Method and apparatus for managing information dealing with medical tests for assessing a given medical condition

Abstract

The present invention relates to a method for managing information dealing with medical tests for assessing a predetermined medical condition by a distributed system (100) comprising a plurality of communication devices (210, 312, 322, 410), the method comprising: obtaining, by a user communication device (210), information regarding an access code provided on a test kit for assessing a predetermined medical condition, the user communication device (210) being configured to receive and display a message addressed to the unique identifier. The method further comprises providing instructions for analyzing the medical sample. A negative analysis result is communicated to the user communication device (210) of the user. In the case of a positive analysis result, a consultation with a medical entity (medical institution or organization) is established. Further aspects relate to a user communication device, a computer program product, a central server, and a medical test kit for use with the proposed method.

Description

[Technical Field]

[0001] The present invention relates to a method for managing information dealing with medical tests for assessing predetermined medical conditions, and a medical test kit is provided. Further aspects relate to a user communication device, a computer program product, a central server, and a medical test kit for use with the proposed method. [Background technology]

[0002] Medical self-tests exist for many diseases and other conditions and can be used by individuals to easily and anonymously obtain a reliable diagnosis. These self-tests, particularly for infectious diseases, can provide an important contribution to public health care. For example, as early as 2016, the WHO encouraged the implementation of self-testing to augment existing HIV (human immunodeficiency virus) testing services. As a result, 59 countries worldwide have implemented HIV self-testing policies, and 53 other countries are currently developing such policies. Currently, there are several obstacles to early HIV diagnosis. Primarily, fear of shame and stigma, inconvenient access, refusal, and time investment are the most powerful factors contributing to low testing rates, contributing to the fact that even at this stage, 25% of HIV-positive patients remain undiagnosed. Similar issues apply, particularly for other sexually transmitted diseases (STDIs).

[0003] For example, while rapid HIV self-tests have a high acceptability, potential users still have concerns about correct use, interpretation of test results, and linkage to care. To assist users in performing medical self-tests, it is known to provide software in the form of "apps" that can be run on user devices such as smartphones, tablets, or general-purpose computers. With such "apps," each self-test can be supported by a third party, such as a medical entity, making the self-test a supported medical self-test.

[0004] The paper by Ivan C Balan et al., "SMARTtest: A Smartphone App to Facilitate HIV and Syphilis Self- and Partner-Testing, Interpretation of Results, and Linkage to Care," AIDS Behav. 2020 May 24(5):1560-1573, describes an app that supports self-testing and partner testing. The app provides step-by-step instructions with videos and pictures, as well as sample test results ("positive" or "negative") presented in text. The app is further designed to provide awareness and disclosure of HIV / syphilis status and linkage to care.

[0005] A problem with known methods and apps for supporting self-testing, particularly for infectious diseases such as HIV, is that they mainly address the step of communicating the test results. They do not provide appropriate assistance to users if the test result is positive. In particular, known methods and apps cannot ensure that users receive appropriate treatment for their condition. Furthermore, if the test result is negative, known methods and apps cannot provide further assistance regarding prevention and / or further testing.

[0006] It is therefore an object of the present invention to provide an integrated method and corresponding system that ensures that users of medical self-testing receive the necessary support and guidance in accordance with best medical practice.

[0007] A further problem with medical self-testing, or medical testing in general, is the difficulty of testing. Many high-risk patients do not meet the recommended testing frequency. Furthermore, social stigma and fear of a positive test result may prevent many patients from testing using known testing procedures.

[0008] It is therefore a further object of the present invention to provide an improved method and system for managing information regarding medical tests, thereby ensuring patient anonymity and privacy while enabling patients to receive appropriate guidance and advice from qualified medical practitioners.

[0009] Another problem with known methods of supporting testing is the long turnaround time, which increases when a confirmatory test using a second analytical method is required to verify a first positive test result. The need to wait for a long time is a significant burden on patients, especially when testing for severe illnesses.

[0010] It is therefore a further object of the present invention to provide a method and system that assists communication between the entities involved so that an integrated testing process is provided, particularly when a second analytical method is required to verify a first positive test result. Summary of the Invention

[0011] A method for managing information dealing with medical tests for assessing a predetermined medical condition is proposed, the method comprising providing a medical test kit, the medical test kit comprising an access code and a sampling unit for obtaining a medical sample, the method further comprising: - a user inputting an access code into a user communication device, the access code being verified and, after verification, being used as a unique identifier or a unique identifier being generated, the user communication device being configured to receive messages addressed to the respective unique identifier; - a user shipping a medical sample labeled with a sample identifier associated with a unique identifier to a laboratory entity for analysis, the medical sample being obtained using a component of the sampling unit; receiving, by the laboratory entity, the shipped medical specimen and analyzing the received medical specimen using a first analytical method; - by the laboratory entity, if the result of the first analytical method is negative, using the laboratory communication device to send a message addressed by using the unique identifier to the user communication device, the message informing the user of the negative test result, or if the result of the first analytical method is positive, performing further processing, the further processing including: - analyzing the received medical sample using a second analytical method by the laboratory entity or by a further laboratory entity; - by the laboratory entity or the further laboratory entity, if the result of the second analytical method is negative, sending, by the laboratory communication device or the further laboratory communication device, a message addressed by using the unique identifier to the user communication device, wherein the message informs the user about the negative test result, or, if the result of the second analytical method is positive, establishing a consultation by a medical entity, such as a doctor, wherein establishing - sending, by the laboratory entity or the further laboratory entity, a message using the laboratory communication device or the further laboratory communication device to a practitioner communication device of the medical entity, the message including an indication of the positive test result and the unique identifier; and performing further processing, including: communicating, by the medical entity, with the user, wherein the communication is established using a practitioner communication device configured to contact the user communication device identified by the unique identifier.

[0012] The proposed method utilizes a distributed communication system comprising a user communication device, further laboratory communication devices, if present, and further practitioner communication devices, which protects the privacy of users of medical tests, as the user communication devices are only addressable by a unique identifier, which is not associated with any further personal data and does not allow the user's identity to be revealed.

