustments to the operation of the specimen property discrimination device are necessary.

The object of the present invention is to verify the operation of a specimen property discrimination device that discriminates the properties of a specimen.

One aspect of the present invention is a method for confirming the operation of a specimen characteristic discrimination device that discriminates the characteristics of a specimen, the method comprising the steps of: irradiating light from a light source onto a pseudo specimen containing pseudo fibrin or pseudo clots , imaging the pseudo specimen with an imaging unit installed on the opposite side of the light source with the pseudo specimen in between; irradiating light from the light source onto a non- pseudo specimen that does not contain the pseudo fibrin or pseudo clots , imaging the non-pseudo specimen with the imaging unit; and confirming the operation of the specimen characteristic discrimination device based on the pseudo specimen image generated by imaging the pseudo specimen and the non-pseudo specimen image generated by imaging the non-pseudo specimen.

One aspect of the present invention is a specimen characteristic discrimination device that discriminates the characteristics of a specimen, comprising: a light source installed on one side of an imaging position for a specimen; an imaging unit installed on the opposite side of the light source across the imaging position for imaging the specimen at the imaging position; and a confirmation unit that confirms the operation of the device, wherein a pseudo-specimen containing pseudo fibrin or pseudo clot is imaged by the imaging unit with light from the light source irradiated onto the pseudo-specimen, and a non-pseudo-specimen not containing the pseudo fibrin or pseudo clot is imaged by the imaging unit with light from the light source irradiated onto the non-pseudo-specimen, and the confirmation unit confirms the operation of the device based on the pseudo-specimen image generated by imaging the pseudo-specimen and the non-pseudo-specimen image generated by imaging the non-pseudo-specimen.

According to one aspect of the present invention, it is possible to confirm the operation of a sample property determination device that determines the properties of a sample.

1 is a block diagram showing functions of a sample characteristic determination device according to an embodiment; FIG. 1 is a diagram illustrating a configuration of an imaging apparatus. FIG. 1 is a diagram illustrating a configuration of an imaging apparatus. 4 is a flowchart showing a flow of an operation checking method according to the first embodiment. FIG. 4 is a diagram showing a screen according to the first embodiment; 10 is a flowchart showing a flow of an operation checking method according to a second embodiment. FIG. 11 is a diagram showing a screen according to the second embodiment. 13 is a flowchart showing a flow of an operation checking method according to a third embodiment.

The sample characteristic determination device according to the embodiment will be described with reference to FIG. 1. FIG. 1 is a block diagram showing an example of the configuration of the sample characteristic determination device according to the embodiment.

The specimen property determination device according to the embodiment is, for example, a device that measures abnormalities in specimen properties based on shadows in an image formed by transmitted light. Abnormalities in specimen properties include, for example, blood coagulation and fibrin.

The sample characteristic determination device according to the embodiment includes an imaging device 10, an equipment control unit 12 that controls the devices that constitute the imaging device 10, a sample characteristic determination unit 14, an operation confirmation unit 16, a display unit 18, and an input unit 20.

The imaging device 10 includes a light source and an imaging unit, and is a device that images the specimen 30. For example, the imaging device 10 may image the specimen 30 while rocking a container that holds the specimen 30, or may image the specimen 30 without rocking the container. An image representing the specimen 30 is generated by this imaging.

The device control unit 12 controls the operation of the sample characteristic determination device. For example, the device control unit 12 controls the operation of the imaging device 10, etc.

The specimen characteristics discrimination unit 14 discriminates the characteristics of the specimen 30 based on the image generated by imaging using the imaging device 10. For example, the specimen characteristics discrimination unit 14 applies image processing or discrimination processing using artificial intelligence (AI) to the image to determine whether or not there is an abnormality in the characteristics of the specimen 30, and detects an abnormal specimen having abnormal characteristics. Publicly known image processing or judgment processing may be used as the discrimination processing using image processing or artificial intelligence.

The operation confirmation unit 16 confirms the operation of the specimen characteristic discrimination device based on the image generated by the imaging device 10. The operation confirmation unit 16 may determine the presence or absence of an abnormality in the operation of the specimen characteristic discrimination device based on the image, or may determine whether or not the operation of the specimen characteristic discrimination device needs to be adjusted. The operation of the specimen characteristic discrimination device is, for example, the operation of the light source and imaging unit included in the imaging device 10, or the shaking of the specimen when the specimen is imaged by the imaging device 10.

For example, the operation confirmation unit 16 confirms the operation of the specimen property discrimination device based on a pseudo specimen image generated by imaging a pseudo specimen containing pseudo foreign matter and a non-pseudo specimen image generated by imaging a non-pseudo specimen not containing pseudo foreign matter. The pseudo foreign matter is, for example, a pseudo coagulate or pseudo fibrin. The pseudo foreign matter is an object that remains stable over time. For example, an object whose shape or color does not change over time is used as the pseudo foreign matter.

Specifically, the operation confirmation unit 16 compares the pseudo-sample image with the non-pseudo-sample image, and confirms the operation of the sample characteristic discrimination device based on the comparison result. The operation confirmation unit 16 may evaluate the presence or absence of pseudo foreign matter in the pseudo-sample by performing image analysis on the pseudo-sample image, and evaluate the presence or absence of pseudo foreign matter in the non-pseudo-sample by performing image analysis on the non-pseudo-sample image, and confirm the operation of the sample characteristic discrimination device based on these evaluations.

The display unit 18 is a display such as a liquid crystal display or an EL display. The input unit 20 is a keyboard or a pointing device (e.g., a mouse, a trackball, a pen tablet, a touch pad, a touch panel, etc.). A user interface (e.g., a touch panel, etc.) that combines the display unit 18 and the input unit 20 may be included in the sample property discrimination device.

The device control unit 12 includes an imaging control unit 22, a light source control unit 24, a drive control unit 26, and a system control unit 28.

The imaging control unit 22 controls the imaging unit included in the imaging device 10. The imaging unit is, for example, the camera 34 shown in FIG. 2. The imaging data output from the camera 34 is input to the imaging control unit 22. The imaging control unit 22 converts, for example, compressed imaging data into uncompressed video data such as RGB signals, and outputs an imaging control signal to the system control unit 28 for performing exposure and focus adjustments, etc. according to the brightness and gradation of the video. The imaging control signal is input to the system control unit 28.

The light source control unit 24 controls the light source included in the imaging device 10. The light source is, for example, the backlight 32 shown in FIG. 2. The light source control unit 24 controls the brightness of the backlight 32 according to a light source control signal sent from the system control unit 28. The light source control signal is a signal for controlling the brightness of the backlight 32, which is a light source. For example, the light source control unit 24 controls the brightness of the backlight 32 by outputting a light source voltage signal for controlling the brightness of the backlight 32 to the backlight 32. When a lack of light or halation occurs, the imaging control unit 22 adjusts the exposure by the aperture of the camera 34, etc. When the lack of light or halation cannot be eliminated by this adjustment, the light source control unit 24 adjusts the amount of light output by the backlight 32. Of course, this is just one example of control, and other controls may be performed.

