Analytical method for detecting at least one analyte in a bodily fluid

Abstract

The present invention relates to a computer-implemented analytical method for detecting at least one analyte in a bodily fluid, the method comprising: iii) selecting at least one algorithm from a set of algorithms; and iv) applying the at least one algorithm to at least a part of the measurement data retrieved in step i); wherein, in step iii), at least one predetermined default algorithm from the set of algorithms is selected, wherein, by applying the default algorithm to at least a part of the measurement data in step iv), at least one preliminary item of information describing one or both of the presence of the analyte in the bodily fluid and the concentration of the analyte in the bodily fluid is generated, wherein the preliminary item of information is subjected to at least one sufficiency test, wherein the at least one sufficiency test comprises at least one test selected from the group consisting of: - checking if the preliminary item of information contains a value within at least one predetermined range; - checking if the preliminary item of information fulfills at least one plausibility condition; - checking if the preliminary item of information contains accuracy information fulfilling at least one accuracy condition; - checking if the preliminary item of information indicates that at least one geometrical feature has been detected in the analytical measurement data; - checking if an obtained estimate value determined by using the selected at least one predetermined default algorithm from the set of algorithms is within a concentration range for which the predetermined default algorithm is optimized and / or selected.

Description

[0001] Analytical method for detecting at least one analyte in a bodily fluid

[0002] Technical Field

[0003] The invention relates to a computer-implemented analytical method, an analytical device, a computer program, a computer-readable medium for detecting at least one analyte in a bodily fluid. The invention further relates to a use of the computer-implemented analytical method.

[0004] The invention specifically may be used in medical diagnostics in order to quantitatively or qualitatively detect one or more properties of a sample of a bodily fluid. As an example, the methods and devices may be used for qualitatively and / or quantitatively detecting the presence of one or more analytes in a sample of a bodily fluid, such as for detecting glucose. Additionally or alternatively, as an example, the invention may be used for detecting the presence of a virus, such as the SARS-CoV-2 coronavirus, in a sample of a bodily fluid. Other fields of application of the present invention, however, are also feasible.

[0005] Background Art

[0006] In the field of medical diagnostics, in many cases, one or more analytes have to be detected in samples of a body fluid, such as blood, interstitial fluid, urine, saliva or other types of body fluids. Examples of analytes to be detected are viruses, such as the SARS-CoV-2 coronavirus. However, the present invention may also be used for other types of analytes, such as glucose, triglycerides, lactate, cholesterol or other types of analytes, that, typically, are present in these body fluids. According to the concentration and / or the presence of the analyte, an appropriate treatment may be chosen, if necessary.

[0007] Generally, devices and methods known to the skilled person make use of test elements comprising one or more test chemicals, which, in presence of the analyte to be detected, are capable of performing one or more detectable detection reactions, such as optically detectable detection reactions. As an example, in the field of glucose detection, with regard to the test chemicals comprised in test elements, reference may be made e.g. to J. Hoenes et al.: The Technology Behind Glucose Meters: Test Strips, Diabetes Technology & Therapeutics, Volume 10, Supplement 1, 2008, S-10 to S-26. Other types of test chemistry are possible and may be used for performing the present invention.

[0008] As a further example that may be of particular interest for the resent invention, for point-of- care (POC) testing or for other situations where a quick result is desirable, a variety of lateral flow (LF) tests detecting viral antigens are commercially available. For example, in the case of SARS-CoV-2, LF tests detecting the nucleocapsid antigen are widely used, but also the spike antigen may be detected. However, also tests detecting viral nucleic acids have been proposed as lateral flow tests, cf. e.g. WO 2021 / 228839 and references cited therein, which are also referred to as "SHERLOCK" tests. Further, instead of blood tests, saliva was proposed as a suitable sample material for SARS-CoV-2 detection (Wyllie et al. (2020), medRxiv 2020.04.16.20067835; doi.org / 10.1101 / 2020.04.16.20067835). B. Ince and M. K. Sezgintiirk provide in “Lateral flow assays for viruses diagnosis: Up-to-date technology and future prospects”, 2022, TrAC Trends in Analytical Chemistry, Volume 157, 116725, an overview of current problems and accessible solutions in detecting infectious agents and diseases by lateral flow assay (LFA), focusing on increasing sensitivity with various detection methods. Further, the sensitivity of SARS-CoV-2 antigen rapid diagnostic tests (Ag RDT) was 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., Eurosur-veillance, 26, 2100441 (2021).

[0009] EP 4 083 852 Al discloses a method for detecting and quantifying viruses in samples in the form of liquid droplets and dry residues deposited on a surface, by means of the digital processing of hyperspectral images of diffuse optical reflectance obtained in the visible and near infrared ranges, wherein the method comprises the steps of extracting pixels from the samples, delimiting the contour thereof; labelling and extracting the individual spectra from each pixel of the samples and from the support surface; calculating mean spectra; aligning the spectra in previously specified ranges; calculating estimators that quantify features of the spectra, classifying each individual pixel and each sample as positive or negative based on estimator values by means of statistical classification or classification by means of artificial intelligence; and quantifying the viral load by means of interpolation of estimator values.

[0010] US 2016 / 0239766 Al discloses a method for evaluating Quality, Health, Safety, and Environment (QHSE) data that can include providing a user interface. A preferred group of analysis algorithms can be identified, automatically with the one or more processors, from a set of analysis algorithms based upon category selections. The QHSE data can be analyzed, automatically with the one or more processors, with the preferred group of analysis algorithms. Posterior testing can be performed, automatically with the one or more processors, on each of the preferred group of analysis algorithms. A validation object can be provided and can selectively provide results of the posterior testing indicative of a fit between the QHSE data and one of the preferred group of analysis algorithms.

[0011] WO 2022 / 076516 Al discloses a framework for a few-shot learning method. In a first part, self-supervision and classification supervision are used to train a feature extractor. An example self-supervision method comprises running grayscale images through an edge filter, normalizing the filtered images, setting the normalized images to ground truth, generating feature-extracted images, using a decoder to reconstruct images from the feature-extracted images, determining a loss between the reconstructed images and the ground truth images, and using the loss to update parameters of the feature extractor. In a second part, a few-shot adaptation process is performed to adapt the model to a novel rapid test kit.

[0012] US 2021 / 109088 Al discloses methods, devices and systems for detecting an analyte in a body fluid. A sample of body fluid is applied to a test element having a test field including a test material adapted to change a measurable property in the presence of the analyte. The test element includes a capillary to guide the sample across said test field. The measurable property is measured in a first measurement location providing a first measurement value, and in a second measurement location providing a second measurement value. The analyte is detected by using an evaluation algorithm having at least a first input variable including a difference between the first measurement value and the second measurement value, and at least a second input variable including information relating to an analyte-induced change of the measurable property of the test material in at least part of the test field.

[0013] EP 2 839264 Bl discloses devices and methods for performing point of care diagnostic tests for detecting and quantifying at least one analyte in a biological sample (e.g., a body fluid). Disclosed are assay cassettes and testing devices that can be used to provide rapid, accurate, affordable laboratory-quality testing at the point of care. Such assay cassettes and testing devices are designed to provide rapid, quantitative test results in a point-of-care setting or the like where, in the past, only qualitative or semi quantitative results have typically been available. Likewise, such assay cassettes and testing devices may eliminate or replace expensive, centralized clinical testing equipment and technical personnel. Such testing devices may include automated data reporting and decision support.

[0014] US 2015 / 286778 Al discloses methods for detecting an analyte concentration / presence in a body fluid sample that include providing a set of at least two different evaluation rules, each evaluation rule adapted to derive a set characteristic values from an optical measurement curve, where at least one first characteristic value is derived from at least one first evaluation rule and at least one second characteristic value is derived from at least one second evaluation rule. The methods also include performing at least one multivariate analysis of the at least one first and second characteristic values by using at least one predetermined multivariate evaluation algorithm to derive at least one estimate value for at least one target variable Y of the state variables. The methods also include determining at least one analyte concentration by using the at least one target variable Y. Also provided are computer programs and devices that incorporate the same.

[0015] As it is typical for smartphone optical diagnostic test strip measurement applications, a generic optical readout platform runs a readout algorithm to determine an analyte concentration. The readout algorithm may be based on first principles equations and / or on machine learning models. In general, the algorithm may be trained on a data set representing the desired analyte measurement range. Especially for lateral flow tests, there may be differing approaches required to get the best possible result. A challenge may particularly be that in case of low concentrations hardly any colour may be determined for the test lines but rather only ‘gray’ intensity information may represent the measured analyte. Whereas for higher concentrations, the colorization may play a stronger role. An algorithm that is optimized on colour detection may, consequently, be limited when it comes to the analyses of low concentrations.

[0016] Problem to be solved

[0017] It is therefore desirable to provide a computer-implemented analytical method, an analytical device, a computer program, a computer-readable medium for detecting at least one analyte in a bodily fluid and a use. In particular, it is an object of the present invention to enhance the reliability, accuracy, and performance of a detection of an analyte in a sample of the bodily fluid.

[0018] Summary

[0019] This problem is addressed by the computer-implemented analytical method, the analytical device, the computer program, the computer-readable medium for detecting at least one analyte in a bodily fluid and the use with the features of the independent claims. Advantageous embodiments which might be realized in an isolated fashion or in any arbitrary combinations are listed in the dependent claims as well as throughout the specification.

[0020] As used in the following, the terms “have”, “comprise” or “include” or any arbitrary grammatical variations thereof are used in a non-exclusive way. Thus, these terms may both refer to a situation in which, besides the feature 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 both refer to a situation in which, besides B, no other element is present in A (i.e. a situation in which A solely and exclusively consists 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.

[0021] Further, it shall be noted that the terms “at least one”, “one or more” or similar expressions indicating that a feature or element may be present once or more than once typically will be used only once when introducing the respective feature or element. In the following, in most cases, when referring to the respective feature or element, the expressions “at least one” or “one or more” will not be repeated, non-withstanding the fact that the respective feature or element may be present once or more than once.

[0022] Further, as used in the following, the terms "preferably", "more preferably", "particularly", "more particularly", "specifically", "more specifically" or similar terms are used in conjunction with optional features, without restricting alternative possibilities. Thus, features introduced by these terms are optional features and are not intended to restrict the scope of the claims in any way. The invention may, as the skilled person will recognize, be performed by using alternative features. Similarly, features introduced by "in an embodiment of the invention" or similar expressions are intended to be optional features, without any restriction regarding alternative embodiments of the invention, without any restrictions regarding the scope of the invention and without any restriction regarding the possibility of combining the features introduced in such way with other optional or non-optional features of the invention.

[0023] In a first aspect, a computer-implemented analytical method for detecting at least one analyte in a bodily fluid is disclosed. For this aspect, reference may be made to any definition, Embodiment and / or further aspect as disclosed elsewhere herein.

[0024] The computer-implemented analytical method for detecting at least one analyte in a bodily fluid comprises the following steps, which may be performed in the given order. A different order, however, may also be feasible. Further, two or more of the method steps may be performed simultaneously. Thereby the method steps may at least partly overlap in time. Further, the method steps may be performed once or repeatedly. Thus, one or more or even all of the method steps may be performed once or repeatedly. The method may comprise additional method steps, which are not listed herein.

[0025] The term "computer-implemented" as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to a method which is performed by using computer programming, and / or by using at least one computer and / or at least one computer network. Thus, as an example, one or more or even all of the method steps may be performed by appropriate software, e.g. by using computer- readable instructions which, when executed on a computer or a computer network, cause the computer or computer network to perform the method steps. The term “software” as used herein may, specifically, refer to a computer program. The computer and / or computer network may comprise at least one processor, which is configured for performing at least one, more than one or all of the method steps of the method according to the present invention. Specifically, each of the method steps is performed by the computer and / or computer network. The method may be performed completely automatically, specifically without user interaction.

