Information processing device, information management method, computer program, and specimen collection kit

Abstract

Thus, the result of determining the infection state can be obtained offline, and whether the determination result is disclosed or not can be selected. The information processing apparatus is communicably connected to a management server via a network, and includes an acquisition unit, an operation unit, a notification unit, and a controller. The controller performs: an acquisition process of acquiring, via the acquisition unit, acquisition information corresponding to a result of acquisition of a sample by a user; a determination process of determining an infection state of the user based on the acquired information without transmitting the acquired information to the management server; a notification process for notifying a user of the result of the determination of the infection state via a notification unit; a permission acceptance process for accepting permission information for permitting the disclosure of the result of the determination of the infection state via the operation unit; and a transmission process for transmitting, to the management server, determination information relating to the result of the determination of the infection state, on the condition that the permission information has been accepted.

Description

Technical Field

[0001] The technologies disclosed in this specification relate to information processing devices, information management methods, computer programs, and specimen collection kits. Background Technology

[0002] Conventionally, technologies are known that allow users, such as those undergoing testing, to obtain diagnostic results regarding the presence or absence of antibodies or antigens using mobile terminals. For example, in a first technology, a camera unit installed in a mobile phone captures a determination unit displaying a colored sample. The mobile phone then sends 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 sends diagnostic data corresponding to the detected presence or concentration to the mobile phone (see, for example, Patent Document 1). In a second technology, an antigen testing terminal performs antigen testing based on an inserted immunochromatographic testing kit and automatically sends the test results and the status of infection to a mobile terminal held by the person undergoing testing (see, for example, Patent Document 2).

[0003] In addition, blood collection devices for collecting blood from puncture sites in the human body are known (for example, see Patent Document 2). Conventional blood collection devices have a capillary tube and a press-down chamber. The capillary tube has a small-diameter tip portion and a large-diameter base portion. The chamber communicates with the intermediate portion between the tip and base portions of the capillary tube. With the tip portion of the capillary tube in contact with blood flowing from the puncture site, when the chamber is pressed, blood is drawn from the tip portion of the capillary tube to the base portion (for example, see Patent Document 3).

[0004] Existing technical documents

[0005] Patent documents

[0006] Patent Document 1: Japanese Patent Application Publication No. 2010-190867

[0007] Patent Document 2: Japanese Patent Application Publication No. 2022-115777

[0008] Patent Document 3: Japanese Patent Application Publication No. 2022-161878 Summary of the Invention

[0009] The problem the invention aims to solve

[0010] The aforementioned prior art 1 and 2 have the following problems: if the user's mobile terminal or other information processing device is not connected online to the diagnostic server or other management server, the user cannot obtain the infection status determination result. Furthermore, in technology 1, there is a problem that the user's infection status determination result is disclosed to a third party regardless of the user's intention.

[0011] Furthermore, the aforementioned conventional blood collection devices are dropper-type suction devices that utilize the suction force generated by the recovery force of the chamber. Therefore, the suction is relatively weak, and it may be impossible to collect a sufficient amount of blood for examination. This issue is not limited to blood collection but is a common issue in the collection and examination of specimens other than blood. Specimens refer to substances excreted or collected from the human body, including, in addition to blood, materials obtained manually or surgically such as urine, feces, sputum, saliva, and swabs.

[0012] This specification discloses a technique capable of solving at least one of the above-mentioned problems.

[0013] means for solving problems

[0014] The techniques disclosed in this specification can be implemented, for example, in the following ways.

[0015] (1) The information processing apparatus disclosed in this specification can be communicatively connected to a management server via a network. The information processing apparatus includes an acquisition unit, an operation unit, a notification unit, and a controller. The controller performs the following processes: an acquisition process, acquiring collection information corresponding to the collection results of a user's sample via the acquisition unit; a determination process, determining the user's infection status based on the collection information without sending the collection information to the management server; a notification process, notifying the user of the infection status determination result via the notification unit; a permission acceptance process, accepting permission information for disclosing the infection status determination result via the operation unit; and a transmission process, sending determination information related to the infection status determination result to the management server, conditional upon acceptance of the permission information. According to this information processing apparatus, the user can obtain the infection status determination result offline and can choose whether or not to disclose the determination result. Therefore, by ensuring confidentiality, the psychological barrier to accepting the infection status determination is reduced.

[0016] (2) In the above-described information processing apparatus, the controller may also be configured to perform a selection acceptance process, in which the operation unit accepts selection information for selecting a public object from a plurality of different user-related information associated with the user; and in the transmission process, the controller, in addition to the determination information, sends the user-related information selected using the selection information to the management server, provided that the permission information has been accepted. According to this configuration, the user can select the scope of public access for user-related information associated with themselves.

[0017] (3) In the above information processing device, it can also be configured such that, when the infection status determination result is positive and the selection information includes the user's location information, the controller notifies the user of available hospital information corresponding to the location information during the notification processing. According to this configuration, the user can obtain available hospital information by providing their location information.

[0018] (4) In the above-described information processing apparatus, the controller may also be configured to perform a designated acceptance process, in which, if the infection status determination result is positive, the controller accepts designated information from at least two of the following: obtaining infection awareness information, online communication with medical personnel, and face-to-face communication with medical personnel; and in the notification process, the controller notifies the user of information related to the communication corresponding to the designated information. According to this configuration, the user can obtain information such as infection-related coping methods through methods with varying degrees of confidentiality.

[0019] (5) In the above information processing apparatus, the controller may also be configured such that it performs a period acceptance process, which accepts the infection recall period via the operation unit; and in the notification process, if the infection status determination result is negative, the controller notifies the user via the notification unit whether the infection status determination result is valid based on the recall period. According to this configuration, the user can know that there is a possibility that the result is negative because it was not a suitable determination period.

[0020] (6) In the above-described information processing apparatus, the acquisition unit may also be configured such that the camera is used to capture images of the detection area in the inspection kit that is colored according to the reaction with the collected specimen during the acquisition process, and the image of the detection area is acquired as the acquisition information; during the determination process, the controller converts the image of the detection area into a binary image, detects the presence or absence of a line based on the number of points in the binary image, and determines the infection status based on the detection result of the presence or absence of the line. According to this configuration, the presence or absence of a line in the inspection kit can be determined without relying on the user's visual confirmation.

[0021] (7) The collection device disclosed in this specification is a collection device for collecting specimens. The collection device comprises: a syringe having a barrel and a receiving portion, the barrel having an internal space, the receiving portion covering an opening at one end of the barrel; and a plunger inserted into the internal space of the barrel. A through hole is formed in the receiving portion, extending from the outer surface of the receiving portion to the internal space of the barrel. The through hole includes a first hole opening toward the outer surface of the receiving portion and a second hole located between the first hole and the internal space of the barrel. A first area of ​​the cross-section of the first hole is larger than a second area of ​​the cross-section of the second hole, and the second area of ​​the second hole is smaller than the internal area of ​​the cross-section of the internal space of the barrel.

[0022] 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 structure where the first area of ​​the first hole is less than or equal to the second area of ​​the second hole, it is easier for the sample to enter the through hole of the receiving portion. Conversely, since the second area of ​​the second hole is smaller than the first area of ​​the first hole, the sample in the first hole is less likely to move into the internal space of the cylinder, making it easier to control the amount of sample collected in the first hole. After the sample is placed into the through hole, the sample in the first hole is drawn into the internal space of the cylinder through the second hole by the suction force generated by pulling the plunger away from the receiving portion. Since the second area of ​​the second hole is smaller than the area of ​​the internal space of the cylinder, it is possible to suppress the backflow of the sample that has moved into the internal space into the first hole. Thus, according to this structure, ease of sample collection, control over the amount of sample collected, and leakage suppression of the collected sample can be achieved.

[0023] (8) In the above-described collection device, the first hole may also be configured such that the area of ​​its cross-section expands from the second hole side toward the outer surface side of the receiving portion. According to this configuration, compared to a configuration in which, for example, the area of ​​the cross-section of the first hole is constant, it is easier for the specimen to enter the through hole (first hole).

[0024] (9) In the above-described collection device, the through hole may also include a third hole located between the first hole and the outer surface of the receiving portion, wherein the expansion rate of the third hole is different from that of the first hole. According to this configuration, sufficient space for buffer solution is ensured, and the boundary between the first and third holes is easily visually confirmed.

[0025] (10) The above-described specimen collection kit may also be configured as having the above-described collection device and a housing space for accommodating the examination kit. The housing has a connecting portion that connects to the receiving portion of the collection device. A communicating hole is formed in the connecting portion, which communicates with the first hole of the connected receiving portion and with the housing space of the housing. According to this configuration, by connecting the collection device to the housing and pressing in the plunger of the collection device, the specimen inside the cylinder can drip into the examination kit.

[0026] (11) In the above-described specimen collection kit, the through hole may also include a fourth hole located between the first hole and the outer surface of the receiving portion. The fourth hole opens in such a way that its cross-sectional area expands from the first hole side toward the outer surface side of the receiving portion. The connecting portion of the box has a contact portion that makes full circumferential contact with the inner circumferential surface of the fourth hole of the through hole. According to this configuration, the tight contact between the inner circumferential surface of the fourth hole and the contact portion can suppress leakage of the specimen and air.