The drive control unit 26 controls a motor for rocking the sample according to a drive control signal sent from the system control unit 28. The drive control signal is a signal for controlling the angle, speed, number of times, etc. of the rocking. For example, the drive control unit 26 controls the motor by outputting a motor voltage signal for driving the motor to the motor, thereby controlling the rocking of the sample.

The system control unit 28 controls the light source control unit 24 and the drive control unit 26 by outputting a light source control signal to the light source control unit 24 and a drive control signal to the drive control unit 26.

Figure 2 shows the configuration of the imaging device 10. The imaging device 10 includes a backlight 32, which is an example of a light source, and a camera 34, which is an example of an imaging unit.

The backlight 32 is installed on one side of the imaging position of the specimen, and the camera 34 is installed on the opposite side of the light source with the imaging position between them. In other words, the backlight 32 and the camera 34 are installed on opposite sides of the specimen, and the specimen is placed between the backlight 32 and the camera 34. The light from the backlight 32 is irradiated onto the specimen, and the specimen is imaged by the camera 34 installed on the opposite side of the backlight 32 with the specimen in between. In this way, the specimen at the imaging position is imaged. The specimen is contained in, for example, a tubular container 36 (e.g., a blood collection tube, etc.). The container 36 is placed between the backlight 32 and the camera 34, and the specimen contained in the container 36 is imaged by the camera 34.

The backlight 32 is an infrared light source or a visible light source, etc. The camera 34 is a color camera, an infrared camera, an ultraviolet camera, etc. The light emitted from the backlight 32 is irradiated onto the specimen 38 contained in the container 36. The light that passes through the specimen 38 is incident on the camera 34. In this way, the camera 34 captures an image of the specimen 38 in the container 36.

Under the control of the drive control unit 26, the container 36 is swung by a motor around axis O as indicated by arrow A. In the example shown in FIG. 2, the container 36 is swung within a range of 0° to 90°. This angle range is merely an example, and the container 36 may be swung within other angle ranges. For example, while the container 36 is being swung, the camera 34 captures an image of the specimen 38 in the container 36, thereby generating an image showing the state of the specimen 38 during the swinging. The angle, speed, and number of swings are controlled by the drive control unit 26. For example, the specimen 38 is mixed by inversion by swinging the container 36, and the specimen is stirred.

To confirm the operation of the specimen property discrimination device, a pseudo specimen containing pseudo foreign matter and a non-pseudo specimen containing no pseudo foreign matter are used. In the example shown in FIG. 2, a pseudo clot 40, which is an example of a pseudo foreign matter, is contained in the specimen 38. The specimen 38 containing the pseudo clot 40 is a pseudo specimen.

Also, as shown in FIG. 3, pseudo fibrin 42, which is an example of a pseudo foreign body, may be contained in the specimen 38. The specimen 38 containing the pseudo fibrin 42 is a pseudo specimen.

The specimen 38 containing the pseudo clot 40 and the specimen 38 containing the pseudo fibrin 42 can be said to be pseudo abnormal specimens. The pseudo abnormal specimens are used to check for the presence or absence of abnormalities in the operation of the specimen property discrimination device. In addition, the pseudo abnormal specimens are used to calibrate the specimen gender discrimination device. The pseudo abnormal specimens can be said to be specimens for calibration.

The following describes a method for creating a sample 38 containing a pseudo coagulant 40, which is an example of a pseudo sample.

First, a calcium solution is added to the citrated horse blood. Next, a specified amount of the solution is poured into a silicon tube or a mold that can be peeled off (for example, a mold made by a 3D printer), thereby creating a clot. Next, the clot is peeled off from the silicon tube or the mold. The peeled clot is used as a pseudo clot 40, which is an example of a pseudo foreign body. The pseudo clot 40 is placed in a whole blood sample, which is an example of a specimen 38. For example, a whole blood sample is contained in a container 36 as the specimen 38, and the pseudo clot 40 is placed in the whole blood sample contained in the container 36. In this way, a specimen 38 containing the pseudo clot 40, that is, a pseudo specimen, is created. It is to be noted that a specified amount of the solution may be poured directly into the container 36 without using a silicon tube or a mold to create a clot. The pseudo clot 40 created in this way is an object whose shape, color, and other conditions do not change over time.

The following describes a method for creating a sample 38 containing pseudo fibrin 42, which is an example of a pseudo sample.

First, colored water resembling serum is created. Next, fibrinogen and thrombin are added to the colored water and the mixture is placed in a mold to create pseudo-fibrin 42. The pseudo-fibrin 42 is peeled from the mold and placed in any aqueous solution. In this way, a specimen 38 containing pseudo-fibrin 42, that is, a pseudo-specimen, is created. The pseudo-fibrin 42 created in this way is an object whose shape, color, and other conditions do not change over time.

A pseudo specimen containing a clot 40 or fibrin 42 whose position has been adjusted may also be created. First, blood or colored water is solidified in the container 36 by a gel. Next, a pseudo clot 40 or pseudo fibrin 42 is placed on the solidified object. Then, gel or blood is poured into the container 36 from above. By adjusting the amount of blood, colored water or gel, a pseudo specimen is created in which the pseudo clot 40 or pseudo fibrin 42 is stably present at any desired position. For example, by using 1-carrageenan as a gel, a pseudo specimen similar to an actual specimen can be created.

Below, we will explain the operation confirmation method for checking the operation of the sample property discrimination device using a pseudo sample.

Example 1
The operation checking method according to the first embodiment will be described below with reference to Fig. 4. Fig. 4 is a flowchart showing the flow of the operation checking method according to the first embodiment.

First, when the user uses the input unit 20 to instruct the device to transition to the operation check mode, the system control unit 28 transitions the mode of the sample property discrimination device to the operation check mode (S01).

Next, a non-simulated specimen N that does not contain any simulated foreign matter is fed into the specimen characterization device (S02). In other words, a non-simulated specimen N that does not contain any simulated coagulants 40 or simulated fibrin 42 is fed into the specimen characterization device.

Next, the imaging device 10 generates a non-pseudo-specimen image representing the non-pseudo-specimen N by imaging the non-pseudo-specimen N (S03). Specifically, a container 36 containing the non-pseudo-specimen N is placed between the backlight 32 and the camera 34, light is irradiated from the backlight 32 onto the non-pseudo-specimen N, and the non-pseudo-specimen N is imaged by the camera 34. In this way, a non-pseudo-specimen image representing the non-pseudo-specimen N is generated. Multiple non-pseudo-specimens N may be imaged, or only one non-pseudo-specimen N may be imaged. The non-pseudo-specimen image is output to the operation confirmation unit 16. The non-pseudo-specimen N may be swung as indicated by the arrow A shown in FIG. 2, and the non-pseudo-specimen N during the swinging may be imaged by the imaging device 10.