[0026] The term “analytical method”, may refer to a procedure for performing at least one procedure for determining the composition, the structure, and / or one or more property of at least one object and / or item. The analytical method for detecting at least one analyte in a bodily fluid may determine the presence of the analyte. The term “detecting” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to a quantitative and / or qualitative determination of the at least one property of the sample of the bodily fluid, such as at least one of a physical, a chemical and a biological property. The determination of the at least one property may specifically comprise quantitatively or qualitatively detecting at least one analyte in the bodily fluid.

[0027] The “analyte” may be or may comprise at least one arbitrary, dedicated 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 comprise at least one specific virus and / or any parts thereof. The result of the analytical method may be or may comprise at least one item of information indicating the presence or absence of the virus or parts thereof in the sample of the bodily fluid. For example, the analyte may be a chemical compound which takes part in metabolism, such as one or more of glucose, lactate, cholesterol or triglycerides. Additionally or alternatively, other types of analytes or parameters may be determined, such as a pH value or the like. As will be understood by the skilled person, a "presence" of an analyte, for example, may be a presence of said analyte in an amount above a detection limit of the test used.

[0028] The analytical method comprises: i. retrieving analytical measurement data obtained by applying at least one analytical measurement method to a sample of the bodily fluid; ii. providing a set of algorithms, the set of algorithms comprising at least two different analytical algorithms, each analytical algorithm being configured for deriving at least one estimate value from the analytical measurement data, each estimate value describing at least one of a presence of the analyte in the bodily fluid and a concentration of the analyte in the bodily fluid; iii. selecting at least one algorithm from the set of algorithms; and iv. applying the at least one algorithm to at least a part of the measurement data retrieved in step i., thereby generating at least one item of information describing one or both of the presence of the analyte in the bodily fluid and the concentration of the analyte in the bodily fluid; wherein, in step iii., at least one predetermined default algorithm from the set of algorithms is selected, wherein, by applying the default algorithm to at least a part of the measurement data in step iv., at least one preliminary item of information describing one or both of the presence of the analyte in the bodily fluid and the concentration of the analyte in the bodily fluid is generated, wherein the preliminary item of information is subjected to at least one sufficiency test. The at least one sufficiency test comprises at least one test selected from the group consisting of: checking if the preliminary item of information contains a value within at least one predetermined range; checking if the preliminary item of information fulfills at least one plausibility condition; checking if the preliminary item of information contains accuracy information fulfilling at least one accuracy condition; checking if the preliminary item of information indicate that at least one geometrical feature has been detected in the analytical measurement data; checking if an obtained estimate value determined by using the selected at least one predetermined default algorithm from the set of algorithms is within a concentration range for which the predetermined default algorithm is optimized and / or selected.

[0029] Depending on the result of the at least one sufficiency test, the predetermined default algorithm may be selected as the at least one algorithm in step iii .. Specifically if the sufficiency test indicates a pass.

[0030] As already disclosed, the method comprises a step i. of retrieving analytical measurement data obtained by applying at least one analytical measurement method to a sample of the bodily fluid.

[0031] The term “retrieving” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to the process of getting access to and / or possession of data, specifically a retrieving device may get access to and / or possession of the data. The data may be, specifically, the analytical measurement data. The data may be provided by a providing device configured for allowing access to the data. For allowing access to the data, the providing device may exchange the data with the retrieving device, such as by sending or transferring the data. The respective data may be exchanged via network, such as the internet. Consequently, the providing device may be a sending device or a measurement device. The providing device may be a field device such as a user device, particularly a mobile device. Alternatively, or in addition, the providing device may be a storage device. The retrieving device may be a server, particularly a cloud server. For retrieving the data, the data may be requested by the retrieving device, such as by sending a query to the providing device. Retrieving the data may comprise requesting the data. For retrieving the data, the data may be generated in a process, such as a measurement process in the physical world. Retrieving may comprise the process of obtaining and / or generating the data. Exemplarily, retrieving the analytical measurement data may comprise the process of obtaining and / or generating the analytical measurement data, such as by performing the analytical measurement. Performing the analytical measurement may be part of the step of receiving the analytical measurement data in a manner that the measurement is actively performed by the computer-implemented analytical method.

[0032] The term “analytical measurement data” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to at least one item of information of the analytical measurement data. The analytical measurement data may be obtained by performing at least one analytical measurement method. The term “obtain" may refer to the process of acquiring, getting and / or securing an object and / or on item. For obtaining the analytical measurement data the at least one analytical measurement method may be performed, particularly in a manner that the analytical measurement data is generated in the measurement process. The analytical measurement data may be generated in the process of performing the analytical measurement method.

[0033] The analytical measurement data may be retrieved from a storage device. The data storage device may be comprised by a measurement device configured for applying at least one analytical measurement method to the bodily fluid. The analytical measurement data may be retrieved via a computer network, particularly allowing a data transfer between the measurement device configured for applying at least one analytical measurement method to a sample of the bodily fluid and the retrieving device. The computer network may be the internet.

[0034] The term “sample of a bodily fluid” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to an arbitrary aliquot part or aliquant part of a biological fluid which directly is a bodily fluid or which is derived from a bodily fluid, such as by one or more pre-processing steps, e.g. by transferring a bodily fluid to at least one sampling fluid, by diluting a bodily fluid, by centrifugation of a bodily fluid or the like. The bodily fluid may comprise one or more of saliva, blood, interstitial fluid, urine or other types of body fluids. The sample of the bodily fluid may be collected via at least one nasopharyngeal swab, at least one swab of the anterior nares or from saliva, such as by applying a cotton swab to a surface of the anterior nares and / or the throat. The collected sample of bodily fluid may be transferred to the at least sampling or reagent fluid by immersing the cotton swab in the sampling or reagent fluid. The sampling or reagent fluid may specifically comprise lysis reagents. Alternatively or additionally, the sample of the bodily fluid may be a droplet of a body fluid as gathered from the body of a person, such as a droplet of saliva and / or blood and / or interstitial fluid or the like. The sample of the bodily fluid may specifically comprise at least one preparation of the bodily fluid, such as a cell preparation of the bodily fluid, e.g. a stained cell preparation of the bodily fluid. The sample of bodily fluid may also be simply referred to as the sample or the test sample. Preferably, the analytical measurement method may comprise in vitro measurements of the bodily fluid.

[0035] The retrieving in step i. may comprise at least one of: performing at least a part of the analytical measurement method, specifically performing at least one detection measurement for detecting the detectable detection reaction; controlling at least a part of the analytical measurement method, specifically controlling at least one of an optical measurement by using at least one optical detector, more specifically at least one camera, and / or an electrochemical measurement by using at least one electrochemical measurement device; prompting the user to perform at least a part of the analytical measurement method, specifically prompting the user to apply the sample of the bodily fluid to the at least one test element.

[0036] As already disclosed, the retrieving in step i. may comprise performing at least a part of the analytical measurement method, specifically performing at least one detection measurement for detecting the detectable detection reaction.

[0037] The term “measurement” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to an experimental process in which measurement data is obtained. In the detection measurement, measurement data on the detection reaction may be obtained. As used herein, the term "detection reaction" refers to a detectable reaction occurring in the presence of the analyte in the sample. The detectable reaction may be detectable by using the measurement device configured for applying at least one analytical measurement method to a sample of the bodily fluid. The detection reaction may be an optical detection. The optical detection may be a detection of a reaction using an optical test chemical, such as a color-change test chemical, which changes in color in the presence of the analyte. The color change specifically may depend on the amount of analyte present in the sample. Techniques for detecting the analyte by optical detection and in particular analyzing color of the spot on the test filed are generally known to the skilled person. The optical detection reaction may comprise a color formation reaction. The term "color formation reaction" as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to a chemical, biological or physical reaction during which a color, specifically a reflectance, of at least one element involved in the reaction, changes with the progress of the reaction.

[0038] Alternatively or in addition, the retrieving in step i. may comprise controlling at least a part of the analytical measurement method, specifically controlling at least one of an optical measurement by using at least one optical detector, more specifically at least one camera, and / or an electrochemical measurement by using at least one electrochemical measurement device.

[0039] The term “control” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to the process of managing at least one element and / or at least one object involved in the execution of a specific procedure. Controlling may comprise addressing at least one electronic component in a manner that the at least one electronic component performs a specific task. Controlling the optical detector may comprise causing the optical detector to generate the optical measurement data, such as by sending a respective command to the optical detector.

[0040] In the optical measurement, optical measurement data may be obtained, particularly wherein the optical measurement data is measurement data that is generated by using the optical detector. The optical measurement data may be data comprising information on electromagnetic radiation, such as light. The optical measurement data may be image data.

[0041] The term “image data” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to a collection of information representing visual content in a digital format. Typically, image data may comprise one or more pixels. The one or more pixels may be arranged in a known manner, particularly a known grid. Any one of the one or more pixels may comprise at least one numerical value defining a color and / or an intensity of the respective pixel. The numerical value may be binary data and / or data of a known color model, such as RGB (Red, Green, Blue) or CMYK (Cyan, Magenta, Yellow, Black). Alternatively or in addition, the image data may be vector image data. The vector image data may be at least one of: one or more points, one or more lines, one or more curves, and one or more further geometric elements.

[0042] The term “optical detector” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to an arbitrary device configured for generating optical measurement data, such as an image generation unit or a camera. The term “camera” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to a device having at least one imaging element configured for recording or capturing spatially resolved one-dimensional, two-dimensional or even three-dimensional optical data or information. As an example, the camera may comprise at least one camera chip, such as at least one CCD chip and / or at least one CMOS chip configured for recording images. As used herein, without limitation, the term “image” specifically may relate to data recorded by using the camera, such as a plurality of electronic readings from the imaging device, such as the pixels of the camera chip.

[0043] The term “electrochemical measurement device” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to a sensor which is configured to conduct an electrochemical measurement in order to detect the at least one analyte contained in the body fluid. The term “electrochemical measurement” refers to a detection of an electrochemically detectable property of the analyte, such as an electrochemical detection reaction. Thus, for example, the electrochemical detection reaction may be detected by comparing one or more electrode potentials. The electrochemical measurement device specifically may be configured for and / or may be usable to generate at least one electrical sensor signal which directly or indirectly indicates the presence and / or the extent of the electrochemical detection reaction, such as at least one current and / or at least one voltage. For this purpose the at least one electrochemical sensor may provide two or more electrodes, which also are referred to as a sensor electrodes. The detection may be analyte-specific. The measurement may be a qualitative and / or a quantitative measurement. Still, other embodiments are feasible. As further used herein, the term "electrode" may generally refer to an arbitrary element which is configured to or which is usable to electrically or electrochemically detect the analyte. Specifically, each electrode may comprise at least one conductive pad or conductive element, such as at least one metal pad and / or at least one metal element and / or at least one pad or element made of at least one conductive inorganic or organic material such as carbon and / or a conductive polymer. The at least one conductive pad or conductive element may be uncovered and / or may be covered with at least one additional material, such as at least one sensor chemical, as will be outlined in further detail below. The at least two electrodes of the sensor may be embodied such that an electrochemical reaction may take place at one or more of the electrodes, such as one or more working electrodes. Thus, the electrodes may be embodied such that an oxidation reaction and / or reduction reaction may take place at one or more of the electrodes. The electrochemical detection reaction may be detected by comparing one or more electrode potentials, such as an electrostatic potential of a working electrode with an electrostatic potential of one or more further electrodes such as a counter electrode or a reference electrode. Generally, as an example, the two or more electrodes may be usable for one or more of an amperometric, an amperostatic, a potentiometric or a potentiostatic measurement. These types of measurements generally are known to the skilled person in the art of analyte detection, such as from WO 2007 / 071562 Al and / or the prior art documents disclosed therein. For potential setups of the electrodes, electrode materials or measurement setups, reference may be made to this document. It shall be noted, however, that other setups, electrode materials or measurement setups may be used within the present invention.

