DE202021102008U1 - Diagnostic test device and computer program product for documenting results of the diagnostic test device - Google Patents

Abstract

Diagnostic test device, in particular a lateral flow test strip, comprising a test field (4) which displays a test result of the diagnostic test after use of the diagnostic test device, characterized in that spatially adjacent to the test field (4), on a surface section of the same surface side like the test field, a QR code (2) is applied to the diagnostic test device, the QR code (2) representing an individualized identification of the individual diagnostic test device and the spatial arrangement of the QR code (2) in relation to the test field (4) A photographic capture of the QR code (2) together with the test field (4) is permitted.

Description

The invention relates to a diagnostic test device and in particular to a diagnostic test device, for example a lateral flow test strip, which is specially designed to be able to be recorded electrically and processed further.

In connection with diseases that can spread pandemically or epidemically, it is becoming increasingly important to electronically record test results from diagnostic test devices for later evaluation.

Diagnostic test devices, e.g. in the form of antigen tests, also known as rapid tests, can be carried out mobile with little effort. Test kits are also known which can also be carried out for use by non-medically trained personnel, in particular by the test subject concerned. However, the problem arises that the evaluation of these test results, which are later to serve as evidence of a negative test result for the subject in question, cannot be stored reliably and in a forgery-proof manner.

There is therefore a need for diagnostic test devices and for computer programs for evaluating and transmitting the test results, which make it possible to record the test results in a forgery-proof manner as possible and to make them available for further processing.

The object is achieved by a diagnostic test device according to claim 1 and by a computer program product according to claims 12 and 13.

A special feature of the diagnostic test device of the present invention is that the test device enables the individual diagnostic test devices to be clearly identified and displays them in the form of a forgery-proof QR code next to the test field. According to the invention, the QR code is attached spatially adjacent to the test field in such a way that a photographic detection of the QR code together with the test field is made possible.

As a result, the test result can be recorded unaltered together with the identification of the test by simply taking a photo and transmitted electronically. For later evaluation of the test results, the test result can be called up from a central database together with the identification of the test device and preferably further data, in particular the time the test was carried out and / or the time the test result was transmitted. This makes it possible for a user to test himself for a disease by means of a self-test and to transmit the test result. The latter can be done with a conventional smart device, for example. It is particularly important that the assignment of the test result to the diagnostic test device is unambiguous in order to rule out manipulation of the transmitted test results. For example, this makes it impossible to store the same test result at different times as a valid test in the central database. This invalidates the test clearly identified by the QR code, i.e. the test device cannot be used to store a result again in the central database. This protection against forgery means that the data from the central database can not only be used for reliable statistical analysis. It is furthermore also possible that this data can be used, for example, as a type of electronic identification by the test subject concerned for presentation.

According to a preferred embodiment, the individualized QR code can be generated using a Universal Unique Identifier, UUID. A QR code can be generated by UUID, which unambiguously identifies the test device so that a test device cannot be transmitted several times at different times as a valid test result.

According to a preferred embodiment, the individualized QR code comprises encryption information that enables the identification to be decrypted on a central database. This protects the communication between the user and the central data acquisition.

According to a preferred embodiment, the encrypted identification is based on two-factor encryption, in particular on asymmetric encryption. For example, the personal key can be contained in the QR code. Any manipulation of the information in the QR code would then be detected as a forgery at the latest after it was transmitted on the recipient's side.

According to a preferred embodiment, the QR code has usage information on the diagnostic test device, in particular for using the test and / or for photographing and electronically transmitting the test result. In this embodiment, the QR code can first be scanned in order to display information on the correct application of the test and on the electronic transmission of the test result on a user device. Since different tests differ in their application, an individual test can be used for the specific test Usage description can be displayed to the user.

According to a preferred embodiment, the QR code has further information on the diagnostic test device, in particular the product name, manufacturer, REF number, serial number, LOT number, batch number, date of manufacture, expiry date, information on the effect, side effects and / or contraindications. This information may also be helpful for the user or for the recipient of the test result for an evaluation of the test result. For example, defective or expired test devices can be identified and either already displayed to the user or taken into account as possibly defective when the test results are stored in the central database.

