Analytical method for determining at least one characteristic of a sample of body fluid - Patents.com

Abstract

An analytical system and method for determining at least one characteristic of at least one sample of bodily fluid is disclosed. The method includes using at least one first mobile device (112) and at least one second mobile device (114), each of which includes at least one camera (116) and at least one processor (118). Prior to applying the sample of bodily fluid to a reagent testing area (122), at least one first image is acquired by the first mobile device (112). The first image is stored in a database (128) along with a time stamp and at least one first identifying information. The second mobile device (114) acquires at least one second image and determines at least one characteristic of the sample by using the information of the first mobile device (112) stored in the database (128).

Description

[Technical Field]

[0001] The present invention relates to analytical methods, particularly in vitro analytical methods, for determining at least one characteristic of at least one sample of bodily fluid, a method for operating a first mobile device, and a method for operating a second mobile device. Furthermore, the present invention relates to a first mobile device, a second mobile device, an analytical system including the first mobile device and the second mobile device, as well as a computer program and a computer-readable storage medium for carrying out the methods. These methods and devices may be used in medical diagnostics, particularly for quantitatively or qualitatively detecting one or more characteristics of a sample of bodily fluid. As an example, these methods and devices may be used to detect the presence of SARS-CoV-2 coronavirus in a sample of bodily fluid. However, other fields of application of the present invention are also feasible. [Background technology]

[0002] In the field of medical diagnostics, samples of bodily fluids, such as saliva, blood, interstitial fluid, urine, or other types of bodily fluids, must often be analyzed to detect, for example, the presence and / or concentration of an analyte in the bodily fluid sample. Examples of analytes to be detected include viruses, such as the SARS-CoV-2 coronavirus. However, the present invention may also be used with other types of analytes, such as glucose, triglycerides, lactate, cholesterol, or other types of analytes typically present in these bodily fluids. Without narrowing its scope, the present invention may be specifically described with respect to the detection of the SARS-CoV-2 coronavirus.

[0003] Generally, devices and methods known to those skilled in the art utilize test elements containing one or more test chemicals capable of performing one or more detectable detection reactions, such as optically detectable detection reactions, in the presence of an analyte to be detected. As an example, International Publication No. 2022 / 049440 discloses an apparatus including a mobile computing device physically coupled to a light box. The apparatus includes camera hardware configured to capture image data relating to an output signal region of a biological chromatographic test strip inserted into a receiving slot of the light box. The apparatus further includes processing circuitry in communication with the camera hardware, the processing circuitry configured to determine the concentration of the analyte of interest in a test sample presented via the biological chromatographic test strip based on the image data captured by the camera hardware. The apparatus further includes an interface in communication with the processing circuitry, the interface configured to output data representing the concentration of the analyte of interest determined by the processing circuitry.

[0004] U.S. Patent Application Publication No. 2021 / 0241456 discloses a system and method for analyzing a visible chemical reaction. In one embodiment, the method can include receiving, from an image sensor coupled to a mobile communication device, an image of a reagent pad proximate a colored surface having at least one pair of colored reference elements. The method includes identifying the reagent pad, a first colored reference element, and a second colored reference element in the image. Thereafter, the method includes using the first colored reference element and the second colored reference element to determine the extent of the chemical reaction on the reagent pad independent of local lighting conditions. The method then includes providing, by the mobile communication device, data based on the extent of the chemical reaction.

[0005] U.S. Patent No. 1,106,0968 discloses a method including receiving a sample of interest to be chemically analyzed in a microfluidic device that is part of an assay card. The microfluidic device includes at least one input layer configured to receive the sample of interest, at least one intermediate layer, and at least one readout layer configured to present one or more color attributes in one or more readout regions in response to one or more colorimetric responses to the sample of interest. An image of the readout layer of the microfluidic device is acquired. A calibration file corresponding to the assay card is acquired. The calibration file includes a calibrated model of at least one color attribute based on data from at least one known chemical attribute of at least one standard sample processed by the calibration card. A data processing function is performed on the acquired image by comparing the one or more color attributes in the one or more readout regions with the calibrated model of the at least one color attribute to determine at least one chemical attribute of the sample of interest.

[0006] WO 2020 / 123858 describes techniques and apparatus for capturing images of a person's retinal fundus, identifying the person, accessing various electronic records (including health records) or accounts or devices associated with the person, determining the person's predisposition to certain diseases, and / or diagnosing the person's health problems. Some embodiments provide an imaging apparatus having one or more imaging devices for capturing one or more images of the person's eyes. The imaging apparatus described herein may include electronics for analyzing and / or exchanging the captured images and / or health data with other devices. Alternatively or additionally, according to various embodiments, the imaging apparatus described herein may be configured for biometric authentication and / or health status determination technologies.

[0007] International Publication No. WO 2021 / 138477 describes methods and techniques for determining changes in one or more skin conditions of a user over time. Changes in skin condition over time may be used to aid a physician in diagnosis and / or treatment. Furthermore, changes in skin condition over time may also be used in computer-implemented methods for providing diagnostic and / or treatment advice. In some examples, calibration techniques and methods achieve improved image quality. In these examples, improvements in image accuracy and quality are achieved by addressing, among other issues, issues associated with unpredictable and inconsistent lighting conditions. In one example, a system includes a mobile computing device and an object (e.g., a control) with known lighting and / or color attributes. Such an object serves as a calibration device for images captured by the mobile computing device.

[0008] U.S. Patent Application Publication No. 2021 / 0073681 discloses a method, apparatus, system, and computer-readable medium for identifying and executing one or more interactive condition assessment tests and collecting and analyzing user behavior data to generate an output. In some examples, user information may be received and one or more interactive condition assessment tests may be identified. Instructions may be sent to and executed on a user's computing device to enable functionality of one or more sensors that may be used in the identified tests. When a test is initiated, data may be collected from one or more sensors. The collected sensor data may be sent to a system and processed using one or more machine learning datasets. Additionally, user behavior data may be collected and processed using one or more machine learning datasets. The sensor data, user behavior data, and other data may be used in combination to generate an output.

[0009] Various testing systems for testing samples for the presence or concentration of viruses are widely known. Various lateral flow (LF) tests that detect viral antigens are commercially available for point-of-care (POC) testing or other situations where rapid results are desired. For example, in the case of SARS-CoV-2, LF tests that detect nucleocapsid antigens are widely used, but spike antigens can also be detected. However, a test that detects viral nucleic acid, also known as the "SHERLOCK" test, has also been proposed as a lateral flow test (see, for example, WO 2021 / 228839 and the references cited therein). Furthermore, instead of blood tests, saliva has been proposed as a suitable sample material for detecting SARS-CoV-2 (Wyllie et al. (2020), medRxiv 2020.04.16.20067835; doi.org / 10.1101 / 2020.04.16.20067835). B. Ince and M.K. Sezginturk provide an overview of current challenges and accessible solutions in the detection of infectious agents and diseases by lateral flow assays (LFAs), focusing on the improvement of sensitivity with different detection methods, in "Lateral flow assays for virus diagnosis: Up-to-date technology and future prospects," 2022, TrAC Trends in Analytical Chemistry, Volume 157, 116725. Furthermore, the sensitivity of SARS-CoV-2 antigen rapid diagnostic tests (Ag RDTs) is evaluated in "Comparative sensitivity evaluation for 122 CE-marked rapid diagnostic tests for SARS-CoV-2 antigen, Germany, September 2020 to April 2021," H. Scheiblauer et al., Eurosurveillance, 26, 2100441 (2021).

[0010] U.S. Patent Application Publication No. 2020 / 0225166 discloses a reagent test paddle including a contamination detection medium, a reference color bar, at least one chemical test medium, and a unique identifier. The contamination detection medium includes a reagent that changes color in the presence of or upon exposure to an unfavorable or harsh environment. Each chemical test medium includes a reagent that reacts to a respective analyte in a biological sample. The reference color bar includes reference color samples of various colors. A unique identifier, such as a serial number, identifies a particular paddle and its chemical test medium and allows it to be uniquely and anonymously associated with a user. One method includes automatically capturing and interpreting digital images of a biologically unexposed reagent test paddle and a subsequent exposed reagent test paddle in a calibrated environment at various delay times, locating the paddle in the multiple digital images, extracting a reference color bar in each digital image, and locating the contamination detection medium and the chemical test medium. Color changes in the chemical test medium and the contaminated medium are detected at various delay times after sample exposure. To determine the validity of the test results, the method further compares the detected color of the contamination detection medium with predetermined colors expected in the absence and presence of contamination.

[0011] U.S. Patent No. 10,928,325 describes a system that generates nutritional advice based on the results of a home urine test. A user applies a urine sample to a card containing multiple tests and can use a phone to capture an image of the card. An analysis system running on the phone or in the cloud can analyze the image and determine the test results. The test card and analysis system can compensate for variations in lighting conditions and exposure time to the urine sample. Based on the test results, the system can recommend the intake of specific amounts of nutrients, such as vitamins, minerals, and foods. It can also recommend water or electrolyte intake based on measured hydration, or stress reduction techniques or sleep based on measured cortisol. Recommendations can be customized based on factors such as the user's characteristics (gender, weight, etc.), predicted nutrient absorption from foods or nutritional supplements, and the user's dietary preferences or restrictions.

[0012] Generally, when one or more mobile devices such as smartphones are used as diagnostic devices for evaluating optically detectable detection reactions using optical test elements, the entire physical measurement sequence, i.e., the measurement sequence not involving cloud-supported computations, etc., may be performed from start to finish on the very same mobile device. For safety reasons, e.g., to ensure valid, unused, and functional test elements and / or appropriate environmental conditions, the standard measurement procedure for many optical test elements may include a first initial scan before applying the sample, a second scan after applying the sample, and a predetermined waiting or reaction time between the first and second scans.

