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]

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

[0002] Conventionally, there are known techniques that allow a user, such as a test subject, to obtain diagnostic results for the presence or absence of antibodies or antigens using a mobile terminal or the like. For example, in a first technique, a camera unit provided in a mobile phone captures an image of a test specimen displaying a colored state. The mobile phone transmits the obtained image data to a diagnostic server. The diagnostic server detects the presence or concentration of a specific component based on the received image data, and transmits diagnostic data corresponding to the detected presence or concentration of the specific component to the mobile phone (see, for example, Patent Document 1). In a second technique, an antigen test terminal performs an antigen test based on an inserted immunochromatographic test kit, and automatically transmits the test results and the infection status to a mobile terminal owned by the test subject (see, for example, Patent Document 2).

[0003] Also known is a blood collection device for collecting blood from a puncture site in the human body (see, for example, Patent Document 2). A conventional blood collection device has a capillary tube and a push-down chamber. The capillary tube has a small-diameter tip portion and a large-diameter base portion. The chamber is connected to an intermediate portion of the capillary tube between the tip and base portions. When the tip portion of the capillary tube is brought into contact with blood coming out of the puncture site and the chamber is pushed down, blood is sucked from the tip portion to the base portion of the capillary tube (see, for example, Patent Document 3). [Prior art documents] [Patent documents]

[0004] [Patent Document 1] Japanese Patent Application Laid-Open No. 2010-190867 [Patent Document 2] Japanese Patent Publication No. 2022-115777 [Patent Document 3] Japanese Patent Publication No. 2022-161878 Summary of the Invention [Problem to be solved by the invention]

[0005] The above-mentioned conventional techniques 1 and 2 have a problem in that the user cannot obtain the result of the infection status assessment unless the information processing device such as a mobile terminal owned by the user and a management server such as a diagnostic server are connected online. Also, technique 1 has a problem in that the result of the infection status assessment of the user is disclosed to a third party regardless of the user's intention.

[0006] Furthermore, the conventional blood collection device is a so-called dropper-type suction device that utilizes suction force due to the restoring force of the chamber. Therefore, the suction force is relatively weak, and there is a risk that a sufficient amount of blood for testing cannot be collected. This problem is not limited to blood collection, but is common to collection and testing of specimens other than blood. A specimen is something excreted or collected from the human body, and includes, in addition to blood, materials obtained by manual procedures or surgery, such as urine, feces, sputum, saliva, and scrapings.

[0007] This specification discloses a technique that can solve at least one of the above-mentioned problems. [Means for solving the problem]

[0008] The technology disclosed in this specification can be realized, for example, in the following forms. (1) An information processing device disclosed in this specification is communicatively connected to a management server via a network. The information processing device includes an acquisition unit, an operation unit, a notification unit, and a controller. The controller executes the following operations: an acquisition process for acquiring collection information corresponding to a sample collection result of a user via the acquisition unit; a determination process for determining the infection status of the user based on the collection information without transmitting the collection information to the management server; a notification process for notifying the user of the infection status determination result via the notification unit; a permission acceptance process for accepting, via the operation unit, permission information permitting disclosure of the infection status determination result; and a transmission process for transmitting the infection status determination result to the management server, on condition that the permission information is accepted. This information processing device allows a user to obtain the infection status determination result offline and can also choose whether or not to disclose the determination result. This ensures confidentiality, lowering the psychological hurdle of having the infection status determined.

[0009] (2) In the information processing device, the controller may further execute a selection receiving process for receiving, via the operation unit, selection information for selecting a target to be disclosed from among a plurality of different pieces of user-related information related to the user, and in the transmission process, on the condition that the permission information has been received, 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 range of user-related information related to the user to be disclosed.

[0010] (3) In the information processing device, if the infection status determination result is positive and the selection information includes the user's location information, the controller may notify the user of available hospital information corresponding to the location information in the notification process. With this configuration, the user can obtain available hospital information by providing their location information.

[0011] (4) In the information processing device, the controller may further be configured to, when the infection status determination result is positive, execute a designation receiving process for receiving, via the operation unit, designation information for designating one of at least two of obtaining infection warning information, online communication with a medical professional, and face-to-face communication with a medical professional, and notify the user of information regarding the communication corresponding to the designation information in the notification process. With this configuration, users can obtain information on how to deal with infection, etc., by methods with different levels of confidentiality.

[0012] (5) In the information processing device, the controller may further execute a timing reception process for receiving a timing of recall of infection via the operation unit, and in the notification process, if the infection status determination result is negative, the controller may notify the user via the notification unit of the validity of the infection status determination result based on the recall time. With this configuration, the user can know that the negative result may have been due to the inappropriate timing for the determination.

[0013] (6) In the information processing device, the acquisition unit may have a camera, and the controller may, in the acquisition process, cause the camera to capture an image of a test area of ​​the test kit where a line develops color in response to a reaction with 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 binary image, detect the presence or absence of a line based on the number of dots in the binary image, and determine the infection state based on the detection result of the presence or absence of the line. With this configuration, the presence or absence of a line on the test kit can be determined without relying on visual inspection by a user.

[0014] (7) The collection tool disclosed herein is a collection tool for collecting a specimen. The collection tool includes a syringe having a tubular portion with an internal space and a receiving portion covering an opening at one end of the tubular portion, and a plunger inserted into the internal space of the tubular 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 tubular portion. The through-hole includes a first hole that opens toward the outer surface of the receiving portion and a second hole located between the first hole and the internal space of the tubular portion. A first area of ​​a cross-section of the first hole is larger than a second area of ​​a 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 tubular portion.

[0015] In this configuration, the first area of ​​the first hole opening on the outer surface of the receiving portion is larger than the second area of ​​the second hole. Therefore, for example, compared to a configuration in which the first area of ​​the first hole is equal to or smaller than the second area of ​​the second hole, it is easier to insert a specimen into the through-hole of the receiving portion. Conversely, because the second area of ​​the second hole is smaller than the first area of ​​the first hole, the specimen in the first hole is less likely to move into the internal space of the cylindrical body, making it easier to grasp the amount of specimen collected in the first hole. After the specimen is inserted into the through-hole, the specimen in the first hole is sucked into the internal space of the cylindrical body through the second hole by the suction force generated when the plunger is pulled in a direction away from the receiving portion. 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 prevent the specimen that has moved into the internal space from flowing back into the first hole. Thus, this configuration facilitates specimen collection, makes it easier to grasp the collected specimen amount, and prevents leakage of the collected specimen.

