Analytical measurement method for detecting multiple analytes in a bodily fluid

Abstract

The present invention relates to a computer-implemented analytical measurement method for detecting a first analyte and a second analyte in a single sample of a bodily fluid, - wherein the first analyte is detectable from a first reagent test region (25) of a hybrid test element (40), the first reagent test region being configured for performing an optical detection reaction in the presence of the first analyte; - wherein the second analyte is detectable from a second reagent test region (26) of the hybrid test element, the second reagent test region being configured for performing an electrochemical detection reaction in the presence of the second analyte; and - wherein the first analyte is detectable from the first reagent test region, by using a camera (64) of a mobile device (60), when the hybrid test element is connected to an electrochemical reader unit (70); the method comprising: i) receiving an image captured by the camera of the mobile device, the image comprising a part of the first reagent test region having a first part of the single sample of the bodily fluid applied thereto; the image being captured when the hybrid test element is connected to an electrochemical reader unit; and ii) detecting the first analyte by using the image received in step i); and iii) detecting the second analyte by iii.a) using the image received in step i), the image further comprising a part of the electrochemical reader unit having an optically detectable indicator element (78) which is indicative of the electrochemical detection reaction; or iii.b) using a wireless signal received from the electrochemical reader unit (transmission unit 82), the wireless signal being indicative of the electrochemical detection reaction; wherein the second reagent test region has a second part of the single sample of the bodily fluid applied thereto.

Description

[0001] Analytical measurement method for detecting multiple analytes in a bodily fluid

[0002] Technical Field

[0003] The present invention relates to an analytical measurement method for detecting at least two analytes in a single sample of a bodily fluid, wherein one analyte is detected by means of an optical detection reaction, and another analyte is detected by means of an electrochemical detection reaction. Further, the invention relates to a hybrid test element for detection of the at least two analytes; and to an electrochemical reader unit for detection of at least a second analyte in a single sample of a bodily fluid; and to a mobile device having a camera; and to a kit comprising at least two of a hybrid test element, an electrochemical reader unit, and a mobile device. The hybrid test element, the electrochemical reader unit, and the mobile device each are adapted to be used in the analytical measurement method. Further, the invention relates to computer programs and computer-readable storage media for carrying out the analytical measurement method. The method, hybrid test element, electrochemical reader unit, mobile device, computer programs and storage media specifically may be used in medical diagnostics, particularly in order to qualitatively or quantitatively detect two or more analytes in bodily fluids, such as for detecting glucose, or other metabolites, virus load, or other biomarkers, such as related to cardiovascular diseases, in blood or in interstitial fluid.

[0004] Background art

[0005] In the field of medical diagnostics, in many cases, one or more analytes have to be detected in samples of a bodily fluid, such as blood, interstitial fluid, urine, saliva or other types of bodily fluids. Examples of analytes to be detected are glucose, triglycerides, lactate, cholesterol, or other metabolites; any type of bio-markers, such as related to cardiovascular diseases; or other types of analytes, like viruses; all of which typically may be present in these bodily fluids. According to the concentration and / or the presence of the analyte, an appropriate treatment may be chosen, if necessary.

[0006] Generally, devices and methods known to the skilled person make use of test elements comprising one or more test chemicals, which, in the presence of the analyte to be detected, are capable of performing one or more detectable detection reactions, such as optically detectable detection reactions and electrochemically detectable detection reactions. With regard to the test chemicals comprised in such test elements, as well as to the corresponding optically or electrochemically detectable detection reactions, reference may be made e.g. to f. Hoenes et al.: The Technology Behind Glucose Meters: Test Strips, Diabetes Technology & Therapeutics, Volume 10, Supplement 1, 2008, S-10 to S-26. Other test chemicals, e.g. for detecting viruses, particularly by using lateral flow assays, are known to the person skilled in the art.

[0007] From a medical point of view, a user often may benefit from performing more than one analytical measurement in parallel, i.e. essentially at the same time, or a patient may even be required to perform such multiple analytical measurements in parallel in order to take care of several afflictions. In such situations, e.g. combined measurements of a specific bio-marker on the one hand and a specific parameter on the other hand may be beneficial to an individual user.

[0008] So far, however, a user needs to employ various different test elements, e.g. test strips available, each one relating to a different analyte. Generally, each of a plurality of test elements is unique in that it comes with its own vial, and has a specific shelf-life, use-by period, and individual read-out solutions / methods associated therewith. Thus, dealing with a number of considerably distinct analytical measurement systems, in parallel or at the same time, may present some challenges, specifically for layman users. Particularly, with a view to ensure that reliable results are obtained from such analytical measurements, the right usage / handling of each individual analytical measurement system is of high importance. For example, two distinct analytical measurement systems, each involving use of a different test strip for a different analyte, may require different sample volumes, different waiting times before a result is obtained, etc.

[0009] For analytical measurements carried out by layman users in home testing scenarios, dedicated analytical devices, such as handheld analytical meters, e.g. blood glucose meters, have been widely used for many years. For example, electrochemical test strips allow convenient high- precision blood glucose measurements, and colorimetric test strips, based on optical detection reactions, are well-established for various other analytes, e.g. bio-markers related to cardiovascular disease or kidney disease. Besides using such dedicated handheld analytical devices, the use of generally available electronics, such as smart phones and portable computers, or other mobile devices, has become more and more popular over the recent years.

[0010] As opposed to laboratory measurements and measurements performed by using dedicated analytical measurement devices, when using mobile computing devices such as smart phones, additional influences need to be taken into account, such as lighting conditions and positioning aspects. Nonetheless, in view of their widespread availability, it is desirable to further simplify and ameliorate the usability of such mobile devices for performing analytical measurements, specifically in a home testing scenario by layman users. EP2972125B1 describes a method of determining concentrations of a plurality of analytes from a single blood sample, the method i.a. making use of a hybrid test strip having an elongated disbursement layer, three stacks, and an electrochemical testing member, wherein a colored response at the bottom of each stack is proportional to a concentration of an analyte in the blood sample. US2011155590A1 also relates to a method of determining concentrations of a plurality of analytes from a single blood sample, wherein analytes are determined from a colored response or from an electrical property. US7887750B2 relates to a cartridge comprising at least one reagent and at least two test sites, each test site having at least one test site read zone for the detection or quantification of an analyte, wherein the testing techniques for the detection or quantification of the analytes may be selected from optical and electrochemical techniques, respectively.

[0011] US8737971B2 discloses a universal personal diagnostic platform system, i.a. comprising a patient diagnostic device comprising a mobile communication device, a universal personal diagnostic platform physically connected to the mobile communication device, and a lateral flow device or an electrochemical reader inserted into the universal personal diagnostic platform. Thereby, the mobile communication device may be used together with a lateral flow device or an electrochemical reader, such as using a data connection via USB, or using a wireless data connection.

[0012] US20220260556A1 relates to a saliva test system for performing an ELISA or ELONA test, the system comprising a saliva receiver; an incubation chamber having bioreceptors for binding to the analyte and reagent; a test chamber having biosensing test electrodes; a controller to control the biosensing test electrodes to perform the biosensing test; and a user interface to indicate a status of a user based on a result of the biosensing test indicating presence or concentration of the analyte in the collected saliva, wherein the system further comprises a narrowing of the inlet channel and a vent hole. The user status indication may be, e.g., on a display of a reader device connectable to a test strip, and / or by wireless communication to a remote computing device such as a mobile phone that displays the status using an app.

[0013] Despite the advantages involved in using mobile computing devices for the purpose of performing an analytical measurement, one of the remaining technical challenges still is to further simplify and enhance the usability of common mobile devices for performing analytical measurements in a home testing scenario by layman users, specifically when more than one analyte is to be detected, and particularly if different analytes require different measurement techniques to be employed. Problem to be solved

[0014] It is therefore desirable to provide methods and devices which at least partially address the above-mentioned challenges. Specifically, it is desirable to provide methods and devices which allow for a reliable detection of at least two different analytes in parallel, or essentially simultaneously, which methods and devices facilitate mobile-based analytical measurements which demand an accurate detection of an analyte in a bodily fluid. Thus, although different detection methods may be employed for the different analytes to be detected, it is desirable that only one single sample, and only one test element, is required to perform at least two analytical measurements of at least two different analytes. Specifically, it is desirable to provide an easy and safe way of performing multiple analytical measurements of different analytes, involving use of a mobile device, specifically for layman users in a home testing scenario. Furthermore, it is desirable to further simplify and enhance the usability of common mobile devices for performing analytical measurements in a home testing scenario.

[0015] Summary

[0016] This problem is addressed by an analytical measurement method, specifically a computer- implemented analytical measurement method, for detecting at least a first analyte and a second analyte in a single sample of a bodily fluid; further, by a hybrid test element for detection of at least a first and a second analyte in a single sample of a bodily fluid; further, by an electrochemical reader unit for detection of at least a second analyte in a single sample of a bodily fluid; even further, by a mobile device having at least one camera, and specifically having at least one processor; by a kit comprising at least two of a hybrid test element, an electrochemical reader unit, and a mobile device; and by computer programs and computer-readable storage media; 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.

[0017] Summarizing, a hybrid test element for detecting at least a first analyte by means of an optical detection reaction and at least a second analyte by means of an electrochemical detection reaction, an electrochemical reader unit configured to receive the hybrid test element, and a mobile device having a camera, are provided for use in an analytical measurement method. The hybrid test element, the electrochemical reader unit, and the mobile device each are adapted to be used together in the analytical measurement method, wherein the first analyte is detected by means of an optical detection reaction, using the camera of the mobile device, and the sec- ond analyte is detected by means of an electrochemical detection reaction, using the electrochemical reader unit. In the analytical measurement method, specifically, the hybrid test element is connected to the electrochemical reader unit, e.g. the hybrid test element may be inserted, at least partially, in the electrochemical reader unit. The hybrid test element is configured such that, when it is, specifically partially, inserted in the electrochemical reader unit, the first analyte is optically detectable from at least one first reagent test region of the hybrid test element by using the mobile device having the camera; and the second analyte is electrochemically detectable from at least one second reagent test region of the hybrid test element by using the electrochemical reader unit. Thereby, the first analyte and the second analyte can be detected, specifically essentially simultaneously, by using the hybrid test element together with the electrochemical reader unit and with the mobile device having a camera.

[0018] The method, the hybrid test element, the electrochemical reader unit, and the mobile device, may specifically be used in medical diagnostics, particularly in order to qualitatively or quantitatively detect two or more analytes in bodily fluids, such as for detecting glucose, triglycerides, lactate, cholesterol, or other metabolites; any type of bio-markers, such as related to cardiovascular diseases; or other types of analytes, like viruses; all of which typically may be present in a bodily fluid. According to the concentration and / or the presence of the analyte to be detected, an appropriate treatment may be chosen, if necessary.

[0019] 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.

[0020] 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 a plurality of 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. Further, as used in the following, the terms „preferably“, „more preferably11, particularly11, „more particularly11, specifically11, „more specifically11, 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 invention11or 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.

[0021] In a first aspect, the present invention relates to an analytical measurement method, specifically a computer-implemented analytical measurement method, for detecting, specifically essentially simultaneously, at least a first analyte and a second analyte in a single sample of a bodily fluid. Generally, the second analyte is different from the first analyte.

[0022] The first analyte is detectable from at least one first reagent test region of a hybrid test element. The at least one first reagent test region is configured for performing at least one optical detection reaction in the presence of the first analyte. The second analyte is detectable from at least one second reagent test region of the hybrid test element. The at least one second reagent test region is configured for performing at least one electrochemical detection reaction in the presence of the second analyte.

[0023] Furthermore, the first analyte is detectable from the at least one first reagent test region, by using a camera of a mobile device, when the hybrid test element is connected to an electrochemical reader unit, specifically when the hybrid test element is inserted, at least partially, in the electrochemical reader unit.