According to a preferred embodiment, the QR code is printed directly on the surface section adjacent to the test field by means of a permanent printing process, or applied to the said surface section by applying an adhesive film, the adhesive film not being detachable from the surface section without being destroyed. As a result, the QR code is permanently connected to the specific test device, so that the test device cannot be used again at a later point in time to give an incorrect result. The code can be stuck on using an adhesive film at the manufacturer of the test device. However, an adhesive strip can also be sent, which is first stuck to a suitable but not yet individualized test device by the user.

According to a preferred embodiment, the test device further comprises one or more markings on the surface section adjacent to the test field and the QR code. The markings can be color markings which are used to evaluate the displayed test result in the test field by means of electronic image processing. This is helpful because the color rendering of the cameras used can be different. The markings can also include position markings which indicate the position of the test field for automated image recognition. The marking makes it possible to automatically recognize the test result relatively reliably from the test window by means of electronic image processing, because the position of the strips displayed in the test field is fixed in relation to the position markings.

According to a preferred embodiment, the diagnostic test comprises an antigen test for a coronavirus, in particular 2019-nCoV. Due to the pandemic spread of this virus strain, electronic recording and evaluation of the test results is particularly preferred because a large number of test results have to be collected and processed.

According to a preferred embodiment, the diagnostic test is approved for a self-test by a layperson. Conventional self-tests have so far only been used to provide the user with self-information. The design of the test device according to the invention makes it possible, however, to use the test result for forgery-proof documentation even in self-tests.

According to a preferred embodiment, the QR code is located on a template which is glued onto the diagnostic test device template. Markings as mentioned above can also be located on the template. As a result, a conventional test device can be modified into a test device according to the invention with a unique identifier. Furthermore, it can be provided that several preferably identical QR codes are also applied to the diagnostic test device with the template, with one or more QR codes being able to be separated by the user. These QR codes can remain with the user, e.g. to authenticate themselves to access the results from the central database.

According to a further aspect of the invention, a computer program product according to claim 12 is provided. The method carried out by the computer can be used by a user to document the test result of the diagnostic test device and to transmit it electronically to a central database. Since the diagnostic test device is individualized and the corresponding identification is sent, it is possible on the part of the central database to uniquely assign the transmitted data to a user of the method. If the same test result is transmitted again at a later point in time, it can be identified as a forgery because the unique identification number of the diagnostic test device is then already contained in the central database. In addition, information relating to the user of the program and in particular the time at which the image was captured can also be transmitted together with the transmitted image. This also prevents a user from transmitting a test result of a diagnostic test only with a time delay, with the intention of wanting to specify a test result that is possibly no longer up-to-date at a later point in time.

In another aspect, the present invention includes a Computer program product according to claim 13. This computer program carries out the evaluation of the transmitted test result on the part of a server and stores the test result together with the identification of the diagnostic test device. In addition, the time of acquisition and any accompanying information that was sent with the image is also recorded centrally. The time of transmission is preferably determined by the internal clock of the server. This time can therefore not be manipulated by the user. The results can be called up from this database for checking a test result. Authentication is necessary for this. This can take place, for example, in that the user himself transmits the relevant QR code or a copy of the code, whereby the user is authenticated. Furthermore, it is also possible for authorized persons or organizations to call up the test results from the central database in anonymized form or with personal data of the person who transmitted the test result.

• 1 zeigt ein Ablaufdiagramm zum Erfassung und Übermitteln eines Testergebnisses einer diagnostischen Testvorrichtung gemäß einer Ausführungsform der Erfindung.
• 2 zeigt ein Ablaufdiagramm für die Erstellung und Übermittlung eines QR-Codes für Ausführungsformen der diagnostischen Testvorrichtung.
• 3 zeigt die Aufsicht auf einen Oberflächenabschnitt einer diagnostischen Testvorrichtung gemäß einer Ausführungsform.
• 4 zeigt die perspektivische Darstellung einer Testvorrichtung gemäß einer alternative Ausführungsform vor und nach dem Durchführen eines Tests.
• 5 zeigt verschiedene Muster von Testergebnissen in einem Testfeld einer Testvorrichtung gemäß einer Ausführungsform.
• 6 zeigt ein Beispiel eines Dokuments, welches mit einem QR-Code kompatibel zu den QR-Codes gemäß den Testvorrichtungen der vorliegenden Erfindung aufweist.
• 7 zeigt eine alternative Ausführungsform einer diagnostischen Testvorrichtung mit einer Aufklebeschablone, wobei die Testvorrichtung ohne Schablone, mit aufgeklebter Schablone und mit einem abgetrennten Abschnitt der Schablone separat dargestellt sind.