[0013] However, despite the advantages achieved by known methods and devices, several technical challenges remain. For example, in COVID-19 testing centers or other point-of-care settings, mobile device-based measurements may be performed not by individual patients or customers, but by one or more dedicated personnel using one or more mobile devices. In these settings, multiple tests may be performed in parallel, particularly due to typical waiting times. Therefore, performing the entire physical measurement sequence using one identical mobile device requires strict organizational allocation of testing and performing staff. This is generally prone to error and reduces the overall throughput of measurements performed. Summary of the Invention

[0014] Therefore, it is desirable to provide a method and a device that at least partially addresses the above-mentioned technical problems. Specifically, a method and a device should be proposed that allows for an easy-to-use and robust analytical method for determining at least one characteristic of at least one sample of a body fluid. More specifically, a method and a device should be proposed that allows for a high-throughput, for example, 50 or more tests per day, high-volume testing situations, particularly in one or more testing centers, while still being safe and with a low error rate.

[0015] This problem is addressed by an analytical method for determining at least one property of at least one sample of body fluid, a method for operating a first mobile device, a method for operating a second mobile device, a first mobile device and a second mobile device, an analytical system including the first mobile device and the second mobile device, as well as a computer program and a computer-readable storage medium for carrying out said method, comprising the features of the independent claims. Advantageous embodiments, which may be realized alone or in any combination, are listed in the dependent claims and in the specification as a whole.

[0016] When used below, the terms "having," "comprising," or "including," or any grammatical variants thereof, are used in a non-exclusive manner. Thus, these terms may refer both to a situation in which, besides the features introduced by these terms, no further features are present in the entity described in this context, and to a situation in which one or more further features are present. As an example, the expressions "A has B," "A comprises B," and "A includes B" may refer both to a situation in which no other elements are present in A besides B (i.e., a situation in which A consists exclusively of B), and to a situation in which, besides B, one or more further elements are present in entity A, such as element C, elements C and D, or even further elements.

[0017] Furthermore, it should be noted that the terms "at least one" or "one or more," or similar expressions, indicating that a feature or element may be present more than once, are typically used only once when introducing each feature or element. In the following, in most cases, when referring to each feature or element, the expressions "at least one" or "one or more" will not be repeated, despite the fact that each feature or element may be present more than once.

[0018] Furthermore, when used hereinafter, the terms "preferably," "more preferably," "particularly," "even more particularly," "particularly," "more particularly," or similar terms are used in conjunction with optional features without limiting the possibilities for substitution. Features introduced by these terms are therefore optional features and are not intended to limit the scope of the claims in any way. The present invention may be implemented by using alternative features, as would be understood by one skilled in the art. Similarly, features introduced by "in an embodiment of the invention" or similar phrases are intended to be optional features without any limitations regarding alternative embodiments of the invention, without any limitations regarding the scope of the invention, and without any limitations regarding the possibility of combining a feature introduced in this manner with other optional or non-optional features of the invention.

[0019] In a first aspect of the present invention, an analytical method, in particular an in vitro analytical method, is disclosed for determining at least one characteristic of at least one sample of a body fluid, in particular for detecting at least one analyte in the body fluid.

[0020] As used herein, the term "analytical method" is a broad term and should be given its common and ordinary meaning to those skilled in the art, without being limited to a specific or special meaning. This term may specifically refer to, but is not limited to, the quantitative and / or qualitative determination of at least one property of a sample of bodily fluid, such as at least one of a physical, chemical, and biological property. The determination of at least one property may specifically include the quantitative or qualitative detection of at least one analyte in the sample of bodily fluid. The result of the analytical method may be, for example, at least one piece of information regarding at least one property of the sample, such as at least one piece of information regarding the presence or absence of the analyte of interest. Alternatively, or in addition, the result of the analytical method may include at least one piece of information representing the concentration of the at least one analyte of interest. The analyte may be or may include at least one arbitrary, specific, and / or predetermined chemical or biological substance or species, such as at least one molecule or at least one chemical and / or biological compound. For example, the analyte may be or may include at least one specific virus and / or a portion thereof. The result of the analytical method may be or may include at least one piece of information indicating the presence or absence of a virus or a portion thereof in a sample of bodily fluid. For example, the analyte may be a compound involved in metabolism, such as one or more of glucose, lactate, cholesterol, or triglycerides. In this example, the analytical method may be a blood glucose measurement, and therefore the result of the analytical method may be, for example, a blood glucose concentration. Additionally or alternatively, other types of analytes or parameters, such as, for example, a pH value, may also be determined. As will be understood by those skilled in the art, the "presence" of an analyte may refer, for example, to the analyte being present in an amount above the detection limit of the test used.

[0021] As used herein, the term "in vitro" is a broad term and should be given its common and ordinary meaning to those skilled in the art, and should not be limited to a specific or particular meaning. This term may specifically, but not exclusively, refer to methods that use components of a living organism and are performed at least partially isolated from the normal biological environment of the components of the organism. For example, an in vitro analytical method may involve using a sample of bodily fluid isolated from a user or patient, specifically using the sample of bodily fluid in at least one optical test element, as outlined in more detail below.

[0022] The analytical method may specifically relate to a method for detecting RNA viruses in a sample of bodily fluid. This method may specifically include the steps of releasing viral RNA from the sample, amplifying at least a portion of the viral RNA contained in the sample, and contacting the amplified viral RNA with at least one detection reagent, such as at least one detection reagent containing at least one nuclease, such as in the Sherlock test described herein above. As an example, the analytical method may include binding a viral antigen to an antibody, which may contain a detectable label, such as gold particles, a dye, or the like. As another example, the analytical method may include performing a lateral flow test, suitable methods of which are known in the art.

[0023] As used herein, the term "characteristic" is a broad term and should be given its common and ordinary meaning to those skilled in the art and should not be limited to a specific or special meaning. This term may specifically, but not exclusively, refer to at least one piece of information representative of a state or characteristic of a sample of bodily fluid. The characteristic may be an inherent property of the sample and thus may be determined, for example, in a measurement using an analytical method. The characteristic may specifically be an optically detectable characteristic, such as a property of the sample of bodily fluid that causes an optically detectable detection reaction. For example, the at least one characteristic of the sample may include at least one of the presence of at least one predetermined analyte in the bodily fluid and the concentration of at least one predetermined analyte in the bodily fluid.For example, the sample characteristics may include the presence of at least one predetermined type of virus in the sample, specifically the presence of at least one predetermined type of RNA virus, more specifically the presence of SARS-CoV-2 coronavirus and / or the presence of influenza virus A and / or the presence of influenza virus B; the concentration of at least one predetermined type of virus in the sample, specifically the concentration of at least one predetermined type of RNA virus, more specifically the concentration of SARS-CoV-2 coronavirus and / or the concentration of influenza virus A and / or the concentration of influenza virus B; the presence of at least one predetermined type of antibody in the sample, specifically at least one antibody against at least one RNA virus. The presence of one predetermined type of antibody, more particularly the presence of at least one antibody against SARS-CoV-2 coronavirus and / or the presence of at least one antibody against influenza virus A and / or the presence of at least one antibody against influenza virus B; the concentration of at least one predetermined type of antibody in the sample, particularly the concentration of at least one predetermined type of antibody against at least one RNA virus, more particularly the concentration of at least one antibody against SARS-CoV-2 coronavirus and / or the concentration of at least one antibody against influenza virus A and / or the concentration of at least one antibody against influenza virus B.

[0024] As used herein, the term "body fluid sample" is a broad term and should be given its common and ordinary meaning to those skilled in the art and should not be limited to a specific or special meaning. This term may specifically, but not exclusively, refer to any aliquot or portion of a biological fluid, whether directly a body fluid or derived from a body fluid by one or more pre-processing steps, such as transferring the body fluid to at least one collection fluid, diluting the body fluid, centrifuging the body fluid, etc. The body fluid may include one or more of saliva, blood, interstitial fluid, urine, or other types of body fluid. The body fluid sample may be collected by at least one nasopharyngeal swab, or by at least one swab of the anterior nares, such as by applying a cotton swab to the surface of the anterior nares and / or throat, or may be collected from saliva. The collected body fluid sample may be transferred to at least a collection or reagent liquid by immersing the cotton swab in the collection or reagent liquid. The collection or reagent liquid may specifically include a lysis reagent. Alternatively or additionally, the sample of bodily fluid may be a drop of bodily fluid collected from the human body, such as a drop of saliva and / or blood and / or interstitial fluid. The sample of bodily fluid may specifically include at least one preparation of the bodily fluid, such as a cellular preparation of the bodily fluid, e.g., a cellular staining preparation of the bodily fluid. The sample of bodily fluid may also be simply referred to as a sample or a test sample.

[0025] The method includes using at least one first mobile device and at least one second mobile device, each of the mobile devices comprising at least one camera and at least one processor. As used herein, the term "mobile device" is a broad term and should be given its common and ordinary meaning to those skilled in the art, and should not be limited to a specific or special meaning. The term may specifically refer to, but is not limited to, portable electronic devices, more specifically portable communication devices such as mobile phones and / or smartphones. Additionally or alternatively, the mobile device may refer to a notebook, tablet computer, or other type of portable computer having at least one camera. Thus, generally, the first and second mobile devices may be independently selected from the group consisting of a mobile phone having at least one camera, specifically a smartphone, and / or a portable computer having at least one camera, specifically a notebook and / or a tablet computer. The terms "first" and "second" used in the context of the first and second mobile devices are used for naming purposes only and do not impose any rank or order on these items. Specifically, it may be possible to use one, two, or even more first and / or second mobile devices. The first and second mobile devices may be embodied with similar or identical configurations, or may be embodied differently from each other. The first and second mobile devices may be non-identical. As used herein, the term "non-identical" may refer to the fact that the first and second mobile devices may be two different entities or devices. However, the non-identical nature of the first and second mobile devices does not preclude similar implementations or configurations of both devices.In particular, the first mobile device and the second mobile device may be embodied with similar or identical configurations, e.g., having similar or identical features and / or functionality, even if they are non-identical, e.g., two different devices or entities. However, different embodiments of non-identical first and second mobile devices may also be possible, e.g., where the first and second mobile devices are different entities with different configurations.

