EP4275216A1 - A system, a non-volatile memory and a method for collecting test data relating to a pathogen - Google Patents

A system, a non-volatile memory and a method for collecting test data relating to a pathogen

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Publication number
EP4275216A1
EP4275216A1 EP22700019.7A EP22700019A EP4275216A1 EP 4275216 A1 EP4275216 A1 EP 4275216A1 EP 22700019 A EP22700019 A EP 22700019A EP 4275216 A1 EP4275216 A1 EP 4275216A1
Authority
EP
European Patent Office
Prior art keywords
test
identification
virus
pathogen
unit
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP22700019.7A
Other languages
German (de)
French (fr)
Inventor
Marijana WOLFS
Bert WOLFS
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Individual
Original Assignee
Individual
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Filing date
Publication date
Application filed by Individual filed Critical Individual
Publication of EP4275216A1 publication Critical patent/EP4275216A1/en
Pending legal-status Critical Current

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Classifications

    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H10/00ICT specially adapted for the handling or processing of patient-related medical or healthcare data
    • G16H10/40ICT specially adapted for the handling or processing of patient-related medical or healthcare data for data related to laboratory analysis, e.g. patient specimen analysis
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H50/00ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics
    • G16H50/80ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for detecting, monitoring or modelling epidemics or pandemics, e.g. flu

Definitions

  • the present invention relates to a system and method of collecting medical diagnostic test data indicative of a test relating to a pathogen in a subject that is a human or animal.
  • test methods for determining if a subject is infected with a certain contagious pathogen are known in the art.
  • Commercially available diagnostic kits are available for some of those pathogens.
  • the test result together with the information about the subject and the geographic location of the test are manually collected after the test.
  • the problem in the conventional methods is to link data from a confirmed positive test to the geographical location where the test was conducted.
  • the test results can be evaluated, e.g. by the rate of positivity or by the geographic location, usually after several days or at least several hours. It is difficult to create a snapshot illustrating the test results.
  • speed is important to take suitable measures, e.g. for reducing or stopping, spread of a disease
  • slow procedure may be inappropriate.
  • a fast spreading pathogen is involved in an epidemic or pandemic such as the Corona virus of COVID-19
  • fast evaluation of the situation may be paramount in order to get control over the epidemic or pandemic or in order to take specific measures against the epidemic or pandemic.
  • the present invention is a system for collecting test data indicative of a test for a pathogen in a subject.
  • the system comprises a testing unit, a clock, a position determination unit and a communication unit.
  • the testing unit is provided with an identification of the test configured to determine the presence of the pathogen as a result of the test.
  • the clock is configured to generate a time stamp for the test.
  • the position determination unit is configured to provide geographic location information of the test.
  • the processing unit is configured to generate test data comprising the identification of the testing unit, the time stamp generated by the clock, the geographic location information provided by the position determining unit as well as the result of the test.
  • the communication unit is configured to transmit the generated test data to a predefined destination.
  • test result By preferably automatically augmenting the test result with additional data such as the location of the test, the type of the test and the time of the test, evaluation can be decisively improved.
  • additional data such as the location of the test, the type of the test and the time of the test.
  • evaluation can be decisively improved.
  • the speed and accuracy of the process can be improved such that the situation can more specifically be grasped, and more specific measures can be taken.
  • the present invention is a non-volatile memory provided with a computer program for collecting test data indicative of a test for a pathogen, wherein the test is provided with an identification and determines the presence of the pathogen as result of the test, wherein the computer program comprises: a clock module configured to generate a time stamp for the test, a position determination module configured to provide geographic location information of the test, a processing module configured to collect the test data including the identification, the time stamp and the geographic location information as well as a result of the test, and a communication module configured to send the test data to a predefined destination.
  • the present invention relates to a method for collecting test data indicative of a test for a pathogen in a subject, comprising the steps of: generating or providing an identification of the test, performing the test indicating presence of the pathogen as a result, generating a time stamp of the test, determining geographic location information of the test, and transmitting the identification of the test, the result of the test, the time stamp and the geographic location information to a predefined destination.
  • All three aspects of the invention allow for a high performance and accurate evaluation of the situation of a spread of a disease or pathogen. A widely automized fast evaluation can be achieved, which allows for improving decision-making process in the context of taking appropriate measures to prevent spread of the disease or pathogen.
  • Such evaluation my involve statistical analysis of data gathered by the system.
  • the system itself can be configured to analyse the data and to provide results as basis for taking measures against spread of the disease or pathogen.
  • the statistical analysis may include geographic evaluation.
  • the identification of the test (QR code) may be scanned and verified as to postal or ZIP information.
  • Data relevant to following parameters may be collected, e.g., from the National Institute of Statistics (NIS) of each country involved: soil such as soil or airborne, animals such as water, sand flies.
  • the geographic evaluation may use quantile regression forests (WRF) which may be programmed on a computer of the system in R. The 5th, 50th, 95th quantiles can be predicted through a quantregForest R package.
  • WRF quantile regression forests
  • the statistical analysis may include population properties evaluation.
  • population properties evaluation In this context, several scientific studies have proven that the following factors have an influence on the probability of the exposure to pathogens: living accommodation such as city versus rural area; individual house versus apartment building; level of sanitation such as developed versus non- developed; contacts with pets and animals; time spent in an area such as none, several hours, a day, a week, a month or more; economic development such as advanced, well-developed or less- developed; transportation such as individual versus intense public transportation, air transportation; identifier result; and population density such as per postal code.
  • the population density may be the number of people per unit of area, usually quoted per square kilometer or sq. mile. These numbers may be based on Census data from National Statistics Agencies. However, to increase the accuracy, population-weighted density may be used.
  • the statistical analysis may work with a disease quotient.
  • quotient may equal the % of state population with the disease/ % of national population with the disease.
  • the statistical analysis may include public sentiment evaluation. Automatic detection of emotional or opinionated statements in a text statement, e.g., provide in social media, may be used in such sentiment evaluation.
  • the complexity of Sentiment Analysis and Opinion Mining on data from social media is due to non-standard linguistics, heavy use of emotions and emojis, slang and incorrect grammar. Due to several constraints, lexicon-based approaches, i.e., corpuses may be used. Twitter Inc. offers a comprehensive search API, up to seven days back in time. The streaming API data may be used to measure the sentiment towards the disease in a local area.
  • the statistical analysis may include micro-mobility evaluation.
  • data from local or regional telecom providers may be used.
  • POI data static data
  • dynamic data data from movements across time and space
  • dynamic data is used.
  • the goal is to predict the regional outbreaks for 30-60 days.
  • the dynamic data may be used to separate latitude and longitude.
  • a trip may be considered as a movement of a minimum time of 45 minutes between two different postal codes.
  • Hawkes process outcomes can be delivered of within region mobility and the length of pathogen transmission chains be determined over a certain area.
  • the statistical analysis comprises geographic evaluation, population properties evaluation, disease quotient evaluation, public sentiment evaluation and micro-mobility evaluation.
  • geographic evaluation e.g., geographic evaluation, population properties evaluation, disease quotient evaluation, public sentiment evaluation and micro-mobility evaluation.
  • the term “comprise/comprising” is generally used in the sense of include/including, i.e. permitting the presence of one or more features or components.
  • the terms “comprise” and “comprising” also encompass the more restricted terms “consist” and “consisting”.
  • the singular form “a”, “an” and “the” include plural references unless the context clearly dictates otherwise.
  • the term “about” in relation to a numerical value x means, for example, +/-10%.
  • the word “substantially” does not exclude “completely,” e.g., a composition which is "substantially free” from Y may be completely free from Y.
  • the computer program may be stored on a suitable medium such as a non-volatile memory including an optical storage medium, or a solid-state medium supplied together with or as part of other hardware but may also be distributed in other forms such as via the Internet or other wired or wireless telecommunication systems.
  • a computer program can be a computer program product stored on a computer readable medium which computer program product can have computer executable program code adapted to be executed to implement a specific method such as the method according to the invention.
  • a computer program can also be a data structure product or a signal for embodying a specific method such as the method according to the invention.
  • pathogen term is used to describe an infectious microorganism or agent, such as a virus, bacterium, protozoan, prion, viroid, or fungus.
  • infectious microorganism or agent such as a virus, bacterium, protozoan, prion, viroid, or fungus.
  • the pathogen has preferably the potential to cause an epidemic or a pandemic.
  • An “epidemic” is the rapid spread of disease to many people in a given population within a short period of time. For example, in meningococcal infections, an attack rate of more than 15 cases per 100,000 people for two consecutive weeks is considered an epidemic. A “pandemic” is a worldwide epidemic.
  • test relates to a medical diagnostic test that determines the presence of the pathogen.
  • subject can refer to a human or another mammal, including dog, cat, rat, mouse, monkey, cow, horse, goat, sheep, pig, but also birds. The term does not denote a particular age or sex of said subject.
  • the term “identification” in connection with the testing unit relates to information that can be used to identify the specific testing unit indicative for the test conducted.
  • the information may include the name of the pathogen, whose presence is to be determined, the disease the pathogen can cause, the name of the testing method or any other related information such as an identifier of the subject to be tested.
  • the identification of the test may be a unique identifier.
  • testing unit relates to a device or test kit for determining the presence of a pathogen in a sample from a subject.
  • the sample is a bodily fluid, but other biological samples of the subject are possible.
  • the testing unit can comprise one or more parts and a receiving part for receiving the biological sample to be tested. It can contain a further reagent part for one or more biochemical reactions to take place as to give a detection signal that is indicated on the test unit. In some embodiment the signal is detected at another part of the testing unit. In some embodiments, further reagents can be added to the testing unit to trigger the biochemical reaction(s) necessary for detection.
  • the application of the sample, the biochemical reaction(s) and detection thereof are taking place at the same part of the testing unit.
  • the testing unit can create the result, e.g., indicating the test is positive or negative, and pass the test result for further processing.
  • the result of the test can be “positive” or “negative”.
  • the determination of the pathogen in the sample can be also done using an external device.
  • clock relates to a means that measures the time. It can be in form of an integrated circuit such as real-time clock or realised as a software solution that receives the time from another device or an operating system.
  • the term “position determination unit” relates to a means that can determine the geographic location where the test is being or has been performed.
  • the position determination unit can be in form of or comprise a Global Positioning System (GPS) receiver, or any other satellite-based radio navigation system.
  • GPS Global Positioning System
  • it can be or comprise a distinct indication of a location where the test is performed such as, e.g., a name of a registered or official test center.
  • the position may be determined by a user selecting a test center from a list of test centers or by inputting a test center name in a user interface, such that the user interface and/or the device executing it correspond to the position determination unit. More specifically, a predefined list may contain 20 locations where the testing unit supposed to be used and the position determination unit refers to one the 20 locations.
  • test data relates to the relevant information about the test. It can include the time stamp indicating the time at which the test being conducted, the identification indicative the kind of the test, the geographic location where the test being performed, and the result indicating the presence or non-presence of the pathogen, e.g., positive, or negative.
  • the test data may be provided in a digital form such as an electronic message.
  • the message can be represented for example in XML, HTTP, a plain text, or the like.
  • the message can be parsed, e.g., using any regular expression or database commands, so that the contents in the message can be evaluated. In case of need the message can be encrypted to prevent the leakage of personal information.
  • processing unit relates to a means that executes instructions to perform the required tasks, e.g., collecting or gathering the test data, which can be done in the push or pull manner. In other words, the processing unit can actively retrieve the information such as the time or identification from the other units or passively receives the test data once they are passed to the processing unit by the other units.
  • communication unit in relates to a means that conveys information from one entity to anther in generic term. In particular, the communication unit can transmit the test data in form of the electronic message to the predefined destination.
  • predefined destination relates to a place where the test data for all tests performed can be centrally stored.
  • predefined destination can refer to a server hosting a database to which the communication unit can transmit the test data.