[0027] Furthermore, the technology disclosed in this specification can be implemented in various ways, such as as a collection device, a blood collection device, a specimen collection kit, a blood collection kit, a receiving component (accessory) installed on a syringe, an information processing device, a reader, an infection determination device, an information management method, an information management program, an infection determination method, an infection determination program, etc. Attached Figure Description

[0028] Figure 1 This is a perspective view that schematically represents the overall structure of the blood collection kit 1 in the first embodiment.

[0029] Figure 2 This is an explanatory diagram showing the structure of a longitudinal section of the blood collection device 100.

[0030] Figure 3 This is an explanatory diagram showing the structure of the side of Annex 30.

[0031] Figure 4 This is an explanatory diagram showing the structure of the longitudinal section of Annex 30.

[0032] Figure 5 This is an explanatory diagram showing the planar structure of Annex 30.

[0033] Figure 6 This is a perspective view showing the external structure of box 200.

[0034] Figure 7 This is an explanatory diagram showing the state changes of the blood collection device 100 during blood collection.

[0035] Figure 8This is an explanatory diagram showing the connection process between the blood collection device 100 and the box 200.

[0036] Figure 9 This is an explanatory diagram showing the state of blood B after it has moved from the blood collection device 100 to the box 200.

[0037] Figure 10 This is an explanatory diagram showing the structure of the information management system in the second embodiment.

[0038] Figure 11 This is a top view showing the external structure of the box and reader.

[0039] Figure 12 It is a cross-sectional view showing the internal structure of the box and reader.

[0040] Figure 13 This is a top view showing the structure of the main body of the box.

[0041] Figure 14 It is a three-dimensional diagram showing the structure of the box cap.

[0042] Figure 15 This is a side view showing the structure of the box cap.

[0043] Figure 16 It is an enlarged representation Figure 12 A cross-sectional view of the front part of the box.

[0044] Figure 17 This is an explanatory diagram showing the process of using the box.

[0045] Figure 18 This is a flowchart illustrating the infection determination and processing.

[0046] Figure 19 This is an explanatory diagram showing the detection process of the presence or absence of lines on an immunochromatographic test strip.

[0047] Figure 20 This is an explanatory diagram showing the screen display on a mobile terminal. Detailed Implementation

[0048] A. First implementation method: A-1. Structure of Blood Collection Kit 1: Figure 1 This is a perspective view schematically showing the overall structure of the blood collection kit 1 in this first embodiment. The blood collection kit 1 is an example of a specimen collection kit. The blood collection kit 1 is used to collect blood B (see below) from a human body. Figure 7The blood sample (B) is then added to an immunochromatographic test strip to determine the presence of specific diseases. Furthermore, immunochromatography (immunoassay) is a method that uses antigen-antibody reactions to determine the presence of antibodies or antigens. The blood collection kit 1 allows individuals to safely and appropriately perform the entire process, from collecting blood sample B to adding it to the immunochromatographic test strip, at home, without relying on experts such as medical personnel.

[0049] like Figure 1 As shown, the blood collection kit 1 includes a blood collection device 100 and a box 200. The blood collection device 100 is used to collect blood B flowing from a puncture site in the human body. The blood collection device 100 is an example of a collection device, and blood B is an example of a sample. The box 200 is a housing that contains an immunochromatographic test strip. Figure 1 The image shows the state in which the blood collection device 100 is connected to the box 200.

[0050] (Structure of blood collection device 100): Figure 2 This is an explanatory diagram showing the longitudinal section of the blood collection device 100. In this specification, "longitudinal section" refers to the section along the length of the blood collection device 100 (hereinafter referred to as the syringe 10). Figure 1 and Figure 2 A cross-section (vertical section) is a section perpendicular to the length direction of the paper. For example... Figure 1 and Figure 2 As shown, the blood collection device 100 includes a syringe 10 and a plunger 20. The syringe 10 is sometimes referred to as a syringe barrel or outer barrel. The plunger 20 is sometimes referred to as a pusher.

[0051] The syringe 10 has a barrel portion 11 and an attachment 30. The syringe 10 is preferably made of a light-transmitting material (glass, resin, etc.). The attachment 30 is an example of a receiving portion. The attachment 30 is provided at one end of the barrel portion 11 in the longitudinal direction. Hereinafter, the side of the syringe 10 (barrel portion 11) with attachment 30 will be referred to as the "top end side", and the side opposite to attachment 30 will be referred to as the "base end side".

[0052] The cylindrical section 11 is a cylindrical body that extends in a straight line. The cylindrical section 11 has a feed cylinder 15 and a Luer connector 16 located at the top end of the feed cylinder 15 (see reference). Figure 2 The feed cylinder 15 extends from the base end of the cylinder 11 towards the top end. Figure 1 and Figure 2 The portion extending from the top of the cylinder 11 toward the base end (in the direction below the paper) is the Luer joint 16. Figure 1 and Figure 2 The portion extending (in the direction shown on the paper). The outer diameter of the barrel 15 is larger than the outer diameter of the Luer connector 16.

[0053] The internal space of the barrel 15, namely the barrel space 15A, extends linearly along the length of the barrel portion 11. The barrel space 15A is a cylindrical space with the same diameter along its entire length. The internal space of the Luer connector 16, namely the Luer connector space 16A, extends linearly along the length of the barrel portion 11. The Luer connector space 16A is a cylindrical space with the same diameter along its entire length. The top end of the barrel space 15A communicates with the base end of the Luer connector space 16A. The inner diameter of the Luer connector 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 connector space 16A. The barrel space 15A and the Luer connector space 16A are examples of internal spaces.

[0054] An annular portion 18 is provided at the top end of the cylindrical portion 11. The annular portion 18 is configured to surround the Luer connector 16 from the top end of the barrel 15. An annular gap 14 is formed between the Luer connector 16 and the annular portion 18. A radially outwardly protruding flange 12 is formed on the outer peripheral surface of the base end of the cylindrical portion 11. The flange 12 functions as a handle for hooking the operator's fingers.

[0055] Annex 30 is configured to cover the opening on the top side of the cylindrical portion 11. The structure of Annex 30 will be described later.

[0056] The plunger 20 is a rod-shaped body extending in a straight line. The plunger 20 is formed, for example, from glass or resin. The plunger 20 is inserted into the barrel space 15A of the barrel portion 11 in a way that allows it to move along the length of the barrel portion 11. A washer 22 is engaged at the top of the plunger 20. The washer 22 is, for example, an elastic member, made of rubber. The outer diameter of the washer 22 is approximately the same as the inner diameter of the barrel space 15A, and the outer circumferential surface of the washer 22 is in close contact with the inner circumferential surface of the barrel portion 11 constituting the barrel space 15A throughout its circumference. Since the outer diameter of the washer 22 is larger than the inner diameter of the Luer connector space 16A, the movement of the washer 22 (plunger 20) towards the top side beyond the step 17 is restricted.

[0057] A gripping portion 24 and a flange 26 are provided at the base end of the plunger 20. The flange 26 is formed such that it protrudes radially outward from the outer peripheral surface of the base end of the plunger 20. Figure 2 As shown, the flange 26 is configured to contact the flange 12 when the washer 22 moves to a position abutting against the step 17 of the cylinder portion 11 or directly in front of it. The gripping portion 24 is a portion that protrudes from the base end of the plunger 20 towards the base end side of the flange 26. For example, as Figure 1 and Figure 2 As shown, with the washer 22 pressed into the top side of the barrel space 15A of the barrel 11, the operator can pinch the gripping part 24 with his fingers to pull the plunger 20 out of the barrel space 15A of the barrel 11.

[0058] (Detailed structure of Annex 30): Figure 3 This is an explanatory diagram showing the structure of the side of Annex 30. Figure 4 This is an explanatory diagram showing the structure of the longitudinal section of Annex 30. Figure 5 This is an explanatory diagram showing the planar structure of Annex 30. Figure 4 It shows Figure 3 The cross-sectional structure of Annex 30 at position IV-IV.

[0059] like Figures 3 to 5 As shown, Attachment 30 is a cylindrical component. Attachment 30 is, for example, made of resin. Attachment 30 includes a mounting portion 31 and a receiving portion 33 located at the top end of the mounting portion 31. The mounting portion 31 and the receiving portion 33 are integrally formed, but they can also be formed separately. The mounting portion 31 is the portion that includes the base end of 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 connector 16 of the cylindrical portion 11, and the outer diameter of the mounting portion 31 is smaller than the inner diameter of the annular portion 18 (see reference). Figure 2 Therefore, the mounting portion 31 can be inserted into the gap 14 between the Luer connector 16 and the annular portion 18. An external thread 35 is formed on the outer peripheral surface of the mounting portion 31 (see reference). Figure 3 and Figure 4 An internal thread (not shown) is formed on the inner circumferential surface of the annular portion 18 to engage with the external thread 35. By engaging the external thread 35 of the mounting portion 31 with the internal thread of the annular portion 18, the accessory 30 can be mounted on the top end of the cylindrical portion 11. The accessory 30 may or may not be detachable from the cylindrical portion 11.