[0044] Alternatively or in addition, the retrieving in step i. may comprise prompting the user to perform at least a part of the analytical measurement method, specifically prompting the user to apply the sample of the bodily fluid to the at least one test element.

[0045] The term “test element” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to an arbitrary element or device configured for performing one or more detection reactions in the presence of the at least one analyte. The test element may specifically be a strip-shaped test element. As used herein, the term “strip-shaped” refers to an element having an elongated shape and a thickness, wherein an extension of the element in a lateral dimension exceeds the thickness of the element, such as by at least a factor of 2, preferably by at least a factor of 5, more preferably by at least a factor of 10 and most preferably by at least a factor of 20 or even at least a factor of 30. Thus, the test element may also be referred to as test strip. The term “prompt” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to requesting a user to perform a specific action, such as by giving one or more signals or indications to the user. The one or more signals or indications may be verbal, visible and / or haptic indication. For prompting the user, a prompting device configured for indicating the prompt to the user may be used. The prompting device may be at least one display, at least one speaker and / or at least one vibrating motor.

[0046] The analytical measurement data may be selected from the group consisting of: image data of at least one part of at least one test field of an optical test element having the sample of the bodily fluid applied thereto, the test field comprising at least one test chemical configured for performing at least one optically detectable detection reaction in the presence of the analyte, specifically image data of at least a part of at least one test field an optical test element selected from the group consisting of a color-formation test strip and a lateral flow test strip; electrochemical measurement data obtained by applying at least one electrochemical measurement method to the sample of the bodily fluid.

[0047] As already disclosed, the analytical measurement data may be image data of at least one part of at least one test field of an optical test element having the sample of the bodily fluid applied thereto, the test field comprising at least one test chemical configured for performing at least one optically detectable detection reaction in the presence of the analyte, specifically image data of at least a part of at least one test field an optical test element selected from the group consisting of a color-formation test strip and a lateral flow test strip.

[0048] The term “test chemical” specifically may refer to an arbitrary material or a composition of materials adapted to change at least one detectable property in the presence of at least one analyte. Specifically, the at least one test chemical may be a highly selective test chemical, which only changes the property if the analyte is present in the body fluid whereas no change occurs if the analyte is not present. The degree or change of the at least one property may be dependent on the concentration of the analyte in the body fluid, in order to allow a quantitative detection of the analyte. As an example, the test chemical may comprise at least one enzyme, such as glucose oxidase and / or glucose dehydrogenase. The term "test field" relates to a continuous or discontinuous amount of test chemistry, which, preferably, is held by at least one carrier, such as by at least one carrier film. Thus, the test chemistry may form or may be comprised in one or more films or layers of the test field, and / or the test field may comprise a layer setup having one or more layers, wherein at least one of the layers comprises the test chemistry. Thus, the test field may comprise a layer setup disposed on a carrier, wherein the sample of the body fluid may be applied to the layer setup from at least one application side, such as from an edge of the test field and / or from an application surface of the test field. For allowing a flow of the at least one analyte in a bodily fluid from the application side to the test field, the test strip may comprise a transport fleece and / or a transport capillary.

[0049] The term “optical test element” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to an arbitrary element or device configured for performing an optical detection reaction, for example a color-change detection reaction and / or a reaction during which one or more optically detectable features on or within the test element become visible, such as one or more markings, such as linear markings known from rapid COVID testing. The optical test element may, as an example, be embodied as a test stick or as a test element.

[0050] The optical test element may be a digital-type test element for digitally detecting the presence or absence of at least one predetermined analyte in the sample. Thus, the optical test element may be a test element capable of providing the information “positive” if the at least one predetermined analyte is determined to be present in the sample, or “negative” if the at least one predetermined analyte is determined not to be present in the sample. The optical test element may be configured for changing at least one optically detectable property of at least one feature when the analyte is detected in the sample, whereas the at least one optically detectable property of the at least one feature may be kept 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 & Flu A / B rapid antigen test.

[0051] The term “color-formation test strip” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to an arbitrary element configured to change at least partially its color in the presence of the at least one analyte by a color-change detection reaction. The term “lateral flow test strip” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to an arbitrary element configured to allow a test sample to flow along at least one membrane of the arbitrary element. The test sample may flow from the test field to the test chemical, which may be distant from each other. The lateral flow test strip may comprise a control line configured to visibly indicate that the test sample has flowed through the membrane.

[0052] The analytical measurement data may contain image data of at least one part of at least one test field of an optical test element having the sample of the bodily fluid applied thereto, the test field may comprise at least one test chemical configured for performing at least one optically detectable detection reaction in the presence of the analyte, specifically image data of at least a part of at least one test field of an optical test element selected from the group consisting of a color-formation test strip and a lateral flow test strip, wherein, in step iii ., at least two algorithms are selected, wherein step iv. may comprise applying, successively or in parallel, the at least two algorithms to the image data.

[0053] The term “algorithm” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to a finite sequence of a plurality of instructions. An algorithm may, typically, be used to solve one or more specific problems and / or to perform a computation. The algorithm may be computer- implemented.

[0054] As already disclosed, the analytical measurement data may be electrochemical measurement data obtained by applying at least one electrochemical measurement method to the sample of the bodily fluid.

[0055] The term “electrochemical measurement data” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to one or more items of information obtained and / or generated by performing one or more electrochemical measurements.

[0056] The term “obtaining”, or any grammatical variation thereof, as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to the procedure of generating data. The obtained data may be generated by using a measurement device configured for applying at least one analytical measurement method to a sample of the bodily fluid and the retrieving device. Obtaining the measurement data may comprise performing and / or controlling the analytical measurement. The analytical measurement method of step i . , by which the analytical measurement data are obtained, may comprise applying the sample of the bodily fluid to at least one test element comprising at least one test chemical configured for performing at least one detectable detection reaction in the presence of the analyte.

[0057] The term “applying the sample of the bodily fluid to at least one test element” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to bringing the sample in contact with the test element. The applied sample may get in contact with the test chemical in order to perform the detection reaction.

[0058] For obtaining the analytical measurement data in step i., the method may comprise using at least one mobile device having at least one camera.

[0059] The term “mobile device” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to a mobile electronic device, specifically a personal mobile device (PDA), more specifically to a mobile communication device such as a cell phone and / or a smartphone. Additionally or alternatively, the mobile device may also refer to a notebook, a tablet computer or another type of portable computer, such as a wearable, specifically smart glasses, having at least one camera. Alternatively or in addition, a smartphone having an external camera may be used. The external camera may be comprised by spectacles. The mobile device may have a direct internet access, particularly in a manner that the mobile device is not required of being required to connect to a network, such as a wireless local area network (LAN) network, for connecting to the internet. Thus, generally, the mobile devices may be selected from the group consisting of: a cell phone having at least one camera, specifically a smart phone; a portable computer having at least one camera, specifically at least one of a notebook and a tablet computer. The mobile device may comprise a processor, particularly for performing the computer-implemented analytical method.

[0060] Using the at least one mobile device having the at least one camera for obtaining the analytical measurement data in step i. may comprise capturing at least one image by using the camera in order to generate the image data. The term “capturing at least one image” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to one or more of imaging, image recording, image acquisition, image capturing. Capturing of the at least one image may comprise recording a single image and / or a plurality of images such as a sequence of images. For example, the recording of the image may comprise recording continuously a sequence of images such as a video or a movie. The recording of the at least one image may be initiated by a user action or may automatically be initiated, e.g. once the presence of the at least one object within a field of view and / or within a predetermined sector of the field of view of the camera is automatically detected. These automatic image acquisition techniques are known e.g. in the field of automatic bar-code readers, such as from automatic barcode reading apps. The recording of the images may take place, as an example, by acquiring a stream or “live stream” of images with the camera, wherein one or more of the images, automatically or by user interaction such as pushing a button, are stored and used as the at least one first image or the at least one second image, respectively. The image acquisition may be supported by the processor of the mobile device.

[0061] The term “analytical measurement method” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to a procedure for determining at least one chemical or physical property of a sample. The analytical measurement method may be performed in order to detect the at least one analyte in a bodily fluid, specifically a sample of the bodily fluid.

[0062] Step i. of the method may comprise prompting a user to perform the at least one analytical measurement method. The term “user” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to a human being or an animal, independent from the fact that the human being or animal, respectively, may be in a healthy condition or may suffer from one or more diseases. The user may assist performing the analytical method. The sample may be from the user or a further human being or animal, such as a patient.

[0063] As already disclosed, the method comprises a step ii. of providing a set of algorithms, the set of algorithms comprising at least two different analytical algorithms, each analytical algorithm being configured for deriving at least one estimate value from the analytical measurement data, each estimate value describing at least one of a presence of the analyte in the bodily fluid and a concentration of the analyte in the bodily fluid. The term “providing” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to making at least one arbitrary element available by a providing unit. The element may be provided by a data storage device. The element may be provided via a computer network. The computer network may be a local area network (LAN) or the internet.

[0064] The term “set of algorithms” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to a plurality of algorithms, such as at least two, three or four algorithms. With particular regard to the present invention, the algorithms may be analytical algorithms. As already disclosed, the algorithms may be different analytical algorithms. The different analytical algorithms may have a differing accuracy and / or precision to detect the at least one analyte for one or more specific analyte concentration values and / or for specific analyte concentration ranges in the sample. Consequently, a first analytical algorithm may have a first accuracy and / or precision for a first analyte concentration value and / or for a first analyte concentration range and a second analytical algorithm may have a second accuracy and / or second precision for a second analyte concentration value and / or for a second analyte concentration range, wherein the first analyte concentration value and / or for a first analyte concentration range is different from the second analyte concentration value and / or for a second analyte concentration range. The term “accuracy” may refer to a measure of how close a set of measured values, e.g. a set of estimate values, are to their true value. The term “precision” may refer to a measure of how close a set of measured values, e.g. a set of estimate values, are to each other.

[0065] The term "estimate value” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to a value derived by performing the analytical measurement. For deriving the estimate value the analytical measurement data may be evaluated by using at least one detection algorithm. The estimate value may indicate the presence of the analyte in the bodily fluid. Alternatively or in addition, the estimate value may indicate the concentration of the analyte in the bodily fluid. Alternatively or in addition, the estimate value may indicate a negative result, i.e. that the presence of the analyte in the bodily fluid and / or the concentration of the analyte in the bodily fluid could not be determined. The estimate value may be the detected at least one analyte in a bodily fluid or the measurement result. That the presence of the analyte in the bodily fluid and / or the concentration of the analyte in the bodily fluid could not be determined may be caused by the fact that the analyte concentration in analyte in the bodily fluid is 0 or that the algorithm used did not detect the analyte and returns a false negative. This might be the case when a feature, such as a line, generated by the detection reaction is not detected by the algorithm. That a feature, such as a line, generated by the detection reaction is not detected by the algorithm may be caused by the fact that the analyte concentration in analyte in the bodily fluid is 0 or that the algorithm used did not detect the analyte and returns a false negative.

[0066] At least one of the analytical algorithm may comprise of at least one of: a calibration curve transforming at least a part of the measurement data into the estimate value; a lookup table containing a plurality of data pairs, each data pair comprising a data value of the measurement data and an estimate value assigned to the data value of the measurement data; a feature detection algorithm for detecting at least one feature in the analytical measurement data, specifically at least one one-dimensional or two-dimensional geometrical feature, more specifically a line detection algorithm.

[0067] The term "calibration” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to the process of adjusting and / or aligning a measurement system in a manner that it generates accurate and / or precise measurement results. At least one of the analytical algorithms may be obtained by performing at least one calibration measurement, the at least one calibration measurement comprising determining data values for a plurality of calibration samples having differing known analyte concentrations. In the calibration process a calibration curve may be obtained in order to minimize a deviation between an estimate value and a true value for one or more analyte concentrations. The calibration curve may be a function assigning at least a part of the measurement data to an estimate value depending on the analyte concentration.