[0013] A distributed communication system comprising a user communication device, a laboratory communication device, optionally further laboratory communication devices, and a practitioner communication device implements a method for managing information dealing with medical tests for assessing a predetermined medical condition, the method comprising: - obtaining, by a user communication device, information regarding an access code provided on a test kit for assessing a predetermined medical condition, wherein the user communication device is configured to verify the access code and receive and display a message addressed to the unique identifier, and the unique identifier is generated or the access code is used as the unique identifier; - providing suggestions to the user on a display of the user communication device to assist in obtaining a medical sample using components of a sampling unit provided in the test kit; - providing instructions to the user for shipping the acquired medical sample to a laboratory entity for analysis on a display of the user communication device, the medical sample being labeled with a sample identifier associated with the unique identifier; - obtaining, by a laboratory communication device, a unique identifier associated with the shipped medical sample and providing instructions to a laboratory entity to perform a first analysis of the medical sample; - obtaining results of a first analysis of the medical sample by the laboratory communication device, and if the results are negative for the predetermined condition, sending a message to the user communication device regarding the negative test result by the unique identifier, and if the test result is positive for the predetermined condition, providing instructions associated with the unique identifier to the laboratory entity or a further laboratory entity to perform a second analysis of the medical sample using a second analysis method; - if a second analysis has been performed, obtaining the results of the second analysis of the medical sample by the laboratory communication device or a further laboratory communication device, and if the test result is negative for the predetermined pathology, sending a message about the negative test result by means of the unique identifier to the user communication device, and if the test result is positive for the predetermined pathology, sending a message including the unique identifier to the practitioner communication device in order to establish a consultation with a medical entity, such as a doctor; Includes.

[0014] In connection with the described method, the user communication device is configured to receive messages sent to the user communication device and addressed by the unique identifier. In particular, the user communication device is configured to receive a message indicating that a medical sample has been received and to receive a message indicating a negative test result. Furthermore, the user communication device can be configured to alert the user that a message has been received and to display the contents of the message.

[0015] According to certain embodiments, the user communication device, the laboratory communication device, if present, the further laboratory communication device, and / or the further practitioner communication device are smart devices such as smartphones or tablets, or are Internet-enabled PCs. Such communication devices are essentially general-purpose computers with a processor and memory, the processor being configured to execute instructions of a computer program that may be stored in the memory. Each communication device, particularly the laboratory / further laboratory communication device and the practitioner communication device, may be part of an existing information management system, such as an electronic health record (EMR) system of a doctor's office or hospital, or a laboratory information system.

[0016] Suitable smart devices, such as smartphones or tablets, are well known and include, among other things, any smartphone or tablet running the iOS or Android operating systems. Suitable internet-enabled PCs include, among other things, any desktop or laptop PC running common operating systems such as Windows, Mac OS, and Linux.

[0017] Each computer program may be configured to cause a processor of the computer to perform the steps of a method executed by a respective one of the communication devices. In this embodiment, a respective software application ("app") is installed on each communication device configured to execute the steps of the method executed by the respective communication device. Such an "app" may be provided on a computer-readable medium such as a USB pen drive, a CD-ROM, a DVD, or a Blu-ray disc. Alternatively, such an "app" may be provided downloadable via a communication network such as the Internet. The app may be stored in the memory of each communication device.

[0018] Alternatively, each "app" may be configured as a "web app" running on a server, such as a web server, and the communication device may be configured to run a web browser or terminal software that connects the communication device to the server. Such a server is essentially a computer with a processor and memory, and the processor is configured to execute computer program instructions. The computer program running on the server causes the server's processor to perform the respective steps of the method performed by the respective communication device. In this case, input and output are relayed to the respective entity's actual communication device, which serves as a front end for the application running on the server. For example, the user communication device may be a smartphone running a common web browser. For example, to perform the relevant steps of the method performed by the user communication device, the user opens a provided website on their user communication device.

[0019] According to certain embodiments, each communication device comprises output means, such as a display or speaker, for presenting information. Additionally, each communication device may comprise input means for receiving input, such as a unique identifier. Suitable input means include, among others, a touchscreen, a keyboard, a pointing device such as a mouse, a camera, an RFID reader, and a microphone.

[0020] According to certain embodiments, the user communication device, the laboratory communication device, if present, and the practitioner communication device are configured to communicate with a central server to relay messages between said devices.

[0021] Each communication device and / or the central server may be equipped with communication means, such as wired or wireless communication means, for connecting to a communication network, such as the Internet.

[0022] Suitable wireless communication means include communication modules configured for Wi-Fi, Bluetooth, GSM, UMTS, LTE, 5G, or any other known wireless communication standard. Suitable wired communication means include communication modules such as a modem or an Ethernet interface.

[0023] The communication means may be configured to connect each communication device and / or the central server to a common communication network, such as the Internet.

[0024] A user may be any person or patient who wishes to be tested for a particular medical condition, such as a disease caused by a virus, bacteria, fungus, or parasite, including any infectious disease. Examples of disease-causing viruses and bacteria include human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV), human papillomavirus (HPV), Chlamydia trachomatis, herpes simplex virus (HSV), Treponema pallidum, and coronaviruses such as severe acute respiratory syndrome coronavirus 2 (SARS-Cov-2). A user may utilize a user communication device to send and receive communications regarding medical tests.

[0025] The laboratory entity or further laboratory entity may be any institution and / or any person with appropriate training to perform analyses related to medical tests, such as a medical individual. Furthermore, the terms "laboratory entity" and "further laboratory entity" are intended to encompass any medical personnel and associated staff who receive and / or process the laboratory analysis results of the first and / or second analyses. The terms "laboratory entity" and "further laboratory entity" are also intended to encompass any agent that manages the process of obtaining the first / second analytical test results and entering the respective analytical test results into a laboratory / further laboratory communication device. The laboratory entity, and, if present, the further laboratory entity, may utilize a laboratory communication device / further laboratory communication device to send and receive communications dealing with medical tests.

[0026] A medical entity can be any facility and / or any person with appropriate training to treat patients and / or provide medical guidance, such as a physician or physicians (including physician support staff or physicians such as nurses). In the case of a facility, the medical entity may be, for example, a clinic or hospital including any of the respective personnel / staff. The medical entity can utilize a practitioner communication device to send and receive communications dealing with medical tests.