[0060] The receiving portion 33 includes the top end of the attachment 30. The receiving portion 33 is cylindrical and has a through hole 34 extending along the central axis of the attachment 30 (the length direction of the syringe 10). Figure 4 The base of the through hole 34 communicates with the space 32 on the inner periphery of the mounting portion 31, and the top of the through hole 34 opens on the top surface 36 (an example of the outer surface) of the attachment 30.

[0061] Through hole 34 includes first hole 34A, second hole 34B, third hole 34C and fourth hole 34D (see reference). Figure 4 ).

[0062] The first hole 34A is a recess that opens radially toward the top surface 36 of the attachment 30. The second hole 34B is located on the base end side of the first hole 34A. The base end of the first hole 34A communicates with the top end of the second hole 34B. The first area of ​​the cross-section of the first hole 34A (the opening area of ​​the top end of the first hole 34A) is larger than the second area of ​​the cross-section of the second hole 34B. The second area of ​​the second hole 34B is smaller than the internal area of ​​the cross-section of the Luer joint space 16A of the cylindrical portion 11. That is, the diameter of the second hole 34B (for example, a diameter of 1.5 mm or less) is smaller than the diameter of the first hole 34A and smaller than the diameter of the Luer joint space 16A (see reference). Figure 2 ).

[0063] The first hole 34A opens in such a way that its cross-sectional area expands from the side of the second hole 34B toward the top surface 36 of the attachment 30. That is, the shape of the first hole 34A is a cone that opens radially toward the top surface 36. The diameter of the second hole 34B is approximately the same along its entire length.

[0064] The third hole 34C is located on the top side of the first hole 34A. The base of the third hole 34C communicates with the top of the first hole 34A. The diameter of the third hole 34C is greater than the opening diameter of the top of the first hole 34A. The diameter of the third hole 34C is approximately the same along its entire length. That is, the expansion rate of the third hole 34C is smaller than that of the first hole 34A. The expansion rate refers to the degree to which the opening area (diameter) of each hole expands towards the top surface 36. Preferably, there is no step between the first hole 34A and the third hole 34C.

[0065] The fourth hole 34D is located between the third hole 34C and the top surface 36 of the attachment 30. The top surface of the fourth hole 34D faces the top surface 36, and the base of the fourth hole 34D communicates with the third hole 34C. The fourth hole 34D opens in such a way that its cross-sectional area expands toward the top surface 36. That is, the inner circumferential surface 40 constituting the fourth hole 34D is a conical surface that opens radially toward the top surface 36. When viewed from the axial direction (the length direction of the syringe 10) of the attachment 30, the fourth hole 34D is located outside the first hole 34A (the third hole 34C) and is configured to surround the entire circumference of the first hole 34A (the third hole 34C).

[0066] like Figure 3 and Figure 5 As shown, the accessory 30 has a plurality of (e.g., four) protrusions 42. Each protrusion 42 protrudes radially outward from the outer peripheral surface of the top portion of the accessory 30. The plurality of protrusions 42 are arranged at equal intervals in the circumferential direction of the central axis of the accessory 30.

[0067] (Structure of Box 200): Figure 6 This is a perspective view showing the external structure of box 200.

[0068] The box 200 is generally rectangular in shape. The box 200 has a base 210 and a cover 220. A rectangular receiving space 211 is formed on the upper surface of the base 210. The receiving space 211 is a space for receiving immunochromatographic test strips (not shown).

[0069] The cover 220 is a rectangular plate-like component, preferably formed of a light-transmitting material (glass, resin, etc.). The cover 220 is configured to cover the receiving space 211 of the base 210. The cover 220 is configured to cover the entire immunochromatographic test strip contained within the receiving space 211.

[0070] The cover 220 has a connecting portion 221. A communicating hole 224 is formed in the connecting portion 221. The communicating hole 224 communicates with the through hole 34 of the attached accessory 30 and with the receiving space 211 of the box 200. The communicating hole 224 is configured to be located directly above the sample pad of the immunochromatographic test strip received in the receiving space 211.

[0071] The connecting portion 221 has a plurality of (e.g., four) engaging portions 226. Each engaging portion 226 protrudes radially inward toward the communicating hole 224. The plurality of engaging portions 226 are arranged at equal intervals in the circumferential direction of the communicating hole 224. The protrusions 42 of the accessory 30 are inserted into the inner side of the communicating hole 224, which is closer to the cover 220 than the engaging portions 226, through the space between two adjacent engaging portions 226. Figure 6 (The lower side). Next, by rotating the attachment 30, each protrusion 42 moves downwards towards each engaging portion 226. Thus, the attachment 30 is connected to the cover 220, preventing it from falling off.

[0072] The connecting portion 221 has a contact portion 228. The contact portion 228 contacts the inner peripheral surface 40 of the attachment 30 connected to the connecting portion 221 over its entire circumference. The contact portion 228 is an annular portion surrounding the entire circumference of the connecting hole 224, and is a conical surface whose diameter decreases upward (towards the side opposite to the attachment 30).

[0073] The cover 220 has a camera window 222. The camera window 222 is positioned directly above the membrane (where the test lines and control lines appear) of the immunochromatographic test strip housed in the receiving space 211. The camera window 222 is thinner than the rest of the cover 220 and has higher light transmittance. Therefore, it is possible to clearly photograph the lines presented on the immunochromatographic test strip using an external camera.

[0074] A-2. Instructions for using Blood Collection Kit 1: (Blood collection for blood sample B): Figure 7This is an explanatory diagram showing the state changes of the blood collection device 100 during blood collection. First, the blood collection device 100 is in the pressed-in state. The pressed-in state is the state in which the plunger 20 is pressed into the barrel space 15A so that the washer 22 is located at the top of the barrel space 15A of the syringe 10. Next, for example, the fingertip is punctured with a lancet (not shown) to induce bleeding. Then, as... Figure 7 As shown in the right figure, with the attachment 30 of the blood collection device 100 in the pressed-in state facing upwards, the bleeding fingertip contacts the opening of the through hole 34 of the attachment 30, causing 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) that prevents blood B from passing through the second hole 34B due to surface tension, etc., caused by its own weight. Therefore, as... Figure 7 As shown in the central image, the collected blood B is stored in the first well 34A of accessory 30. The volume of the first well 34A is a volume that can be normally examined by an immunochromatographic assay strip (e.g., more than 45 μml and less than 55 μml).

[0075] Next, when buffer C is added to the blood B accumulated in well 34A using dropper 230, the added buffer C accumulates in well 34C. Buffer C is used to reduce the viscosity of the sample, allowing it to pass through the membrane without retention; it is buffer C (e.g., saline). Then, as... Figure 7 As shown in the left figure, by moving the plunger 20 in the direction of separation from the attachment 30 ( Figure 7 A strong attraction is generated by pulling the paper (in the direction below the paper). Through this attraction, the blood B in the first hole 34A and the buffer solution C in the third hole 34C move through the second hole 34B into the internal space of the cylinder 11 (the material cylinder space 15A and the Luer connector space 16A) and mix to form a mixture M. Thus, the blood collection of blood B ends. The volume of the first hole 34A (through hole 34) is larger than the volume of the material cylinder space 15A of the cylinder 11. Therefore, all the mixture M in the through hole 34 can be introduced into the material cylinder space 15A.

[0076] (Addition of blood B to the immunochromatographic test strip): Figure 8 This is an explanatory diagram showing the connection process between the blood collection device 100 and the box 200. Figure 9 This is an explanatory diagram showing the state of blood B after it has moved from the blood collection device 100 to the container 200. (For example...) Figure 8 As shown in the diagram above, the attachment 30 of the blood collection device 100 is positioned downwards and connected to the connection portion 221 of the box 200. At this time, the mixture M contained in the internal space of the cylindrical portion 11 will not pass through the second hole 34B due to its own weight. In other words, it is possible to prevent the mixture M from falling from the blood collection device 100.

[0077] When the top end of the attachment 30 is inserted into the communicating hole 224 of the connecting part 221 and the attachment 30 is rotated, then as follows: Figure 8 As shown in the figure below, the protrusion 42 of the attachment 30 engages with the engaging portion 226 of the connecting portion 221. Thus, the blood collection device 100 is connected to the connecting portion 221 (box 200) in an anti-detachment state. At this time, the inner circumferential surface 40 of the attachment 30 and the contact portion 228 of the connecting portion 221 are in close contact throughout their circumference. Therefore, the through hole 34 of the attachment 30 and the connecting hole 224 of the connecting portion 221 are in a sealed state of communication.

[0078] Next, as Figure 9 As shown, when the plunger 20 is pressed into the barrel space 15A, the mixture M is dropped onto the sample pad of the immunochromatographic test strip through the second hole 34B and the connecting hole 224. By inserting the cartridge 200 containing the immunochromatographic test strip with the added mixture M into a known judgment device (not shown), the immunochromatographic test result can be obtained.