[0068] The term "lookup table” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to an array in which one or more specific estimate values are each assigned to one specific data value of the measurement data. A specific estimate value and the specific data value of the measurement data to which the specific estimate value is assigned to may be a data pair. The term "feature detection algorithm” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to an arbitrary algorithm configured for detecting at least one feature generated by the optical detection reaction caused by the presence of the at least one analyte. The feature detection algorithm may be configured for recognizing the feature, such as by recognizing at least one of: a shape; a color; a position of the feature, particularly in relation to at least one further element of the test element, such as a housing; an intensity, wherein the intensity may be determined by evaluating at least one numerical value defining a color and an intensity of the respective pixel within the image data, specifically by evaluating at least one of: a Red pixel, a Green pixel, a Blue pixel or by evaluating at least one of: a Cyan pixel, a Magenta pixel, a Yellow pixel, a Black pixel; of the feature.

[0069] At least two algorithms of the set of algorithms may be assigned to different designated concentration ranges of the analyte in the bodily fluid. The term "concentration range” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to a span of a plurality of concentration values to which a specific algorithm is assigned to. Each algorithm may be assigned to a specific concentration range. These concentration ranges may be different in a manner that they are incongruent. The concentration ranges may overlap partially.

[0070] The algorithms of the set of algorithms may be assigned to the different designated concentration ranges of the analyte in the bodily fluid according to at least one assignment criterion. The term "assignment criterion” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to a condition describing at least one attribute of an object and / or a candidate that is evaluated to determine an assignment.

[0071] The assignment criterion may be selected from the group consisting of: the algorithm fulfills at least one quality criterion in the concentration range, specifically at least one criterion quantifying at least one of: the precision; the accuracy by which the estimate value matches, particularly the true value of, the analyte concentration in the bodily fluid in the concentration range, more specifically the estimate value being within a predetermined tolerance range around, particularly the true value of, the analyte concentration in the bodily fluid in the concentration range; the algorithm is suited to identify, specifically suited to identify with a higher success rate than one or any further available algorithm within the respective concentration range, at least one predetermined feature in the analytical measurement data when the analyte concentration is within the concentration range, specifically at least one one-dimensional or two-dimensional geometrical feature, more specifically is suited to detect at least one line in image data contained in the measurement data, wherein the image data are image data of at least one part of at least one test field of an optical test element having the sample of the bodily fluid applied thereto, the test field comprising at least one test chemical configured for performing at least one optically detectable detection reaction in the presence of the analyte, with the analyte concentration being in the concentration range.

[0072] The term "quality” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, a measure of one or more inherent characteristics of an object. The quality of the object may be determined by evaluating a quality criterion. The “quality criterion” may be a preselected degree of the correctness of an algorithm, particularly for a specific analyte concentration. The algorithm may fulfill at least one quality criterion in the concentration range when the degree of the correctness of the algorithm equals to or is larger than the preselected degree of the correctness of the algorithm, particularly for a specific analyte concentration.

[0073] The performance of each algorithm may depend on the analyte concentration of the sample. The term "performance” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to the correctness of the algorithm to determine an estimate value for a specific range of analyte concentration. The correctness may depend on the accuracy and / or precision of the algorithm, particularly in a manner that the correctness increases when the accuracy and / or the precision of the algorithm increases.

[0074] The at least two algorithms may comprise at least one first algorithm optimized and / or selected for a first range of analyte concentration, specifically a high analyte concentration range, and at least one second algorithm may be optimized and / or selected for a second range of analyte concentration, specifically a low analyte concentration range, wherein the first and second ranges may be not identical. The at least two algorithms further may comprise at least one third algorithm optimized for a third range of analyte concentration, specifically an intermediate range of analyte concentration. The term ’’optimize”, or any grammatical variation thereof, as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to the capability of the algorithm to determine an estimate value having a high correctness for a specific range of analyte concentration. The correctness of the first algorithm for determining the analyte concentration in the first range of analyte concentration may be higher than the correctness of the second algorithm for determining the analyte concentration in the second range of analyte concentration. As already disclosed, the correctness may depend and the accuracy and / or precision of the algorithm, particularly in a manner that the correctness increases when the accuracy and / or the precision of the algorithm increases. The first and second ranges may overlap. The terms "optimal" and "optimized" may not imply an active optimization of the algorithm. An algorithm may determine more accuracy and / or precise measurement results without active optimization and / or by chance in at least one concentration range. The term “selected”, or any grammatical variation thereof, as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to the choosing a specific algorithm that determines an estimate value having a high correctness for a specific range of analyte concentration, particularly when compared to one or any further algorithm. The algorithm may be selected in a manner that the correctness of the first algorithm for determining the analyte concentration in the first range of analyte concentration may be higher than the correctness of the second algorithm for determining the analyte concentration in the second range of analyte concentration.

[0075] The results obtained by using the at least two algorithms may be combined, specifically averaged, specifically in order to improve accuracy and / or the precision of a measurement result. The term ’’combine”, or any grammatical variation thereof, as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to a procedure of generating a common result by evaluating at least two variables, such as a first variable and a second variable. The common result may depend on each of the at least two variables. In that sense, the common result may be different for at least two different first variables and the common result may be different for at least two different second variables; and so on. The results obtained by using the at least two or more algorithms may be combined by at least one of: averaging the results; determining one or more medians of the result; determining one or more weighted averages of the result, particularly wherein at least one weighting parameter is obtained by evaluating the correctness of the algorithm for the respective concentration range.

[0076] As already disclosed, the method comprises a step iii. of selecting at least one algorithm from the set of algorithms. In step iii., a plurality of algorithms may be selected from the set of algorithms. Selecting the one or more algorithm may comprise evaluating the assignment criterion.

[0077] The term ’’select”, or any grammatical variation thereof, as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to the procedure of choosing at least one object. The object may be selected from a set comprising a plurality of objects. The object may be selected depending on at least one selection criterion. The term ’’set” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to a collection of at least one object comprising one or, preferably, more objects.

[0078] As already disclosed, in step iii., at least one predetermined default algorithm from the set of algorithms is selected, wherein, by applying the default algorithm to at least a part of the measurement data in step iv., at least one preliminary item of information describing one or both of the presence of the analyte in the bodily fluid and the concentration of the analyte in the bodily fluid is generated, wherein the preliminary item of information is subjected to at least one sufficiency test.

[0079] The term “predetermined default algorithm” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to a specific algorithm of the set of algorithms. In this context, the term “predetermined” refers to the default algorithm being known and selected in advance of determining the preliminary item of information by using the selected predetermined default algorithm. The predetermined default algorithm may be selected randomly, such as by using a random number generator. Alternatively or in addition, the predetermined default algorithm may be preselected in a manner that the algorithm is known and selected in advance of performing the method, such as by fixing and / or hard coding the predetermined default algorithm. Alternatively or in addition, the predetermined default algorithm may be a preselected sequence of algorithms in a manner that the sequence of algorithms is known and selected in advance of performing the method, such as by fixing and / or hard coding the sequence of algorithms. Alternatively or in addition, different predetermined default algorithms may be used in at least two measurements.

[0080] As already indicated, in step iii . , at least one predetermined default algorithm from the set of algorithms is selected. Thereby, one or more predetermined default algorithms from the set of algorithms may be selected. In this context, any algorithm of the set of algorithms may be a predetermined default algorithm. In case a plurality of the predetermined default algorithms is selected, the at least two predetermined default algorithms may run simultaneously.

[0081] The term “preliminary item of information” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to a value derived by performing the analytical measurement. For deriving the preliminary item of information the analytical measurement data may be evaluated by using at least one predetermined default algorithm. The preliminary item of information may indicate the presence of the analyte in the bodily fluid. Alternatively or in addition, the preliminary item of information may indicate the concentration of the analyte in the bodily fluid. Alternatively or in addition, the preliminary item of information may indicate a negative result, i.e. that the presence of the analyte in the bodily fluid and / or the concentration of the analyte in the bodily fluid could not be determined or was determined to be 0. This might be the case when a feature, such as a line, generated by the detection reaction is not detected by the algorithm or if there is no line.

[0082] The term “sufficiency” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to a property of an element or device fulfilling at least one condition indicating the capability of the element or device of performing one or more predetermined functions. Thus, as an example, the sufficiency may be qualified or quantified by using one or more characteristic parameter(s) of the device. These one or more characteristic parameters may, individually or according to a predetermined combination, be compared with one or more conditions. As a simple example, the individual parameters or one or more of the parameters may be compared with one or more comparative values, reference values or standard values, wherein the comparison may be a qualitative or a quantitative comparison and may result in a binary result such as “sufficient” or “not suffi cient” / ”insuffi ci ent”. As an example, the at least one comparative or reference value may comprise at least one threshold value. Additionally or alternatively, however, the comparison may result in a quantitative result, such as a figure indicating a degree of sufficiency. The comparative values, reference values or standard values may be derived, as an example, from experiments or from boundary conditions determined e.g. by the accuracy and / or precision to be achieved. The sufficiency may be determined in at least one “sufficiency test”, particularly by subjecting the preliminary item of information to at least one sufficiency test.

[0083] The method further may comprise, depending on the result of the sufficiency test, selecting at least one further algorithm from the set of algorithms and applying the at least one further algorithm to at least a part of the measurement data, specifically selecting and applying at least one further algorithm adapted to the result of the sufficiency test. In case a further algorithm is selected, the at least one predetermined default algorithm and the further algorithm may run successively. When the at least one predetermined default algorithm and the further algorithm run successively, a first preliminary item of information obtained by using the predetermined default algorithm may have failed the sufficiency test and, then, the further algorithm may run subsequent to the predetermined default algorithm to obtain a further preliminary item of information. By applying the further algorithm to at least a part of the measurement data in step iv., a further preliminary item of information describing one or both of the presence of the analyte in the bodily fluid and the concentration of the analyte in the bodily fluid is generated, wherein the further preliminary item of information may be subjected to at least one further sufficiency test. Depending on the result of the at least one further sufficiency test, the predetermined default algorithm may be selected as the at least one algorithm in step iii.. Specifically if the at least one further sufficiency test indicates a pass.

[0084] The method further may comprise, depending on the result of the further sufficiency test, selecting at least one third algorithm from the set of algorithms and applying the at least one further algorithm to at least a part of the measurement data. By applying the third algorithm to at least a part of the measurement data in step iv., a third preliminary item of information describing one or both of the presence of the analyte in the bodily fluid and the concentration of the analyte in the bodily fluid is generated, wherein the third preliminary item of information may be subjected to at least one third sufficiency test. Depending on the result of even further sufficiency tests, such as a third, fourth, fifth, sixth, seventh and so on, sufficiency test, the method may comprise selecting at least one third, fourth, fifth, sixth, seventh, eighth and so on algorithm from the set of algorithms and applying the at least one respective algorithm to at least a part of the measurement data. Depending on the result of the at least one respective sufficiency test, the predetermined default algorithm may be selected as the at least one algorithm in step iii.. Specifically if the at least one respective sufficiency test indicates a pass.

[0085] The at least one further sufficiency test may comprise at least one test selected from the group consisting of: checking if the further preliminary item of information, respectively, contains a value within at least one predetermined range, specifically, if a concentration of the analyte is within at least one predetermined concentration range; checking if the further preliminary item of information, respectively, fulfills at least one plausibility condition; checking if the preliminary item of information or the further preliminary item of information, respectively, contains accuracy information fulfilling at least one accuracy condition; checking if the further preliminary item of information, respectively, indicate that at least one geometrical feature has been detected in the analytical measurement data, specifically in analytical image data, more specifically indicate that at least one line has been detected.

[0086] In case the obtained estimate value determined by using the selected at least one predetermined default algorithm from the set of algorithms is not within a concentration range for which the predetermined default algorithm is optimized and / or selected, a further algorithm from the set of algorithms may be used for obtaining at least one further estimate value, wherein the further algorithm may be optimized and / or selected for the concentration range determined by the predetermined default algorithm.