[0026] As used herein, the term "camera" is a broad term and should be given its common and ordinary meaning to those skilled in the art and should not be limited to any specific or special meaning. The term may specifically, but not exclusively, refer to an apparatus having at least one imaging element configured to record or capture spatially resolved one-, two-, or three-dimensional optical data or information. As an example, a camera may include at least one camera chip, such as at least one CCD chip and / or at least one CMOS chip, configured to record an image. As used herein, but not exclusively, the term "image" may specifically relate to data recorded using a camera, such as a plurality of electronic readings from an imaging device, such as the pixels of a camera chip.

[0027] In addition to at least one camera chip or imaging chip, the camera may also include one or more optical elements, such as one or more lenses. For example, the camera may be a fixed-focus camera with at least one lens that is fixedly adjusted relative to the camera. Alternatively, however, the camera may include one or more variable lenses that may be automatically or manually adjusted. The present invention is particularly applicable to cameras commonly used in mobile applications, such as notebook computers, tablets, or mobile phones, particularly smartphones. Thus, in particular, the camera may be part of a mobile device that includes one or more data processing devices, such as one or more data processors, in addition to at least one camera. However, other cameras are also possible.

[0028] The camera may be a color camera. Therefore, for example, each pixel may provide or generate color information, such as three color values ​​(R, G, and B). A larger number of color values, such as four color values ​​(R, G, G, and B), is also possible. Color cameras are well known to those skilled in the art. Thus, for example, each pixel of a camera chip may have three or more different color sensors, such as one pixel for red (R), one pixel for green (G), and one pixel for blue (B). For each pixel (R, G, B, etc.), a value corresponding to the intensity of each color may be recorded by the pixel, such as a digital value ranging from 0 to 255. Instead of using three colors (R, G, B), for example, four colors (R, G, G, B or C, M, Y, K) may be used. The color sensitivity of a pixel may be generated by a color filter or by the appropriate inherent sensitivity of the sensor element used in the camera pixel. These techniques are well known to those skilled in the art.

[0029] As used herein, the term "processor" is a broad term and should be given its common and ordinary meaning to those skilled in the art and should not be limited to any specific or special meaning. The term may specifically, but not exclusively, refer to any logic circuitry configured to perform the basic operations of a computer or system, and / or generally to a device configured to perform calculations or logical operations. In particular, a processor may be configured to process the basic instructions that run a computer or system. By way of example, a processor may include at least one arithmetic logic unit (ALU), at least one floating-point unit (FPU), such as a math coprocessor or numeric coprocessor, multiple registers, specifically registers configured to provide operands to the ALU and store calculation results, and memory, such as L1 and L2 cache memories. In particular, a processor may be a multi-core processor. In particular, a processor may be or comprise a central processing unit (CPU). Additionally or alternatively, the processor may be or comprise a microprocessor, and thus, in particular, elements of the processor may be included on one single integrated circuit (IC) chip. Additionally or alternatively, the processor may be or comprise one or more chips, such as one or more application-specific integrated circuits (ASICs) and / or one or more field-programmable gate arrays (FPGAs) and / or one or more tensor processing units (TPUs) and / or dedicated machine learning optimization chips, etc. The processor may be specifically configured, such as by software programming, to perform one or more evaluation operations as described in more detail below.

[0030] The method further includes using at least one optical test element, the optical test element comprising at least one reagent test area and at least one unique identifier associated with the optical test element.

[0031] As used herein, the term "optical test element" is a broad term and should be given its common and ordinary meaning to those skilled in the art and should not be limited to a specific or special meaning. This term may specifically refer to any element or device configured to perform an optical detection reaction, such as, but not limited to, a color change detection reaction and / or a reaction in which one or more optically detectable features become visible on or within the test element, such as, for example, a linear marking known from a rapid COVID test. The optical test element may be embodied, for example, as a test stick or test element. The optical test element may have, among other things, at least one reagent test area containing at least one test chemical sensitive to a property of the sample, e.g., to detect at least one analyte. The optical test element may, by way of example, comprise one or more application sites for applying at least one sample. The application sites may be different from the location of the at least one reagent test area and may be fluidly connected to the reagent test area by, for example, one or more capillary elements, e.g., one or more porous elements capable of transporting liquids. The optical test element may, for example, comprise at least one substrate, such as at least one carrier, to which at least one reagent test area is applied or incorporated. The optical test element may, in particular, comprise at least one control area located adjacent to the reagent test area, for example, surrounding or encircling the reagent test area and / or positioned behind the reagent test area in the direction of flow of the bodily fluid sample on the optical test element. The control area may be a separate field independently disposed on the substrate or carrier. The control area may be configured to indicate that the bodily fluid sample has been correctly applied to the optical test element. The carrier may, for example, be strip-shaped, thereby making the optical test element a test strip. These test strips are commonly used and available. A test strip may carry a single reagent test area or multiple reagent test areas with the same or different test chemistries.Additionally or alternatively, the optical test element may be embodied as a stick or chip and may have a housing in which the substrate described above is disposed, e.g., a housing having one or more application openings for applying a sample and one or more detection windows for allowing optical detection of at least one detection reaction.

[0032] The optical test element may be a digital test element for digitally detecting the presence or absence of at least one predetermined analyte in a sample. Thus, the optical test element may be a test element capable of providing "positive" information when the at least one predetermined analyte is determined to be present in the sample and "negative" information when the at least one predetermined analyte is determined to be absent in the sample. The optical test element may be configured such that at least one optically detectable property of the at least one feature changes when the analyte is detected in the sample, whereas at least one optically detectable property of the at least one feature may remain unchanged when the analyte is not detected in the sample. As an example, the optical test element may be a SARS-CoV-2 rapid antigen test, specifically a SARS-CoV-2 and Influenza A / B rapid antigen test.

[0033] As used herein, the term "reagent test area" is a broad term and should be given its common and ordinary meaning to those skilled in the art and should not be limited to a specific or special meaning. This term may specifically refer to, but is not limited to, an aggregated test chemical or a field having one or more layers of material, such as a circular, polygonal, or rectangular field, with at least one layer containing the test chemical. Other layers may be present to provide specific optical properties, such as reflectivity, diffusivity for diffusing the sample, or separation properties, such as for separating particulate components of the sample, such as cellular components. A sample of bodily fluid may be applied directly to the reagent test area, such as in a blood glucose test, where a drop of blood may be applied directly to a test strip comprising a reagent test area, or may be applied indirectly to the reagent test area, such as by applying the sample to a reservoir or application site of an optical test element, where the sample of bodily fluid may flow from a reservoir at the application site of the optical test element to the reagent test area, for example, by capillary forces acting on the sample of bodily fluid.

[0034] As used herein, the term “unique identifier” is a broad term and should be given its common and ordinary meaning to those skilled in the art and should not be limited to a specific or special meaning. The term may specifically, but not exclusively, refer to an element or combination of elements configured to store one or more pieces of identification information identifying the optical inspection element, for example, in a readable format, particularly in a machine-readable format. The unique identifier may include at least one of an optical identifier, an electronic identifier, a magnetic identifier, or a mechanical identifier. By way of example, the unique identifier, specifically an optical identifier, may be or comprise at least one of a one-dimensional or two-dimensional code and / or a readable information tag, such as one or more of a barcode, a QR code, or another type of code, directly or indirectly attached to and / or integrated with the optical inspection element, for example, by being applied directly to the optical inspection element and / or by being attached to the optical inspection element via at least one label or tag. The identification information stored in the unique identifier may be obtained using an appropriate reading device, such as using a camera of the first and / or second mobile device. Additionally, the unique identifier may be configured to assess the validity of the assigned optical inspection element, for example by enabling verification of the expiration date, manufacturer, and / or whether the optical inspection element has already been used or registered.

[0035] The method includes, by way of example, the following steps, which may be performed in a given order. However, it should be noted that a different order is generally possible. Furthermore, it may be possible to perform one or more of the method steps once or repeatedly. Furthermore, two or more method steps may be performed simultaneously or overlapping in time. The method may include additional method steps not listed.

[0036] The method further includes using at least one database, specifically at least one cloud-based database. As used herein, the term "database" is a broad term and should be given its common and ordinary meaning to those skilled in the art and should not be limited to any specific or special meaning. Specifically, the term may refer, but is not limited to, to an organized collection of data, typically stored and electronically accessed by a computer or computer system. A database may comprise or be constituted by a data storage device. A database may comprise at least one database management system comprising software running on a computer or computer system, the software enabling interaction with one or more users, applications, or the database itself, for example, to retrieve and analyze data contained in the database. A database management system may further include facilities for managing the database. Thus, a database containing data may be constituted by a database system that contains, in addition to the data, one or more related information and / or one or more related applications. A database may specifically be a cloud-based database. The cloud-based database may have data storage independent of the first and second mobile devices and may be accessible via at least one data connection, particularly a wireless data connection.