[0079] A-3. Effects of this implementation method: As described above, in this embodiment, the first area of ​​the cross-section of the first hole 34A is larger than the second area of ​​the cross-section of the second hole 34B (refer to...). Figure 4 Therefore, for example, compared to a structure where the first area of ​​the first hole 34A is less than or equal to the second area of ​​the second hole 34B, it is easier to place the sample (blood B) into the through hole 34 of the accessory 30. Conversely, since the second area of ​​the second hole 34B is smaller than the first area of ​​the first hole 34A, it is difficult for the sample in the first hole 34A to move into the internal space of the syringe 10 (material cylinder space 15A), and it is also easier to control the amount of sample collected from the first hole 34A.

[0080] After the sample is placed into the through hole 34, the suction force generated by pulling the plunger 20 away from the accessory 30 draws the sample in the first hole 34A through the second hole 34B into the internal space (cylinder space 15A) of the syringe 10. The second area of ​​the second hole 34B is smaller than the area of ​​the internal space (cylinder space 15A) (see reference). Figure 2 Therefore, it can suppress the backflow of the specimen that has moved into the internal space to the first hole 34A.

[0081] Thus, according to this embodiment, it is possible to achieve ease of specimen collection, control over the amount of specimen collected, and suppression of leakage of the collected specimen.

[0082] In this embodiment, the first hole 34A opens in such a way that the cross-sectional area expands from the second hole 34B side toward the top surface 36 side of the attachment 30 (see reference). Figure 4Therefore, compared to a structure with a constant cross-sectional area of ​​the first hole 34A, it is easier to insert the specimen into the through hole 34 (first hole 34A).

[0083] Well 34C is located closer to the top than Well 34A, ensuring sufficient space for buffer C. The expansion rate of Well 34C differs from that of Well 34A. Therefore, the boundary between Well 34C and Well 34A can be easily visually confirmed by using the displacement of their expansion rates as markers. Since the expansion rate of Well 34C is smaller than that of Well 34A, it is easy to determine whether any buffer C has dripped into Well 34C.

[0084] B. Second implementation method: B-1. Structure of Information Management System 1A: Figure 10 This is an explanatory diagram showing the structure of the information management system 1A in this embodiment. The information management system 1A includes multiple terminal devices 11A (first terminal device 11A1, second terminal device 11A2) for each of multiple medical institutions 10A (first medical institution 10A1, second medical institution 10A2), a terminal device 51 for a public institution 50, a management server 400, and multiple user terminal devices 500. All devices and systems are interconnected via a network NW. Medical institutions 10A include facilities such as hospitals, clinics, home care stations, nursing assistance centers, and nursing service centers. Public institutions 50 include facilities such as social welfare corporations, medical corporations, health centers, and municipal / village government agencies. Figure 10 The diagram shows two medical institutions 10A, but the information management system 1A can include one or more medical institutions 10A. Similarly, in Figure 10 Two user terminal devices 500 are shown, but the information management system 1A may include one or more user terminal devices 500. Figure 10 The diagram shows one public agency 50, but the information management system 1A may include two or more public agencies 50. The user terminal device 500 is an example of an information processing device.

[0085] The terminal device 11A of the medical institution 10A is a computer that records medical information such as consultation results and examination results produced by doctors and staff members belonging to the medical institution 10A, and can be viewed when needed to support the work of doctors and staff members. The terminal device 11A may be, for example, a personal computer, a tablet computer, or a smartphone.

[0086] Terminal device 11A includes a control unit 120, a storage unit 130, and a communication unit 140. The storage unit 130, for example, comprises a hard disk drive (hereinafter referred to as "HDD"), ROM, RAM, or a cloud to prevent the leakage of confidential information, and stores various data such as medical information of users (patients, etc.), and various programs used to control the terminal device 11A. The communication unit 140 is an interface for communicating with external devices via wireless or wired communication. The control unit 120, for example, comprises a central control unit (hereinafter referred to as "CPU"), and controls the various parts of the terminal device 11A according to the programs read from the storage unit 130.

[0087] The terminal device 51 owned by the public institution 50 is a computer that records medical information such as consultation results and examination results produced by employees of the public institution 50, and can be viewed when needed to support the work of doctors and employees. The terminal device 51 may be, for example, a personal computer, a tablet computer, or a smartphone.

[0088] The terminal device 51 includes a control unit 52, a storage unit 54, and a communication unit 56. The storage unit 54, for example, comprises a hard disk drive (hereinafter referred to as "HDD"), ROM, RAM, or a cloud storage device to prevent the leakage of confidential information, and stores various data such as user medical information, as well as various programs used to control the terminal device 51. The communication unit 56 is an interface for communicating with external devices via wireless or wired communication. The control unit 120, for example, comprises a CPU, and controls the various parts of the terminal device 51 according to the programs read from the storage unit 52.

[0089] The management server 400 is a device that manages user personal information and information related to infection diagnosis results sent 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, for example, is composed of HDD, ROM, RAM, or a cloud to prevent leakage of confidential information, and stores various data such as user medical information and various programs used to control the management server 400. The communication unit 440 is an interface for communication with external devices via wireless or wired communication. The operation unit 450, for example, is composed of a keyboard or mouse, and handles operations by the administrator. The display unit 460, for example, is composed of a liquid crystal display. The control unit 420, for example, is composed of a CPU, and controls the various parts of the management server 400 according to the programs read from the storage unit 430.

[0090] User terminal device 500 is a device used by a user, such as a personal computer, tablet computer, or smartphone. User terminal device 500 may be located in a user's home, workplace, medical institution 10A, or public institution 50. 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. Storage unit 530 may consist of, for example, HDD, ROM, RAM, or cloud storage to prevent leakage of confidential information, storing various data and various programs used to control user terminal device 500 (including the infection detection processing program described later). Communication unit 540 is an interface for communicating with external devices via wireless or wired communication. In this embodiment, reader 300 is communicatively connected to user terminal device 500 via communication unit 540. Operation unit 550 may consist of, for example, a keyboard or mouse, and handles user operations. Display unit 560 may consist of, for example, a liquid crystal display (see below). Figure 20 The control unit 520, for example, is composed of a CPU, and controls various parts of the user terminal device 500 according to a program read from the storage unit 530. The control unit 520 is an example of a controller, and the display unit 560 is an example of a notification unit.

[0091] B-2. Structure of the box and reader: Figure 11 This is a top view showing the external structure of the box 200A and the reader 300. Figure 12 This is a cross-sectional view showing the internal structure of the box 200A and the reader 300. Figure 12 It shows Figure 11 The cross-sectional structure of cartridge 200A and reader 300 at positions XII-XII. Cartridge 200A contains immunochromatographic test strip P (see below). Figure 19 The reader 300 captures the lines displayed on the immunochromatographic test strip P contained in cartridge 200A (see below). Figure 19 The image data of the line is generated and sent to the user terminal device 500.

[0092] like Figure 11 and Figure 12 As shown, the reader 300 includes a frame 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 frame 311 is formed, for example, from a resin material, bioplastic, or metal.

[0093] The frame 311 is a rectangular box. A box-receiving space 318 and a device-receiving space S1 are provided within the frame 311. The box-receiving space 318 is a space extending linearly along the length of the frame 311. An insertion port 318A is formed at one end face (the face on the positive Y-axis direction) of the frame 311 along its length. The box-receiving space 318 communicates with the insertion port 318A. The box 200A is accommodated within the box-receiving space 318 via the insertion port 318A. A connecting path 317 is formed within the frame 311, connecting the box-receiving space 318 and the device-receiving space S1. The connecting path 317 is a path extending vertically (Z-axis direction). The connecting path 317 is configured such that the camera window 222A (described later) of the box 200A, accommodated in the box-receiving space 318, is located directly below this connecting path 317.

[0094] The device housing space S1 houses a camera 313, a control board 314, and a battery 315. The camera 313 is positioned 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 positioned to capture images of the camera window 222A (the membrane of the immunochromatographic test strip P) of the cartridge 200A, which is housed in the cartridge housing 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. Alternatively, the reader 300 may be configured to be powered from an external power source (e.g., the user terminal device 500) without a battery 315. The communication port 316 is connected to the user terminal device 500 via a wired connection, such as a USB (Universal Serial Bus) cable, enabling communication. Alternatively, the reader 300 may be configured to be communicatively connected to the user terminal device 500 via wireless communication.

[0095] The control board 314 controls the various devices included in the reader 300. A first indicator lamp 312a and a second indicator lamp 312b are disposed on the outer surface (upper surface) of the frame 311. The first indicator lamp 312a and the second indicator lamp 312b are illuminated in various illumination modes corresponding to the determination results of the reader 300's operating state and infection state. Specifically, the control board 314, for example, controls the illumination operation of the first indicator lamp 312a and the second indicator lamp 312b in a plurality of mutually recognizable illumination modes based on at least two determination results from (a) to (d) below.

[0096] (a) Judgment results related to the configuration location of box 200A: The determination of the placement position refers to whether the cartridge 200A is placed in the aforementioned reference position within the cartridge housing space 318 (the position where the camera 313 can normally capture images of the membrane of the immunochromatographic test strip P housed in the cartridge 200A). The control substrate 314, for example, determines that the cartridge 200A is placed in the reference position based on image data output by the camera 313, provided that the quality control portion Pc and the detection portion Pt are detected in the captured image.