Further advantages and features of the present invention will become clear from the following description of preferred embodiments, which are described in connection with the accompanying figures. The figures show the following:

• 1 shows a flowchart for acquiring and transmitting a test result of a diagnostic test device according to an embodiment of the invention.
• 2 shows a flow chart for the creation and transmission of a QR code for embodiments of the diagnostic test device.
• 3 shows the plan view of a surface section of a diagnostic test device according to an embodiment.
• 4th shows the perspective view of a test device according to an alternative embodiment before and after performing a test.
• 5 shows different patterns of test results in a test field of a test device according to an embodiment.
• 6th Fig. 10 shows an example of a document having a QR code compatible with the QR codes according to the test devices of the present invention.
• 7th shows an alternative embodiment of a diagnostic test device with an adhesive template, the test device being shown separately without a template, with an adhesive template and with a detached section of the template.

The invention relates to a system which includes a link between QR codes, database and software. The system can generate a unique QR code that is embedded in a database environment. With the help of a camera image of the unique QR code, the image of a product or other documents (e.g. a test result, implant, aids, nutritional products, medication, vaccination, laboratory data result, examination result) together with a forgery-proof time stamp, a clear link between the product / document and the Documented QR code.

By providing a document / product with the individual QR code, the document or product itself becomes an individual object. Product photos and documents can be analyzed with the help of further algorithms (e.g. automated reading of test results, text recognition using OCR). Although the data acquisition can also take place sequentially, whereby a QR code is first read and then a photo of the test is carried out, the data acquisition of the QR code together with the image of a test carried out has the advantage that the result of the test is forgery-proof that in the QR Code is assigned to the information contained in the code. For example, it is not possible to assign a QR code that identifies a specific test or a specific person to a different test result.

The invention makes use of this knowledge in that a diagnostic test device is provided which both displays the result in a test field and also contains a QR code which is arranged on the test device in such a way that it is simultaneously captured by a photographic image can be. The execution of the test at a certain point in time can therefore be documented with the test result or transmitted electronically. Furthermore, the system is forgery-proof to the extent that the same test device cannot be used multiple times for documentation with different identification numbers. This increases the security against forgery of the data obtained from the test result.

Create QR code information digitally and create database entries

Each QR code is created individually (e.g. using a Universally Unique Identifier UUID) and stored in a database. The individual identification of the QR code is created as a key that allows access to a central database. Information about the access rights (read, write) as well as information about encryption can be stored. The encryption information enables, for example, a 2-factor encryption by another key is stored in a separate database and decryption is only possible by merging the two keys. The second key can also be stored locally on a computer, smartphone or tablet, for example.

Further data on the product, document or, for example, tests can be stored in the database (e.g. product name, manufacturer, REF number, serial number, LOT number, batch number, date of manufacture, expiry date, information such as effects, side effects, contraindications and / or information on the product ). This information can be contained in the QR code. The QR code is created through encrypted access to software that automatically generates a QR code with a UUID. In addition, log files can be created that enable the reading and writing of a database to be checked. Software in the sense of a QR code generator is used to create the QR code with the communicating database.

The QR code has a UUID that refers to database entries. The database entries have certain access rights that can be defined and a definable number of data entries.

In addition to the database QR code, another, e.g. dynamic QR code, which points to a website and contains content-related data about other specific information, can be integrated into the workflow. For example, a QR code can be attached to the outer packaging of a product, which refers to an explanation of how to operate the product. At the same time, the configuration for reading in the pattern can be configured in the system (e.g. the smartphone app). After using the product, the scan itself is carried out in a preconfigured screen, e.g. with an example of the correct camera setting for performing the scan.

A workflow for performing the scan from reading the scan on the outer packaging to scanning the test result is in 1 shown.