  • viruses are submicroscopic infectious agent that replicates only inside the living cells of an organism.
  • the Baltimore classification of viruses is based on the mechanism of mRNA production. Viruses must generate mRNAs from their genomes to produce proteins and replicate themselves, but different mechanisms are used to achieve this in each virus family.
  • Viral genomes may be single-stranded (ss) or double-stranded (ds), RNA or DNA, and may or may not use reverse transcriptase (RT).
  • ssRNA viruses may be either sense (+) or antisense (-). This classification places viruses into seven groups :
  • dsDNA viruses e.g. Adenoviruses, Herpesviruses, Poxviruses
  • ssDNA viruses (+ strand or "sense" DNA (e.g., Parvoviruses)
  • dsRNA viruses e.g., Reoviruses
  • (+)ssRNA viruses (+ strand or sense) RNA e.g., Coronaviruses, Picornaviruses, Togaviruses
  • V. (-)ssRNA viruses (- strand or antisense) RNA (e.g., Orthomyxoviruses, Rhabdoviruses)
  • ssRNA-RT viruses (+ strand or sense) RNA with DNA intermediate in lifecycle (e.g., Retroviruses)
  • dsDNA-RT viruses DNA with RNA intermediate in lifecycle (e.g., Hepadnaviruses)
  • “Influenza virus” also “Orthomyxoviridae” is a family of negative-sense RNA viruses. It includes seven genera: Alphainfluenzavirus, Betainfluenzavirus, Deltainfluenzavirus, Gammainfluenzavirus, Isavirus, Thogotovirus, and Quaranjavirus. The first four genera contain viruses that cause influenza in vertebrates, including humans, other mammals, and birds. Isaviruses infect salmon; the thogotovi ruses are arboviruses, infecting vertebrates, and invertebrates, such as ticks and mosquitoes. The Quaranjaviruses are also arboviruses, infecting arthropods as well as birds.
  • influenza virus There are four genera of influenza virus, each containing only a single species, or type. Influenza A and C infect a variety of species (including humans), while influenza B almost exclusively infects humans, and influenza D infects cattle and pigs. Influenza A viruses are further classified, based on the viral surface proteins hemagglutinin (HA or H) and neuraminidase (NA or N). Sixteen H subtypes (or serotypes) and nine N subtypes of influenza A virus have been identified.
  • HA or H hemagglutinin
  • NA or N neuraminidase
  • influenza strain isolates are identified by a standard nomenclature specifying virus type, geographical location where first isolated, sequential number of isolations, year of isolation, and HA and NA subtype.
  • the type A viruses are the most virulent human pathogens among the three influenza types and cause the most severe disease.
  • the serotypes that have been confirmed in humans, ordered by the number of known human pandemic deaths, are:
  • H1 N1 caused “Spanish flu” in 1918 and “Swine flu” in 2009.
  • Influenza B virus is mostly a human pathogen, and is less common than influenza A.
  • influenza C virus infects humans and pigs and can cause severe illness and local epidemics. However, influenza C is less common than the other types and usually causes mild disease in children.
  • influenza D virus is a genus that appears to be most closely related to Influenza C, from which it diverged several hundred years ago. There are at least two extant strains of this genus. The main hosts appear to be cattle, but the virus has been known to infect pigs as well.
  • Coronaviruses are a group of RNA viruses that cause diseases in mammals and birds. They cause respiratory tract infections that can range from mild to lethal. Mild illnesses in humans include some cases of the common cold (which is also caused by other viruses, predominantly rhinoviruses), while more lethal varieties can cause Severe acute respiratory syndrome (SARS), Middle East respiratory syndrome (MERS), and COVID-19. In cows and pigs, coronaviruses cause diarrhea, while in mice they cause hepatitis and encephalomyelitis.
  • Coronaviruses constitute the subfamily Orthocoronavirinae, in the family Coronaviridae, order Nidovirales, and realm Riboviria. They are enveloped viruses with a positive-sense single- stranded RNA genome and a nucleocapsid of helical symmetry. The genome size of coronaviruses ranges from approximately 26 to 32 kilobases, one of the largest among RNA viruses. They have characteristic club-shaped spikes that project from their surface, which in electron micrographs create an image reminiscent of the solar corona, from which their name derives.
  • Coronavirus disease 2019 is a highly contagious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
  • SARS-CoV-2 severe acute respiratory syndrome coronavirus 2
  • the coronaviruses responsible for COVID-19 may exist in various mutations such as the alpha, beta, gamma, delta and omicron mutations.
  • MERS Middle East respiratory syndrome
  • camel flu is a viral respiratory infection caused by the MERS-coronavirus (MERS-CoV). Typical symptoms include fever, cough, diarrhea, and shortness of breath.
  • Mumps virus is the virus that causes mumps.
  • MuV contains a single-stranded, negative-sense genome made of ribonucleic acid (RNA).
  • Filoviruses are filament-like viruses that cause viral hemorrhagic fever and include Ebolaviruses and marburgviruses.
  • Equid alphaherpesvirus 1 formerly Equine herpesvirus 1 (EHV-1), is a virus of the family Herpesviridae that causes abortion, respiratory disease and occasionally neonatal mortality in horses. Encephalitis can occur in affected animals, leading to ataxia, paralysis, and death.
  • African horse sickness is a highly infectious and deadly disease caused by African horse sickness virus. It commonly affects horses, mules, and donkeys. It is caused by a virus of the genus Orbivirus belonging to the family Reoviridae. This disease can be caused by any of the nine serotypes of this virus.
  • AHS is not directly contagious but is known to be spread by insect vectors.
  • West Nile virus is a single-stranded RNA virus that causes West Nile fever. It is a member of the family Flaviviridae, specifically from the genus Flavivirus, which also contains the Zika virus, dengue virus, and yellow fever virus. West Nile virus is primarily transmitted by mosquitoes, mostly species of Culex. In humans, West Nile virus can cause a disease known as West Nile fever. In horses the virus infection is often lethal.
  • Foot-and-mouth disease or hoof-and-mouth disease (HMD) is an infectious and sometimes fatal viral disease that affects cloven-hoofed animals, including domestic and wild bovids caused by the foot-and-mouth disease virus.
  • “Pathogenic bacteria” are a major cause of human death and disease and cause infections such as tetanus (Clostridium tetani), typhoid fever (by Salmonella typhi), diphtheria (Corynebacterium diphtheriae), leprosy (Micobacterium leprae) and tuberculosis (mycobacterium tuberculosis).
  • Pertussis (Whooping cough) is an acute contagious and potentially epidemic bacterial infection caused by Bordetella pertussis, or less commonly, B bronchoseptica and B parapertussis, which affects children ⁇ age 5.
  • Bacterial diseases in farm animals include Johne's disease, mastitis, salmonella and anthrax.
  • “Strangles” (equine distemper) is a contagious upper respiratory tract infection of horses and other equines caused by a Gram-positive bacterium, Streptococcus equi. As a result, the lymph nodes swell, compressing the pharynx, larynx, and trachea, and can cause airway obstruction leading to death.
  • a “nasopharyngeal swab” (or nasopharyngeal culture) is a method for collecting a clinical test sample of nasal secretions from the back of the nose and throat. The sample is then analyzed for the presence of the pathogen.
  • a “oropharyngeal swab” is a method for collecting a clinical test sample of fluid from the back of the mouth. The sample is then analyzed for the presence of the pathogen.
  • the pathogen is a virus.
  • the virus may be selected from any of the viruses mentioned above in the definitions. Especially the virus can be selected from the group consisting of influenza virus A, B, C or D, corona virus, Ebola virus, Marburg virus, mumps virus, foot and mouth disease virus, and EHV-1.
  • the pathogen is SARS-CoV-2 causing Covid-19 or variants thereof such as B.1.1.7 (alpha), Cluster 5, 20A.EU1, VUI -202012/01, B.1.351 (beta), P.1 (gamma), B.1.617.2 (delta) and B.1.1.529 (omcron).
  • the virus is MERS-CoV causing MERS.
  • the virus is an influenza virus type A like for example H5N1 also called avian flu, Ebola virus, Marburg virus or SARS-CoV-2 or variants thereof like alpha, beta, gamma, delta or omicron.
  • the pathogen is a bacterium.
  • the bacterium can be selected from the any of the bacteria mentioned above in the definitions.
  • the bacterium is selected from bacteria causing pertussis, tetanus, typhoid fever, diphtheria, leprosy, tuberculosis or strangles.
  • the test kit is measuring the presence of a pathogen in a bodily fluid from a subject such as from a nasopharyngeal or oropharyngeal swab, saliva, exhaling air, blood or urine.
  • the invention allows for taking timely measures such as closing borders and schools, ending a curfew, the momentum of the disease outbreak and its rate of decay needs to be forecasted.
  • the invention may focus on comparably small sets of data and fast spreading diseases.
  • the identification of the test comprises a code pattern image
  • the processing unit is configured to obtain the identification by scanning the code pattern image.
  • the code pattern image may include address or location information of the predefined destination.
  • the code pattern can be placed at the testing unit or on the package containing the testing unit.
  • the code pattern image can be represented in a photographic image that contains machine-readable information such as the method of the test and the name of the pathogen as before discussed. Further, it can include the location or address of the predefined destination such as a server, e.g., in a form of an internet address or a Uniform Resource Identifier, URI, or more specifically Uniform Resource Locator, URL. This enables that the communication unit to send the data test to the server.
  • the code pattern image is represented in a Quick Response code, QR code.
  • the QR code is machine-readable image and simplifies the extract of the information contained therein.
  • the communication unit is configured to establish data communication with the predefined destination or server.
  • the data communication can be based on any protocol that is suitable to transmit the message containing the test data.
  • the message can be transmitted via the Internet Protocol such as via TCP or UDP protocol to the server.
  • the message or the communication channel can be encrypted to prevent leakage of personal related data.
  • the test data may be provided in a form that the test data does not contain any personal information.
  • the processing unit preferably is configured to extract the address of the predefined destination form the identification, to establish the data communication to the predefined destination via the communication unit and to transmit the generated test data to the predefined destination via the established data communication.
  • Such configuration allows for an efficient handling and transmission of the test data.
  • the electronic device can be a mobile device in form of a smartphone.
  • the mobile device can be provided with at least one of the above functions, either by a hardware component or a software module of the operating system of the mobile device. Further, the identification of the test can be also selected from the mobile device when collecting the test data.
  • the testing unit can be manufactured in an integrated apparatus that provides the above functions so that there is no additional apparatus required for collecting the test data.
  • the code pattern image such as QR code is no longer required since the integrated apparatus allows to input or determine the kind of test.
  • the predefined destination can be entered into the apparatus, e.g., during the initiation of the apparatus.
  • the integrated apparatus may include the clock, the position unit, the processing unit, that can collect the test data including the required information like time and location of the test and send the test data to the predefined the destination, e.g., using a wireless or mobile data connection.
  • the predefined destination is a node hosting the test data.
  • the node e.g., a network node, can be a computer server that hosts a database for storing the test data.
  • the server can be reached via a unique identifier such as internet address or URL by the system according to the present invention.
  • the predefined destination can be configured to gather plural test data and to evaluate the gathered test data for various purposes.
  • the system comprises an identification generation unit configured to generate the identification of the testing unit.
  • identification generation unit allows for providing a unique identification of the testing unit or test to efficiently identify the specific test performed.
  • the identification generation unit can be embodied at the predefined destination or server.
  • the predefined destination comprises a data evaluation unit configured to evaluate the identification of the testing unit, the time stamp, the geographic location information and the result of the test.
  • a data evaluation unit configured to evaluate the identification of the testing unit, the time stamp, the geographic location information and the result of the test.
  • Such evaluation unit allows for efficiently providing statistics and other evaluations to define measures to be taken.
  • the present invention relates a non-volatile memory provided with a computer program for collecting test data indicative of a test for a pathogen.