[0037] The method comprises: i. acquiring at least one first image including at least a portion of the unique identifier by using a camera of a first mobile device before applying a sample of the bodily fluid to a reagent test area of ​​the optical test element; ii. storing in a database at least one time stamp and at least one first identification information derived from the unique identifier in the first image for the at least one optical inspection element; iii. acquiring at least one second image using a camera of a second mobile device, the second image including at least a portion of the at least one unique identifier and at least a portion of the reagent test area of ​​the optical test element to which the sample of bodily fluid has been applied; iv. verifying, by using the database, whether the unique identifiers in the first image and the second image are identical, and whether at least a predetermined minimum waiting time has elapsed since the point in time determined by the time stamp; Including, Based on the result of the verification, the method - discontinuing further evaluation of the optical inspection element if the unique identifiers in the first and second images are not identical; - interrupting further evaluation of the optical inspection element in question if a predetermined minimum waiting time has not yet elapsed from the point in time determined by the time stamp; - discontinuing further evaluation of the optical inspection element in question after at least a predetermined maximum waiting time has elapsed from the point in time determined by the time stamp; - determining at least one characteristic of the sample by using at least a second image of the optical inspection element in question; and performing an action selected from a group of actions including:

[0038] As used herein, the term “capturing at least one image” is a broad term and should be given its common and ordinary meaning to those skilled in the art and should not be limited to a specific or special meaning. This term may specifically refer, without limitation, to one or more of imaging, recording an image, acquiring an image, or capturing an image. The term “capturing at least one image” may include capturing a single image and / or multiple images, such as a series of images. For example, image capture may include continuously recording a series of images, such as a video or movie. The capture of at least one image may be initiated by a user action or may be initiated automatically, such as when the presence of at least one object is automatically detected within the camera's field of view and / or within a predetermined sector of the field of view. These automatic image capture techniques are known in the field of automated barcode readers, for example, from automated barcode reading apps. Image capture may be performed, for example, by capturing a stream or “live stream” of images by a camera, with one or more of the images being stored and used as at least one first image or at least one second image, respectively, automatically or through user interaction, such as pressing a button. Acquisition of the images may be assisted by a processor of the first and / or second mobile device, and storage of the images may occur in data storage of the first and / or second mobile device. Alternatively or additionally, the captured images may be transferred in whole or in part to a cloud-based system, and storage of the images may occur in whole or in part in data storage of the cloud-based system.

[0039] As used herein, the term "first image" is a broad term and should be given its common and ordinary meaning to one of ordinary skill in the art, and should not be limited to a specific or special meaning. This term may specifically, but not exclusively, refer to an image of the optical test element as defined above without a sample of bodily fluid being applied to the reagent test area. Specifically, the first image may be at least one image of a new optical test element and / or an unused optical test element. The first image includes at least a portion of the unique identifier, specifically, at least a portion of the unique identifier sufficient to derive one or more pieces of identification information that identify the optical test element from the unique identifier.

[0040] As used herein, the term "time stamp" is a broad term and should be given its common and ordinary meaning to one of ordinary skill in the art and should not be limited to a specific or special meaning. The term may specifically refer to any sequence or arrangement of symbols, such as, but not limited to, a sequence or arrangement of numbers and / or letters that indicate a time point. Specifically, the time stamp may indicate the start of a predetermined minimum waiting time. Specifically, the time stamp may be used as a proxy for determining when a sample of bodily fluid can be applied to the optical test element. For example, the time stamp may indicate the start of a predetermined minimum waiting time.

[0041] As used herein, the term "predetermined minimum waiting time" is a broad term and should be given its common and ordinary meaning to those skilled in the art and should not be limited to a specific or special meaning. This term may specifically, but not exclusively, refer to a time interval defining the time between the acquisition of a first image and the acquisition of a second image. The predetermined minimum waiting time may be defined prior to execution of an analytical method. The predetermined minimum waiting time may be defined to allow an optical detection reaction, such as a color change detection reaction, particularly in a reagent test area of ​​the optical test element, to progress sufficiently to be detectable. The predetermined minimum waiting time may define a minimum waiting time that must elapse to ensure that a characteristic of a sample can be reliably determined in the optical test element. The predetermined minimum waiting time may be shorter than a predetermined maximum waiting time, which is the time after which it becomes impossible to reliably determine the characteristic from the optical test element, for example, due to artifacts adversely affecting the optical detection reaction in the optical test element. The predetermined minimum waiting time may depend on the particular analyte of interest. For example, the analyte may be or may include the SARS-CoV-2 coronavirus. In this case, the predetermined minimum waiting time may be at least 15 minutes, specifically not more than 60 minutes, more specifically not more than 45 minutes, and most specifically not more than 30 minutes.

[0042] The predetermined minimum waiting time in step iv. may be any particular value within a range of 5 to 60 minutes, specifically within a range of 10 to 45 minutes, more specifically within a range of 15 to 30 minutes, most specifically 15 minutes. The predetermined minimum waiting time may begin at a time determined by a time stamp, specifically a time selected from the time of application of the bodily fluid sample to the reagent test area and the time of application of the bodily fluid sample to the reagent test area. In particular, the method may include prompting the user to apply the bodily fluid sample to the reagent test area. The time of the prompt may indicate the time of application of the bodily fluid sample to the reagent test area and / or the time of application of the bodily fluid sample to the reagent test area. Alternatively, or in addition, the user may be prompted to confirm application of the bodily fluid sample to the optical test element. The time of the user confirmation may be used as a time stamp, specifically as the starting point of the predetermined minimum waiting time. For example, the method may include prompting the user to apply the bodily fluid sample to the optical test element, specifically the reagent test area, in step ii. The application of a sample of bodily fluid to the optical test element, specifically the reagent test area, may determine the starting point of a predetermined minimum wait time.

[0043] As used herein, the term "identity information" in the context of first identity information and / or second identity information is a broad term and should be given its common and ordinary meaning to those skilled in the art and should not be limited to a specific or special meaning. Specifically, the term may refer to information such as, but not limited to, a sequence or arrangement of numbers and / or letters that encodes the identity of an individual optical inspection element. The identity information may be unique for each individual optical inspection element. Thus, each identity information may be used to identify the individual optical inspection element. For example, the identity information may include a test ID of the optical inspection element. The identity information may further include and / or be associated with at least one of the expiration date of the optical inspection element, the manufacturer of the optical inspection element, and information about whether the optical inspection element has already been used or registered.

[0044] As used herein, the term "second image" is a broad term and should be given its common and ordinary meaning to those skilled in the art and should not be limited to a specific or special meaning. This term may specifically, but not exclusively, refer to an image, as defined above, of an optical test element having a sample of bodily fluid applied to the reagent test area. Specifically, the second image may be acquired after a predetermined minimum waiting time. The second image may be acquired when an optical detection reaction, e.g., a color change detection reaction, in the optical test element, specifically in the reagent test area, has progressed sufficiently to be detectable, which may be ensured by verifying that a predetermined minimum waiting time has elapsed from a time determined by a time stamp. The second image includes at least a portion of the unique identifier and at least a portion of the reagent test area, specifically, a portion of the unique identifier sufficient to derive one or more pieces of identification information that identify the optical test element from the unique identifier and a portion of the reagent test area sufficient to evaluate the optical detection reaction.

[0045] As used herein, the term "verify" is a broad term and should be given its common and ordinary meaning to those skilled in the art and should not be limited to a specific or special meaning. Specifically, the term may refer to the process of establishing at least one piece of information regarding the truth, accuracy, or reality of at least one statement, question, or condition. Thus, the term may specifically, but not exclusively, refer to the process of confirming the identity of two or more identifiers. The verification may include comparing the unique identifiers in the first and second images, specifically comparing one or more pieces of identity information stored in the respective unique identifiers in the first and second images. The verification may include determining whether the first identity is stored in a database. If only non-identical identity information is found in the database for the second identity, the second identity may be flagged as an invalid optical inspection element, preventing further use of the optical inspection element. The result of the verification may be information indicating whether the verified unique identifiers are "identical" or "not identical." For example, if one or more pieces of identity information derived from the unique identifier in the first image can also be derived from the unique identifier in the second image, the result of the verification may be "same." For example, if one or more pieces of identity information derived from the unique identifier in the first image cannot be derived from the unique identifier in the second image, the result of the verification may be "not same."

[0046] As used herein, the term "identical" is a broad term and should be given its common and ordinary meaning to one of ordinary skill in the art, and should not be limited to a specific or special meaning. The term may specifically, but not be limited to, a situation in which the unique identifiers being compared contain one or more pieces of identifying information that are identical. Specifically, two or more unique identifiers may be assumed to be identical if one or more pieces of identifying information stored in one unique identifier can also be derived from the other unique identifier.

[0047] Alternatively, or in addition, the verification may include determining whether a predetermined minimum waiting time has elapsed since the time determined by the time stamp. For example, the verification may include comparing the time when the second image was acquired with a time determined by the elapse of a predetermined minimum waiting time starting from the time determined by the time stamp. If the predetermined minimum waiting time has elapsed and the time indicating the acquisition of the second image does not exceed a predetermined maximum waiting time from the time determined by the time stamp, the result of the verification may be information indicating that the optical inspection element is ready for evaluation. If the predetermined minimum waiting time has not yet elapsed, the result of the verification may be information indicating that the waiting time is insufficient, for example, by prompting the user of the second mobile device for the remaining waiting time until the predetermined minimum waiting time has elapsed. If the predetermined minimum waiting time has elapsed and the time indicating the acquisition of the second image exceeds the predetermined maximum waiting time from the time determined by the time stamp, the result of the verification may be information indicating that the optical inspection element is invalid. In this case, evaluation of the optical inspection element may be aborted. If the optical inspection element is ready for evaluation, e.g., because it has the same identity and a predetermined minimum waiting time has elapsed, the method may proceed with the evaluation of the optical inspection element and storing the determined characteristics in a database. In this case, the inspection ID of the optical inspection element may be assigned information indicating that the evaluation has ended, e.g., "inspection completed." This may therefore make it possible to automatically ensure proper processing of the optical inspection element and its evaluation.

[0048] Alternatively or additionally, the verification may include checking whether a predetermined maximum waiting time has not been exceeded from the time determined by the time stamp. For example, the verification may include comparing the time of acquisition of the second image with a time determined by the passage of a predetermined maximum waiting time starting from the time determined by the time stamp. If the predetermined maximum waiting time has not been exceeded from the time determined by the time stamp and the predetermined minimum waiting time has elapsed, the result of the verification may be information indicating that the optical inspection element is ready for evaluation. If the predetermined maximum waiting time has been exceeded from the time determined by the time stamp, the result of the verification may be information indicating that the optical inspection element is invalid, and evaluation of the invalid optical inspection element may be prevented.