[0016] (8) In the collecting tool, the first hole may be configured to open so that the cross-sectional area thereof expands from the second hole toward the outer surface of the receiving part. This configuration makes it easier to introduce the specimen into the through-hole (first hole) than, for example, a configuration in which the cross-sectional area of ​​the first hole is constant.

[0017] (9) In the above-described collection tool, the through-hole may further include 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 different from that of the first hole. This configuration ensures a space for accommodating the buffer solution and makes the boundary between the first hole and the third hole easily visible.

[0018] (10) The specimen collection kit may be configured to include the collection tool and a cartridge having a storage space for storing a test kit. The cartridge has a connecting part that connects to the receiving part of the collection tool. The connecting part has a communication hole that communicates with the first hole of the connected receiving part and with the storage space of the cartridge. With this configuration, by connecting the collection tool to the cartridge and pushing in the plunger of the collection tool, the specimen in the cylindrical body can be dripped into the test kit.

[0019] (11) In the above-described specimen collection kit, 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 is open so that its cross-sectional area expands from the first hole side toward the outer surface of the receiving portion. The connecting portion of the cartridge has a contact portion that contacts the entire inner circumferential surface of the fourth hole of the through-hole. With this configuration, the tight contact between the inner circumferential surface of the fourth hole and the contact portion can prevent leakage of specimen or air.

[0020] The technology disclosed in this specification can be realized in various forms, such as a collection device, a blood collection device, a specimen collection kit, a blood collection kit, a receiving member (attachment) attached to 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, etc. [Brief explanation of the drawings]

[0021] [Figure 1] FIG. 1 is a perspective view showing the overall configuration of a blood collection kit 1 according to a first embodiment. [Figure 2] FIG. 1 is an explanatory diagram showing the configuration of a vertical cross section of the blood collection device 100. [Figure 3] FIG. 10 is an explanatory diagram showing the configuration of the side of the attachment 30. [Figure 4] FIG. 1 is an explanatory diagram showing the vertical cross-sectional configuration of the attachment 30. [Figure 5] FIG. 10 is an explanatory diagram showing the planar configuration of the attachment 30. [Figure 6] FIG. 1 is a perspective view showing the external configuration of a cartridge 200. [Figure 7] 1 is an explanatory diagram showing changes in state of the blood collection tool 100 during blood collection. [Figure 8] An explanatory diagram showing the process of connecting the blood collection tool 100 and the cartridge 200. [Figure 9] FIG. 10 is an explanatory diagram showing the state after blood B has been transferred from the blood collection device 100 to the cartridge 200. [Figure 10] FIG. 10 is an explanatory diagram showing the configuration of an information management system according to a second embodiment. [Figure 11] Top view showing the external configuration of the cartridge and reader [Figure 12] Cross-sectional view showing the internal structure of the cartridge and reader [Figure 13] Top view showing the configuration of the cartridge body [Figure 14] FIG. 1 is a perspective view showing the configuration of a cartridge cap. [Figure 15] Side view showing the configuration of the cartridge cap [Figure 16] FIG. 13 is an enlarged cross-sectional view showing the front portion of the cartridge in FIG. 12. [Figure 17] An explanatory diagram showing the cartridge usage process [Figure 18] Flowchart showing infection determination processing [Figure 19] An explanatory diagram showing the process of detecting the presence or absence of a line on an immunochromatographic test piece. [Figure 20] FIG. 10 is an explanatory diagram showing a screen display of a mobile terminal; DETAILED DESCRIPTION OF THE INVENTION

[0022] A. First embodiment: A-1. Blood Collection Kit 1: FIG. 1 is a perspective view showing a schematic diagram of the overall configuration of a blood collection kit 1 according to the 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 a specific disease by collecting blood B (see FIG. 7 described below) from a human body and dripping the blood B onto an immunochromatographic test piece. Immunochromatography (immunochromatography) is a testing method that determines the presence or absence of antibodies or antigens by utilizing an antigen-antibody reaction. The blood collection kit 1 enables an individual to properly and safely perform a series of steps, from collecting blood B to dripping blood B onto the immunochromatographic test piece, at home or the like, without relying on a specialist such as a medical professional.

[0023] As shown in FIG. 1, the blood collection kit 1 includes a blood collection device 100 and a cartridge 200. The blood collection device 100 is an instrument 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 the blood B is an example of a specimen. The cartridge 200 is a case that contains an immunochromatographic test piece. FIG. 1 shows the blood collection device 100 and cartridge 200 connected together.

[0024] (Configuration of blood collection device 100): FIG. 2 is an explanatory diagram showing the configuration of a longitudinal cross section of the blood collection device 100. In this specification, a "longitudinal cross section" refers to a cross section along the longitudinal direction (the vertical direction on the paper of FIGS. 1 and 2) of the blood collection device 100 (syringe 10 described below), and a "transverse cross section" refers to a cross section perpendicular to the longitudinal direction. As shown in FIGS. 1 and 2, the blood collection device 100 includes a syringe 10 and a plunger 20. The syringe 10 is sometimes called a syringe barrel or an outer barrel. The plunger 20 is sometimes called a pusher.

[0025] Syringe 10 has a cylindrical portion 11 and an attachment 30. Syringe 10 is preferably formed of, for example, an optically transparent material (glass, resin, etc.). Attachment 30 is an example of a receiving portion. Attachment 30 is provided on one longitudinal end side of cylindrical portion 11. Hereinafter, the side of syringe 10 (cylindrical portion 11) that faces attachment 30 will be referred to as the "tip side," and the side opposite attachment 30 will be referred to as the "base side."

[0026] The tubular portion 11 is a cylindrical body that extends linearly as a whole. The tubular portion 11 has a barrel 15 and a luer 16 located on the tip side of the barrel 15 (see FIG. 2). The barrel 15 is a portion that extends from the base end of the tubular portion 11 toward the tip side (downward in the plane of the paper in FIGS. 1 and 2), and the luer 16 is a portion that extends from the tip of the tubular portion 11 toward the base end side (upward in the plane of the paper in FIGS. 1 and 2). The outer diameter of the barrel 15 is larger than the outer diameter of the luer 16.

