Sample collection cartridge

Abstract

To enable determination results regarding an infection state to be obtained offline and make it possible to select whether to disclose the determination results.SOLUTION: An information processing device is communicably connected to a management server via a network, and comprises an acquisition unit, an operation unit, a notification unit, and a controller. The controller executes: acquisition processing for, through the acquisition unit, acquiring collection information corresponding to a collection result regarding a specimen of a user; determination processing for determining the infection state of the user on the basis of the collection information without transmitting the collection information to the management server; notification processing for notifying the user of the determination result of the infection state through the notification unit; permission reception processing for receiving, through the operation unit, permission information for permitting disclosure of the determination result regarding the infection state; and transmission processing for transmitting determination information regarding the determination result of the infection state to the management server on the condition that the permission information has been received.SELECTED DRAWING: Figure 20

Description

Technical Field

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[0001] The technology disclosed in this specification relates to an information processing apparatus, an information management method, a computer program, and a specimen collection kit.

Background Art

[0002] Conventionally, there has been known a technology in which a user such as a person to be examined can obtain a diagnosis result of the presence or absence of an antibody or an antigen using a mobile terminal or the like. For example, in the first technology, a camera unit provided in a mobile phone images a judgment part of a test body in which a coloring state is displayed. The mobile phone transmits the obtained image data to a diagnosis server. The diagnosis server detects the presence or absence or concentration of a specific component based on the received image data, and transmits diagnosis data corresponding to the presence or absence or concentration of the detected specific component to the mobile phone (see, for example, Patent Document 1). In the second technology, an antigen test terminal executes an antigen test based on an inserted immunochromatography test kit, and automatically transmits the test result and the presence or absence of infection to a mobile terminal owned by the person to be examined (see, for example, Patent Document 2).

[0003] Also, a blood collection tool for collecting blood from a puncture part of the human body is known (see, for example, Patent Document 2). A conventional blood collection tool has a capillary tube and a push-down chamber. The capillary tube has a tip portion with a small diameter and a base end portion with a large diameter. The chamber communicates with an intermediate portion between the tip portion and the base end portion of the capillary tube. When the chamber is pushed down in a state where the tip portion of the capillary tube is in contact with the blood that has come out of the puncture part, the blood is sucked from the tip portion of the capillary tube to the base end portion (see, for example, Patent Document 3).

Prior Art Documents

Patent Documents

[0004]

Patent Document 1

Patent Document 2

[0005] Conventional technologies 1 and 2 described above have the problem that users cannot obtain the infection status determination result unless their mobile device or other information processing device is connected online to a management server such as a diagnostic server. Furthermore, technology 1 has the problem that the user's infection status determination result is disclosed to a third party regardless of the user's wishes.

[0006] Furthermore, the conventional blood collection devices described above are so-called dropper-type suction devices that utilize the suction force generated by the chamber's restorative force. As a result, the suction force is relatively weak, and there is a risk that a sufficient amount of blood for testing may not be collected. This problem is not limited to blood collection, but is a common issue for the collection and testing of specimens other than blood. A specimen is something that is expelled from or collected from the human body, and in addition to blood, it includes materials obtained through procedures or surgery, such as urine, feces, sputum, saliva, and swabs.

[0007] This specification discloses a technology capable of solving at least one of the problems described above. [Means for solving the problem]

[0008] The technologies disclosed herein can be implemented, for example, in the following forms: (1) The information processing device disclosed herein is connected to a management server via a network for communication. The information processing device comprises an acquisition unit, an operation unit, a notification unit, and a controller. The controller performs the following: an acquisition process for acquiring collection information via the acquisition unit according to the results of the user's sample collection; a determination process for determining the user's infection status based on the collection information without transmitting the collection information to the management server; a notification process for notifying the user of the determination result of the infection status via the notification unit; a permission acceptance process for receiving permission information via the operation unit to permit the disclosure of the determination result of the infection status; and a transmission process for transmitting the determination information regarding the determination result of the infection status to the management server, provided that the permission information has been received. According to this information processing device, a user can obtain the determination result of their infection status offline and can choose whether or not to disclose the determination result. As a result, confidentiality is ensured, and the psychological barrier to receiving an infection status determination is lowered.

[0009] (2) In the above information processing device, the controller may further perform a selection reception process via the operation unit to receive selection information for selecting a set of user-related information to be disclosed from among a plurality of different user-related pieces of information relating to the user, and in the transmission process, on the condition that the permission information has been received, the controller may transmit the user-related information selected by the selection information to the management server in addition to the determination information. With this configuration, the user can select the scope of disclosure of user-related information relating to themselves.

[0010] (3) In the above-mentioned information processing device, the controller may be configured to notify the user of hospitals where they can receive treatment according to their location information in the notification process if the result of the infection status determination is positive and the selection information includes the user's location information. With this configuration, the user can obtain hospitals where they can receive treatment by providing their location information.

[0011] (4) In the above-described information processing device, the controller may further perform a designation reception process via the operation unit to receive designation information, which specifies one of at least two options: obtaining infection warning information, online communication with medical personnel, and face-to-face communication with medical personnel, if the result of the infection status determination is positive. In the notification process, the controller may notify the user of information regarding communication corresponding to the designation information. With this configuration, the user can obtain information such as methods for dealing with the infection in ways that have different levels of confidentiality.

[0012] (5) In the above information processing device, the controller may further perform a timing reception process to receive the timing of recall of infection via the operation unit, and in the notification process, if the result of the infection status determination is negative, the controller may notify the user via the notification unit whether or not the result of the infection status determination is valid based on the timing of recall. With this configuration, the user can know that the result may have been negative because it was not the appropriate time for determination.

[0013] (6) In the above-described information processing device, the acquisition unit may have a camera, and the controller may, in the acquisition process, cause the camera to photograph a test area in the test kit where lines develop color in response to the collected sample, and acquire the image of the test area as the collection information, and in the determination process, convert the image of the test area into a binarized image, detect the presence or absence of lines based on the number of dots in the binarized image, and determine the infection status based on the detection result of the presence or absence of lines. With this configuration, the presence or absence of lines in the test kit can be determined without relying on visual inspection by the user.

[0014] (7) The sampling device disclosed herein is a sampling device for collecting a specimen. The sampling device comprises a syringe having a cylindrical portion having an internal space and a receiving portion covering an opening at one end of the cylindrical portion, and a plunger inserted into the internal space of the cylindrical portion. The receiving portion has a through hole formed therein that penetrates from the outer surface of the receiving portion to the internal space of the cylindrical portion. The through hole includes a first hole opening toward the outer surface of the receiving portion and a second hole located between the first hole and the internal space of the cylindrical portion. The first area of ​​the cross-section of the first hole is greater than the second area of ​​the cross-section of the second hole, and the second area of ​​the second hole is smaller than the internal area of ​​the cross-section of the internal space of the cylindrical portion.

[0015] In this configuration, the first area of ​​the first hole opening to the outer surface of the receiving part is larger than the second area of ​​the second hole. Therefore, compared to a configuration where, for example, the first area of ​​the first hole is less than or equal to the second area of ​​the second hole, it is easier to insert the sample into the through-hole of the receiving part. Conversely, because the second area of ​​the second hole is smaller than the first area of ​​the first hole, the sample in the first hole is less likely to move into the internal space of the cylindrical body, making it easier to determine the amount of sample collected in the first hole. After the sample is inserted into the through-hole, the suction force generated by the plunger being pulled away from the receiving part draws the sample in the first hole into the internal space of the cylindrical body through the second hole. Because the second area of ​​the second hole is smaller than the area of ​​the internal space of the cylindrical body, it is possible to suppress the backflow of the sample that has moved into the internal space back into the first hole. Thus, this configuration makes it possible to achieve ease of sample collection, ease of determining the amount of sample collected, and prevention of leakage of collected sample.

[0016] (8) In the above-described sampling device, the first hole may be configured to open such that the area of ​​its cross-section expands from the side of the second hole toward the outer surface of the receiving portion. With this configuration, for example, it is easier to insert the sample into the through hole (first hole) compared to a configuration in which the area of ​​the cross-section of the first hole is constant.

[0017] (9) In the sampling device described above, the through hole further includes a third hole located between the first hole and the outer surface of the receiving portion, and the expansion rate of the third hole may be configured to be different from the expansion rate of the first hole. This configuration ensures space for the buffer solution and makes it easy to see the boundary between the first hole and the third hole.

[0018] (10) The sample collection kit may be configured to include the sample collection tool and a cartridge having a storage space for housing a test kit. The cartridge has a connecting portion which is connected to the receiving portion of the sample collection tool. The connecting portion has a communication hole which communicates with the first hole of the connected receiving portion and also communicates with the storage space of the cartridge. With this configuration, the sample collection tool can be connected to the cartridge and the plunger of the sample collection tool can be pushed in to dispense the sample inside the cylinder into the test kit.