[0024] The term “analytical measurement”, also referred to as “detecting an analyte in 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 a quantitative and / or qualitative detection (also referred to as a ’’determination”, as used herein) of at least one analyte in an arbitrary sample or aliquot of bodily fluid. For example, the bodily fluid may comprise one or more of blood, interstitial fluid, urine, saliva or other types of body fluids, particularly blood. The result of the analytical measurement, or of the detection, e.g. of a determining of a concentration, as an example, may be a concentration of the analyte and / or the presence or ab- sence of the analyte to be detected. Specifically, as an example, the analytical measurement may be a blood glucose measurement, thus the result of the analytical measurement may for example be a blood glucose concentration. In particular, an analytical measurement result value may be determined by the analytical measurement. Thus, as used herein, the terms “detection” and “determination” of an analyte bay way of an analytical measurement may relate to any one or more of monitoring, reading-out, analyzing, and evaluating an analytical detection reaction, such as an optical detection reaction or an electrochemical detection reaction.

[0025] Consequently, the term “analyte concentration value”, often also referred to as “analytical measurement result 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 numerical indication of an analyte concentration in a sample. Additionally or alternatively, the term may specifically refer, without limitation, to an indication of the presence or absence of the analyte to be detected.

[0026] The term “essentially simultaneously”, 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 situations, wherein the first analyte and the second analyte both are detected within a specific time frame, which may be pre-determined. Said specific time frame may comprise a period of time of less than 1 minute, e.g. 20 or 30 s; or of one or more minutes, e.g. 1, 2, 3, 5 or 10 min. The “essentially simultaneous” detection of the first analyte and the second analyte generally refers to one or more test results being obtained from an analytical measurement of the first analyte on the one hand and of the second analyte on the other hand, wherein all of the test results are obtained within the specific time frame. In this regard, both of said analytical measurements may be performed in parallel, or subsequently. If both of said analytical measurements are performed subsequently, the detection of the first analyte and the second analyte still is considered to be “essentially simultaneous”, with the proviso that the one or more test results from the analytical measurement of the first and the second analyte are obtained within the specific time frame.

[0027] The at least first and second analyte, as an example, each may be or may comprise, independently from one another, one or more specific chemical compounds and / or other parameters. As an example, one or more analytes may be determined which take part in metabolism, such as blood glucose, cholesterol, triglycerides, lactate, etc. Additionally or alternatively, other types of analytes or parameters may be determined, such as bio-markers related to any car- diovascular disease, kidney disease, etc., e.g. NT-proBNP, Troponin T, potassium, creatinine, as well as a pH value, a virus, such as influenza virus type A or type B, SARS-CoV-2, etc. Without narrowing the scope, the invention specifically may be described with respect to optical analyte measurements, using NT-proBNP as the first analyte, and with respect to electrochemical analyte measurements, using blood glucose as the second analyte. It shall be noted, however, that the present invention may also be used for other types of analytical measurements using hybrid test elements, in particular for analytes other than NT-proBNP and blood glucose.

[0028] In the analytical measurement method for detecting the first analyte in the bodily fluid, the first analyte is detectable from the first reagent test region of the hybrid test element. The first reagent test region is configured for performing at least one optical detection reaction in the presence of the first analyte. Specifically, the first reagent test region is adapted for receiving a first part of the single sample of the bodily fluid, and the reagent test region is adapted to undergo, at least partially, an optical detection reaction, when the first part of the sample of the bodily fluid is applied to the first reagent test region. The first reagent test region may also be referred to as a “test field” herein. Herein, the term “is applied to” includes any way of bringing the first part of the sample of the bodily fluid in contact with the first reagent test region, particularly by flow of the first part of the sample of the bodily fluid from a sample application site of the hybrid test element to the first reagent test region, by flow of the first part of the sample of the bodily fluid from the second reagent test region to the first reagent test region, or by direct application of the sample of the bodily fluid to the first reagent test region. The optical detection reaction may specifically comprise “a color formation reaction”, specifically involving a color-change. More specifically, a color-change involved in an optical detection reaction may result in a change of a color of a reagent test region, e.g. from yellow to green, from white to grey or black, or from white to red or purple. Additionally or alternatively, the color formation reaction may specifically comprise a development of a color which has not been present before the optical detection reaction was performed; this type of optical detection reaction e.g. typically is observed with lateral flow assays. In such lateral flow assays, usually one or more bands, or lines, can be observed in the reagent test region after sample application, and usually after a pre-determined period of waiting time, in case of a positive test result. The terms “optical detection reaction” and “color formation reaction” 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. Specifically, the terms “optical detection reaction” and “color formation reaction” shall comprise any optically detectable changes of the first reagent test re- gion which are attributed to a color formation and / or a development of a color which has not been present before the optical detection reaction was performed.

[0029] In the analytical measurement method for detecting the second analyte in the bodily fluid, the second analyte is detectable from the second reagent test region of the hybrid test element. The second reagent test region is configured for performing at least one electrochemical detection reaction in the presence of the second analyte. Specifically, the second reagent test region is adapted for receiving a second part of the single sample of the bodily fluid, and the second reagent test region is adapted to undergo, at least partially, an electrochemical detection reaction, when the second part of the sample of the bodily fluid is applied to the second reagent test region. Herein, the term “is applied to” includes any way of bringing the second part of the sample of the bodily fluid in contact with the second reagent test region, particularly by flow of the second part of the sample of the bodily fluid from a sample application site of the hybrid test element to the second reagent test region, by flow of the second part of the sample of the bodily fluid from the first reagent test region to the second reagent test region, or by direct application of the sample of the bodily fluid to the second reagent test region. The second reagent test region may also be referred to as a “test field” herein. The electrochemical detection reaction may specifically be detected by using an electrochemical sensor.

[0030] The term “electrochemical sensor” 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, based on an electrochemical detection reaction, in order to detect at least the second analyte contained in the bodily fluid. Specifically, the electrochemical sensor may be associated to, or at least partially or fully integrated in, the second reagent test region of the hybrid test element. The term “electrochemical measurement” refers to a detection of an electrochemically detectable property of the analyte, specifically of the second 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 sensor 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 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. The at least two electrodes of the sensor may be embodied such that an electrochemical detection 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 US 5,286,362 A and 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. Specifically, the afore-mentioned types of measurements can be performed by using a measurement circuit, more specifically a measurement circuit of an electrochemical reader unit according to the present invention which is described herein below in more detail. It shall be noted, however, that other setups, electrode materials or measurement setups may be used within the present invention.

[0031] By applying at least one electrochemical measurement method to the sample of the bodily fluid, measurement data can be obtained, specifically by a measurement circuit, from an electrochemical sensor, which data may also be referred to herein as electrochemical sensor data, or as electrochemical measurement data. The term “measurement data”, or “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 raw data obtained from an electrochemical sensor, e.g. analog signals such as a current, a voltage, a frequency, an impedance, or the like, and / or may include data that has been obtained from processing, at least partially, such raw data. For example, raw data comprising one or more analog signals may be processed by an A / D converter, and may thus be converted into one or more digital signals. Then, the digitized raw data may be further processed and / or evaluated, e.g. by a processor, or by an evaluation unit. Specifically, the “measurement data”, or “electrochemical measurement data”, as used herein is indicative of the at least one electrochemical detection reaction in the presence of the second analyte. Furthermore, one or more items of information may be derived from such “measurement data”, or from such “electrochemical measurement data”, specifically an item of information about the detecting of the second analyte; such an item of information may comprise at least one of a presence, an absence, and a concentration, of the second analyte in the single sample of the bodily fluid. More specifically, the one or more items of information may be derived from such “measurement data” by a processor of an electrochemical reader unit, specifically an electrochemical reader unit according to the present invention, or by a processor of a mobile device, specifically a mobile device according to the present invention.

[0032] The term “hybrid 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 on the one hand, specifically involving a color change, and additionally configured for performing an electrochemical detection reaction on the other hand. The hybrid test element may also be referred to as test strip or test element, wherein all three terms may refer to the same element. The hybrid test element has a first and a second reagent test region, each of which contains, independently from one another, at least one test chemical for detecting at least one analyte. The hybrid test element, as an example, may comprise at least one substrate, such as at least one carrier, with at least the first and the second reagent test region, respectively, applied thereto or integrated therein. As an example, the at least one carrier may be strip-shaped, thereby rendering the test element a test strip. One test strip may carry at least two test fields, or a plurality of test fields, having identical or different test chemicals comprised therein. Furthermore, lateral flow assays which are widely used for various analytes to be detected, e.g. for viruses, usually are comprised of a housing carrying a membrane, a reagent test region being integrated or impregnated into the membrane. The architectures and designs of such lateral flow assays are generally known to the person skilled in the art.

[0033] In particular, the hybrid test element further comprises one or more reference areas, such as a white field, a black field, a grey- scale, and / or a plurality of color reference fields of known characteristics. Additionally or alternatively, the substrate or carrier itself may be or may comprise such a reference area. The hybrid test element comprises a reference area which is adapted to facilitate detection of the first analyte. Such a reference area is arranged in proximity to, specifically adjacent to, the first reagent test region of the hybrid test element, such that an image captured by a camera of a mobile device may comprise both the first reagent test region and the reference area. Specifically, the reference area comprises all components of the first reagent test region of the hybrid test element, but is configured to be inaccessible for the sample of bodily fluid. Thereby, external factors like ambient light conditions, which may adversely impact the detection of the first analyte by using a camera of a mobile device, affect both the first reagent test region and the reference field in the same way. Thus, any measurement values obtained from an analytical measurement of the first reagent test region may be compared to measurement values obtained from an analytical measurement of the reference field. Such a comparison allows for taking into account, at least partially, any impacts from external factors like ambient light conditions. As an example of a test element having a reference area which comprises all components of a reagent test region and which is configured to be inaccessible for the sample of bodily fluid, reference may be made to EP3647774B1.

[0034] As further used herein, the term “reagent test region” (also referred to as a “test field” 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 coherent amount of the test chemical, such as to a field or a membrane, e.g. a field or a membrane of round, polygonal or rectangular shape, having one or more layers of material, with at least one layer of the test field having the test chemical comprised therein. With regard to the test chemicals comprised in such test elements, as well as to the corresponding optically or electrochemically detectable detection reactions, reference is 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.

[0035] The analytical measurement method comprises the following steps which, as an example, may be performed in the given order. It shall be noted, however, that a different order may also be possible. Further, it may also be possible to perform one or more of the method steps once or repeatedly. Further, it may be possible to perform two or more of the method steps simultaneously or in a timely overlapping fashion. The method may comprise further method steps which are not listed.

[0036] The analytical measurement method comprises, in a first step i), receiving, specifically by the mobile device, at least one image captured by using the camera of the mobile device. Herein, the at least one image comprises at least a part of, specifically all of, the first reagent test region of the hybrid test element. Further, the at least one first reagent test region has at least a first part of the single sample of the bodily fluid applied thereto.

[0037] The term “mobile device” as used herein is a broad term it is to be given its ordinary and customary meaning to person of ordinary skill in the art and is not to be limited to a special customized meaning. The term specifically may refer, without limitation, to a mobile electronics device, more specifically to a mobile communication device, such as a cell phone and / or a smart phone. Additionally or alternatively, the mobile device may also refer to a notebook, a tablet computer or another type of portable computer having at least one camera. Thus, generally, the mobile device 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 specifically be used in the method for detecting at least a first analyte and a second analyte in a single sample of a bodily fluid, particularly for performing said analytical measurement method, as will be outlined in further detail below. The mobile device, besides the at least one camera, may comprise further elements, such as one or more processors and one or more displays or screens. As an example, the mobile device may comprise more than one camera, such as a front camera, e.g. arranged on the same side as the one or more displays or screens, and a back camera, e.g. arranged on a side opposing the side on which the front camera is arranged.