[0027] The barrel space 15A, which is the internal space of the barrel 15, extends linearly along the longitudinal direction of the tubular portion 11. The barrel space 15A is a cylindrical space with a constant diameter along its entire longitudinal length. The luer space 16A, which is the internal space of the luer 16, extends linearly along the longitudinal direction of the tubular portion 11. The luer space 16A is a cylindrical space with a constant diameter along its entire longitudinal length. The tip and base ends of the barrel space 15A are connected. 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 tubular portion 11. The annular portion 18 is arranged so as to surround the periphery of the luer 16 from the tip of the barrel 15. An annular gap 14 is formed between the luer 16 and the annular portion 18. A flange 12 that protrudes radially outward is formed on the outer circumferential surface of the base end of the tubular portion 11. The flange 12 functions as a finger grip for hooking the operator's fingers.

[0029] The attachment 30 is disposed so as to cover the opening at the tip end of the tubular portion 11. The configuration of the attachment 30 will be described later.

[0030] The plunger 20 is a rod-shaped body extending linearly. The plunger 20 is formed of, for example, glass or resin. The plunger 20 is inserted into the barrel space 15A of the tubular portion 11 so as to be movable in the longitudinal direction of the tubular portion 11. A gasket 22 is bonded to the tip of the plunger 20. The gasket 22 is, for example, an elastic member made of, for example, rubber. The outer diameter of the gasket 22 is approximately the same as the inner diameter of the barrel space 15A, and the outer peripheral surface of the gasket 22 is in close contact with the inner peripheral surface of the tubular portion 11 that constitutes the barrel space 15A over the entire circumference. Because the outer diameter of the gasket 22 is larger than the inner diameter of the luer space 16A, movement of the gasket 22 (plunger 20) toward the tip side beyond the step 17 is restricted.

[0031] The plunger 20 has a knob portion 24 and a flange 26 at its base end. 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 FIG. 2, the flange 26 is configured to come into contact with the flange 12 when the gasket 22 moves to a position where it abuts against the step 17 of the tubular portion 11 or to a position just before that. The knob portion 24 is a portion that protrudes from the base end of the plunger 20 toward the base end beyond the flange 26. For example, as shown in FIGS. 1 and 2, when the gasket 22 is pushed all the way into the barrel space 15A of the tubular portion 11 toward the tip, an operator can grasp the knob portion 24 with their fingers and pull the plunger 20 out of the barrel space 15A of the tubular portion 11.

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

[0033] As shown in FIGS. 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 at the distal end of the mounting portion 31. The mounting portion 31 and the receiving portion 33 are integrally formed, but may be separate. The mounting portion 31 is a portion including 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 tubular portion 11 and smaller than the inner diameter of the annular portion 18 (see FIG. 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 peripheral surface of the mounting portion 31 (see FIGS. 3 and 4), and a female thread (not shown) that threadably engages with the male thread 35 is formed on the inner peripheral surface of the annular portion 18. The attachment 30 can be attached to the tip of the tubular portion 11 by threading the male thread 35 of the mounting portion 31 into the female thread of the annular portion 18. The attachment 30 may be detachable from the tubular portion 11, or may not be detachable.

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

[0036] The first hole 34A is a recess that opens radially toward the distal end surface 36 of the attachment 30. The second hole 34B is located on the proximal end side of the first hole 34A. The proximal end of the first hole 34A is in communication with the distal end of the second hole 34B. A first area of ​​the cross section of the first hole 34A (the opening area of ​​the distal end of the first hole 34A) is larger than a 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 tubular portion 11. That is, the diameter of the second hole 34B (e.g., a diameter of 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 FIG. 2).

[0037] The first hole 34A opens such that the cross-sectional area expands from the second hole 34B side toward the tip surface 36 of the attachment 30. In other words, 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 approximately constant over the entire length of the second hole 34B.

[0038] The third hole 34C is located closer to the distal end than the first hole 34A. The base end of the third hole 34C is connected to the distal end of the first hole 34A. The diameter of the third hole 34C is equal to or larger than the opening diameter of the distal end of the first hole 34A. The diameter of the third hole 34C is substantially constant over the entire length of the third hole 34C. In other words, the expansion rate of the third hole 34C is smaller than the expansion rate of the first hole 34A. The expansion rate is the degree to which the opening area (diameter) of each hole expands toward the distal end 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 distal end surface 36 of the attachment 30. The distal end of the fourth hole 34D faces the distal end surface 36, and the proximal end of the fourth hole 34D communicates with the third hole 34C. The fourth hole 34D opens such that the cross-sectional area thereof expands toward the distal end surface 36. That is, the inner circumferential surface 40 of the fourth hole 34D is a tapered surface that opens radially toward the distal end surface 36. The fourth hole 34D is located outside the first hole 34A (third hole 34C) when viewed in the axial direction of the attachment 30 (the longitudinal direction of the syringe 10), and is disposed so as to surround the entire circumference of the first hole 34A (third hole 34C).

[0040] 3 and 5, the attachment 30 has a plurality of (for example, four) protrusions 42. Each protrusion 42 protrudes radially outward from the outer peripheral 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): FIG. 6 is a perspective view showing the external configuration of the cartridge 200. As shown in FIG. Cartridge 200 has an overall rectangular plate shape. Cartridge 200 has a base 210 and a cover 220. A rectangular storage space 211 is formed on the upper surface of base 210. Storage space 211 is a space for storing an immunochromatographic test piece (not shown).

[0042] Cover 220 is a rectangular plate-like member, and is preferably formed of, for example, a light-transmitting material (glass, resin, etc.). Cover 220 is arranged so as to cover storage space 211 of base 210. Cover 220 is arranged so as to cover the entire immunochromatographic test piece stored in storage 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 storage space 211 of the cartridge 200. The communication hole 224 is disposed so as to be located directly above the sample pad of the immunochromatographic test piece stored in the storage space 211.

[0044] The connecting portion 221 has a plurality of (for example, four) engaging portions 226. Each engaging portion 226 protrudes radially inward of the communicating hole 224. The plurality of engaging portions 226 are arranged at equal intervals in the circumferential direction of the communicating hole 224. Each protruding portion 42 of the attachment 30 is inserted between two adjacent engaging portions 226 until it is located further back (lower in FIG. 6 ) into the communicating hole 224 of the cover 220 than the engaging portions 226. Next, by rotating the attachment 30, each protruding portion 42 moves below the corresponding 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 comes into contact over the entire circumference with the inner circumferential surface 40 of the attachment 30 connected to the connecting portion 221. The contact portion 228 is an annular portion that surrounds the entire circumference of the communication hole 224, and has a tapered surface whose diameter decreases toward 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 so as to be located directly above the membrane (the portion where the test line and control line appear) of the immunochromatographic test piece housed in the housing space 211. The camera window 222 is thinner than the other portions of the cover 220, and has high light transmittance. This allows each line appearing on the immunochromatographic test piece to be clearly photographed by an external camera.