[0027] The access code is used as authentication or proof of purchase. The access code may also be a code or identifier number to identify the test kit. According to certain embodiments, the access code is unique. The access code may be verified by the user communication device or transmitted to a central server for verification. Verification can be performed, for example, by comparing the access code to known valid access codes stored in a database or by applying a mathematical function to the access code.

[0028] The unique identifier is a code used to address the user communication device, particularly enabling the sending of messages to the user communication device when steps of the proposed method require contacting the user, and further enabling the association of a medical sample with the user. The unique identifier does not allow the identity of the user to be revealed, thus allowing the user to perform anonymous medical tests. If the access code is unique, it can also be used as a unique identifier. If the access code is not used as a unique identifier, the user communication device can generate a unique identifier and send it to the central server, or the central server can generate a unique identifier and send it to the user communication device. According to certain embodiments, the unique identifier is randomly generated, selected from a database containing pre-generated identifiers, or generated by a deterministic mathematical function.

[0029] If the unique identifier is not the same as the access code, the central server may have a database in which the generated / selected unique identifiers are stored and associated with the access code.

[0030] The sample identifier is a code used to identify the acquired medical sample. The sample identifier may be identical to the access code. If the access code is used as the unique identifier, the sample identifier is also identical to the unique identifier. If the unique identifier is different from the access code and / or if the sample identifier is different from the access code, the sample identifier is associated with the unique identifier. For example, such association can be performed during access code verification by a database that links together the access code and the corresponding sample identifier. Thus, the association step may be performed, inter alia, by a central server in communication with the user communication device.

[0031] After a user obtains a test kit, the user typically first sets up the user communication device for use in one of the described methods, which may include, among other things, downloading and / or installing an appropriate software application ("app") on the user communication device or launching a web browser to access an appropriate website or web application.

[0032] To facilitate initial setup of the user communication device, the medical test may include a reference to a downloadable computer program / software application ("app"). Such a reference may be provided in the form of a hyperlink. The hyperlink may be encoded in the form of a barcode, such as a 2D matrix code (e.g., a QR code) that can be printed on paper or a card, or may be encoded on an RFID tag. In particular, the hyperlink may direct the user to an application directory or app store to select, download, and install the application.

[0033] After the initial setup of the user communication device, the user can launch the respective "app" to proceed.

[0034] The user communication device may further be configured to provide general information about medical tests and / or medical conditions. Such information may include text, images, and / or video related to the use of the medical test or medical condition, such as an infectious disease.

[0035] According to certain embodiments, the step of entering the access code into or obtaining the access code by the user communication device includes scanning a 1D or 2D matrix code or scanning an RFID tag using a camera of the user communication device. Examples of 2D matrix codes include QR (Quick Response) codes.

[0036] The user communication device may provide instructions to the user for entering the access code, for example, the user communication device may show a video on a display device explaining how an access code provided in the form of a bar code or QR code should be scanned.

[0037] After the access code is entered into the user communication device, the access code can be verified, and after successful verification, the user communication device guides the user through the following steps of the method.

[0038] According to certain embodiments, prior to the step of shipping the medical sample, the user communication device provides detailed instructions to the user, the instructions including text, images, audio, and / or video. In particular, the detailed instructions can explain the use of the test kit to obtain the medical sample.

[0039] Such text, images, audio and / or video instructions may be stored along with a computer program / software application that implements the respective method steps on a user communication device or may be provided in the form of an internet link.

[0040] Additionally, the user communication device may present detailed instructions explaining how the acquired medical example should be shipped to the laboratory entity. This may include displaying an email address on the display of the user communication device. Alternatively, the medical example may include a pre-prepared mailing label or a pre-labeled mailing package, such as a bag or box.

[0041] The sampling unit may include a self-sampling device, or a sample carrier such as a plasma separation card or swab and / or a bag or container for collecting a medical sample. According to certain embodiments, the sample carrier also includes a sample identifier, for example, in the form of a barcode, a 2D matrix code, or an RFID tag. This sample identifier may be the same as or different from the access code and may be the same as or associated with a unique identifier. The access code may be used to associate the unique identifier with the sample identifier, for example, by a database that links the access code to the corresponding sample identifier.

[0042] According to certain embodiments, the sampling unit is configured so that sufficient material is collected as a medical sample so that two independent analytical methods can be used to analyze the medical sample. For example, the sampling unit may include two sample carriers, or a single sample carrier may be configured to collect sufficient material to perform two independent analytical methods.

[0043] The laboratory entity receives the medical sample by shipment and begins processing after receiving the medical sample. According to certain embodiments, if the sample identifier is different from the unique identifier, the laboratory entity does not receive any information that could reveal the user's identity, such as an email address or phone number, but only the unique identifier and the sample identifier.

[0044] After receiving the medical sample, the laboratory entity can enter the received sample identification and / or unique identifier into the laboratory communication device, for example, by scanning a barcode, 2D matrix code, or RFID tag. If the sample identifier is not identical to the unique identifier, the laboratory communication device can obtain the unique identifier from a central server having a database linking unique identifiers to sample identifiers.

[0045] According to certain embodiments, the method further includes sending, by the laboratory entity, a message addressed using the unique identifier to the user communication device and notifying the user that the sample has been received and / or the sample has been tested and / or the testing has been completed. For example, the laboratory communication device can automatically generate and send such a message after a barcode associated with a received medical sample is scanned. This allows the user to stay up to date and makes the entire process as transparent as possible.

[0046] Upon receiving the medical sample, the laboratory entity begins analyzing the medical sample using a first analytical method.

[0047] According to specific embodiments, the first analytical method detects proteins such as antibodies and / or antigens. According to certain embodiments, the second analytical method detects nucleic acids such as DNA or RNA. Suitable methods for detecting nucleic acids are or include polymerase chain reaction (PCR) and reverse transcription polymerase chain reaction (RT-PCR).

[0048] According to certain embodiments, the first analytical method provides rapid results, is easy to perform, is inexpensive, and can be performed in large quantities. In the first analytical method, the occurrence of some false-positive test results is acceptable, and a second, different analytical method can be used to confirm the positive test results. Antibody or antigen tests are particularly suitable as the first analytical method because they typically deliver test results in 10 to 20 minutes, are relatively inexpensive, and can process large quantities of samples.