[0097] (b) Judgment results related to immunochromatographic assay strip P contained in cartridge 200A: The determination of the immunochromatographic test strip P is based on whether the immunochromatographic test strip P contained in the cartridge 200A matches the test item specified by the user. The control board 314 detects the test item currently being tested using the immunochromatographic test strip P contained in the cartridge 200A, for example, based on image data output from the camera 313. The control board 314 detects the category of the test item based on the identification code (e.g., barcode) displayed on the immunochromatographic test strip P and the color of a specific area (conjugation pad, etc.) on the immunochromatographic test strip P. The control board 314 determines that a normal immunochromatographic test strip P is contained in the cartridge 200A if the detected test item matches the category of the test item specified by the user through the user terminal device 500.

[0098] (c) Judgment results related to the proper implementation of the immunochromatographic assay strip P: The determination of whether the inspection was carried out normally refers to whether the inspection of the immunochromatographic test strip P has been carried out normally. The control substrate 314 determines that the inspection of the immunochromatographic test strip P has been carried out normally, for example, based on image data output from the camera 313, provided that a control line on the immunochromatographic test strip P has been detected.

[0099] (d) Results related to infection status: The determination of infection status refers to whether the test result of the examination item is positive or negative. The control substrate 314, for example, based on the image data output by the camera 313, determines a positive result if both the control line and the test line on the immunochromatographic test strip P are detected; a negative result if the control line is detected but the test line is not detected; and a result that cannot be determined if the control line is not detected.

[0100] Furthermore, the determination notification unit that notifies the external device of the determination results of (a) to (d) above is not limited to a light-emitting device that emits light in a plurality of mutually recognizable light-emitting modes based on the determination results, but may also be a display device that displays text corresponding to the determination results, a sound-emitting device that emits sound corresponding to the determination results, or a transmission device that sends determination result data corresponding to the determination results to an external device (500, etc.).

[0101] Box 200A includes box body 202A and box cap 230A. Figure 13 This is a top view showing the structure of the box body 202A. Figure 14 This is a perspective view showing the structure of the cap 230A (excluding the cap piece 231 described later). Figure 15 This is a side view showing the structure of the 230A box cap. Figure 16 It is an enlarged representation Figure 12 A cross-sectional view of the front portion H of the box.

[0102] like Figure 13 As shown, the main body 202A of the box is generally rectangular. The main body 202A has a base 210A and a cover 220A. A rectangular receiving space S2 is formed on the upper surface of the base 210A. The receiving space S2 is the space for receiving the immunochromatographic test strip P.

[0103] The cap 220A is a rectangular plate-like component, preferably formed of a light-transmitting material (glass, resin, etc.). The cap 220A is configured to cover the receiving space S2 of the base 210A. The cap 220A is configured to cover the entire immunochromatographic test strip P contained within the receiving space S2.

[0104] The cover 220A has a connecting portion 221A. A communicating hole 224A is formed in the connecting portion 221A. The communicating hole 224A communicates with the receiving space S2 of the box body 202A. The communicating hole 224A is a hole that penetrates the cover 220A in a direction orthogonal to the base 210A (vertical direction), and the communicating hole 224A is configured to be located directly above the sample pad of the immunochromatographic test strip P received in the receiving space S2. The communicating hole 224A includes a first communicating hole 224B, a second communicating hole 224C, and a third communicating hole 224D. The first communicating hole 224B is a hole in the connecting portion 221A that opens on the side opposite to the receiving space S2 (base 210A). The first communicating hole 224B is a cylindrical hole with a substantially uniform diameter along its entire length in the direction of the central axis (vertical direction) of the communicating hole 224A. The second connecting hole 224C is located directly below the first connecting hole 224B and is a conical hole whose diameter decreases as it approaches the base 210A. The third connecting hole 224D is located directly below the second connecting hole 224C and is a hole with a diameter approximately the same as the minimum diameter of the second connecting hole 224C. The connecting part 221A is an example of a receiving part, the second connecting hole 224C is an example of a first hole, the third connecting hole 224D is an example of a second hole, and the first connecting hole 224B is an example of a third hole.

[0105] Furthermore, a cutout 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 is shaped to allow insertion into the cutout 210C. Therefore, for example, it prevents the cover 220A from being positioned opposite to the base 210A. In the box body 202A (base 210A), the shapes of the two corners of the top portion inserted into the box receiving space 318 are different from each other. Specifically, the shape of one corner (positive X-axis direction side) is angular, while the shape of the other corner 210B (negative X-axis direction side) is cut flat. The inner wall surface of the frame 311 forming the box receiving space 318 is shaped to correspond to the shape of each corner. Therefore, for example, when the box body 202A is inserted into the box receiving space 318 with the orientation reversed, the box body 202A will not reach the aforementioned reference position.

[0106] like Figure 14 and Figure 15 As shown, the cap 230A includes a cap plate 231, a disc portion 233, and a foot portion 238. The cap 230A is formed of resin material, bioplastic, rubber material, etc. The cap 230A is preferably formed of an elastic material. The foot portion 238 is an example of a press-fit portion.

[0107] The disk portion 233 is generally flat and has a protruding portion 233A that protrudes in one direction (positive Y-axis direction). A receiving hole 232 for receiving buffer solution C is formed on the upper surface of the disk portion 233. The receiving hole 232 includes a first receiving hole 234 and a second receiving hole 236. The first receiving hole 234 faces the bottom surface 234A of the receiving hole 232. The first receiving hole 234 is defined by a radially shaped inner circumferential surface 234B whose diameter increases with distance from the bottom surface 234A. The first receiving hole 234 has a first protruding hole 234D that protrudes towards the protruding portion 233A. The first protruding hole 234D has a shape that narrows in width towards the tip in the protruding direction.

[0108] The second receiving hole 236 is located directly above the first receiving hole 234 and communicates with it. The second receiving hole 236 is defined by a radially shaped inner circumferential surface 236B, whose diameter increases with distance from the bottom surface 234A. Furthermore, the inclination angle of the inner circumferential surface 234B relative to the bottom surface 234A is gentler than the inclination angle of the inner circumferential surface 236B relative to the bottom surface 234A. The second receiving hole 236 has a second protruding hole 236D that protrudes in one of the aforementioned directions (positive Y-axis direction). The second protruding hole 236D has a shape that narrows in width towards its apex in the protruding direction. Furthermore, the protrusion angle (the angle between the two sides forming the protruding portion) of the second protruding hole 236D is smaller than the protrusion angle of the first protruding hole 234D.

[0109] The foot 238 protrudes downward from the lower surface of the disk 233. The foot 238 is generally cylindrical. A radially outward protrusion 238A is formed on the outer circumference of the foot 238. When the foot 238 is inserted into the connecting hole 224A, the connecting hole 224A becomes sealed due to the compression deformation of the protrusion 238A. The top surface 238B of the foot 238 is a conical surface whose diameter decreases as it moves away from the disk 233. The inclination angle of the top surface 238B relative to the base 210A is approximately the same as the inclination angle of the second connecting hole 224C relative to the base 210A.

[0110] The cover 220A has a pair of pressing parts 224E, 224E (see reference) Figure 16Each pressing part 224E is formed to protrude downward from the lower surface of the cover 220A opposite to the base 210A. When viewed from the central axis direction (Z-axis direction) of the connecting hole 224A, the pair of pressing parts 224E, 224E are positioned to clamp the third connecting hole 224D in the longitudinal direction (Y-axis direction) of the box body 202A (immunochromatographic test strip P). Directly below the third connecting hole 224D within the receiving space S2, the pair of pressing parts 224E, 224E ensures a gap between the lower surface of the cover 220A and the immunochromatographic test strip P, and inhibits the floating of the immunochromatographic test strip P. Furthermore, the pair of pressing parts 224E, 224E are positioned to clamp the third connecting hole 224D in the width direction (X-axis direction) of the box body 202A (immunochromatographic test strip P).

[0111] The cover 220A has a pair of pressing parts 224F, 224F (see reference) Figure 13 Each pressing part 224F is formed to protrude downward from the lower surface of the cover 220A opposite to the base 210A. When viewed from the central axis direction (Z-axis direction) of the connecting hole 224A, the pair of pressing parts 224F, 224F are positioned to sandwich the third connecting hole 224D in the width direction (X-axis direction) of the box body 202A (immunochromatographic test strip P). The pair of pressing parts 224F, 224F, are located directly below the third connecting hole 224D within the receiving space S2, ensuring a gap between the lower surface of the cover 220A and the immunochromatographic test strip P, and pressing the two sides of the immunochromatographic test strip P in the width direction. This inhibits leakage of blood B dripping from the third connecting hole 224D from the immunochromatographic test strip P and guides it towards the membrane.