[0019] (11) In the sample collection kit described above, the through hole may further include a fourth hole located between the first hole and the outer surface of the receiving portion. The fourth hole opens such that the area of ​​its cross-section expands from the side of the first hole toward the side of the outer surface of the receiving portion. The connecting portion of the cartridge has a contact portion that contacts the inner circumferential surface of the fourth hole of the through hole over its entire circumference. With this configuration, leakage of samples and air can be suppressed by the tight contact between the inner circumferential surface of the fourth hole and the contact portion.

[0020] Furthermore, the technologies disclosed herein can be implemented in various forms, for example, as a collection device, a blood collection device, a specimen collection kit, a blood collection kit, a receiving member (attachment) provided on a syringe, an information processing device, a reader, an infection determination device, an information management method, an information management program, an infection determination method, an infection determination program, and so on. [Brief explanation of the drawing]

[0021] [Figure 1] A schematic perspective view showing the overall configuration of the blood collection kit 1 in the first embodiment. [Figure 2] Explanatory drawing showing the configuration of the longitudinal section of the blood collection device 100 [Figure 3] Explanatory drawing showing the configuration of the side surface of the attachment 30 [Figure 4] Explanatory drawing showing the configuration of the longitudinal section of the attachment 30 [Figure 5] Explanatory drawing showing the configuration of the plane of the attachment 30 [Figure 6] Perspective view showing the external appearance configuration of the cartridge 200 [Figure 7] Explanatory drawing showing the state change of the blood collection device 100 during blood collection [Figure 8] Explanatory drawing showing the connection process between the blood collection device 100 and the cartridge 200 [Figure 9] Explanatory drawing showing the state after the transfer of blood B from the blood collection device 100 to the cartridge 200 [Figure 10] Explanatory drawing showing the configuration of the information management system in the second embodiment [Figure 11] Top view showing the external appearance configuration of the cartridge and the reader [Figure 12] Cross-sectional view showing the internal configuration of the cartridge and the reader [Figure 13] Top view showing the configuration of the cartridge body [Figure 14] Perspective view showing the configuration of the cartridge cap [Figure 15] Side view showing the configuration of the cartridge cap [Figure 16] Cross-sectional view showing an enlarged front side portion of the cartridge in FIG. 12 [Figure 17] Explanatory drawing showing the usage process of the cartridge [Figure 18] Flowchart showing the infection determination process [Figure 19] Explanatory drawing showing the detection process of the presence or absence of lines on the immunochromatographic test strip [Figure 20] Explanatory drawing showing the screen display of the mobile terminal

Modes for Carrying Out the Invention

[0022] A. First Embodiment: A-1. Components of blood collection kit 1: Figure 1 is a schematic perspective view showing the overall configuration of the blood collection kit 1 in this first embodiment. The blood collection kit 1 is an example of a specimen collection kit. The blood collection kit 1 is used in specimen testing to determine the presence or absence of specific diseases by collecting blood B (see Figure 7 below) from the human body and dropping that blood B onto an immunochromatographic test piece. Immunochromatography (immunochromatographic method) is a testing method that uses antigen-antibody reactions to determine the presence or absence of antibodies or antigens. The blood collection kit 1 makes it possible for individuals to properly and safely perform the series of operations from blood B collection to dropping blood B onto an immunochromatographic test piece at home or elsewhere, without relying on specialists such as medical personnel.

[0023] As shown in Figure 1, the blood collection kit 1 comprises a blood collection device 100 and a cartridge 200. The blood collection device 100 is a device for collecting blood B from a puncture site in the human body. The blood collection device 100 is an example of a collection device, and blood B is an example of a specimen. The cartridge 200 is a case for containing an immunochromatographic test piece. Figure 1 shows the blood collection device 100 and the cartridge 200 connected together.

[0024] (Composition of blood collection device 100): Figure 2 is an explanatory diagram showing the configuration of the longitudinal section of the blood collection device 100. In this specification, "longitudinal section" refers to a section along the longitudinal direction (up and down direction in the paper of Figures 1 and 2) of the blood collection device 100 (syringe 10 described later), and "transverse section" refers to a section perpendicular to the longitudinal direction. As shown in Figures 1 and 2, the blood collection device 100 comprises a syringe 10 and a plunger 20. The syringe 10 is sometimes called a syringe barrel or outer barrel. The plunger 20 is sometimes called a plunger.

[0025] The syringe 10 has a cylindrical portion 11 and an attachment 30. Preferably, the syringe 10 is made of a light-transmitting material (such as glass or resin). The attachment 30 is an example of a receiving portion. The attachment 30 is provided on one end of the cylindrical portion 11 in the longitudinal direction. Hereinafter, the side of the syringe 10 (cylindrical portion 11) with the attachment 30 will be referred to as the "tip side," and the side opposite to the attachment 30 will be referred to as the "base end side."

[0026] The cylindrical portion 11 is a cylindrical body that extends in a straight line as a whole. The cylindrical portion 11 has a barrel 15 and a lure 16 located on the tip side of the barrel 15 (see Figure 2). The barrel 15 is the portion that extends from the base end to the tip side of the cylindrical portion 11 (downward direction in the plane of the paper in Figures 1 and 2), and the lure 16 is the portion that extends from the tip side to the base end side of the cylindrical portion 11 (upward direction in the plane of the paper in Figures 1 and 2). The outer diameter of the barrel 15 is larger than the outer diameter of the lure 16.

[0027] The barrel space 15A, which is the internal space of the barrel 15, extends linearly along the longitudinal direction of the cylindrical portion 11. The barrel space 15A is a cylindrical space with the same diameter along its entire length in the longitudinal direction. The Luer space 16A, which is the internal space of the Luer 16, extends linearly along the longitudinal direction of the cylindrical portion 11. The Luer space 16A is a cylindrical space with the same diameter along its entire length in the longitudinal direction. The tip of the barrel space 15A and the base end of the Luer space 16A are in communication. The inner diameter of the Luer space 16A is smaller than the inner diameter of the barrel space 15A, and a step 17 is formed between the barrel space 15A and the Luer space 16A. The barrel space 15A and the Luer space 16A are examples of internal spaces.

[0028] An annular portion 18 is provided at the tip of the cylindrical portion 11. The annular portion 18 is positioned to surround the lure 16 from the tip of the barrel 15. An annular gap 14 is formed between the lure 16 and the annular portion 18. A flange 12 is formed on the outer circumferential surface of the base end of the cylindrical portion 11, projecting radially outward. The flange 12 functions as a finger grip for the operator to hook their fingers onto.

[0029] The attachment 30 is positioned to cover the opening at the tip of the cylindrical portion 11. The configuration of the attachment 30 will be described later.

[0030] The plunger 20 is a rod-shaped body that extends in a straight line. The plunger 20 is made of, for example, glass or resin. The plunger 20 is inserted into the barrel space 15A of the cylindrical portion 11 so as to be movable in the longitudinal direction of the cylindrical portion 11. A gasket 22 is joined to the tip of the plunger 20. The gasket 22 is made of, for example, an elastic material, such as rubber. The outer diameter of the gasket 22 is approximately the same as the inner diameter of the barrel space 15A, and the outer surface of the gasket 22 is in close contact with the inner surface of the cylindrical portion 11 that constitutes the barrel space 15A over its entire circumference. Since the outer diameter of the gasket 22 is larger than the inner diameter of the lure space 16A, the movement of the gasket 22 (plunger 20) toward the tip side of the step 17 is restricted.

[0031] The base end of the plunger 20 is provided with a gripping portion 24 and a flange 26. The flange 26 is formed to protrude radially outward from the outer circumferential surface of the base end of the plunger 20. As shown in Figure 2, the flange 26 is configured to contact the flange 12 when the gasket 22 moves to a position where it abuts the step 17 of the cylindrical portion 11 or to a position just before that. The gripping portion 24 is the part of the plunger 20 that protrudes further towards the base end than the flange 26. For example, as shown in Figures 1 and 2, when the gasket 22 is pushed in to the tip side of the barrel space 15A of the cylindrical portion 11, the operator can grasp the gripping portion 24 with their fingers and pull the plunger 20 out of the barrel space 15A of the cylindrical portion 11.

[0032] (Detailed configuration of attachment 30): Figure 3 is an explanatory diagram showing the side configuration of attachment 30, Figure 4 is an explanatory diagram showing the longitudinal cross-sectional configuration of attachment 30, and Figure 5 is an explanatory diagram showing the planar configuration of attachment 30. Figure 4 shows the cross-sectional configuration of attachment 30 at position IV-IV in Figure 3.