Next, a pseudo specimen P containing pseudo foreign matter is input into the specimen property discrimination device (S04). As the pseudo specimen P, only a specimen 38 containing pseudo clots 40 may be used, only a specimen 38 containing pseudo fibrin 42 may be used, or both a specimen 38 containing pseudo clots 40 and a specimen 38 containing pseudo fibrin 42 may be used.

Next, the imaging device 10 generates a pseudo-specimen image representing the pseudo-specimen P by imaging the pseudo-specimen P (S05). Specifically, a container 36 containing the pseudo-specimen P is placed between the backlight 32 and the camera 34, light is irradiated from the backlight 32 onto the pseudo-specimen P, and the pseudo-specimen P is imaged by the camera 34. In this way, a pseudo-specimen image representing the pseudo-specimen P is generated. Multiple pseudo-specimens P may be imaged, or only one pseudo-specimen P may be imaged. The pseudo-specimen image is output to the operation confirmation unit 16. The pseudo-specimen P may be swung as indicated by the arrow A shown in FIG. 2, and the pseudo-specimen P during the swinging may be imaged by the imaging device 10.

The operation confirmation unit 16 confirms the operation of the specimen property discrimination device based on the non-pseudo specimen image and the pseudo specimen image. Specifically, the operation confirmation unit 16 detects pseudo foreign matter (e.g., pseudo coagulant 40 and pseudo fibrin 42) from the non-pseudo specimen image and the pseudo specimen image by applying discrimination processing using image analysis and artificial intelligence to the non-pseudo specimen image and the pseudo specimen image. As the image analysis and discrimination processing, a publicly known image analysis and discrimination processing may be used.

If no pseudo foreign matter (e.g., pseudo clot 40 or pseudo fibrin 42) is detected in the non-pseudo sample image and a pseudo foreign matter is detected in the pseudo sample image (S06, Yes), the operation confirmation unit 16 determines that the operation of the sample property determination device is normal (S07). The operation confirmation unit 16 outputs the determination result to the user (S08). For example, the operation confirmation unit 16 causes the display unit 18 to display the determination result, the non-pseudo sample image, and the pseudo sample image. This display will be described later with reference to FIG. 5.

If a pseudo foreign object is detected from the non-pseudo sample image, if a pseudo foreign object is not detected from the pseudo sample image, or if both are true (S06, No), the operation confirmation unit 16 determines that the operation of the sample characteristic discrimination device is abnormal (S09). In this case, the operation confirmation unit 16 may notify a person in charge of maintenance service for the sample characteristic discrimination device that the operation of the sample characteristic discrimination device is abnormal. The operation confirmation unit 16 may also output the determination result to the user. For example, the operation confirmation unit 16 causes the display unit 18 to display the determination result, the non-pseudo sample image, and the pseudo sample image.

In addition, a plurality of non-pseudo specimens N and a plurality of pseudo specimens P may be imaged, and a plurality of non-pseudo specimen images and a plurality of pseudo specimen images may be generated. In this case, if no pseudo foreign matter is detected from a number of non-pseudo specimen images equal to or greater than a predetermined first threshold, and if pseudo foreign matter is detected from a number of pseudo specimen images equal to or greater than a predetermined second threshold, the operation confirmation unit 16 may determine that the operation of the specimen characteristic discrimination device is normal. In other cases, the operation confirmation unit 16 may determine that the operation of the specimen characteristic discrimination device is abnormal.

Referring to FIG. 5, the judgment results output to the user in steps S08 and S09 will be described. FIG. 5 shows an example of a screen 44 displayed on the display unit 18. The operation confirmation unit 16 displays the screen 44 on the display unit 18. The screen 44 includes an image display area 46, a device status display area 48, and a confirmation result display area 50.

The image display area 46 displays a non-pseudo-sample image 52 representing a non-pseudo-sample N and a pseudo-sample image 54 representing a pseudo-sample P. The device status display area 48 displays the status of the sample characteristic discrimination device. The confirmation result display area 50 displays the results of a confirmation of the operation of the sample characteristic discrimination device. If the operation is determined to be normal, information indicating that the operation is normal is displayed in the confirmation result display area 50. If the operation is determined to be abnormal, information indicating that the operation is abnormal is displayed in the confirmation result display area 50.

In the example shown in FIG. 5, a pseudo foreign body 56 (e.g., a pseudo clot or pseudo fibrin) is shown in the pseudo specimen image 54. A recognition area 58 to which image processing has been applied to detect the pseudo foreign body 56 is also indicated on the pseudo specimen image 54.

According to the operation confirmation method of Example 1, a pseudo specimen containing pseudo foreign matter (e.g., pseudo coagulate 40 or pseudo fibrin 42) can be used to confirm whether the specimen characteristic discrimination device is operating normally. The pseudo foreign matter is more stable over time than actual foreign matter (e.g., foreign matter contained in a specimen collected from a patient), and the shape, color, and other conditions of the pseudo foreign matter remain constant over time. Therefore, by using a pseudo specimen containing pseudo foreign matter, the operation of the specimen characteristic discrimination device can be stably confirmed.

Because there are many different types of actual abnormal samples, and because actual abnormal samples are unstable, it is difficult to stably confirm the operation of the sample characterization device when using actual abnormal samples. It is also difficult to quantitatively evaluate the performance of the sample characterization device. In contrast, by using pseudo samples that contain pseudo foreign matter, it is possible to stably confirm the operation of the sample characterization device and quantitatively evaluate its performance.

In addition, by displaying the determination result as shown in FIG. 5, the determination result (e.g., an abnormality in the operation of the sample characteristic determination device) can be clearly indicated to the user. This allows the user to visually confirm whether or not there is an abnormality in the operation of the sample characteristic determination device.

Example 2
The operation checking method according to the second embodiment will be described below with reference to Fig. 6. Fig. 6 is a flowchart showing the flow of the operation checking method according to the second embodiment.

In Example 2, pseudo fibrin 42 is used as the pseudo foreign matter. In other words, a specimen containing pseudo fibrin 42 is used as the pseudo specimen. The operation of the specimen property determination device to be confirmed is the operation of the light source and the imaging unit included in the imaging device 10, specifically, the operation of the backlight 32 and the camera 34.

First, when the user uses the input unit 20 to instruct the device to transition to the fibrin detection operation mode, the system control unit 28 transitions the mode of the sample property discrimination device to the fibrin detection operation mode (S11).

Next, the system control unit 28 accepts input of fibrin detection conditions (S12). The detection conditions include the number of samples and the size of the fibrin. For example, the system control unit 28 causes the display unit 18 to display a screen for inputting the fibrin detection conditions. The user inputs the detection conditions on that screen. The system control unit 28 accepts the detection conditions input on that screen.

Figure 7 shows an example of a screen 60 for inputting detection conditions. The screen 60 is displayed on the display unit 18. The screen 60 includes an input field 62 for inputting the detection conditions, an image display area 64, an apparatus status display area 66, and an adjustment result display area 68.