[0047] A-2. How to use Blood Collection Kit 1: (Blood B collection): FIG. 7 is an explanatory diagram showing the state changes of the blood collection device 100 during blood collection. First, the blood collection device 100 is placed in a pressed-in state. In this pressed-in state, the plunger 20 is pressed into the barrel space 15A of the syringe 10 so that the gasket 22 is positioned at the tip of the barrel space 15A. Next, the fingertip is punctured with, for example, a lancet (not shown) to induce bleeding. Next, as shown in the right diagram of FIG. 7, the attachment 30 of the pressed-in blood collection device 100 is turned upside down, and the bleeding fingertip is placed against the opening of the through-hole 34 of the attachment 30, allowing blood B to drip into the through-hole 34. The diameter of the second hole 34B is set to a size (e.g., 1 mm or more and 1.5 mm or less) such that the blood B does not pass through the second hole 34B under its own weight due to surface tension or the like. Therefore, as shown in the center diagram of FIG. 7, the collected blood B accumulates in the first hole 34A of the attachment 30. The capacity of the first hole 34A is an amount that can be normally tested using an immunochromatographic test strip (for example, 45 μml or more and 55 μml or less).

[0048] Next, a buffer solution C is dripped onto the blood B pooled in the first hole 34A using a dropper 230. The dripped buffer solution C accumulates in the third hole 34C. The buffer solution C reduces the viscosity of the specimen, allowing the specimen to pass smoothly through the membrane. The buffer solution C is a buffer solution C (e.g., saline solution). Next, as shown in the left diagram of FIG. 7, a strong suction force is generated by pulling the plunger 20 away from the attachment 30 (downward in the plane of FIG. 7). This suction force causes the blood B in the first hole 34A and the buffer solution C in the third hole 34C to pass through the second hole 34B and mix while moving into the internal space (barrel space 15A and Luer space 16A) of the tubular portion 11, forming a mixed liquid M. This completes the 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 tubular portion 11. Therefore, the mixed liquid M in the through-hole 34 can be entirely drawn into the barrel space 15A.

[0049] (Dropping of blood B onto immunochromatographic test strip): Fig. 8 is an explanatory diagram showing the process of connecting the blood collection device 100 and the cartridge 200, and Fig. 9 is an explanatory diagram showing the state after blood B has been transferred from the blood collection device 100 to the cartridge 200. As shown in the upper diagram of Fig. 8, after blood collection, the attachment 30 of the blood collection device 100 is placed downward 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 tubular part 11 does not pass through the second hole 34B due to its own weight. In other words, the mixed liquid M can be prevented from falling from 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 protrusion 42 of the attachment 30 engages with the engagement part 226 of the connecting part 221, as shown in the lower diagram of Figure 8. This causes the blood collection device 100 to be connected to the connecting part 221 (cartridge 200) in a locked state. At this time, the inner circumferential surface 40 of the attachment 30 and the contact part 228 of the connecting part 221 come into close contact over the entire circumference. As a result, the through hole 34 of the attachment 30 and the communication hole 224 of the connecting part 221 communicate in a sealed state.

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

[0052] A-3. Advantages of this embodiment: As described above, in this embodiment, the first area of ​​the cross section of first hole 34A is larger than the second area of ​​the cross section of second hole 34B (see FIG. 4). Therefore, it is easier to introduce the specimen (blood B) into through-hole 34 of attachment 30 compared to, for example, a configuration in which the first area of ​​first hole 34A is equal to or smaller than the second area of ​​second hole 34B. Conversely, because the second area of ​​second hole 34B is smaller than the first area of ​​first hole 34A, the specimen in first hole 34A is less likely to move into the internal space (barrel space 15A) of syringe 10, and it is also easier to determine the amount of specimen collected in first hole 34A.

[0053] After the specimen is placed in through-hole 34, plunger 20 is pulled in a direction away from attachment 30, generating a suction force that draws the specimen in first hole 34A through second hole 34B into the internal space (barrel space 15A) of syringe 10. Since the second area of ​​second hole 34B is smaller than the area of ​​the internal space (barrel space 15A) (see FIG. 2), the specimen that has moved into the internal space can be prevented from flowing back into first hole 34A.

[0054] As described above, according to this embodiment, it is possible to facilitate the collection of a specimen, to grasp the amount of specimen collected, and to prevent leakage of the collected specimen.

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

[0056] The third hole 34C is located closer to the tip than the first hole 34A, ensuring a storage space for the buffer solution C. 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 visually recognized by using the position of the change in the expansion rate between the first hole 34A and the third hole 34C as a landmark. Because 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 the buffer solution C has been dropped into the third hole 34C.

[0057] B. Second embodiment: B-1. Configuration of Information Management System 1A: FIG. 10 is an explanatory diagram showing the configuration of an information management system 1A according to this embodiment. The information management system 1A includes a plurality of terminal devices 11A (first terminal device 11A1, second terminal device 11A2) owned by a plurality of 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 a plurality of user terminal devices 500. The devices and systems are connected to each other via a network NW. The medical institutions 10A are facilities such as hospitals, clinics, visiting nursing stations, care support offices, and care service offices. The public institutions 50 are facilities such as social welfare corporations, medical corporations, health centers, and municipal offices. While FIG. 10 shows two medical institutions 10A, the number of medical institutions 10A included in the information management system 1A may be one or three or more. Similarly, while two user terminal devices 500 are shown in Fig. 10, the number of user terminal devices 500 included in the information management system 1A may be one, or three or more. Although one public institution 50 is shown in Fig. 10, 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, staff member, etc. by recording medical information such as examination results and test results created by each doctor, staff member, etc. belonging to the medical institution 10A and enabling the information to be viewed as needed. As the terminal device 11A, for example, a personal computer, a tablet terminal, a smartphone, etc. may be used.

[0059] The terminal device 11A includes a control unit 120, a storage unit 130, and a communication unit 140. The storage unit 130 is configured, for example, by a hard disk drive (hereinafter referred to as "HDD"), ROM, RAM, a cloud that is guaranteed to prevent confidential information leaks, or the like, and stores various data such as medical information of users (patients, etc.), various programs for controlling the terminal device 11A, and the like. The communication unit 140 is an interface that communicates with external devices via wireless communication or wired communication. The control unit 120 is configured, for example, by a central control unit (hereinafter referred to as "CPU"), or the like, and controls each unit of the terminal device 11A in accordance with a 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 each doctor and staff member by recording medical information such as examination results and test results created by each staff member belonging to the public institution 50 and making it possible to view the information when necessary. As the terminal device 51, for example, a personal computer, a tablet terminal, a smartphone, etc. may be used.