[0087] As already disclosed, the method comprises a step iv. of applying the at least one algorithm to at least a part of the measurement data retrieved in step i., thereby generating at least one item of information describing one or both of the presence of the analyte in the bodily fluid and the concentration of the analyte in the bodily fluid. Steps iii. and iv. may be performed repeatedly.

[0088] Generating the at least one item of information may comprise selecting a specific preliminary item of information from the at least one preliminary item of information subjected to at least one sufficiency test. The selected specific preliminary item of information may be used as the item of information describing one or both of the presence of the analyte in the bodily fluid and the concentration of the analyte in the bodily fluid.

[0089] The selected specific preliminary item of information may be at least one of:

[0090] - the first preliminary item of information that is classified sufficient in the sufficiency test;

[0091] - a plurality preliminary item of information that are derived by algorithms that are preselected for a concentration range corresponding to their preliminary item of information, particularly and, thereby, classified sufficient in the sufficiency test, particularly when the at least one preliminary item of information is derived by running the algorithms successively.

[0092] Alternatively or in addition, the selected specific preliminary item of information may be at least one of

[0093] - one preliminary item of information that is derived by an algorithm that is preselected for a concentration range corresponding to the preliminary item of information, particularly and, thereby, classified sufficient in the sufficiency test;

[0094] - a plurality of preliminary items of information that are derived by algorithms that are preselected for a concentration range corresponding to their preliminary items of information, particularly and, thereby, classified sufficient in the sufficiency test, particularly when the at least one preliminary item of information is derived by running the algorithms simultaneously.

[0095] In step iv., the algorithms of the plurality of algorithms may be applied to the at least one part of the measurement data one or both of simultaneously and successively, specifically by using a predetermined sequence of algorithms.

[0096] In step iv., with each of the algorithms, at least one item of information describing one or both of the presence of the analyte in the bodily fluid and the concentration of the analyte in the bodily fluid may be determined from the measurement data, wherein step iv. further may comprise combining the items of information, thereby generating at least one combined item of information describing one or both of the presence of the analyte in the bodily fluid and the concentration of the analyte in the bodily fluid. The combined item of information may be determined by averaging the items of information determined by using the at least two algorithms. The combined algorithms may be the plurality of preliminary items of information that are derived by algorithms that are preselected for a concentration range corresponding to their preliminary items of information, particularly and, thereby, classified sufficient in the sufficiency test.

[0097] The combined items of information may have passed the sufficiency test.

[0098] In a further aspect, an analytical device for detecting at least one analyte in a bodily fluid is disclosed. The analytical device comprises at least one processor, the processor being configured for performing the method as elsewhere disclosed herein. The analytical device may be a mobile device, specifically a mobile device having at least one camera. For this aspect, reference may be made to any definition, Embodiment and / or further aspect as disclosed elsewhere herein.

[0099] The term “processor” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to an arbitrary logic circuitry configured for performing basic operations of a computer or system, and / or, generally, to a device which is configured for performing calculations or logic operations. In particular, the processor may be configured for processing basic instructions that drive the computer or system. As an example, the processor may comprise at least one arithmetic logic unit (ALU), at least one floating-point unit (FPU), such as a math co-processor or a numeric co-processor, a plurality of registers, specifically registers configured for supplying operands to the ALU and storing results of operations, and a memory, such as an LI and L2 cache memory. In particular, the processor may be a multi-core processor. Specifically, the processor may be or may comprise a central processing unit (CPU). Additionally or alternatively, the processor may be or may comprise a microprocessor, thus specifically the processor’s elements may be contained in one single integrated circuitry (IC) chip. Additionally or alternatively, the processor may be or may comprise 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 unit (TPU) and / or one or more chip, such as a dedicated machine learning optimized chip, or the like. The processor specifically may be configured, such as by software programming.

[0100] In a further aspect, a computer program is disclosed comprising instructions which, when the program is executed by the analytical device as elsewhere disclosed herein, cause the analytical device to perform the method as elsewhere disclosed herein. For this aspect, reference may be made to any definition, Embodiment and / or further aspect as disclosed elsewhere herein.

[0101] In a further aspect, a computer-readable medium, specifically a non-transient computer-readable storage medium, is disclosed comprising instructions which, when the instructions are executed by the analytical device as elsewhere disclosed herein cause the analytical device to perform the method as elsewhere disclosed herein. For this aspect, reference may be made to any definition, Embodiment and / or further aspect as disclosed elsewhere herein.

[0102] As used herein, the term “computer-readable storage medium” specifically may refer to non- transitory data storage means, such as a hardware storage medium having stored thereon computer-executable instructions. The computer-readable storage medium specifically may be or may comprise a storage medium such as a random-access memory (RAM) and / or a read-only memory (ROM). For details, options and definitions, reference may be made to any further aspect discussed elsewhere herein

[0103] In a further aspect, a use of at least one of the method as disclosed elsewhere herein and of the analytical device as disclosed elsewhere herein, for a purpose of use selected from the group consisting of determining the concentration of glucose in blood; the presence and / or concentration of at least one predetermined virus, specifically the presence of SARS-CoV- 2.

[0104] Further disclosed and proposed herein is a computer program including computer-executable instructions for performing the method according to the present invention in one or more of the embodiments enclosed herein when the instructions are executed on a computer or computer network. Specifically, the computer program may be stored on a computer-readable data carrier and / or on a computer-readable storage medium.

[0105] As used herein, the terms “computer-readable data carrier” and “computer-readable storage medium” specifically may refer to non-transitory data storage means, such as a hardware storage medium having stored thereon computer-executable instructions. The computer- readable data carrier or storage medium specifically may be or may comprise a storage medium such as a random-access memory (RAM) and / or a read-only memory (ROM). Thus, specifically, one, more than one or even all of method steps a) to d) as indicated above may be performed by using a computer or a computer network, preferably by using a computer program.

[0106] Further disclosed and proposed herein is a computer program product having program code means, in order to perform the method according to the present invention in one or more of the embodiments enclosed herein when the program is executed on a computer or computer network. Specifically, the program code means may be stored on a computer-readable data carrier and / or on a computer-readable storage medium.

[0107] Further disclosed and proposed herein is a data carrier having a data structure stored thereon, which, after loading into a computer or computer network, such as into a working memory or main memory of the computer or computer network, may execute the method according to one or more of the embodiments disclosed herein.

[0108] Further disclosed and proposed herein is a non-transient computer-readable medium including instructions that, when executed by one or more processors, cause the one or more processors to perform the method as elsewhere disclosed herein.

[0109] Further disclosed and proposed herein is a computer program product with program code means stored on a machine-readable carrier, in order to perform the method according to one or more of the embodiments disclosed herein, when the program is executed on a computer or computer network. As used herein, a computer program product refers to the program as a tradable product. The product may generally exist in an arbitrary format, such as in a paper format, or on a computer-readable data carrier and / or on a computer-readable storage medium. Specifically, the computer program product may be distributed over a data network.

[0110] Finally, disclosed and proposed herein is a modulated data signal which contains instructions readable by a computer system or computer network, for performing the method according to one or more of the embodiments disclosed herein.

[0111] Referring to the computer-implemented aspects of the invention, one or more of the method steps or even all of the method steps of the method according to one or more of the embodiments disclosed herein may be performed by using a computer or computer network. Thus, generally, any of the method steps including provision and / or manipulation of data may be performed by using a computer or computer network. Generally, these method steps may include any of the method steps, typically except for method steps requiring manual work, such as providing the samples and / or certain aspects of performing the actual measurements.

[0112] Specifically, further disclosed herein are:

[0113] - a computer or computer network comprising at least one processor, wherein the processor is adapted to perform the method according to one of the embodiments described in this description,

[0114] - a computer loadable data structure that is adapted to perform the method according to one of the embodiments described in this description while the data structure is being executed on a computer,

[0115] - a computer program, wherein the computer program is adapted to perform the method according to one of the embodiments described in this description while the program is being executed on a computer,

[0116] - a computer program comprising program means for performing the method according to one of the embodiments described in this description while the computer program is being executed on a computer or on a computer network,

[0117] - a computer program comprising program means according to the preceding embodiment, wherein the program means are stored on a storage medium readable to a computer,

[0118] - a storage medium, wherein a data structure is stored on the storage medium and wherein the data structure is adapted to perform the method according to one of the embodiments described in this description after having been loaded into a main and / or working storage of a computer or of a computer network, and

[0119] - a computer program product having program code means, wherein the program code means can be stored or are stored on a storage medium, for performing the method according to one of the embodiments described in this description, if the program code means are executed on a computer or on a computer network.

[0120] The methods and devices according to the present invention may provide a large number of advantages compared with known methods and devices. The methods and devices according to the present invention enhance the reliability, accuracy, performance of a detection of an analyte in a sample of the bodily fluid.

[0121] It is proposed to apply various methods with performances that depend on the virus concentration. These methods are meant to be evaluated in a pipeline that gathers the best possible joint performances of all methods in each virus concentration range. A photo app may be used on a mobile device, in particular in a home-testing scenario, wherein one or more images of an optical test element, e.g. a color-formation test and / or a blood glucose test and / or a lateral flow test, such as a rapid antigen test, may be captured by the camera of the mobile device.

[0122] From optically at least one detectable change within a test field of the optical test element, such as at least one graphical element, specifically a line, and / or a color formation, the presence and / or the concentration of at least one analyte may be determined. According to the present invention, different evaluation algorithms, which may be specifically adapted, i.e. optimized, for high, mid and / or low analyte concentrations may be used, respectively. Thereby, a highly reliable read-out of optical tests over a wide range of analyte concentration may be achieved.

[0123] The different algorithms may be applied successively or in parallel. Alternatively or in addition, two or more, e.g. three, different algorithms may be used in the method. Alternatively or in addition, a plurality of different algorithms to at least partially overlapping ranges of analyte concentrations may be used. Alternatively or in addition, averaged results from two or more, e.g. three, algorithms may be used, in order to improve accuracy of the measurement result. Alternatively or in addition, at least one optical test reaction and / or electrochemical test reaction may be analyzed.

[0124] The analytical method for determining a concentration of an analyte in a bodily fluid may require using a mobile device having a camera. In this case, the method may be described using the following words:

[0125] An analytical method for determining a concentration of an analyte in a bodily fluid by using a mobile device having a camera, comprising:

[0126] - receiving an image of an optical test element having a sample of the bodily fluid applied onto a reagent test region; and

[0127] - applying, successively or in parallel, two or more, e.g. three, algorithms for analyte detection to the image, wherein the performance of each algorithm depends on the analyte concentration of the sample applied to the test element; and

[0128] - wherein the two or more algorithms comprise at least one algorithm optimized for a first range of analyte concentration, e.g. high analyte concentration, and at least one algorithm optimized for a second range of analyte concentration, e.g. low analyte concentration, wherein the analyte concentration ranges may at least partially overlap; and optionally at least one algorithm optimized for a third range of analyte concentration, e.g. intermediate analyte concentration.

[0129] Summarizing and without excluding further possible embodiments, the following embodiments may be envisaged:

[0130] Embodiment 1 : A computer-implemented analytical method for detecting at least one analyte in a bodily fluid, the method comprising: i. retrieving analytical measurement data obtained by applying at least one analytical measurement method to a sample of the bodily fluid; ii. providing a set of algorithms, the set of algorithms comprising at least two different analytical algorithms, each analytical algorithm being configured for deriving at least one estimate value from the analytical measurement data, each estimate value describing at least one of a presence of the analyte in the bodily fluid and a concentration of the analyte in the bodily fluid; iii. selecting at least one algorithm from the set of algorithms; and iv. applying the at least one algorithm to at least a part of the measurement data retrieved in step i., thereby generating at least one item of information describing one or both of the presence of the analyte in the bodily fluid and the concentration of the analyte in the bodily fluid.