In the input field 62, the user inputs search conditions such as the number of samples and the size of fibrin. In the image display area 64, images such as non-pseudo sample images and pseudo sample images are displayed. As with the screen 44 shown in FIG. 5, pseudo foreign bodies and recognition areas to which image processing has been applied may be displayed. In the device status display area 66, the status of the sample characterization device is displayed. In the adjustment result display area 68, the result of checking the operation of the sample characterization device and whether or not adjustment of the sample characterization device is necessary are displayed. For example, if adjustment of the sample characterization device is not necessary, information indicating that adjustment is not necessary is displayed in the adjustment result display area 68. If adjustment of the sample characterization device is necessary, information indicating that adjustment is necessary and information indicating the adjustment to be performed are displayed in the adjustment result display area 68. If a serious error that cannot be resolved by adjustment has occurred in the sample characterization device, a warning indicating a serious error is displayed in the adjustment result display area 68.

Next, non-pseudo specimens N that do not contain pseudo foreign matter and pseudo specimens P that contain pseudo fibrin 42 are each input into the specimen characterization device (S13). Here, non-pseudo specimens N and pseudo specimens P are each input into the specimen characterization device according to the specimen conditions input in step S12. For example, if the respective numbers of non-pseudo specimens N and pseudo specimens P are specified as detection conditions, the specified numbers of non-pseudo specimens N and pseudo specimens P are input into the specimen characterization device.

Next, the imaging device 10 generates a non-pseudo-specimen image representing the non-pseudo-specimen N by imaging the non-pseudo-specimen N, and generates a pseudo-specimen image representing the pseudo-specimen P by imaging the pseudo-specimen P (S14). As shown in FIG. 2, a container 36 containing the non-pseudo-specimen N may be oscillated, and the imaging device 10 may image the non-pseudo-specimen N while it is oscillating. Similarly, a container 36 containing the pseudo-specimen P may be oscillated, and the imaging device 10 may image the pseudo-specimen P while it is oscillating. The imaging device 10 images the non-pseudo-specimen N and the pseudo-specimen P for the number of specimens specified as the detection conditions, and generates non-pseudo-specimen images and pseudo-specimen images for the number of specimens.

If the number of non-pseudo-sample images and pseudo-sample images for the specified number of samples have not been generated (S15, No), the processes of steps S13 and S14 are repeated.

When non-pseudo-specimen images and pseudo-specimen images are generated for the specified number of specimens (S15, Yes), the operation confirmation unit 16 performs image analysis on the non-pseudo-specimen images and pseudo-specimen images to detect pseudo fibrin 42 from each of the non-pseudo-specimen images and pseudo-specimen images, and scores the presence or absence of pseudo fibrin 42 (S16).

For example, image analysis using artificial intelligence or the like is used as the image analysis. Known image analysis may be used as the image analysis. For example, a value between 0 and 1 is obtained as a result of the image analysis. The value is obtained by scoring. The value "0" indicates that no pseudo fibrin 42 is detected, and the value "1" indicates that pseudo fibrin 42 is detected. A value between 0 and 1 corresponds to the probability that pseudo fibrin 42 is present. An image that obtains a value close to the value "0" is an image that is likely to not have pseudo fibrin 42, and an image that obtains a value close to the value "1" is an image that is likely to have pseudo fibrin 42.

That is, the operation confirmation unit 16 performs image analysis on the non-pseudo-sample image to evaluate the presence or absence of pseudo fibrin 42 in the non-pseudo-sample N by scoring, and performs image analysis on the pseudo-sample image to evaluate the presence or absence of pseudo fibrin 42 in the pseudo-sample P by scoring. The operation confirmation unit 16 determines the presence or absence of an abnormality in the operation of the specimen characteristics discrimination device based on the evaluation of the non-pseudo-sample image (i.e., the value obtained by scoring) and the evaluation of the pseudo-sample image (i.e., the value obtained by scoring). Specifically, the operation confirmation unit 16 determines the presence or absence of an abnormality in the operation of the specimen characteristics discrimination device by the processing from step S17 described below. In addition, the operation confirmation unit 16 determines whether or not adjustment of the operation of the specimen characteristics discrimination device is necessary based on the evaluation of the non-pseudo-sample image and the evaluation of the pseudo-sample image. The processing from step S17 onwards will be described below.

The operation confirmation unit 16 judges whether the value obtained by the scoring satisfies criterion 1 (S17). Criterion 1 is a criterion for judging that the operation of the specimen characteristic discrimination device is normal if the value obtained by scoring the non-pseudo-sample image representing a non-pseudo-sample N is in the range of 0 to 0.2, and the value obtained by scoring the pseudo-sample image representing a pseudo-sample P is in the range of 0.8 to 1.0. In other words, criterion 1 is a criterion for judging that the operation of the specimen characteristic discrimination device is normal if the value obtained by scoring the non-pseudo-sample image is less than 0.2, and the value obtained by scoring the pseudo-sample image is 0.8 or more.

If the value obtained from the non-pseudo-sample image and the value obtained from the pseudo-sample image are each within the range indicated by criterion 1, the operation confirmation unit 16 determines that the value obtained by scoring satisfies criterion 1 (S17, Yes). In this case, the operation confirmation unit 16 ends the adjustment of the operation of the sample characteristic discrimination device (S18). In other words, if the value obtained from the non-pseudo-sample image is less than 0.2 and the value obtained from the pseudo-sample image is 0.8 or greater, the operation confirmation unit 16 determines that the value obtained by scoring satisfies criterion 1 and ends the adjustment of the operation of the sample characteristic discrimination device.

The operation confirmation unit 16 may cause the display unit 18 to display a message indicating that adjustment of the operation of the sample characteristic discrimination device is to be completed, a message indicating that the adjustment is not necessary, a message indicating that the sample characteristic discrimination device is operating normally, or the like. For example, these messages are displayed in the adjustment result display area 68 in the screen 60 shown in FIG. 7.

If the value obtained by scoring satisfies criterion 1, it means that pseudo fibrin 42 is not detected in a non-pseudo-specimen image in which pseudo fibrin 42 should not be detected, and pseudo fibrin 42 is detected in a pseudo-specimen image in which pseudo fibrin 42 should be detected. This means that the specimen characterization device is operating normally. In this case, there is no need to adjust the operation of the specimen characterization device, so the adjustment ends.

If at least one of the values obtained from the non-pseudo-sample image and the pseudo-sample image is not within the range indicated by criterion 1, the operation confirmation unit 16 determines that the value obtained by scoring does not satisfy criterion 1 (S17, No). In this case, the process proceeds to step S19. That is, if the value obtained by scoring the non-pseudo-sample image is 0.2 or more, if the value obtained by scoring the pseudo-sample image is less than 0.8, or if both of these conditions are met, the operation confirmation unit 16 determines that the value obtained by scoring does not satisfy criterion 1.