  • the computer program can run on an electronic device that may be in form of a smartphone and the test is provided with an identification and determines the presence of the pathogen because of the test.
  • the computer program comprises: a clock module configured to generate a time stamp for the test, a position determination module configured to provide geographic location information of the test, a processing module configured to collect the test data including the identification, the time stamp and the geographic location information of the test, and a communication module configured to send the test data to a predefined destination.
  • non-volatile memory according to the invention and its preferred embodiments described below allow for efficiently implementing the effects and benefits of the system according to the invention and its preferred embodiments.
  • module relates to a software module that provides the required functionality such as providing the time stamp, determining the geographic location, collecting the test data, and sending the test data to the predefined destination.
  • the computer program may be in form of an App which can be downloaded from the internet and installed on a generic purpose device such as a smartphone.
  • At least one of following modules that are the clock module, the position determination module, processing module and the communication module is running on an electronic device such as a mobile device.
  • the modules can be distributed in several devices, e.g. the clock is running on a testing unit whereas the remaining modules are running as the App on the mobile device.
  • the identification of the test comprises a code pattern image
  • the processing module is configured to obtain the identification by scanning the code pattern image which can be in form of a QR code.
  • the present invention relates to a method for collecting test data indicative of a test for a pathogen in a subject.
  • the method comprises the steps of: generating an identification of the test; performing the test indicating presence of the pathogen as a result; generating a time stamp of the test; determining geographic location information of the test; and transmitting the identification of the test, the result of the test, the time stamp and the geographic location information to a predefined destination.
  • the method according to the invention can be a computer implemented method.
  • Such computer implemented method can be embodied as computer program or software.
  • Software can comprise one or plural applications executed on one or plural devices.
  • the computer program or software can comprise an identification management subsystem being responsible for creation, maintenance, and distribution of unique identifications such as QR codes to manufacturers, wholesalers, and retailers.
  • Each unique identification may contain the information of target destination such as a website endpoint together with an identifier of the test kit.
  • the computer program or software can comprise a manufacturing packaging subsystem being an external workflow that is not controlled by the identification management subsystem and specific to each manufacturer.
  • the identification can be included inside (with the corresponding manual) or outside of the package, e.g., if wholesalers and retailers are to be targeted.
  • the computer program or software can comprise a mobile application subsystem being the only interface for the user submitting the result of the test.
  • the user who scans the identifier with the camera of his mobile device is forwarded to the target destination, e.g., via decision website link being, e.g., a unique link such as a URL embedded in the identification or QR code.
  • the decision website link forwards automatically the user to download the right mobile application according to the mobile operating system or by manually selecting the right operating system such as iOS or Android.
  • the downloaded application requests the user to enter required (positive/negative test) and non-mandatory fields of information. Once submitted the information together with the information extracted from the user mobile phone (Bluetooth adapter address, GPS location etc) is sent for processing to the identification management subsystem for proper storing, e.g., according to GDPR regulations.
  • the computer program may scans the identification or QR code and verify postal or ZIP info. It may collect the data relevant to following parameters, e.g., from the National Institute of Statistics (NIS) of each country: soil such as soil or airborne insects such as water flies, sand flies and mosquitos.
  • the computer program or software may use quantile regression forests (WRF) which may be programmed in R. The 5th, 50th, 95th quantiles can be predicted through the quantregForest R package.
  • WRF quantile regression forests
  • the computer program or software may work with a disease quotient.
  • quotient may equal the % of state population with the disease/ % of national population with the disease.
  • the computer program or software may use sentiment analysis referring to the automatic detection of emotional or opinionated statements in a text statement.
  • the complexity of Sentiment Analysis and Opinion Mining on data from social media is due to non-standard linguistics, heavy use of emotions and emojis, slang and incorrect grammar. Due to several constraints, lexicon-based approaches, i.e., corpuses may be used. Twitter Inc. offers a comprehensive search API, up to seven days back in time. The streaming API data may be used to measure the sentiment towards the disease in a local area.
  • Twitter Inc. offers a comprehensive search API, up to seven days back in time. The streaming API data may be used to measure the sentiment towards the disease in a local area.
  • the computer program or software may take the data from local or regional telecom providers. In pandemic situations, most governments recommend their citizens to reduce contacts and stay home.
  • POI data static data
  • dynamic data data from movements across time and space
  • the goal is to predict the regional outbreaks for 30-60 days.
  • the dynamic data may be used to separate latitude and longitude.
  • a trip may be considered as a movement of a minimum time of 45 minutes between two different postal codes.
  • Hawkes process outcomes can be delivered of within region mobility and the length of pathogen transmission chains be determined over a certain area.
  • the method comprising a step of providing the generated identification of the test to a testing unit configured to determine the presence of the pathogen as the result of the test.
  • a testing unit configured to determine the presence of the pathogen as the result of the test.
  • provision of the identifier can, e.g., be implemented by printing the identifier and attaching the printed identifier to the testing unit.
  • the testing unit and the test can be uniquely identified.
  • the identification of the test comprises a code pattern image.
  • the code pattern image preferably is a QR code.
  • the identification preferably is scanned at the testing unit and the scanned identification is transmitted to the predefined destination. Such scanning and transmission allow for efficiently identifying the testing unit or test at the predefined destination. Like this, efficient evaluation of the test data at the predefined destination is possible.
  • the identification of the test comprises an address of the predefined destination. Such inclusion of the address allows for efficiently transmitting the test data to the predefined destination once the test has been performed.
  • the method preferably comprises steps of: extracting the address of the predefined destination form the identification; establishing a data communication to the predefined destination; and transmitting the identification of the test, the result of the test, the time stamp and the geographic location information to the predefined destination the established data communication.
  • the pathogen may be a virus selected from the group consisting of corona virus, influenza virus, MERS virus, Ebola virus, mumps virus, foot and mouth disease virus, Marburg virus and EHV virus.
  • the virus is an influenza virus type A like for example H5N 1 also called avian flu, Ebola virus, Marburg virus or SARS-CoV-2 or variants thereof like alpha, beta, gamma, delta or omicron.
  • the pathogen may be a bacterium selected from bacteria causing pertussis, tetanus, typhoid fever, diphtheria, leprosy, tuberculosis or strangles.
  • the subject may be a human being, or an animal selected from the group consisting of pigs, cows, horses, dogs, cats.
  • the method comprises a step of evaluating the identification of the test, the time stamp, the geographic location information, and the result of the test at the predefined destination.
  • Embodiment 1 is a system for collecting test data indicative of a test for a pathogen in a subject, which comprises a testing unit provided with an identification of the test, wherein the testing unit is configured to determine the presence of the pathogen as a result of the test; a clock configured to generate a time stamp for the test; a position determination unit configured to provide geographic location information of the test; a processing unit configured to collect the test data comprising the identification, the time stamp and the geographic location information as well as the result of the test; and a communication unit configured to transmit the test data to a predefined destination.
  • Embodiment 2 is the system of embodiment 1, wherein the identification of the test comprises a code pattern image, and wherein the processing unit is configured to obtain the identification by scanning the code pattern image.
  • Embodiment 3 is the system of embodiment 2, wherein the code pattern image is represented in a QR code.
  • Embodiment 4 is the system of embodiment 2 or 3, wherein the code pattern image includes location information of the predefined destination.
  • Embodiment 5 is the system of any one of embodiments 1 to 4, wherein the communication unit is configured to establish a data communication with the predefined destination.
  • Embodiment 6 is the system of any one of embodiments 1 to 5, wherein at least one of followings that are the clock (30), the position determination unit (40), processing unit (50) and the communication unit (60) is embedded in an electronic device (200) such as a mobile device.
  • Embodiment 7 is the system of any one of embodiments 1 to 6, wherein the predefined destination is a node hosting the test data.
  • Embodiment 8 is the system of any one of embodiments 1 to 7, wherein the pathogen is a virus selected from the group consisting of corona virus, influenza virus, MERS virus, Ebola virus, mumps virus, foot and mouth disease virus, Marburg virus and EHV virus.
  • the pathogen is a virus selected from the group consisting of corona virus, influenza virus, MERS virus, Ebola virus, mumps virus, foot and mouth disease virus, Marburg virus and EHV virus.
  • Embodiment 9 is the system of any one of embodiments 1 to 8, wherein the pathogen is a bacterium selected from bacteria causing pertussis, tetanus, typhoid fever, diphtheria, leprosy, tuberculosis or strangles.
  • the pathogen is a bacterium selected from bacteria causing pertussis, tetanus, typhoid fever, diphtheria, leprosy, tuberculosis or strangles.
  • Embodiment 10 is the system of any one of embodiments 1 to 9, wherein the subject is a human being, or an animal selected from the group consisting of pigs, cows, horses, dogs, cats.
  • Embodiment 11 is a non-volatile memory provided with a computer program for collecting test data indicative of a test for a pathogen, wherein the test is provided with an identification and determines the presence of the pathogen as result of the test, wherein the computer program comprises: a clock module configured to generate a time stamp for the test; a position determination module configured to provide geographic location information of the test; a processing module configured to collect the test data including the identification, the time stamp and the geographic location information as well as a result of the test; and a communication module configured to send the test data to a predefined destination.
  • Embodiment 12 is the non-volatile memory of embodiment 11 , wherein the identification of the test comprises a code pattern image, and wherein the processing module is configured to obtain the identification by scanning the code pattern image.
  • Embodiment 13 is the non-volatile memory embodiment 11 or 12, wherein at least one of followings that are the clock module, the positioning module, processing module and the communication module is running on an electronic device such as a mobile device.
  • Embodiment 14 is the system of embodiment 2, wherein the code pattern image is represented in a QR code.
  • Embodiment 15 is a method for collecting test data indicative of a test for a pathogen in a subject, comprising the steps of: providing an identification of the test; performing the test indicating the presence of the pathogen as a result; generating a time stamp of the test; determining geographic location information of the test; colleting the test data including the identification, the time stamp and the geographic location information as well as the test result of the test; and transmitting the test data to a predefined destination.
  • Fig. 1 shows an embodiment of the system according to the present invention
  • Fig. 2 shows another embodiment of system according to the present invention
  • Fig. 3 shows an embodiment of the test data tracking system according to the present invention.
  • Fig. 4 shows another embodiment of a system according to the invention.
  • Fig. 1 illustrates an embodiment of the system 1 according to the present invention, comprising an apparatus 100 including the identification 10 of the medical diagnostic test and the testing unit 20 with a test field 25 to receive the test agent of the subject.
  • the testing unit 20 comprises a reagents or dye, with an opening where the sample is inserted. Once the sample is inserted into the opening, the reagents or the dye can show the test result, i.e. , positive or negative.
  • identification is a QR code 10 indicating the kind of the test.
  • the QR code can be displayed or printed on a sticker adhered adjacent to testing unit 20.
  • the mobile device 200 comprises a camera 55 for scanning the QR code 10. After scanning the information can be extracted from the QR code.
  • the mobile device 100 also includes a clock to time stamp the time of the test and the position determination unit 40 to receive the GPS signal for determination of the geographic location.
  • the proceeding unit 50 of the mobile collects the information such as the time stamp, the GPS coordination, the URL, and the test name extracted from the QR code, and forwards to the communication unit 60 to the server at the URL.
  • the unique QR code 10 can be printed on the packaging of each test kit so that there are two independent components or parts of the test kit, i.e., the packaging with the QR code printed on it and the test component which is to be found in the packaging itself.
  • the mobile device 200 can be a smartphone that is already provided with the components that can be used for the purpose of collecting test data.
  • An application downloaded and installed on the smartphone can manage the tasks of collecting the test data using the existing components.
  • Fig. 2 shows another embodiment of the system 1 according to the present invention.
  • the components such as the clock 30, the position determination unit 40, the processing unit 50 and the communication unit 60 are integrated in the apparatus 100, together with the testing unit 20.