[0038] As mentioned above, the mobile device may further comprise at least one processor. 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, for performing one or more operations of determination of an image quality and / or one or more operations of detection of an analyte, as will be outlined in further detail below.

[0039] 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 onedimensional, 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 a camera, such as a plurality of electronic readings from the imaging device, such as the pixels of the camera chip.

[0040] The camera, besides the at least one camera chip or imaging chip, may comprise further elements, such as one or more optical elements, e.g. one or more lenses. As an example, the camera may be a fix-focus camera, having at least one lens which is fixedly adjusted with respect to the camera. Alternatively, however, the camera may also comprise one or more variable lenses which may be adjusted, automatically or manually. The invention specifically shall be applicable to cameras as usually used in mobile applications such as notebook computers, tablets or, specifically, cell phones such as smart phones. Thus, specifically, the camera may be part of a mobile device which, besides the at least one camera, comprises one or more data processing devices such as one or more data processors. Other cameras, however, are feasible.

[0041] As outlined above, the method comprises, in step i), receiving at least one image captured by using the camera of the mobile device. The image comprises at least a part of, specifically all of, the first reagent test region of the hybrid test element having a first part of the sample of the bodily fluid applied thereto. The term “receiving 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. The term “receiving at least one image” may comprise receiving and / or capturing a single image and / or a plurality of images such as a sequence of images. For example, the receiving and / or capturing of the image may comprise recording continuously a sequence of images such as a video or a movie. The receiving and / or capturing of the at least one image may be initiated by the user action or may automatically be initiated, e.g. once the pres- ence of the hybrid test element 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 barcode readers, such as from automatic barcode reading apps. The receiving and / or capturing of the images may take place, as an example, by acquiring a stream or “fife 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 image of step i). The image acquisition may be supported by a processor of the mobile device, and the storing of the images may take place in a data storage device of the mobile device.

[0042] The receiving and / or capturing of the at least one image comprises receiving and / or capturing at least one image with having the sample of the bodily fluid applied to the test strip and, further and optionally, such as before capturing the image with the sample applied to the test strip, receiving and / or capturing at least one image without having the sample of the body fluid applied to the test strip. The latter image specifically may be used for comparative purposes and may also be referred to as a “blank image” or “dry image”. The sample application generally may take place, as an example, directly or indirectly, e.g. via at least one capillary element. The at least one image received and / or captured after sample application may typically also be referred to as the “wet image”, even though the sample may have dried when the image is actually captured. The wet image typically may be received and / or taken after having waited for at least a predetermined waiting time, such as after five seconds or more, in order to allow for at least the optical detection reaction to take place. Thus, as an example, the method may comprise, between receiving and / or taking the at least one optional dry image and the at least one wet image, waiting for at least a predetermined minimum amount of time. This predetermined minimum amount of time specifically may be sufficient for a detection reaction to take place in the test strip, in particular an optical detection reaction and / or an electrochemical detection reaction. As an example, the minimum amount of waiting time may be at least 5 s, or up to 15 min in the case of SARS-CoV-2 rapid antigen LFA (lateral flow assay) self-tests for use by a patient.

[0043] The analytical measurement method further comprises, in step ii): detecting, specifically by using the mobile device, more specifically, by using a camera and / or a processor of the mobile device, the first analyte by using the at least one image received in step i).

[0044] In step ii), detecting at least the first analyte in the single sample of the bodily fluid may comprise detecting the presence or absence of the first analyte. Additionally or alternatively, step ii) may comprise determining a concentration of the first analyte, particularly an analyte con- centration value. Specifically, the presence, absence, and / or concentration of the first analyte may be detected from color formation of the first reagent test region. Additionally or alternatively, the presence, absence, and / or concentration of the first analyte may be detected from another optical change occurring in the first reagent test region, such as the appearance or disappearance of graphical elements, e.g. lines, particularly lines of grey, black, red, orange, blue color, or of any other color. Thus, the analytical measurement method may include a change of at least one optical property of a hybrid test element, such as a hybrid test strip or a hybrid lateral flow assay, which change may be measured or determined visually by using the camera. Specifically, the analytical measurement may be or may comprise a color formation reaction in the presence of the first analyte to be detected. The term “color formation reaction” as used herein has been defined herein above. The color formation may be detected by the mobile device, such as by a processor of the mobile device, and may be evaluated qualitatively, and specifically quantitatively, such as by deriving, from the at least one image, at least one parameter quantifying or characterizing the color formation of the first reagent test region due to the presence of the first analyte in the bodily fluid. To this end, one or more specific color coordinates may be used. Thus, the mobile device and specifically the processor of the mobile device may be configured for determining a color change by determining a change of one or more color coordinates taking place due to the optical detection reaction.

[0045] The presence or absence of the first analyte, or the concentration of the first analyte, particularly the concentration value of the first analyte, is determined from a color formation of the first reagent test region. For this purpose, the at least one image is used. The analyte concentration value, as an example, may be a numerical value indicator of a result of the analytical measurement, such as indicative of the concentration of the first analyte in the sample, such as a NT-proBNP concentration, a blood glucose concentration, or a virus load. For example, for detection of NT-proBNP based on an optical detection reaction, a color formation reaction of the first reagent test region may lead to a development of a color which has not been present before the optical detection reaction was performed, particularly by formation of a red line in the first reagent test region. Such an optical measurement of NT-proBNP can be performed e.g. by using a CARDIAC POC NT-proBNP (LFA) test element together with a cobas h 232 handheld measurement system, both of which are offered by company Roche Diagnostics GmbH, Germany, and are known to the skilled person. As another example of an optical detection reaction, blood sugar may be detected from a color formation reaction of the first reagent test region, wherein the first reagent test region may undergo a color change after sample application. Methods, test elements, and mobile devices which can be used for such an optical detection of blood sugar are described in detail e.g. in EP 3477270A1, US2021 / 0088506A1, and EP 3990902A1. The method further comprises, in step iii): detecting, specifically by using the mobile device; more specifically, by using a camera and / or a processor of the mobile device, the second analyte. In step iii), the detecting the second analyte is achieved either by iii.a) using the at least one image received in step i); or by iii.b) using at least one wireless signal received, specifically by the mobile device, from the electrochemical reader unit.

[0046] For both of steps iii.a) and iii.b), respectively, the at least one second reagent test region has at least a second part of the single sample of the bodily fluid applied thereto.

[0047] Furthermore, for the detection of the first and the second analyte, the hybrid test element generally is connected to the electrochemical reader unit. Specifically, the hybrid test element may be inserted, at least partially, in the electrochemical reader unit. When the hybrid test element is connected to the electrochemical reader unit, at least the second reagent test region is in contact, specifically in electrical contact, with a measurement circuit of the electrochemical reader unit. Thus, the electrochemical sensor may provide measurement data, e.g. sensor raw data, to the measurement circuit of the electrochemical reader unit. A processor of the electrochemical reader unit may receive, and optionally process, the measurement data from the measurement circuit. The measurement data is indicative of the at least one electrochemical detection reaction in the presence of the second analyte. From the measurement data, at least one item of information about the detection of the second analyte may be derived, specifically by a processor of the electrochemical reader unit or by a processor of the mobile device. The item of information may comprise an indication of a presence, an absence, and / or a concentration of the second analyte.

[0048] When the hybrid test element is connected to the electrochemical reader unit, specifically to the measurement circuit of the electrochemical reader unit, at least the first reagent test region still is visually accessible, specifically by the camera of the mobile device. Thereby, the first and the second analyte can be detected in parallel, specifically essentially simultaneously.

[0049] According to step iii.a), the second analyte is detected by using the at least one image received in step i). To this end, the at least one image further comprises at least a part of the electrochemical reader unit, wherein the part of the electrochemical reader unit comprises at least one optically detectable indicator element. The optically detectable indicator element is indicative of the at least one electrochemical detection reaction in the presence of the second analyte. Specifically, the optically detectable indicator element may display the at least one item of information about the detection of the second analyte derived from the measurement data obtained from the electrochemical sensor. For example, the item of information may be a numerical representation of a concentration value of the second analyte in the sample of bodily fluid. Further details about the optically detectable indicator element will be provided herein below.

[0050] Alternatively, according to step iii.b), the second analyte is detected by using at least one wireless signal. The wireless signal is received, specifically by the mobile device, from the electrochemical reader unit. The at least one wireless signal is indicative of the at least one electrochemical detection reaction in the presence of the second analyte. As mentioned herein above, the electrochemical sensor may provide measurement data to the electrochemical reader unit, specifically to a measurement circuit of the electrochemical reader unit. The measurement data is indicative of the at least one electrochemical detection reaction in the presence of the second analyte. From the measurement data, at least one item of information about the detection of the second analyte may be derived, specifically by a processor of the electrochemical reader unit or by a processor of the mobile device. The item of information may comprise an indication of a presence, an absence, and / or a concentration of the second analyte. For example, the at least one wireless signal may comprise, fully or at least partly, measurement data obtained from the electrochemical sensor of the electrochemical reader unit, and / or the item of information derived from said measurement data. Further details about the wireless signal will be provided herein below.

[0051] Accordingly, in the first aspect, the present invention particularly relates to an analytical measurement method, specifically a computer-implemented analytical measurement method, for detecting, specifically essentially simultaneously, at least a first analyte and a second analyte, the second analyte being different from the first analyte, in a single sample of a bodily fluid,

[0052] - wherein the first analyte is detectable from at least one first reagent test region of a hybrid test element, the at least one first reagent test region being configured for performing at least one optical detection reaction in the presence of the first analyte;

[0053] - wherein the second analyte is detectable from at least one second reagent test region of the hybrid test element, the at least one second reagent test region being configured for performing at least one electrochemical detection reaction in the presence of the second analyte; and

[0054] - wherein the first analyte is detectable from the at least one first reagent test region, by using a camera of a mobile device, when the hybrid test element is connected to an electrochemical reader unit, specifically when the hybrid test element is inserted, at least partially, in the electrochemical reader unit; the analytical measurement method comprising: i) receiving, specifically by the mobile device, at least one image captured by using the camera of the mobile device, wherein the at least one image comprises at least a part of the first reagent test region of the hybrid test element, wherein the at least one first reagent test region has at least a first part of the single sample of the bodily fluid applied thereto; the at least one image being captured when the hybrid test element is connected to an electrochemical reader unit; ii) detecting, specifically by using the mobile device, more specifically by using a processor of the mobile device, the first analyte by using the at least one image received in step i); iii) detecting, specifically by using the mobile device, more specifically by using the processor of the mobile device, the second analyte by iii.a) using the at least one image received in step i), wherein the at least one image further comprises at least a part of the electrochemical reader unit, wherein the part of the electrochemical reader unit comprises at least one optically detectable indicator element, the optically detectable indicator element being indicative of the at least one electrochemical detection reaction in the presence of the second analyte; or iii.b) using at least one wireless signal received, specifically by the mobile device, from the electrochemical reader unit, the at least one wireless signal being indicative of the at least one electrochemical detection reaction in the presence of the second analyte; wherein, both for step iii.a) and step iii.b, the at least one second reagent test region has at least a second part of the single sample of the bodily fluid applied thereto.

[0055] The analytical measurement method, making use of the specific hybrid test element, the specific electrochemical reader unit, and the mobile device, provide for a reliable detection of at least two different analytes in parallel, or essentially simultaneously. Although different detection methods are employed, inter alia using an image captured by the mobile device, only one single sample and only one test element, namely the hybrid test element, are required to be used. Thereby, an easy and safe way of performing multiple analytical measurements of different analytes, involving use of a mobile device, is provided. This is specifically beneficial for layman users in a home testing scenario. In particular, a combined use of the hybrid test element, the electrochemical reader unit, and the mobile device contributes to facilitating mo- bile-based analytical measurements which demand an accurate detection of multiple analytes in a bodily fluid.