[0131] Embodiment 2: The method according to the preceding embodiment, wherein the analytical measurement method of step i., by which the analytical measurement data are obtained, comprises applying the sample of the bodily fluid to at least one test element comprising at least one test chemical configured for performing at least one detectable detection reaction in the presence of the analyte.

[0132] Embodiment 3 : The method according to any one of the preceding embodiments, wherein the retrieving in step i. comprises at least one of: performing at least a part of the analytical measurement method, specifically performing at least one detection measurement for detecting the detectable detection reaction; controlling at least a part of the analytical measurement method, specifically controlling at least one of an optical measurement by using at least one optical detector, more specifically at least one camera, and / or an electrochemical measurement by using at least one electrochemical measurement device; prompting the user to perform at least a part of the analytical measurement method, specifically prompting the user to apply the sample of the bodily fluid to the at least one test element. Embodiment 4: The method according to any one of the preceding embodiments, wherein the analytical measurement method of step i., by which the analytical measurement data are obtained, comprises using at least one mobile device having at least one camera.

[0133] Embodiment 5: The method according to any one of the preceding embodiments, wherein the analytical measurement data are selected from the group consisting of: image data of at least one part of at least one test field of an optical test element having the sample of the bodily fluid applied thereto, the test field comprising at least one test chemical configured for performing at least one optically detectable detection reaction in the presence of the analyte, specifically image data of at least a part of at least one test field an optical test element selected from the group consisting of a color-formation test strip and a lateral flow test strip; electrochemical measurement data obtained by applying at least one electrochemical measurement method to the sample of the bodily fluid.

[0134] Embodiment 6: The method according to any one of the preceding embodiments, wherein step i. comprises prompting a user to perform the at least one analytical measurement method.

[0135] Embodiment 7: The method according to any one of the preceding embodiments, wherein at least one of the analytical algorithms comprises at least one of: a calibration curve transforming at least a part of the measurement data into the estimate value; a lookup table containing a plurality of data pairs, each data pair comprising a data value of the measurement data and an estimate value assigned to the data value of the measurement data; a feature detection algorithm for detecting at least one feature in the analytical measurement data, specifically at least one one-dimensional or two-dimensional geometrical feature, more specifically a line detection algorithm.

[0136] Embodiment 8: The method according to any one of the preceding embodiments, wherein at least one of the analytical algorithms is obtained by performing at least one calibration measurement, the at least one calibration measurement comprising determining data values for a plurality of calibration samples having differing known analyte concentrations.

[0137] Embodiment 9: The method according to any one of the preceding embodiments, wherein at least two algorithms of the set of algorithms are assigned to different designated concentration ranges of the analyte in the bodily fluid. Embodiment 10: The method according to the preceding embodiment, wherein the algorithms of the set of algorithms are assigned to the different designated concentration ranges of the analyte in the bodily fluid according to at least one assignment criterion.

[0138] Embodiment 11 : The method according to the preceding embodiment, wherein the assignment criterion is selected from the group consisting of: the algorithm fulfills at least one quality criterion in the concentration range, specifically at least one criterion quantifying at least one of: the precision; the accuracy by which the estimate value matches the analyte concentration in the bodily fluid in the concentration range, more specifically the estimate value being within a predetermined tolerance range around the analyte concentration in the bodily fluid in the concentration range; the algorithm is suited to identify, specifically suited to identify with a higher success rate than one or any further available algorithm within the respective concentration range, at least one predetermined feature in the analytical measurement data when the analyte concentration is within the concentration range, specifically at least one onedimensional or two-dimensional geometrical feature, more specifically is suited to detect at least one line in image data contained in the measurement data, wherein the image data are image data of at least one part of at least one test field of an optical test element having the sample of the bodily fluid applied thereto, the test field comprising at least one test chemical configured for performing at least one optically detectable detection reaction in the presence of the analyte, with the analyte concentration being in the concentration range.

[0139] Embodiment 12: The method according to any one of the preceding embodiments, wherein, in step iii ., a plurality of algorithms is selected from the set of algorithms.

[0140] Embodiment 13 : The method according to the preceding embodiment, wherein, in step iv., the algorithms of the plurality of algorithms are applied to the at least one part of the measurement data one or both of simultaneously and successively, specifically by using a predetermined sequence of algorithms.

[0141] Embodiment 14: The method according to any one of the two preceding embodiments, wherein, in step iv., with each of the algorithms, at least one item of information describing one or both of the presence of the analyte in the bodily fluid and the concentration of the analyte in the bodily fluid is determined from the measurement data, wherein step iv. further comprises combining the items of information, thereby generating at least one combined item of information describing one or both of the presence of the analyte in the bodily fluid and the concentration of the analyte in the bodily fluid.

[0142] Embodiment 15: The method according to the preceding embodiment, wherein the combined item of information is determined by averaging the items of information determined by using the at least two algorithms.

[0143] Embodiment 16: The method according to any one of the preceding embodiments, wherein, in step iii . , at least one predetermined default algorithm from the set of algorithms is selected, wherein, by applying the default algorithm to at least a part of the measurement data in step iv., at least one preliminary item of information describing one or both of the presence of the analyte in the bodily fluid and the concentration of the analyte in the bodily fluid is generated, wherein the preliminary item of information is subjected to at least one sufficiency test.

[0144] Embodiment 17: The method according to the preceding embodiment, wherein the method further comprises, depending on the result of the sufficiency test, selecting at least one further algorithm from the set of algorithms and applying the at least one further algorithm to at least a part of the measurement data, specifically selecting and applying at least one further algorithm adapted to the result of the sufficiency test.

[0145] Embodiment 18: The method according to the preceding embodiment, wherein, by applying the further algorithm to at least a part of the measurement data in step iv., a further preliminary item of information describing one or both of the presence of the analyte in the bodily fluid and the concentration of the analyte in the bodily fluid is generated, wherein the further preliminary item of information is subjected to at least one further sufficiency test.

[0146] Embodiment 19: The method according to the preceding embodiment, wherein the method further comprises, depending on the result of the further sufficiency test, selecting at least one third algorithm from the set of algorithms and applying the at least one further algorithm to at least a part of the measurement data.

[0147] Embodiment 20: The method according to any one of the four preceding embodiments, wherein the at least one sufficiency test or further sufficiency test, respectively, comprises at least one test selected from the group consisting of: checking if the preliminary item of information or the further preliminary item of information, respectively, contains a value within at least one predetermined range, specifically, if a concentration of the analyte is within at least one predetermined concentration range; checking if the preliminary item of information or the further preliminary item of information, respectively, fulfills at least one plausibility condition; checking if the preliminary item of information or the further preliminary item of information, respectively, contains accuracy information fulfilling at least one accuracy condition; checking if the preliminary item of information or the further preliminary item of information, respectively, indicate that at least one geometrical feature has been detected in the analytical measurement data, specifically in analytical image data, more specifically indicate that at least one line has been detected; checking if an obtained estimate value determined by using the selected at least one predetermined default algorithm from the set of algorithms is within a concentration range for which the predetermined default algorithm is optimized and / or selected.

[0148] Embodiment 21 : The method according to any one of the preceding embodiments, wherein steps iii. and iv. are performed repeatedly.

[0149] Embodiment 22: The method according to any one of the preceding embodiments, wherein the analytical measurement data contain image data of at least one part of at least one test field of an optical test element having the sample of the bodily fluid applied thereto, the test field comprising at least one test chemical configured for performing at least one optically detectable detection reaction in the presence of the analyte, specifically image data of at least a part of at least one test field an optical test element selected from the group consisting of a color-formation test strip and a lateral flow test strip, wherein, in step iii., at least two algorithms are selected, wherein step iv. comprises applying, successively or in parallel, the at least two algorithms to the image data.

[0150] Embodiment 23 : The method according to the preceding embodiment, wherein the performance of each algorithm depends on the analyte concentration of the sample.

[0151] Embodiment 24: The method according to any one of the two preceding embodiments, wherein the at least two algorithms comprise at least one first algorithm optimized for a first range of analyte concentration, specifically a high analyte concentration range, and at least one second algorithm optimized for a second range of analyte concentration, specifically a low analyte concentration range, wherein the first and second ranges are not identical.

[0152] Embodiment 25 : The method according to the preceding embodiment, wherein the first and second ranges overlap.

[0153] Embodiment 26: The method according to any one of the two preceding embodiments, wherein the at least two algorithms further comprise at least one third algorithm optimized for a third range of analyte concentration, specifically an intermediate range of analyte concentration.

[0154] Embodiment 27 : The method according to any one of the five preceding embodiments, wherein results obtained by using the at least two algorithms are combined, specifically averaged, specifically in order to improve accuracy and / or the precision of a measurement result.

[0155] Embodiment 28: An analytical device for detecting at least one analyte in a bodily fluid, the analytical device comprising at least one processor, the processor being configured for performing the method according to any one of the preceding embodiments.

[0156] Embodiment 29: The analytical device according to the preceding embodiment, wherein the analytical device is a mobile device, specifically a mobile device having at least one camera.

[0157] Embodiment 30: A computer program comprising instructions which, when the program is executed by the analytical device according to any one of the preceding embodiments referring to an analytical device, cause the analytical device to perform the method according to any one of the preceding embodiments referring to a method.

[0158] Embodiment 31 : A computer-readable medium, specifically a non-transient computer-readable storage medium, comprising instructions which, when the instructions are executed by the analytical device according to any one of the preceding embodiments referring to an analytical device, cause the analytical device to perform the method according to any one of the preceding embodiments referring to a method.

[0159] Embodiment 32: A use of at least one of the method according to any one of the preceding embodiments referring to a method and of the analytical device according to any one of the preceding embodiments referring to an analytical device, for a purpose of use selected from the group consisting of: determining the concentration of glucose in blood; the presence and / or concentration of at least one predetermined virus, specifically the presence of SARS- CoV-2.

[0160] Short description of the Figures

[0161] Further optional features and embodiments will be disclosed in more detail in the subsequent description of embodiments, preferably in conjunction with the dependent claims. Therein, the respective optional features may be realized in an isolated fashion as well as in any arbitrary feasible combination, as the skilled person will realize. The scope of the invention is not restricted by the preferred embodiments. The embodiments are schematically depicted in the Figures. Therein, identical reference numbers in these Figures refer to identical or functionally comparable elements.

[0162] In the Figures:

[0163] Figure 1 shows an exemplary computer-implemented analytical method for detecting at least one analyte in a bodily fluid; and

[0164] Figure 2 shows an exemplary analytical device for detecting at least one analyte in a bodily fluid;

[0165] Figure 3 shows correct virus presence predictions as a function of the virus concentration for three different algorithms optimized for different concentration ranges;

[0166] Figure 4 shows an exemplary method for detecting at least one analyte in a bodily fluid using three algorithms optimized for different concentration ranges in a successive manner;

[0167] Figure 5 shows an exemplary method for detecting at least one analyte in a bodily fluid using three algorithms optimized for different concentration ranges to in a simultaneous manner; Figure 6 shows the prediction of glucose concentration for a signal using a first direct current optimized for a concentration range; and

[0168] Figure 7 shows the prediction of glucose concentration for a signal using a second direct current optimized for a concentration range.