[0061] The terminal device 51 includes a control unit 52, a storage unit 54, and a communication unit 56. The storage unit 54 is configured, for example, by a hard disk drive (hereinafter referred to as "HDD"), ROM, RAM, a cloud that is guaranteed to prevent confidential information from leaking, or the like, 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 an external device via wireless communication or wired communication. The control unit 120 is configured, for example, by a CPU, or the like, and controls each unit of the terminal device 51 in accordance with a program read from the storage unit 52.

[0062] The management server 400 is a device that manages information related to personal information of users and infection diagnosis results transmitted from each user terminal device 500. The management server 400 includes 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 configured, for example, with a hard disk drive (HDD), a read-only memory (ROM), a random access memory (RAM), or a cloud service that ensures confidential information leak prevention. The storage unit 430 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 via wireless or wired communication. The operation unit 450 is configured, for example, with a keyboard and a mouse, and accepts operations by an administrator. The display unit 460 is configured, for example, with a liquid crystal display. The control unit 420 is configured, for example, with a CPU, and controls each unit of the management server 400 according to a program read from the storage unit 430.

[0063] The user terminal device 500 is a device used by a user, such as a personal computer, tablet terminal, smartphone, or the like. The user terminal device 500 is installed, for example, at the user's home, the user's workplace, each medical institution 10A, or a public institution 50. The user terminal device 500 includes 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 configured, for example, with a hard disk drive (HDD), a read-only memory (ROM), a random access memory (RAM), or a cloud service that ensures confidential information leak prevention, and stores various data and various programs for controlling the user terminal device 500 (including the infection determination processing program described below). The communication unit 540 is an interface that communicates with external devices via wireless or wired communication. In this embodiment, the reader 300 is communicably connected to the user terminal device 500 via the communication unit 540. The operation unit 550 is configured, for example, with a keyboard, a mouse, or the like, and accepts user operations. Display unit 560 is configured, for example, by a liquid crystal display or the like (see FIG. 20 described below). Control unit 520 is configured, for example, by a CPU or the like, and controls each unit of user terminal device 500 in accordance with a program read from storage unit 530. Control unit 520 is an example of a controller, and display unit 560 is an example of a notification unit.

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

[0065] 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 formed of, for example, a resin material, a bioplastic, or a metal.

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

[0067] The device accommodating space S1 accommodates a camera 313, a control board 314, and a battery 315. The camera 313 is disposed above the communication path 317. The camera 313 captures an image directly below the communication path 317 and outputs image data corresponding to the captured image. The camera 313 is disposed in a position where it can capture an image of the camera window 222A (membrane of the immunochromatographic test strip P) of the cartridge 200A accommodated in the cartridge accommodating space 318 at its normal reference position via the communication path 317. The battery 315 supplies power to the camera 313 and the control board 314. The reader 300 may be configured to receive power from an external power source (e.g., the user terminal device 500) without the battery 315. The communication port 316 is communicatively connected to the user terminal device 500 via a wire, such as a USB (Universal Serial Bus) cable. The reader 300 may be configured to be communicably connected to the user terminal device 500 via wireless communication.

[0068] The control board 314 controls each device included in the reader 300. The first indicator light 312a and the second indicator light 312b are arranged 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 operating state and infection state determination results of the reader 300. Specifically, the control board 314 controls the light emitting operation of the first indicator light 312a and the second indicator light 312b in a plurality of distinguishable light emitting patterns according to at least two of the following determination results (a) to (d), for example:

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

[0070] The judgment notification unit that notifies the outside of the judgment results (a) to (d) above is not limited to a light-emitting device that emits light in multiple, mutually distinguishable light patterns depending on the judgment result, but may also be a display device that displays characters or the like depending on the judgment result, a pronunciation device that emits sound depending on the judgment result, or a transmission device that transmits judgment result data depending on the judgment result to an external device (500, etc.).

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

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

[0073] Cover 220A is a rectangular plate-like member, and is preferably formed of, for example, a light-transmitting material (glass, resin, etc.). Cover 220A is arranged to cover storage space S2 of base 210A. Cover 220A is arranged to cover the entire immunochromatographic test piece P stored in storage 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 storage 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 (the up-down direction), and is arranged so as to be located directly above the sample pad of the immunochromatographic test piece P stored in the storage 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 that opens on the side of the connecting portion 221A opposite to the storage space S2 (base 210A). The first communication hole 224B is a cylindrical hole having a substantially constant diameter over the entire length along 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 is a hole having a diameter substantially the same as the smallest diameter of the second communication hole 224C. The connecting portion 221A is an example of a receiving portion, the second communication hole 224C is an example of a first hole, the third communication hole 224D is an example of a second hole, and the first communication hole 224B is an example of a third hole.

[0075] A notch 210C is formed at one end of the base 210A. A protrusion 222B is formed at one end of the cover 220A. The protrusion 222B has a shape that allows it to be inserted into the notch 210C. This prevents, for example, the cover 220A from being disposed upside down relative to the base 210A. The cartridge body 202A (base 210A) has two corners at its tip that are inserted into the cartridge accommodating space 318 that have different shapes. Specifically, the corner on one side (the positive X-axis direction side) is angular, and the corner 210B on the other side (the negative X-axis direction side) is notched flat. The inner wall surfaces of the housing 311 that form the cartridge accommodating space 318 have shapes that correspond to the shapes of the respective corners. Therefore, for example, if the cartridge body 202A is inserted into the cartridge accommodating space 318 in an upside-down orientation, the cartridge body 202A will not reach the reference position.

[0076] 14 and 15, cartridge cap 230A includes cap sheet 231, dish portion 233, and leg portion 238. Cartridge cap 230A is made of a resin material, bioplastic, rubber material, or the like. Cartridge cap 230A is preferably made of an elastic material. Leg portion 238 is an example of a press-fit portion.