[0056] The detecting of the at least first analyte and second analyte may comprise, independently from one another, determining one or more of a presence, an absence, a concentration of the first analyte, of the second analyte, or of both, in the bodily fluid. The hybrid test element may comprise at least one of a test strip, a test card, and a test cassette.

[0057] In the analytical measurement method, the hybrid test element specifically is configured to receive the single sample of the bodily fluid at a single sample application site. More specifically, the hybrid test element is configured to allow a flow of the first part of the single sample of the bodily fluid to the at least one first reagent test region, and to allow a flow of the second part of the single sample of the bodily fluid to the at least one second test region. Even more specifically, the hybrid test element is configured to allow a flow of only the first part of the single sample of the bodily fluid to the at least one first reagent test region, and to allow a flow of only the second part of the single sample of the bodily fluid to the at least one second test region. Thereby, the second part of the single sample of the bodily fluid does not get into contact with the first reagent test region, such that any contamination issues can be reliably avoided. Alternatively, the hybrid test element may be configured to allow a flow of the first and the second part of the single sample of the bodily fluid to the at least one first reagent test region, and to allow a subsequent flow of the second part of the single sample of the bodily fluid to the at least one second reagent test region.

[0058] The electrochemical reader unit may comprise at least one fight source, specifically, one or more LED’s. The light source is configured to illuminate the at least one first reagent test region, when the hybrid test element is connected to the electrochemical reader unit, specifically when the hybrid test element is inserted, at least partially, in the electrochemical reader unit.

[0059] The optically detectable indicator element comprises at least one of electrical and electronic indicator elements, particularly a display. Specifically, the optically detectable indicator element comprises one or more of a Liquid Crystal Display (LCD), an Organic Light -Emitting Diode (OLED) Display, and an Electronic Paper Display (such as e-ink type displays, e.g. e- ink type displays by the company E Ink which are used in many e-book readers).

[0060] Additionally or alternatively, the optically detectable indicator element may display a font which is adapted to be read out reliably by Optical Character Recognition (OCR) technique.

[0061] The at least one wireless signal may be transmitted by at least one of Bluetooth, such as any of Bluetooth standard 3.0, 4.0, and 5; including any sub-standard thereof; Bluetooth Low Energy (BLE); radio frequency (RF), e.g. WLAN, ZIGBEE; Ultra-Wide Band (UWB); and Near Field Communication (NFC). When the second analyte is detected according to step iii.a), the optically detectable indicator element may indicate at least one of

[0062] - measurement data obtained from a measurement circuit of the electrochemical reader unit, e.g. sensor raw data, the measurement data being indicative of the at least one electrochemical detection reaction in the presence of the second analyte; wherein the detecting of the second analyte in step iii) comprises evaluating said measurement data, specifically by using the mobile device, more specifically by using the processor of the mobile device, thereby deriving at least one item of information about the detecting of the second analyte;

[0063] - at least one item of information about the detecting of the second analyte, derived, by the electrochemical reader unit, specifically by using a processor of the electrochemical reader unit, from evaluating measurement data obtained from a measurement circuit of the electrochemical reader unit, e.g. sensor raw data, the measurement data being indicative of the at least one electrochemical detection reaction in the presence of the second analyte.

[0064] When the second analyte is detected according to step iii.b), the at least one wireless signal generally originates from the electrochemical reader unit. In this case, similarly, the at least one wireless signal may comprise at least one of

[0065] - measurement data obtained from a measurement circuit of the electrochemical reader unit, e.g. sensor raw data, the measurement data being indicative of the at least one electrochemical detection reaction in the presence of the second analyte; wherein the detecting of the second analyte in step iii) comprises evaluating said measurement data, specifically by using the mobile device, more specifically by using the processor of the mobile device, thereby deriving at least one item of information about the detecting of the second analyte;

[0066] - at least one item of information about the detecting of the second analyte, derived, by the electrochemical reader unit, specifically by using a processor of the electrochemical reader unit, from evaluating measurement data obtained from a measurement circuit of the electrochemical reader unit, e.g. sensor raw data, the measurement data being indicative of the at least one electrochemical detection reaction in the presence of the second analyte.

[0067] In both cases, i.e. when the second analyte is detected according to step iii.a) or step iii.b), the item of information about the detecting of the second analyte may comprise at least one of a presence, an absence, and a concentration, of the second analyte in the single sample of the bodily fluid.

[0068] The analytical measurement method may further comprise a step of displaying one or more test results, e.g. one or more analyte concentration values, for the detection of the first analyte and the second analyte in the single sample of the bodily fluid, such as on a display of the mobile device. Additionally or alternatively, the method may comprise storing the one or more test results in at least one data storage device of the mobile device. Again additionally and alternatively, the method may further comprise transmitting the one or more test results via at least one interface and / or via at least one data transmission network, such as to another computer, e.g. for further evaluation or processing.

[0069] The analytical measurement method may further comprise providing one or more of the hybrid test element, the electrochemical reader unit, the mobile device having a camera, or any combination thereof. Specifically, the analytical measurement method further comprises providing one or more of the hybrid test element of the invention, i.e. the hybrid test element according to any one of claims 6 to 7; the electrochemical reader unit of the invention, i.e. the electrochemical reader unit according to any one of claims 8 to 11; the mobile device having a camera of the invention, i.e. the mobile device according to claim 12; or any combination thereof.

[0070] In a further aspect, the present invention relates to a hybrid test element for detection of at least a first and a second analyte in a single sample of a bodily fluid, the second analyte being different from the first analyte.

[0071] The hybrid test element is adapted for use, specifically for simultaneous use, together with

[0072] - an electrochemical reader unit of the invention, i.e. an electrochemical reader unit according to any one of claims 9 to 11; and

[0073] - a mobile device having a camera, specifically a mobile device of the invention, i.e. a mobile device according to claim 12.

[0074] The hybrid test element comprises

[0075] - at least one first reagent test region, the at least one first reagent test region being configured for performing at least one optical detection reaction in the presence of the first analyte; and

[0076] - at least one second reagent test region, the at least one second reagent test region being configured for performing at least one electrochemical detection reaction in the presence of the second analyte.

[0077] The hybrid test element further comprises

[0078] - a single sample application site to receive the single sample of the bodily fluid. In this aspect, the hybrid test element further is configured to allow a flow of a first part of the single sample of the bodily fluid to the at least one first reagent test region, and to allow a flow of a second part of the single sample of the bodily fluid to the at least one second test region.

[0079] Specifically, the hybrid test element may be configured to allow a flow of only the first part of the single sample of the bodily fluid to the at least one first reagent test region, and to allow a flow of only the second part of the single sample of the bodily fluid to the at least one second test region. Alternatively, the hybrid test element may be configured to allow a flow of the first and the second part of the single sample of the bodily fluid to the at least one first reagent test region, and to allow a subsequent flow of the second part of the single sample of the bodily fluid to the at least one second reagent test region. Still alternatively, the hybrid test element may be configured to allow a flow of the first and the second part of the single sample of the bodily fluid to the at least one second reagent test region, and to allow a subsequent flow of the first part of the single sample of the bodily fluid to the at least one first reagent test region. Optionally, the hybrid test element can be configured to allow direct application of the sample of bodily fluid to either the first or to the second reagent test region, respectively.

[0080] The hybrid test element further comprises

[0081] - one or more reference areas adapted to facilitate detection of the first analyte, wherein the reference area is arranged in proximity to the first reagent test region of the hybrid test element.

[0082] The one or more reference areas may comprise all components of the first reagent test region of the hybrid test element, but are configured to be inaccessible for the sample of bodily fluid.

[0083] In this aspect, the hybrid test element may be connected to the electrochemical reader unit. Specifically, the hybrid test element may, at least partly, be inserted in the electrochemical reader unit. More specifically, the hybrid test element may be connected to a measurement circuit of the electrochemical reader unit.

[0084] In such a scenario,

[0085] - the first analyte is optically detectable from the at least one first reagent test region by using the mobile device having the camera; and

[0086] - the second analyte is electrochemically detectable from the at least one second reagent test region by using the electrochemical reader unit, specifically by using a measurement circuit of the electrochemical reader unit. Thereby, the first analyte and the second analyte can be detected, specifically essentially simultaneously, by using the hybrid test element together with the electrochemical reader unit and with the mobile device having a camera.

[0087] In a further aspect, the present invention relates to an electrochemical reader unit for detection of at least a second analyte in a single sample of a bodily fluid.

[0088] The electrochemical reader unit is adapted for a simultaneous use together with

[0089] - a hybrid test element for detection of at least a first and the second analyte in a single sample of a bodily fluid of the invention, i.e. a hybrid test element according to any one of claims 6 to 8; and

[0090] - a mobile device having a camera, specifically a mobile device of the invention, i.e. a mobile device according to claim 12.

[0091] Generally, the electrochemical reader unit comprises a measurement circuit which is configured to perform an analytical measurement based on an electrochemical detection reaction as described herein above. The measurement circuit may obtain measurement data from the electrochemical sensor of the hybrid test element, and may provide said measurement data to a processor of the electrochemical reader unit, e.g. for further evaluation or processing. Additionally or alternatively, the measurement circuit may provide said measurement data to an evaluation unit of the electrochemical reader unit, as described herein below. Still additionally or alternatively, the measurement circuit may provide said measurement data to a transmission unit of the electrochemical reader unit, as described herein below. Still additionally or alternatively, the measurement circuit may provide said measurement data to an optically detectable indicator element of the electrochemical reader unit, as described herein below. For the purposes of further evaluation or processing, the electrochemical reader unit, the measurement circuit, and / or the evaluation unit, specifically the measurement circuit, may comprise an A / D converter for conversion of analog measurement data, such as analog measurement signals from an electrochemical sensor, into digital measurement data.

[0092] In this aspect, the hybrid test element may be connected to the electrochemical reader unit. Specifically, the hybrid test element may, at least partly, be inserted in the electrochemical reader unit. More specifically, the hybrid test element may be connected to a measurement circuit of the electrochemical reader unit.

[0093] In such a scenario, - the first analyte is optically detectable from the at least one first reagent test region by using the mobile device having the camera; and

[0094] - the second analyte is electrochemically detectable from the at least one second reagent test region by using the electrochemical reader unit; specifically, by using a measurement circuit of the electrochemical reader unit, the electrochemical sensor being configured to generate measurement data (e.g. sensor raw data) being indicative of the at least one electrochemical detection reaction in the presence of the second analyte.

[0095] The electrochemical reader unit further comprises at least one of

[0096] - at least one optically detectable indicator element, the optically detectable indicator element being indicative of the at least one electrochemical detection reaction in the presence of the second analyte, wherein the optically detectable indicator element comprises at least one of electrical and electronic indicator elements, specifically one or more of a Liquid Crystal Display (LCD), an Organic Light-Emitting Diode (OLED) Display, and an Electronic Paper Display;

[0097] - a transmission unit for transmitting at least one wireless signal to the mobile device, the at least one wireless signal being indicative of the at least one electrochemical detection reaction in the presence of the second analyte.

[0098] Specifically, the Electronic Paper Display may comprise e-ink type displays, e.g. e-ink type displays by the company E Ink which are used in many e-book readers.

[0099] The optically detectable indicator element is located on an upper surface of the electrochemical reader unit, such that an image captured by a camera of a mobile device may comprise both the first reagent test region of the hybrid test element and the optically detectable indicator element.

[0100] As defined above, the optically detectable indicator element is indicative of the at least one electrochemical detection reaction in the presence of the second analyte. For example, one or more items of information displayed on a display of the optically detectable indicator element may relate to measurement data obtained from any one of the measurement circuit, an evaluation unit, and a processor of the electrochemical reader unit, or may relate to an item of information derived from such measurement data, wherein the measurement data is indicative of the at least one electrochemical detection reaction in the presence of the second analyte. Specifically, the measurement data may be indicative of at least one analytical measurement result, such as an analytical measurement value and / or a presence or an absence of an analyte. More specifically, the measurement data may be indicative of at least one analytical measurement result of the second analyte, based on the electrochemical detection reaction in the presence of the second analyte.