Create a QR code

After the QR code has been created digitally, an individual QR code is produced (e.g. printed) and attached to the test device. The UUID of the QR code is the basis of the process and the creation of the printed QR code, whereby further information (e.g. website, link to a website, etc.) can also be stored. A graphic processing of the QR code (insertion of colors, motifs, logos) is possible and individually configurable. The QR code can be printed directly on the test device or, for example, printed on vignettes, paper or adhesive foils, which are then stuck onto the test device. The type of adhesion is such that it can later be removed from the test device only by destroying it.

Read and modify QR code information

During the entire process, data relating to the QR code can be imported into the database. This means that both during the creation of the QR code, but also in the further process, it is possible to store further information in the database relating to this QR code. This information can relate to the product itself (e.g. product name, etc.), but also further information in the entire workflow of the product from manufacture (place, date, personnel), packaging, delivery to use. The data can be stored in a dynamic database, which allows fields to be generated continuously depending on the amount of information added. It is also possible to store the information “test device used” to mark a digital cancellation of the test device. The "invalidation" of a QR code is therefore nothing more than the digital storage of the information "Test was used", possibly with storage of further data such as date and time. In addition, e.g. the photo of the test, date and time as well as other information (e.g. IP address) can be stored in the database assigned to the QR code.

2 shows a representation of the workflow for creating the UUID of the QR code, creating and describing the database fields, creating the QR code, reading and writing database entries.

3 shows a surface of a diagnostic test device with the QR code 2 as well as a biochemical test with a window for reading the test result, the so-called test field 4th . The QR code 2 is printed or stuck on the test (ideally with a waterproof film that will be destroyed when you try to remove it). The test field 4th is attached and aligned in a standardized manner. Position markings 6th on the surface make reading easier and color contrast fields 8th allow the differentiation of the color shade between test fields 4th and test marking 10 by an algorithm using automatic image recognition.

4th shows an alternative embodiment. The QR code 2 is applied to the test device and is the first step with the test read in and coded as scanned in the database. After the test has been carried out, the result is photographed in the second step and the test result is analyzed and referenced to the same QR code. Both scan times or just one scan time can be stored in the database. It is important that both the QR code 2 as well as the test field 4th are recorded together in a single image after a successful test.

In addition to the QR code, further information can be recognized in the photo created by a smartphone: QR code 2 , Texts on the test 12th , Test result (no line, line at A, line at B, line at A and B) in the test field 4th . The creation of the photo can be simplified by showing a sample photo or by showing the photo of the test in the background of the image. By reading the QR code and storing the test, the image recognition can recognize certain properties of the test. Attaching markers 6th , 8th Eg shapes (triangle, circle, square) to improve image recognition or to display contrast (eg black / white) are possible.

Decipher the pattern arrangement via QR code

To prevent manipulation when reading the test results, certain patterns can be created in the test result and the arrangement can be stored in the database assigned to the QR code. This means that it is only possible to read the correct result of a test, which is also entered in the database, by combining it with a QR code and pattern recognition. This can reduce the risk of manipulation. Sample variants of patterns, the order or arrangement of which is stored in the database of the assigned QR code, are shown in 5 shown. In the top two cases on the left, results A and B can only be assigned by assigning the test result using a QR code. Bottom right and top left can only be uniquely deciphered using pattern recognition and assignment to the QR code. This has the advantage that the user of the test does not yet know the test result before photographing and transferring the test field. A falsification of the test results in such a way that the user only transmits positive or negative test results according to his own preferences can thereby be prevented.

Compatible products / documents

During the entire process, data relating to the QR code can be imported into the database. This means that additional information can be stored in the database both during the creation of the QR code and later. For example, the documentation for a vaccination can be saved in the database

A document is provided for this purpose, including a QR code and text fields 12th and a documentation field 12th includes. In the documentation field 12th For example, a successful vaccination or other treatment by medical staff can be documented. The edges are marked to simplify the scanning algorithm, a contrast field (bottom right) is shown as an example for color matching or black / white matching. The document can be captured photographically in the same way as a test result and transmitted to a central database of the server.