[0077] The dish portion 233 is generally flat and has a protruding portion 233A that protrudes in one direction (the positive direction of the Y-axis). A storage hole 232 that stores the 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 a 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 with increasing distance 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 accommodating hole 236 is located directly above the first accommodating hole 234 and is connected to the first accommodating hole 234. The second accommodating hole 236 is a hole defined by a radial inner circumferential surface 236B whose diameter increases with increasing distance from the bottom surface 234A. The inclination angle of the inner circumferential surface 236B relative to the bottom surface 234A is gentler than the inclination angle of the inner circumferential surface 234B relative to the bottom surface 234A. The second accommodating hole 236 has a second protruding hole 236D protruding in the above-mentioned one direction (the positive direction of the Y-axis). The second protruding hole 236D has a shape in which its width narrows toward its tip in the protruding direction. The protruding angle of the second protruding hole 236D (the angle between the two sides forming the protruding portion) is smaller than the protruding 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 generally cylindrical. A convex portion 238A protruding radially outward is formed around the entire outer circumferential 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, thereby sealing the inside of the communication hole 224A. The tip surface 238B of the leg portion 238 is a tapered surface whose diameter decreases with increasing distance from the dish portion 233. The inclination angle of the tip surface 238B relative to the base 210A is generally the same as the inclination angle of the second communication hole 224C relative to the base 210A.

[0080] Cover 220A has a pair of retaining portions 224E, 224E (see FIG. 16). Each retaining portion 224E is formed to protrude downward from the surface (lower surface) of cover 220A facing base 210A. When viewed along the central axis (Z-axis direction) of communicating hole 224A, the pair of retaining portions 224E, 224E are positioned to sandwich third communicating hole 224D between them in the longitudinal direction (Y-axis direction) of cartridge main body 202A (immunochromatographic test strip P). The pair of retaining portions 224E, 224E prevent immunochromatographic test strip P from floating up while maintaining a gap between the lower surface of cover 220A and immunochromatographic test strip P directly below third communicating hole 224D within storage space S2. The pair of pressing portions 224E, 224E are disposed at positions sandwiching the third communication hole 224D therebetween in the lateral direction (X-axis direction) of the cartridge body 202A (immunochromatographic test strip P).

[0081] Cover 220A has a pair of pressing portions 224F, 224F (see FIG. 13). Each pressing portion 224F is formed to protrude downward from the surface (lower surface) of cover 220A facing base 210A. When viewed along the central axis (Z-axis direction) of communicating hole 224A, the pair of pressing portions 224F, 224F are positioned to sandwich third communicating hole 224D between them in the lateral direction (X-axis direction) of cartridge body 202A (immunochromatographic test strip P). The pair of pressing portions 224F, 224F press both sides of the lateral direction of immunochromatographic test strip P directly below third communicating hole 224D within storage space S2, while maintaining a gap between the lower surface of cover 220A and immunochromatographic test strip P. This prevents blood B dripped from the third communication hole 224D from leaking out from the immunochromatographic test piece P, and allows the blood B to be guided to the membrane.

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

[0083] B-3. ​​How to use Cartridge 200A: FIG. 17 is an explanatory diagram showing the steps of using the 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 to open the communication hole 224A (see FIG. 16). Next, the user pricks their fingertip with, for example, a lancet (not shown) to induce bleeding. Next, as shown in the upper diagram of FIG. 17, the user positions the cartridge body 202A so that the communication hole 224A opens upward, places the bleeding fingertip against the opening of the communication hole 224A, and drips blood B into the communication hole 224A. The diameter of the third communication hole 224D is set to a size (e.g., 1 mm or more and 1.5 mm or less) such that blood B does not pass through the third communication hole 224D under its own weight due to surface tension or the like. Therefore, as shown in the center diagram of FIG. 17, the collected blood B accumulates in the second communication hole 224C. The capacity of second communication hole 224C is an amount that can be normally tested using an immunochromatographic test piece (for example, 45 μml or more and 55 μml or less).

[0084] Next, the user peels cap sheet 231 from dish 233 and drips buffer solution C contained in storage hole 232 of dish 233 onto blood B accumulated in second communication hole 224C. At this time, the user positions the tip of dish 233 directly above the opening of communication hole 224A and tilts dish 233 so that leg 238 moves upward. This allows buffer solution C to smoothly drip from storage hole 232 through first protrusion hole 234D and second protrusion hole 236D into communication hole 224A. The dripped buffer solution C accumulates in first communication hole 224B. Next, as shown in the lower diagram of FIG. 17 , the user pushes leg 238 of dish 233 into communication hole 224A. Then, the blood B in the second communication hole 224C and the buffer solution C in the first communication hole 224B mix together and pass through the third communication hole 224D, becoming a mixed liquid 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 showing the infection determination process. The user communicatively connects the reader 300 to the user terminal device 500 and inserts the cartridge 200A containing the immunochromatographic test strip P from which blood has been collected 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 out 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 for determining the infection status of the user based on image data (hereinafter referred to as "membrane image data") generated by the reader 300 by photographing the membrane of the immunochromatographic test strip P.

[0086] As shown in FIG. 18, the control unit 520 acquires specimen data (membrane image data) (S110). Specifically, the control unit 520 transmits an image capturing instruction to the reader 300. Based on the image capturing instruction received from the user terminal device 500, the control board 314 of the reader 300 controls the camera 313 to capture an image of a portion including the membrane of the immunochromatographic test piece P housed in the cartridge 200A, 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 of S110 is an example of an acquisition process and an acquisition step, and the membrane image data is an example of collection information corresponding to the collection results of the user's specimen.

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

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

[0089] FIG. 19 is an explanatory diagram showing the process of detecting the presence or absence of a line on an immunochromatographic test strip P. FIG. 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 strip 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 including the control portion Pc and the test region Gt including the test portion Pt of the membrane image E.

[0090] The frame detection process involves sequentially moving a predetermined scan frame F along the longitudinal direction of the target area P and detecting the presence or absence of a line based on the number of dots within the scan frame F at each scan position within the target area. In this embodiment, the control area Gc and the test area Gt are both rectangular. The horizontal width of the scan frame F (the length in the short direction of the immunochromatographic test strip P) is approximately the same as the horizontal width of each target area (control area Gc, test area Gt). The vertical width of the scan frame F (the length in the long direction of the immunochromatographic test strip P) is shorter than the vertical width of each target area (e.g., 1 / 5 or less). The scan frame F moves along the longitudinal direction of the immunochromatographic test strip P, passing through both the control area Gc and the test area Gt. Note that in the frame detection process, the control unit 520 may count the number of dots across the entire membrane image E and detect the presence or absence of a line based on the number of dots. However, as in this embodiment, the accuracy of line detection is improved by detecting the presence or absence of lines in certain regions (control region Gc, test region Gt) of the captured image (membrane image E) that include each portion (control portion Pc, test portion Pt) of the immunochromatographic test strip P. Furthermore, as in this embodiment, the accuracy of line detection is further improved by using a scan frame F that is shorter in vertical width than each target region and detecting the presence or absence of lines based on the number of dots within the scan frame F at each scan position.