[0101] The optically detectable indicator element may provide any type of graphical representation which represents an analytical measurement result as described herein above. The type of graphical representation may in particular include any one or more of, or a combination of any one or more of: a number; a letter; a punctuation mark; a 1 -dimensional or 2-dimensional graphical code, such as a barcode or a datamatrix code, e.g. a QR code or an ArUco code; and a color.

[0102] If the graphical representation uses numbers and / or letters, advantageously, the optically detectable indicator element may display a font which is adapted to be read out reliably by Optical Character Recognition (OCR) technique. Such OCR technique may be available on a mobile device used together with the electrochemical reader unit. Use of a graphical representation by numbers and / or letters (e.g. “11.1 mmol / 1” as an example of a blood glucose measurement value) allows the information contained to be read by a user, even without a mobile device readily at hand. On the other hand, as the skilled person is aware of, particularly a 2- dimensional datamatrix code usually may be put into practice more efficiently, due to improved ease of use, and since errors which may occur during scanning may be rectified automatically.

[0103] The electrochemical reader unit may further comprise an evaluation unit for evaluating measurement data, e.g. raw data from an electrochemical sensor, being indicative of the at least one electrochemical detection reaction in the presence of the second analyte. Thus, the evaluation unit can be configured to derive at least one item of information about the detecting of the second analyte. Therein, the item of information about the detecting of the second analyte may comprise at least one of a presence, an absence, and a concentration, of the second analyte in the single sample of the bodily fluid. The evaluation unit, or a processor, of the electrochemical reader unit may provide the measurement data, or the item of information derived therefrom, to a transmission unit or to an optically detectable indicator element of the electrochemical reader unit. Generally, the evaluation unit may be provided separately from a processor of the electrochemical reader unit, or the evaluation unit may be integrated in a processor of the electrochemical reader unit.

[0104] The electrochemical reader unit may still further comprise at least one light source, specifically one or more LED’s. The at least one light source may be configured to illuminate, at least partially, the at least one first reagent test region, when the hybrid test element is connected to the electrochemical reader unit, specifically when the hybrid test element is inserted, at least partially, in the electrochemical reader unit. Thereby, external factors like varying ambient light conditions, which may adversely impact the detection of the first analyte by using a camera of a mobile device, may effectively be reduced since the spectral composition of the light source is known.

[0105] Optionally, the electrochemical reader unit may further comprise, on its upper surface, one or more reference areas, such as a white field, a black field, a grey-scale, and / or a plurality of color reference fields of known characteristics. Such a reference area may be provided to facilitate detection of the first analyte. An image captured by a camera of a mobile device may thus comprise both the first reagent test region and the reference area. Thereby, external factors like ambient light conditions, which may adversely impact the detection of the first analyte by using a camera of a mobile device, may be effectively reduced and / or can be taken into account appropriately when detecting the first analyte, specifically in cases where the electrochemical reader unit does not comprise a light source for illumination of the first reagent test area.

[0106] Summarizing, the first analyte and the second analyte can be detected, specifically essentially simultaneously, by using the electrochemical reader unit together with the hybrid test element and with the mobile device having a camera.

[0107] In a further aspect, the present invention relates to a mobile device having at least one camera and specifically at least one processor, the mobile device being configured for detecting, specifically essentially simultaneously, at least a first analyte and a second analyte in a single sample of a bodily fluid.

[0108] In this aspect,

[0109] - the first analyte is detectable from at least one first reagent test region of a hybrid test element, the at least one first reagent test region being configured for performing at least one optical detection reaction in the presence of the first analyte; and

[0110] - the second analyte is detectable from at least one second reagent test region of the hybrid test element, the at least one second reagent test region being configured for performing at least one electrochemical detection reaction in the presence of the second analyte.

[0111] Furthermore, the mobile device is configured for performing at least steps i) to iii) of the analytical measurement method of the invention, i.e. according to any one of claims 1 to 5. In a further aspect, the present invention relates to a kit, comprising at least two of

[0112] - the hybrid test element of the invention, i.e. a hybrid test element according to any one of claims 6 to 8;

[0113] - the electrochemical reader unit of the invention, i.e. electrochemical reader unit according to any one of claims 9 to 11;

[0114] - the mobile device of the invention, i.e. the mobile device according to claim 12.

[0115] In this aspect, the hybrid test element may comprise at least one of a test strip, a test card, and a test cassette.

[0116] In still a further aspect, the present invention relates to a computer program comprising instructions which, when the program is executed by the mobile device of the invention, i.e. the mobile device according to claim 12, cause the mobile device to carry out at least steps i) to iii) of the analytical measurement method of the invention, i.e. the analytical measurement method according to any one of claims 1 to 5.

[0117] In still a further aspect, the present invention relates to a computer-readable storage medium comprising instructions which, when executed by the mobile device of the invention, i.e. the mobile device according to claim 12, cause the mobile device to carry out at least steps i) to iii) of the analytical measurement method of the invention, i.e. the analytical measurement method according to any one of claims 1 to 5.

[0118] The methods and devices proposed provide for a reliable detection of at least two different analytes in parallel, or essentially simultaneously, by different detection methods, inter alia using an image captured by a mobile device. Only one single sample and one hybrid test element are required to be used by a user, specifically by a layman user in a home testing scenario. In particular, a combined use of the hybrid test element, the electrochemical reader unit, and the mobile device contributes to facilitating mobile-based analytical measurements which demand an accurate detection of multiple analytes in a bodily fluid.

[0119] The analytical measurement method, the hybrid test element, the electrochemical reader unit, and the mobile device, are specifically suitable to be used in medical diagnostics, particularly in order to qualitatively or quantitatively detect two, or more, analytes in bodily fluids.

[0120] Short description of the figures Fig. 1 shows a schematic cross section through the reactive area of photometric (left) and amperometric (right) test strips, respectively.

[0121] Fig. 2 shows a schematic embodiment of a hybrid test element.

[0122] Fig. 3 shows another schematic embodiment of a hybrid test element.

[0123] Fig. 4 shows a schematic embodiment of an electrochemical reader unit.

[0124] Fig. 5 shows the electrochemical reader unit of Fig. 4, having a hybrid test element inserted therein.

[0125] Fig. 6 shows an embodiment of a kit, including a hybrid test element, an electrochemical reader unit, and a mobile device, for performing an analytical measurement method according to the invention, illustrated in a perspective view.

[0126] Fig. 7 illustrates a flow chart of an exemplary embodiment for carrying out the analytical measurement method.

[0127] Detailed description of the figures

[0128] Fig. 1 shows a schematic cross section through the reactive area, i.e. the reagent test region (20), of photometric (left) and amperometric (right) test fields, respectively. Photometric test fields and amperometric test fields are quite similar, each of them comprising a carrier layer (10) and a reagent test region (20) on top thereof. Electrochemical test fields like amperometric test fields generally further comprise two or more electrodes (30) adjacent to the reagent test region (20). Color formed from an optical detection reaction of glucose can be observed, particularly by means of a camera of a mobile device, from the side opposite to the sample (50) through the transparent carrier layer (10) in photometric test fields (left). Electrode reactions in amperometric test fields (right) occur at the bottom of the reagent test region (20) where the electrodes (30) are located, opposite to the side where the sample (50) is received. In either case, the reagent test regions (20) exchange glucose, reaction products, and all soluble ingredients with the sample (50) by means of diffusion. For example, arrow A indicates diffusion of glucose from the sample (50) into the reagent test region (20), and arrow B indicates diffusion of reaction products from the reagent test region (20) back into the sample (50). With regard to the test chemicals comprised in such test elements, as well as to the corresponding optically or electrochemically detectable detection reactions, 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 test chemicals, e.g. for detecting viruses, particularly by using lateral flow assays, are known to the person skilled in the art.

[0129] Fig. 2 shows a schematic embodiment of a hybrid test element (40) according to the invention. The hybrid test element (40) is comprised of a carrier layer (10) having a first reagent test region (25) and a second reagent test region (26) arranged on the carrier layer (10). The first reagent test region (25) is configured for performing an optical detection reaction in the presence of a first analyte, such as NT-proBNP. Thereby, the first analyte is optically detectable from the first reagent test region (25) by using a mobile device (60) having a camera (64). The second reagent test region (26) generally comprises two or more electrodes (30) and is configured for performing an electrochemical detection reaction in the presence of a second analyte, such as glucose. Thereby, the second analyte is detectable from the second reagent test region (26) by using an electrochemical reader unit (70) which generally comprises a measurement circuit configured for detecting an electrochemical detection reaction.

[0130] For detection of the second analyte, the hybrid test element (40) may be connected to, specifically inserted into, an insertion slot (76) of the electrochemical reader unit (70). Importantly, the hybrid test element (40) is configured such that, when the hybrid test element (40) is connected to the electrochemical reader unit (70), the first reagent test region (25) still can be observed by a camera (64) of a mobile device (60).

[0131] Advantageously, a single sample of bodily fluid (50) can be applied at a single sample application site (42). Both a first part of the sample of bodily fluid (52) and a second part of the sample of bodily fluid (54) flow along the direction of arrow C. Thereby, the first part of the sample of bodily fluid (52) is applied to the first reagent test region (25), and at least the second part of the sample of bodily fluid (54) is applied to the second reagent test region (26). As will be understood by the person skilled in the art, in this embodiment a flow path of the sample of bodily fluid (50) may advantageously be designed such that only the first part of the sample of bodily fluid (52) is applied to the first reagent test region (25), whereas the second part of the sample of bodily fluid (54) is applied only to the second reagent test region (26), without contacting the first reagent test region (25). Alternative designs of a flow path of the sample of bodily fluid (50) may be conceived.

[0132] Fig. 3 shows another schematic embodiment of a hybrid test element (40) according to the invention. The hybrid test element (40) of fig. 3 is similar to the hybrid test element (40) shown in fig. 2, but has a different location of the single sample application site (42). The test element architecture of this embodiment allows for an efficient separation of the first part of the sample of bodily fluid (52) on the one hand, and of the second part of the sample of bodily fluid (54) on the other hand. The first part of the sample of bodily fluid (52) flows along the direction of arrow E, thereby being applied to the first reagent test region (25). The second part of the sample of bodily fluid (54) flows along the direction of arrow D, thereby being applied to the second reagent test region (26).

[0133] Again, the hybrid test element (40) is configured such that, when the hybrid test element (40) is connected to an electrochemical reader unit (70), the first reagent test region (25) still can be observed by a camera (64) of a mobile device (60).

[0134] The exemplary embodiments of a hybrid test element (40) of fig. 2 and fig. 3, respectively, are specifically configured to allow for a detection of the first analyte and the second analyte, specifically essentially simultaneously, by using the hybrid test element (40) together with the electrochemical reader unit (70) according to the invention and with the mobile device (60) having a camera (64) according to the invention.

[0135] Fig. 4 shows a schematic embodiment of an electrochemical reader unit (70) according to the invention, for detection of at least a second analyte in a single sample of a bodily fluid (50). The electrochemical reader unit (70) comprises a slot (76) for partial insertion of a hybrid test element (40), such that the hybrid test element (40) may be connected to the electrochemical reader unit (70). Specifically, when the hybrid test element (40) is partially inserted in the slot (76), the second reagent test region (26) is connected to a measurement circuit (74) of the electrochemical reader unit. The measurement circuit (74) is configured to perform an analytical measurement based on an electrochemical detection reaction. The measurement circuit (74) may thus obtain measurement data from the electrochemical sensor of the hybrid test element (40), said electrochemical sensor being formed at least by the second reagent test region (26) and the electrodes (30). The electrochemical sensor is configured to generate measurement data, e.g. sensor raw data, being indicative of at least one electrochemical detection reaction in the presence of the second analyte. Specifically, the measurement circuit (74) may comprise an A / D converter for conversion of analog measurement data into digital measurement data. Thereby, measurement raw data may be further processed and / or evaluated, e.g. by a processor (62, 72), or by an evaluation unit (84).