[0049] As used herein, the term "predetermined maximum waiting time" is a broad term and should be given its common and ordinary meaning to those skilled in the art and should not be limited to a specific or special meaning. Specifically, the term may refer to, but is not limited to, a time interval defining a maximum read time of an optical test element. Specifically, the maximum waiting time may define a time interval beginning with application of a sample after which it becomes impossible to reliably determine a characteristic from the optical test element due to, for example, artifacts adversely affecting the optical detection response in the optical test element. The predetermined maximum waiting time may begin at a point defined by a time stamp. The predetermined maximum waiting time may be 1 hour, specifically 2 hours, more specifically 5 hours, more specifically 10 hours, even more specifically 24 hours, and most specifically 48 hours or more. The predetermined maximum waiting time may depend on the particular analyte of interest. For example, the analyte may be or may include the SARS-CoV-2 coronavirus. In this example, the predetermined maximum waiting time may be 60 minutes, specifically 45 minutes, or more specifically 30 minutes.

[0050] The method includes storing a time stamp and at least one first identification information for at least one optical test element in a database, as described above. The at least one first identification information is derived from a unique identifier in the first image. Furthermore, the first image acquired in step i. and / or the image acquisition settings of the camera of the first mobile device may be stored in the database. Additionally or alternatively, the database may include information regarding the status of the optical test element associated with the first identification information. For example, the database may include information regarding "test started" when, specifically, a first image is acquired, a sample of bodily fluid is applied to the optical test element, and a time stamp is saved. For example, the database may include information regarding "test completed" when, specifically, a second image is acquired, the optical test element is successfully evaluated, and corresponding characteristics of the sample are saved. For example, the database may include information regarding "test invalid" when, specifically, a predetermined maximum waiting time for acquiring the second image has elapsed or when a second image is acquired without saving "test started" information for the optical test element in the database. For example, the database may include information such as "Inspection Expired" specifically if a first image was acquired but the optical inspection element has expired.

[0051] Step ii. may include checking whether the optical inspection element has already been used, particularly before storing the time stamp and the first identity. For example, step ii. may include checking whether the first identity is already stored in a database. If the first identity is already stored in the database, the optical inspection element may be classified as in use, and the additional first image may be rejected. If the first identity is not stored in the database, the optical inspection element may be classified as unused, and the method may continue, for example, by creating a new database entry to store the time stamp and the first identity.

[0052] The method may include, in step iv., deriving at least one second identity for the at least one optical inspection element from the unique identifier in the second image. Verifying whether the unique identifiers in the first image and the second image are identical in step iv. may include verifying whether the second identity is identical to at least one of the first identity in the database.

[0053] The method may further include retrieving a time stamp and identification information for the at least one optical inspection element from a database in step iv. Specifically, using the database in step iv. may include retrieving a time stamp and identification information for the at least one optical inspection element from the database.

[0054] The method may further include repeating steps iii. and iv. if further evaluation of the optical inspection element is interrupted because the unique identifiers in the first and second images are not identical or because a predetermined minimum waiting time has not elapsed since the time stamp. The method may include providing at least one notification using the second mobile device. The notification may be one or more of a visual notification, a tactile notification, and / or an audio notification. Specifically, the method may include displaying a notification via at least one display device of the second mobile device. The notification may include prompting a user of the second mobile device to repeat execution of step iii.

[0055] The analytical method may include using a plurality of test samples and a plurality of optical test elements. Each test sample may be assigned to an optical test element. In the method: step i. may include generating a set of first images by acquiring at least one first image for each of the optical inspection elements; Step iii. may include generating a set of second images by acquiring at least one second image for each of the optical inspection elements; Step iv. may include verifying, for each second image in the set of second images, whether a unique identifier in the second image is also present in at least one first image in the set of first images.

[0056] Furthermore, the verification in step iv. may be performed individually and independently for each of the optical inspection elements.

[0057] The analytical method may include high-volume testing of multiple samples at a testing center, specifically at least one of a public testing center and a hospital testing center. As used herein, the term "high-volume testing" is a broad term and should be given its common and ordinary meaning to those skilled in the art and should not be limited to a specific or special meaning. The term may specifically, but not be limited to, multiple runs of the analytical method. High-volume testing may include performing the analytical method, specifically steps i.-iv., multiple times, specifically at least twice, more specifically at least five times, even more specifically at least 10 times, or even more frequently. As an example, high-volume testing may include performing the analytical method, specifically steps i.-iv., multiple times per day, specifically at least twice per day, more specifically at least five times per day, even more specifically at least 10 times per day, or even more frequently.

[0058] Steps i-iv may be performed at least once on a given sample from a single user or patient. Bulk testing may specifically involve performing the analytical method on multiple samples, which may be taken, for example, from multiple different users or patients. Bulk testing may specifically involve performing steps i-iv on multiple samples in parallel or at least in a time-overlapping manner.

[0059] In a further aspect of the present invention, a method of operating a first mobile device is disclosed. The method of operating a first mobile device may be used in or be part of the analysis method described above or in further detail below. The first mobile device comprises the features defined for the analysis method according to the present invention. The method includes the first mobile device performing at least steps i. and ii. of the analysis method according to the present invention, such as the analysis method according to any one of the embodiments disclosed above and / or any one of the embodiments disclosed in further detail below. The method further includes, specifically prior to step ii., the processor of the first mobile device deriving at least one first identity information for at least one optical inspection element from a unique identifier in the first image.

[0060] For definitions of terms and possible embodiments of the method of operating a first mobile device, reference is made to the description of the analysis method set out above and / or explained in more detail below.

[0061] In a further aspect of the present invention, a method of operating a second mobile device is disclosed. The method of operating a second mobile device may be used in or be part of the analysis method described above or in further detail below. The second mobile device has the characteristics defined for the analysis method according to the present invention. The method includes performing at least steps iii. and iv. of an analysis method according to the present invention, such as an analysis method according to any one of the embodiments disclosed above and / or any one of the embodiments disclosed in further detail below. The method further includes a processor of the second mobile device deriving at least one second identity information for the at least one optical inspection element from a unique identifier in the second image in step iv. The method further includes, in step iv., the processor of the second mobile device verifying whether the second identity is identical to at least one of the first identities in the database storing a plurality of first identities by using a method for operating a first mobile device according to the present invention, such as a method according to any one of the embodiments disclosed above and / or any one of the embodiments disclosed in further detail below.

[0062] For definitions of terms and possible embodiments of the method for operating a second mobile device, reference is made to the description of the analysis method set out above and / or explained in more detail below.

[0063] In a further aspect of the present invention, a computer program is disclosed comprising instructions which, when executed by a processor of a first mobile device having the features as defined in an analysis method according to the present invention, such as the analysis method according to any one of the embodiments disclosed above and / or any one of the embodiments disclosed in more detail below, cause the processor to control the first mobile device to perform a method for operating a first mobile device according to the present invention, such as the method according to any one of the embodiments disclosed above and / or any one of the embodiments disclosed in more detail below.

[0064] Similarly, a computer-readable storage medium, in particular a non-transitory storage medium, is disclosed comprising instructions which, when executed by a processor of a first mobile device having the characteristics as defined in an analysis method according to the present invention, such as the analysis method according to any one of the embodiments disclosed above and / or any one of the embodiments disclosed in more detail below, cause the processor to control the first mobile device to perform a method for operating a first mobile device according to the present invention, such as the method according to any one of the embodiments disclosed above and / or any one of the embodiments disclosed in more detail below.

[0065] As used herein, the term "computer-readable storage medium" may specifically refer to a non-transitory data storage means, such as a hardware storage medium that stores computer-executable instructions. The computer-readable storage medium may specifically be or comprise a storage medium, such as a random access memory (RAM) and / or a read-only memory (ROM).

[0066] In a further aspect of the present invention, a computer program is disclosed comprising instructions which, when executed by a processor of a second mobile device having the features as defined in an analysis method according to the present invention, such as the analysis method according to any one of the embodiments disclosed above and / or any one of the embodiments disclosed in more detail below, cause the processor to control the second mobile device to perform a method for operating a second mobile device according to the present invention, such as the method according to any one of the embodiments disclosed above and / or any one of the embodiments disclosed in more detail below.

[0067] Similarly, a computer-readable storage medium, in particular a non-transitory storage medium, is disclosed comprising instructions which, when executed by a processor of a second mobile device having the characteristics as defined in an analysis method according to the present invention, such as the analysis method according to any one of the embodiments disclosed above and / or any one of the embodiments disclosed in more detail below, cause the processor to control the second mobile device to perform a method for operating a second mobile device according to the present invention, such as the method according to any one of the embodiments disclosed above and / or any one of the embodiments disclosed in more detail below.

[0068] In a further aspect of the present invention, a first mobile device is disclosed comprising at least one camera and at least one processor, the first mobile device being configured to perform a method for operating a first mobile device according to the present invention, such as a method according to any one of the embodiments disclosed above and / or any one of the embodiments disclosed in more detail below.

[0069] For a definition of the term first mobile device and possible embodiments, reference is made to the description of the analysis method described above and / or further detailed below.

[0070] In a further aspect of the present invention, a second mobile device is disclosed comprising at least one camera and at least one processor, the second mobile device being configured to perform a method for operating a second mobile device according to the present invention, such as a method according to any one of the embodiments disclosed above and / or any one of the embodiments disclosed in more detail below.

[0071] For a definition of the term first mobile device and possible embodiments, reference is made to the description of the analysis method described above and / or further detailed below.

[0072] In a further aspect of the present invention, an analytical system is disclosed comprising at least one first mobile device, specifically at least one first mobile device according to the present invention, such as a first mobile device according to any one of the above-disclosed embodiments and / or any one of the embodiments disclosed in more detail below, and at least one second mobile device, specifically at least one second mobile device according to the present invention, such as a second mobile device according to any one of the above-disclosed embodiments and / or any one of the embodiments disclosed in more detail below. Each of the first and second mobile devices comprises at least one camera and at least one processor. The analytical system further comprises at least one optical test element, the optical test element comprising at least one reagent test area and at least one unique identifier associated with the optical test element. The analytical system further comprises at least one database, specifically at least one cloud-based database. The analytical system is configured to perform an analytical method according to the present invention, such as an analytical method according to any one of the above-disclosed embodiments and / or any one of the embodiments disclosed in more detail below.