[0033] As shown in Figures 3 to 5, the attachment 30 is a cylindrical member as a whole. The attachment 30 is made of, for example, resin. The attachment 30 includes a mounting portion 31 and a receiving portion 33 located on the tip side of the mounting portion 31. The mounting portion 31 and the receiving portion 33 are integrally formed, but they may be separate parts. The mounting portion 31 is the portion that includes the base end of the attachment 30. The mounting portion 31 is cylindrical, and the inner diameter of the mounting portion 31 is larger than the outer diameter of the Luer 16 of the cylindrical portion 11, and the outer diameter of the mounting portion 31 is smaller than the inner diameter of the annular portion 18 (see Figure 2). Therefore, the mounting portion 31 can be inserted into the gap 14 between the Luer 16 and the annular portion 18. A male thread 35 is formed on the outer circumferential surface of the mounting portion 31 (see Figures 3 and 4), and a female thread (not shown) that screws into the male thread 35 is formed on the inner circumferential surface of the annular portion 18. The attachment 30 can be attached to the tip of the cylindrical portion 11 by screwing the male thread 35 of the mounting portion 31 into the female thread of the annular portion 18. The attachment 30 may or may not be detachable from the cylindrical portion 11.

[0034] The receiving portion 33 is the part that includes the tip of the attachment 30. The receiving portion 33 is cylindrical and has a through hole 34 that penetrates it in the direction of the central axis of the attachment 30 (the longitudinal direction of the syringe 10) (see Figure 4). The base end of the through hole 34 communicates with the space 32 on the inner circumference side of the mounting portion 31, and the tip of the through hole 34 opens to the tip surface 36 (an example of the outer surface) of the attachment 30.

[0035] The through hole 34 includes a first hole 34A, a second hole 34B, a third hole 34C, and a fourth hole 34D (see Figure 4).

[0036] The first hole 34A is a recess that opens radially toward the tip surface 36 of the attachment 30. The second hole 34B is located on the base side of the first hole 34A. The base end of the first hole 34A communicates with the tip of the second hole 34B. The first area of ​​the cross-section of the first hole 34A (the opening area at the tip of the first hole 34A) is larger than the second area of ​​the cross-section of the second hole 34B. The second area of ​​the second hole 34B is smaller than the internal area of ​​the cross-section of the Luer space 16A of the cylindrical portion 11. That is, the diameter of the second hole 34B (for example, 1.5 mm or less) is smaller than the diameter of the first hole 34A and also smaller than the diameter of the Luer space 16A (see Figure 2).

[0037] The first hole 34A opens such that its cross-sectional area expands from the side of the second hole 34B toward the tip surface 36 of the attachment 30. That is, the shape of the first hole 34A is a cone that opens radially toward the tip surface 36. The diameter of the second hole 34B is substantially the same along its entire length.

[0038] The third hole 34C is located closer to the tip than the first hole 34A. The base end of the third hole 34C communicates with the tip of the first hole 34A. The diameter of the third hole 34C is greater than or equal to the opening diameter at the tip of the first hole 34A. The diameter of the third hole 34C is substantially the same along its entire length. In other words, the expansion ratio of the third hole 34C is smaller than the expansion ratio of the first hole 34A. The expansion ratio is the degree to which the opening area (diameter) of each hole expands towards the tip surface 36. It is preferable that there is no step between the first hole 34A and the third hole 34C.

[0039] The fourth hole 34D is located between the third hole 34C and the tip surface 36 of the attachment 30. The tip of the fourth hole 34D faces the tip surface 36, and the base end of the fourth hole 34D communicates with the third hole 34C. The fourth hole 34D opens such that the area of ​​its cross-section expands toward the tip surface 36. That is, the inner circumferential surface 40 constituting the fourth hole 34D is a tapered surface that opens radially toward the tip surface 36. When viewed in the axial direction of the attachment 30 (the longitudinal direction of the syringe 10), the fourth hole 34D is located outside the first hole 34A (third hole 34C) and is arranged to surround the entire circumference of the first hole 34A (third hole 34C).

[0040] As shown in Figures 3 and 5, the attachment 30 has a plurality (for example, four) of protrusions 42. Each protrusion 42 projects radially outward from the outer circumferential surface of the tip of the attachment 30. The plurality of protrusions 42 are arranged at equal intervals in the circumferential direction of the central axis of the attachment 30.

[0041] (Cartridge 200 configuration) Figure 6 is a perspective view showing the external configuration of cartridge 200. The cartridge 200 is rectangular in shape overall. The cartridge 200 has a base 210 and a cover 220. A rectangular housing space 211 is formed on the upper surface of the base 210. The housing space 211 is a space for housing an immunochromatographic test specimen (not shown).

[0042] The cover 220 is a rectangular plate-like member, preferably made of a light-transmitting material (such as glass or resin). The cover 220 is positioned to cover the housing space 211 of the base 210. The cover 220 is positioned to cover the entire immunochromatographic test specimen housed in the housing space 211.

[0043] The cover 220 has a connecting portion 221. A communication hole 224 is formed in the connecting portion 221. The communication hole 224 communicates with the through hole 34 of the connected attachment 30 and also communicates with the housing space 211 of the cartridge 200. The communication hole 224 is positioned directly above the sample pad of the immunochromatographic test specimen housed in the housing space 211.

[0044] The connecting portion 221 has a plurality (for example, four) of engaging portions 226. Each engaging portion 226 protrudes radially inward from the communication hole 224. The plurality of engaging portions 226 are arranged at equal intervals in the circumferential direction of the communication hole 224. Each protruding portion 42 of the attachment 30 is inserted between two adjacent engaging portions 226, to the back side of the communication hole 224 of the cover 220 (lower side in Figure 6) beyond the engaging portions 226. Next, by rotating the attachment 30, each protruding portion 42 moves downward from each engaging portion 226. This connects the attachment 30 to the cover 220 and prevents it from coming loose.

[0045] The connecting portion 221 has a contact portion 228. The contact portion 228 contacts the inner circumferential surface 40 of the attachment 30 connected to the connecting portion 221 over its entire circumference. The contact portion 228 is an annular portion that surrounds the entire circumference of the communication hole 224 and has a tapered surface that decreases in diameter towards the upper side (the side facing the attachment 30).

[0046] A camera window 222 is formed in the cover 220. The camera window 222 is positioned directly above the membrane (the part where the test lines and control lines appear) of the immunochromatographic test specimen housed in the containment space 211. The camera window 222 is thinner than the rest of the cover 220 and has high light transmittance. As a result, each line appearing on the immunochromatographic test specimen can be clearly photographed by an external camera.

[0047] A-2. How to use blood collection kit 1: (Blood sample collection for blood type B): Figure 7 is an explanatory diagram showing the changes in the state of the blood collection device 100 during blood collection. First, the blood collection device 100 is put into a pushed-in state. The pushed-in state is when the plunger 20 is pushed into the barrel space 15A such that the gasket 22 is located at the tip of the barrel space 15A of the syringe 10. Next, the fingertip is punctured with a lancet (not shown) to induce bleeding. Next, as shown in the right diagram of Figure 7, the attachment 30 of the blood collection device 100 in the pushed-in state is placed upwards, and the bleeding fingertip is placed against the opening of the through-hole 34 of the attachment 30, allowing the blood B to drip into the through-hole 34. The diameter of the second hole 34B is set to a size (for example, 1 mm or more and 1.5 mm or less) such that the blood B cannot pass through the second hole 34B by its own weight due to surface tension, etc. Therefore, as shown in the center diagram of Figure 7, the collected blood B accumulates in the first hole 34A of the attachment 30. The volume of the first well 34A is an amount that can be normally tested by an immunochromatographic test specimen (e.g., 45 μml or more, and 55 μml or less).

[0048] Next, buffer solution C is dropped onto the blood B accumulated in the first hole 34A using the dropper 230, and the dropped buffer solution C accumulates in the third hole 34C. Buffer solution C is used to reduce the viscosity of the sample, allowing it to pass smoothly over the membrane, and is buffer solution C (e.g., saline solution). Next, as shown in the left diagram of Figure 7, a strong suction force is generated by pulling the plunger 20 away from the attachment 30 (downward in Figure 7). Due to this suction force, the blood B in the first hole 34A and the buffer solution C in the third hole 34C move through the second hole 34B and mix within the internal space of the cylindrical part 11 (barrel space 15A and Luer space 16A), becoming a mixed solution M. This completes the blood collection of blood B. The volume of the first hole 34A (through hole 34) is larger than the volume of the barrel space 15A of the cylindrical part 11. Therefore, all of the mixed liquid M in the through-hole 34 can be drawn into the barrel space 15A.

[0049] (Dropping of blood B onto an immunochromatographic test strip): Figure 8 is an explanatory diagram showing the process of connecting the blood collection device 100 and the cartridge 200, and Figure 9 is an explanatory diagram showing the state after the blood B has been transferred from the blood collection device 100 to the cartridge 200. As shown in the upper part of Figure 8, the attachment 30 of the blood collection device 100 is placed downwards after blood collection and connected to the connecting part 221 of the cartridge 200. At this time, the mixed liquid M contained in the internal space of the cylindrical part 11 does not pass through the second hole 34B due to its own weight. In other words, it is possible to prevent the mixed liquid M from falling out of the blood collection device 100.

