Remote medical-diagnosis system

Abstract

The invention concerns a remote medical-diagnosis system comprising 1) a self-sampling medical device, 2) at least one reception device, 3) at least one analysis device; and 4) a server configured to register a subject and his biological analysis request, to record the data related to the self-sampling medical device and its associated biological sample, to select at least one biological test to be realized on the self-sampling medical device, to request the at least one analysis device for performing the at least one selected biological test; to receive the data corresponding to the results of the at least one selected biological test performed by the at least one analysis device on the self-sampling medical device and produce and transmit to the subject a report comprising these results and / or eventually request a medical appointment for the subject.

Description

[REMOTE MEDICAL-DIAGNOSIS SYSTEMDomain of the invention

[0001] The present invention relates to a system for assisting diagnosis based on selfsampling.Prior art

[0002] In this field, a patient classically consults a healthcare professional deciding that a biological analysis comprising one or more biological tests is useful to assist in the diagnostic process. The patient then contacts a biological analysis service. The biological analysis service typically comprises one or more collection points and a technical platform distant from the collection point. The technical platform performs the tests. The results of the tests are then sent directly to the prescribing healthcare professional and directly to the patient in a secure manner by mail and / or email. The results are expressed in raw form and without any link to medical and scientific information accessible to the patient. The results are transmitted without any medical support for interpretation. Thus, a new in-person appointment with a healthcare professional will be necessary for their interpretation. of the invention

[0003] The invention aims to favour a new logistics chain without going through the collection point of a biology laboratory. This new logistics chain uses only self-sampling medical devices, a registration platform for the self-sampling, and a rapid transport logistics chain (type post, UPS, etc.) to the laboratory's technical platform.

[0004] This new logistics chain is associated with support from the biological analysis service so that the patient can obtain on the secure registration platform reliable and objective medical and scientific information and links to healthcare professionals for a rapid appointment via videoconference.

[0005] The system of the invention is based on a computerized and secure method of selfsampling registration, coupled with an offer of biological analysis reports associated through a computerized module of machine learning type, with a specific bibliographicsearch of the artificial intelligence type, and the possibility of organizing an online medical appointment to obtain advice and / or new prescriptions.

[0006] Accordingly, a first object of the invention relates to a remote medical-diagnosis system comprising:

[0007] A) a self-sampling medical device for performing biological sample self-sampling by a subject, which medical device is associated with at least one identification means;

[0008] B) at least one reception device identifying the at least one identification means of the self-sampling medical device;

[0009] C) at least one analysis device for performing at least one biological test on the subject’s biological sample collected by the self-sampling medical device;

[0010] D) A server configured to:1. register the subject and his at least one biological analysis request2. record the data related to the self-sampling medical device and its associated biological sample,3. select at least one biological test to be realized on the self-sampling medical device,4. eventually, select the technical platform to which address the selfsampling medical device to carry out the corresponding selected at least one biological test,5. confirm the technical platform reception of the self-sampling medical device by the at least one reception device6. request the at least one analysis device for performing at least one selected biological test,7. receive the data corresponding to the results of the at least one selected biological test performed by the at least one analysis device on the selfsampling medical device;8. production of a report comprising at least the results of the at least one selected biological test; and,9. transmitting the report to the subject and / or eventually request a medical appointment for the subject.

[0011] A second object of the invention relates to a method of performing a remote medical diagnosis, preferably ex vivo, using the abovementioned system and comprising the steps of:

[0012] - eventually, sampling a biological sample of a subject on a self-sampling medical device associated with at least one identification means,

[0013] - registering the subject and his at least one biological analysis request,

[0014] - record the data related to the self-sampling medical device and its associated biological sample,

[0015] - selecting at least one biological test to be realized on the self-sampling medical device,

[0016] - eventually, select the technical platform to which address the self-sampling medical device to carry out the corresponding selected at least one biological test,

[0017] - confirming the technical platform reception of the self-sampling medical device by the at least one reception device,

[0018] - requesting the at least one analysis device for performing at least one selected biological test,

[0019] - receiving the data corresponding to the results of the at least one selected biological test performed by the at least one analysis device on the self-sampling medical device,

[0020] - producing / editing of a report comprising at least the results of the at least one selected biological test; and

[0021] - transmitting the report to the subject and / or eventually request a medical appointment for the subject.

[0022] DETAILED DESCRIPTION

[0023] Self-sampling allows for the direct and non-invasive collection by the patient themselves of their own fluids (vaginal, oral, salivary, urine, blood, sweat, anal, dermal, etc.). This medical device for self-sampling is done using a swab, a collection veil, a collection sponge, FTA card, or any other device enabling the collection and preservation of a fluid at room temperature. Keeping the sample at room temperature allows for its transport through a rapid logistics chain (post, UPS, etc.) to the laboratory's technical platform.

[0024] Accordingly, a biological sample may refer to subject’s fluid, such as a vaginal fluid, an oral fluid, salivary, urine, blood, sweat, an anal fluid or a dermal fluid.

[0025] As used herein, a “medical device for performing self-sampling” or “selfsampling medical device” corresponds to any device enabling the collection and preservation, preferably at room temperature, of a subject’s fluid, such as a swab, a collection veil, a collection sponge or an FTA card.

[0026] This self-sampling medical device is further associated with at least one identification means.

[0027] This identification means provides a specific identifier for its associated selfsampling medical device.

[0028] A skilled person may simply identify useful identification means. As an example of such identification means, one may cite a RFID tag, a QR code or a barcode.

[0029] The subject may be a man or a woman.

[0030] The subject register himself (identity card, insurances, mutual insurance card, medical record...), and a self-sampling medical device on the server. Such a registration may be simply realized using a dedicated application available on internet. The selfsampling medical device registration is realised using its at least one identification means.

[0031] The subject indicates his requested biologic analysis to be done on its selfsampling medical device.

[0032] For convenience, the server can suggest several biological analyses and / or potential reasons of using such a self-sampling medical device, and among which the subject will make his own selection.

[0033] According to a preferred embodiment, the system further comprises at least one storage for recording the data associated with the self-sampling medical device, the subject, the biological test, and / or the results.

[0034] The selection of at least one biological test to be carried out on the self-sampling medical device may be done by the server first by identifying the biological tests compatible with said self-sampling medical device, then with the biological tests associated with the biological analyses requested by the subject.

[0035] Accordingly, the selected biological tests may comprise or consist in the ones eventually requested by the subject or related to the biological analyses requested by the subject.