[0169] Detailed description of the embodiments

[0170] In Figure 1, an exemplary computer-implemented analytical method 110 for detecting at least one analyte in a bodily fluid is disclosed. The method 110 comprises the following steps: i. (denoted by reference number 112) retrieving analytical measurement data obtained by applying at least one analytical measurement method to a sample of the bodily fluid; ii. (denoted by reference number 114) providing a set of algorithms, the set of algorithms comprising at least two different analytical algorithms, each analytical algorithm being configured for deriving at least one estimate value from the analytical measurement data, each estimate value describing at least one of a presence of the analyte in the bodily fluid and a concentration of the analyte in the bodily fluid; iii. (denoted by reference number 116) selecting at least one algorithm from the set of algorithms; and iv. (denoted by reference number 118) applying the at least one algorithm to at least a part of the measurement data retrieved in step i. (denoted by reference number 112), thereby generating at least one item of information describing one or both of the presence of the analyte in the bodily fluid and the concentration of the analyte in the bodily fluid; wherein, in step iii. (denoted by reference number 116), at least one predetermined default algorithm from the set of algorithms is selected, wherein, by applying the default algorithm to at least a part of the measurement data in step iv. (denoted by reference number 118), at least one preliminary item of information describing one or both of the presence of the analyte in the bodily fluid and the concentration of the analyte in the bodily fluid is generated, wherein the preliminary item of information is subjected to at least one sufficiency test. The at least one sufficiency test comprises at least one test selected from the group consisting of: checking if the preliminary item of information contains a value within at least one predetermined range; checking if the preliminary item of information fulfills at least one plausibility condition; checking if the preliminary item of information contains accuracy information fulfilling at least one accuracy condition; checking if the preliminary item of information indicate that at least one geometrical feature has been detected in the analytical measurement data; checking if an obtained estimate value determined by using the selected at least one predetermined default algorithm from the set of algorithms is within a concentration range for which the predetermined default algorithm is optimized and / or selected.

[0171] The analytical measurement method of step i. (denoted by reference number 112), by which the analytical measurement data are obtained, may comprise applying the sample of the bodily fluid to at least one test element 126 comprising at least one test chemical 128 configured for performing at least one detectable detection reaction in the presence of the analyte.

[0172] The retrieving in step i. (denoted by reference number 112) may comprise at least one of: performing at least a part of the analytical measurement method, specifically performing at least one detection measurement for detecting the detectable detection reaction; controlling at least a part of the analytical measurement method, specifically controlling at least one of an optical measurement by using at least one optical detector 134, more specifically at least one camera 124, and / or an electrochemical measurement by using at least one electrochemical measurement device; prompting the user to perform at least a part of the analytical measurement method, specifically prompting the user to apply the sample of the bodily fluid to the at least one test element 126.

[0173] The analytical measurement method of step i. (denoted by reference number 112), by which the analytical measurement data are obtained, may comprise using at least one mobile device having at least one camera 124.

[0174] The analytical measurement data may be selected from the group consisting of: image data of at least one part of at least one test field 130 of an optical test element 132 having the sample of the bodily fluid applied thereto, the test field 130 comprising at least one test chemical 128 configured for performing at least one optically detectable detection reaction in the presence of the analyte, specifically image data of at least a part of at least one test field 130 an optical test element 132 selected from the group consisting of a color-formation test strip and a lateral flow test strip; electrochemical measurement data obtained by applying at least one electrochemical measurement method to the sample of the bodily fluid.

[0175] Step i. (denoted by reference number 112) of the method may comprise prompting a user to perform the at least one analytical measurement method.

[0176] At least one of the analytical algorithms may comprise at least one of: a calibration curve transforming at least a part of the measurement data into the estimate value; a lookup table containing a plurality of data pairs, each data pair comprising a data value of the measurement data and an estimate value assigned to the data value of the measurement data; a feature detection algorithm for detecting at least one feature in the analytical measurement data, specifically at least one one-dimensional or two-dimensional geometrical feature, more specifically a line detection algorithm.

[0177] At least one of the analytical algorithms may be obtained by performing at least one calibration measurement, the at least one calibration measurement comprising determining data values for a plurality of calibration samples having differing known analyte concentrations.

[0178] At least two algorithms of the set of algorithms may be assigned to different designated concentration ranges of the analyte in the bodily fluid.

[0179] The algorithms of the set of algorithms may be assigned to the different designated concentration ranges of the analyte in the bodily fluid according to at least one assignment criterion.

[0180] The assignment criterion may be selected from the group consisting of: the algorithm fulfills at least one quality criterion in the concentration range, specifically at least one criterion quantifying at least one of: the precision; the accuracy by which the estimate value matches the analyte concentration in the bodily fluid in the concentration range, more specifically the estimate value being within a predetermined tolerance range around the analyte concentration in the bodily fluid in the concentration range; the algorithm is suited to identify, specifically suited to identify with a higher success rate than one or any further available algorithm within the respective concentration range, at least one predetermined feature in the analytical measurement data when the analyte concentration is within the concentration range, specifically at least one one-dimensional or two-dimensional geometrical feature, more specifically is suited to detect at least one line in image data contained in the measurement data, wherein the image data are image data of at least one part of at least one test field 130 of an optical test element 132 having the sample of the bodily fluid applied thereto, the test field 130 comprising at least one test chemical 128 configured for performing at least one optically detectable detection reaction in the presence of the analyte, with the analyte concentration being in the concentration range.

[0181] In step iii. (denoted by reference number 116), a plurality of algorithms may be selected from the set of algorithms.

[0182] In step iv. (denoted by reference number 118), the algorithms of the plurality of algorithms may be applied to the at least one part of the measurement data one or both of simultaneously and successively, specifically by using a predetermined sequence of algorithms.

[0183] In step iv. (denoted by reference number 118), with each of the algorithms, at least one item of information may describe one or both of the presence of the analyte in the bodily fluid and the concentration of the analyte in the bodily fluid may be determined from the measurement data, wherein step iv. (denoted by reference number 118) further may comprise combining the items of information, thereby generating at least one combined item of information describing one or both of the presence of the analyte in the bodily fluid and the concentration of the analyte in the bodily fluid.

[0184] The combined item of information may be determined by averaging the items of information determined by using the at least two algorithms.

[0185] The method may further comprise, depending on the result of the sufficiency test, selecting at least one further algorithm from the set of algorithms and applying the at least one further algorithm to at least a part of the measurement data, specifically selecting and applying at least one further algorithm adapted to the result of the sufficiency test.

[0186] By applying the further algorithm to at least a part of the measurement data in step iv. (denoted by reference number 118), a further preliminary item of information describing one or both of the presence of the analyte in the bodily fluid and the concentration of the analyte in the bodily fluid may be generated, wherein the further preliminary item of information is subjected to at least one further sufficiency test.

[0187] The method may further comprise, depending on the result of the further sufficiency test, selecting at least one third algorithm from the set of algorithms and applying the at least one further algorithm to at least a part of the measurement data.

[0188] The at least one further sufficiency test may comprise at least one test selected from the group consisting of: checking if the further preliminary item of information, respectively, contains a value within at least one predetermined range, specifically, if a concentration of the analyte is within at least one predetermined concentration range; checking if the further preliminary item of information, respectively, fulfills at least one plausibility condition; checking if the further preliminary item of information, respectively, contains accuracy information fulfilling at least one accuracy condition; checking if the further preliminary item of information, respectively, indicate that at least one geometrical feature has been detected in the analytical measurement data, specifically in analytical image data, more specifically indicate that at least one line has been detected.

[0189] Steps iii. (denoted by reference number 116) and iv. (denoted by reference number 118) may be performed repeatedly.

[0190] The analytical measurement data may contain image data of at least one part of at least one test field 130 of an optical test element 132 having the sample of the bodily fluid applied thereto, the test field 130 comprising at least one test chemical 128 configured for performing at least one optically detectable detection reaction in the presence of the analyte, specifically image data of at least a part of at least one test field 130 an optical test element 132 selected from the group consisting of a color-formation test strip and a lateral flow test strip, wherein, in step iii. (denoted by reference number 116), at least two algorithms are selected, wherein step iv. (denoted by reference number 118) comprises applying, successively or in parallel, the at least two algorithms to the image data.

[0191] The performance of each algorithm may depend on the analyte concentration of the sample. The at least two algorithms may comprise at least one first algorithm optimized for a first range of analyte concentration, specifically a high analyte concentration range, and at least one second algorithm optimized for a second range of analyte concentration, specifically a low analyte concentration range, wherein the first and second ranges are not identical. The first and second ranges may overlap.

[0192] The at least two algorithms may further comprise at least one third algorithm optimized for a third range of analyte concentration, specifically an intermediate range of analyte concentration. Results obtained by using the at least two algorithms may be combined, specifically averaged, specifically in order to improve accuracy and / or the precision of a measurement result.

[0193] In Figure 2, an exemplary analytical device 120 for detecting at least one analyte in a bodily fluid is disclosed. The analytical device 120 comprises at least one processor 122, the processor 122 being configured for performing the method 110. The analytical device 120 may be a mobile device, as exemplarily depicted in Figure 2, specifically a mobile device having at least one camera 124.

[0194] The exemplary analytical device 120 is exemplarily running a computer program comprising instructions which, when the program is executed by the analytical device 120, cause the analytical device 120 to perform the method 110.

[0195] Further disclosed is a computer-readable medium, specifically a non-transient computer- readable storage medium (not depicted), comprising instructions which, when the instructions are executed by the analytical device 120, cause the analytical device 120 to perform the method 110.

[0196] The method 110 and the analytical device 120 may be used for a purpose of use selected from the group consisting of: determining the concentration of glucose in blood; the presence and / or concentration of at least one predetermined virus, specifically the presence of SARS- CoV-2. Further details concerning the present invention may be derived from Figure 3. Figure 3 shows the relative amount of correct virus presence predictions for three different algorithms. On the horizontal axis 136, the virus concentration is depicted in arbitrary units. On the vertical axis 138, the relative amount of correct predictions in percent is depicted. The correct virus presence predictions 140 of the different algorithms are indicated by using different line styles.

[0197] For obtaining Figure 3, a set of 2275 images has been collected in the laboratory. Before capturing the images, a sample has been applied to a lateral flow test element indicating the presence of the analyte via a test line. The samples span a broad range of concentrations; from zero, including very low concentrations, to very high virus concentrations, e.g. 50-500 arbitrary units. Test lines in the images with low concentrations are harder to detect, because the lines generated are very faint. In contrast, test lines generated with high virus concentrations yield very bold lines that are fairly easy to detect.

[0198] As already indicated, three different algorithms have been tested. The correct virus presence predictions 140 of algorithm 1 (denoted by reference number 142) are illustrated by using the solid line. Algorithm 1 (denoted by reference number 142) uses the brightness of the image and determines the presences of lines after correcting for illumination. The correct virus presence predictions 140 of algorithm 2 (denoted by reference number 148) are illustrated by using the dashed line. Algorithm 2 (denoted by reference number 148) weights the image colors, e.g. RGB colors, to gather the largest variation from the background color to the line color and then determines the presences of lines. The correct virus presence predictions 140 of algorithm 3 (denoted by reference number 152) are illustrated by using the dashed-dotted line. Algorithm 3 (denoted by reference number 152) uses the brightness of the image and looks for brightness changes having a specific geometry that precisely matches an expected test line geometry.

[0199] The relative amount of correct virus presence predictions of each implemented algorithm depends on the virus concentration of the solutions applied to the lateral flow tests before capturing the images. In Figure 4, the relative amount of correct virus presence predictions of each algorithm is shown in dependence on the virus concentration. Any tested algorithm correctly predicts 100% of the samples having high virus concentrations. In the intermediate ranges, however, the relative amount of correct virus presence predictions of each algorithm differs. For intermediate-high concentrations between 10 and 20, the relative amount of correct virus presence predictions of algorithm 1 (denoted by reference number 142) is higher than for the further two algorithms. For intermediate-low concentrations between 5 and 10, the relative amount of correct virus presence predictions of algorithm 2 (denoted by reference number 148) is higher than of the further two algorithms. For very low concentration around 1, algorithm 3 (denoted by reference number 152) is able to detect 4% of the positive tests, while the further two algorithms do not detect any. The parameters of the three algorithms are set such that zero false positives are returned.

[0200] As may be derived from Figure 3, in different concentration ranges, there may be an algorithm that outperforms the others in terms of correctly predicting a higher percentage of tests. In order to yield the highest possible performance in all virus concentration ranges, an exemplary method 110 using the three algorithms of Figure 3 in a successive manner is illustrated in Figure 4.