[0049] After the first analysis is completed, the test results can be entered into the laboratory communication device. According to certain embodiments, the information system of the laboratory entity, which may be coupled to a machine used in connection with performing the first analysis, and the laboratory communication device are networked together so that the analysis results are automatically entered into the laboratory communication device. In such embodiments, the laboratory communication device may be part of an existing laboratory information system. For example, an existing computer system may be configured to perform the steps of the laboratory communication device by providing appropriate software. Alternatively, the analysis results are manually entered into the laboratory communication device. To assist the laboratory entity's staff in this task, the laboratory communication device may be configured, among other things, to scan results encoded in barcodes.

[0050] If the test result of the first analytical method is positive, a further test using a second analytical method is performed as a confirmatory test, either by the same laboratory entity or a different laboratory entity. If the second analytical method is performed by another, additional laboratory entity, the laboratory communication device can provide instructions, such as an email address, to the laboratory entity to organize the transfer of the medical sample to the additional laboratory entity. Furthermore, the laboratory communication device can send a message including a unique identifier to the additional laboratory communication device to notify the additional laboratory entity of the need for a second analysis. According to certain embodiments, the same sample carrier used to perform the first analytical method is provided to perform the second analysis. Advantageously, this avoids the time required to obtain a second medical sample from the patient, significantly reducing test turnaround time.

[0051] After receiving the medical sample, the further testing entity may enter the sample identification and / or unique identifier upon receipt into the further laboratory communication device, for example by scanning a barcode, 2D matrix code or RFID tag.

[0052] Upon receiving the medical sample, the further laboratory entity begins analyzing the medical sample using a second analytical method.

[0053] If the second analytical method is performed by the same laboratory entity as the first analysis, the respective laboratory entity may immediately begin analyzing the medical sample using the second analytical method.

[0054] Advantageously, the second analytical method provides a high degree of certainty and therefore a low percentage of false-positive test results. Because the second analytical method is used only if the first analytical method produces a positive test result, it is acceptable for the second analytical method to be slower and more expensive. PCR (polymerase chain reaction) and RT-PCR (reverse transcription polymerase chain reaction) are particularly suitable as second analytical methods because they have a very low false-positive rate.

[0055] After the second analysis is completed, the test results can be entered into the (further) laboratory communication device. According to certain embodiments, the information system of the (further) laboratory entity, which may be coupled to the machine used in connection with performing the second analysis, and the further communication device are networked with each other so that the analysis results are automatically entered into the (further) laboratory communication device. Alternatively, the analysis results are manually entered into the (further) laboratory communication device. To assist the laboratory entity staff in this task, the (further) laboratory communication device can be configured, in particular, to scan results encoded in a barcode.

[0056] The first and / or second analytical methods may test for a medical condition, which may be correlated with a sexually transmitted disease and / or the medical condition may be a disease caused by a virus, bacterium, fungus or parasite, for example, a virus or bacterium selected from the group consisting of human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV), human papillomavirus (HPV), Chlamydia trachomatis, herpes simplex virus (HSV), Treponema pallidum, and a coronavirus such as severe acute respiratory syndrome coronavirus 2 (SARS-Cov-2).

[0057] If the first or second analytical method results in a negative test result, the laboratory entity or further laboratory entity may indicate the negative test result by the respective laboratory communication device and send an appropriate message addressed by the unique identifier to the user.

[0058] If both analytical methods yield a positive test result, it would be inappropriate to present the test result to the user by a simple message.

[0059] A positive test result may cause distress to the user, especially if the condition is related to an incurable condition or disease, and therefore the user should not be left alone. Therefore, the proposed method establishes direct communication between a medical practitioner and the user to report a positive test result.

[0060] According to certain embodiments, the user further provides a region code, e.g., a zip code, and the medical entity is selected based on the provided region code. Accordingly, the user communication device can be configured to obtain the region code from the user. Furthermore, if several eligible laboratory entities are available, the region code can be used to provide the user with addresses of laboratories close to the user's location to speed up the process. According to certain embodiments, the region code is used only to select medical entities and / or laboratories close to the user's location and is not used for any other purpose. In particular, the region code may not be disclosed to any of the entities involved in the method, such as laboratories or medical entities.

[0061] According to certain embodiments, the step of communicating with the user includes establishing an audio (telephone) and / or video link between the user communication device and another practitioner communication device addressed by using a unique identifier. This audio and / or video link can be established using a software application "app" running on the user communication device and the practitioner communication device so that personal addresses such as the user's phone number are not exposed. In particular, this functionality can be provided as an "in-app call." The audio or video link may be established, for example, by voice over IP using a communications network such as the Internet. Alternatively or additionally, communication with the user may be performed in the form of a text chat. Advantageously, this allows the user to remain anonymous while simultaneously allowing appropriate medical counseling, which is particularly important when a positive test result and its implications are communicated to the user.

[0062] According to certain embodiments, after establishing the consultation with the medical entity, the method further includes scheduling an appointment for the user with the medical entity, and the unique identifier is transmitted by the user communication device to the medical entity's appointment system for identification of the user.

[0063] To schedule an appointment, the practitioner communication device can interface with the medical entity's reservation system and receive one or more open dates for the appointment. The one or more open dates are then sent to the user communication device, and the unique identifier is again used to address the user communication device and presented to the user. The user can then select an appropriate date for the appointment and then transmit their response to the reservation system via the practitioner communication device.

[0064] Alternatively, for scheduling an appointment, the practitioner communication device can provide an internet link to the appointment system to the user communication device, and the user can then open the provided link, for example, using a web browser installed on their user communication device, and subsequently schedule an appointment.

[0065] The practitioner communication device may be provided as part of an existing electronic health record (EMR) system, for example, an existing computer system may be configured to perform the steps of the practitioner communication device by providing appropriate software.

[0066] According to certain embodiments, the method includes the steps of obtaining, by the user communication device when a message indicating a negative test result is received, a user input indicating whether the user belongs to a high-risk group for a predetermined medical condition; and if the user belongs to the high-risk group: - generating, by the user communication device, a reminder for the user to repeat the test after a predetermined time has elapsed; and / or providing, by the user communication device, further tests to assess whether the user is eligible for preventative treatment for a predetermined medical condition; and performing one or more of:

[0067] For example, after administering a test for HIV, the user communication device may inquire of the user whether the patient would like their liver / kidney function tested to assess whether they are well enough to receive prescribed PREP (pre-exposure prophylaxis). If so, the user communication device may present information regarding further medical tests to test liver / kidney function. In particular, such medical tests may evaluate creatinine and serum phosphate as biomarkers of liver and kidney function, respectively.