[0036] For facilitating this selection step by the server, this selection will be realised on the basis of 1, 2, 3, 4, 5, or more selection criterions, preferably, 3, 4, 5 or more selection criterions, and still preferably 4, 5 or more selection criterions.

[0037] Each selection criterion makes it possible to determine, if it is met, that an envisaged biological test is compatible with the self-sampling medical device. Useful selection criterions may be simply identified by the skilled person. As an example, such selection criterions can be related to the self-sampling device, to the biological sample of the self-sampling device, to the self-sampling device reagents, to the self-sampling-device instruction of use (IFU), to the self-sampling medical device transport requirements, to the self-sampling device registrations, certifications, recommendations and / or exclusions, to the envisaged biological test, to the envisaged biological test reagents, to the envisaged biological test instruction of use (IFU), to the envisaged biological test registrations, certifications, recommendations and / or exclusions, to the subject’s territory, to the available technical platform for the territory and / or for the envisaged biological test.

[0038] Preferably, each selection criterion is an inclusive criterion.

[0039] As used herein, an “inclusive” criterion is a criterion that must be satisfied for an envisaged biological test to be selected.

[0040] As an example, such selection criterion may be related to an existing (i.e., known or published) use, certification, registration and / or recommendation for the self-sampling device, the biological sample of the self-sampling device, to the self-sampling device reagents, to the transport of the self-sampling medical device and the associated biological sample, to the envisaged biological test, to the envisaged biological test reagents, to the subject’s territory, to the available technical platform for the territory and / or for the envisaged biological test.

[0041] Advantageous, the selection criterions are selected in the group comprising:

[0042] 1- existing certification / registration for the used self-sampling medical device

[0043] 2- existing certification / registration for the envisaged biological test

[0044] 3- compatibility of the envisaged biological test with the used self-sampling medical device

[0045] 4- existing use description of the envisaged biological test with the used selfsampling medical device

[0046] 5- existing use recommendation of the envisaged biological test with the used self- sampling medical device

[0047] In relation with an existing certification / registration for the self-sampling medical device or for the envisaged biological test, the server will identify and select those having a certificate for the envisaged territory (IVD, FDA, SWISS MEDIC. . .).

[0048] In relation with the compatibility of the envisaged biological test with the used self-sampling medical device, the server will cross analysed their corresponding instruction for use (IFU), notably their reagents, and select those being compatible.

[0049] In relation with an existing or a recommended use of the envisaged biological test with the used self-sampling medical device, the server will identify and select such documented uses by identifying pertinent publications (e.g., on PUBMED).

[0050] The analysis of whether each criterion is met can be carried out by the server by searching in identified databases information related to the selected criterions. Such a search can be done using adapted tags that can by simply identified by the skilled person (e.g., acronym, key word, expression related to the domain of the self-sampling medical device, such as "vaginal sampling," "microbiota sampling," "salivary sampling," "urinary sampling,", to the requested biological analysis, etc.).

[0051] For facilitating and improving such search, the system further comprises at least one domestic database.

[0052] According to a preferred embodiment, the server further comprises at least one domestic database.

[0053] Such domestic database comprised previously identified or tagged documents related to biological tests and / or self-sampling medical devices. Such at least one domestic database may be regularly updated by periodic extraction in selected databases. Such identified or tagged documents may be related to self-sampling medical devices, biologicals tests. Now, such tagged documents or publications may be further associated with a territory or to a relevance index by the server. The relevance index is for example representative of the distance between the tagged document or publication and the information relating to the biological test and the type of self-sampling medical device.

[0054] As used herein, a “domestic database” is a database hosted on a storage dedicated solely to the server. Accordingly, this domestic database can not be consulted by unauthorized user.

[0055] According to another preferred embodiment, a value is assigned to each selection criterion depending on whether it is satisfied (10%, 25%, 1, ...) or not (0%, 0, ...), thus facilitating its consideration by the server. Depending on its importance, the value of each selection criterion, and notably each satisfied selection criterion, may be identical or different, preferably identical.

[0056] Preferably, the value of each selection criterion for an envisaged biological test in relation with a specific self-sampling medical device is integrated in a dedicated formula, typically a sum of all associated selection criterions values, thus obtaining a global value, called herein “singularity index” for this case.

[0057] Then, the server selects the biological tests having the required global value or singularity index (i.e., the required satisfied selection criterions) for a specific selfsampling medical device.

[0058] If no biological test can be selected based on the selection criterions (i.e., because of at least one unsatisfied selection criterion), the server may reinitiate a selection step using at least one exclusion criterion for each unsatisfied selection criterion.

[0059] As used herein, an “exclusion” criterion is a criterion that must be satisfied for excluding an envisaged biological test because of an unsatisfied selection criterion.

[0060] Useful exclusion criterions may be simply identified by the skilled person as previously for each unsatisfied selection criterion.

[0061] As an example, such exclusion criterion may be related to an existing (i.e., known or published) non-admission, exclusion, refusal, and / or rejection for the self-sampling device, the biological sample of the self-sampling device, to the self-sampling device reagents, to the transport of the self-sampling medical device and the associated biological sample, to the envisaged biological test, to the envisaged biological test reagents, to the subject’s territory, to the available technical platform for the territory and / or for the envisaged biological test.

[0062] Advantageous, such exclusion criterions are selected in the group comprising:

[0063] 1- use exclusion of the self-sampling medical device for the territory of the subject and / or of the technical platform

[0064] 2- use exclusion of the envisaged biological test for the territory of the subject and / or of the technical platform

[0065] 3- use exclusion of the envisaged biological test with the used self-sampling medical device

[0066] 4- use exclusion description of the envisaged biological test with the used selfsampling medical device

[0067] 5- use exclusion recommendation of the envisaged biological test with the used self-sampling medical device

[0068] The analysis of whether each criterion is met can be carried out by the server by searching in identified databases (e.g. a domestic database) information related to the exclusion criterions.

[0069] As an example, and in relation with an use exclusion of the envisaged biological test with the used self-sampling medical device, a biological test on RNA is not compatible with a self-sampling medical devices without any RNA conservative agent.

[0070] A value may be assigned to each exclusion criterion depending on whether it is satisfied (100%, 0, ...) or not (0%, 1, ...), which value is herein called “criticality index” for its corresponding unsatisfied selection criterion.

[0071] According to a preferred embodiment, the server selects the biological tests having the required global value or singularity index (i.e., in relation with satisfied selection criterions) for a specific self-sampling medical device and having no satisfied (i.e., resulting in the exclusion) exclusion criterion associated with an unsatisfied selection criterion.