[0201] The starting point of the method is denoted by reference number 141. In case an image of a high concentration sample is provided, there is a high chance that algorithm 1 (denoted by reference number 142) would detect a feature caused by the detection reaction, such as a line. Once algorithm 1 (denoted by reference number 142) generated at least one item of information describing the presence of the analyte in the bodily fluid, the item of information describing the presence of the analyte in the bodily fluid is evaluated in order to derive if the analyte is present or not (denoted by reference number 144). If the feature is detected, which may indicate that the analyte is present, by algorithm 1 (denoted by reference number 142), a positive result may be indicated to a user (denoted by reference number 146). Alternatively or in addition, the algorithm 2 (denoted by reference number 148) may generate at least one item of information describing the presence of the analyte in the bodily fluid. The item of information describing the presence of the analyte in the bodily fluid generated by algorithm 1 (denoted by reference number 142) and algorithm 2 (denoted by reference number 148) may be combined. The combined item of information describing the presence of the analyte in the bodily fluid may be indicated to the user (denoted by reference number 146). Alternatively or in addition, algorithm 2 (denoted by reference number 148) may be used for a plausibility check.

[0202] In case no feature is detected by algorithm 1 (denoted by reference number 142), algorithm 2 (denoted by reference number 148) may be applied to generate at least one item of information describing the presence of the analyte in the bodily fluid. This may typically be the case, when an intermediate-low concentration sample is provided. Once algorithm 2 (denoted by reference number 148) generated at least one item of information describing the presence of the analyte in the bodily fluid, the item of information describing the presence of the analyte in the bodily fluid is evaluated in order to derive if the analyte is present or not (denoted by reference number 150). If the feature is detected, which may indicate that the analyte is present, by algorithm 2 (denoted by reference number 148), a positive result may be indicated to a user (denoted by reference number 146). Alternatively or in addition, algorithm 3 (denoted by reference number 152) may generate at least one item of information describing the presence of the analyte in the bodily fluid. The item of information describing the presence of the analyte in the bodily fluid generated by algorithm 2 (denoted by reference number 148) and algorithm 3 (denoted by reference number 152) may be combined. The combined item of information describing the presence of the analyte in the bodily fluid may be indicated to the user (denoted by reference number 146). Alternatively or in addition, algorithm 3 (denoted by reference number 152) may be used for a plausibility check.

[0203] In case no feature is detected by algorithm 2 (denoted by reference number 148), algorithm 3 (denoted by reference number 152) may be applied to generated at least one item of information describing the presence of the analyte in the bodily fluid. Once algorithm 3 (denoted by reference number 152) generated at least one item of information describing the presence of the analyte in the bodily fluid, the item of information describing the presence of the analyte in the bodily fluid is evaluated in order to derive if the analyte is present or not (denoted by reference number 154). The result may be indicated to a user (denoted by reference number 146). The scheme of method may comprise at least one further algorithm 4, 5, 6, 7 and so on and / or may be used to determine the concentration of the analyte.

[0204] As may be derived from Figure 5, the method described in Figure 4 may also be can also be implemented in a manner that the algorithms generate the at least one item of information describing the presence of the analyte in the bodily fluid simultaneously. The most demanding computational task may be the evaluation of the images by each algorithm. When computational power is available, time may also be optimized by parallelizing the evaluation of the images with each algorithm. The decision on whether a line was found is then computed with logical operators.

[0205] A further example is an electro-chemical system used for measuring glucose with, in this example, two independent direct current signals DC33 and DC23 analysed by using different algorithms f23 and f33. The prediction of algorithm f33 of the glucose concentration is indicated in Figure 6. On the horizontal axis 156, the signal D33 in nA is indicated. On the vertical axis 158, the glucose concentration in milligram per decilitres (mg / dl) is indicated. The prediction of the glucose concentration of algorithm f33 is indicated by reference number 159. The dots 160 indicate measurement data points. Further, an algorithm switching threshold 162 is indicated. The prediction of algorithm f23 of the glucose concentration is indicated in Figure 7. On the horizontal axis 164, the signal D23 in nA is indicated. On the vertical axis 166, the glucose concentration in mg / dl is indicated. The prediction of the glucose concentration of algorithm f23 is indicated by reference number 167. The dots 160 indicate the measurement data points. Further, the algorithm switching threshold 162 is indicated.

[0206] The signal DC33 is suitable for covering the whole concentration range of the analyte from 0 to approximately 2100 mg / dl. The signal DC23 shows a very good glucose correlation up to approx. 600 mg / dl. Above 600 mg / dl, the change of signal per concentration change is underestimating the true concentration values.

[0207] The signal DC33 is derived by using an algorithm, such as a predetermined relation f33, between DC33 and glucose concentration, using the full glucose range. The relation f33 may be a linear or quadratic or other fit suitable to model the correlation between DC33 and glucose concentration. The second model may be a predetermined relation f23 between DC23 and glucose concentration, that is only valid for a reduced glucose range, e.g.0-600 mg / dl in this example. Again, the relation f23 may be a linear or quadratic fit suitable to model the correlation between DC23 and glucose concentration for glucose concentrations below 600 mg / dl.

[0208] During a measurement, the glucose concentration may be estimated by the measured signal DC33 using model f33. In case the estimated concentration is above a certain threshold, such as 600 mg / dl, the final result of the measurement will be estimated concentration. If the estimated concentration is below this limit, a second concentration estimation gc23 is calculated using DC23 and algorithm f23. In this case, the final result may be a combination, specifically the average of both estimations. Averaging two independent estimations may lead to an increased precision in the concentration range below the threshold 600 mg / dl.

[0209] List of reference numbers

[0210] 110 computer-implemented analytical method for detecting at least one analyte in a bodily fluid retrieving analytical measurement data providing a set of algorithms selecting at least one algorithm applying the at least one algorithm to at least a part of the measurement data analytical device processor camera test element test chemical test field optical test element optical detector horizontal axis vertical axis correct virus presence predictions starting point algorithm 1 evaluating item of information describing the presence of the analyte in the bodily fluid generated by the algorithm 1 indicating result algorithm 2 evaluating item of information describing the presence of the analyte in the bodily fluid generated by the algorithm 2 algorithm 3 evaluating item of information describing the presence of the analyte in the bodily fluid generated by the algorithm 3 horizontal axis vertical axis prediction of the glucose concentration of algorithm f33 data points algorithm switching threshold horizontal axis vertical axis prediction of the glucose concentration of algorithm f23

Claims

Claims1. A computer-implemented analytical method for detecting at least one analyte in a bodily fluid, the method comprising: i. retrieving analytical measurement data obtained by applying at least one analytical measurement method to a sample of the bodily fluid; ii. providing a set of algorithms, the set of algorithms comprising at least two different analytical algorithms, each analytical algorithm being configured for deriving at least one estimate value from the analytical measurement data, each estimate value describing at least one of a presence of the analyte in the bodily fluid and a concentration of the analyte in the bodily fluid; iii. selecting at least one algorithm from the set of algorithms; and iv. applying the at least one algorithm to at least a part of the measurement data retrieved in step i., thereby generating at least one item of information describing one or both of the presence of the analyte in the bodily fluid and the concentration of the analyte in the bodily fluid; wherein, in step iii., at least one predetermined default algorithm from the set of algorithms is selected, wherein, by applying the default algorithm to at least a part of the measurement data in step iv., at least one preliminary item of information describing one or both of the presence of the analyte in the bodily fluid and the concentration of the analyte in the bodily fluid is generated, wherein the preliminary item of information is subjected to at least one sufficiency test, wherein the at least one sufficiency test comprises at least one test selected from the group consisting of: checking if the preliminary item of information contains a value within at least one predetermined range; checking if the preliminary item of information fulfills at least one plausibility condition; checking if the preliminary item of information contains accuracy information fulfilling at least one accuracy condition; checking if the preliminary item of information indicates that at least one geometrical feature has been detected in the analytical measurement data; checking if an obtained estimate value determined by using the selected at least one predetermined default algorithm from the set of algorithms is within a concentration range for which the predetermined default algorithm is optimized and / or selected.

2. The method according to the preceding claim, wherein the analytical measurement method of step i., by which the analytical measurement data are obtained, comprises using at least one mobile device having at least one camera (124).

3. The method according to any one of the preceding claims, wherein the analytical measurement data are selected from the group consisting of: image data of at least one part of at least one test field (130) of an optical test element (132) having the sample of the bodily fluid applied thereto, the test field (130) comprising at least one test chemical (128) configured for performing at least one optically detectable detection reaction in the presence of the analyte; electrochemical measurement data obtained by applying at least one electrochemical measurement method to the sample of the bodily fluid.

4. The method according to any one of the preceding claims, wherein at least one of the analytical algorithms comprises at least one of: a calibration curve transforming at least a part of the measurement data into the estimate value; a lookup table containing a plurality of data pairs, each data pair comprising a data value of the measurement data and an estimate value assigned to the data value of the measurement data; a feature detection algorithm for detecting at least one feature in the analytical measurement data.

5. The method according to any one of the preceding claims, wherein the algorithms of the set of algorithms are assigned to different designated concentration ranges of the analyte in the bodily fluid according to at least one assignment criterion, wherein the assignment criterion is selected from the group consisting of: the algorithm fulfills at least one quality criterion in the concentration range, the at least one criterion quantifying at least one of: the precision; the accuracy by which the estimate value matches the analyte concentration in the bodily fluid in the concentration range; the algorithm is suited to identify at least one predetermined feature in the analytical measurement data when the analyte concentration is within the concentration range.

6. The method according to any one of the preceding claims, wherein, in step iii ., a plurality of algorithms is selected from the set of algorithms.

7. The method according to the preceding claim, wherein, in step iv., the algorithms of the plurality of algorithms are applied to the at least one part of the measurement data simultaneously or successively.

8. The method according to any one of the two preceding claims, wherein, in step iv., with each of the algorithms, at least one item of information describing one or both of the presence of the analyte in the bodily fluid and the concentration of the analyte in the bodily fluid is determined from the measurement data, wherein step iv. further comprises combining the items of information, thereby generating at least one combined item of information describing one or both of the presence of the analyte in the bodily fluid and the concentration of the analyte in the bodily fluid.

9. The method according to any one of the preceding claims, wherein the method further comprises, depending on the result of the sufficiency test, selecting at least one further algorithm from the set of algorithms and applying the at least one further algorithm to at least a part of the measurement data.

10. The method according to the preceding claim, wherein, by applying the further algorithm to at least a part of the measurement data in step iv., a further preliminary item of information describing one or both of the presence of the analyte in the bodily fluid and the concentration of the analyte in the bodily fluid is generated, wherein the further preliminary item of information is subjected to at least one further sufficiency test.

11. The method according to the preceding claim, wherein the method further comprises, depending on the result of the further sufficiency test, selecting at least one third algorithm from the set of algorithms and applying the at least one further algorithm to at least a part of the measurement data.

12. The method according to any one of the two preceding claims, wherein the at least one further sufficiency test comprises at least one test selected from the group consisting of: checking if the further preliminary item of information, respectively, contains a value within at least one predetermined range; checking if the further preliminary item of information, respectively, fulfills at least one plausibility condition;checking if the further preliminary item of information, respectively, contains accuracy information fulfilling at least one accuracy condition; checking if the further preliminary item of information, respectively, indicate that at least one geometrical feature has been detected in the analytical measurement data.

13. An analytical device (120) for detecting at least one analyte in a bodily fluid, the analytical device (120) comprising at least one processor (122), the processor (122) being configured for performing the method according to any one of the preceding claims.

14. A computer program comprising instructions which, when the program is executed by the analytical device (120) according to any one of the preceding claims referring to an analytical device (120), cause the analytical device (120) to perform the method according to any one of the preceding claims referring to a method.

15. A computer-readable medium comprising instructions which, when the instructions are executed by the analytical device (120) according to any one of the preceding claims referring to an analytical device (120), cause the analytical device (120) to perform the method according to any one of the preceding claims referring to a method.

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