[0050] When the tip of the attachment 30 is inserted into the communication hole 224 of the connecting part 221 and the attachment 30 is rotated, the protruding part 42 of the attachment 30 and the engaging part 226 of the connecting part 221 engage, as shown in the lower diagram of Figure 8. As a result, the blood collection device 100 is connected to the connecting part 221 (cartridge 200) in a state where it cannot be detached. At this time, the inner circumferential surface 40 of the attachment 30 and the contact part 228 of the connecting part 221 are in close contact around the entire circumference. Therefore, the through hole 34 of the attachment 30 and the communication hole 224 of the connecting part 221 communicate in a sealed state.

[0051] Next, as shown in Figure 9, when the plunger 20 is pushed into the barrel space 15A, the mixed liquid M passes through the second hole 34B and is dropped onto the sample pad of the immunochromatographic test specimen through the communication hole 224. The immunochromatographic test result can be obtained by inserting the cartridge 200 containing the immunochromatographic test specimen onto which the mixed liquid M has been dropped into a known determination device (not shown).

[0052] A-3. Effects of this embodiment: As explained above, in this embodiment, the first area of ​​the cross-section of the first hole 34A is larger than the second area of ​​the cross-section of the second hole 34B (see Figure 4). For this reason, compared to a configuration in which, for example, the first area of ​​the first hole 34A is less than or equal to the second area of ​​the second hole 34B, it is easier to place the sample (blood B) into the through-hole 34 of the attachment 30. Conversely, because the second area of ​​the second hole 34B is smaller than the first area of ​​the first hole 34A, it is difficult for the sample in the first hole 34A to move into the internal space (barrel space 15A) of the syringe 10, and it is easier to grasp the amount of sample collected in the first hole 34A.

[0053] After the sample is placed in the through-hole 34, the suction force generated by the plunger 20 being pulled away from the attachment 30 draws the sample in the first hole 34A through the second hole 34B into the internal space (barrel space 15A) of the syringe 10. Since the second area of ​​the second hole 34B is smaller than the area of ​​the internal space (barrel space 15A) (see Figure 2), it is possible to suppress the backflow of the sample that has moved into the internal space back into the first hole 34A.

[0054] Thus, according to this embodiment, it is possible to achieve ease of sample collection, control over the amount of sample collected, and prevention of leakage of the collected sample.

[0055] In this embodiment, the first hole 34A opens such that the cross-sectional area expands from the side of the second hole 34B toward the tip surface 36 of the attachment 30 (see Figure 4). This makes it easier to insert the specimen into the through hole 34 (first hole 34A) compared to, for example, a configuration in which the cross-sectional area of ​​the first hole 34A is constant.

[0056] The third hole 34C is located closer to the tip than the first hole 34A, and space for buffer solution C is secured. The expansion rate of the third hole 34C is different from that of the first hole 34A. Therefore, the boundary between the first hole 34A and the third hole 34C can be easily identified by the difference in their expansion rates. Since the expansion rate of the third hole 34C is smaller than that of the first hole 34A, it is easy to determine whether or not buffer solution C has been dropped into the third hole 34C.

[0057] B. Second Embodiment: B-1. Configuration of Information Management System 1A: Figure 10 is an explanatory diagram showing the configuration of the information management system 1A in this embodiment. The information management system 1A comprises multiple terminal devices 11A (first terminal device 11A1, second terminal device 11A2) each owned by multiple medical institutions 10A (first medical institution 10A1, second medical institution 10A2), a terminal device 51 owned by a public institution 50, a management server 400, and multiple user terminal devices 500. Each device and system is connected to each other via a network NW. Medical institutions 10A are, for example, facilities such as hospitals, clinics, medical offices, home nursing stations, care support offices, and care service offices. Public institutions 50 are, for example, facilities such as social welfare corporations, medical corporations, public health centers, and municipal offices. Although two medical institutions 10A are shown in Figure 10, the number of medical institutions 10A included in the information management system 1A may be one or three or more. Similarly, although Figure 10 shows two user terminal devices 500, the number of user terminal devices 500 included in the information management system 1A may be one or three or more. Although Figure 10 shows one public institution 50, the number of public institutions 50 included in the information management system 1A may be two or more. The user terminal device 500 is an example of an information processing device.

[0058] The terminal device 11A owned by the medical institution 10A is a computer that supports the work of each doctor and staff member by enabling them to record and access medical information such as examination results and test results created by each doctor and staff member belonging to the medical institution 10A. Examples of terminal devices 11A include personal computers, tablet terminals, and smartphones.

[0059] The terminal device 11A comprises a control unit 120, a storage unit 130, and a communication unit 140. The storage unit 130 is composed of, for example, a hard disk drive (hereinafter referred to as "HDD"), ROM, RAM, or a cloud that ensures the prevention of confidential information leakage, and stores various data such as the medical information of the user (patient, etc.) and various programs for controlling the terminal device 11A. The communication unit 140 is an interface that communicates with external devices using a wireless communication method or a wired communication method. The control unit 120 is composed of, for example, a central control unit (hereinafter referred to as "CPU"), and controls each part of the terminal device 11A according to the program read from the storage unit 130.

[0060] The terminal device 51 owned by the public institution 50 is a computer that supports the work of doctors and other staff members by enabling them to record and, when necessary, access medical information such as examination results and test results created by each staff member belonging to the public institution 50. Examples of terminal devices 51 include personal computers, tablet terminals, and smartphones.

[0061] The terminal device 51 comprises a control unit 52, a storage unit 54, and a communication unit 56. The storage unit 54 is composed of, for example, a hard disk drive (hereinafter referred to as "HDD"), ROM, RAM, or a cloud that ensures the prevention of confidential information leakage, and stores various data such as the user's medical information and various programs for controlling the terminal device 51. The communication unit 56 is an interface that communicates with external devices using wireless or wired communication methods. The control unit 120 is composed of, for example, a CPU, and controls each part of the terminal device 51 according to the program read from the storage unit 52.

[0062] The management server 400 is a device that manages personal information of users and information regarding infection diagnosis results transmitted from each user terminal device 500. The management server 400 comprises a control unit 420, a storage unit 430, a communication unit 440, an operation unit 450, and a display unit 460. The storage unit 430 is composed of, for example, an HDD, ROM, RAM, or a cloud with guaranteed protection against confidential information leakage, and stores various data such as users' medical information and various programs for controlling the management server 400. The communication unit 440 is an interface that communicates with external devices using wireless or wired communication methods. The operation unit 450 is composed of, for example, a keyboard or mouse, and accepts operations from the administrator. The display unit 460 is composed of, for example, a liquid crystal display. The control unit 420 is composed of, for example, a CPU, and controls each part of the management server 400 according to the program read from the storage unit 430.

[0063] The user terminal device 500 is a device used by the user, such as a personal computer, tablet, or smartphone. The user terminal device 500 is installed, for example, at the user's home, workplace, medical institutions 10A, or public institutions 50. The user terminal device 500 comprises a control unit 520, a storage unit 530, a communication unit 540, an operation unit 550, and a display unit 560. The storage unit 530 is composed of, for example, an HDD, ROM, RAM, or a cloud with guaranteed protection against confidential information leakage, and stores various data and various programs for controlling the user terminal device 500 (including the infection detection processing program described later). The communication unit 540 is an interface that communicates with external devices using wireless or wired communication methods. In this embodiment, the reader 300 is connected to the user terminal device 500 via the communication unit 540 in a communicative manner. The operation unit 550 is composed of, for example, a keyboard or mouse, and accepts user operations. The display unit 560 is composed of, for example, a liquid crystal display (see Figure 20 below). The control unit 520 is composed of, for example, a CPU, and controls each part of the user terminal device 500 according to the program read from the storage unit 530. The control unit 520 is an example of a controller, and the display unit 560 is an example of a notification unit.

[0064] B-2. Cartridge and Reader Configuration: Figure 11 is a top view showing the external configuration of cartridge 200A and reader 300, and Figure 12 is a cross-sectional view showing the internal configuration of cartridge 200A and reader 300. Figure 12 shows the cross-sectional configuration of cartridge 200A and reader 300 at position XII-XII in Figure 11. Cartridge 200A houses the immunochromatographic test specimen P (see Figure 19 below). Reader 300 photographs each line appearing on the immunochromatographic test specimen P housed in cartridge 200A (see Figure 19 below), generates image data of the lines, and transmits it to the user terminal device 500.

[0065] As shown in Figures 11 and 12, the reader 300 includes a housing 311, a camera 313, a control board 314, a battery 315, a communication port 316, a first indicator light 312a, and a second indicator light 312b. The housing 311 is made of, for example, a resin material, bioplastic, or metal.