[0072] Eventually, the biological tests selection by the server is submitted to the subject for validation. In this case, the subject may select among several biological tests, each related to a specific price.

[0073] Once the server has selected the biological test(s), the server will select a technical platform having the capacity to carry it out on the used self-sampling medical device. Now, the technical platform may be selected in a previous step, the selection of the biological test to be realised being thus limited to the ones that can be realized by thechosen technical platform. Such a technical platform may be characterized by an identifier, a location data, and / or communication data.

[0074] Following the technical platform selection / identification, the server edits a shipping voucher to be associated with the used self-sampling medical device.

[0075] Then, the subject may address his used self-sampling medical device by post. Alternatively, the server registration of the self-collection medical device by the subject will initiate its collection and transport by a deliverer (e.g., from DHL) from the subject to the technical platform. As part of such a collection and transport step, the deliverer will be able to scan the shipping voucher associated with the used self-sampling medical device and indicating the technical platform to which it should be delivered. Now, the deliverer may also scan at least one identification means of the self-sampling medical device for obtaining the indication of the technical platform to which it should be delivered.

[0076] In relation with this collection / transport step, such scanning by the deliverer may result in the recording of collection data (date, location, temperature (refrigerated or not, etc.)) on the server.

[0077] Following the delivery of the self-sampling medical device to the technical platform, the self-sampling medical device is handled by at least one reception device in said technical platform. Said reception device identifies the used self-sampling medical device with its at least one identification means. Accordingly, the reception device will include a means for reading / decoding said at least one identification means. Such reception devices are well known from the skilled person and just depends on the used identification means. Typically, this reception device takes the form of a QR code reader if the identification means is a QR code.

[0078] This reception device is connected to the server allowing the identification of the self-sampling medical device's file. Now, such connection also allows the recording on the server of technical platform reception data for this self-sampling medical device (e.g., date, ...)

[0079] Depending on the at least one selected biological test, the corresponding selfsampling medical device is then addressed within the technical platform to at least one analysis device. Such addressing is based on a server request following its biological test selection.

[0080] Now, the technical platform can comprise a panel of analysis devices among which said at least one analysis device is selected. Eventually, the self-sampling medical device can be addressed successively to several analysis devices for realizing several selected biological tests. Such an eventuality is possible only if compatible with the selfsampling medical device.

[0081] Said at least one analysis device is such that it can perform the selected biological test on the biological sample collected by the self-sampling medical device. The biological test made by the analysis device corresponds to the measure of at least one biological constant and / or at least one biological parameter (infections, microbiological balance, microbiota, genetic mutations, circulating DNA fractionation, molecular cytology, proteins, peptides, VOC panels, etc.) in the collected biological sample.

[0082] Accordingly, such at least one analysis device is adapted to the required biologic test (ex: PCR, RT-PCR, ELISA, mass spectrometry, chromatography, ...) and to the corresponding collected biological sample (blood, saliva, cells, ....).

[0083] The at least one analysis device provides a qualitative and quantitative measurement result of the selected biological test realized on the collected biological sample of the self-sampling medical device. This measurement result comprises the measured magnitude itself but may also comprises additional information, such as remarks, alerts, or notifications, which may depend on the value of the measured magnitude or a report or ratio of several measured magnitudes.

[0084] Preferably, the at least one analysis device includes a means for reading / decoding the at least one identification means of the self-sampling medical device.

[0085] This analysis device is also connected to the server allowing the recording on the server of measurement result of the selected biological test realized on the collected biological sample of the self-sampling medical device.

[0086] The server comprises interface adapted to receive the data of each of the abovementioned device (i.e., reception device, analysis device, . . . .) and interlocutor (i.e., subject, deliverer, technical platform, ...). The components of the system (i.e., reception device, analysis device, server, databases ...) may communicate with each other in any appropriate manner, for example through a biological laboratory network type LIS for entering or exchanging information.

[0087] Then, the server produces a report with the measurement result to the at least one selected biological test realized on the biological sample collected by the self-sampling medical device. This report may further include the self-sampling medical device identifier, the patient identifier, an identifier of a document or publication corresponding to the panel of selected biological tests.

[0088] Now, this report may also be associated with ay identified or tag documents providing information to the subject in relation with the results of the biological test realized on his biological sample collected by the self-sampling medical device.

[0089] The system may further comprise an interface module adapted to return the results (potentially the report) once the results of the biological analysis are available and to schedule a videoconference with a healthcare professional selected by the interface module and eventually previously accepted by the patient.

[0090] For setting up a videoconference with a healthcare professional, the interface module may first validate that the healthcare professional is competent for the selected biological test, that the subject is eligible for such healthcare professional because of linguistic, medical, and / or regulatory knowledge of the geographical territory of the subject.

[0091] The system may further comprise one or more clocks used to date one or more data. Thus, the information relating to the self-sampling medical device and the selected biological test will comprise an identifier as such, as well as a patient identifier, an identifier of the collection point, as well as timestamp data of the patient's care by the self-sampling logistics system.

[0092] Accordingly, each step relating to the biological sample may also be timestamped, and the timestamp information added to the information relating to the biological sample.

[0093] Thus, at this stage, a data sheet relating to the biological test of the subject may comprise the following data:

[0094] - Self-sampling medical device identifier,

[0095] - Biological test identifier,

[0096] subject identifier,

[0097] - Timestamps related to the deliverer handling of the self-sampling medical device,

[0098] - Technical platform identifier,

[0099] - Timestamps related to the technical platform reception of the self-sampling medical device,

[0100] - Timestamps related to the analysis device,

[0101] - Analysis personnel identifier,

[0102] - Identifiers of the technical platform equipment (storage equipment, analysis equipment, reagents...),

[0103] - Timestamp of the report and its transmission to the subject,

[0104] - Timestamp of the result of the bibliographic research comprising at least the values of the analysis report of the biological tests, the normal value(s) for the biological test (if applicable, depending on the age and / or gender of the patient and / or the physiological and...) and the selection of a panel of biological tests.

[0105] Timestamp of the setting up and realization of a videoconference with a healthcare professional selected by the interface module and accepted by the subject.

[0106] According to another aspect, the invention relates to a computer program comprising program code instructions for executing the steps of the method when said program is executed on a computer

[0107] Examples

[0108] 1) Vaginal self-sampling device

[0109] The self-sampling medical device used is a device that allows for self-collection of vaginal samples of fluid and / or menstrual blood (from a swab, a tampon, a sponge, or a brush). Now, the self-sampling device may eventually allow for self-sampling of urine (and any other bodily fluid).