  • the embodiment of the system provides a standalone solution in an integrated apparatus 100 that can perform the medical diagnostic test with the testing unit 20 as well as collects and send the test data to the predefined destination.
  • the identification of the medical diagnostic test does not need to be shown as a QR code for scanning with a septate mobile device 200.
  • the identification of the test or the URL may be hardcoded or manually entered into the apparatus 100, prior or after the medical diagnostic test.
  • the similar applies to the predefined destination which can be also configured during the initialisation of the apparatus 100.
  • the integrated standalone apparatus 100 has all components required for collecting and transmitting the test data. This approach enables the test itself and collecting test data being performed with the same apparatus which is not dependent on any further device.
  • system 1 only using a part of the components on the mobile device 200, e.g., the camera 55 and the communication unit 60.
  • the other functionalities such as time and location determination are provided on the apparatus 100.
  • the system 1 can be configured flexibly, and its components can be distributed across the apparatus 100 and the mobile device 200, depending on the need.
  • the functionality of the components can be provided in hardware and/or software solution.
  • a chip is embedded on the box of the apparatus 100 next to the opening, which reads the test result and transmits the following data via Wi-Fi connection into the server.
  • the test data comprises a time stamp, the test result, and the geographical location. In either embodiment shown in Fig. 1 or 2, the test data is unique for each person or animal tested.
  • Fig. 3 illustrates an embodiment of a test data tracking system as system according to the present invention.
  • the tracking system utilises the code pattern and provides a solution for tracking the medical diagnostic results, geo-localization of testing users, storage of results and dissemination of information including geo-localization information for internal or external usage.
  • the code pattern tracking system may include a code pattern management subsystem 600, a mobile application subsystem 300 and test data management subsystem 400.
  • the code pattern management 600 creates a unique code pattern such as a QR code and distributes it to the system 1.
  • the code pattern can include a unique identifier for the medical diagnostic test and the URL of the mobile application subsystem 300.
  • the system 1 extracts this identification information from the code pattern, e.g., by scanning the coder pattern image. Then the system 1 collects the extracted identification information together with the other test data and sends to the mobile application subsystem 300.
  • the URL indicating the web server may be provided like: https://www.domain.com/0qrf-fdk2-fhkk-3423-3521.
  • the system 1 can be provided as a manufacturing packaging subsystem for the customer who conducts the test. It is, however, not controlled by the code pattern tracking system and can be specific to each manufacture or customer depending on the need.
  • the mobile application subsystem 300 is the preferred interface for the user submitting the result of the medical diagnostic test.
  • the system 1 scans the code pattern with a camera and extracts the URL of the website 310 from the code pattern.
  • the website link automatically forwards a link to the system 1 for downloading and installing, if not yet, a mobile application according to the mobile operating system or by manually selecting the right operating system such as iOS 330 and Android 320.
  • the user can enter required information such as positive/negative test result and fields of information to be determined.
  • information such as positive/negative test result and fields of information to be determined.
  • the information together with the information extracted from the user mobile phone is submitted, e.g., including Bluetooth adapter address, GPS location etc., it is sent for processing to the test data management subsystem 400 for proper storing according to GDPR regulations.
  • the data gathered will be kept confidential and not shared with any third parties. Only the end user will receive the information and it will be stored on the server. Third parties do not have access to personal data, thereby avoiding data leakage.
  • the person to be tested can be identified by a third-party with the zip code of domicile or any other generic code which does not contain personal related data such as name and addresses.
  • test data management subsystem 300 It can be further determined if the website or the mobile application will send the information to the test data management subsystem 300. Furthermore, it can be determined more suitable automated way to decrease human interaction and human error. The automation of the entire process of gathering tracing data can minimise involving medical personnel entering data into the system, which can prevent human errors.
  • the test data management subsystem 300 can include a storage of information received from the mobile application subsystem in GDPR compliant way as discussed before. Further, it represents as preferred interface for the external users or customers to retrieve or search data based on specific criteria. The interface will be accessible via an Application Programming Interface, API, that can be used in varies application, such as by the mobile application subsystem 300 for storing test data, the customer or other external subsystem such as users and external programs that can pull information, or the management of external users including permissions and access control etc.
  • API Application Programming Interface
  • the test data management subsystem 400 can interface, either manually or automatically, to the code pattern management subsystem 600 for importing valid codes that have been submitted to the manufacture.
  • the customer external subsystem 500 can represent the customer to the service and information as a product.
  • the customer represented as machine/user is accessing the test data management system via API as M2M, Machine to machine, interface for retrieval of information as XML/JSON file format based on search criteria query sent to the test data management system.
  • Fig. 4 shows another embodiment of a system 1 according to the invention implementing an embodiment of a method according to the invention.
  • the system comprises a main administration and evaluation center 800 (AEC) as predefined destination and several test centers 700.
  • AEC administration and evaluation center 800
  • Each test center 700 manages several testing apparatus 100 with testing units by means of a test center computing environment 710.
  • the AEC 800 runs a server computing environment 810 which is in data communication with the test center computing environments 710 via the Internet.
  • each of the test centers 700 is registered in the server computing environment 810 of the AEC 800. Then the AEC 800 generates identifiers in the form of QR codes for each of the test apparatus 100 of each test center 700 and transmits the QR codes to the respective test center 700 via the data communication. At the test centers 700, the QR codes are printed and attached to the test apparatus.
  • test apparatus 100 are used in the test centers 700, the QR code is scanned and gathered by the test center computing environment 710.
  • the test center computing environments 710 generate test data for each used test apparatus.
  • the test data comprise the identification of the test data from the QR code, a time stamp generated by a clock of the test center computing environment 710, a test center I D as geographic location information and the result of the test obtained by the test apparatus 100.
  • the test data are transmitted by the test center computing environments 710 to the server computing environment 810 of the AEC 800.
  • test data are rapidly evaluated wherein specifically, the results at the various locations of the test centers 700 can be considered. For example, such evaluation allows for providing more or less continuous automatic information about spread of a disease.
  • evaluation allows for providing more or less continuous automatic information about spread of a disease.

Abstract

The present invention provides a system for collecting test data indicative of a test for a pathogen in a subject, comprising: a testing unit provided with an identification of the test, wherein the testing unit is configured to determine the presence of the pathogen because of the test. The system further comprises a clock configured to generate a time stamp for the test, a position determination unit configured to provide geographic location information of the test, a processing unit configured to collect the test data comprising the identification, the time stamp and the geographic location information as well as the result of the test, and a communication unit configured to transmit the test data to a predefined destination.

Description

DESCRI PTION
Title
A SYSTEM, A NON-VOLATILE MEMORY AND A METHOD FOR COLLECTING TEST DATA
RELATING TO A PATHOGEN
Technical Field
[0001] The present invention relates to a system and method of collecting medical diagnostic test data indicative of a test relating to a pathogen in a subject that is a human or animal.
Background Art
[0002] Various test methods for determining if a subject is infected with a certain contagious pathogen are known in the art. Commercially available diagnostic kits are available for some of those pathogens. In the conventional approaches, the test result together with the information about the subject and the geographic location of the test are manually collected after the test.
[0003] The problem in the conventional methods is to link data from a confirmed positive test to the geographical location where the test was conducted. The test results can be evaluated, e.g. by the rate of positivity or by the geographic location, usually after several days or at least several hours. It is difficult to create a snapshot illustrating the test results. Moreover, in situations where speed is important to take suitable measures, e.g. for reducing or stopping, spread of a disease, such slow procedure may be inappropriate. For example, when a fast spreading pathogen is involved in an epidemic or pandemic such as the Corona virus of COVID-19, fast evaluation of the situation may be paramount in order to get control over the epidemic or pandemic or in order to take specific measures against the epidemic or pandemic.
[0004] Therefore, there is a need for an improved system and method for collecting the test results including associated test information allowing an evaluation being carried out in an automatic way and in a real time manner.
Summary of the Invention [0005] According to the invention this need is settled by the system, the non-volatile memory and the method as defined in independent claims. Preferred embodiments are subject of the dependent claims.
[0006] In a first aspect, the present invention is a system for collecting test data indicative of a test for a pathogen in a subject. The system comprises a testing unit, a clock, a position determination unit and a communication unit. The testing unit is provided with an identification of the test configured to determine the presence of the pathogen as a result of the test. The clock is configured to generate a time stamp for the test. The position determination unit is configured to provide geographic location information of the test. The processing unit is configured to generate test data comprising the identification of the testing unit, the time stamp generated by the clock, the geographic location information provided by the position determining unit as well as the result of the test. The communication unit is configured to transmit the generated test data to a predefined destination.
[0007] By preferably automatically augmenting the test result with additional data such as the location of the test, the type of the test and the time of the test, evaluation can be decisively improved. Moreover, by preferably automatically transmit the test data to the predefined destination such as a data evaluation center, the speed and accuracy of the process can be improved such that the situation can more specifically be grasped, and more specific measures can be taken.
[0008] In a second aspect, the present invention is a non-volatile memory provided with a computer program for collecting test data indicative of a test for a pathogen, wherein the test is provided with an identification and determines the presence of the pathogen as result of the test, wherein the computer program comprises: a clock module configured to generate a time stamp for the test, a position determination module configured to provide geographic location information of the test, a processing module configured to collect the test data including the identification, the time stamp and the geographic location information as well as a result of the test, and a communication module configured to send the test data to a predefined destination.
[0009] In a third aspect, the present invention relates to a method for collecting test data indicative of a test for a pathogen in a subject, comprising the steps of: generating or providing an identification of the test, performing the test indicating presence of the pathogen as a result, generating a time stamp of the test, determining geographic location information of the test, and transmitting the identification of the test, the result of the test, the time stamp and the geographic location information to a predefined destination. [0010] All three aspects of the invention allow for a high performance and accurate evaluation of the situation of a spread of a disease or pathogen. A widely automized fast evaluation can be achieved, which allows for improving decision-making process in the context of taking appropriate measures to prevent spread of the disease or pathogen.
[0011] Such evaluation my involve statistical analysis of data gathered by the system. In particular, the system itself can be configured to analyse the data and to provide results as basis for taking measures against spread of the disease or pathogen.
[0012] For example, the statistical analysis may include geographic evaluation. Thereby, the identification of the test (QR code) may be scanned and verified as to postal or ZIP information. Data relevant to following parameters may be collected, e.g., from the National Institute of Statistics (NIS) of each country involved: soil such as soil or airborne, animals such as water, sand flies. The geographic evaluation may use quantile regression forests (WRF) which may be programmed on a computer of the system in R. The 5th, 50th, 95th quantiles can be predicted through a quantregForest R package.
[0013] Further, the statistical analysis may include population properties evaluation. In this context, several scientific studies have proven that the following factors have an influence on the probability of the exposure to pathogens: living accommodation such as city versus rural area; individual house versus apartment building; level of sanitation such as developed versus non- developed; contacts with pets and animals; time spent in an area such as none, several hours, a day, a week, a month or more; economic development such as advanced, well-developed or less- developed; transportation such as individual versus intense public transportation, air transportation; identifier result; and population density such as per postal code. The population density may be the number of people per unit of area, usually quoted per square kilometer or sq. mile. These numbers may be based on Census data from National Statistics Agencies. However, to increase the accuracy, population-weighted density may be used.
[0014] Still further, the statistical analysis may work with a disease quotient. Such quotient may equal the % of state population with the disease/ % of national population with the disease.
[0015] Still further, the statistical analysis may include public sentiment evaluation. Automatic detection of emotional or opinionated statements in a text statement, e.g., provide in social media, may be used in such sentiment evaluation. The complexity of Sentiment Analysis and Opinion Mining on data from social media is due to non-standard linguistics, heavy use of emotions and emojis, slang and incorrect grammar. Due to several constraints, lexicon-based approaches, i.e., corpuses may be used. Twitter Inc. offers a comprehensive search API, up to seven days back in time. The streaming API data may be used to measure the sentiment towards the disease in a local area.