[0073] For definitions of the term analysis system and possible embodiments, reference is made to the description of the analysis method above.

[0074] As used herein, the term "system" is a broad term and should be given its common and ordinary meaning to those skilled in the art and should not be limited to a specific or special meaning. The term may specifically, but not exclusively, refer to any set of interacting or interdependent component parts forming a whole. A system may comprise multiple components, e.g., at least two or more components. At least two components may be treated independently or may be coupled or connectable. The components of a system may interact with each other to perform at least one common function. Thus, as used herein, the term "analytical system" may refer to a system for performing at least one analytical function, specifically a system for performing at least one analytical measurement, such as at least one analytical measurement described above.

[0075] In a further aspect of the present invention, a computer program is disclosed comprising instructions which, when executed by an analytical system according to the present invention, such as an analytical system according to any one of the embodiments disclosed above and / or any one of the embodiments disclosed in more detail below, cause the analytical system to perform an analytical method according to the present invention, such as an analytical method according to any one of the embodiments disclosed above and / or any one of the embodiments disclosed in more detail below.

[0076] Similarly, a computer-readable storage medium, in particular a non-transitory storage medium, is disclosed that contains instructions which, when executed by an analytical system according to the invention, such as an analytical system according to any one of the embodiments disclosed above and / or any one of the embodiments disclosed in more detail below, cause the analytical system to perform an analytical method according to the invention, such as an analytical method according to any one of the embodiments disclosed above and / or any one of the embodiments disclosed in more detail below.

[0077] The method and device according to the present invention may offer a number of advantages over known methods and devices. In particular, the use of the method and device according to the present invention makes it possible to avoid a strict organizational allocation of optical test elements to be analyzed and performing staff. Allocation may be avoided by using two different mobile devices for the evaluation of the optical test elements. Furthermore, the two mobile devices provide more flexibility in the evaluation of the optical test elements, which may reduce handling errors and increase the overall throughput of the measurement.

[0078] Specifically, the analytical method may be implemented in a photo app on a mobile device such as a smartphone. For an optical test element, e.g., a lateral flow test assay such as that used in a rapid antigen test for detecting SARS-CoV-2 coronavirus, first and second images may be captured using the mobile device's camera. Optically detectable changes within the reagent test area, such as the appearance of a graphic element (e.g., a bar, dot, or other geometric element) or the formation of a specific color in the reagent test area, may determine the presence or absence of an analyte and / or its concentration value. For example, in the context of SARS-CoV-2 coronavirus testing, such as at a large-scale public testing center, each individual optical test element may have at least one unique identifier that can be scanned with a photo app and uploaded to a cloud-based database to confirm validity by checking, for example, the expiration date, manufacturer, and / or whether the optical test element has already been used or registered. The first image, particularly providing an initial or blank scan, and the second image, particularly providing a final scan after a specific reaction time, may be acquired using different mobile devices, particularly different smartphones, and the validity information required for the second image may be retrieved from a cloud-based database.

[0079] In summary, without excluding further embodiments, the following embodiments can be envisaged:

[0080] Embodiment 1: An analytical method, in particular an in vitro analytical method, for determining at least one characteristic of at least one sample of a body fluid, in particular for detecting at least one analyte in said body fluid, comprising: The method includes using at least one first mobile device and at least one second mobile device, each of the mobile devices comprising at least one camera and at least one processor, the method further includes using at least one optical test element, the optical test element comprising at least one reagent test area and at least one unique identifier associated with the optical test element, the method further includes using at least one database, in particular at least one cloud-based database, the method including: i. acquiring at least one first image including at least a portion of the unique identifier by using a camera of a first mobile device before applying a sample of the bodily fluid to a reagent test area of ​​the optical test element; ii. storing in a database at least one time stamp and at least one first identification information derived from the unique identifier in the first image for the at least one optical inspection element; iii. acquiring at least one second image using a camera of a second mobile device, the second image including at least a portion of the at least one unique identifier and at least a portion of the reagent test area of ​​the optical test element to which the sample of bodily fluid has been applied; iv. verifying, by using the database, whether the unique identifiers in the first image and the second image are identical, and whether at least a predetermined minimum waiting time has elapsed since the point in time determined by the time stamp; Including, Based on the result of the verification, the method - discontinuing further evaluation of the optical inspection element if the unique identifiers in the first and second images are not identical; - interrupting further evaluation of the optical inspection element in question if a predetermined minimum waiting time has not yet elapsed from the point in time determined by the time stamp; - discontinuing further evaluation of the optical inspection element in question after at least a predetermined maximum waiting time has elapsed from the point in time determined by the time stamp; - determining at least one characteristic of the sample by using at least a second image of the optical inspection element in question; The method of analysis further includes performing an action selected from a group of actions including:

[0081] Embodiment 2: The analytical method of embodiment 1, wherein the predetermined minimum waiting time in step iv. is any particular value in the range of 5 minutes to 60 minutes, specifically in the range of 10 minutes to 45 minutes, more specifically in the range of 15 minutes to 30 minutes, most specifically 15 minutes.

[0082] Embodiment 3: The method includes, in step iv., deriving at least one second identity information for the at least one optical inspection element from a unique identifier in the second image; 3. The analysis method of claim 1 or 2, wherein verifying whether the unique identifiers in the first image and the second image are identical includes verifying whether the second identity is identical to at least one of the first identities in the database.

[0083] Embodiment 4: The analytical method of embodiment 3, wherein the database is a cloud-based database.

[0084] Embodiment 5: The analytical method includes using a plurality of test samples and a plurality of optical test elements, each test sample being assigned to an optical test element; - step i. includes generating a set of first images by acquiring at least one first image for each of the optical inspection elements; step iii. includes generating a set of second images by acquiring at least one second image for each of the optical inspection elements; step iv. includes verifying, for each second image of the set of second images, whether a unique identifier in that second image is also present in at least one first image of the set of first images; The analysis method according to any one of embodiments 1 to 4.

[0085] Embodiment 6: The analytical method of embodiment 5, wherein the verification in step iv. is performed individually and independently for each of the optical inspection elements.

[0086] Embodiment 7: The analytical method of any one of embodiments 1 to 6, wherein the at least one characteristic of the sample includes at least one of the presence of at least one predetermined analyte in the bodily fluid and the concentration of at least one predetermined analyte in the bodily fluid.

[0087] Embodiment 8: The characteristics of the sample include the presence of at least one predetermined type of virus in the sample, in particular the presence of at least one predetermined type of RNA virus, more particularly the presence of SARS-CoV-2 coronavirus and / or the presence of influenza virus A and / or the presence of influenza virus B; the concentration of at least one predetermined type of virus in the sample, in particular the concentration of at least one predetermined type of RNA virus, more particularly the concentration of SARS-CoV-2 coronavirus and / or the concentration of influenza virus A and / or the concentration of influenza virus B; the presence of at least one predetermined type of antibody in the sample, in particular the concentration of at least one predetermined type of antibody against at least one RNA virus. The analytical method according to any one of embodiments 1 to 7, wherein the assay result is selected from the group consisting of: presence of antibodies, more particularly the presence of at least one antibody against SARS-CoV-2 coronavirus and / or the presence of at least one antibody against influenza virus A and / or the presence of at least one antibody against influenza virus B; concentration of at least one predetermined type of antibody in the sample, particularly the concentration of at least one predetermined type of antibody against at least one RNA virus, more particularly the concentration of at least one antibody against SARS-CoV-2 coronavirus and / or the concentration of at least one antibody against influenza virus A and / or the concentration of at least one antibody against influenza virus B.

[0088] Embodiment 9: An analytical method described in any one of embodiments 1 to 8, wherein the optical test element is a digital test element for digitally detecting the presence of at least one predetermined analyte, and the optical test element is configured to change at least one optically detectable property of the at least one feature when the analyte is detected in the sample.

[0089] Embodiment 10: The analytical method of any one of embodiments 1 to 9, wherein the method comprises testing a large number of samples in a testing center, particularly at least one of a public testing center and an in-hospital testing center.

[0090] Embodiment 11: The analytical method of any one of embodiments 1 to 10, wherein the predetermined minimum waiting time begins at a time determined by a time stamp, specifically a time selected from the time of application of the sample of bodily fluid to the reagent test area and the time of application of the sample of bodily fluid to the reagent test area.

[0091] Embodiment 12: The analysis method according to any one of embodiments 1 to 11, wherein the first mobile device and the second mobile device are not identical.

[0092] Embodiment 13: An analytical method described in any one of embodiments 1 to 12, wherein in step iv., the method includes specifically using a database to obtain time stamps and identification information for at least one optical inspection element from the database.

[0093] Embodiment 14: An analytical method according to any one of claims 1 to 13, wherein step ii comprises checking whether the optical inspection element has already been used, in particular before storing the time stamp and the first identity information.

[0094] Embodiment 15: An analysis method described in any one of claims 1 to 14, further comprising repeating steps iii. and iv. if further evaluation of the optical inspection element in question is interrupted because the unique identifiers in the first and second images are not identical or because a predetermined minimum waiting time has not elapsed from the point in time determined by the time stamp.

[0095] Embodiment 16: The analysis method of claim 15, further comprising providing at least one notification using a second mobile device, in particular displaying at least one notification via at least one display device of the second mobile device, wherein the notification includes prompting a user of the second mobile device to repeat execution of step iii.

[0096] Embodiment 17: A method of operating a first mobile device having the features described in embodiment 1, the method comprising performing at least steps i. and ii. of the method described in any one of embodiments 1 to 16 on the first mobile device, and the method further comprising, particularly before step ii., deriving, by a processor of the first mobile device, at least one first identity information relating to at least one optical inspection element from a unique identifier in the first image.