[0110] This vaginal self-sampling medical device thus allows to collect a sample (comprising potentially cells and genetic material necessary for microbiological analysis, particularly of infectious agents) allowing to identify the risks of gynecological pathologies that have consequences for human health, fertility, and / or factors that contribute to the risk of endometriosis.

[0111] The selected self-sampling medical device is preferably regulatory -registered in the territory where the sample is taken (CE for a territory in Europe (such as the COPAN 552C.80PB VAGINAL SWAB BP80 IN DRY TUBE W / PEELABLE BARCODE CE- registered), in Switzerland by Swiss Medic (such as the COPAN code 5E089N swab registered to Swiss Medic), in the USA by the FDA (Copan Swab and Copan URISPONGE®).

[0112] The self-sampling medical device includes at least one identification means, which may take the form, for example, of QR code affixed to the device. Now, and for traceability purposes, another identification means may be associated with the packaging of the self-sampling medical device and / or to an envelope (or any other shipping means that can be the packaging of the self-sampling medical device). Potentially, the same identification means, like the same QR code, may be associated with the self-sampling medical device, its packaging and / or its shipping means.

[0113] After using the self-sampling medical device according to the manufacturer’s instructions for use (IFU), the subject registers on a server the self-sampling medical device that he used, and potentially further records the biological analyses he requests to be performed on his associated biological sample.

[0114] The self-sampling medical device registration on the server is done using its associated at least one identification means, such as a QR code. In this way, and for traceability, this self-sampling medical device, and its associated biological sample will be associated (i.e., registered) with the subject who used it on the server.

[0115] For more convenience, this step can be done by the further registration of the subject himself on the server, for example, by using a dedicated application. This dedicated application typically allows the creation of a subject’s personal account, wherein the subject may record various personal data.

[0116] Then, the selection of a panel of biological tests for the self-sampling medical device is done by the server.

[0117] If the selected biological tests comprise or consist in the ones requested by the subject, the server will first identify the biological tests compatible with said selfsampling medical device.

[0118] Such selection is done by the server by determining a singularity index for each biological test identified in relation with the used self-sampling medical device. In this example, the singularity index combines 4 criteria for obtaining a maximum value of 100%.

[0119] Table: Determination of a biological test singularity index related to a specific self-sampling medical device using 4 specific criterions (Crit)

[0120] For the criterion 1, a first updated table integrating every new self-sampling medical device and associated national or regional certification / regi strati on (IVD, FDA, SWISS MEDIC. . .) is built on the server. This determination step can be done using the reference of the self-sampling medical device, its national certificate number and can further use for example its batch number. Depending on this first table and on the territory of the subject and / or of the technical platform, the value for this criterion 1 is 25 % if the self-sampling medical device is registered for a clinical use in the corresponding territory, or 0% if not.

[0121] For the criterion 2, a second updated table integrating every new biological test and associated national or regional certification / registration (IVD, FDA, SWISS MEDIC...) is built on the server. This determination step can also be done using the reference of the biological test, its national certificate number. Depending on this second table and on the territory of the subject and / or of the technical platform, the value for this criterion 2 is 25 % if the biological test is registered for a clinical use in the corresponding territory, or 0% if not.

[0122] For the criterion 3, an updated compatibility table integrating every condition associated with IFU of each new self-sampling medical and every condition associated with IFU of each new biological test is built on the server. The determination of the value for this criterion3 is as follows:

[0123] - 25 % if these conditions are compatible. As an example, such a condition corresponds to the existence of a scientific article published in PUBMED with the same or a similar self-sampling medical device and the same biological reagents of the envisaged biological test.

[0124] - 0% if these conditions are not compatible not. As an example, such a condition corresponds to a self-sampling medical device having a CE registration but said registration is for a sample (ex: saliva) different from the one(s) of used in the envisaged biological test (ex: only validated on a gynecological or urine sample).

[0125] For the criterion 4, a fourth updated table integrating every publication from medical reference (e.g., WHO, HAS, FDA, University, working group or representing a medical profession, etc.) and associated recommendation of any biological test for any self-sampling medical device is built on the server. On the basis of this fourth table, the value for this criterion 4 is 25% if a medical reference recommends the envisaged biological test with the used self-sampling medical device, and 0% if not.

[0126] On the basis of these criterions, the biological tests having the required singularity index (i.e., 100% with all the criterions satisfied) with the used self-sampling medical device are selected.

[0127] Now, if no biological test has the required singularity index (i.e., a value less than 100%), then a criticality index is determined for each of singularity index’s criterion, or for each singularity index’s criterion not being satisfied. As an example, such criticality indexes are determined when no biological test corresponding to the subject’s request can be selected. For selecting an envisaged biological test with the used self-sampling medical device, the criticality index of each unsatisfied singularity index criterion(s) must be acceptable (i.e., 100%). In this example, the criticality index for each singularity index criterion is disclosed in the table hereafter.

[0128] Table: Determination of the criticality index of each singularity index’s criterion (Crit)

[0129] This leads to the implementation of the criticality index determination so that the server can select or not a biological test with 100% to select in the event of a singularity index of the 4 criteria being less than 100%.

[0130] Once the server has selected the biological test, the server will select a technical platform having the capacity to carry it out on the used self-sampling medical device.

[0131] Then, the server edits a shipping voucher to be associated with the used selfsampling medical device and initiate a collection and transport step of this device by a deliverer from the subject to the technical platform. For its collection, the deliverer scan at least one identification means (e.g., QR code) of the self-sampling medical device for obtaining the indication of the technical platform to which it should be delivered. Such scanning by the deliverer result in the recording of collection data (date, location, temperature (refrigerated or not, etc.)) on the server.

[0132] Following the delivery of the self-sampling medical device to the technical platform, the self-sampling medical device is handled by at least one reception device in said technical platform. Said reception device identifies the used self-sampling medical device with its at least one identification means (e.g., QR code). Said reception device is connected to the server, allowing the identification of the self-sampling medical device and the recording of its associated reception date in the technical platform on the server.

[0133] Then, the server informs the technical platform of the selected biological test to be realized on the self-sampling medical device by one of its analysis device.

[0134] This analysis device thus provides to the server, to which it is connected, a qualitative and quantitative measurement result of the biological test realized on the biological sample collected by the used self-sampling medical device.

[0135] Accordingly, the data related to the self-sampling medical device and its corresponding biological sample recorded by the server includes self-sampling medical device identification code, patient's identity (identity card, insurances, mutual insurance card, medical record...), biological tests requested by the patient.