[0112] Cap 231 is a sheet material that seals the receiving hole 232 of the cap 230A. Cap 231 has the same shape as the disc portion 233 of the cap 230A. The peripheral portion of cap 231 is peelably bonded to the periphery of the receiving hole 232 in the disc portion 233. Thus, the buffer solution C is contained within the receiving hole 232 in a sealed state (see reference). Figure 16 Cap piece 231 is, for example, an aluminum piece.

[0113] B-3. ​​Instructions for using Box 200A: Figure 17 This is an explanatory diagram showing the usage process of box 200A. First, the user removes the foot 238 of the box cap 230A from the connecting hole 224A of the box body 202A to open the connecting hole 224A (see...). Figure 16 Next, the user, for example, pricks the fingertip with a lancet (not shown) to induce bleeding. Then, as... Figure 17As shown in the diagram above, the user configures the box body 202A with the connecting hole 224A opening upwards, so that the bleeding fingertip contacts the opening of the connecting hole 224A, causing blood B to drip into the connecting hole 224A. The diameter of the third connecting hole 224D is set to a size (e.g., 1 mm or more but less than 1.5 mm) that prevents blood B from passing through the third connecting hole 224D due to surface tension and other factors. Therefore, as... Figure 17 As shown in the central diagram, the collected blood B is stored in the second connecting well 224C. The capacity of the second connecting well 224C is a volume that can be normally examined by an immunochromatographic assay strip (e.g., more than 45 μml and less than 55 μml).

[0114] Next, the user peels off the cap 231 from the disc 233 and drips the buffer solution C contained in the receiving hole 232 of the disc 233 onto the blood B accumulated in the second connecting hole 224C. At this time, the user positions the top of the disc 233 directly above the opening of the connecting hole 224A, tilting the disc 233 so that the foot 238 moves laterally upward. As a result, the buffer solution C smoothly drips from the receiving hole 232 through the first protruding hole 234D and the second protruding hole 236D into the connecting hole 224A. The dripped buffer solution C accumulates in the first connecting hole 224B. Then, as... Figure 17 As shown in the figure below, the user presses the foot 238 of the disc 233 into the connecting hole 224A. The blood B in the second connecting hole 224C then mixes with the buffer solution C in the first connecting hole 224B and passes through the third connecting hole 224D to form a mixture M, which is then dropped onto the sample pad of the immunochromatographic test strip P.

[0115] B-4. Infection Determination and Treatment: Figure 18 This is a flowchart illustrating the infection determination process. The user communicatively connects the reader 318 to the user terminal device 500 and inserts the cartridge 200A containing the completed immunochromatographic test strip P into the insertion port 318A of the strip reader 300. Next, the user performs a prescribed operation through the operation unit 550 of the user terminal device 500, thereby causing the control unit 520 to read the infection determination process from the storage unit 530 and execute it. Figure 18 The infection determination process shown is a process for determining the user's infection status based on image data (hereinafter referred to as "membrane image data") generated by the reader 300 capturing images of the membrane of the immunochromatographic test strip P.

[0116] like Figure 18As shown, the control unit 520 acquires sample data (membrane image data) (S110). Specifically, the control unit 520 sends an imaging instruction to the reader 300. Based on the imaging 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 the membrane-containing portion of the immunochromatographic test strip P contained in the cartridge 200A, generating membrane image data. The control board 314 transmits the generated membrane image data to the user terminal device 500 via the communication port 316. The control unit 520 acquires the membrane image data via the communication unit 540. The communication unit 540 is an example of an acquisition unit, the processing in S110 is an example of an acquisition process, and the membrane image data is an example of acquisition information corresponding to the user's sample acquisition results.

[0117] The control unit 520 does not send the membrane image data acquired from the reader 300 to the management server 400. Based on the acquired membrane image data, the control unit 520 performs a determination process to ascertain the user's infection status. This will be explained in detail below. In this embodiment, the infection status includes reference values ​​indicating the presence or absence of any tested items (antigen, antibody) and the level of infection (degree, amount of antigen, antibody).

[0118] The control unit 520 performs image conversion processing on the acquired membrane image data (S120). Specifically, the control unit 520 first converts the membrane image data (e.g., color image data or grayscale image data) into binarized image data. Next, the control unit 520 divides the binarized image data into units of predetermined scan frames F, detects the presence or absence of lines based on the number of points within each scan frame F, and determines the infection status based on the detection results of the presence or absence of lines (S130). S130 is an example of the determination processing and determination step.

[0119] Figure 19 This is an explanatory diagram illustrating the detection process for the presence or absence of the P line on an immunochromatographic test strip. Figure 19 A membrane image E captured by camera 313 of reader 300 is shown. Membrane image E includes a control region Pc and a detection region Pt in an immunochromatographic test strip P. The control region Pc is the portion displaying the control line (C), and the detection region Pt is the portion displaying the detection line (T). Control unit 520 treats the control region Gc, including the control region Pc, and the detection region Gt, including the detection region Pt, in membrane image E as objects and performs frame detection processing.

[0120] Frame detection processing involves moving a defined scanning frame F sequentially along the length of the immunochromatographic test strip P within the target area, and detecting the presence or absence of lines at each scanning position within the target area based on the number of points within the scanning frame F. In this embodiment, both the quality control area Gc and the detection area Gt are rectangular. The width of the scanning frame F (the length in the width direction of the immunochromatographic test strip P) is approximately the same as the width of each target area (quality control area Gc, detection area Gt). The width of the scanning frame F (the length in the length direction of the immunochromatographic test strip P) is shorter than the width of each target area (for example, less than 1 / 5). The scanning frame F moves along the length direction of the immunochromatographic test strip P, passing through the quality control area Gc and the detection area Gt respectively. Furthermore, in frame detection processing, the control unit 520 can also count the number of points for the entire membrane image E and detect the presence or absence of lines based on this number of points. However, as in this embodiment, if the presence or absence of lines is detected by targeting regions (quality control region Gc, detection region Gt) that include portions of the immunochromatographic test strip P (quality control region Pc, detection region Pt) in the captured image (membrane image E), the detection accuracy of the lines is improved. Furthermore, as in this embodiment, if a scanning frame F shorter in width and height than the target region is used for each target region, and the presence or absence of lines is detected based on the number of points within the scanning frame F at each scanning position, the detection accuracy of the lines is further improved.

[0121] The control unit 520 counts the number of detected points (hereinafter referred to as "point detection count") at each scanning position within each target area. If the point detection count exceeds a certain threshold, the control unit 520 determines that a line exists at that scanning position. Based on the line detection results, the control unit 520 determines the infection status as follows.

[0122] (a) Negative: The control unit 520 determines that a line exists in the quality control area Gc and that no line exists in the detection area Gt.

[0123] (b) Positive: The control unit 520 determines that a line exists in the quality control area Gc and also determines that a line exists in the detection area Gt.

[0124] (c) Error detection: Control unit 520 determines that a line does not exist in the quality control area Gc.

[0125] The control unit 520 notifies the determination result (S140). Specifically, the control unit 520 sends the determination result to the reader 300 via the communication unit 540. The control board 314 of the reader 300 illuminates the first display lamp 312a and the second display lamp 312b in a light-emitting pattern corresponding to the received determination result. Thus, by observing the light-emitting patterns of the light-emitting devices (first display lamp 312a, second display lamp 312b) on the reader 300, the user can understand their infection status (whether they have an infection such as a disease requiring examination). The control unit 520 displays the infection result on the display unit 560. Thus, by observing the display content on the display unit 560 on the user terminal device 500, the user can understand their infection status. S140 is an example of notification processing and notification procedures.

[0126] Figure 20 This is an explanatory diagram showing the screen displayed on the display unit 560 of the user terminal device 500. When the control unit 520 determines that the determination result is positive (S150: Yes), it will... Figure 20 The positive result of (A) is displayed on the display unit 560. The positive result screen includes a result column 562, a disclosure level selection column 564, and a feedback column 565.

[0127] The determination result column 562 displays the determination result of the infection status. In the case of a positive determination result (S150: Yes), the determination result column 562 displays a message indicating "positive" and urging the patient to go to the hospital for a doctor's examination (e.g., "examination required"). The determination result column 562 also displays the aforementioned reference values. The reference values ​​are estimated quantities of the antigens and antibodies tested. In the aforementioned line detection process, the control unit 520 calculates the total number of points detected within the detection area Gt (or, the total number of points detected within the scan frame F at the scan position of the detected line), determines the reference value related to that total number of points, and displays the determined reference value in the determination result column 562.

[0128] Control unit 520 accepts the permission information for disclosing the infection status determination result via the disclosure level selection column 564, and selects the disclosure object from multiple types of user-related information (S160). The processing of S160 is an example of permission acceptance processing (permission acceptance procedure) and selection acceptance processing (selection acceptance procedure).

[0129] Specifically, the disclosure level selection bar 564 allows users to choose the disclosure level of user-related information related to the judgment result. User-related information includes, for example, attribute information and infection cause information. Attribute information is related to the user's attributes, and types of attribute information include, for example, information related to the user's physical condition (gender, age, infection history, occupation, symptoms, disease), and the user's location information (home and workplace locations (GPS)). Infection cause information is related to the reason for the user's infection, and types of infection cause information include, for example, the time of infection onset, the location of infection onset, and the actions taken during infection onset. An example of the options displayed in the disclosure level selection bar 564 is shown below.