[0097] Embodiment 18: A method of operating a second mobile device having the features described in embodiment 1, the method comprising performing at least steps iii. and iv. of the method described in any one of embodiments 1 to 16, the method further comprising, by a processor of the second mobile device, deriving at least one second identity information for at least one optical inspection element from a unique identifier in the second image in step iv., the method further comprising, by the processor of the second mobile device, verifying in step iv. whether the second identity information is identical to at least one of the first identity information in a database storing a plurality of first identity information by using the method described in embodiment 17.

[0098] Embodiment 19: A computer program comprising instructions, which when executed by a processor of a first mobile device having the features described in embodiment 1, cause the processor to control the first mobile device to perform the method described in embodiment 17.

[0099] Embodiment 20: A computer-readable storage medium, in particular a non-transitory storage medium, containing instructions which, when executed by a processor of a first mobile device having the features described in embodiment 1, cause the processor to control the first mobile device to perform the method described in embodiment 17.

[0100] Embodiment 21: A computer program comprising instructions, which when executed by a processor of a second mobile device having the features described in embodiment 1, cause the processor to control the second mobile device to perform the method described in embodiment 18.

[0101] Embodiment 22: A computer-readable storage medium, in particular a non-transitory storage medium, containing instructions which, when executed by a processor of a second mobile device having the features described in embodiment 1, cause the processor to control the second mobile device to perform the method described in embodiment 18.

[0102] Embodiment 23: A first mobile device comprising at least one camera and at least one processor and configured to perform the method described in embodiment 17.

[0103] Embodiment 24: A second mobile device comprising at least one camera and at least one processor and configured to perform the method of embodiment 18.

[0104] Embodiment 25: An analysis system comprising at least one first mobile device, in particular at least one first mobile device as described in embodiment 23, and at least one second mobile device, in particular at least one second mobile device as described in embodiment 24, wherein each of the first and second mobile devices comprises at least one camera and at least one processor, the analysis system further comprising at least one optical test element, the optical test element comprising at least one reagent test area and at least one unique identifier associated with the optical test element, the analysis system further comprising at least one database, in particular at least one cloud-based database, the analysis system being configured to perform the analysis method as described in any one of embodiments 1 to 16.

[0105] Embodiment 26: A computer program comprising instructions, which when executed by an analytical system described in embodiment 25, cause the analytical system to perform the analytical method described in any one of embodiments 1 to 16.

[0106] Embodiment 27: A computer-readable storage medium, in particular a non-transitory storage medium, containing instructions which, when executed by the analytical system of embodiment 25, cause the analytical system to perform the analytical method of any one of embodiments 1 to 16. [Brief explanation of the drawings]

[0107] Further optional features and embodiments are disclosed in more detail in the subsequent description of the embodiments, preferably in conjunction with the dependent claims. Each optional feature therein may be realized in an independent manner as well as in any possible combination, as will be understood by those skilled in the art. The scope of the present invention is not limited by the preferred embodiments. The embodiments are illustrated diagrammatically in the figures, where identical reference numerals in these figures refer to identical or functionally equivalent elements.

[0108] [Figure 1] 1 illustrates an embodiment of an analytical system comprising at least one first mobile device and at least one second mobile device. [Figure 2] 1 shows a flow chart of one embodiment of an analytical method for determining at least one characteristic of at least one sample of bodily fluid. [Figure 3] 1 shows a flowchart of an embodiment of a method of operating a first mobile device and a method of operating a second mobile device. DETAILED DESCRIPTION OF THE INVENTION

[0109] 1 illustrates an exemplary embodiment of an analysis system 110 including at least one first mobile device 112 and at least one second mobile device 114. Each of the first mobile device 112 and the second mobile device 114 includes at least one camera 116 and at least one processor 118. As can be seen in FIG. 1, the first mobile device 112 and the second mobile device 114 are not necessarily the same entity, and may be non-identical, specifically two different mobile device entities. The analysis system 110 may include the first mobile device 112 configured to perform a method for operating the first mobile device 112 according to the present invention, such as the method according to the exemplary embodiment shown in FIG. 3 and / or any other embodiment disclosed herein. The analysis system 110 may specifically include a second mobile device 114 configured to perform a method for operating a second mobile device 114 according to the present invention, such as a method according to the exemplary embodiment shown in FIG. 3 and / or a method according to any other embodiment disclosed herein.

[0110] The analytical system 110 further includes at least one optical test element 120, which includes at least one reagent test area 122 and at least one unique identifier 124 associated with the optical test element 120. In the example of FIG. 1, the optical test element 120 may be at least one lateral flow test assay 126, such as one used in a rapid antigen test for detecting the SARS-CoV-2 coronavirus. Thus, in this example, the characteristic of the sample determined by the analytical system 110 may be the presence of at least one predetermined type of RNA virus, specifically the presence of the SARS-CoV-2 coronavirus. The optical test element 120 may specifically be a digital test element for digitally detecting the presence of the SARS-CoV-2 coronavirus. The optical test element 120 may be configured to change at least one optically detectable property of at least one feature when the SARS-CoV-2 coronavirus is detected in the sample.

[0111] The analysis system 110 further includes at least one database 128. The database 128 may specifically be a cloud-based database 130. As shown in Figure 1, the first mobile device 112 and the second mobile device 114 may be configured to exchange information with the database 128, for example, by storing information in and / or retrieving information from the database 128.

[0112] The analytical system 110 is configured to perform an analytical method according to the present invention, such as an analytical method according to the exemplary embodiment shown in Figure 2 and / or according to other embodiments of analytical methods disclosed herein. Accordingly, reference is made to the description of Figure 2 for a description of the analytical method.

[0113] 2 shows a flow chart of a first exemplary embodiment of an analytical method for determining at least one characteristic of at least one sample of bodily fluid. Specifically, the analytical method may be configured to detect at least one analyte in the bodily fluid, such as, for example, to detect the presence of SARS-CoV-2 coronavirus in the sample of bodily fluid.

[0114] The method includes using at least one first mobile device 112 and at least one second mobile device 114, as exemplarily shown in Figure 1. Each of these mobile devices 112, 114 includes at least one camera 116 and at least one processor 118. The method further includes using at least one optical inspection element 120, the optical inspection element 120 including at least one reagent inspection area 122 and at least one unique identifier 124 associated with the optical inspection element 120. The method further includes using at least one database 128, specifically at least one cloud-based database 130.

[0115] The method includes, by way of example, the following steps, which may be performed in a given order. However, it should be noted that a different order is generally possible. Furthermore, it may be possible to perform one or more of the method steps once or repeatedly. Furthermore, two or more of the method steps may be performed simultaneously or overlapping in time. The method may include additional method steps not listed.

[0116] The method comprises: i. acquiring at least one first image (indicated by reference numeral 132) including at least a portion of the unique identifier 124 by using the camera 116 of the first mobile device 112 before applying a sample of the bodily fluid to the reagent test area 122 of the optical test element 120; ii. storing in a database (indicated by reference numeral 134) at least one time stamp and at least one first identification information derived from the unique identifier in the first image for the at least one optical inspection element; iii. acquiring at least one second image (indicated by reference numeral 136) using the camera 116 of the second mobile device 114, the second image including at least a portion of the at least one unique identifier 124 and at least a portion of the reagent test area 122 of the optical test element 120 to which the sample of bodily fluid has been applied; iv. verifying, by using the database 128, whether the unique identifiers 124 in the first image and in the second image are identical, and verifying whether at least a predetermined minimum waiting time has elapsed since the point in time determined by the time stamp (indicated by reference numeral 138); Including, Based on the result of the verification, the method - if the unique identifier 124 in the first and second images is not identical, interrupting further evaluation of the optical inspection element 120 in question (indicated by reference numeral 140); - interrupting further evaluation of the optical inspection element 120 in question if a predetermined minimum waiting time has not yet elapsed from the point in time determined by the time stamp (indicated by reference number 140); - interrupting further evaluation of the optical inspection element 120 in question (indicated by reference number 140) if at least a predetermined maximum waiting time has elapsed since the point in time determined by the time stamp; - determining at least one characteristic of the sample by using at least a second image of the corresponding optical inspection element 120 (indicated by reference number 142); and performing an action selected from a group of actions including:

[0117] Specifically, the analysis method may include using multiple test samples and multiple optical inspection elements 120, with each test sample assigned to an optical inspection element 120. In this example, step i. may include generating a first set of images by acquiring at least one first image for each of the optical inspection elements 120. step iii. may include generating a second set of images by acquiring at least one second image for each of the optical inspection elements 120. step iv. may include verifying, for each second image in the second set of images, whether the unique identifier 124 in the corresponding second image is also present in at least one first image in the first set of images. Specifically, the verification in step iv. may be performed individually and independently for each optical inspection element 120.

[0118] 3 shows a flowchart of an example embodiment of a method for operating a first mobile device 112 and a method for operating a second mobile device 114. Specifically, the flowchart of FIG. 3 shows a flowchart of a combination of an embodiment of a method for operating a first mobile device 112 (indicated by reference numeral 144) and a method for operating a second mobile device 114 (indicated by reference numeral 146). The first mobile device 112 and the second mobile device 114 may each be embodied as shown in FIG. 1. Therefore, for a description of the first mobile device 112 and the second mobile device 114, reference is made to the description of FIG. 1.