[0136] On this basis, the server produces a composite report comprising the results of the biological tests realized on the biological sample collected by the self-sampling medical device, and potentially also the patient identifier, the device identifier, a document or publication corresponding to the selected biological tests. The server may also schedule a videoconference with a healthcare professional selected by the interface module and accepted by the subject.

[0137] 1-1 Biologic analyses in relation with fertility troubles and / or to endometriosis

[0138] For the abovementioned self-sampling device, the subject has requested biological analyses in relation with fertility troubles and / or with endometriosis.

[0139] On this basis, the server may first select a biological test using a kit for the identification of germs responsible for sexually transmitted diseases, vaginal ulcers, and vaginal infections (vaginosis), often associated with an imbalance in the vaginal microbiota (dysbiosis).

[0140] On this basis, the computerized bibliographic search module has identified and selected the following documents as pertinent for the server selection.

[0141] [1] BALASHOVA S et al., Multiplex quantitative polymerase chain reaction assay for the identification and quantitation of major vaginal lactobacilli, J. diagmicrobio,, DOI : 10.1016, 2013.

[0142] [2] DEMKIN V et al., A novel real-time PCR assay for highly specific detection and quantification of vaginal lactobacilli., j.mcp, DOI : 10.1016, 2016.

[0143] [3] BUSTIN S et al., The MIQE Guidelines : Minimum Information for Publication of Quantitative Real-Time PCR Experiments

[0144] [4] KUSTERS GE et al., Dorigo-ZetsmaA multiplex real-time PCR assay for routine diagnosis of bacterial vaginosis DOI : 10.1007 / sl0096-015-2412-z.

[0145] [5] MENARD JP et al, Molecular quantification of Gardnerella vaginalis and Atopobium vaginae loads to predict bacterial vaginosis, DOI : 10.1086 / 588661.

[0146] [6] LOQUET A et al, Classification and Regression Trees for Bacterial Vaginosis Diagnosis in Pregnant Women Based on High-Throughput Quantitative PCR,. DOI : 10.1016 / j.jmoldx.2020.11.004.

[0147] [7] SINGH R et al, Assessing a diagnosis tool for bacterial vaginosis., Eur J Clin Microbiol Infect Dis., 2020 Aug ; 39(8) : 1481-1485. DOI : 10.1007 / s 10096-020- 03862-3. Epub 2020 Mar 20.

[0148] [8] MITRA A et al, Genital tract microbiota composition profiles and use of prebiotics and probiotics in gynaecological cancer prevention : review of the current evidence, the European Society of Gynaecological Oncology prevention committee statement , Lancet Microbe 2024 Mar ;5(3) :e291-e300. Doi : 10.1016 / S2666- 5247(23)00257-4. Epub 2023 Dec 20

[0149] [9] NODJIKOUAMBAYE et al, .Infect Dis Obstet Gynecol.. Accuracy of Curable Sexually Transmitted Infections and Genital Mycoplasmas Screening by Multiplex Real-Time PCR Using a Self-Collected Veil among Adult Women in Sub- Saharan Africa. 2019 Jul 15 ;2019 :8639510. Doi : 10.1155 / 2019 / 8639510. eCollection 2019.PMID : 31379424

[0150]

[0010] MULJADI et al, A pilot clinical validation study of a self-collected vaginal swab device for the detection of chlamydia trachomatis in women. J.Front Bioeng Biotechnol. 2022 Oct 4 ; 10 : 1008761. Doi : 10.3389 / fbioe.2022.1008761. eCollection 2022.PMID : 36267446.

[0151]

[0011] QUARANTA M et al.„ Sci Transl Med. 2014 Jul 9;6(244):244ra90. doi: 10.1126 / scitranslmed.3008946. PMID: 25009230

[0152] These documents establish that a notable balance was observed between the Lactobacillus load and the A. vaginae and G. vaginalis loads. Now, the coexistence of A.vaginae and G. vaginalis has been documented in 78-96% of samples with bacterial vaginosis, whereas this association was only present in 5-10% of samples with normal flora. It should be further notice that A. vaginae is even more specific than G. vaginalis in bacterial vaginosis and the combination of an A. vaginae DNA level of 108copies / ml and a G. vaginalis DNA level of 109copies / ml seems to be the best biological diagnostic definition of bacterial vaginosis as a cause of infertility / endometriosis risk.

[0153] On this basis, the server may select the biological tests realized by:

[0154] - the kit ALLPEX Bacterial Vaginosis plus assay from SEEGENE, allowing he detection / quanti fi cation by PCR of: Gardnerella vaginalis - Atopobium vaginae - Lactobacillus spp. - Megasphaera type 1 - BV-associated bacteria 2 Mobihincus spp. - B. fragilis.

[0155] - the kit ALLPEX Bacterial Vaginitis plus assay from SEEGENE, allowing he detection / quanti fi cation by PCR of: Atopobium vaginae - Candida albicans - Candida others - Gardnerella vaginalis- Lactobacillus spp. - Mobiluncus spp. Trichomonas vaginalis.

[0156] Now, the server may select also the biological tests realized by:

[0157] - the kit ALLPEX Sexually transmitted infection (STI) Essential kit from the company SEEGENE allowing the research and quantification of Chlamydia trachomatis (CT), Mycoplasma genitalium (MG), Mycoplasma hominis (Quantitative) (MH), Neisseria gonorrhoeae (NG), Trichomonas vaginalis (TV), Ureaplasma parvum (UP), Ureaplasma urealyticum (Quantitative) (UU).

[0158] - the kit ALLPEX Genical Ulcer kit from the company SEEGENE allowing the research and quantification of Cytomegalovirus (CMV), Haemophilus ducreyi (HD), Herpes simplex virus type 1 (HSV1), Herpes simplex virus type 2 (HSV2), Lymphogranuloma venereum (LGV), Treponema pallidum (TP), Varicella-zoster virus (VZV).

[0159] - the kit ALLPEX Genical Ulcer Candidiasis kit from the company SEEGENE allowing the research and quantification of the following fungi: Candida albicans (CA),Candida dubliniensis (CD), Candida glabrata (CG), Candida krusei (CK), Candida lusitaniae (CL), Candida parapsilosis (CP), Candida tropicalis (CTp).

[0160] Accordingly, the used self-sampling medical device is directed to a PCR device using one of this kit following its reception by (the reception device of) the technical platform depending on the subject’s final selection / confirmation.