[0066] The housing 311 is a rectangular box-shaped body overall. Inside the housing 311, a cartridge storage space 318 and an equipment storage space S1 are provided. The cartridge storage space 318 is a space that extends linearly along the longitudinal direction of the housing 311. An insertion slot 318A is formed on one end face in the longitudinal direction of the housing 311 (the face on the positive Y-axis side). The cartridge storage space 318 communicates with the insertion slot 318A. The cartridge 200A is housed in the cartridge storage space 318 via the insertion slot 318A. Inside the housing 311, a passage 317 is formed that connects the cartridge storage space 318 and the equipment storage space S1. The passage 317 is a path that penetrates in the vertical direction (Z-axis direction). The passage 317 is positioned such that the camera window 222A of the cartridge 200A housed in the cartridge storage space 318 (described later) is located directly below the passage 317.

[0067] The equipment housing space S1 houses a camera 313, a control board 314, and a battery 315. The camera 313 is positioned above the communication passage 317. The camera 313 captures an image directly below the communication passage 317 and outputs image data corresponding to the captured image. The camera 313 is positioned so as to be able to capture the camera window 222A (membrane of the immunochromatographic test piece P) of the cartridge 200A, which is housed in the normal reference position in the cartridge housing space 318, via the communication passage 317. The battery 315 supplies power to the camera 313 and the control board 314. The reader 300 may be configured to be powered by an external power source (e.g., a user terminal device 500) without a battery 315. The communication port 316 is connected to the user terminal device 500 via a wired connection, such as a USB (Universal Serial Bus) cable. The reader 300 may also be configured to be connected to the user terminal device 500 via wireless communication.

[0068] The control board 314 controls each device of the reader 300. The first indicator light 312a and the second indicator light 312b are located on the outer surface (top surface) of the housing 311. The first indicator light 312a and the second indicator light 312b light up in various lighting patterns according to the determination results of the operating state and infection state of the reader 300. Specifically, the control board 314 controls the light emission operation of the first indicator light 312a and the second indicator light 312b in multiple light emission patterns that are distinguishable from each other according to at least two of the determination results from (a) to (d) below.

[0069] (a) Determination result regarding the placement of cartridge 200A: The determination result regarding the placement position is whether or not the cartridge 200A is placed in the above-mentioned reference position (a position in which the camera 313 can properly photograph the membrane of the immunochromatographic test piece P housed in the cartridge 200A) within the cartridge housing space 318. The control board 314 determines, for example, that the cartridge 200A is placed in the reference position based on the image data output by the camera 313, provided that the control portion Pc and the test portion Pt are detected in the captured image. (b) Results of the immunochromatographic test specimen P contained in cartridge 200A: The determination result for the immunochromatographic test specimen P is whether or not the immunochromatographic test specimen P contained in the cartridge 200A matches the inspection item specified by the user. The control board 314 detects the inspection item targeted by the immunochromatographic test specimen P currently contained in the cartridge 200A, for example, based on image data output by the camera 313. The control board 314 detects the type of inspection item based on the identification code (e.g., barcode) displayed on the immunochromatographic test specimen P or the color of a specific part of the immunochromatographic test specimen P (e.g., conjugate pad). The control board 314 determines that a normal immunochromatographic test specimen P is contained in the cartridge 200A, provided that the detected inspection item matches the type of inspection item specified by the user on the user terminal device 500. (c) Judgment results regarding the normal execution of the test using immunochromatographic specimen P: The determination result regarding the successful execution of the inspection is the determination result of whether or not the inspection using the immunochromatographic test piece P was performed successfully. The control board 314 determines, for example, that the inspection using the immunochromatographic test piece P was performed successfully, based on the image data output by the camera 313, provided that the control line on the immunochromatographic test piece P is detected. (d) Results regarding the infection status: The result of the infection status determination is whether the test result for the test item is positive or negative. The control board 314 determines, for example, that the result is positive if both the control line and the test line on the immunochromatographic test piece P are detected based on the image data output by the camera 313, determines that the result is negative if the control line is detected but the test line is not, and determines that the result is undetermined if the control line is not detected.

[0070] Furthermore, the judgment notification unit that notifies the judgment results of (a) to (d) above to an external party is not limited to a light-emitting device that emits light in multiple light-emitting patterns that are mutually identifiable according to the judgment result, but may also be a display device that displays characters or the like according to the judgment result, a sound-producing device that emits sound according to the judgment result, or a transmission device that transmits judgment result data according to the judgment result to an external device (such as 500).

[0071] Cartridge 200A includes a cartridge body 202A and a cartridge cap 230A. Figure 13 is a top view showing the configuration of the cartridge body 202A. Figure 14 is a perspective view showing the configuration of the cartridge cap 230A (excluding the cap sheet 231 described later), and Figure 15 is a side view showing the configuration of the cartridge cap 230A. Figure 16 is an enlarged cross-sectional view showing the front portion H of the cartridge in Figure 12.

[0072] As shown in Figure 13, the cartridge body 202A is rectangular in shape overall. The cartridge body 202A has a base 210A and a cover 220A. A rectangular storage space S2 is formed on the upper surface of the base 210A. The storage space S2 is a space for housing the immunochromatographic test specimen P.

[0073] The cover 220A is a rectangular plate-like member, preferably made of a light-transmitting material (such as glass or resin). The cover 220A is positioned to cover the housing space S2 of the base 210A. The cover 220A is positioned to cover the entire immunochromatographic test specimen P housed in the housing space S2.

[0074] The cover 220A has a connecting portion 221A. A communication hole 224A is formed in the connecting portion 221A. The communication hole 224A communicates with the housing space S2 of the cartridge body 202A. The communication hole 224A is a hole that penetrates the cover 220A in a direction perpendicular to the base 210A (vertical direction), and the communication hole 224A is positioned so as to be directly above the sample pad of the immunochromatographic test piece P housed in the housing space S2. The communication hole 224A includes a first communication hole 224B, a second communication hole 224C, and a third communication hole 224D. The first communication hole 224B is a hole in the connecting portion 221A that opens on the side opposite to the housing space S2 (base 210A). The first communication hole 224B is a cylindrical hole whose diameter is approximately the same along its entire length in the direction of the central axis (vertical direction) of the communication hole 224A. The second communication hole 224C is located directly below the first communication hole 224B and is a conical hole whose diameter decreases as it approaches the base 210A. The third communication hole 224D is located directly below the second communication hole 224C and has a diameter approximately the same as the minimum diameter of the second communication hole 224C. The connecting part 221A is an example of a receiving part, the second communication hole 224C is an example of the first hole, the third communication hole 224D is an example of the second hole, and the first communication hole 224B is an example of the third hole.

[0075] A notch 210C is formed at one end of the base 210A. A projection 222B is formed at one end of the cover 220A. The projection 222B is shaped to be insertable into the notch 210C. This prevents, for example, the cover 220A from being positioned in the opposite direction to the base 210A. The two corners of the tip of the cartridge body 202A (base 210A) that is inserted into the cartridge housing space 318 have different shapes. Specifically, the corner on one side (positive X-axis direction side) is angular, while the corner 210B on the other side (negative X-axis direction side) is cut in a flat shape. The inner wall surface of the housing 311 that forms the cartridge housing space 318 has a shape corresponding to the shape of each corner. Therefore, for example, if the cartridge body 202A is inserted into the cartridge housing space 318 in an inverted orientation, the cartridge body 202A will not reach the reference position.

[0076] As shown in Figures 14 and 15, the cartridge cap 230A includes a cap sheet 231, a dish portion 233, and leg portions 238. The cartridge cap 230A is formed from a resin material, bioplastic, rubber material, etc. Preferably, the cartridge cap 230A is formed from an elastic material. The leg portions 238 are an example of a press-fit portion.

[0077] The dish portion 233 is substantially flat and has a protruding portion 233A that protrudes in one direction (positive Y-axis direction). A storage hole 232 for containing buffer solution C is formed on the upper surface of the dish portion 233. The storage hole 232 includes a first storage hole 234 and a second storage hole 236. The first storage hole 234 faces the bottom surface 234A of the storage hole 232. The first storage hole 234 is a hole defined by a radial inner circumferential surface 234B whose diameter increases as it moves away from the bottom surface 234A. The first storage hole 234 has a first protruding hole 234D that protrudes toward the protruding portion 233A. The first protruding hole 234D has a shape that narrows in width toward the tip in the protruding direction.

[0078] The second housing hole 236 is located directly above the first housing hole 234 and communicates with the first housing hole 234. The second housing hole 236 is defined by a radial inner circumferential surface 236B whose diameter increases as it moves away from the bottom surface 234A. The inclination angle of the inner circumferential surface 236B with respect to the bottom surface 234A is gentler than the inclination angle of the inner circumferential surface 234B with respect to the bottom surface 234A. The second housing hole 236 has a second protruding hole 236D that protrudes in the direction described above (positive Y-axis direction). The second protruding hole 236D has a shape that narrows in width towards the tip in the protruding direction. The protrusion angle of the second protruding hole 236D (the angle between the two sides that form the protruding portion) is smaller than the protrusion angle of the first protruding hole 234D.