[0119] 3, the method of operating the first mobile device 112 may begin by initiating a measurement sequence (indicated by reference numeral 148). The method of operating the first mobile device 112 includes the first mobile device 112 performing at least step i. of an analysis method according to the present invention, such as the analysis method according to the exemplary embodiment shown in FIG. 2 and / or any other embodiment disclosed herein, i.e., acquiring at least one first image using the camera 116 of the first mobile device 112 (indicated by reference numeral 150). The method further includes the processor 118 of the first mobile device 112 deriving at least one first identification information for the at least one optical inspection element 120 from the unique identifier 124 in the first image (indicated by reference numeral 152). Deriving the first identity information may further include validating the optical test element 120 based on the derived first identity information, such as by verifying one or more of the optical test element 120's expiration date, manufacturer, and whether the optical test element 120 has already been used or registered. If this validation reveals an invalid optical test element 120, the processor 118 of the first mobile device 112 may abort the method (indicated by reference numeral 154). If the optical test element 120 is confirmed to be valid, the method may continue by registering the optical test element 120 (indicated by reference numeral 156). The method further includes performing step ii., i.e., storing a time stamp and at least one first identity information in at least one database 128 (indicated by reference numeral 158), specifically, storing a time point determining the start of a predetermined minimum waiting time for the analytical method. For example, the time stamp may indicate the time of application of a sample of bodily fluid to the reagent test area 122. Specifically, the information stored in database 128 may include at least the first identity information and at least one time stamp, such as a time point that determines the start of a predetermined minimum waiting period.Additionally, the first image captured in step i. and / or the image capture settings of the camera 116 of the first mobile device 112 may be stored in the database 128 .

[0120] 3, the method of operating the second mobile device 114 includes performing step iii. of the analysis method according to the present invention, such as the analysis method according to the exemplary embodiment shown in FIG. 2 and / or any other embodiment disclosed herein, i.e., acquiring at least one second image using the camera 116 of the second mobile device 114 (indicated by reference numeral 160). Furthermore, the method of operating the second mobile device 114 includes performing step iv. of the analysis method according to the present invention, such as the analysis method according to the exemplary embodiment shown in FIG. 2 and / or any other embodiment disclosed herein, i.e., verifying whether the unique identifiers 124 in the first image and the second image are identical (indicated by reference numeral 162). The method includes, in step iv., the processor 118 of the second mobile device 114 deriving at least one second identity for the at least one optical inspection element 120 from the unique identifier 124 in the second image and verifying whether the second identity is identical to at least one of the first identities in the database 128 storing a plurality of first identities by using the method of operating the first mobile device 112 as described above. If the first and second identities are not identical, the processor 118 of the second mobile device 114 may abort the method (indicated by reference numeral 154). If the first and second identities are identical, the method may further include the processor 118 of the second mobile device 114 determining whether a predetermined minimum waiting time has elapsed since the point in time determined by the time stamp, specifically, determining whether the optical inspection element 120 is ready to perform a measurement (indicated by reference numeral 164). If a predetermined minimum waiting time has not yet elapsed from the point determined by the time stamp, the processor 118 of the second mobile device 114 may interrupt the method (indicated by reference numeral 154). The interruption of the method at step 154 ​​may specifically be a temporary interruption.Specifically, the method may further include repeating steps iii and iv if further evaluation of the optical inspection element 120 is interrupted because the unique identifiers 124 in the first and second images are not identical or because a predetermined minimum waiting time has not elapsed since the time stamp. For example, the method may include providing at least one notification using the second mobile device 114, such as displaying a notification via at least one display device of the second mobile device 114. The notification may include prompting a user of the second mobile device 114 to repeat performing step iii.

[0121] If a predetermined minimum waiting time has elapsed from the time defined by the time stamp, the method may further include determining (indicated by reference numeral 166) at least one property of the sample using at least a second image of the corresponding optical inspection element 120. However, if a predetermined maximum waiting time has elapsed from the time defined by the time stamp, the method may include aborting further evaluation of the corresponding optical inspection element 120. In this case, the aborting of the method may be final, and the corresponding optical inspection element 120 may be flagged as invalid. [Explanation of symbols]

[0122] 110 Analysis System 112 First Mobile Device 114 Secondary Mobile Device 116 Camera 118 processors 120 Optical Inspection Elements 122 Reagent testing area 124 unique identifier 126 Lateral Flow Test Assays 128 databases 130 cloud-based databases 132 Get the first image 134 storing time stamp and first identification information about the optical inspection element in a database 136 Get the second image 138 Verify Unique Identifier 140 Further evaluation suspended Determine at least one characteristic of 142 samples 144 First Mobile Device Operation Method 146 Method of operation of second mobile device 148 Start of measurement sequence 150 Get the first image 152 Derive first identity information 154 Discontinuing this method 156 Registering Optical Inspection Elements 158 time stamp and first identity stored in database 160 Get the second image 162 Unique Identifier Verification 164 Determine if a predetermined minimum wait time has elapsed 166 Sample Characterization

Claims

1. 1. An analytical method for determining at least one characteristic of at least one sample of a body fluid, comprising: The method includes using at least one first mobile device (112) and at least one second mobile device (114), each of the mobile devices (112, 114) comprising at least one camera (116) and at least one processor (118), the method further includes using at least one optical inspection element (120), the optical inspection element (120) comprising at least one reagent inspection area (122) and at least one unique identifier (124) associated with the optical inspection element (120), the method further includes using at least one database (128), the method i. acquiring at least one first image including at least a portion of the unique identifier (124) by using the camera (116) of the first mobile device (112) prior to applying the sample of the bodily fluid to the reagent test area (122) of the optical test element (120); ii. storing in said database (128) at least one time stamp and at least one first identification information derived from said unique identifier (124) in said first image for said at least one optical inspection element (120); iii. acquiring at least one second image using the camera (116) of the second mobile device (114) that includes at least a portion of the at least one unique identifier (124) and at least a portion of the reagent test area (122) of the optical test element (120) to which the sample of the bodily fluid has been applied; iv. verifying whether the unique identifiers (124) in the first image and the second image are identical by using the database (128) and verifying whether at least a predetermined minimum waiting time has elapsed since the point in time determined by the time stamp; Including, Based on the result of the verification, the method if the unique identifier (124) in the first and second images is not identical, discontinue further evaluation of the optical inspection element (120); interrupting further evaluation of the optical test element (120) if the predetermined minimum waiting time has not yet elapsed from the point in time determined by the time stamp; interrupting further evaluation of the optical test element (120) if at least a predetermined maximum waiting time has elapsed from the time determined by the time stamp; determining said at least one characteristic of said sample by using at least said second image of the corresponding optical inspection element (120); The method of analysis further includes performing an action selected from a group of actions including:

2. The method includes, in step iv., deriving at least one second identity information for the at least one optical inspection element (120) from the unique identifier (124) in the second image; 2. The analysis method of claim 1, wherein verifying whether the unique identifiers (124) in the first image and the second image are identical includes verifying whether the second identity is identical to at least one of the first identities in the database (128).

3. The analytical method includes using a plurality of test samples and a plurality of optical test elements (120), each test sample being assigned to an optical test element (120); Step i. comprises generating a set of first images by acquiring at least one first image for each of said optical inspection elements (120); Step iii. comprises generating a set of second images by acquiring at least one second image for each of said optical inspection elements (120); Step iv. includes verifying, for each second image in the set of second images, whether the unique identifier (124) in that second image is also present in at least one first image in the set of first images; 3. The analytical method according to claim 1 or 2, wherein optionally, the verification in step iv. is performed individually and independently for each of the optical inspection elements (120).

4. 4. The analytical method of any one of claims 1 to 3, wherein the method comprises mass testing of multiple samples in a testing center.

5. A method of operating the first mobile device (112) comprising the features of claim 1, comprising: The method includes performing at least steps i. and ii. of the method of any one of the preceding claims relating to an analysis method on the first mobile device (112), and the method further includes deriving, by the processor (118) of the first mobile device (112), the at least one first identity information for the at least one optical inspection element (120) from the unique identifier (124) in the first image.

6. A method of operating the second mobile device (114) comprising the features of claim 1, comprising: The method includes performing at least steps iii and iv of the method according to any one of the preceding claims relating to an analysis method, the method further including deriving, by the processor (118) of the second mobile device (114), in step iv, at least one second identity information for the at least one optical inspection element (120) from the unique identifier (124) in the second image, and the method further includes verifying, by the processor (118) of the second mobile device (114), in step iv, whether the second identity information is identical to at least one of first identities in the database (128) storing a plurality of first identities by using the method according to claim 5.

7. A computer program containing instructions, 10. A computer program product comprising instructions, when executed by the processor of the first mobile device, the instructions causing the processor to control the first mobile device to perform the method of claim 5, wherein the program comprises the features of claim 1.

8. A computer-readable storage medium containing instructions, 10. A computer-readable storage medium comprising instructions, the instructions, when executed by the processor of the first mobile device, comprising the features of claim 1, that cause the processor to control the first mobile device to perform the method of claim 5.

9. A computer program containing instructions, The instructions, when executed by the processor (118) of the second mobile device (114), cause the processor (118) to: A computer program product for controlling the second mobile device (114) to perform the method of claim 6.

10. A computer-readable storage medium containing instructions, The instructions, when executed by the processor (118) of the second mobile device (114), comprise the features of claim 1. A computer-readable storage medium for controlling the second mobile device (114) to perform the method of claim 6.

11. A first mobile device (112) comprising at least one camera (116) and at least one processor (118), the first mobile device configured to perform the method of claim 5.

12. A second mobile device (114) comprising at least one camera (116) and at least one processor (118) and configured to perform the method of claim 6.

13. An analysis system (110) comprising at least one first mobile device (112) and at least one second mobile device (114), The first mobile device (112) and the second mobile device (114) each comprise at least one camera (116) and at least one processor (118), the analysis system (110) further comprises at least one optical inspection element (120), the optical inspection element (120) comprising at least one reagent inspection area (122) and at least one unique identifier (124) associated with the optical inspection element (120), the analysis system (110) further comprises at least one database (128), and the analysis system (110) is configured to perform an analysis method according to any one of the preceding claims relating to an analysis method.

14. A computer program containing instructions, 14. A computer program, the instructions of which, when executed by an analytical system (110) according to claim 13, cause the analytical system (110) to carry out an analytical method according to any one of the preceding claims relating to analytical methods.

15. A computer-readable storage medium containing instructions, 14. A computer-readable storage medium, the instructions, when executed by an analytical system (110) according to claim 13, causing the analytical system (110) to perform an analytical method according to any one of the preceding claims relating to analytical methods.

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