[0130] (a) Whether there is a public license for the judgment result

[0131] (b) Whether there is a public license for the attribute information (which may also include whether there is a public license for each of the above-mentioned attribute information).

[0132] (c) Whether there is permission to disclose information about the cause of infection (which may also include permission to disclose information about each of the plurality of causes of infection mentioned above).

[0133] The user operates the operation unit 550 to select any option from the plurality of options shown in the disclosure level selection bar 564. The control unit 520 processes the aforementioned permission information and selection information based on the user's selection result. In addition, the control unit 520 may also display options (b) and (c) in the disclosure level selection bar 564 if the permission disclosure determination result selected in (a) is a necessary condition.

[0134] The control unit 520 sends the judgment information and user association information corresponding to the option selected in the disclosure level selection bar 564 to the management server 400 (S170). Specifically, if the user selects not to disclose the judgment result, the control unit 520 will not send the judgment information to the management server 400. As a result, the user can go to the hospital for treatment while ensuring the confidentiality of the judgment result in the user terminal device 500.

[0135] When the user selects to allow the public disclosure of the determination result, the control unit 520 sends the determination information related to the positive determination result to the management server 400. This process is an example of a sending process (sending procedure). Furthermore, when the user selects to allow the public disclosure of the determination result, the control unit 520 can also send the aforementioned membrane image data (which can be the data before or after binarization) to the management server 400. The management server 400 can perform infection status determination processing based on the received membrane image data, determining an infection status with higher accuracy than the infection determination processing in the user terminal device 500, and send the determination result to the user terminal device 500. The user terminal device 500 can also display the determination result from the management server 400, for example, on the display unit 560. Thus, in addition to being able to access the simplified (offline) determination result from the user terminal device 500, the user can also access the high-precision determination result from the management server 400 (online).

[0136] The control unit 520 sends user association information of the type selected in the public access level selection field 564 to the management server 400. The control unit 520 takes the user's selection of public access permission as a necessary condition, and sends the user association information to the management server 400 along with the decision information. Alternatively, the control unit 520 may send user association information to the management server 400 regardless of whether the user has granted public access permission.

[0137] The control unit 520 displays feedback information in the feedback bar 565 corresponding to the type of user association information selected in the disclosure level selection bar 564 (or, if multiple types of user association information are selected, a combination pattern of multiple types of user association information) (S180), and ends this infection determination process. The feedback information is as follows.

[0138] (a) When information related to the user's health is selected: advice from medical professionals (doctors, etc.) related to the health information (e.g., coping methods, precautions, information related to the infected disease, etc., corresponding to age, gender, and infection history), and contact information of specialist doctors (telephone number, email address, etc.).

[0139] (b) In cases where the user's location information is selected: hospital information for specialist doctors of the infected disease (e.g., information on available hospitals corresponding to the user's location (information on hospitals near the user's location, etc.)).

[0140] (c) If information on the cause of infection is selected: advice from healthcare professionals corresponding to the cause of infection (e.g., coping methods, precautions, etc., corresponding to the period from the onset of infection).

[0141] (d) Information related to communication with healthcare professionals (healthcare-related 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, telephone communication with healthcare professionals, etc., and information related to each communication method (e.g., how to use it, contact information, etc.)).

[0142] In addition, the feedback information is pre-stored in the storage unit 530 of the user terminal device 500, and can be information provided offline or information provided online from the management server 400.

[0143] If the determination result is negative (S150: No), the control unit 520 displays on the display unit 560. Figure 20 The negative result screen (B) includes the result screen 562, the infection recurrence period screen 566, and the feedback screen 565. If the result is negative (S150: No), the result screen 562 displays the meaning of "negative" and the reference value.

[0144] The infection recall period field 566 is a field for users to input the infection recall period (e.g., year, month, day, date, and time). The infection recall period may be the time when the user engaged in an activity that could have caused the infection, or the time when symptoms associated with the infection (such as fever) appeared. The control unit 520 determines whether the infection recall period has been entered into the infection recall period field 566 (S190). The processing in S190 is an example of period acceptance processing. If the control unit 520 determines that an infection recall period has been entered (S190: Yes), it determines the validity of the infection status determination result based on that infection recall period (S200). For example, if the control unit 520 determines that the infection status is negative during the period from the time of infection onset to the date of execution of the infection determination process performed by the user terminal device 500 (hereinafter referred to as the "infection period") within the appropriate period for checking items (such as influenza) (e.g., 12 hours after the onset of illness), the determination result of the infection status is valid. If the infection period is outside the appropriate period for checking (e.g., 12 hours before the onset of illness), the determination result of the infection status is invalid.

[0145] The control unit 520 displays feedback information corresponding to the suitability determination result on the display unit 560 (S210) and ends the infection determination process. For example, if the determination result (negative) indicating an infection status is valid, the control unit 520 displays a message indicating that the determination result (negative) is valid in the feedback column 565. If the determination result (negative) indicating an infection status is invalid, the control unit 520 displays information related to the appropriate examination period (e.g., the date and time when the appropriate examination period has elapsed since the onset of illness). Furthermore, an alarm setting may also be displayed in the feedback column 565. The alarm setting is a setting used to notify the user of this information when the infection period falls within the appropriate examination period (e.g., by displaying an alarm on the display unit 560). The user can enable the alarm function by setting the alarm setting to "on".

[0146] The control unit 520 can also, before infection determination processing, determine the examination items contained in the immunochromatographic test strip P housed in the reader 300 based on the image data captured from the reader 300 (identification information of the examination items displayed on the immunochromatographic test strip P), and determine whether the determined examination items are consistent with the examination items specified by the user through the operation unit 550. Information related to the examination items specified by the user can also be displayed on the display unit 560. Figure 20 (The judgment result display screen, etc.).

[0147] The management server 400 can also send the judgment information and user association information received from each user terminal device 500 to the terminal devices 11A of each medical institution 10A and the terminal devices 51 of the public institution 50. In each medical institution 10A, for example, the received judgment information and user association information can be used for the examination of patients visiting the hospital. The public institution 50, for example, can manage the received judgment information and user association information as big data and, based on this big data, utilize it for determining the infection area and predicting infection.

[0148] C. Variation example: The technology disclosed in this specification is not limited to the above-described embodiments, and can be modified in various ways without departing from its spirit, for example, the following modifications are also possible.

[0149] The structure of the blood collection kit 1, blood collection device 100, and reader 300 in the first embodiment described above is merely one example and can be modified in various ways. For example, in the first embodiment described above, the cylindrical portion 11 and the accessory 30 are joined by screwing, but they can also be joined by pressing, bonding, or other methods. In the first embodiment described above, the accessory 30 is shown as a receiving part that is separate from the cylindrical portion 11, but the receiving part can also be integrally formed with the cylindrical portion 11.

[0150] In the first embodiment described above, the through hole 34 of the attachment 30 extends along the central axis of the barrel 11 (injector 10), but it may also extend in a direction inclined relative to the central axis. The shape of the through hole 34 in the longitudinal section is not limited to a straight line, but may also be curved or crank-shaped. The shape of the through hole 34 in the cross section is not limited to a circle, but may also be polygonal or elliptical.

[0151] The shape of the first hole 34A in the longitudinal section is not limited to a radial shape; for example, it can also be rectangular, or a pointed shape whose diameter decreases towards the top. The diameter of the second hole 34B can be radial, increasing towards the top, or a pointed shape whose diameter decreases towards the top. The expansion rate of the third hole 34C can be the same as or greater than that of the third hole 34C. In the above embodiment, the maximum opening area (opening diameter) of the first hole 34A is larger than the area (inner diameter) of the cross section of the internal space (barrel space 15A) of the syringe 10, but it can also be smaller than or less than the area (inner diameter) of the cross section of the internal space (barrel space 15A).

[0152] In the above embodiments, the forming material of each component is just one example, and it may also be formed from other materials.

[0153] In the first embodiment described above, a blood collection device (blood collection kit) for collecting blood B is exemplified as a collection apparatus (sample collection kit), but the collection apparatus (sample collection kit) also includes collection apparatus (sample collection kits) for collecting specimens other than blood B. The specimens, in addition to blood B, include, for example, urine, stool, sputum, saliva, and liquid materials obtained through surgery. The examination items include infectious diseases such as influenza and coronavirus infection, and sexually transmitted diseases (syphilis, human immunodeficiency virus, etc.).

[0154] The examination (determination of infection status) used in this invention is, for example, a visually-based rapid diagnostic method. Visually-based rapid diagnostic methods utilize structures that react with antigens and antibodies in a sample to visually determine the presence or absence of disease. Examples of visually-based rapid diagnostic methods are LFA (Lateral Flow Assay) and RDT (Rapid Diagnostic Test). LFA is a rapid diagnostic method (immunochromatography) where the sample (liquid sample) flows through capillary action, allowing for visual determination of the presence or absence of specific substances. Examples of LFA include COVID-19 antigen testing, pregnancy testing, rapid influenza diagnosis, and detection of food allergens and pathogens. RDT, for example, is a test that uses diffusion amplification (also known as isothermal amplification) to amplify nucleic acids (DNA, RNA) without heating and cycling them. Specific examples include LAMP (Loop-mediated isothermal amplification), RPA (Recombinase Polymerase Amplification), and NASBA (Nucleic Acid Sequence-Based Amplification).