[0161] Following the analyses with both kits on a self-sampling medical device dedicated to a specific subject (i.e., used to collect biological sample from this subject), and depending on the results, a teleconsultation with a specialist was proposed and, eventually, an application based on the above-mentioned selected articles providing recommendations and possible treatment for the subject.

[0162] 1 ,2- Biologic analyses in relation with HPV infection related to cervical cancer and oral cancer

[0163] For the abovementioned self-sampling device, the subject has requested biological analyses in relation with HPV infection and cervical or oral cancer risk.

[0164] On this basis, the server may first select a biological test using a kit for the screening of different genotypes of papilloma virus, responsible for cervical cancer and oral cancer and the measurement of viral load.

[0165] On this basis, the computerized bibliographic search module has identified and selected the following documents as pertinent for the server selection.

[0166] [1] GREUEL et al., Accuracy of HPV testing on self-collected and clinician- collected samples for different screening strategies in African settings: A systematic review and meta-analysis., Gynecol Oncol., 2022 Aug;166(2):358-368. doi: 10.1016 / j.ygyno.2022.06.012. Epub 2022 Jun 30.PMID: 35781165.

[0167] [2] DUAN et al, An evaluation of solid versus liquid transport media for high- risk HPV detection and cervical cancer screening on self-collected specimens, group.Infect Agent Cancer., 2020 Nov 30;15(l):72. doi: 10.1186 / sl3027-020-00333- 4.PMID: 33292341.

[0168] [3] MESSAOUDI etal., Circulating cell free DNA: Preanalytical considerations., .Clin Chim Acta. 2013 Sep 23;424:222-30. doi: 10.1016 / j .cca.2013.05.022. Epub 2013 May 30.PMID: 23727028.

[0169] [4] ERTIK et al., CoCoss-Trial: Concurrent Comparison of Self-Sampling Devices for HPV-Detection., Int J Environ Res Public Health, 2021 Oct 2; 18(19): 10388. doi: 10.3390 / ijerphl81910388.PMID: 34639688.

[0170] [5] WEVER et al., DNA methylation testing for endometrial cancer detection in urine, cervicovaginal self-samples and cervical scrapes., Int J Cancer., 2023 Jul 15;153(2):341-351. doi: 10.1002 / ijc.34504. Epub 2023 Mar 23.PMID: 36912267.

[0171] [6] CHEN et al., Engaging Adolescent and Young Adults in Microbiome Sample Self-Collection: Strategies for Success., .Biol Res Nurs. 2021 Jul;23(3):402-407. doi: 10.1177 / 1099800420979606. Epub 2020 Dec 9.PMID: 33291949.

[0172] [7] ONUMA et al, Evaluation of the concordance in HPV type between self- and physician-collected samples using a brush-based device and a PCR-based HPV DNA test in Japanese referred patients with abnormal cytology or HPV infection., .Int J Clin Oncol., 2020 Oct;25(10): 1854-1860. doi: 10.1007 / sl0147-020-01727-5. Epub 2020 Jun 24.PMID: 32583223.

[0173] [8] DAPONTE et al, HPV-Based Self-Sampling in Cervical Cancer Screening: An Updated Review of the Current Evidence in the Literature., Cancers (Basel). 2023 Mar 8;15(6): 1669. doi: 10.3390 / cancersl5061669.PMID: 36980555.

[0174] [9] CHAOS etal, HPV Self-Sampling for Primary Cervical Cancer Screening: A Review of Diagnostic Test Accuracy and Clinical Evidence - An Update., Canadian Agency for Drugs and Technologies in Health; 2019 May 30.PMID: 31433604 .

[0175]

[0010] MURCHLAND et al., HPV self-sampling acceptability in rural and indigenous communities in Guatemala: a cross-sectional study., BMJ Open. 2019 Oct 28;9(10):e029158. doi: 10.1136 / bmjopen-2019-029158.PMID: 31662358.

[0176]

[0011] HAWKES et al., Self-Collection for Cervical Screening Programs: From Research to Reality., Cancers (Basel), 2020 Apr 24;12(4):1053. doi: 10.3390 / cancersl2041053.PMID: 32344565.

[0177]

[0012] DEL MISTRO et al, Methylation analysis and HPV genotyping of self- collected cervical samples from women not responding to screening invitation and review of the literature, PLoS One. 2017 Mar 6;12(3):e0172226. doi: 10.1371 / joumal. pone.0172226. eCollection 2017.PMID: 28263992 .

[0178]

[0013] SAGAWA et al., Accelerating Cervical Cancer Screening With Human Papillomavirus Genotyping, Am J Prev Med., 2023 Apr ;64(4) :552-555. Doi : 10.1016 / j.amepre.2022.10.014. Epub 2023 Feb 15.PMID : 36935166

[0179] These documents establish that research and genotyping must be apply to at least 14 HPVs, including high-risk HPVs. HPV genotyping can also be associated with the measurement of the viral load of the genotype. These analysis have to be correlated to a control of subjects having according to the criteria of SAGAWA et al. As a result, the most frequently obtained anomaly is a positive HPV test with high-risk genotype with normal cytology (40.1% of cases). In high-risk HPV-positive subjects with normal or high-grade cytology, HPV genotyping could accelerate management (immediate colposcopy and accelerated treatment) in 5.4% of all these people with abnormal screening test results. If HPV genotyping had been carried out in all high-risk HPV- positive people with normal cytology, 13.1% could have benefited from accelerated management.

[0180] On this basis, the server may select the biological tests realized by:

[0181] - the kit ANYPLEX HPV HR detection of SEEGENE

[0182] - the kit ALLPEX II HPV HR detection of SEEGENE,

[0183] Both enabling simultaneous amplification and detection of target nucleic acids of 14 high-risk HPV types (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68).

[0184] Accordingly, the used self-sampling medical device is directed to a PCR device using one of this kit following its reception by (the reception device of) the technical platform depending on the subject’s final selection / confirmation.

[0185] Following the analyses on a self-sampling medical device dedicated to a specific subject (i.e., used to collect biological sample from this subject), and depending on the results, a teleconsultation with a specialist was proposed and, eventually, an application based on the above-mentioned selected articles providing recommendations and possible treatment for the subj ect.

[0186] 1,3- Biologic analyses in relation with potential cervical cancer

[0187] For the abovementioned self-sampling device, the subject has requested biological analyses in relation with cervical cancer risk, potentially because of HPV infection.

[0188] On this basis, the server may first select a biological test using a kit for the screening of different genotypes of papilloma virus, responsible for cervical cancer and oral cancer and the measurement of viral load.

[0189] On this basis, the computerized bibliographic search module has identified and selected the following documents as pertinent for the server selection.