[0068] In a further example, the user communication device can schedule an alert to warn the user after a predetermined time has passed that the user communication device should repeat the test. A calendar function of the user communication device can be used for this purpose. The predetermined time can be selected depending on the respective medical condition and current medical recommendations.

[0069] The user communication device may further be configured to provide general health information, such as general information about STDIs (sexually transmitted diseases).

[0070] A further aspect of the present invention provides a user communications device configured for use in one of the methods described herein, the user communications device being configured to obtain an access code or a unique identifier by user input, verify the access code, and generate the unique identifier or use the access code as the unique identifier, the user communications device being further configured to receive a message from a server addressed to the unique identifier.

[0071] Similarly, a further aspect of the present invention provides a computer program comprising instructions which, when executed by a computer, cause the computer to perform the steps performed by a user communication device of one of the methods described herein, the computer program comprising instructions causing the computer to obtain an access code by user input, generate a unique identifier or use the access code as the unique identifier, and receive a message addressed to the unique identifier.

[0072] A further aspect of the present invention provides a laboratory communication device, and optionally a further laboratory communication device, configured for use in one of the methods described herein.

[0073] Similarly, a further aspect of the present invention provides a computer program comprising instructions which, when executed by a computer, cause the computer to perform the steps performed by the laboratory communication device of one of the methods described herein.

[0074] A further aspect of the present invention provides a practitioner communication device configured for use in one of the methods described herein.

[0075] Similarly, a further aspect of the present invention provides a computer program comprising instructions which, when executed by a computer, cause the computer to perform the steps performed by an implementer communication device of one of the methods described herein.

[0076] Each communication device may be configured essentially as a general-purpose computer including a processor and a memory, the processor being configured to execute instructions of a computer program, which may be stored in the memory of each communication device.

[0077] According to certain embodiments, each communication device comprises output means, such as a display or a speaker, for presenting information. Furthermore, each communication device may comprise input means for receiving input. Suitable input means include, among others, a touchscreen, a keyboard, a pointing device such as a mouse, a camera, an RFID reader, and a microphone.

[0078] Each communication device comprises communication means such as wired or wireless communication means for connecting to a communication network such as the Internet.

[0079] Suitable wireless communication means include communication modules configured for Wi-Fi, Bluetooth, GSM, UMTS, LTE, 5G, or any other known wireless communication standard. Suitable wired communication means include communication modules such as a modem or an Ethernet interface.

[0080] The communication means may be configured to connect each communication device to a common communication network, such as the Internet.

[0081] To implement each step of the method, each communication device may include a specialized module. For example, a communication device may include a messaging module that handles sending and / or receiving messages addressed by a unique identifier and relayed by the central server. Thus, the central server may also include modules for implementing specific steps of the method, such as a messaging module for relaying messages addressed by a unique identifier.

[0082] Another aspect of the present invention provides a central server configured to perform the central server steps of one of the methods described herein.

[0083] The central server is essentially a general-purpose computer with a processor and memory, the processor configured to execute instructions of a computer program, which may be stored in the memory of the central server. The central server may be configured as a dedicated machine that implements the method steps performed by the central server, or as a virtual server or so-called "cloud server," where one or more virtual servers share resources provided by one or more physical servers.

[0084] The central server is provided with communication means, such as wired or wireless communication means, for connecting to a communication network, such as the Internet.

[0085] The central server cooperates with the user communication device, the laboratory communication device, if present, and the practitioner communication device to form a distributed communication system capable of managing information relating to medical tests for evaluating predetermined medical conditions, the components of the system being interconnected by a common communication network such as the Internet.

[0086] Advantageously, the provided system with individual communication devices allows for management of the entire testing process and allows communication between the involved entities and the user without revealing the user's true identity. Thus, the user's privacy is protected while ensuring smooth operation and providing the user with the necessary medical assistance and counseling. Furthermore, the system further supports the follow-up process, such as scheduling an appointment for further assistance from a medical practitioner, reminding the user to repeat the test at appropriate intervals, and / or assisting the user in further health programs, such as prevention.

[0087] From the user's perspective, the user has only a single point of contact with the system / method provided by the user's user communication device. In the case of a smart device such as a smartphone or tablet as the user communication device, only a single software application ("app") running on the user communication device is sufficient to provide all features and services to the user.

[0088] The user communication device (the software "app" running on the user communication device) can advantageously provide the functionality of a guidance app that instructs the user how to perform self-sampling with the provided sampling unit, the functionality of a medical information system for each medical condition, the functionality of an appointment scheduling system, and the functionality of a results communication system.

[0089] A further aspect of the present invention is to provide a medical test kit including an access code, a reference to a downloadable computer program that executes on a user communication device, and a sampling unit for obtaining a medical sample, the medical test kit being configured for use in the course of one of the methods described herein.

[0090] The sampling unit for obtaining a medical sample can be any suitable device, including a self-sampling device, and can include at least a sample carrier, such as a plasma separation card or a swab. Additionally, the sampling unit can include one or more of the following: a disinfectant, a tourniquet, a lancet, a capillary tube, a dispenser, a small transparent sample bag, a large sample bag, an envelope, and tape / plaster. In one embodiment, the sample is obtained or obtained by a non-invasive method, i.e., a method that does not invade or destroy healthy tissue, such as a swab (e.g., vaginal or nasal), hair, tear, sweat, stool, or urine sample.

[0091] A bag containing desiccant may be included to protect the contents of the test kit from humidity and moisture.

[0092] To provide the user with an access code and / or sample identifier that links the sampling unit to a user communication device and thus enables a communication method, the medical test kit may include one or more code carriers in the form of a card or sticker with a barcode, a 2D matrix code and / or an RFID tag.

[0093] The access code may be different from or the same as the sample identifier. If the access code and the sample identifier are the same, the medical test kit may include at least two identical code carriers. One of the code carriers is then attached to the sample carrier to associate the sample carrier with the user, and at least one code carrier is intended to remain with the user to enable use of the user communication device. If the access code and the sample identifier are different, the code carrier encoding the access code is intended to remain with the user, and the code carrier encoding the sample identifier is intended to be attached to the sample carrier.