Alternative embodiment

The combination between QR code 2 and testing device can also be done by having a medical test on a template 14th is glued on. The stencil 14th comes with one or two identical QR codes 2 fitted. A code can be given to the user of the test for documentation purposes, for later check-in or for reading into their own app. The second QR code 2 is used to allow the assignment of the test result to the QR code. Through the photo of the stencil 14th (with the QR code applied here) and the affixed test, the test result can be related to the QR code. Preferably the template is 14th so on the test device with an adhesive strip 18th stuck that one of the QR codes 2 is connected to the test device in such a way that it can no longer be removed without destroying the sticker. A QR code 2 can be along a cutting edge 16 be separated, for example, to remain with the user. The user can authenticate himself with this section in order, for example, to call up test results or other personal data from the database.

List of reference symbols

2

QR code

4th

Test window

6th

Position marking

8th

Color marking

10

Test marking

12th

Text field and / or documentation field

14th

template

16

Cutting edge

18th

Adhesive tape

Claims (15)

Diagnostic test device, in particular a lateral flow test strip, comprising a test field (4) which displays a test result of the diagnostic test after use of the diagnostic test device, characterized in that spatially adjacent to the test field (4), on a surface section of the same surface side like the test field, a QR code (2) is applied to the diagnostic test device, the QR code (2) representing an individualized identification of the individual diagnostic test device and the spatial arrangement of the QR code (2) in relation to the test field (4) A photographic capture of the QR code (2) together with the test field (4) is permitted. Diagnostic test device according to Claim 1 , whereby the individualized QR code (2) can be generated via a Universal Unique Identifier, UUID. Diagnostic test device according to one of the preceding claims, wherein the individualized QR code (2) comprises encryption information that enables the identification to be decrypted on a central database. Diagnostic test device according to Claim 3 , the encrypted identification being based on two-factor encryption, in particular on asymmetric encryption. Diagnostic test device according to one of the preceding claims, wherein the QR code (2) has usage information on the diagnostic test device, in particular for using the test and / or for photographing and electronically transmitting the test result. Diagnostic test device according to one of the preceding claims, wherein the QR code (2) has further information on the diagnostic test device, in particular product name, manufacturer, REF number, serial number, LOT number, batch number, date of manufacture, expiry date, information on the effect, side effects and / or include contraindications. Diagnostic test device according to one of the preceding claims, wherein the QR code (2) is printed by means of a permanent printing process directly on the surface section adjacent to the test field, or by applying an adhesive film to said surface section, the adhesive film not being non-destructive from the surface section is solvable. Diagnostic test device according to one of the preceding claims, wherein markings (6; 8) are attached to the surface section spatially adjacent to the test field (4) and the QR code (6), which allow an alignment of the test field and / or a color contrast for reading the Support test results in the test field for automatic image acquisition. Diagnostic test device according to one of the preceding claims, wherein the diagnostic test comprises an antigen test for a coronavirus, in particular 2019-nCoV. Diagnostic test device according to one of the preceding claims, wherein the diagnostic test is approved for a self-test by a layperson. Diagnostic test device according to one of the preceding claims, wherein the QR code (2) is located on a template which is glued onto the diagnostic test device. Computer program product which has commands which, when executed on a computer, in particular a smart device such as a smartphone or tablet computer, cause the computer to carry out the following method: Displaying a user interface which prompts the user to create and read in an image of the test field (4) and the QR code (2) of the diagnostic test device according to one of the preceding claims, after the test has been carried out, preferably with an integrated camera; electronically transferring the scanned image to a central database. Computer program product which has instructions which, when executed by a computer, preferably by a server, cause the computer to carry out the following method: reading in an image which has been electronically transmitted to the computer; Evaluation of a QR code (2) from the image to a diagnostic test device according to one of the Claims 1 to 9 to be identified and recorded in a database; Evaluating a test result (4) from the test field of the diagnostic device, which is shown on the image, by means of electronic image processing; and storing the test result together with the identification of the diagnostic test device and a current time which reflects when the image was transmitted and / or when the diagnostic test was carried out; in a central data band. Computer program product according to Claim 13 , which further comprises commands following Execution on the computer, carry out the following method steps: Providing data from the central database in response to a request, which contains the identification of the diagnostic test device in question and / or contains an identification of the user who transmitted the image to the central database. Computer program product according to Claim 12 , 13th or 14th , the electronic transmission of the image, the receipt of the request and / or the transmission of the test result with identification taking place through encrypted electronic communication.

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