[0136] Thus, the second analyte is electrochemically detectable from a second reagent test region (26) of a hybrid test element (40) by using the measurement circuit (74) of the electrochemical reader unit (70). Furthermore, when the hybrid test element (40) is partially inserted in the slot (76), a first analyte is optically detectable from the first reagent test region (25) by using a mobile device (60) having a camera (64).

[0137] The measurement circuit (74) may provide the measurement data obtained, particularly after conversion by an A / D converter, to a processor (72) of the electrochemical reader unit (70), e.g. for further evaluation or processing. Additionally or alternatively, the measurement circuit (74) may provide said measurement data to an evaluation unit (84) of the electrochemical reader unit (70). Still additionally or alternatively, the measurement circuit (74) may provide said measurement data to a transmission unit (82) of the electrochemical reader unit (70). Still additionally or alternatively, the measurement circuit (74) may provide said measurement data to an optically detectable indicator element (78) of the electrochemical reader unit (70). In any of these scenarios, the measurement data may firstly be provided by the measurement circuit (74) to the processor (72), and the processor may further provide the measurement data, or measurement data which has been, at least partially, processed, to one or more of the evaluation unit (84), the transmission unit (82), and the optically detectable indicator element (78).

[0138] Thus, the electrochemical reader unit (70) may further comprise an evaluation unit (84) for evaluating measurement data, e.g. raw data from an electrochemical sensor, being indicative of the electrochemical detection reaction in the presence of the second analyte. The evaluation unit (84) may be configured to derive at least one item of information about the detecting of the second analyte. Said item of information may comprise at least one of a presence, an absence, and a concentration, of the second analyte in the single sample of the bodily fluid. In this embodiment, the evaluation unit (84) is integrated in a processor (72) of the electrochemical reader unit. Alternatively, the evaluation unit (84) may be provided separately from the processor (72) of the electrochemical reader unit (70). The evaluation unit (84), or the processor (72), may provide the measurement data, or the item of information derived therefrom, to a transmission unit (82) or to an optically detectable indicator element (78) of the electrochemical reader unit (70).

[0139] Further, the electrochemical reader unit (70) may comprise a transmission unit (82) for transmitting at least one wireless signal to a mobile device (60), the at least one wireless signal being indicative of the at least one electrochemical detection reaction in the presence of the second analyte. For example, the transmission unit (82) may receive measurement data, or an item of information derived therefrom, from the measurement circuit (74), from the processor (72), or from the evaluation unit (84) of the electrochemical reader unit (70). Alternative to the transmission unit (82), the electrochemical reader unit (70) may comprise an optically detectable indicator element (78), the optically detectable indicator element (78) being indicative of the electrochemical detection reaction in the presence of the second analyte. For example, the optically detectable indicator element (78) may receive measurement data, or an item of information derived therefrom, from the measurement circuit (74), from the processor (72), or from the evaluation unit (84) of the electrochemical reader unit (70). The optically detectable indicator element (78) comprises e.g. a Liquid Crystal Display (LCD), but other types of displays are feasible as well.

[0140] As shown in fig. 4, the optically detectable indicator element (78) is located on an upper surface of the electrochemical reader unit (70). Therefore, an image captured by a camera (64) of a mobile device (60) may comprise both the first reagent test region (25) of the hybrid test element (40) and the optically detectable indicator element (78). The optically detectable indicator element (78) is indicative of the at least one electrochemical detection reaction in the presence of the second analyte. An item of information displayed on a display of the optically detectable indicator (78) element may relate to measurement data obtained e.g. from the measurement circuit (74) of the electrochemical reader unit, or may relate to an item of information derived from such measurement data, wherein the measurement data is indicative of the at least one electrochemical detection reaction in the presence of the second analyte. The measurement data is e.g. indicative of an analytical measurement result of the second analyte, such as an analytical measurement value and / or a presence or an absence of the second analyte. The optically detectable indicator element (78) may provide a graphical representation of the analytical measurement result of the second analyte, e.g. by representing a number, such as an analytical measurement value for a concentration of the second analyte in the sample of bodily fluid.

[0141] Optionally, the electrochemical reader unit (70) comprises a light source (80), e.g. a LED.

[0142] Thus, the first analyte and the second analyte can reliably be detected, specifically essentially simultaneously, by a layman by using the electrochemical reader unit (70) together with the hybrid test element (40) and with the mobile device (60) having a camera (64).

[0143] Fig. 5 shows the electrochemical reader unit (70) of Fig. 4, having a hybrid test element (40) inserted in the insertion slot (76) of the electrochemical reader unit (70). The optional light source (80) is configured to illuminate, at least partially, the first reagent test region (25), when the hybrid test element (40) is, at least partially, inserted in the electrochemical reader unit (70). From fig. 5, it can be seen that the hybrid test element (40) is configured such that, when the hybrid test element (40) is connected to the electrochemical reader unit (70), the first reagent test region (25) still can be observed by a camera (64) of a mobile device (60). In particular, an image captured by the camera (64) of the mobile device (60) may readily comprise both the first reagent test region (25) and the optically detectable indicator element (78).

[0144] The exemplary embodiments of the electrochemical reader unit (70) of fig. 4 and 5, respectively, are specifically configured to allow for a detection of the first analyte and the second analyte, specifically essentially simultaneously, by using the electrochemical reader unit (70) together with the hybrid test element (40) according to the invention and with the mobile device (60) having a camera (64) according to the invention.

[0145] Fig. 6 shows an embodiment of a kit (90), including a hybrid test element (40), an electrochemical reader unit (70), and a mobile device (60), for performing an analytical measurement method according to the invention, illustrated in a perspective view.

[0146] The hybrid test element (40) may be a hybrid test element (40) according to the invention, configured for detection of at least a first and a different second analyte in a single sample of a bodily fluid. In particular, the hybrid test element (40) specifically has a first reagent test region (25) being configured for performing an optical detection reaction in the presence of the first analyte, and a second reagent test region (26) being configured for performing an electrochemical detection reaction in the presence of the second analyte. As an example only, the first analyte may be NT-proBNP, and the second analyte may be blood glucose. The reagent test regions (25), (26) generally each contain at least one test chemical for detecting at least one analyte in the sample of bodily fluid (50). The hybrid test element (40) has a single sample application site (42) to receive the single sample of the bodily fluid (50). Further, the hybrid test element (40) is configured to allow a flow of a first part of the single sample of the bodily fluid (52) to the first reagent test region (25), and to allow a flow of a second part of the single sample of the bodily fluid (54) to the second reagent test region (26).

[0147] The hybrid test element (40) is partially inserted in an insertion slot (76) of the electrochemical reader unit (70), such that the second reagent test region (26) is connected to a measurement circuit (74) of the electrochemical reader unit (70). The measurement circuit (74) is configured to perform an analytical measurement of the second analyte, based on an electrochemical detection reaction. Specifically, for further details regarding the measurement circuit (74), it may be referred to the measurement circuit (74) as described herein with regard to fig. 4. When the hybrid test element (40) is partially inserted in the electrochemical reader unit (70), the first reagent test region (25) still is located completely outside of the electrochemical reader unit (70). Thus, the first analyte is optically detectable from the first reagent test region (25) by using the mobile device (60) having the camera (64), and the second analyte is electrochemically detectable from the second reagent test region (26) by using the electrochemical reader unit (70).

[0148] The electrochemical reader unit (70) may be an electrochemical reader unit (70) according to the invention, specifically as described herein in further detail with regard to fig. 4.

[0149] The mobile device (60), having a camera (64), may be a mobile device (60) according to the invention, and may further comprise a processor (62). The mobile device (60), specifically by using the processor (62), is configured for performing the analytical measurement method described herein. The camera (64) of the mobile device (60), as illustrated in fig. 6, may be used to capture the at least one image received in step i) of the analytical measurement method according to the invention. Here, the image comprises the first reagent test region (25) having the first part of the sample of the bodily fluid (52) applied thereto and, in addition to that, at least the optically detectable indicator element (78) of the electrochemical reader unit (70). The optically detectable indicator element (78) is indicative of the electrochemical detection reaction in the presence of the second analyte, and may e.g. provide a graphical representation of an analytical measurement result of the second analyte, such as a numerical analyte measurement value indicating a concentration of the second analyte in the sample of bodily fluid (50). From the image received in step i), the mobile device (60), specifically by using the processor (62), may thus derive analytical measurement results for both the first and the second analyte, respectively. For example, a first analytical measurement value indicating a concentration of the first analyte in the sample of bodily fluid (50) may be derived from evaluating a color from a color formation reaction, using a part of the image received in step i) which contains the first reagent test region (25); and a second analytical measurement value indicating a concentration of the second analyte in the sample of bodily fluid (50) may be derived from evaluating a part of the image received in step i) which contains the optically detectable indicator element (78). Alternatively, the mobile device (60), having a camera (64), may receive an analytical measurement value indicating a concentration of the second analyte in the sample of bodily fluid (50) from a transmission unit (82) of the electrochemical reader unit (70); in such a scenario, the image received in step i) is used to detect the first analyte only.

[0150] As illustrated herein above, the kit (90) is specifically configured for detection of the first and the second analyte, specifically essentially simultaneously, in a single sample of bodily fluid (50), by using the hybrid test element (40) together with the electrochemical reader unit (70) and with the mobile device (60) having a camera (64).

[0151] Fig. 7 illustrates a flow chart of an exemplary embodiment for carrying out the analytical measurement method, specifically a computer-implemented method and / or an in-vitro method, for detecting, specifically essentially simultaneously, at least a first analyte and a second analyte in a single sample of a bodily fluid (50), e.g. by making use of the kit (90) as shown in fig. 6.

[0152] The method comprises, in step i), depicted with reference numeral 100 in fig. 7, receiving, by a mobile device (60), at least one image captured by using a camera (64) of the mobile device (60). The image comprises a first reagent test region (25) of a hybrid test element (40), having a first part of the single sample of the bodily fluid (52) applied thereto. The first reagent test region (25) is configured for performing at least one optical detection reaction, such as a color formation reaction, in the presence of the first analyte. Thereby, the first analyte is detectable from the first reagent test region (25) of the hybrid test element (40). Additionally, the image may comprise an optically detectable indicator element (78) of the electrochemical reader unit (70), which may allow detecting the second analyte, as will be explained herein below at step iii.a).

[0153] The image is captured, by the camera (64) of the mobile device (60), when the hybrid test element (40) is partially inserted in an insertion slot (76) of an electrochemical reader unit (70). In this setup, a second reagent test region (26) of the hybrid test element (40) is connected to a measurement circuit (74) of the electrochemical reader unit (70). The second reagent test region (26) has a second part of the single sample of the bodily fluid (54) applied thereto. The second reagent test region (26) is configured for performing at least one electrochemical detection reaction in the presence of the second analyte. Thereby, the second analyte is detectable from the second reagent test region (26) of the hybrid test element. In particular, the measurement circuit (74) is configured to perform an analytical measurement of the second analyte, based on the electrochemical detection reaction. Specifically, for further details regarding the measurement circuit (74), it may be referred to the measurement circuit (74) of the electrochemical reader unit (70) as described herein with regard to fig. 4. Furthermore, the electrochemical reader unit (70) may be an electrochemical reader unit (70) according to the invention, specifically as described herein in further detail with regard to fig. 4.

[0154] When the hybrid test element (40) is partially inserted in the electrochemical reader unit (70), the first reagent test region (25) still is located completely outside of the electrochemical read- er unit (70). Thus, the first analyte is optically detectable from the first reagent test region (25) by using the mobile device (60) having the camera (64), and the second analyte is electrochemically detectable, essentially simultaneously, from the second reagent test region (26) by using the electrochemical reader unit (70).