[0190] [1] BAKKUM-GAMEZ et al., Detection of endometrial cancer using tamponbased collection and methylated DNA markers, Gynecol Oncol., 2023 Jul; 174: 11-20. doi: 10.1016 / j .ygyno.2023.04.014. Epub 2023 May 2.PMID: 37141817.

[0191] [2] VERHOEF et al, Evaluation of DNA methylation biomarkers ASCL1 and LHX8 on HPV-positive self-collected samples from primary HPV-based screening, Br J Cancer. 2023 Jul; 129(1): 104-111. doi: 10.1038 / s41416-023-02277-z. Epub 2023 Apr 26.PMID: 37100874 .

[0192] [3] MOULIERE et al, Clinical validation of the detection of KRAS and BRAF mutations from circulating tumor DNA. Thierry AR, Mouliere F, El Messaoudi S, Mollevi C, Lopez-Crapez E, Rolet F, Gillet B, Gongora C, Dechelotte P, Robert B, Del Rio M, Lamy PJ, Bibeau F, Nouaille M, Loriot V, Jarrousse AS, Molina F, MathonnetM, Pezet D, Ychou M.Nat Med. 2014 Apr;20(4):430-5. doi: 10.1038 / nm.351 L Epub2014 Mar 23.PMID: 24658074

[0193] [4] DAPONTE et al., HPV-Based Self-Sampling in Cervical Cancer Screening: An Updated Review of the Current Evidence in the Literature., Cancers (Basel). 2023 Mar 8;15(6):1669. doi: 10.3390 / cancersl5061669.PMID: 36980555.

[0194] [5] CHAOS etal, HPV Self-Sampling for Primary Cervical Cancer Screening: A Review of Diagnostic Test Accuracy and Clinical Evidence - An Update., Canadian Agency for Drugs and Technologies in Health; 2019 May 30.PMID: 31433604.

[0195] [6] DEL MISTRO et al, Methylation analysis and HPV genotyping of self- collected cervical samples from women not responding to screening invitation and review of the literature, PLoS One. 2017 Mar 6;12(3):e0172226. doi: 10.1371 / joumal. pone.0172226. eCollection 2017.PMID: 28263992 .

[0196] [7] ORANRATANAPHAN et al., CyclinAl Promoter Methylation in Self- Sampling Test., Asian Pac J Cancer Prev., 2020 Oct l;21(10):2913-2917. doi: 10.31557 / APJCP.2020.21.10.2913.PMID: 33112548.

[0197] [8] PASTOR et al., Monitoring levels of circulating cell-free DNA in patients with metastatic colorectal cancer as a potential biomarker of responses to regorafenib treatment, Mol Oncol. 2021 Sep;15(9):2401-2411. doi: 10.1002 / 1878-0261.12972. Epub 2021 Jun 22.PMID: 33934494.

[0198] [9] FAN et al, Screening of Cervical Cancer with Self-Collected Cervical Samples and Next-Generation Sequencing, Dis Markers., 2018 Nov 14;2018:4826547. doi: 10.1155 / 2018 / 4826547. eCollection 2018.PMID: 30538783.

[0199]

[0010] KRISHNAN et al., Self-supervised learning in medicine and healthcare, Nat Biomed Eng., 2022 Dec;6(12): 1346-1352. doi: 10.1038 / s41551-022-00914-1. Epub 2022 Aug l l.PMID: 35953649.

[0200]

[0011] DERMODY et al., Trans-Renal Cell-Free Tumor DNA for Urine- Based Liquid Biopsy of Cancer, Front Genet., 2022 Apr 27;13:879108. doi: 10.3389 / fgene.2022.879108. eCollection 2022.PMID: 35571046.

[0201]

[0012] SILVA et al., Y chromosome DNA in cervicovaginal self-collected samples of childbearing age women: Implications for epitheliotropic sexually transmitted infections?, Life Sci., 2015 Oct 15; 139:62-8. doi: 10.1016 / j lfs.2015.07.027. Epub 2015 Aug 15.PMID: 26281916.

[0202]

[0013] HESSELINK et al., Methylation marker analysis of self-sampled cervicovaginal lavage specimens to triage high-risk HPV-positive women for colposcopy, Int J Cancer. 2014 Aug 15;135(4):880-6. doi: 10.1002 / ijc.28723. Epub 2014 Jan 28.PMID: 24474183.

[0203]

[0014] KRISHNAN et al., Identification and Validation of a 3- Gene Methylation Classifier for HPV-Based Cervical Screening on Self-Samples. Verjat W, Snoek BC, Heideman DAM, Wilting SM, Snijders PJF, Novianti PW, van Splunter AP, Peeters CFW, van Trommel NE, Massuger LFAG, Bekkers RLM, Melchers WJG, van Kemenade FJ, Berkhof J, van de Wiel MA, Meijer CJLM, Steenbergen RDM. Clin Cancer Res. 2018 Jul 15;24(14):3456-3464. doi: 10.1158 / 1078-0432.CCR-17-3615. Epub 2018 Apr 9.PMID: 29632006 Free PMC article.

[0204] On this basis, the server may select the biological tests realized by:

[0205] - the QIASURE test from QIAGENE

[0206] Accordingly, the used self-sampling medical device is directed to a QIAGEN technical platform to realize this biological test.

[0207] Following the analyses on a self-sampling medical device dedicated to a specific subject (i.e., used to collect biological sample from this subject), and depending on the results, a teleconsultation with a specialist was proposed and, eventually, an application based on the above-mentioned selected articles providing recommendations and possible treatment for the subj ect.

Claims

CLAIMS1. A remote medical-diagnosis system comprising: a) a self-sampling medical device performing biological sample selfsampling by a subject, which medical device is associated with at least one identification means; b) at least one reception device for identifying the at least one identification means of the self-sampling medical device; c) at least one analysis device for performing at least one biological test on the biological sample collected by the self-sampling medical device; and d) a server configured to: i. register the subject and his at least one biological analysis request; ii. record the data related to the self-sampling medical device and its associated biological sample; iii. select at least one biological test to be realized on the selfsampling medical device; iv. eventually, select the technical platform to which address the self-sampling medical device to carry out the corresponding selected at least one biological test; v. confirm the technical platform reception of the selfsampling medical device by the at least one reception device; vi. request the at least one analysis device for performing the at least one selected biological test;vii. receive the data corresponding to the results of the at least one selected biological test performed by the at least one analysis device on the self-sampling medical device; viii. production of a report comprising at least the results of the at least one selected biological test; and ix. transmitting the report to the subject and / or eventually request a medical appointment for the subject2. The system of claim 1, wherein the biological sample refer to any subject’s fluid selected in the group comprising vaginal fluid, oral fluid, salivary, urine, blood, sweat, anal fluid or dermal fluid.