[0155] The test kit is not limited to immunochromatographic test strips; it can be any test kit used in the examinations described above in this invention. For example, a test kit may have a detection area that displays prescribed identification information (marks such as lines, color changes, etc.) based on the reaction with the collected sample. Examples of test kits include simplified PCR test kits, novel coronavirus nucleic acid test kits, and rapid influenza diagnostic kits.

[0156] In the second embodiment described above, a user terminal device 500, such as a smartphone, is exemplified as an information processing device, but it is not limited to this; it could also be a dedicated device (infection determination device) with communication functions in the reader 300. The notification unit is not limited to the display unit 560; it could also be a sending device that sends notification information to an external device, a sound-emitting device, or the like. The camera is not limited to the camera 313 included in the reader 300; it could also be a camera included in the user terminal device 500.

[0157] In the second embodiment described above, the inclination angle of the inner circumferential surface 236B relative to the bottom surface 234A of the cap 230A can be greater than the inclination angle of the inner circumferential surface 234B relative to the bottom surface 234A.

[0158] In the second embodiment described above, the infection determination process is merely one example. The control board 314 of the reader 300 can also perform this process. Figure 18 The infection determination process described above involves at least a portion of the treatment. In the second embodiment described above, the immunochromatographic test strip P is an immunochromatographic test strip P having a control portion Pc and a detection portion Pt, but it is not limited to this; it may also be an immunochromatographic test strip having at least one of a plurality of control portions Pc and detection portions Pt. For example, when the immunochromatographic test strip has a plurality of detection portions Pt, the control unit 520 of the user terminal device 500 may also set a plurality of detection regions Gt corresponding to the plurality of detection portions Pt (corresponding to a plurality of different test items), and detect whether there is a test line for each detection region Gt. By performing an infection determination process once using an immunochromatographic test strip, the infection status related to a plurality of types of test items (antigens, antibodies) can be determined.

[0159] When using a testing kit, after the sample is applied to the kit, a waiting time (e.g., about 10 to 30 minutes) is sometimes required before the test results are reflected. Therefore, in the second embodiment described above, the control unit 520 may, for example, start the infection determination process (acquisition (capture) image data acquisition process) as a necessary condition, provided that the aforementioned waiting time has elapsed since the cartridge 200A was inserted into the reader 300. Figure 18 The control unit 520 can also detect that the cartridge 200A has been inserted into the reader 300, for example, if the user has performed an input operation on the operation unit 550 (such as a start indication operation) or the control board 314 of the reader 300 has detected the cartridge 200A (or an inspection kit such as an immunochromatographic test strip P) based on image data from the camera 313. The control unit 520 can change the inspection standby time to the time corresponding to the inspection item detected from the inspection kit, based on the correspondence information between a plurality of inspection items and inspection standby times specified for each plurality of inspection items.

[0160] Explanation of reference numerals in the attached figures: 1: Blood collection kit 1A: Information management system 10: Syringe 10A: Medical institution 11: Cylinder 11A: Terminal device 14: Gap 15: Cylinder 15A: Cylinder space 16: Luer connector 16A: Luer connector space 17: Step 18: Annular part 20: Plunger 22: Washer 24: Pinch part 30: Accessory 31: Mounting part 32: Space 33: Receiving part 34: Through hole 34A: First hole 34B: Second Two holes 34C: Third hole 34D: Fourth hole 35: External thread 36: Top surface 40: Inner circumferential surface 42: Protrusion 50: Common structure 100: Blood collection device 200, 200A: Box 202A: Box body 210, 210A: Base 211: Receiving space 220, 220A: Cover 221, 221A: Connecting part 222, 222A: Camera window 222B: Protrusion 224, 224A: Connecting part Hole 224B: First connecting hole; 224C: Second connecting hole; 224D: Third connecting hole; 224E: Pressing part; 224F: Pressing part; 226: Engaging part; 228: Contact part; 230: Dropper; 230A: Cap; 231: Cap piece; 232: Receiving hole; 233: Disc part; 233A: Protruding part; 234: First receiving hole; 234D: First protruding hole; 236: Second receiving hole; 236D: Second protruding hole; 238: Foot. 238A: Protrusion 300: Reader 311: Frame 312a: First indicator light 312b: Second indicator light 313: Camera 314: Control board 315: Battery 316: Communication port 317: Communication path 318: Box housing 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. An information processing device, communicatively connected to a management server via a network, wherein, The information processing device includes an acquisition unit, an operation unit, a notification unit, and a controller. The controller performs the following processing: The acquisition process involves acquiring acquisition information corresponding to the acquisition results of the user's specimen via the acquisition unit. The decision-making process involves not sending the collected information to the management server, but instead determining the user's infection status based on the collected information. The notification process involves notifying the user of the infection status determination result via the notification unit. The operation unit accepts and processes the license application, disclosing the license information of the infection status determination result. as well as The system sends out processing information, provided that the permission information has been accepted, and sends the determination information related to the determination result of the infection status to the management server.

2. The information processing apparatus according to claim 1, wherein, The controller also performs a selection acceptance process, in which the operation unit accepts selection information for selecting a public object from a plurality of user association information that are different from each other and associated with the user. In the sending process, the controller, upon accepting the permission information, will send the user association information selected using the selection information to the management server, in addition to the determination information.

3. The information processing apparatus according to claim 2, wherein, If the infection status is determined to be positive and the selection information includes the user's location information, the controller will notify the user of the hospital information corresponding to the location information during the notification processing.

4. The information processing apparatus according to claim 1, wherein, The controller also performs a designated acceptance process, in which, if the infection status determination result is positive, the controller accepts designated information via the operation unit, specifying at least one of the following: obtaining infection awareness information, online communication with medical personnel, and face-to-face communication with medical personnel. In the notification processing, the controller notifies the user of information related to communication corresponding to the specified information.

5. The information processing apparatus according to claim 1 or 2, wherein, The controller also performs periodic processing for the period during which an infection is detected via the operation unit; In the notification processing, if the infection status determination result is negative, the controller, based on the recall period, notifies the user via the notification unit whether the infection status determination result is valid.

6. The information processing apparatus according to claim 1, wherein, The acquisition unit includes a camera. In the acquisition process, the controller causes the camera to capture images of the detection area in the inspection kit that is colored according to the reaction with the collected specimen, and acquires the image of the detection area as the acquisition information. In the determination process, the controller converts the image of the detection area into a binary image, detects the presence or absence of lines based on the number of points in the binary image, and determines the infection status based on the detection result of the presence or absence of lines.

7. An information management method, wherein, Perform the following procedures: This enables the information processing device to acquire collection information corresponding to the collection results of the user's specimen; The information processing device determines the user's infection status based on the collected information; The information processing device displays the result of the infection status determination on its display device. The information processing device may, via its operating unit, grant permission to disclose the determination result of the infection status. Conditional upon acceptance of the permission information, determination information related to the determination result of the infection status is sent from the information processing device to an external device via a network.

8. A computer program that causes an information processing device to perform the following processes: Obtain the collection information corresponding to the collection results of the user's specimen; The infection status of the user is determined based on the collected information; The notification will state the result of the infection status assessment. The license information for disclosing the determination results of the infection status was accepted. Conditional upon acceptance of the permission information, the determination information related to the determination result of the infection status is sent to an external device via the network.

9. A specimen collection kit for collecting specimens, wherein, have: The box has a compartment to hold the inspection kit; as well as A receiving part is provided in the box. A through hole is formed in the receiving portion, extending from the outer surface of the receiving portion to the receiving space. The through hole includes a first hole opening toward the outer surface of the receiving portion and a second hole located between the first hole and the receiving space. The first area of ​​the cross-section of the first hole is larger than the second area of ​​the cross-section of the second hole. The second area of ​​the second hole is smaller than the internal area of ​​the cross section of the accommodating space.

10. The specimen collection kit according to claim 9, wherein, The first hole opens in such a way that the cross-sectional area expands from the second hole side toward the outer surface side of the receiving part.

11. The specimen collection kit according to claim 10, wherein, The through hole also includes a third hole located between the first hole and the outer surface of the receiving part. The expansion rate of the third hole is different from that of the first hole.

12. The specimen collection kit according to claim 9, wherein, The through hole also includes a fourth hole located between the first hole and the outer surface of the receiving part. The fourth hole opens in such a way that the cross-sectional area expands from the first hole side toward the outer surface side of the receiving part. The box has a contact portion that makes full circumferential contact with the inner circumferential surface of the fourth hole of the through hole.

13. The specimen collection kit according to claim 9, wherein, It also has a cap, which has a press-in portion that is pressed into the through hole.

14. The specimen collection kit according to claim 13, wherein, The cap has a receiving hole for containing a buffer solution.

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