If the value obtained by scoring does not satisfy criterion 1, it means that there is a possibility that pseudo fibrin 42 will be detected from a non-pseudo sample image in which pseudo fibrin 42 should not be detected, that pseudo fibrin 42 will not be detected from a pseudo sample image in which pseudo fibrin 42 should be detected, or that there is a possibility of both. This means that the operation of the specimen characterization device needs to be adjusted, or that a serious error may have occurred in the specimen characterization device. Therefore, further determination processing from step S19 onwards is performed without terminating the adjustment of the operation of the specimen characterization device.

When multiple non-pseudo-sample images N are imaged to generate multiple non-pseudo-sample images, if the values obtained from a number of non-pseudo-sample images equal to or greater than a threshold value among the multiple non-pseudo-sample images do not satisfy criterion 1, the operation confirmation unit 16 may determine that the value obtained by scoring does not satisfy criterion 1. In other words, if the number of non-pseudo-sample images from which values not satisfying criterion 1 are obtained is equal to or greater than a threshold value, the operation confirmation unit 16 may determine that the value obtained by scoring does not satisfy criterion 1.

Similarly, when multiple pseudo sample images P are imaged to generate multiple pseudo sample images, if the values obtained from a number of pseudo sample images among the multiple pseudo sample images equal to or greater than a threshold value do not satisfy criterion 1, the operation confirmation unit 16 may determine that the value obtained by scoring does not satisfy criterion 1. In other words, if the number of pseudo sample images from which values not satisfying criterion 1 are obtained is equal to or greater than a threshold value, the operation confirmation unit 16 may determine that the value obtained by scoring does not satisfy criterion 1.

The value compared with criterion 1 may also be the average of the values obtained by scoring. For example, the operation confirmation unit 16 calculates the average of the values obtained from a plurality of non-pseudo-analyte images (hereinafter referred to as the "non-pseudo-analyte average value"), and calculates the average of the values obtained from a plurality of pseudo-analyte images (hereinafter referred to as the "pseudo-analyte average value"). If the non-pseudo-analyte average value and the pseudo-analyte average value are each included within the range indicated by criterion 1, the operation confirmation unit 16 determines that the value obtained by scoring satisfies criterion 1. If at least one of the non-pseudo-analyte average value and the pseudo-analyte average value is not included within the range indicated by criterion 1, the operation confirmation unit 16 determines that the value obtained by scoring does not satisfy criterion 1.

In step S19, the operation confirmation unit 16 determines whether the value obtained by scoring satisfies criterion 2.

Criterion 2 is a criterion for determining that a serious error has occurred in the sample characteristic discrimination device when the value obtained by scoring a non-pseudo-sample image representing a non-pseudo-sample N is greater than the value obtained by scoring a pseudo-sample image representing a pseudo-sample P, and the value obtained by scoring the pseudo-sample image is within the range of 0 to 0.5 (i.e., the value obtained by scoring the pseudo-sample image is less than 0.5).

If the value obtained by scoring the non-pseudo-sample image is greater than the value obtained by scoring the pseudo-sample image and the value obtained by scoring the pseudo-sample image is within the range of 0 to 0.5 (i.e., the value obtained by scoring the pseudo-sample image is less than 0.5), the operation confirmation unit 16 determines that the value obtained by scoring satisfies criterion 2 (S19, Yes). In this case, the operation confirmation unit 16 issues a serious error warning (S20).

For example, the operation confirmation unit 16 causes the display unit 18 to display a message indicating a warning of a serious error. Specifically, the message is displayed in the adjustment result display area 68 on the screen 60 shown in FIG. 7.

The fact that the value obtained by the scoring satisfies the criterion 2 means that there is a high possibility that pseudo fibrin 42 is detected from a non-pseudo specimen image in which pseudo fibrin 42 should not be detected, and that pseudo fibrin 42 is not detected from a pseudo specimen image in which pseudo fibrin 42 should be detected. This means that there is a possibility that a serious error that cannot be resolved by adjusting the brightness of the backlight 32 or the settings of the camera 34 has occurred in the specimen property discrimination device, or that there is a problem with the pseudo specimen. In this case, since the error cannot be resolved by adjusting the brightness of the backlight 32 or the settings of the camera 34, the operation confirmation unit 16 issues a serious error warning without prompting the user to make the adjustment. For example, the operation confirmation unit 16 causes the display unit 18 to display a message prompting the user to replace the backlight 32 or the camera 34, or a message prompting the user to replace the pseudo specimen, as a message indicating a serious error warning.

If there is at least one non-pseudo-sample image that yields a value greater than the value obtained from the pseudo-sample image, and the value obtained from the pseudo-sample image is within the range of 0 to 0.5, the operation confirmation unit 16 may determine that the value obtained by scoring satisfies criterion 2.

Each value may be an average value. That is, the operation confirmation unit 16 calculates the average value of the values obtained from the multiple non-pseudo-analyte images (i.e., the non-pseudo-analyte average value), and calculates the average value of the values obtained from the multiple pseudo-analyte images (i.e., the pseudo-analyte average value). If the non-pseudo-analyte average value is greater than the pseudo-analyte average value and the pseudo-analyte average value is within the range of 0 to 0.5, the operation confirmation unit 16 may determine that the value obtained by scoring satisfies criterion 2.

If the value obtained by scoring the non-pseudo-specimen image is not greater than the value obtained by scoring the pseudo-specimen image, if the value obtained by scoring the pseudo-specimen image is not within the range of 0 to 0.5 (i.e., if the value is 0.5 or more), or if both of these are true, the operation confirmation unit 16 determines that the value obtained by scoring does not satisfy criterion 2 (S19, No). In this case, at least one of the backlight 32, which is a light source, and the camera 34, which is an imaging unit, is adjusted (S21). For example, the brightness of the backlight 32 is adjusted, or the settings of the camera 34 are adjusted. The adjustment may be performed by the user, or may be performed automatically by the imaging control unit 22 or the light source control unit 24. Specifically, the brightness of the backlight 32 and the settings of the camera 34 are adjusted so that the value obtained by scoring the pseudo-specimen image approaches "1" and the value obtained by scoring the non-pseudo-specimen image approaches "0".

Once the brightness of the backlight 32 and the settings of the camera 34 have been adjusted, processing returns to step S12, and processing from step S12 onwards is executed.

The operation confirmation unit 16 may cause the display unit 18 to display a message prompting the user to adjust the brightness of the backlight 32 or the settings of the camera 34. For example, the message is displayed in the adjustment result display area 68 on the screen 60 shown in FIG. 7.

If the value obtained by scoring does not satisfy criterion 2, it means that there is no possibility that a serious error that cannot be resolved by adjusting the brightness of the backlight 32 or the settings of the camera 34 has occurred in the specimen characterization device, or that no malfunction has occurred in the pseudo specimen. However, because the value obtained by scoring does not satisfy criterion 1, this means that at least the operation of the specimen characterization device needs to be adjusted. For example, this means that the brightness of the backlight 32 or the settings of the camera 34 need to be adjusted, and that such adjustments will allow imaging to be performed under better conditions. Therefore, the brightness of the backlight 32 or the settings of the camera 34 are adjusted.