[0016] Still further, the statistical analysis may include micro-mobility evaluation. Thereby, data from local or regional telecom providers may be used. E.g., in pandemic situations, most governments recommend their citizens to reduce contacts and stay home. To obtain mobility data, there are two options: either POI data (static data) or data from movements across time and space (dynamic data) can be involved. Advantageously, dynamic data is used. The goal is to predict the regional outbreaks for 30-60 days. The dynamic data may be used to separate latitude and longitude. A trip may be considered as a movement of a minimum time of 45 minutes between two different postal codes. By using Hawkes process, outcomes can be delivered of within region mobility and the length of pathogen transmission chains be determined over a certain area.
[0017] Most preferably, the statistical analysis comprises geographic evaluation, population properties evaluation, disease quotient evaluation, public sentiment evaluation and micro-mobility evaluation. By combining these evaluations in the statistical analysis, a high level of quality for the decision-making of appropriate measures can be achieved. Also, such decision-making can be reproducible, reliable, and quick.
Disclosure of the Invention
[0018] All publications, patent applications, patents, and other references mentioned herein are incorporated by reference in their entirety. The publications and applications discussed herein are provided solely for their disclosure prior to the filing date of the present application. In addition, the materials, methods, and examples are illustrative only and are not intended to be limiting.
[0019] In case of conflict, the present specification including the definitions therein will prevail. Unless defined otherwise, all technical and scientific terms used herein will have the same meaning as commonly understood by one of skill in the art to which the subject-matter herein belongs. As used herein, the following definitions are supplied to facilitate the understanding of the present invention.
[0020] As used herein, the term “comprise/comprising” is generally used in the sense of include/including, i.e. permitting the presence of one or more features or components. The terms “comprise” and “comprising” also encompass the more restricted terms “consist” and “consisting”. As used herein, the singular form “a”, “an” and “the” include plural references unless the context clearly dictates otherwise. As used herein, the term "about" in relation to a numerical value x means, for example, +/-10%. As used herein, the word "substantially" does not exclude "completely," e.g., a composition which is "substantially free" from Y may be completely free from Y. Where necessary, the word "substantially" may be omitted from the definition of the invention. [0021] The computer program may be stored on a suitable medium such as a non-volatile memory including an optical storage medium, or a solid-state medium supplied together with or as part of other hardware but may also be distributed in other forms such as via the Internet or other wired or wireless telecommunication systems. In particular, e.g., a computer program can be a computer program product stored on a computer readable medium which computer program product can have computer executable program code adapted to be executed to implement a specific method such as the method according to the invention. Furthermore, a computer program can also be a data structure product or a signal for embodying a specific method such as the method according to the invention.
[0022] The term “pathogen” term is used to describe an infectious microorganism or agent, such as a virus, bacterium, protozoan, prion, viroid, or fungus. For the understanding of the present disclosure the pathogen has preferably the potential to cause an epidemic or a pandemic.
[0023] An “epidemic” is the rapid spread of disease to many people in a given population within a short period of time. For example, in meningococcal infections, an attack rate of more than 15 cases per 100,000 people for two consecutive weeks is considered an epidemic. A “pandemic” is a worldwide epidemic.
[0024] The term “test” relates to a medical diagnostic test that determines the presence of the pathogen. The term “subject” can refer to a human or another mammal, including dog, cat, rat, mouse, monkey, cow, horse, goat, sheep, pig, but also birds. The term does not denote a particular age or sex of said subject.
[0025] The term “identification” in connection with the testing unit relates to information that can be used to identify the specific testing unit indicative for the test conducted. The information may include the name of the pathogen, whose presence is to be determined, the disease the pathogen can cause, the name of the testing method or any other related information such as an identifier of the subject to be tested. In general, the identification of the test may be a unique identifier.
[0026] The term “testing unit” relates to a device or test kit for determining the presence of a pathogen in a sample from a subject. Usually, the sample is a bodily fluid, but other biological samples of the subject are possible. The testing unit can comprise one or more parts and a receiving part for receiving the biological sample to be tested. It can contain a further reagent part for one or more biochemical reactions to take place as to give a detection signal that is indicated on the test unit. In some embodiment the signal is detected at another part of the testing unit. In some embodiments, further reagents can be added to the testing unit to trigger the biochemical reaction(s) necessary for detection. In some embodiments the application of the sample, the biochemical reaction(s) and detection thereof are taking place at the same part of the testing unit. Once the presence or non-presence of the pathogen in the sample is determined, the testing unit can create the result, e.g., indicating the test is positive or negative, and pass the test result for further processing. Thus, in general the result of the test can be “positive” or “negative”. In another embodiment of the present invention, the determination of the pathogen in the sample can be also done using an external device.
[0027] The term “clock” relates to a means that measures the time. It can be in form of an integrated circuit such as real-time clock or realised as a software solution that receives the time from another device or an operating system.
[0028] The term “position determination unit” relates to a means that can determine the geographic location where the test is being or has been performed. In an embodiment, the position determination unit can be in form of or comprise a Global Positioning System (GPS) receiver, or any other satellite-based radio navigation system. In another embodiment, it can be or comprise a distinct indication of a location where the test is performed such as, e.g., a name of a registered or official test center. For instance, the position may be determined by a user selecting a test center from a list of test centers or by inputting a test center name in a user interface, such that the user interface and/or the device executing it correspond to the position determination unit. More specifically, a predefined list may contain 20 locations where the testing unit supposed to be used and the position determination unit refers to one the 20 locations.
[0029] The term “test data” relates to the relevant information about the test. It can include the time stamp indicating the time at which the test being conducted, the identification indicative the kind of the test, the geographic location where the test being performed, and the result indicating the presence or non-presence of the pathogen, e.g., positive, or negative. The test data may be provided in a digital form such as an electronic message. The message can be represented for example in XML, HTTP, a plain text, or the like. Preferably, the message can be parsed, e.g., using any regular expression or database commands, so that the contents in the message can be evaluated. In case of need the message can be encrypted to prevent the leakage of personal information.
[0030] The term “processing unit” relates to a means that executes instructions to perform the required tasks, e.g., collecting or gathering the test data, which can be done in the push or pull manner. In other words, the processing unit can actively retrieve the information such as the time or identification from the other units or passively receives the test data once they are passed to the processing unit by the other units. [0031] The term “communication unit” in relates to a means that conveys information from one entity to anther in generic term. In particular, the communication unit can transmit the test data in form of the electronic message to the predefined destination.
[0032] The term “predefined destination” relates to a place where the test data for all tests performed can be centrally stored. For instance, predefined destination can refer to a server hosting a database to which the communication unit can transmit the test data.
[0033] A “virus” is a submicroscopic infectious agent that replicates only inside the living cells of an organism. The Baltimore classification of viruses is based on the mechanism of mRNA production. Viruses must generate mRNAs from their genomes to produce proteins and replicate themselves, but different mechanisms are used to achieve this in each virus family. Viral genomes may be single-stranded (ss) or double-stranded (ds), RNA or DNA, and may or may not use reverse transcriptase (RT). In addition, ssRNA viruses may be either sense (+) or antisense (-). This classification places viruses into seven groups :
I. dsDNA viruses (e.g. Adenoviruses, Herpesviruses, Poxviruses)
II. ssDNA viruses (+ strand or "sense") DNA (e.g., Parvoviruses)
III. dsRNA viruses (e.g., Reoviruses)
IV. (+)ssRNA viruses (+ strand or sense) RNA (e.g., Coronaviruses, Picornaviruses, Togaviruses)
V. (-)ssRNA viruses (- strand or antisense) RNA (e.g., Orthomyxoviruses, Rhabdoviruses)
VI. ssRNA-RT viruses (+ strand or sense) RNA with DNA intermediate in lifecycle (e.g., Retroviruses)
VII. dsDNA-RT viruses DNA with RNA intermediate in lifecycle (e.g., Hepadnaviruses)
[0034] “Influenza virus” also “Orthomyxoviridae” is a family of negative-sense RNA viruses. It includes seven genera: Alphainfluenzavirus, Betainfluenzavirus, Deltainfluenzavirus, Gammainfluenzavirus, Isavirus, Thogotovirus, and Quaranjavirus. The first four genera contain viruses that cause influenza in vertebrates, including humans, other mammals, and birds. Isaviruses infect salmon; the thogotovi ruses are arboviruses, infecting vertebrates, and invertebrates, such as ticks and mosquitoes. The Quaranjaviruses are also arboviruses, infecting arthropods as well as birds.
[0035] The four genera of Influenza virus that infect vertebrates, which are identified by antigenic differences in their nucleoprotein and matrix protein, are as follows:
• Alphainfluenzavirus infects humans, other mammals, and birds, and causes all flu pandemics
• Betainfluenzavirus infects humans and seals • Deltainfluenzavirus infects pigs and cattle
• Gammainfluenzavirus infects humans, pigs, and dogs.
[0036] There are four genera of influenza virus, each containing only a single species, or type. Influenza A and C infect a variety of species (including humans), while influenza B almost exclusively infects humans, and influenza D infects cattle and pigs. Influenza A viruses are further classified, based on the viral surface proteins hemagglutinin (HA or H) and neuraminidase (NA or N). Sixteen H subtypes (or serotypes) and nine N subtypes of influenza A virus have been identified.
[0037] Further variation exists; thus, specific influenza strain isolates are identified by a standard nomenclature specifying virus type, geographical location where first isolated, sequential number of isolations, year of isolation, and HA and NA subtype.
[0038] The type A viruses are the most virulent human pathogens among the three influenza types and cause the most severe disease. The serotypes that have been confirmed in humans, ordered by the number of known human pandemic deaths, are:
H1 N1 caused "Spanish flu" in 1918 and "Swine flu" in 2009.
H2N2 caused "Asian Flu".
• H3N2 caused "Hong Kong Flu".
H5N1, "avian" or "bird flu".
• H7N7 has unusual zoonotic potential.
• H1 N2 infects pigs and humans.
H9N2, H7N2, H7N3, H10N7.
[0039] Influenza B virus is mostly a human pathogen, and is less common than influenza A.
[0040] The influenza C virus infects humans and pigs and can cause severe illness and local epidemics. However, influenza C is less common than the other types and usually causes mild disease in children.
[0041] The influenza D virus is a genus that appears to be most closely related to Influenza C, from which it diverged several hundred years ago. There are at least two extant strains of this genus. The main hosts appear to be cattle, but the virus has been known to infect pigs as well.
[0042] “Coronaviruses” are a group of RNA viruses that cause diseases in mammals and birds. They cause respiratory tract infections that can range from mild to lethal. Mild illnesses in humans include some cases of the common cold (which is also caused by other viruses, predominantly rhinoviruses), while more lethal varieties can cause Severe acute respiratory syndrome (SARS), Middle East respiratory syndrome (MERS), and COVID-19. In cows and pigs, coronaviruses cause diarrhea, while in mice they cause hepatitis and encephalomyelitis.
[0043] Coronaviruses constitute the subfamily Orthocoronavirinae, in the family Coronaviridae, order Nidovirales, and realm Riboviria. They are enveloped viruses with a positive-sense single- stranded RNA genome and a nucleocapsid of helical symmetry. The genome size of coronaviruses ranges from approximately 26 to 32 kilobases, one of the largest among RNA viruses. They have characteristic club-shaped spikes that project from their surface, which in electron micrographs create an image reminiscent of the solar corona, from which their name derives.
[0044] Coronavirus disease 2019 (COVID-19) is a highly contagious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The coronaviruses responsible for COVID-19 may exist in various mutations such as the alpha, beta, gamma, delta and omicron mutations.
[0045] Middle East respiratory syndrome (MERS), also known as camel flu, is a viral respiratory infection caused by the MERS-coronavirus (MERS-CoV). Typical symptoms include fever, cough, diarrhea, and shortness of breath.