[0094] The reference to the downloadable computer program can be provided in the form of a hyperlink. The hyperlink may be coded in the form of a barcode, such as a 2D matrix code (QR code), or may be coded on an RFID tag. Thus, the medical test kit comprises at least one code carrier that codes the hyperlink.

[0095] In addition to the instructions provided by the downloadable computer program, the medical self-test kit may, of course, also include written instructions, for example in the form of a printed booklet.

[0096] The envelopes can be pre-labeled and even have postage already paid so that the user can ship the envelope after it contains a sealed sample carrier marked with a sample identifier.

[0097] According to certain embodiments, the medical test kit is suitably packaged so as not to require special storage conditions, such as specific humidity and / or temperature ranges. The packaging can also be configured to provide sufficient protection against mechanical damage, so that the medical test kit may be sold, for example, in a vending machine or sent to a user by mail. Advantageously, this ensures the user's privacy of the medical self-test from the outset.

[0098] The anonymity provided by the provided methods, systems and medical test kits is important for overcoming patient inhibitions and therefore increasing testing rates.

[0099] As used in this specification and the appended claims, the singular forms "a," "an," and "the" include the plural unless the context clearly dictates otherwise. Similarly, the words "comprise," "contain," and "encompass" are to be construed inclusively rather than exclusively, i.e., "including but not limited to." Similarly, the word "or" is intended to include "and" unless the context clearly dictates otherwise. The terms "plurality," "multiple," or "multitude" refer to an integer multiple of two or more, i.e., 2 or >2, and the terms "single" or "sole" refer to one, i.e., =1. Furthermore, the term "at least one" should also be understood as one or more, i.e., 1 or >1, which are also integer multiples. Thus, words using the singular or plural also include the plural and singular, respectively. Furthermore, the words "herein," "above," "previously," and "below," and words of similar import, when used in this patent application, shall refer to this patent application as a whole and not to any particular portions of this patent application.

[0100] To avoid repetitive illustrations and descriptions of various aspects and exemplary embodiments, it should be understood that many features are common to multiple aspects and embodiments. The description of specific embodiments of the present disclosure is not intended to be exhaustive or to limit the disclosure to the precise form disclosed. While specific embodiments of, and examples of, the present disclosure have been described herein for illustrative purposes, those skilled in the relevant art will recognize that various equivalent modifications are possible within the scope of the present disclosure. Certain elements of the foregoing embodiments can be combined with, or substituted for, elements of other embodiments. Furthermore, while advantages associated with specific embodiments of the present disclosure have been described in the context of these embodiments, other embodiments may also exhibit such advantages, and not all embodiments need exhibit such advantages to be within the scope of the present disclosure as defined by the appended claims. The omission of an aspect from the description or illustrations does not imply that the aspect is missing from embodiments incorporating that aspect. Instead, aspects may be omitted for the sake of clarity and to avoid redundant description. In this context, the following applies to the remainder of this description: if, for clarity of the drawings, a figure contains reference signs, but those reference signs are not explained in the directly relevant part of the specification, reference is made to the preceding or following description section. Furthermore, for clarity, if not all features of a part are labeled with reference signs in a section of a drawing, reference is made to other sections of the same drawing. Like numbers in two or more figures represent the same or similar elements.

[0101] The following examples are intended to illustrate various specific embodiments of the present invention. Therefore, the specific modifications discussed below should not be interpreted as limitations on the scope of the present invention. It will be apparent to those skilled in the art that various equivalents, modifications, and alterations can be made without departing from the scope of the present invention, and therefore, it should be understood that such equivalent embodiments are included herein. Further aspects and advantages of the present invention will become apparent from the following description of specific embodiments shown in the drawings. [Brief explanation of the drawings]

[0102] The invention will therefore be further explained below on the basis of the drawings: [Figure 1] 1 shows a schematic diagram of a distributed communication system; [Figure 2] 1 illustrates a schematic representation of a user communication device; [Figure 3] 1 shows a flow diagram of a method for managing information. [Figure 4] 1 illustrates a flow diagram of an embodiment of a method for managing information using a distributed communication system. [Explanation of symbols]

[0103] 100 Distributed communication system 100 200 users' homes 210 User Communication Device 211 processor 212 memory 213 Means of communication 214 Output means 215 Input Method 310 First Examination Room 312 Laboratory Communication Devices 320 Second Examination Room 322 Further Laboratory Communication Devices 400 Clinic 402 Practitioner Communication Device 500 central servers 1001 First Step 1002 Second Step 1003 Third Step 1011 First result negative 1012 First result positive 1020 Further processing steps 1021 Second result negative 1022 Second result positive 1031 First result communication step 1032 second result communication step 1040 Transfer Step 1041 First Establishment Step 1042 Second Establishment Step 1043 Third Establishment Step 2001 First Step 2002 Second Step 2003 Third Step 2004 The Fourth Step 2005 The Fifth Step 2011 First result negative 2012 First result positive 2020 Further processing steps 2021 Second result negative 2022 Second result positive 2030 Messaging Steps 2040 Establishment Steps DETAILED DESCRIPTION OF THE INVENTION

[0104] 1 illustrates a schematic representation of a distributed communication system 100. The distributed communication system 100 includes a user communication device 210, a laboratory communication device 312, a further laboratory communication device 322, a practitioner communication device 402, and a central server 500.

[0105] The devices of the distributed communication system 100 are located and used in different locations while being interconnected by a central server 500. The user communication device 210 is located, for example, in the user's home 200. The laboratory communication device 312 is located, for example, in a first laboratory 310 that performs a first analytical method according to one of the methods described herein. The further laboratory communication device 322 is located, for example, in a second laboratory 320 that performs a second analytical method according to one of the methods described herein. The practitioner communication device 402 is located, for example, in a doctor's office 400.

[0106] Figure 2 illustrates a schematic representation of a user communication device 210. While Figure 2 illustrates an exemplary user communication device 210, the other communication devices of the distributed communication system 100, namely, the lab communication device 312, if present, the further lab communication device 322, and the practitioner communication device 402, may have identical configurations and differ only in the computer programs or software applications ("apps") loaded.