[0079] The leg portion 238 protrudes downward from the lower surface of the dish portion 233. The leg portion 238 is approximately cylindrical in shape. A convex portion 238A that protrudes radially outward is formed around the entire circumference of the outer surface of the leg portion 238. When the leg portion 238 is inserted into the communication hole 224A, the convex portion 238A is compressed and deformed, creating a sealed state inside the communication hole 224A. The tip surface 238B of the leg portion 238 is a tapered surface whose diameter decreases as it moves away from the dish portion 233. The inclination angle of the tip surface 238B relative to the base 210A is approximately the same as the inclination angle of the second communication hole 224C relative to the base 210A.

[0080] The cover 220A has a pair of retaining portions 224E, 224E (see Figure 16). Each retaining portion 224E is formed to protrude downward from the surface of the cover 220A facing the base 210A (the bottom surface). The pair of retaining portions 224E, 224E are positioned in the longitudinal direction (Y-axis direction) of the cartridge body 202A (immunochromatographic test piece P) with the third communication hole 224D in between, when viewed in the central axis direction (Z-axis direction) of the communication hole 224A. The pair of retaining portions 224E, 224E are positioned directly below the third communication hole 224D in the housing space S2, ensuring a gap between the bottom surface of the cover 220A and the immunochromatographic test piece P, while suppressing the lifting of the immunochromatographic test piece P. The pair of retaining portions 224E, 224E are positioned in the short-side direction (X-axis direction) of the cartridge body 202A (immunochromatography test piece P) with the third communication hole 224D in between.

[0081] The cover 220A has a pair of pressing portions 224F, 224F (see Figure 13). Each pressing portion 224F is formed to protrude downward from the surface of the cover 220A facing the base 210A (the bottom surface). The pair of pressing portions 224F, 224F are positioned in the short-side direction (X-axis direction) of the cartridge body 202A (immunochromatographic specimen P) with the third communication hole 224D in between, when viewed in the central axis direction (Z-axis direction) of the communication hole 224A. The pair of pressing portions 224F, 224F press both sides of the short-side portion of the immunochromatographic specimen P while ensuring a gap between the bottom surface of the cover 220A and the immunochromatographic specimen P, directly below the third communication hole 224D in the housing space S2. This prevents blood B, which is dripped from the third communication hole 224D, from leaking out of the immunochromatographic test piece P and guides it to the membrane.

[0082] The cap sheet 231 is a sheet material that seals the housing hole 232 of the cartridge cap 230A. The cap sheet 231 has the same outer shape as the dish portion 233 of the cartridge cap 230A. The peripheral portion of the cap sheet 231 and the portion of the dish portion 233 surrounding the housing hole 232 are detachably bonded. This allows the buffer solution C to be contained in the housing hole 232 in a sealed state (see Figure 16). The cap sheet 231 is, for example, an aluminum sheet.

[0083] B-3. ​​How to use Cartridge 200A: Figure 17 is an explanatory diagram showing the usage process of cartridge 200A. First, the user removes the leg portion 238 of the cartridge cap 230A from the communication hole 224A of the cartridge body 202A, opening the communication hole 224A (see Figure 16). Next, the user pricks their fingertip with, for example, a lancet (not shown) to induce bleeding. Then, as shown in the upper diagram of Figure 17, the user positions the cartridge body 202A so that the communication hole 224A opens upwards, and places the bleeding fingertip over the opening of the communication hole 224A, allowing the blood B to drip into the communication hole 224A. The diameter of the third communication hole 224D is set to a size (for example, 1 mm or more and 1.5 mm or less) such that the blood B cannot pass through the third communication hole 224D by its own weight due to surface tension, etc. Therefore, as shown in the center diagram of Figure 17, the collected blood B accumulates in the second communication hole 224C. The volume of the second communication hole 224C is an amount that can be properly examined by an immunochromatographic test specimen (e.g., 45 μml or more, and 55 μml or less).

[0084] Next, the user peels the cap sheet 231 from the dish portion 233 and drops the buffer solution C contained in the storage hole 232 of the dish portion 233 onto the blood B accumulated in the second communication hole 224C. At this time, the user positions the tip of the dish portion 233 directly above the opening of the communication hole 224A and tilts the dish portion 233 so that the leg portion 238 side moves upward. As a result, the buffer solution C is smoothly dropped from the storage hole 232 through the first protruding hole 234D and the second protruding hole 236D into the communication hole 224A. The dropped buffer solution C accumulates in the first communication hole 224B. Next, as shown in the lower diagram of Figure 17, the user pushes the leg portion 238 of the dish portion 233 into the communication hole 224A. Then, the blood B in the second communication hole 224C and the buffer C in the first communication hole 224B mix together as they pass through the third communication hole 224D, becoming a mixture M, which is then dropped onto the sample pad of the immunochromatographic test piece P.

[0085] B-4. Infection detection process: Figure 18 is a flowchart of the infection determination process. The user connects the reader 300 to the user terminal device 500 in a communicative manner and inserts the cartridge 200A containing the immunochromatographic test piece P, which has been collected from the blood, into the insertion port 318A of the reader 300. Next, the user performs a predetermined operation using the operation unit 550 of the user terminal device 500, causing the control unit 520 to read the infection determination process program from the storage unit 530 and execute the infection determination process shown in Figure 18. The infection determination process is a process that determines the user's infection status based on image data generated by the reader 300 when it photographs the membrane of the immunochromatographic test piece P (hereinafter referred to as "membrane image data").

[0086] As shown in Figure 18, the control unit 520 acquires sample data (membrane image data) (S110). Specifically, the control unit 520 transmits a shooting instruction to the reader 300. Based on the shooting instruction received from the user terminal device 500, the control board 314 of the reader 300 controls the camera 313 to photograph the portion of the immunochromatographic test piece P contained in the cartridge 200A that includes the membrane, and generates membrane image data. The control board 314 transmits the generated membrane image data to the user terminal device 500 via the communication port 316. The control unit 520 acquires the membrane image data via the communication unit 540. The communication unit 540 is an example of an acquisition unit, the processing in S110 is an example of an acquisition process and acquisition step, and the membrane image data is an example of collected information corresponding to the user's sample collection results.

[0087] The control unit 520 does not transmit the membrane image data acquired from the reader 300 to the management server 400. Based on the acquired membrane image data, the control unit 520 performs a determination process to determine the user's infection status. This will be explained in detail below. In this embodiment, the infection status includes the presence or absence of infection (antigen or antibody) of the test item and a reference value indicating the level of infection (degree, amount of antigen or antibody).

[0088] The control unit 520 performs image conversion processing on the acquired membrane image data (S120). Specifically, the control unit 520 first converts the membrane image data (for example, color image data or grayscale image data) into binarized image data. Next, the control unit 520 divides the binarized image data into predetermined scan frame units F, detects the presence or absence of lines based on the number of dots within each scan frame F, and determines the infection status based on the detection result of the presence or absence of lines (S130). S130 is an example of the determination process and determination step.

[0089] Figure 19 is an explanatory diagram illustrating the process of detecting the presence or absence of lines on an immunochromatographic test specimen P. Figure 19 shows a membrane image E captured by the camera 313 of the reader 300. The membrane image E includes a control portion Pc and a test portion Pt of the immunochromatographic test specimen P. The control portion Pc is the portion where the control line (C) appears, and the test portion Pt is the portion where the test line (T) appears. The control unit 520 performs frame detection processing on the control region Gc, which includes the control portion Pc, and the test region Gt, which includes the test portion Pt, respectively, of the membrane image E.

[0090] The frame detection process involves sequentially moving a predetermined scan frame F along the longitudinal direction of P within the target area, and detecting the presence or absence of lines at each scan position within the target area based on the number of dots within the scan frame F. In this embodiment, both the control area Gc and the test area Gt are rectangular in shape. The width of the scan frame F (length in the short direction of the immunochromatographic test piece P) is approximately the same as the width of each target area (control area Gc, test area Gt). The height of the scan frame F (length in the longitudinal direction of the immunochromatographic test piece P) is shorter than the height of each target area (for example, 1 / 5 or less). The scan frame F moves along the longitudinal direction of the immunochromatographic test piece P, passing through both the control area Gc and the test area Gt. In addition, during the frame detection process, the control unit 520 may count the number of dots for the entire membrane image E and detect the presence or absence of lines based on that number of dots. However, as in this embodiment, detecting the presence or absence of lines in a portion of the captured image (membrane image E) that includes each part of the immunochromatographic test piece P (control portion Pc, test portion Pt) (control region Gc, test region Gt) improves the accuracy of line detection. Furthermore, as in this embodiment, detecting the presence or absence of lines based on the number of todds within the scan frame F at each scan position using a scan frame F with a shorter vertical width than the target region, further improves the accuracy of line detection.