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

[0092] The control unit 520 notifies the reader 300 of the determination result (S140). Specifically, the control unit 520 transmits the determination result to the reader 300 via the communication unit 540. The control board 314 of the reader 300 causes the first indicator light 312a and the second indicator light 312b to emit light in a light emission pattern according to the received determination result. This allows the user to understand their own infection status (whether or not they are infected with the disease or the like that is being tested) by looking at the light emission patterns of the light-emitting devices (first indicator light 312a, second indicator light 312b) of the reader 300. The control unit 520 causes the display unit 560 to display the infection result. This allows the user to understand their own infection status by looking at the display content of the display unit 560 of the user terminal device 500. S140 is an example of a notification process.

[0093] 20 is an explanatory diagram showing a screen display on 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 of FIG. 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 determination result column 562 is a column that displays the determination result of the infection state. If the determination result is positive (S150: Y), the determination result column 562 displays a message indicating "positive" and a message urging the subject to go to a hospital to see a doctor (for example, "Consultation Required"). The determination result column 562 also displays the reference value. The reference value is an approximate amount of antigen or antibody for the test item. In the line detection process, the control unit 520 calculates the total number of dots detected within the test area Gt (or the total number of dots detected within the scan frame F at the scan position where the line was detected), determines a reference value that correlates to the total number of dots, and displays the determined reference value in the determination result column 562.

[0095] The control unit 520 receives, via the disclosure level selection field 564, permission information permitting disclosure of the infection status determination result and selection information for selecting disclosure targets from multiple types of user-related information (S160). The processing of S160 is an example of a permission receiving process (permission receiving step) and a selection receiving process (selection receiving step).

[0096] Specifically, the disclosure level selection field 564 is a field that allows the user to select the disclosure level of the determination result and user-related information about the user. The user-related information includes, for example, attribute information and infection factor information. The attribute information is information about the user's attributes, and 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 user location information (location of home or workplace (GPS)). The infection factor information is information about the factor that caused the user to become infected, and types of infection factor information include, for example, the time when the user remembered being infected, the place where the user remembered being infected, and the behavior that reminded the user of being infected. Examples of options displayed in the disclosure level selection field 564 are as follows: (a) Whether or not permission to disclose the results of the assessment is granted (b) Whether or not disclosure of attribute information is permitted (this may include whether or not disclosure of each of the above multiple types of attribute information is permitted). (c) Whether or not permission to disclose infection factor information is granted (this may include whether or not permission to disclose each of the above multiple types of infection factor information is granted). The user operates the operation unit 550 to select any option from among multiple options shown in the disclosure level selection field 564. The control unit 520 accepts the permission information and selection information based on the user's selection. Note that the control unit 520 may display the options (b) and (c) in the disclosure level selection field 564, provided that permission to disclose the determination result has been selected in (a) as a necessary condition.

[0097] The control unit 520 transmits the determination 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 not to permit disclosure of the determination result, the control unit 520 does not transmit the determination information to the management server 400. This allows the user to go to a hospital and receive treatment while ensuring the confidentiality of the determination result in the user terminal device 500.

[0098] If the user selects to permit disclosure of the determination result, the control unit 520 transmits determination information regarding the positive determination result to the management server 400. This process is an example of a transmission process (transmission step). If the user selects to permit disclosure of the determination result, the control unit 520 may transmit the membrane image data (which may be data before or after binarization) to the management server 400. The management server 400 may perform an infection state determination process with higher determination accuracy than the infection determination process performed by the user terminal device 500 based on the received membrane image data, and transmit the determination result to the user terminal device 500. The user terminal device 500 may display the determination result by the management server 400 on, for example, the display unit 560. This allows the user to grasp the highly accurate determination result (online) by the management server 400 in addition to the determination result by the simple determination (offline) by the user terminal device 500.

[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 the user-related information to the management server 400 in addition to the determination information, with the necessary condition being that the user has selected permission to disclose the determination result. Note that the control unit 520 may transmit the user-related information to the management server 400 regardless of whether the user has permission to disclose the determination 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 (if multiple types of user-related information are selected, a combination pattern of the multiple types of user-related information) in the feedback field 565 (S180), and ends this infection determination process. The feedback information is, for example, as follows: (a) If the user's physical information is selected: Advice from medical professionals (doctors, etc.) based on the physical information (for example, how to deal with the disease and precautions depending on age, gender, and infection history, information about the disease, etc.) and contact information of specialists (telephone number, email address, etc.) (b) If the user's location information is selected: Hospital information for specialists in the infected disease (for example, information on hospitals where the user can receive treatment based on the user's location (such as information on hospitals near the user's location)) (c) If infection factor information is selected: Advice from medical professionals according to the infection factor (e.g., how to deal with the infection and precautions depending on the time elapsed since the infection occurred) (d) Information regarding communication with healthcare professionals (healthcare personnel) (e.g., options for multiple communication methods, 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 stored in advance in the storage unit 530 of the user terminal device 500 and may be information provided offline, or information provided online from the management server 400 .

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

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

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

[0104] Prior to the infection determination process, the control unit 520 may identify the test items of the immunochromatographic test strip P housed 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 strip 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 FIG. 20).

[0105] The management server 400 may transmit the determination information and user-related information received from each user terminal device 500 to the terminal device 11A of each medical institution 10A and the terminal device 51 of the public institution 50. Each medical institution 10A can use the received determination information and user-related information, for example, when examining users who visit the hospital. The public institution 50 can manage the received determination information and user-related information as big data, and use the big data to identify infected areas, predict infections, and so on.

[0106] C. Variations: The technology disclosed in this specification is not limited to the above-described embodiments, and can be modified into various forms without departing from the spirit thereof, for example, the following modifications are also possible.

[0107] The configurations of the blood collection kit 1, blood collection tool 100, and reader 300 in the first embodiment are merely examples and can be modified in various ways. For example, in the first embodiment, the tubular portion 11 and the attachment 30 are joined by screwing, but they may also be joined by press-fitting, adhesive, or the like. In the first embodiment, the attachment 30 that is separate from the tubular portion 11 is exemplified as the receiving portion, but the receiving portion may also be formed integrally with the tubular portion 11.