According to the operation confirmation method of Example 2, it is possible to confirm whether the specimen property discrimination device operates normally using a pseudo specimen containing pseudo fibrin 42. In addition, by using a pseudo specimen containing pseudo fibrin 42 that is stable over time and has a constant shape, color, and other conditions, it is possible to stably determine whether adjustments to the operation of the specimen property discrimination device are necessary.

Example 3
The operation checking method according to the third embodiment will be described below with reference to Fig. 8. Fig. 8 is a flowchart showing the flow of the operation checking method according to the third embodiment.

In Example 3, a pseudo coagulant 40 is used as a pseudo foreign body. That is, a specimen containing a pseudo coagulant 40 is used as a pseudo specimen. The operation of the specimen property determination device to be confirmed is the shaking of the specimen that is performed when the specimen is imaged by the camera 34. Specifically, the shaking is the shaking of the container 36 containing the specimen, as indicated by the arrow A in FIG. 2.

First, when the user uses the input unit 20 to instruct a transition to the operation mode for clot detection, the system control unit 28 transitions the mode of the specimen property determination device to the operation mode for clot detection (S31).

Next, the system control unit 28 accepts input of detection conditions for clots (S32). The detection conditions include the number of samples and the size of the clots. For example, the system control unit 28 causes the display unit 18 to display a screen for inputting detection conditions for clots. The user inputs the detection conditions on that screen. The system control unit 28 accepts the detection conditions input on that screen. For example, a screen similar to the screen 60 shown in FIG. 7 is displayed on the display unit 18, and the user inputs search conditions on that screen.

Next, non-simulated samples N that do not contain any simulated foreign matter are fed into the sample characterization device (S33). Here, the non-simulated samples N are fed into the sample characterization device according to the detection conditions input in step S32. For example, the number of non-simulated samples N is specified as a detection condition, and the specified number of non-simulated samples N are fed into the sample characterization device.

Next, the imaging device 10 generates a non-simulated specimen image representing the non-simulated specimen N by imaging the non-simulated specimen N (S34). For example, as shown in FIG. 2, a container 36 containing the non-simulated specimen N is swung by a motor around an axis O as indicated by an arrow A. The imaging device 10 generates a non-simulated specimen image by imaging the non-simulated specimen N during the oscillation.

The imaging of non-simulated specimens N is continued until the imaging of the non-simulated specimens N for the number of specimens specified as the detection conditions is completed. When the imaging of the non-simulated specimens N for the number of specimens specified is completed, the process proceeds to step 35.

The operation confirmation unit 16 performs image analysis on the non-pseudo-sample image and confirms whether the luminance value obtained from the non-pseudo-sample image is within a predetermined reference range (S35). When multiple non-pseudo-sample images are generated, the operation confirmation unit 16 may calculate the average value of the luminance values of the multiple non-pseudo-sample images and confirm whether the average value is within a reference range.

If the luminance value is not within the reference range (S35, No), the brightness of the backlight 32, which is the light source, and the settings of the camera 34, which is the imaging unit, are adjusted (S36), and the process returns to step S33. The adjustments may be performed by the user, or may be performed automatically by the imaging control unit 22 and the light source control unit 24. The processes of steps S33 to S36 are repeated until the luminance value is within the reference range.

If the brightness value is within the reference range (S35, Yes), the pseudo specimen P containing the pseudo coagulate 40 is input to the specimen characterization device (S37). Here, the pseudo specimen P is input to the specimen characterization device according to the detection conditions input in step S32. For example, the number of pseudo specimens P is specified as a detection condition, and the specified number of pseudo specimens P are input to the specimen characterization device.

Next, the imaging device 10 generates a pseudo-sample image representing the pseudo-sample P by imaging the pseudo-sample P (S37). For example, as shown in FIG. 2, a container 36 containing the pseudo-sample P is swung by a motor around an axis O as indicated by an arrow A. The imaging device 10 generates a pseudo-sample image by imaging the pseudo-sample P during the oscillation.

Images of the pseudo specimens P are captured until the number of specimens specified as the detection conditions has been captured. If images of the pseudo specimens P have not been captured for the number of specimens specified (S38, No), the process of step S37 is repeated.

When imaging of the specified number of pseudo specimens P is completed (S38, Yes), the operation confirmation unit 16 performs image analysis on the non-pseudo specimen image and the pseudo specimen image to detect pseudo clots 40 from each of the non-pseudo specimen image and the pseudo specimen image, and scores the presence or absence of pseudo clots 40 (S39).

For example, image analysis using artificial intelligence or the like is used as the image analysis. Known image analysis may be used as the image analysis. For example, a value between 0 and 1 is obtained as a result of the image analysis. This value is the value obtained by scoring. The value "0" indicates that no false coagulate 40 is detected, and the value "1" indicates that a false coagulate 40 is detected. A value between 0 and 1 corresponds to the probability that a false coagulate 40 is present. An image that obtains a value close to the value "0" is an image that is likely to have no false coagulate 40, and an image that obtains a value close to the value "1" is an image that is likely to have a false coagulate 40.

That is, the operation confirmation unit 16 performs image analysis on the non-pseudo-sample image to evaluate the presence or absence of pseudo coagulation bodies 40 in the non-pseudo-sample N by scoring, and performs image analysis on the pseudo-sample image to evaluate the presence or absence of pseudo coagulation bodies 40 in the pseudo-sample P by scoring. The operation confirmation unit 16 determines the presence or absence of an abnormality in the operation of the specimen characteristics discrimination device based on the evaluation of the non-pseudo-sample image (i.e., the value obtained by scoring) and the evaluation of the pseudo-sample image (i.e., the value obtained by scoring). Specifically, the operation confirmation unit 16 determines the presence or absence of an abnormality in the operation of the specimen characteristics discrimination device by the processing from step S40 described below. In addition, the operation confirmation unit 16 determines whether or not adjustment of the operation of the specimen characteristics discrimination device is necessary based on the evaluation of the non-pseudo-sample image and the evaluation of the pseudo-sample image. The processing from step S40 onwards will be described below.

The operation confirmation unit 16 determines whether the value obtained by scoring satisfies criterion 1 (S40). Criterion 1 used in Example 3 is the same as criterion 1 described in Example 2. In other words, criterion 1 used in Example 3 is a criterion for determining that the operation of the specimen characteristic discrimination device is normal if the value obtained by scoring the non-pseudo-specimen image is within the range of 0 to 0.2 and the value obtained by scoring the pseudo-specimen image is within the range of 0.8 to 1.0.

If the value obtained from the non-pseudo-sample image and the value obtained from the pseudo-sample image are each within the range indicated by criterion 1, the operation confirmation unit 16 determines that the value obtained by scoring satisfies criterion 1 (S40, Yes). In this case, the operation confirmation unit 16 ends the adjustment of the operation of the sample characteristic discrimination device (S41). In other words, if the value obtained from the non-pseudo-sample image is less than 0.2 and the value obtained from the pseudo-sample image is 0.8 or greater, the operation confirmation unit 16 determines that the value obtained by scoring satisfies criterion 1 and ends the adjustment of the operation of the sample characteristic discrimination device.