[0155] The method further comprises, in step ii), depicted with reference numeral 200 in fig. 7, detecting, specifically by using the mobile device, more specifically by a processor (62) of the mobile device (60), the first analyte by using the image received in step i). The detecting the first analyte from the image received in step i) may be achieved by evaluating a color from a color formation reaction, using a part of the image received in step i) which contains the first reagent test region (25). For example, a first analytical measurement value indicating a concentration of the first analyte in the sample of bodily fluid (50) may be obtained, specifically by the processor (62) of the mobile device (60), from the evaluating of the color from the color formation reaction.

[0156] The method further comprises, in step iii.a), depicted with reference numeral 300 in fig. 7, detecting, specifically by using the mobile device (60), more specifically by the processor (62) of the mobile device (60), the second analyte by using the image received in step i). Herein, the image further comprises an optically detectable indicator element (78) of the electrochemical reader unit (70). The optically detectable indicator element (70) is indicative of the electrochemical detection reaction in the presence of the second analyte. The optically detectable indicator element (78) may receive an analytical measurement result for the second analyte, e.g. from a processor (72) or from an evaluation unit (84) of the electrochemical reader unit (70), either of which are in contact with the measurement circuit (74).

[0157] The optically detectable indicator element (78) may e.g. provide, on a display such as an LED or OLED display, a graphical representation of a numerical analyte measurement value indicating a concentration of the second analyte in the sample of bodily fluid (50). From the image received in step i), the mobile device (60), by using the processor (62), may thus derive an analytical measurement result for the second analyte, in addition to an analytical measurement result for the first analyte. In particular, a second analytical measurement value indicating a concentration of the second analyte in the sample of bodily fluid (50) may be derived from evaluating a part of the image received in step i) which contains the optically detectable indicator element (78).

[0158] Alternatively, the mobile device (60) may receive an analytical measurement value indicating a concentration of the second analyte in the sample of bodily fluid (50) from a transmission unit (82) of the electrochemical reader unit (70). This setup corresponds to step iii.b), depicted with reference numeral 400 in fig. 7, of the analytical measurement method. According to step iii.b), the method may further comprise using at least one wireless signal received, specifically by the mobile device (60), from the electrochemical reader unit (70). Herein, the wireless signal is indicative of the electrochemical detection reaction in the presence of the second analyte. The wireless signal may be transmitted by the transmission unit (82) to the mobile device (60). The transmission unit (82) may receive e.g. an analytical measurement value for the second analyte in the sample of bodily fluid (50) from any one of a processor (72) or from an evaluation unit (84) of the electrochemical reader unit (70), either of which are in contact with the measurement circuit (74).

[0159] Specifically, the second analyte may be detected according to step iii.a), and then the optically detectable indicator element (78) may indicate at least one of; or the second analyte may be detected according to step iii.b), and then the wireless signal originates from the electrochemical reader unit (70) and comprises at least one of

[0160] - measurement data obtained from the measurement circuit (74) of the electrochemical reader unit (70); herein, the measurement data is indicative of the electrochemical detection reaction in the presence of the second analyte; and the detecting of the second analyte comprises evaluating said measurement data, specifically by using the processor (62) of the mobile device (60), thereby deriving at least one item of information about the detecting of the second analyte;

[0161] - at least one item of information about the detecting of the second analyte, derived, by the processor (72) or an evaluation unit (84) of the electrochemical reader unit (70), from evaluating measurement data obtained from the measurement circuit (74) of the electrochemical reader unit (70), e.g. sensor raw data; herein, the measurement data is indicative of the electrochemical detection reaction in the presence of the second analyte.

[0162] The item of information about the detecting of the second analyte may comprise at least one of a presence, an absence, and a concentration, of the second analyte in the single sample of the bodily fluid (50).

[0163] The analytical measurement method may further comprise a step of displaying any of the analytical measurement results, specifically on a display of the mobile device (60). Additionally or alternatively, the method may comprise storing the analytical measurement results in a data storage device of the mobile device (60).

[0164] Furthermore, the present invention comprises the following embodiments: Embodiment 1: An analytical measurement method, specifically a computer-implemented analytical measurement method, for detecting, specifically essentially simultaneously, at least a first analyte and a second analyte, specifically wherein the first analyte is different from the second analyte, in a single sample of a bodily fluid,

[0165] - wherein the first analyte is detectable from at least one first reagent test region of a hybrid test element, the at least one first reagent test region being configured for performing at least one optical detection reaction in the presence of the first analyte;

[0166] - wherein the second analyte is detectable from at least one second reagent test region of the hybrid test element, the at least one second reagent test region being configured for performing at least one electrochemical detection reaction in the presence of the second analyte; and

[0167] - wherein the first analyte is detectable from the at least one first reagent test region, by using a camera of a mobile device, when the hybrid test element is connected to an electrochemical reader unit; the method comprising: i) receiving, specifically by the mobile device, at least one image captured by using the camera of the mobile device, wherein the at least one image comprises at least a part of the first reagent test region of the hybrid test element, wherein the at least one first reagent test region has at least a first part of the single sample of the bodily fluid applied thereto; the at least one image being captured when the hybrid test element is connected to an electrochemical reader unit; and ii) detecting, specifically by using the mobile device, the first analyte by using the at least one image received in step i); and iii) detecting, specifically by using the mobile device, the second analyte by iii.a) using the at least one image received in step i), wherein the at least one image further comprises at least a part of the electrochemical reader unit, wherein the part of the electrochemical reader unit comprises at least one optically detectable indicator element, the optically detectable indicator element being indicative of the at least one electrochemical detection reaction in the presence of the second analyte; or iii.b) using at least one wireless signal received, specifically by the mobile device, from the electrochemical reader unit, the at least one wireless signal being indicative of the at least one electrochemical detection reaction in the presence of the second analyte; wherein the at least one second reagent test region has at least a second part of the single sample of the bodily fluid applied thereto. Embodiment 2: The method according to embodiment 1, wherein the electrochemical reader unit comprises at least one light source, wherein the light source is configured to illuminate the at least one first reagent test region, when the hybrid test element is connected to the electrochemical reader unit, specifically when the hybrid test element is inserted, at least partially, in the electrochemical reader unit.

[0168] Embodiment 3: The method according to embodiment 1 or 2, wherein the optically detectable indicator element comprises at least one of electrical and electronic indicator elements, specifically one or more of a Liquid Crystal Display (LCD), an Organic Light-Emitting Diode (OLED) Display, and an Electronic Paper Display.

[0169] Embodiment 4: The method according to any one of the preceding embodiments, wherein the second analyte is detected according to step iii.a) and the optically detectable indicator element indicates at least one of; or wherein the second analyte is detected according to step iii.b) and the at least one wireless signal originates from the electrochemical reader unit and comprises at least one of

[0170] - measurement data obtained from a measurement circuit of the electrochemical reader unit, the measurement data being indicative of the at least one electrochemical detection reaction in the presence of the second analyte; wherein the detecting of the second analyte in step iii) comprises evaluating said measurement data, specifically by using the mobile device, thereby deriving at least one item of information about the detecting of the second analyte;

[0171] - at least one item of information about the detecting of the second analyte, derived, by the electrochemical reader unit, from evaluating measurement data obtained from a measurement circuit of the electrochemical reader unit, e.g. sensor raw data, the measurement data being indicative of the at least one electrochemical detection reaction in the presence of the second analyte; wherein the item of information about the detecting of the second analyte comprises at least one of a presence, an absence, and a concentration, of the second analyte in the single sample of the bodily fluid.

[0172] Embodiment 5: The method according to any one of the preceding embodiments, wherein the method further comprises providing one or more of the hybrid test element, the electrochemical reader unit, the mobile device having a camera, or any combination thereof; specifically, one or more of the hybrid test element according to any one of embodiments 6 to 7, the electrochemical reader unit according to any one of embodiments 8 to 11, the mobile device having a camera according to embodiment 12, or any combination thereof. Embodiment 6: A hybrid test element for detection of at least a first and a second analyte in a single sample of a bodily fluid, the second analyte being different from the first analyte, wherein the hybrid test element is adapted for simultaneous use together with

[0173] - an electrochemical reader unit according to any one of embodiments 8 to 11; and

[0174] - a mobile device having a camera, specifically a mobile device according to embodiment 12; wherein the hybrid test element comprises

[0175] - at least one first reagent test region, the at least one first reagent test region being configured for performing at least one optical detection reaction in the presence of the first analyte;

[0176] - at least one second reagent test region, the at least one second reagent test region being configured for performing at least one electrochemical detection reaction in the presence of the second analyte; and

[0177] - a single sample application site to receive the single sample of the bodily fluid, wherein the hybrid test element further is configured to allow a flow of a first part of the single sample of the bodily fluid to the at least one first reagent test region, and to allow a flow of a second part of the single sample of the bodily fluid to the at least one second test region; and wherein, when the hybrid test element is connected to the electrochemical reader unit; specifically, when the hybrid test element is, at least partly, inserted in the electrochemical reader unit,

[0178] - the first analyte is optically detectable from the at least one first reagent test region by using the mobile device having the camera; and

[0179] - the second analyte is electrochemically detectable from the at least one second reagent test region by using the electrochemical reader unit; such that the first analyte and the second analyte can be detected, specifically essentially simultaneously, by using the hybrid test element together with the electrochemical reader unit and with the mobile device having a camera.

[0180] Embodiment 7: The hybrid test element according to embodiment 6, wherein the hybrid test element is configured to allow a flow of only the first part of the single sample of the bodily fluid to the at least one first reagent test region, and to allow a flow of only the second part of the single sample of the bodily fluid to the at least one second test region; or, wherein the hybrid test element is configured to allow a flow of the first and the second part of the single sample of the bodily fluid to the at least one first reagent test region, and to allow a subsequent flow of the second part of the single sample of the bodily fluid to the at least one second reagent test region. Embodiment 8: An electrochemical reader unit for detection of at least a second analyte in a single sample of a bodily fluid, the electrochemical reader unit being adapted for a simultaneous use together with

[0181] - a hybrid test element for detection of at least a first and the second analyte in a single sample of a bodily fluid according to any one of embodiments 6 to 7; and

[0182] - a mobile device having a camera, specifically a mobile device according to embodiment 12; wherein, when the hybrid test element is connected to the electrochemical reader unit; specifically, when the hybrid test element is, at least partly, inserted in the electrochemical reader unit,

[0183] - the first analyte is optically detectable from the at least one first reagent test region by using the mobile device having the camera; and

[0184] - the second analyte is electrochemically detectable from the at least one second reagent test region by using the electrochemical reader unit; such that the first analyte and the second analyte can be detected, specifically essentially simultaneously, by using the electrochemical reader unit together with the hybrid test element and with the mobile device having a camera.

[0185] Embodiment 9: An electrochemical reader unit according to embodiment 8, further comprising at least one of

[0186] - at least one optically detectable indicator element, the optically detectable indicator element being indicative of the at least one electrochemical detection reaction in the presence of the second analyte, wherein the optically detectable indicator element comprises at least one of electrical and electronic indicator elements, specifically one or more of a Liquid Crystal Display (LCD), an Organic Light-Emitting Diode (OLED) Display, and an Electronic Paper Display; wherein the optically detectable indicator element may display a font adapted to be read out reliably by Optical Character Recognition (OCR) technique;

[0187] - a transmission unit for transmitting at least one wireless signal to the mobile device, the at least one wireless signal being indicative of the at least one electrochemical detection reaction in the presence of the second analyte.

[0188] Embodiment 10: An electrochemical reader unit according to any one of embodiments 8 to 9, further comprising an evaluation unit for evaluating measurement data, e.g. sensor raw data being indicative of the at least one electrochemical detection reaction in the presence of the second analyte, the evaluation unit being configured to derive at least one item of information about the detecting of the second analyte, wherein the item of information about the detecting of the second analyte comprises at least one of a presence, an absence, and a concentration, of the second analyte in the single sample of the bodily fluid.