[0108] In the first embodiment, the through hole 34 of the attachment 30 extends along the central axis of the cylindrical portion 11 (syringe 10), but may extend in a direction inclined relative to the central axis. The shape of the through hole 34 in a vertical cross section is not limited to a straight line and may be, for example, a curved line or a crank-like line. The shape of the through hole 34 in a horizontal cross section is not limited to a circular line and may be, for example, a polygonal line or an elliptical line.

[0109] The shape of the first hole 34A in the longitudinal cross section is not limited to a radial shape, and may be, for example, a rectangular shape or a tapered shape in which the diameter decreases toward the tip. The diameter of the second hole 34B may be a radial shape in which the diameter increases toward the tip, or a tapered shape in which the diameter decreases toward the tip. The expansion rate of the third hole 34C may be the same as or greater than the expansion rate 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 may be less than the cross-sectional area (inner diameter) of the internal space (barrel space 15A).

[0110] In each of the above embodiments, the materials used to form each component are merely examples, and the components may be formed from other materials.

[0111] In the first embodiment, a blood collection tool (blood collection kit) for collecting blood B was exemplified as the collection tool (specimen collection kit), but the collection tool (specimen collection kit) also includes collection tools (specimen collection kits) for collecting specimens other than blood B. Specimens include, in addition to blood B, urine, feces, sputum, saliva, and liquid materials obtained by surgery. Test items include infectious diseases such as influenza and coronavirus infection, sexually transmitted diseases (syphilis, human immunodeficiency virus, etc.), etc.

[0112] The test (determination of infection status) used in the present invention is, for example, a visual detection-type rapid diagnostic method. A visual detection-type rapid diagnostic method is a test method that visually determines the presence or absence of a disease, etc. by utilizing a mechanism that reacts with antigens or antibodies in a sample. Examples of visual detection-type rapid diagnostic methods are LFAs (Lateral Flow Assays) and RDTs (Rapid Diagnostic Tests). LFAs are rapid diagnostic methods (immunochromatography) that allow a sample (liquid sample) to flow by capillary action and visually determine the presence or absence of a specific substance. Examples of LFAs include COVID-19 antigen tests, pregnancy tests, rapid influenza diagnostics, and the detection of allergens and pathogens in food. RDTs are tests that use diffusion amplification (also known as isothermal amplification) to amplify nucleic acids (DNA or RNA) without a heating cycle. Examples include loop-mediated isothermal amplification (LAMP), recombinase polymerase amplification (RPA), and nucleic acid sequence-based amplification (NASBA).

[0113] The test kit is not limited to an immunochromatographic test strip, and may be any test kit used for the test of the present invention. For example, the test kit is a test kit having a test area in which predetermined identification information (such as a mark such as a line, a color change, etc.) appears depending on the reaction with the collected sample. Examples of test kits include a simple PCR test kit, a novel coronavirus nucleic acid test kit, and a rapid influenza diagnostic kit.

[0114] In the second embodiment, the user terminal device 500 such as a smartphone is exemplified as the information processing device, but the information processing device is not limited to this and may be a dedicated device (infection determination device) equipped with a communication function in the reader 300. The notification unit is not limited to the display unit 560, but may be a transmission device that transmits notification information to an external device, or a sound generation device. The camera is not limited to the camera 313 included in the reader 300, but may be a camera included in the user terminal device 500.

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

[0116] In the second embodiment, the infection determination process is merely an example. The control board 314 of the reader 300 may execute at least part of the infection determination process shown in FIG. 18. In the second embodiment, the immunochromatographic test strip is an immunochromatographic test strip P having one control portion Pc and one test portion Pt. However, this is not limited to this, and the immunochromatographic test strip may have multiple control portions Pc and / or multiple test portions Pt. For example, if the immunochromatographic test strip 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 a single immunochromatographic test strip, the infection state for multiple types of test items (antigens and antibodies) can be determined by executing a single infection determination process.

[0117] When using a test kit, a test standby time (e.g., about 10 to 30 minutes) may be required after dropping a sample onto the test kit until the test results are reflected. Therefore, in the second embodiment, the control unit 520 may start the infection determination process (an acquisition process for acquiring (photographing) image data) on the condition that the test standby time has elapsed since the cartridge 200A was inserted into the reader 300 ("test standby process" in S110 of FIG. 18). The control unit 520 may detect that the cartridge 200A has been inserted into the reader 300 on the condition that, for example, a user has performed an input operation (such as an operation to instruct the start of determination) on the operation unit 550 or that the control board 314 of the reader 300 has detected the cartridge 200A (or a test kit such as the immunochromatographic test strip P) based on image data from the camera 313. The control unit 520 may change the test waiting time to a time corresponding to the test item detected from the test kit based on correspondence information between multiple test items and the test waiting time specified for each of the multiple test items. [Explanation of symbols]

[0118] 1: Blood collection kit 1A: Information management system 10: Syringe 10A: Medical institution 11: Cylindrical portion 11A: Terminal device 14: Gap 15: Barrel 15A: Barrel space 16: Luer 16A: Luer space 17: Step 18: Annular portion 20: Plunger 22: Gasket 24: Grip portion 30: Attachment 31: Mounting portion 32: Space 33: Receiving portion 34: Through hole 34A: First hole 34B: Second hole 34C: Third hole 34D: Fourth hole 35: Male thread 36: Tip surface 40: Inner surface 42: Protrusion 50: Public institution 100: Blood collection tool 200, 200A: Cartridge 202A: Cartridge body 210, 210A: Base 211: Storage space 220, 220A: Cover 221, 221A: Connection part 222, 222A: Camera window 222B: Protrusion 224, 224A: Communication hole 224B: First communication hole 224C: Second communication hole 224D: Third communication hole 224E: Holding part 224F: Pressing part 226: Engagement part 228: Contact part 230: Dropper 230A: Cartridge cap 231: Cap sheet 232: Storage hole 233: Plate part 233A: Protrusion part 234: First storage hole 234D: First protrusion hole 236: Second storage hole 236D: Second protrusion hole 238: Leg part 238A: Convex part 300: Reader 311: Housing 312a: First indicator light 312b: Second indicator light 313: Camera 314: Control board 315: Battery 316: Communication port 317: Communication path 318: Cartridge storage space 318A: Insertion port 400: Management server 500: User terminal device 520: Control unit 530: Storage 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, having a diameter greater than or equal to the maximum diameter of the first hole and an expansion ratio smaller than the expansion ratio of the first hole.

2. A sample collection cartridge according to Claim 1, A sample collection cartridge wherein the third hole has a diameter that is substantially the same along its entire length in the direction along the central axis of the communication hole.

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

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

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