[0107] 2 comprises a processor 211 connected to a memory 212, a communication means 213, an output means 214, and an input means 215. The communication means 213 may be configured to provide a wireless connection to a common communication network, such as the Internet and a central server 500 of the distributed communication system 100, for interconnecting all communication devices. The memory 212 may store computer programs or software applications (“apps”) that cause the processor 211 to perform steps executed by the user communication device 210. The output means 214 may be configured as a display and / or a speaker. The input means 215 may include a camera for scanning barcodes and may further comprise a touchscreen input that allows a user to interact with the user communication device 210.

[0108] 3 is a flow diagram of one embodiment of a method for managing information regarding medical tests for evaluating a predetermined medical condition. In this method, a medical test kit is provided to a user who wishes to perform a medical test. The medical test kit includes an access code and a sampling unit for obtaining a medical sample. Furthermore, the method relies on the use of a communication device by the respective entity. Such a communication device may be provided, for example, in the form of a general-purpose computer connected to the Internet or in the form of a smart device such as a smartphone.

[0109] In a first step 1001 of the method, a user enters an access code for a medical test kit into a user communication device 210 (see FIG. 1), which is verified and, after verification, is used as a unique identifier or a unique identifier is generated. The user communication device 210 is configured, for example, by an installed software application (“app”), to receive messages addressed to the respective unique identifier.

[0110] In a second step 1002, the user mails the medical sample, labeled with the sample identifier associated with the unique identifier, to a laboratory entity for analysis. The user communication device 210 can assist in this step by, for example, providing instructions on how to obtain the medical sample using components of the sampling unit.

[0111] In a third step 1003 of the method, the medical sample is received by a testing entity that receives shipped medical samples, and the testing entity analyzes the received medical sample using a first analytical method.

[0112] If the first result of the first analytical method is negative, the user is notified of the negative test result as indicated by arrow 1011. If the first result is positive for a predetermined condition, further processing occurs as indicated by arrow 1012, which further processing includes further processing step 1020.

[0113] In a further processing step 1020, the medical sample is analyzed using a second analytical method, either by the same laboratory entity or by a further laboratory entity. If the further laboratory entity performs the further processing, the further processing step 1020 also includes transferring the medical sample to the further medical entity.

[0114] If the second result of the second analytical method is negative, the user is notified of the negative test result, as indicated by arrow 1021. If the second result is positive for the predetermined medical condition, the establishment of a consultation with a medical entity is initiated, as indicated by arrow 1022.

[0115] Informing the user about the negative test result comprises a first result communication step 1031 in which a message indicating the negative result is sent by the laboratory communication device 312 of the laboratory entity or the further laboratory communication device 322 of the further laboratory entity to the user's communication device 210 addressed by the respective unique identifier. In a second result communication step 1032, the user communication device 210 displays the received message, thus communicating the negative test result to the user.

[0116] Establishing a consultation by the medical entity if the second test result is positive includes a forwarding step 1040 in which a message is sent by the laboratory communication device 312 or the further laboratory communication device 322 to the medical entity's practitioner communication device 402 (see FIG. 1 ). The message includes an indication of the positive test result and a unique identifier.

[0117] In a first establishing step 1041, the practitioner communication device 402 sends an invite message addressed by the unique identifier to the user's communication device 210. In a second establishing step 1042, the user communication device 210 displays the invite and, in response to user input, may proceed to a third establishing step 1043, in which a call between the user and the medical entity is established, particularly in the form of an in-app call using voice over IP technology.

[0118] Figure 4 shows a flow diagram of an embodiment of a method for managing information using the distributed communication system 100 shown in Figure 1. The distributed communication system described with respect to Figure 1 comprises a user communication device 210, a laboratory communication device 312, an optional further laboratory communication device 322, and a practitioner communication device 402. Additionally, a medical test kit is provided to a user wishing to perform a medical test. The medical test kit comprises an access code and a sampling unit for obtaining a medical sample.

[0119] In a first step 2001 of the method, the user communication device 210 obtains information regarding an access code provided with a test kit for assessing a predetermined medical condition. The user communication device 210 is configured to verify the access code and receive and display a message addressed to the unique identifier, where the unique identifier is generated or the access code is used as the unique identifier.

[0120] In a second step 2002, the user communication device 210 provides suggestions to the user to assist in obtaining a medical sample using components of the sampling unit provided in the test kit on the display of the user communication device 210.

[0121] In a third step 2003, the user communication device 210 provides instructions to the user for sending the obtained medical sample to a laboratory entity for analysis on a display of the user communication device 210. The medical sample is labeled with a sample identifier associated with the unique identifier.

[0122] In a fourth step 2004 of the method, which is performed after receipt of the medical sample by the laboratory entity, a unique identifier associated with the mailed medical sample is obtained by the laboratory communication device 312, and the laboratory communication device 312 provides instructions to the laboratory entity to perform a first analysis of the medical sample.

[0123] In a fifth step 2005 , which is performed after performing the first analysis, a first result of the first analysis of the medical sample is obtained by the laboratory communication device 312 .

[0124] If the first result is negative, a message indicating the negative test result is sent to the user communication device addressed by the unique identifier in messaging step 2030, as indicated by arrow 2011. If the first result is positive for the predetermined medical condition, instructions associated with the unique identifier are provided to the laboratory entity or a further laboratory entity to perform a second analysis of the medical sample using a second analytical method, as indicated by arrow 2012.

[0125] A second result of the second analysis of the medical sample is obtained in a further processing step 2020 by the laboratory communication device 312 or the further laboratory communication device 322 .

[0126] If the second test result is negative for the predetermined condition, a message indicating the negative test result is sent to the user communication device 210 addressed by the unique identifier in a messaging step 2030, as indicated by arrow 2021, and if the test result is positive for the predetermined condition, a message including the unique identifier is sent to the practitioner communication device 402 in an establishment step 2040 to establish a consultation with a medical entity such as a doctor.

[0127] While the present invention has been described with reference to specific embodiments thereof, it should be understood that this description is for illustrative purposes only. The present invention is not limited to the exemplary embodiments set forth herein. Rather, numerous variations are possible within the scope indicated by the claims. Accordingly, it is intended that the present invention be limited only by the scope of the claims appended hereto.