[0091] The control unit 520 counts the number of dots detected at each scan position within each target area (hereinafter referred to as "number of detected dots"), and determines that a line exists at the scan position if the number of detected dots is equal to or greater than a certain threshold value. Based on the line detection results, the control unit 520 determines the infection status as follows. (a) Negative: When the control unit 520 determines that there is a line in the control region Gc and that there is no line in the test region Gt. (b) Positive: When the control unit 520 determines that there is a line in the control area Gc and also determines that there is a line in the test area Gt. (c) Inspection error: When the control unit 520 determines that there is no line in the control area Gc.

[0092] The control unit 520 notifies the judgment result (S140). Specifically, the control unit 520 transmits the judgment result to the reader 300 via the communication unit 540. The control board 314 of the reader 300 illuminates the first indicator light 312a and the second indicator light 312b in a light emission pattern corresponding to the received judgment result. This allows the user to understand their infection status (whether or not they are infected with the disease or other test item) by looking at the light emission pattern of the light emission device (first indicator light 312a, second indicator light 312b) of the reader 300. The control unit 520 displays the infection result on the display unit 560 of the user terminal device 500. S140 is an example of the notification process and notification steps.

[0093] Figure 20 is an explanatory diagram showing the screen display of the display unit 560 of the user terminal device 500. When the control unit 520 determines that the judgment result is positive (S150:Y), it displays the positive judgment result screen shown in Figure 20(A) on the display unit 560. The positive judgment result screen includes a judgment result field 562, a disclosure level selection field 564, and a feedback field 565.

[0094] The result column 562 displays the result of the infection status determination. If the result is positive (S150:Y), the result column 562 displays a message indicating "positive" and a message prompting the user to go to a hospital for a medical examination (for example, "Medical Examination Required"). The result column 562 also displays the above reference value. The reference value is an approximate amount of antigen or antibody of the test item. In the line detection process, the control unit 520 calculates the total number of dots detected in the test area Gt (or the total number of dots detected in the scan frame F at the scan position where the line was detected), determines a reference value correlated with the total number of dots, and displays the determined reference value in the result column 562.

[0095] The control unit 520 receives permission information to permit the disclosure of the infection status determination result, and selection information to select the disclosure target from among several types of user-related information, via the disclosure level selection field 564 (S160). The process in S160 is an example of permission acceptance processing (permission acceptance step) and selection acceptance processing (selection acceptance step).

[0096] Specifically, the disclosure level selection field 564 allows the user to select the level of disclosure for the judgment results and user-related information about the user. User-related information includes, for example, attribute information and infection factor information. Attribute information is information about the user's attributes, and the types of attribute information include, for example, personal information such as information about the user's body (gender, age, infection history, occupation, symptoms, disease) and the user's location information (home and workplace location (GPS)). Infection factor information is information about the factors that led to the user's infection, and the types of infection factor information include, for example, the time of infection recall, the place of infection recall, and the behavior that recalled infection. Examples of the options displayed in the disclosure level selection field 564 are as follows. (a) Whether or not permission is granted to disclose the judgment results. (b) Whether or not permission has been granted to disclose attribute information (this may include whether or not permission has been granted to disclose each of the above-mentioned types of attribute information). (c) Whether or not permission has been granted to disclose information on the cause of infection (this may include whether or not permission has been granted to disclose each of the above-mentioned types of information on the cause of infection). The user operates the operation unit 550 to select an option from among the multiple options shown in the disclosure level selection field 564. The control unit 520 receives the permission information and selection information based on the user's selection. The control unit 520 may also display options (b) and (c) in the disclosure level selection field 564, provided that permission to disclose the judgment result is selected in (a).

[0097] The control unit 520 transmits judgment information and user-related information corresponding to the option selected in the disclosure level selection field 564 to the management server 400 (S170). Specifically, if the user selects "No permission to disclose the judgment result," the control unit 520 does not transmit the judgment information to the management server 400. This allows the user to go to the hospital and receive treatment while ensuring the confidentiality of the judgment result on the user terminal device 500.

[0098] If the user selects permission to disclose the judgment result, the control unit 520 sends judgment information regarding the positive judgment result to the management server 400. This process is an example of a transmission process (transmission step). The control unit 520 may also send the above membrane image data (either data before or after binarization) to the management server 400 if the user selects permission to disclose the judgment result. Based on the received membrane image data, the management server 400 may perform an infection status determination process with higher accuracy than the above infection determination process on the user terminal device 500, and send the determination result to the user terminal device 500. The user terminal device 500 may display the determination result from the management server 400, for example, on the display unit 560. This allows the user to understand not only the judgment result from the simplified determination (offline) by the user terminal device 500, but also the highly accurate determination result (online) from the management server 400.

[0099] The control unit 520 transmits the type of user-related information selected in the disclosure level selection field 564 to the management server 400. The control unit 520 transmits user-related information to the management server 400 in addition to the judgment information, provided that the user has selected permission to disclose the judgment result. The control unit 520 may also transmit user-related information to the management server 400 regardless of whether the user has permission to disclose the judgment result.

[0100] The control unit 520 displays feedback information corresponding to the type of user-related information selected in the disclosure level selection field 564 (or, if multiple types of user-related information are selected, a combination pattern of multiple types of user-related information) in the feedback field 565 (S180), and terminates the infection determination process. The feedback information is, for example, as follows: (a) If information about the user's physical condition is selected: Advice from a healthcare professional (such as a doctor) based on the information about the user's physical condition (e.g., treatment methods and precautions based on age, gender, and infection history, information about the disease the user has contracted, etc.), and contact information for specialists (telephone number, email address, etc.). (b) If user location information is selected: Hospital information of specialists for the infected disease (for example, hospital information available based on the user's location (such as hospital information near the user's location)) (c) If infection factor information is selected: Advice from healthcare professionals appropriate to the infection factor (e.g., coping methods and precautions based on the time elapsed since the suspected infection) (d) Information regarding communication with healthcare professionals (e.g., multiple communication options such as online communication with healthcare professionals, face-to-face communication with healthcare professionals, email communication with healthcare professionals, and telephone communication with healthcare professionals, and information regarding each communication method (e.g., how to use it, contact information, etc.)) The feedback information is pre-stored in the storage unit 530 of the user terminal device 500 and may be provided offline, or it may be provided online from the management server 400.

[0101] If the test result is negative (S150:N), the control unit 520 displays the negative test result screen shown in Figure 20(B) on the display unit 560. The negative test result screen includes the test result field 562, the infection recall time field 566, and the feedback field 565. If the test result is negative (S150:N), the test result field 562 displays a message indicating "negative" and the reference value.

[0102] The infection recall period field 566 is a field where the user enters the infection recall period (e.g., year, month, day, or date). The infection recall period is, for example, the time when the user performed an action that could have been a cause of infection, or the time when symptoms associated with infection (such as fever) developed. The control unit 520 determines whether or not the infection recall period has been entered in the infection recall period field 566 (S190). The process in S190 is an example of a period reception process. If the control unit 520 determines that the infection recall period has been entered (S190:Y), it determines whether or not the infection status determination result is valid based on that infection recall period (S200). For example, the control unit 520 determines that the infection status determination result (negative) is valid if the period from the time of recalling infection to the day the user terminal device 500 performs the infection determination process (hereinafter referred to as the "infection progression period") is within the appropriate testing period for the test item (e.g., influenza) (e.g., 12 hours after the onset of symptoms), and determines that the infection status determination result (negative) is invalid if the infection progression period is outside the appropriate testing period (e.g., before 12 hours after the onset of symptoms).

[0103] The control unit 520 displays feedback information corresponding to the judgment result of suitability for the judgment on the display unit 560 (S210), and terminates the infection judgment process. For example, if the control unit 520 determines that the judgment result of the infection status (negative) is valid, it displays a message in the feedback field 565 indicating that the judgment result of the infection status (negative) is valid. If the control unit 520 determines that the judgment result of the infection status (negative) is invalid, it displays information regarding the appropriate timing for testing (for example, the date and time when the appropriate testing period has elapsed since the onset of symptoms) in the feedback field 565. An alert setting may also be displayed in the feedback field 565. The alert setting is a setting to notify the user when the infection period has reached the appropriate testing period (for example, by displaying an alert on the display unit 560). The user can enable the alert function by setting the alert setting to "ON".

[0104] Before the infection determination process, the control unit 520 may identify the test items of the immunochromatographic test piece P contained in the reader 300 based on the captured image data from the reader 300 (identification information of the test items shown on the immunochromatographic test piece P), and determine whether the identified test items match the test items specified by the user on the operation unit 550. Information regarding the test items specified by the user may be displayed on the display unit 560 (such as the determination result display screen in Figure 20).

[0105] The management server 400 may transmit the judgment information and user-related information received from each user terminal device 500 to the terminal devices 11A of each medical institution 10A and the terminal devices 51 of the public institution 50. Each medical institution 10A can, for example, use the received judgment information and user-related information for the medical examination of the visiting user. The public institution 50 can, for example, manage the received judgment information and user-related information as big data and use that big data to identify infected areas, predict infections, etc.