[0046] Mumps virus (MuV) is the virus that causes mumps. MuV contains a single-stranded, negative-sense genome made of ribonucleic acid (RNA).
[0047] Several highly lethal viral pathogens are members of the “Filoviridae”. Filoviruses are filament-like viruses that cause viral hemorrhagic fever and include Ebolaviruses and marburgviruses.
[0048] “Equid alphaherpesvirus 1”, formerly Equine herpesvirus 1 (EHV-1), is a virus of the family Herpesviridae that causes abortion, respiratory disease and occasionally neonatal mortality in horses. Encephalitis can occur in affected animals, leading to ataxia, paralysis, and death.
[0049] “African horse sickness (AHS)” is a highly infectious and deadly disease caused by African horse sickness virus. It commonly affects horses, mules, and donkeys. It is caused by a virus of the genus Orbivirus belonging to the family Reoviridae. This disease can be caused by any of the nine serotypes of this virus. AHS is not directly contagious but is known to be spread by insect vectors.
[0050] “West Nile virus” (WNV) is a single-stranded RNA virus that causes West Nile fever. It is a member of the family Flaviviridae, specifically from the genus Flavivirus, which also contains the Zika virus, dengue virus, and yellow fever virus. West Nile virus is primarily transmitted by mosquitoes, mostly species of Culex. In humans, West Nile virus can cause a disease known as West Nile fever. In horses the virus infection is often lethal.
[0051] Foot-and-mouth disease (FMD) or hoof-and-mouth disease (HMD) is an infectious and sometimes fatal viral disease that affects cloven-hoofed animals, including domestic and wild bovids caused by the foot-and-mouth disease virus.
[0052] “Pathogenic bacteria” are a major cause of human death and disease and cause infections such as tetanus (Clostridium tetani), typhoid fever (by Salmonella typhi), diphtheria (Corynebacterium diphtheriae), leprosy (Micobacterium leprae) and tuberculosis (mycobacterium tuberculosis).
[0053] “Pertussis” (Whooping cough) is an acute contagious and potentially epidemic bacterial infection caused by Bordetella pertussis, or less commonly, B bronchoseptica and B parapertussis, which affects children < age 5.
[0054] Bacterial diseases in farm animals include Johne's disease, mastitis, salmonella and anthrax.
[0055] “Strangles” (equine distemper) is a contagious upper respiratory tract infection of horses and other equines caused by a Gram-positive bacterium, Streptococcus equi. As a result, the lymph nodes swell, compressing the pharynx, larynx, and trachea, and can cause airway obstruction leading to death.
[0056] A “nasopharyngeal swab” (or nasopharyngeal culture) is a method for collecting a clinical test sample of nasal secretions from the back of the nose and throat. The sample is then analyzed for the presence of the pathogen.
[0057] A “oropharyngeal swab” is a method for collecting a clinical test sample of fluid from the back of the mouth. The sample is then analyzed for the presence of the pathogen.
[0058] In one embodiment the pathogen is a virus. The virus may be selected from any of the viruses mentioned above in the definitions. Especially the virus can be selected from the group consisting of influenza virus A, B, C or D, corona virus, Ebola virus, Marburg virus, mumps virus, foot and mouth disease virus, and EHV-1.
[0059] According to a particular embodiment the pathogen is SARS-CoV-2 causing Covid-19 or variants thereof such as B.1.1.7 (alpha), Cluster 5, 20A.EU1, VUI -202012/01, B.1.351 (beta), P.1 (gamma), B.1.617.2 (delta) and B.1.1.529 (omcron). In another particular embodiment, the virus is MERS-CoV causing MERS. [0060] In yet another embodiment, the virus is an influenza virus type A like for example H5N1 also called avian flu, Ebola virus, Marburg virus or SARS-CoV-2 or variants thereof like alpha, beta, gamma, delta or omicron.
[0061] In another embodiment the pathogen is a bacterium. The bacterium can be selected from the any of the bacteria mentioned above in the definitions. In one embodiment the bacterium is selected from bacteria causing pertussis, tetanus, typhoid fever, diphtheria, leprosy, tuberculosis or strangles.
[0062] In one embodiment, the test kit is measuring the presence of a pathogen in a bodily fluid from a subject such as from a nasopharyngeal or oropharyngeal swab, saliva, exhaling air, blood or urine.
[0063] By collecting the location data of test results, in particular, the positive tests, it is possible to rapidly identify infection hot spots around the world. This information can then be used to take appropriate measurements in that location to prevent or at least helpful to minimise further spread of the pathogen. It can be particularly important to have a snapshot of the situation of the pathogen to make the decision on a timely manner.
[0064] As an epidemic or pandemic is a repaid and widespread of infectious diseases threatening many lives and reducing the economic prosperity, the invention allows for taking timely measures such as closing borders and schools, ending a curfew, the momentum of the disease outbreak and its rate of decay needs to be forecasted. The invention may focus on comparably small sets of data and fast spreading diseases.
[0065] In an exemplary embodiment of the present invention, the identification of the test comprises a code pattern image, and wherein the processing unit is configured to obtain the identification by scanning the code pattern image. Further, the code pattern image may include address or location information of the predefined destination.
[0066] The code pattern can be placed at the testing unit or on the package containing the testing unit.
[0067] The code pattern image can be represented in a photographic image that contains machine-readable information such as the method of the test and the name of the pathogen as before discussed. Further, it can include the location or address of the predefined destination such as a server, e.g., in a form of an internet address or a Uniform Resource Identifier, URI, or more specifically Uniform Resource Locator, URL. This enables that the communication unit to send the data test to the server. [0068] In an exemplary embodiment of the present invention, the code pattern image is represented in a Quick Response code, QR code. The QR code is machine-readable image and simplifies the extract of the information contained therein.
[0069] In an exemplary embodiment of the present invention, the communication unit is configured to establish data communication with the predefined destination or server. The data communication can be based on any protocol that is suitable to transmit the message containing the test data. For instance, the message can be transmitted via the Internet Protocol such as via TCP or UDP protocol to the server. In case of need the message or the communication channel can be encrypted to prevent leakage of personal related data. Further, the test data may be provided in a form that the test data does not contain any personal information.
[0070] Thereby, the processing unit preferably is configured to extract the address of the predefined destination form the identification, to establish the data communication to the predefined destination via the communication unit and to transmit the generated test data to the predefined destination via the established data communication. Such configuration allows for an efficient handling and transmission of the test data.
[0071] In an exemplary embodiment of the present invention, at least one of followings that are the clock, the position determination unit, processing unit and the communication unit is embedded in an electronic device. The electronic device can be a mobile device in form of a smartphone. The mobile device can be provided with at least one of the above functions, either by a hardware component or a software module of the operating system of the mobile device. Further, the identification of the test can be also selected from the mobile device when collecting the test data.
[0072] Alternatively, the testing unit can be manufactured in an integrated apparatus that provides the above functions so that there is no additional apparatus required for collecting the test data. In this case even the code pattern image such as QR code is no longer required since the integrated apparatus allows to input or determine the kind of test. Further, the predefined destination can be entered into the apparatus, e.g., during the initiation of the apparatus. Moreover, the integrated apparatus may include the clock, the position unit, the processing unit, that can collect the test data including the required information like time and location of the test and send the test data to the predefined the destination, e.g., using a wireless or mobile data connection. Like this, it can be achieved that the system according to the present invention is integrated in one apparatus that tests and collects the test data as well as uploads the test data to the database. [0073] In an exemplary embodiment of the present invention, the predefined destination is a node hosting the test data. The node, e.g., a network node, can be a computer server that hosts a database for storing the test data. As indicated above, the server can be reached via a unique identifier such as internet address or URL by the system according to the present invention. The predefined destination can be configured to gather plural test data and to evaluate the gathered test data for various purposes.
[0074] Preferably, the system comprises an identification generation unit configured to generate the identification of the testing unit. Such identification generation unit allows for providing a unique identification of the testing unit or test to efficiently identify the specific test performed. Thereby, the identification generation unit can be embodied at the predefined destination or server.
[0075] Preferably, the predefined destination comprises a data evaluation unit configured to evaluate the identification of the testing unit, the time stamp, the geographic location information and the result of the test. Such evaluation unit allows for efficiently providing statistics and other evaluations to define measures to be taken.
[0076] In the second aspect, the present invention relates a non-volatile memory provided with a computer program for collecting test data indicative of a test for a pathogen. The computer program can run on an electronic device that may be in form of a smartphone and the test is provided with an identification and determines the presence of the pathogen because of the test. The computer program comprises: a clock module configured to generate a time stamp for the test, a position determination module configured to provide geographic location information of the test, a processing module configured to collect the test data including the identification, the time stamp and the geographic location information of the test, and a communication module configured to send the test data to a predefined destination.
[0077] The non-volatile memory according to the invention and its preferred embodiments described below allow for efficiently implementing the effects and benefits of the system according to the invention and its preferred embodiments.
[0078] The term “module” relates to a software module that provides the required functionality such as providing the time stamp, determining the geographic location, collecting the test data, and sending the test data to the predefined destination. The computer program may be in form of an App which can be downloaded from the internet and installed on a generic purpose device such as a smartphone.
[0079] At least one of following modules that are the clock module, the position determination module, processing module and the communication module is running on an electronic device such as a mobile device. Alternatively, the modules can be distributed in several devices, e.g. the clock is running on a testing unit whereas the remaining modules are running as the App on the mobile device.
[0080] The identification of the test comprises a code pattern image, and wherein the processing module is configured to obtain the identification by scanning the code pattern image which can be in form of a QR code.
[0081] In the third aspect, the present invention relates to a method for collecting test data indicative of a test for a pathogen in a subject. The method comprises the steps of: generating an identification of the test; performing the test indicating presence of the pathogen as a result; generating a time stamp of the test; determining geographic location information of the test; and transmitting the identification of the test, the result of the test, the time stamp and the geographic location information to a predefined destination.
[0082] The method according to the invention and its preferred embodiments described below allow for efficiently implementing the effects and benefits of the system according to the invention and its preferred embodiments as well as of the non-volatile memory according to the invention and its preferred embodiments.
[0083] Particularly, the method according to the invention can be a computer implemented method. Such computer implemented method can be embodied as computer program or software. Software can comprise one or plural applications executed on one or plural devices.
[0084] For example, the computer program or software can comprise an identification management subsystem being responsible for creation, maintenance, and distribution of unique identifications such as QR codes to manufacturers, wholesalers, and retailers. Each unique identification may contain the information of target destination such as a website endpoint together with an identifier of the test kit.
[0085] Additionally or alternatively, the computer program or software can comprise a manufacturing packaging subsystem being an external workflow that is not controlled by the identification management subsystem and specific to each manufacturer. The identification can be included inside (with the corresponding manual) or outside of the package, e.g., if wholesalers and retailers are to be targeted.
[0086] Additionally or alternatively, the computer program or software can comprise a mobile application subsystem being the only interface for the user submitting the result of the test. The user who scans the identifier with the camera of his mobile device is forwarded to the target destination, e.g., via decision website link being, e.g., a unique link such as a URL embedded in the identification or QR code. The decision website link forwards automatically the user to download the right mobile application according to the mobile operating system or by manually selecting the right operating system such as iOS or Android. The downloaded application requests the user to enter required (positive/negative test) and non-mandatory fields of information. Once submitted the information together with the information extracted from the user mobile phone (Bluetooth adapter address, GPS location etc) is sent for processing to the identification management subsystem for proper storing, e.g., according to GDPR regulations.
[0087] In connection with geography the computer program may scans the identification or QR code and verify postal or ZIP info. It may collect the data relevant to following parameters, e.g., from the National Institute of Statistics (NIS) of each country: soil such as soil or airborne insects such as water flies, sand flies and mosquitos. The computer program or software may use quantile regression forests (WRF) which may be programmed in R. The 5th, 50th, 95th quantiles can be predicted through the quantregForest R package.