[0189] Embodiment 11: An electrochemical reader unit according to any one of embodiments 8 to 10, further comprising at least one light source, wherein the at least one light source is configured to illuminate the at least one first reagent test region, when the hybrid test element is connected to the electrochemical reader unit, specifically when the hybrid test element is inserted, at least partially, in the electrochemical reader unit.

[0190] Embodiment 12: A mobile device having at least one camera and specifically at least one processor, the mobile device being configured for detecting at least a first analyte and a second analyte in a single sample of a bodily fluid,

[0191] - wherein the first analyte is detectable from at least one first reagent test region of a hybrid test element, the at least one first reagent test region being configured for performing at least one optical detection reaction in the presence of the first analyte; and

[0192] - wherein the second analyte is detectable from at least one second reagent test region of the hybrid test element, the at least one second reagent test region being configured for performing at least one electrochemical detection reaction in the presence of the second analyte; wherein the mobile device further is configured for performing at least steps i) to iii) of the computer-implemented analytical measurement method according to any one of embodiments 1 to 5.

[0193] Embodiment 13: A kit for performing an analytical measurement method, comprising at least two of

[0194] - the hybrid test element according to any one of embodiments 6 to 7; specifically, wherein the hybrid test element comprises at least one of a test strip, a test card, and a test cassette;

[0195] - the electrochemical reader unit according to any one of embodiments 8 to 11;

[0196] - the mobile device according to embodiment 12.

[0197] Embodiment 14: A computer program comprising instructions which, when the program is executed by the mobile device according to embodiment 12, cause the mobile device to carry out at least steps i) to iii) of the computer -implemented analytical measurement method according to any one of embodiments 1 to 5. Embodiment 15: A computer-readable storage medium comprising instructions which, when executed by the mobile device according to embodiment 12, cause the mobile device to carry out at least steps i) to iii) of the computer -implemented analytical measurement method according to any one of embodiments 1 to 5.

[0198] List of reference numbers

[0199] 10 carrier layer

[0200] 20 reagent test region

[0201] 25 first reagent test region

[0202] 26 second reagent test region

[0203] 30 electrode(s)

[0204] 40 hybrid test element

[0205] 42 sample application site

[0206] 50 sample of bodily fluid

[0207] 52 first part of the sample of bodily fluid

[0208] 54 second part of the sample of bodily fluid

[0209] 60 mobile device

[0210] 62,72 processor

[0211] 64 camera

[0212] 68 image

[0213] 70 electrochemical reader unit

[0214] 74 measurement circuit

[0215] 76 slot for insertion of a test element

[0216] 78 optically detectable indicator element

[0217] 80 light source

[0218] 82 transmission unit

[0219] 84 evaluation unit

[0220] 90 kit

[0221] 100 step i) of the method for detecting at least a first analyte and a second analyte in a single sample of a bodily fluid

[0222] 200 step ii) of the method for detecting at least a first analyte and a second analyte in a single sample of a bodily fluid

[0223] 300 step iii.a) of the method for detecting at least a first analyte and a second analyte in a single sample of a bodily fluid

[0224] 400 step iii.b) of the method for detecting at least a first analyte and a second analyte in a single sample of a bodily fluid

Claims

Claims1. A computer-implemented analytical measurement method for detecting, specifically essentially simultaneously, at least a first analyte and a second analyte in a single sample of a bodily fluid,- wherein the first analyte is detectable from at least one first reagent test region of a hybrid test element, the at least one first reagent test region being configured for performing at least one optical detection reaction in the presence of the first analyte;- wherein the second analyte is detectable from at least one second reagent test region of the hybrid test element, the at least one second reagent test region being configured for performing at least one electrochemical detection reaction in the presence of the second analyte; and- wherein the first analyte is detectable from the at least one first reagent test region, by using a camera of a mobile device, when the hybrid test element is connected to an electrochemical reader unit; the method comprising: i) receiving, specifically by the mobile device, at least one image captured by using the camera of the mobile device, wherein the at least one image comprises at least a part of the first reagent test region of the hybrid test element, wherein the at least one first reagent test region has at least a first part of the single sample of the bodily fluid applied thereto; the at least one image being captured when the hybrid test element is connected to an electrochemical reader unit; and ii) detecting, specifically by using the mobile device, the first analyte by using the at least one image received in step i); and iii) detecting, specifically by using the mobile device, the second analyte by iii.a) using the at least one image received in step i), wherein the at least one image further comprises at least a part of the electrochemical reader unit, wherein the part of the electrochemical reader unit comprises at least one optically detectable indicator element, the optically detectable indicator element being indicative of the at least one electrochemical detection reaction in the presence of the second analyte; or iii.b) using at least one wireless signal received, specifically by the mobile device, from the electrochemical reader unit, the at least one wireless signal being indicative of the at least one electrochemical detection reaction in the presence of the second analyte; wherein the at least one second reagent test region has at least a second part of the single sample of the bodily fluid applied thereto.

2. The computer-implemented method according to claim 1, wherein the electrochemical reader unit comprises at least one light source, wherein the light source is configured to illuminate the at least one first reagent test region, when the hybrid test element is connected to the electrochemical reader unit.

3. The computer -implemented method according to claim 1 or 2, wherein the optically detectable indicator element comprises one or more of a Liquid Crystal Display (LCD), an Organic Light-Emitting Diode (OLED) Display, and an Electronic Paper Display.

4. The computer-implemented method according to any one of the preceding claims, wherein the second analyte is detected according to step iii.a) and the optically detectable indicator element indicates at least one of; or wherein the second analyte is detected according to step iii.b) and the at least one wireless signal originates from the electrochemical reader unit and comprises at least one of measurement data obtained from a measurement circuit of the electrochemical reader unit, the measurement data being indicative of the at least one electrochemical detection reaction in the presence of the second analyte; wherein the detecting of the second analyte in step iii) comprises evaluating said measurement data, specifically by using the mobile device, thereby deriving at least one item of information about the detecting of the second analyte; at least one item of information about the detecting of the second analyte, derived, by the electrochemical reader unit, from evaluating measurement data obtained from a measurement circuit of the electrochemical reader unit, the measurement data being indicative of the at least one electrochemical detection reaction in the presence of the second analyte; wherein the item of information about the detecting of the second analyte comprises at least one of a presence, an absence, and a concentration, of the second analyte in the single sample of the bodily fluid.

5. The computer-implemented method according to any one of the preceding claims, wherein the method further comprises providing one or more of the hybrid test element, the electrochemical reader unit, the mobile device having a camera, or any combination thereof.

6. A hybrid test element for detection of at least a first and a second analyte in a single sample of a bodily fluid, the second analyte being different from the first analyte, wherein the hybrid test element is adapted for simultaneous use together withan electrochemical reader unit according to any one of claims 9 to 11; and a mobile device having a camera, specifically a mobile device according to claim 12; wherein the hybrid test element comprises- at least one first reagent test region, the at least one first reagent test region being configured for performing at least one optical detection reaction in the presence of the first analyte;- at least one second reagent test region, the at least one second reagent test region being configured for performing at least one electrochemical detection reaction in the presence of the second analyte;- a single sample application site to receive the single sample of the bodily fluid, wherein the hybrid test element further is configured to allow a flow of a first part of the single sample of the bodily fluid to the at least one first reagent test region, and to allow a flow of a second part of the single sample of the bodily fluid to the at least one second test region; and- wherein the hybrid test element further comprises one or more reference areas adapted to facilitate detection of the first analyte, wherein the reference area is arranged in proximity to the first reagent test region of the hybrid test element; and wherein, when the hybrid test element is connected to the electrochemical reader unit; specifically, when the hybrid test element is, at least partly, inserted in the electrochemical reader unit,- the first analyte is optically detectable from the at least one first reagent test region by using the mobile device having the camera; and- the second analyte is electrochemically detectable from the at least one second reagent test region by using the electrochemical reader unit; such that the first analyte and the second analyte can be detected, specifically essentially simultaneously, by using the hybrid test element together with the electrochemical reader unit and with the mobile device having a camera.

7. The hybrid test element according to claim 6, wherein the one or more reference areas comprise all components of the first reagent test region of the hybrid test element, but are configured to be inaccessible for the sample of bodily fluid.

8. The hybrid test element according to claim 6 or 7, wherein the hybrid test element is configured to allow a flow of only the first part of the single sample of the bodily fluid to the at least one first reagent test region, and to allow a flow of only the second part of the single sample of the bodily fluid to the at least one second test region; or, wherein the hybrid test element is configured to allow a flow of the first and the second part of the singlesample of the bodily fluid to the at least one first reagent test region, and to allow a subsequent flow of the second part of the single sample of the bodily fluid to the at least one second reagent test region.

9. An electrochemical reader unit for detection of at least a second analyte in a single sample of a bodily fluid, the electrochemical reader unit being adapted for a simultaneous use together with- a hybrid test element for detection of at least a first and the second analyte in a single sample of a bodily fluid according to any one of claims 6 to 8; and- a mobile device having a camera, specifically a mobile device according to claim 12; wherein, when the hybrid test element is connected to the electrochemical reader unit; specifically, when the hybrid test element is, at least partly, inserted in the electrochemical reader unit,- the first analyte is optically detectable from the at least one first reagent test region by using the mobile device having the camera; and- the second analyte is electrochemically detectable from the at least one second reagent test region by using the electrochemical reader unit; such that the first analyte and the second analyte can be detected, specifically essentially simultaneously, by using the electrochemical reader unit together with the hybrid test element and with the mobile device having a camera; wherein the electrochemical reader unit further comprises at least one of- at least one optically detectable indicator element, the optically detectable indicator element being indicative of the at least one electrochemical detection reaction in the presence of the second analyte, wherein the optically detectable indicator element comprises at least one of electrical and electronic indicator elements;- a transmission unit for transmitting at least one wireless signal to the mobile device, the at least one wireless signal being indicative of the at least one electrochemical detection reaction in the presence of the second analyte.

10. An electrochemical reader unit according to claim 9, further comprising an evaluation unit for evaluating measurement data, e.g. sensor raw data being indicative of the at least one electrochemical detection reaction in the presence of the second analyte, the evaluation unit being configured to derive at least one item of information about the detecting of the second analyte, wherein the item of information about the detecting of the second analyte comprises at least one of a presence, an absence, and a concentration, of the second analyte in the single sample of the bodily fluid.

11. An electrochemical reader unit according to any one of claims 9 to 10, further comprising at least one light source, wherein the at least one light source is configured to illuminate the at least one first reagent test region, when the hybrid test element is connected to the electrochemical reader unit.

12. A mobile device having at least one camera and specifically at least one processor, the mobile device being configured for detecting at least a first analyte and a second analyte in a single sample of a bodily fluid,- wherein the first analyte is detectable from at least one first reagent test region of a hybrid test element, the at least one first reagent test region being configured for performing at least one optical detection reaction in the presence of the first analyte; and- wherein the second analyte is detectable from at least one second reagent test region of the hybrid test element, the at least one second reagent test region being configured for performing at least one electrochemical detection reaction in the presence of the second analyte; wherein the mobile device further is configured for performing at least steps i) to iii) of the computer-implemented analytical measurement method according to any one of claims 1 to 5.

13. A kit for performing an analytical measurement method, comprising at least two of- the hybrid test element according to any one of claims 6 to 8;- the electrochemical reader unit according to any one of claims 9 to 11;- the mobile device according to claim 12.

14. A computer program comprising instructions which, when the program is executed by the mobile device according to claim 12, cause the mobile device to carry out at least steps i) to iii) of the computer -implemented analytical measurement method according to any one of claims 1 to 5.

15. A computer-readable storage medium comprising instructions which, when executed by the mobile device according to claim 12, cause the mobile device to carry out at least steps i) to iii) of the computer -implemented analytical measurement method according to any one of claims 1 to 5.

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