The operation confirmation unit 16 may cause the display unit 18 to display a message indicating that adjustment of the operation of the sample property discrimination device has been completed, a message indicating that such adjustment is not necessary, a message indicating that the sample property discrimination device is operating normally, etc.

If the value obtained by scoring satisfies criterion 1, it means that no pseudo clot 40 is detected from a non-pseudo-specimen image in which no pseudo clot 40 should be detected, and that a pseudo clot 40 is detected from a pseudo-specimen image in which a pseudo clot 40 should be detected. This means that the specimen property discrimination device is operating normally. In this case, there is no need to adjust the operation of the specimen property discrimination device, and so the adjustment ends.

If at least one of the values obtained from the non-pseudo-sample image and the values obtained from the pseudo-sample image is not within the range indicated by criterion 1, the operation confirmation unit 16 determines that the value obtained by scoring does not satisfy criterion 1 (S40, No). In this case, the process proceeds to step S42.

If the value obtained by scoring does not satisfy criterion 1, it means that there is a possibility that a false clot 40 will be detected from a non-false sample image in which no false clot 40 should be detected, that a false clot 40 will not be detected from a false sample image in which a false clot 40 should be detected, or that there is a possibility of both. This means that the operation of the specimen characterization device needs to be adjusted, or that a serious error may have occurred in the specimen characterization device. Therefore, further determination processing from step S42 onwards is performed without terminating the adjustment of the operation of the specimen characterization device.

When multiple non-pseudo-sample images N are imaged to generate multiple non-pseudo-sample images, if the values obtained from a number of non-pseudo-sample images equal to or greater than a threshold value among the multiple non-pseudo-sample images do not satisfy criterion 1, the operation confirmation unit 16 may determine that the value obtained by scoring does not satisfy criterion 1. In other words, if the number of non-pseudo-sample images from which values not satisfying criterion 1 are obtained is equal to or greater than a threshold value, the operation confirmation unit 16 may determine that the value obtained by scoring does not satisfy criterion 1.

Similarly, when multiple pseudo sample images P are imaged to generate multiple pseudo sample images, if the values obtained from a number of pseudo sample images among the multiple pseudo sample images equal to or greater than a threshold value do not satisfy criterion 1, the operation confirmation unit 16 may determine that the value obtained by scoring does not satisfy criterion 1. In other words, if the number of pseudo sample images from which values not satisfying criterion 1 are obtained is equal to or greater than a threshold value, the operation confirmation unit 16 may determine that the value obtained by scoring does not satisfy criterion 1.

The value compared with criterion 1 may also be the average of the values obtained by scoring. If the non-pseudo-sample average value and the pseudo-sample average value are each included within the range indicated by criterion 1, the operation confirmation unit 16 determines that the value obtained by scoring satisfies criterion 1. If at least one of the non-pseudo-sample average value and the pseudo-sample average value is not included within the range indicated by criterion 1, the operation confirmation unit 16 determines that the value obtained by scoring does not satisfy criterion 1.

In step S42, the operation confirmation unit 16 determines whether the value obtained by scoring satisfies criterion 2.

Criterion 2 used in Example 3 is the same as Criterion 2 described in Example 2. In other words, Criterion 2 used in Example 3 is a criterion for determining that a serious error has occurred in the sample characteristic discrimination device when the value obtained by scoring the non-pseudo-sample image is greater than the value obtained by scoring the pseudo-sample image and the value obtained by scoring the pseudo-sample image is within the range of 0 to 0.5.

If the value obtained by scoring the non-pseudo-sample image is greater than the value obtained by scoring the pseudo-sample image and the value obtained by scoring the pseudo-sample image is within the range of 0 to 0.5, the operation confirmation unit 16 determines that the value obtained by scoring satisfies criterion 2 (S42, Yes). In this case, the operation confirmation unit 16 issues a serious error warning (S43). For example, the operation confirmation unit 16 causes the display unit 18 to display a message indicating a serious error warning.

The fact that the value obtained by the scoring satisfies the criterion 2 means that there is a high possibility that the pseudo clot 40 is detected from the non-pseudo specimen image in which the pseudo clot 40 should not be detected, and that the pseudo clot 40 is not detected from the pseudo specimen image in which the pseudo clot 40 should be detected. This means that there is a possibility that a serious error that cannot be resolved by adjusting the brightness of the backlight 32 or the settings of the camera 34 has occurred in the specimen property discrimination device, or that there is a problem with the pseudo specimen. In this case, since the error cannot be resolved by adjusting the brightness of the backlight 32 or the settings of the camera 34, the operation confirmation unit 16 issues a serious error warning without prompting the user to make the adjustment. For example, the operation confirmation unit 16 causes the display unit 18 to display a message prompting the user to replace the backlight 32 or the camera 34, or a message prompting the user to replace the pseudo specimen, as a message indicating a serious error warning.

If there is at least one non-pseudo-sample image that yields a value greater than the value obtained from the pseudo-sample image, and the value obtained from the pseudo-sample image is within the range of 0 to 0.5, the operation confirmation unit 16 may determine that the value obtained by scoring satisfies criterion 2.

Each value may be an average value. If the non-pseudo-sample average value is greater than the pseudo-sample average value and the pseudo-sample average value is within the range of 0 to 0.5, the operation confirmation unit 16 may determine that the value obtained by scoring satisfies criterion 2.

If the value obtained by scoring the non-pseudo-sample image is not greater than the value obtained by scoring the pseudo-sample image, if the value obtained by scoring the pseudo-sample image is not within the range of 0 to 0.5, or if both of these are true, the operation confirmation unit 16 determines that the value obtained by scoring does not satisfy criterion 2 (S42, No). In this case, the conditions for rocking the sample (hereinafter referred to as "rocking conditions") are adjusted (S44). For example, the rocking conditions include conditions such as the range of rocking angles, the rocking speed, and the number of rocking times. The adjustment may be performed by the user or automatically by the drive control unit 26. Specifically, the rocking conditions are adjusted so that the value obtained by scoring the pseudo-sample image approaches "1" and the value obtained by scoring the non-pseudo-sample image approaches "0".

Once the oscillation conditions have been adjusted, processing returns to step S32, and processing from step S32 onwards is executed.

The operation confirmation unit 16 may cause the display unit 18 to display a message prompting the user to adjust the oscillation conditions.

If the value obtained by scoring does not satisfy criterion 2, it means that there is no possibility that a serious error that cannot be resolved by adjusting the oscillation conditions has occurred in the specimen characterization device, or that no malfunction has occurred in the pseudo specimen. However, because the value obtained by scoring does not satisfy criterion 1, this means that at least the operation of the specimen characterization device needs to be adjusted. For example, this means that the oscillation conditions need to be adjusted. Therefore, the oscillation conditions are adjusted.