Claims

1. 1. A method for managing information dealing with medical tests for assessing a predetermined medical condition, comprising: providing a medical test kit, the medical test kit comprising an access code and a sampling unit for obtaining a medical sample; the method comprising: receiving the access code at a user communication device; the validity of the access code is verified, and as a result of the verification, the access code is used as a unique identifier or a unique identifier is generated from the access code; receiving a message addressed to each of the unique identifiers by the user communications device in response to receiving the input; and thereafter shipping a medical sample labeled with a sample identifier associated with the unique identifier to a laboratory entity for analysis; the medical sample was obtained using a component of the sampling unit; Steps and analyzing the shipped medical sample using a first analytical method by a computer included in the laboratory entity; if the result of the first analytical method is negative, sending, by the computer of the laboratory entity, a message addressed using the unique identifier to the user communication device through a laboratory communication device, the message informing the user of the negative test result; If the result of the first analytical method is positive, performing further processing, - analyzing the received medical sample using a second analytical method by the computer located at the laboratory entity or by a further computer located at a further laboratory entity; - if the result of the second analytical method is negative, sending, by the computer comprised by the laboratory entity or by the further computer comprised by the further laboratory entity, a message addressed using the unique identifier to the user communication device through the laboratory communication device or the further laboratory communication device, wherein the message informs the user of the negative test result; - establishing a consultation with a medical entity if the result of the second analytical method is positive, said establishing comprising: - sending, by the computer of the laboratory entity or the further computer of the further laboratory entity, a message to a practitioner communication device of the medical entity through the laboratory communication device or the further laboratory communication device, the message including an indication of the positive test result and the unique identifier; - communicating with the user by the computer of the medical entity, the communication being established using the practitioner communication device configured to contact the user communication device identified by the unique identifier; and and A method comprising:

2. 10. The method of claim 1, wherein the user communication device, the laboratory communication device, the further laboratory communication device, if present, and the practitioner communication device are configured to communicate with a central server to relay messages between the devices.

3. The method of claim 1 or 2, wherein the user further provides a region code, and the medical entity is selected based on the provided region code.

4. the first analytical method detects a protein, and / or The method of claim 1 , wherein the second analytical method detects a nucleic acid.

5. the first analytical method and / or the second analytical method tests for the disease state; the condition is correlated with a sexually transmitted disease, and / or 5. The method of any one of claims 1 to 4, wherein the condition is a disease caused by a virus, bacteria, fungus or parasite.

6. 6. The method of claim 1, wherein the user communication device, the laboratory communication device, the further laboratory communication device, if present, and / or the practitioner communication device is a smartphone, a tablet, or an internet-enabled PC.

7. 7. The method of claim 1, wherein the step of receiving the access code at the user communication device comprises scanning a 1D or 2D matrix code using a camera of the user communication device, or scanning an RFID tag.

8. 8. The method of claim 1, wherein the step of communicating with the user includes establishing an audio and / or video link between the user communication device and the practitioner communication device addressed by using the unique identifier.

9. 9. The method of claim 1, wherein the user communication device provides the user with detailed instructions, including text, images, audio and / or video, before the medical sample is dispatched.

10. 10. The method of claim 1, further comprising the step of scheduling an appointment for the user with the medical entity after establishing the consultation by the medical entity, wherein the unique identifier is transmitted by the user communication device to a booking system of the medical entity for identification of the user.

11. 11. The method of claim 1, further comprising the steps of: sending, by the computer of the laboratory entity, a message addressed using the unique identifier to the user communication device; and notifying the user of at least one of the following: that the sample has been received, that the sample has been tested, or that testing has been completed.

12. 12. The method of any one of claims 1 to 11, further comprising: upon receiving a message indicating a negative test result, obtaining, by the user communication device, a user input indicating whether the user belongs to a high-risk group for the predetermined medical condition; If the user belongs to a high-risk group, generating, by the user communication device, a reminder to the user to repeat the test after a predetermined time has elapsed; providing, by the user communication device, a further test to assess whether the user is eligible for preventative treatment for the predetermined medical condition; and performing one or more of: A method comprising:

13. 13. A user communications device configured for use in the method of any one of claims 1 to 12, the user communications device being configured to obtain a unique identifier by user input, and further configured to receive a message from a server addressed to the unique identifier.

14. 13. A computer program comprising instructions that, when executed by a computer, cause the computer to perform the steps performed by the user communications device of the method of any one of claims 1 to 12, the computer program causing the computer to: Obtaining an access code via user input; verifying the validity of said access code; generating a unique identifier from the access code as a result of said verification, or using the access code as a unique identifier; receiving a message addressed to the unique identifier in response to receiving a user input; A computer program containing instructions to cause a program to be executed.

15. 1. A method for managing information relating to medical tests for evaluating a predetermined medical condition by a distributed system comprising at least a user communication device, a laboratory communication device, and a practitioner communication device, the method comprising: obtaining, by the user communication device, information regarding an access code provided with a test kit for assessing a predetermined medical condition, the user communication device verifying the validity of said access code; receiving and displaying a message addressed to the unique identifier in response to obtaining said information; It is configured as follows: As a result of said verification, said unique identifier is generated from said access code or said access code is used as a unique identifier. Steps and providing suggestions to the user on a display of the user communication device to assist in obtaining a medical sample using components of a sampling unit provided in the test kit; providing instructions to the user to ship the acquired medical sample to a laboratory entity for analysis on the display of the user communication device, the medical sample being labeled with a sample identifier associated with the unique identifier; obtaining, by the laboratory communication device, the unique identifier associated with the shipped medical sample and providing instructions to a laboratory entity to perform a first analysis of the medical sample; obtaining results of a first analysis of the medical sample by the laboratory communication device, and if the results are negative for the predetermined condition, sending a message regarding the negative test result to the user communication device via the unique identifier, and if the test result is positive for the predetermined condition, providing instructions associated with the unique identifier to the laboratory entity or a further laboratory entity to perform a second analysis of the medical sample using a second analytical method; if a second analysis has been performed, obtaining a result of the second analysis of the medical sample by the laboratory communication device or a further laboratory communication device, and if the test result is negative for the predetermined condition, sending a message regarding the negative test result to the user communication device using the unique identifier, and if the test result is positive for the predetermined condition, sending a message including the unique identifier to a practitioner communication device to establish a consultation with a medical entity; A method comprising:

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