3. The system of claim 1, wherein the self-sampling medical device corresponds to any device enabling the collection and preservation of a subject’s fluid selected in the group comprising swabs, veils, sponges and FTA cards.

4. The system of claim 1, wherein the at least one identification means is selected in the group comprising RFID tags, QR codes and barcodes.

5. The system of claim 1, further comprising: e) at least one storage for recording the data associated with the selfsampling medical device, the subject, the biological test, and / or the results.

6. The system of claim 1, wherein the server is configured to select at least one biological test to be realized on the self-sampling medical device by identifying the biological tests compatible with said self-sampling medical device, then with the biological tests associated with the biological analyses requested by the subject.

7. The system of claim 1, wherein this selection by the server is realized on the basis of 2, 3, 4, 5, or more selection criterions, preferably, 3, 4, 5 or more selection criterions, and still preferably 4, 5 or more selection criterions.

8. The system of claim 7, wherein each selection criterion is related to the selfsampling device, to the biological sample of the self-sampling device, to the self- sampling device reagents, to the self-sampling-device instruction of use (IFU), to the self-sampling medical device transport requirements, to the self-sampling device registrations, certifications, recommendations and / or exclusions, to the envisaged biological test, to the envisaged biological test reagents, to the envisaged biological test instruction of use (IFU), to the envisaged biological test registrations, certifications, recommendations and / or exclusions, to the subject’s territory, to the available technical platform for the territory and / or for the envisaged biological test.

9. The system of claim 7 or 8, wherein each selection criterion is an inclusive criterion.

10. The system of claim 9, wherein each selection criterion is related to an existing use, certification, registration and / or recommendation for the self-sampling device, the biological sample of the self-sampling device, to the self-sampling device reagents, to the transport of the self-sampling medical device and the associated biological sample, to the envisaged biological test, to the envisaged biological test reagents, to the subject’s territory, to the available technical platform for the territory and / or for the envisaged biological test.

11. The system of claim 10, wherein each selection criterion is selected in the group comprising:- Existing certification / registration for the used self-sampling medical device certification / registration for the envisaged biological test compatibility of the envisaged biological test with the used self-sampling medical device existing use description of the envisaged biological test with the used self-sampling medical deviceexisting use recommendation of the envisaged biological test with the used self-sampling medical device.

12. The system of claim 1, further comprising: f) at least one domestic database.

13. The system of any one of claims 7 to 11, wherein a value is assigned to each selection criterion depending on whether it is satisfied or not, and preferably:- the value of each selection criterion for an envisaged biological test in relation with a specific self-sampling medical device is integrated in a dedicated formula, for obtaining a global value, called herein “singularity index”, for this specific self-sampling medical device; and- the server selects the biological tests having the required global value or singularity index for a specific self-sampling medical device.

14. The system of any one of claims 7 to 11 or 13, wherein the server reinitiates a selection step using at least one exclusion criterion for each unsatisfied selection criterion if no biological test can be selected based on the selection criterions.

15. The system of claim 14, wherein said at least one exclusion criterion is related to an existing non-admission, exclusion, refusal, and / or rejection for the selfsampling device, the biological sample of the self-sampling device, to the selfsampling device reagents, to the transport of the self-sampling medical device and the associated biological sample, to the envisaged biological test, to the envisaged biological test reagents, to the subject’s territory, to the available technical platform for the territory and / or for the envisaged biological test.

16. The system of claim 15, wherein each exclusion criterion is selected in the group comprising:use exclusion of the self-sampling medical device for the territory of the subject and / or of the technical platform- use exclusion of the envisaged biological test for the territory of the subject and / or of the technical platform- use exclusion of the envisaged biological test with the used self-sampling medical device- use exclusion description of the envisaged biological test with the used self-sampling medical device- use exclusion recommendation of the envisaged biological test with the used self-sampling medical device.

17. The system of any one of claims 14 to 16, wherein a value is assigned to each exclusion criteria ending on whether it is satisfied or not, which value is herein called “criticality index” for its corresponding unsatisfied selection criterion t, and preferably the server selects the biological tests having the required global value or singularity index for a specific self-sampling medical device and having no satisfied exclusion criterion associated with an unsatisfied selection criterion.

18. The system of claim 1, wherein the server edits a shipping voucher to be associated with the used self-sampling medical device following the technical platform selection / identification.

19. The system of claim 1, wherein the at least one analysis device provides a qualitative and quantitative measurement result for the selected biological test realized on the biological sample collected by the self-sampling medical device.

20. The system of claim 1, wherein the at least one analysis device includes a means for reading / decoding the at least one identification means of the self-sampling medical device.

21. The system of claim 1, wherein the at least one analysis device is connected to the server allowing the recording on the server of measurement result of the selectedbiological test realized on the biological sample collected by the self-sampling medical device.

22. The system of claim 1, wherein report further include the self-sampling medical device identifier, the patient identifier, and / or an identifier of a document or publication corresponding to the at least one selected biological test.

23. The system of claim 1, further comprising: g) an interface module adapted to return the results once the results of the biological analysis are available and eventually to schedule a videoconference with a healthcare professional selected by the interface module and eventually previously accepted by the subject.

24. The system of claim 23, wherein the interface module first validate that the healthcare professional is competent for the selected biological test, that the subject is eligible for such healthcare professional because of linguistic, medical, and / or regulatory knowledge of the geographical territory of the subject.

25. The system of claim 1, further comprising: h) At least one clock to date one or more data, preferably for timestamping each step relating to the biological sample.

26. An ex vivo method of performing a remote medical diagnosis using the system as defined in any one of claims 1 to 25, the method comprising the steps of:- registering the subject and his at least one biological analysis request, recording the data related to the self-sampling medical device and its associated biological sample, selecting at least one biological test to be realized on the self-sampling medical device,eventually, select the technical platform to which address the selfsampling medical device to carry out the corresponding selected at least one biological test, confirming the technical platform reception of the self-sampling medical device by the at least one reception device, requesting the at least one analysis device for performing at least one selected biological test, receiving the data corresponding to the results of the at least one selected biological test performed by the at least one analysis device on the self-sampling medical device,- producing / editing of a report comprising at least the results of the at least one selected biological test; and transmitting the report to the subject and / or eventually request a medical appointment for the subject.

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