According to the operation confirmation method of Example 3, it is possible to confirm whether the specimen property discrimination device operates normally using a pseudo specimen containing a pseudo coagulant 40. In addition, by using a pseudo specimen containing a pseudo coagulant 40 that is stable over time and has a constant shape, color, and other conditions, it is possible to stably determine whether adjustments to the operation of the specimen property discrimination device are necessary.

All or part of the above configurations, functions, processing units, and processing means may be realized by hardware such as an integrated circuit. All or part of the above configurations, functions, processing units, and processing means may be realized by a processor such as a CPU (Central Processing Unit) executing a program. Information such as programs, tables, and files that realize all or part of the above configurations, functions, processing units, and processing means is stored in a storage medium such as a non-volatile semiconductor memory, a hard disk drive, an SSD (Solid State Drive), an IC card, an SD card, or a DVD.

10 imaging device, 16 operation confirmation unit, 18 display unit, 22 imaging control unit, 24 light source control unit, 26 drive control unit, 36 container, 38 specimen, 40 simulated coagulant, 42 simulated fibrin.

Claims (14)

1. A method for verifying the operation of a specimen characteristic discrimination device that discriminates the characteristics of a specimen, comprising:
A pseudo specimen containing pseudo fibrin or a pseudo coagulation is irradiated with light from a light source, and an image of the pseudo specimen is captured by an imaging unit installed on the opposite side of the light source with the pseudo specimen in between;
Irradiating a non-simulated specimen not containing the simulated fibrin or the simulated coagulate with light from the light source, and capturing an image of the non-simulated specimen with the imaging unit;
confirming the operation of the specimen characteristic discrimination device based on a pseudo specimen image generated by imaging the pseudo specimen and a non-pseudo specimen image generated by imaging the non-pseudo specimen;
A method for confirming the operation of a specimen characteristic discriminating device. 2. The method for checking the operation of a specimen characteristic discriminating apparatus according to claim 1,
If the pseudo fibrin or the pseudo clot is detected from the pseudo specimen image and the pseudo fibrin or the pseudo clot is not detected from the non-pseudo specimen image, the operation of the specimen characteristic discrimination device is determined to be normal, and otherwise, the operation of the specimen characteristic discrimination device is determined to be abnormal.
A method for confirming the operation of a specimen characteristic discriminating device. 2. The method for checking the operation of a specimen characteristic discriminating apparatus according to claim 1,
performing image analysis on the pseudo specimen image to evaluate the presence or absence of the pseudo fibrin or the pseudo coagulate in the pseudo specimen;
performing image analysis on the non-simulated specimen image to evaluate the presence or absence of the simulated fibrin or the simulated clot in the non-simulated specimen;
determining whether or not there is an abnormality in the operation of the sample characteristic discriminating device based on the evaluation of the pseudo sample image and the evaluation of the non-pseudo sample image;
A method for confirming the operation of a specimen characteristic discriminating device. 4. The method for checking the operation of a specimen characteristic discriminating apparatus according to claim 3, further comprising:
determining whether or not an adjustment to the operation of the sample characteristic determination device is necessary based on the evaluation of the pseudo sample image and the evaluation of the non-pseudo sample image;
A method for confirming the operation of a specimen characteristic discriminating device. 5. The method for checking the operation of a specimen characteristic discriminating apparatus according to claim 4, further comprising the steps of:
The operation of the sample characteristic determination device is an operation of the light source and the imaging unit, or a vibration of the sample performed when the sample is imaged by the imaging unit.
A method for confirming the operation of a specimen characteristic discriminating device. The method for checking the operation of the specimen characteristic determination device according to any one of claims 1 to 5,
The artificial fibrin is prepared by pouring a predetermined amount of a solution of colored water resembling serum, to which fibrinogen and thrombin have been added, into a predetermined mold, allowing the solution to coagulate, and then peeling off the coagulated mass from the mold.
A method for confirming the operation of a specimen characteristic discriminating device. The method for checking the operation of the specimen characteristic determination device according to any one of claims 1 to 5,
The artificial coagulation body is prepared by pouring a predetermined amount of a solution of citrated horse blood and an aqueous calcium solution into a predetermined mold, allowing the solution to coagulate, and peeling off the coagulated mass from the mold.
A method for confirming the operation of a specimen characteristic discriminating device. A specimen property discrimination device for discriminating the property of a specimen,
A light source disposed on one side of an imaging position of the specimen;
an imaging unit that is installed on the opposite side of the light source across the imaging position and captures an image of a specimen at the imaging position;
A confirmation unit that confirms the operation of the own device;
Including,
a pseudo specimen including a pseudo fibrin or a pseudo coagulant is irradiated with light from the light source, and the pseudo specimen is imaged by the imaging unit;
a non-simulated specimen not containing the simulated fibrin or the simulated coagulate is irradiated with light from the light source, and the non-simulated specimen is imaged by the imaging unit;
the confirmation unit confirms the operation of the device itself based on a pseudo-sample image generated by imaging the pseudo-sample and a non-pseudo-sample image generated by imaging the non-pseudo-sample.
A specimen characteristic discrimination device. The specimen characteristic determination device according to claim 8,
The confirmation unit determines that the operation of the device is normal if the pseudo fibrin or the pseudo clot is detected from the pseudo specimen image and the pseudo fibrin or the pseudo clot is not detected from the non-pseudo specimen image, and otherwise determines that the operation of the device is abnormal.
A specimen characteristic discrimination device comprising: The specimen characteristic determination device according to claim 8,
the confirmation unit evaluates the presence or absence of the pseudo fibrin or the pseudo coagulant in the pseudo specimen by performing image analysis on the pseudo specimen image, evaluates the presence or absence of the pseudo fibrin or the pseudo coagulant in the non-pseudo specimen by performing image analysis on the non-pseudo specimen image, and judges the presence or absence of an abnormality in the operation of the device itself based on the evaluation of the pseudo specimen image and the evaluation of the non-pseudo specimen image.
A specimen characteristic discrimination device comprising: The specimen characteristic determination device according to claim 10,
the confirmation unit determines whether or not adjustment of the operation of the device itself is necessary based on the evaluation of the pseudo sample image and the evaluation of the non-pseudo sample image.
A specimen characteristic discrimination device comprising: The specimen characteristic determination device according to claim 11,
The operation of the own device is an operation of the light source and the imaging unit, or a vibration of the specimen performed when the specimen is imaged by the imaging unit.
A specimen characteristic discrimination device comprising: The specimen characteristic determination device according to any one of claims 8 to 12,
The artificial fibrin is prepared by pouring a predetermined amount of a solution of colored water resembling serum, to which fibrinogen and thrombin have been added, into a predetermined mold, allowing the solution to coagulate, and then peeling off the coagulated mass from the mold.
A specimen characteristic discrimination device. The specimen characteristic determination device according to any one of claims 8 to 12,
The artificial coagulation body is prepared by pouring a predetermined amount of a solution of citrated horse blood and an aqueous calcium solution into a predetermined mold, allowing the solution to coagulate, and peeling off the coagulated mass from the mold.
A specimen characteristic discrimination device comprising:

Images