[0088] In connection with population density, several scientific studies have proven that the following factors have an influence on the probability of the exposure to pathogens: living accommodation such as city versus rural area; individual house versus apartment building; level of sanitation such as developed versus non-developed; contacts with pets and animals, time spent in an area such as none, several hours, a day, a week, a month or more; economic development such as advanced, well-developed or less-developed; transportation such as individual versus intense public transportation, air transportation; identifier result; and population density such as per postal code. The population density may be the number of people per unit of area, usually quoted per square kilometer or sq. mile. These numbers may be based on Census data from National Statistics Agencies. However, to increase the accuracy, population-weighted density may be used.
[0089] The computer program or software may work with a disease quotient. Such quotient may equal the % of state population with the disease/ % of national population with the disease.
[0090] In connection with public sentiment the computer program or software may use sentiment analysis referring to the automatic detection of emotional or opinionated statements in a text statement. The complexity of Sentiment Analysis and Opinion Mining on data from social media is due to non-standard linguistics, heavy use of emotions and emojis, slang and incorrect grammar. Due to several constraints, lexicon-based approaches, i.e., corpuses may be used. Twitter Inc. offers a comprehensive search API, up to seven days back in time. The streaming API data may be used to measure the sentiment towards the disease in a local area. [0091] In connection with micro-mobility the computer program or software may take the data from local or regional telecom providers. In pandemic situations, most governments recommend their citizens to reduce contacts and stay home. To obtain mobility data, there are two options: either POI data (static data) or data from movements across time and space (dynamic data) can be involved. Advantageously, dynamic data is used. The goal is to predict the regional outbreaks for 30-60 days. The dynamic data may be used to separate latitude and longitude. A trip may be considered as a movement of a minimum time of 45 minutes between two different postal codes. By using Hawkes process, outcomes can be delivered of within region mobility and the length of pathogen transmission chains be determined over a certain area.
[0092] Preferably the method comprising a step of providing the generated identification of the test to a testing unit configured to determine the presence of the pathogen as the result of the test. Such provision of the identifier can, e.g., be implemented by printing the identifier and attaching the printed identifier to the testing unit. Like this, within the system, the testing unit and the test can be uniquely identified.
[0093] Preferably, the identification of the test comprises a code pattern image. Thereby, the code pattern image preferably is a QR code.
[0094] The identification preferably is scanned at the testing unit and the scanned identification is transmitted to the predefined destination. Such scanning and transmission allow for efficiently identifying the testing unit or test at the predefined destination. Like this, efficient evaluation of the test data at the predefined destination is possible.
[0095] Preferably the identification of the test comprises an address of the predefined destination. Such inclusion of the address allows for efficiently transmitting the test data to the predefined destination once the test has been performed.
[0096] Thereby, the method preferably comprises steps of: extracting the address of the predefined destination form the identification; establishing a data communication to the predefined destination; and transmitting the identification of the test, the result of the test, the time stamp and the geographic location information to the predefined destination the established data communication.
[0097] The pathogen may be a virus selected from the group consisting of corona virus, influenza virus, MERS virus, Ebola virus, mumps virus, foot and mouth disease virus, Marburg virus and EHV virus. [0098] In yet another particular embodiment, the virus is an influenza virus type A like for example H5N 1 also called avian flu, Ebola virus, Marburg virus or SARS-CoV-2 or variants thereof like alpha, beta, gamma, delta or omicron.
[0099] Alternatively, the pathogen may be a bacterium selected from bacteria causing pertussis, tetanus, typhoid fever, diphtheria, leprosy, tuberculosis or strangles.
[00100] The subject may be a human being, or an animal selected from the group consisting of pigs, cows, horses, dogs, cats.
[00101] Preferably, the method comprises a step of evaluating the identification of the test, the time stamp, the geographic location information, and the result of the test at the predefined destination.
[00102] The present disclosure also comprises the following embodiments:
[00103] Embodiment 1 is a system for collecting test data indicative of a test for a pathogen in a subject, which comprises a testing unit provided with an identification of the test, wherein the testing unit is configured to determine the presence of the pathogen as a result of the test; a clock configured to generate a time stamp for the test; a position determination unit configured to provide geographic location information of the test; a processing unit configured to collect the test data comprising the identification, the time stamp and the geographic location information as well as the result of the test; and a communication unit configured to transmit the test data to a predefined destination.
[00104] Embodiment 2 is the system of embodiment 1, wherein the identification of the test comprises a code pattern image, and wherein the processing unit is configured to obtain the identification by scanning the code pattern image.
[00105] Embodiment 3 is the system of embodiment 2, wherein the code pattern image is represented in a QR code.
[00106] Embodiment 4 is the system of embodiment 2 or 3, wherein the code pattern image includes location information of the predefined destination.
[00107] Embodiment 5 is the system of any one of embodiments 1 to 4, wherein the communication unit is configured to establish a data communication with the predefined destination. [00108] Embodiment 6 is the system of any one of embodiments 1 to 5, wherein at least one of followings that are the clock (30), the position determination unit (40), processing unit (50) and the communication unit (60) is embedded in an electronic device (200) such as a mobile device.
[00109] Embodiment 7 is the system of any one of embodiments 1 to 6, wherein the predefined destination is a node hosting the test data.
[00110] Embodiment 8 is the system of any one of embodiments 1 to 7, wherein the pathogen is a virus selected from the group consisting of corona virus, influenza virus, MERS virus, Ebola virus, mumps virus, foot and mouth disease virus, Marburg virus and EHV virus.
[00111] Embodiment 9 is the system of any one of embodiments 1 to 8, wherein the pathogen is a bacterium selected from bacteria causing pertussis, tetanus, typhoid fever, diphtheria, leprosy, tuberculosis or strangles.
[00112] Embodiment 10 is the system of any one of embodiments 1 to 9, wherein the subject is a human being, or an animal selected from the group consisting of pigs, cows, horses, dogs, cats.
[00113] Embodiment 11 is a non-volatile memory provided with a computer program for collecting test data indicative of a test for a pathogen, wherein the test is provided with an identification and determines the presence of the pathogen as result of the test, wherein the computer program comprises: a clock module configured to generate a time stamp for the test; a position determination module configured to provide geographic location information of the test; a processing module configured to collect the test data including the identification, the time stamp and the geographic location information as well as a result of the test; and a communication module configured to send the test data to a predefined destination.
[00114] Embodiment 12 is the non-volatile memory of embodiment 11 , wherein the identification of the test comprises a code pattern image, and wherein the processing module is configured to obtain the identification by scanning the code pattern image.
[00115] Embodiment 13 is the non-volatile memory embodiment 11 or 12, wherein at least one of followings that are the clock module, the positioning module, processing module and the communication module is running on an electronic device such as a mobile device.
[00116] Embodiment 14 is the system of embodiment 2, wherein the code pattern image is represented in a QR code.
[00117] Embodiment 15 is a method for collecting test data indicative of a test for a pathogen in a subject, comprising the steps of: providing an identification of the test; performing the test indicating the presence of the pathogen as a result; generating a time stamp of the test; determining geographic location information of the test; colleting the test data including the identification, the time stamp and the geographic location information as well as the test result of the test; and transmitting the test data to a predefined destination.
Brief Description of the Drawings
[00118] The system and the non-volatile memory with a computer program as well as the method according to the invention are described in more detail hereinbelow by way of an exemplary embodiment and with reference to the attached drawings, in which:
Fig. 1 shows an embodiment of the system according to the present invention;
Fig. 2 shows another embodiment of system according to the present invention;
Fig. 3 shows an embodiment of the test data tracking system according to the present invention; and
Fig. 4 shows another embodiment of a system according to the invention.
Description of Embodiments
[00119] In the following description certain terms are used for reasons of convenience and are not intended to limit the invention. The terms “right”, “left”, “up”, “down”, “under" and “above" refer to directions in the figures. The terminology comprises the explicitly mentioned terms as well as their derivations and terms with a similar meaning. Also, spatially relative terms, such as "beneath", "below", "lower", "above", "upper", "proximal", "distal", and the like, may be used to describe one element's or feature's relationship to another element or feature as illustrated in the figures. These spatially relative terms are intended to encompass different positions and orientations of the devices in use or operation in addition to the position and orientation shown in the figures. For example, if a device in the figures is turned over, elements described as "below" or "beneath" other elements or features would then be "above" or "over" the other elements or features. Thus, the exemplary term "below" can encompass both positions and orientations of above and below. The devices may be otherwise oriented (rotated 90 degrees or at other orientations), and the spatially relative descriptors used herein interpreted accordingly. Likewise, descriptions of movement along and around various axes include various special device positions and orientations.
[00120] To avoid repetition in the figures and the descriptions of the various aspects and illustrative embodiments, it should be understood that many features are common to many aspects and embodiments. Omission of an aspect from a description or figure does not imply that the aspect is missing from embodiments that incorporate that aspect. Instead, the aspect may have been omitted for clarity and to avoid prolix description. In this context, the following applies to the rest of this description: If, in order to clarify the drawings, a figure contains reference signs which are not explained in the directly associated part of the description, then it is referred to previous or following description sections. Further, for reason of lucidity, if in a drawing not all features of a part are provided with reference signs it is referred to other drawings showing the same part. Like numbers in two or more figures represent the same or similar elements.
[00121] Fig. 1 illustrates an embodiment of the system 1 according to the present invention, comprising an apparatus 100 including the identification 10 of the medical diagnostic test and the testing unit 20 with a test field 25 to receive the test agent of the subject. In other words, the testing unit 20 comprises a reagents or dye, with an opening where the sample is inserted. Once the sample is inserted into the opening, the reagents or the dye can show the test result, i.e. , positive or negative.
[00122] As shown identification is a QR code 10 indicating the kind of the test. The QR code can be displayed or printed on a sticker adhered adjacent to testing unit 20. The mobile device 200 comprises a camera 55 for scanning the QR code 10. After scanning the information can be extracted from the QR code. The mobile device 100 also includes a clock to time stamp the time of the test and the position determination unit 40 to receive the GPS signal for determination of the geographic location. The proceeding unit 50 of the mobile collects the information such as the time stamp, the GPS coordination, the URL, and the test name extracted from the QR code, and forwards to the communication unit 60 to the server at the URL.
[00123] In a preferred embodiment, the unique QR code 10 can be printed on the packaging of each test kit so that there are two independent components or parts of the test kit, i.e., the packaging with the QR code printed on it and the test component which is to be found in the packaging itself.
[00124] Using the components of the mobile device 200 such as the clock 30, position determination unit 40, processing unit 50 and communication unit 60, for collecting the test data provides a simplified apparatus 100. In particular, the mobile device 200 can be a smartphone that is already provided with the components that can be used for the purpose of collecting test data. An application downloaded and installed on the smartphone can manage the tasks of collecting the test data using the existing components.
[00125] Fig. 2 shows another embodiment of the system 1 according to the present invention. In comparison with the embodiment of shown in Fig. 1, the components such as the clock 30, the position determination unit 40, the processing unit 50 and the communication unit 60 are integrated in the apparatus 100, together with the testing unit 20. The embodiment of the system provides a standalone solution in an integrated apparatus 100 that can perform the medical diagnostic test with the testing unit 20 as well as collects and send the test data to the predefined destination. In this case, the identification of the medical diagnostic test does not need to be shown as a QR code for scanning with a septate mobile device 200. Instead of that, the identification of the test or the URL may be hardcoded or manually entered into the apparatus 100, prior or after the medical diagnostic test. The similar applies to the predefined destination which can be also configured during the initialisation of the apparatus 100.
[00126] In this embodiment, the integrated standalone apparatus 100 has all components required for collecting and transmitting the test data. This approach enables the test itself and collecting test data being performed with the same apparatus which is not dependent on any further device.