[0106] C. Variant: The technologies disclosed herein are not limited to the embodiments described above and can be modified in various forms without departing from their essence, for example, the following modifications are possible.

[0107] The configuration of the blood collection kit 1, blood collection device 100, and reader 300 in the first embodiment described above is merely an example and can be modified in various ways. For example, in the first embodiment, the cylindrical portion 11 and the attachment 30 were joined by screwing, but they may be joined by press-fitting, adhesive, or other means. In the first embodiment, the attachment 30, which is separate from the cylindrical portion 11, was exemplified as the receiving portion, but the receiving portion may be formed integrally with the cylindrical portion 11.

[0108] In the first embodiment described above, the through-hole 34 of the attachment 30 extended along the central axis direction of the cylindrical portion 11 (syringe 10), but it may also extend in a direction inclined with respect to the central direction, for example. The shape of the through-hole 34 in the longitudinal section is not limited to a straight line, but may also be curved or crank-shaped, for example. The shape of the through-hole 34 in the cross-section is not limited to a circle, but may also be polygonal or elliptical, for example.

[0109] The shape of the first hole 34A in the longitudinal section is not limited to radial; for example, it may be rectangular or tapered, with the diameter decreasing towards the tip. The diameter of the second hole 34B may be radial, with the diameter increasing towards the tip, or tapered, with the diameter decreasing towards the tip. The expansion ratio of the third hole 34C may be the same as the expansion ratio of the third hole 34C, or it may be greater than the expansion ratio of the third hole 34C. In the above embodiment, the maximum opening area (opening diameter) of the first hole 34A is greater than the cross-sectional area (inner diameter) of the internal space (barrel space 15A) of the syringe 10, but it may also be less than or equal to the cross-sectional area (inner diameter) of the internal space (barrel space 15A).

[0110] In each of the above embodiments, the forming material for each component is merely an example, and other materials may be used.

[0111] In the first embodiment described above, a blood collection device (blood collection kit) for collecting blood B was exemplified as the collection device (sample collection kit), but the collection device (sample collection kit) also includes collection devices (sample collection kits) for collecting samples other than blood B. Samples other than blood B include, for example, urine, feces, sputum, saliva, and liquid materials obtained by surgery. Test items include infectious diseases such as influenza and coronavirus infection, and sexually transmitted infections (syphilis, human immunodeficiency virus, etc.).

[0112] The tests (for determining the state of infection) used in this invention are, for example, visually-based rapid diagnostic methods. Visually-based rapid diagnostic methods are testing methods that visually determine the presence or absence of diseases, etc., by utilizing a mechanism that reacts with antigens or antibodies in a sample. Examples of visually-based rapid diagnostic methods include LFA (Lateral Flow Assay) and RDT (Rapid Diagnostic Test). LFA is a rapid diagnostic method (immunochromatography) in which a sample (liquid sample) is flowed by capillary action and the presence or absence of a specific substance can be visually determined. Examples of LFA include COVID-19 antigen tests, pregnancy tests, rapid influenza diagnostics, and detection of allergens and pathogens in food. RDT is a type of test that uses diffusion amplification (also called isothermal amplification) to amplify nucleic acids (DNA or RNA) without heating cycles. Specific examples include the LAMP method (Loop-mediated isothermal amplification), the RPA method (Recombinase Polymerase Amplification), and the NASBA method (Nucleic Acid Sequence-Based Amplification).

[0113] The test kit is not limited to immunochromatographic test strips; any test kit used for the tests described in the present invention may be used. The test kit is, for example, a test kit having a test area in which predetermined identification information (such as a line or other marker, or a change in color) appears in response to a reaction with a collected sample. Examples of test kits include a rapid PCR test kit, a COVID-19 nucleic acid test kit, and a rapid influenza diagnostic kit.

[0114] In the second embodiment described above, a user terminal device 500 such as a smartphone was given as an example of an information processing device, but it is not limited to this, and a dedicated device (infection detection device) with communication functions attached to the reader 300 may also be used. The notification unit is not limited to the display unit 560, but may also be a transmitting device that sends notification information to an external device, or a sound-producing device, etc. The camera is not limited to the camera 313 of the reader 300, but may also be a camera of the user terminal device 500.

[0115] In the second embodiment described above, the inclination angle of the inner circumferential surface 236B of the cartridge cap 230A with respect to the bottom surface 234A may be greater than or equal to the inclination angle of the inner circumferential surface 234B with respect to the bottom surface 234A.

[0116] In the second embodiment described above, the infection determination process is merely an example. The control board 314 of the reader 300 may perform at least a part of the infection determination process shown in Figure 18. In the second embodiment described above, the immunochromatographic test piece was an immunochromatographic test piece P having one control portion Pc and one test portion Pt, but it is not limited to this, and may be an immunochromatographic test piece having at least one of multiple control portions Pc and test portions Pt. For example, if the immunochromatographic test piece has multiple test portions Pt, the control unit 520 of the user terminal device 500 may set multiple test areas Gt corresponding to each of the multiple test portions Pt (corresponding to multiple different test items) and detect the presence or absence of a test line for each test area Gt. Using one immunochromatographic test piece, the infection status for multiple types of test items (antigens and antibodies) can be determined by performing the infection determination process once.

[0117] When using a test kit, a waiting period (for example, 10 to 30 minutes) may be required after dropping the sample onto the test kit before the test results are reflected. Therefore, in the second embodiment described above, the control unit 520 may start the infection determination process (acquisition process to acquire (photograph) image data) on the condition that the above-mentioned waiting period has elapsed since the cartridge 200A was inserted into the reader 300 (the "waiting process for testing" in S110 of Figure 18). The control unit 520 may also detect that the cartridge 200A has been inserted into the reader 300 on the condition that, for example, the user has made an input operation on the operation unit 550 (such as an operation to instruct the start of determination) or that the control board 314 of the reader 300 has detected the cartridge 200A (or a test kit such as an immunochromatographic test piece P) based on image data from the camera 313. The control unit 520 may change the waiting time for inspection to the time corresponding to the inspection item detected from the inspection kit, based on the correspondence information between multiple inspection items and the waiting time for inspection defined for each of the multiple inspection items. [Explanation of symbols]

[0118] 1: Blood collection kit 1A: Information management system 10: Syringe 10A: Medical institution 11: Tube 11A: Terminal device 14: Gap 15: Barrel 15A: Barrel space 16: Luer 16A: Luer space 17: Step 18: Annular part 20: Plunger 22: Gasket 24: Pinching part 30: Attachment 31: Mounting part 32: Space 33: Receiving part 34: Through hole 34A: First hole 34B: Second hole 34C: Third hole 34D: Fourth hole 35: Male thread 36: Tip surface 40: Inner circumferential surface 42: Protrusion 50: Public institution 100: Blood collection device 200,200A: Cartridge 202A: Cartridge body 210,210A: Base 211: Housing space 220,220A: Cover 221,221A: Connecting part 222,222A: Camera window 222B: Protruding part 224,224A: Communication hole 224B: First communication hole 224C: Second communication hole 224D: Third communication hole 224E: Retaining part 224F: Pressing part 226: Engaging part 228: Contact part 230: Dropper 230A: Cartridge cap 231: Cap sheet 232: Housing hole 233: Dish part 233A: Protruding part 234: First housing hole 234D: First protruding hole 236: Second housing hole 236D: Second protruding hole 238: Leg part 238A: Convex part 300: Leader 311: Housing 312a: First indicator light 312b: Second indicator light 313: Camera 314: Control board 315: Battery 316: Communication port 317: Connecting passage 318: Cartridge housing space 318A: Insertion slot 400: Management server 500: User terminal device 520: Control unit 530: Memory unit 540: Communication unit 550: Operation unit 560: Display unit

Claims

1. A sample collection cartridge for collecting a sample, A cartridge body having a storage space for housing the test kit, The cartridge body is provided with a receiving portion for placing a bleeding fingertip on, The receiving portion has a communication hole that penetrates the receiving portion and connects to the housing space. The aforementioned communication hole is, A first hole that opens such that the area of ​​the cross-section expands toward the opposite side of the aforementioned storage space, A second hole located between the first hole and the containment space, having a diameter substantially the same as the minimum diameter of the first hole, A sample collection cartridge comprising: a third hole extending from the open end of the communication hole opposite to the containment space toward the first hole, the third hole having substantially the same diameter along its entire length in the direction of the central axis of the communication hole.

2. A sample collection cartridge according to Claim 1, Furthermore, a sample collection cartridge is provided, comprising a cartridge cap having a press-fit portion that is press-fitted into the communication hole.

3. A sample collection cartridge according to Claim 2, The aforementioned cartridge cap has a compartment for containing buffer solution, and is a sample collection cartridge.

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