[00127] It is also possible to provide the system 1 only using a part of the components on the mobile device 200, e.g., the camera 55 and the communication unit 60. The other functionalities such as time and location determination are provided on the apparatus 100. In any event, the system 1 can be configured flexibly, and its components can be distributed across the apparatus 100 and the mobile device 200, depending on the need. Furthermore, the functionality of the components can be provided in hardware and/or software solution.
[00128] In this embodiment, a box containing the reagents or the dye, with an opening where the sample can be inserted. Once the sample is inserted into the opening 25, the reagents or the dye can show the test result, either positive or negative. A chip is embedded on the box of the apparatus 100 next to the opening, which reads the test result and transmits the following data via Wi-Fi connection into the server. The test data comprises a time stamp, the test result, and the geographical location. In either embodiment shown in Fig. 1 or 2, the test data is unique for each person or animal tested.
[00129] Fig. 3 illustrates an embodiment of a test data tracking system as system according to the present invention. The tracking system utilises the code pattern and provides a solution for tracking the medical diagnostic results, geo-localization of testing users, storage of results and dissemination of information including geo-localization information for internal or external usage.
[00130] The code pattern tracking system may include a code pattern management subsystem 600, a mobile application subsystem 300 and test data management subsystem 400. In particular, the code pattern management 600 creates a unique code pattern such as a QR code and distributes it to the system 1. The code pattern can include a unique identifier for the medical diagnostic test and the URL of the mobile application subsystem 300. The system 1 extracts this identification information from the code pattern, e.g., by scanning the coder pattern image. Then the system 1 collects the extracted identification information together with the other test data and sends to the mobile application subsystem 300. The URL indicating the web server may be provided like: https://www.domain.com/0qrf-fdk2-fhkk-3423-3521.
[00131] The system 1 can be provided as a manufacturing packaging subsystem for the customer who conducts the test. It is, however, not controlled by the code pattern tracking system and can be specific to each manufacture or customer depending on the need.
[00132] In particular, the mobile application subsystem 300 is the preferred interface for the user submitting the result of the medical diagnostic test. The system 1 scans the code pattern with a camera and extracts the URL of the website 310 from the code pattern. The website link automatically forwards a link to the system 1 for downloading and installing, if not yet, a mobile application according to the mobile operating system or by manually selecting the right operating system such as iOS 330 and Android 320.
[00133] After installation of the application, the user can enter required information such as positive/negative test result and fields of information to be determined. Once the information together with the information extracted from the user mobile phone is submitted, e.g., including Bluetooth adapter address, GPS location etc., it is sent for processing to the test data management subsystem 400 for proper storing according to GDPR regulations. The data gathered will be kept confidential and not shared with any third parties. Only the end user will receive the information and it will be stored on the server. Third parties do not have access to personal data, thereby avoiding data leakage. For example, the person to be tested can be identified by a third-party with the zip code of domicile or any other generic code which does not contain personal related data such as name and addresses.
[00134] It can be further determined if the website or the mobile application will send the information to the test data management subsystem 300. Furthermore, it can be determined more suitable automated way to decrease human interaction and human error. The automation of the entire process of gathering tracing data can minimise involving medical personnel entering data into the system, which can prevent human errors.
[00135] The test data management subsystem 300 can include a storage of information received from the mobile application subsystem in GDPR compliant way as discussed before. Further, it represents as preferred interface for the external users or customers to retrieve or search data based on specific criteria. The interface will be accessible via an Application Programming Interface, API, that can be used in varies application, such as by the mobile application subsystem 300 for storing test data, the customer or other external subsystem such as users and external programs that can pull information, or the management of external users including permissions and access control etc. [00136] The test data management subsystem 400 can interface, either manually or automatically, to the code pattern management subsystem 600 for importing valid codes that have been submitted to the manufacture.
[00137] The customer external subsystem 500 can represent the customer to the service and information as a product. The customer represented as machine/user is accessing the test data management system via API as M2M, Machine to machine, interface for retrieval of information as XML/JSON file format based on search criteria query sent to the test data management system.
[00138] Fig. 4 shows another embodiment of a system 1 according to the invention implementing an embodiment of a method according to the invention. The system comprises a main administration and evaluation center 800 (AEC) as predefined destination and several test centers 700. Each test center 700 manages several testing apparatus 100 with testing units by means of a test center computing environment 710. The AEC 800 runs a server computing environment 810 which is in data communication with the test center computing environments 710 via the Internet.
[00139] In a preparation step, each of the test centers 700 is registered in the server computing environment 810 of the AEC 800. Then the AEC 800 generates identifiers in the form of QR codes for each of the test apparatus 100 of each test center 700 and transmits the QR codes to the respective test center 700 via the data communication. At the test centers 700, the QR codes are printed and attached to the test apparatus.
[00140] Now the test apparatus 100 are used in the test centers 700, the QR code is scanned and gathered by the test center computing environment 710. In particular, the test center computing environments 710 generate test data for each used test apparatus.
[00141] The test data comprise the identification of the test data from the QR code, a time stamp generated by a clock of the test center computing environment 710, a test center I D as geographic location information and the result of the test obtained by the test apparatus 100. The test data are transmitted by the test center computing environments 710 to the server computing environment 810 of the AEC 800.
[00142] At the server computing environment 810, the test data are rapidly evaluated wherein specifically, the results at the various locations of the test centers 700 can be considered. For example, such evaluation allows for providing more or less continuous automatic information about spread of a disease. [00143] This description and the accompanying drawings that illustrate aspects and embodiments of the present invention should not be taken as limiting-the claims defining the protected invention. In other words, while the invention has been illustrated and described in detail in the drawings and foregoing description, such illustration and description are to be considered illustrative or exemplary and not restrictive. Various mechanical, compositional, structural, electrical, and operational changes may be made without departing from the spirit and scope of this description and the claims. In some instances, well-known circuits, structures, and techniques have not been shown in detail in order not to obscure the invention. Thus, it will be understood that changes and modifications may be made by those of ordinary skill within the scope and spirit of the following claims. In particular, the present invention covers further embodiments with any combination of features from different embodiments described above.
[00144] The disclosure also covers all further features shown in the Figs individually although they may not have been described in the afore or following description. Also, single alternatives of the embodiments described in the figures and the description and single alternatives of features thereof can be disclaimed from the subject matter of the invention or from disclosed subject matter. The disclosure comprises subject matter consisting of the features defined in the claims or the exemplary embodiments as well as subject matter comprising said features.

Claims

1. A system (1) for collecting test data indicative of a test for a pathogen in a subject, comprising: a testing unit (20) provided with an identification (10) of the test, wherein the testing unit (20) is configured to determine the presence of the pathogen as a result of the test, a clock (30) configured to generate a time stamp for the test, a position determination unit (40) configured to provide geographic location information of the test, a processing unit (50) configured to generate test data comprising the identification, the time stamp generated by the clock (30), the geographic location information provided by the position determining unit (40) and the result of the test obtained by the testing unit (20), and a communication unit (60) configured to transmit the generated test data to a predefined destination.
2. The system according to claim 1, wherein the identification (10) of the testing unit (20) comprises a code pattern image, and wherein the processing unit (50) is configured to obtain the identification (10) via scanning (55) the code pattern image (10).
3. The system according to claim 1 , comprising a scanning unit (55) configured to scan the identification (10) of the testing unit (20).
4. The system according to claim 2 or 3, wherein the code pattern image is a QR code.
5. The system according to any one of the preceding claims, wherein the identification (10) of the testing unit (20) comprises an address of the predefined destination.
6. The system according to any one of preceding claims, wherein the communication unit (60) is configured to establish data communication to the predefined destination.
7. The system according to claim 5 and 6, wherein the processing unit (50) is configured to extract the address of the predefined destination form the identification (10), to establish the data communication to the predefined destination via the communication unit (60) and to transmit the generated test data to the predefined destination via the established data communication.
8. The system according to any one of preceding claims, wherein at least one of followings that are the clock (30), the position determination unit (40), processing unit (50) and the communication unit (60) is embedded in an electronic device (200) such as a mobile device.
9. The system according to any one of preceding claims, wherein the predefined destination is a node hosting the test data.
10. The system according to any one of preceding claims, wherein the pathogen is a virus selected from corona virus, influenza virus such as influenza virus type A H5N1, MERS virus, Ebola virus, mumps virus, foot and mouth disease virus, Marburg virus, EHV virus, or SARS-CoV-2 or variants thereof like alpha, beta, gamma, delta, or omicron.
11. The system according to any of the claims 1 to 9, wherein the pathogen is a bacterium selected from bacteria causing pertussis, tetanus, typhoid fever, diphtheria, leprosy, tuberculosis or strangles.
12. The system according to any one of preceding claims, wherein the subject is a human being, or an animal selected from the group consisting of pigs, cows, horses, dogs, cats.
13. The system according to any one of the preceding claims, comprising an identification generation unit configured to generate the identification (10) of the testing unit.
14. The system of any one of the preceding claims, wherein the predefined destination comprises a data evaluation unit configured to evaluate the identification of the testing unit (20), the time stamp, the geographic location information and the result of the test.
15. A non-volatile memory provided with a computer program for collecting test data indicative of a test for a pathogen, wherein the test is provided with an identification and determines the presence of the pathogen as result of the test, wherein the computer program comprises: a clock module configured to generate a time stamp for the test, a position determination module configured to provide geographic location information of the test, a processing module configured to collect the test data including the identification, the time stamp, and the geographic location information as well as a result of the test, and a communication module configured to send the test data to a predefined destination.
16. The non-volatile memory according to claim 15, wherein the identification of the test comprises a code pattern image, and wherein the processing module is configured to obtain the identification by scanning the code pattern image.
17. The non-volatile memory according to claim 15 or 16, wherein at least one of followings that are the clock module, the positioning module, processing module and the communication module is running on an electronic device such as a mobile device.
18. A method for collecting test data indicative of a test for a pathogen in a subject, comprising the steps of: generating an identification of the test, performing the test indicating presence of the pathogen as a result, generating a time stamp of the test, determining geographic location information of the test, and transmitting the identification of the test, the result of the test, the time stamp, and the geographic location information to a predefined destination.
19. The method according to claim 18, comprising a step of providing the generated identification of the test to a testing unit (20) configured to determine the presence of the pathogen as the result of the test.
20. The method according to claim 18 or 19, wherein the identification (10) of the test comprises a code pattern image.
21. The method according to claim 20, wherein the code pattern image is a QR code.
22. The method according to any one of claims 19 to 21, wherein the identification (10) is scanned at the testing unit (20) and the scanned identification is transmitted to the predefined destination.
23. The method according to any one of claims 18 to 22, wherein the identification (10) of the test comprises an address of the predefined destination.
24. The method according to claim 23, comprising steps of extracting the address of the predefined destination form the identification (10), establishing a data communication to the predefined destination, and transmitting the identification of the test, the result of the test, the time stamp and the geographic location information to the predefined destination the established data communication.
25. The method according to any one of claims 18 to 24, wherein the pathogen is a virus selected from corona virus, influenza virus such as influenza virus type A H5N1, MERS virus, Ebola virus, mumps virus, foot and mouth disease virus, Marburg virus, EHV virus, or SARS-CoV-2 or variants thereof like alpha, beta, gamma, delta or omicron.
26. The method according to any one of claims 18 to 24, wherein the pathogen is a bacterium selected from bacteria causing pertussis, tetanus, typhoid fever, diphtheria, leprosy, tuberculosis or strangles.
27. The method according to any one of claims 18 to 26, wherein the subject is a human being, or an animal selected from the group consisting of pigs, cows, horses, dogs, cats.
28. The method according to any one of claims 18 to 27, comprising a step of evaluating the identification of the test, the time stamp, the geographic location information and the result of the test at the predefined destination.
EP22700019.7A 2021-01-07 2022-01-07 A system, a non-volatile memory and a method for collecting test data relating to a pathogen Pending EP4275216A1 (en)

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