DE102016202428B4 - Measuring system for colorimetric assays - Google Patents

Abstract

A measuring system (1) for carrying out colorimetric assays (CA) comprising at least one test strip (2) with at least one test field (21) for determining a concentration (KA) of at least one analyte in a test solution (3) by means of a color change of the test field (21) , wherein each test strip (2) is assigned a machine-readable code (22) with data for identification of the test strip (2) and for evaluation by an application (4), only a mobile device (5) with a camera (51) for executing a first receptacle (A1) of at least the machine-readable code (22) before contact of the test strip (2) with the test solution (3) and a second receptacle (A2) of the test strip (2) after contact with the test solution (3) and with the Application (4) for evaluating the first and second recordings (A1, A2) installed on the mobile device (5), the application (4) being provided at least on the basis of the readout via the first record (A1) Machine readable codes (22) automatically verify the usability of the test strip (2) for the respective measurement (V) and, in the case of usability, access the colorimetric assays (CA) and calibration data (KD) stored in the mobile device (5) to determine for this test strip (2) associated colorimetric assay (CA) and associated calibration data (KD) automatically for the evaluation of the color change of the test strip (2) (F), and only then by means of the second image (A2) using the colorimetric assay (CA ) to automatically determine the color change of the test field (s) (21) and to calculate thereon the concentration (KA) of the analyte based on the calibration data (KD).

Description

Field of the invention

The invention relates to a measuring system for carrying out colorimetric assays and a corresponding method with this measuring system.

Background of the invention

Colorimetric assays with test strips are widely used in analytics. These range from simple pH determination, through the detection of water hardness to the detection of medical parameters in urine or other samples. Typically, the test strips have one or more reaction fields which are chemically treated to cause a color reaction by the presence of the analyte. For detection of the analyte, the test strip is usually immersed in the sample and the color reaction read. The degree of color change correlates with the concentration of the analyte.

Frequently, the test strips are visually read with the naked eye. In this case, the color of the test field is usually compared with a color scale and thus determines the concentration of the analyte. However, this comparison is susceptible to user errors, for example, the ambient light significantly influences the color interpretation. Alternatively, most assays can of course also be carried out with quantitative methods, but this then requires a higher expenditure on equipment, which precludes a simple, rapid and possibly mobile analysis. For many questions, it is sufficient to determine semi-quantitative values.

The publication WO 2014/025415 A2 discloses a diagnostic instrument having a plurality of test strips, again having a plurality of test fields for particular biological analytes, for enabling the diagnostic instrument to simultaneously test or determine the presence of a series of diseases or various body conditions of a patient in a simultaneous measurement. The test fields show a characteristic color change after contact with the test solution, which corresponds to the concentration of the corresponding biological analytes. For holding the test strips, the diagnostic instrument comprises a contact surface with a plurality of indentations in a region of the diagnostic instrument intended for contact with the test solution, in which the respective test strips are fastened and held for the measurement. On the diagnostic instrument several color reference fields are arranged to assess the color change of the test fields of the test strips, so that the color changes of each different test fields can be determined with the necessary accuracy. To carry out the measurement, the diagnostic instrument is immersed in the test solution in question and then the color change of the test fields caused by the corresponding biological analytes is evaluated with a mobile electronic device. An identification label is also provided on the contact surface of the diagnostic instrument, separate from the test strips, which may comprise coded data for identification of the instrument and color interpretation tables to be used for color change evaluation.

The publication WO 02/088739 A1 discloses diagnostic test devices, including diagnostic strip tests, in which the information to be identified and the test result are machine readable. Furthermore, it discloses methods for obtaining identifying information and test results of the diagnostic test devices.

The US application US 2013/0273528 A1 discloses assay cassettes and test equipment that can be used for fast, accurate and affordable lab-quality tests at the treatment site. Such test cartridges and test devices are designed to provide rapid, quantitative test results in a point-of-care environment or the like. Similarly, such test cassettes and test devices can eliminate or replace expensive, centralized clinical test equipment and technical personnel. Such a testing device may include automated data reporting and decision support. The application also discloses methods for performing diagnostic tests at the treatment site.

Furthermore, the German utility model publication DE 202011005278 U1 A slide for the examination of biological material, which has a marking and at least one surface for incubation of the biological material, characterized in that the marking contains at least information about properties and / or production of the slide and is designed such that even before a first incubation each individual slide is clearly identifiable to another slide.

The publication US 2015/0211987 A1 discloses methods and electronic devices for performing color-based reaction testing of biological materials. The method includes capturing and interpreting digital images of an unexposed and subsequently exposed paddle at different delay times within an automatically calibrated environment. The test paddle contains a unique Identification Mechanism (UID), a reference color bar (RCB) that provides samples of standardized colors for image color calibration, compensation and corrections, and multiple test-specific sequences of chemical test pads (CTP). The method further includes locating the paddle in the image, extracting the UID and validating the paddle, extracting the RCB, and locating the plurality of CTPs in each image. The method also reduces image noise in the CTP and automatically calibrates the image according to the illumination measurements taken at the RCB. To determine the test results, the method further determines a plurality of distances between the CTP and its possible trajectory in the color space described by the manufacturer's interpretation color map.

However, it would be desirable to have available instruments for determining concentrations of analytes in test solutions that are more compact and less complex than the above diagnostic tools, yet allow for user-friendly and reliable determination of analyte concentrations in test solutions, and additionally flexible should be reliably usable for different analysis purposes in any order.

Summary of the invention

It is therefore an object of the invention to provide an instrument and a corresponding method for determining concentrations of analytes in test solutions, the instrument being as compact and simple as possible, yet allowing a user-friendly and reliable determination of concentrations of analytes in test solutions and additionally flexible is reliably usable for different analysis purposes in any order.

This object is achieved by a measuring system for carrying out colorimetric assays comprising at least one test strip having at least one test field for determining a concentration of at least one analyte in a test solution by means of a color change of the test field, each test strip having a machine-readable code with data for identifying the test strip and for evaluation is assigned by an application, only a mobile device with a camera for performing a first recording of at least the machine-readable code before contact of the test strip with the test solution and a second recording of the test strip after contact with the test solution and the application for evaluation of the first and second recordings installed on the mobile device, wherein the application is at least provided on the basis of read on the first recording machine readable code, the usability of the test strip for the respective Mes automatically verify and, in the case of usability, access the colorimetric assays and calibration data stored in the mobile device and automatically determine the colorimetric assay associated with that test strip and associated calibration data for evaluation of the color change of the test strip and the second image using the colorimetric assay Automatically determine the color change of the test field (s) and calculate the concentration of the analyte based on the calibration data.

The measuring system according to the invention allows a user-friendly and reliable determination of concentrations of analytes in test solutions, since the user of the measuring system can perform the measurement without previous selection steps on menus offered, in particular the user does not need to select any suitable for the measurement test strips from a menu. In addition, the user does not need to look at any reference color gamut associated with the gauge and analyze the color changes of the test strip. As a result, the inventive measuring system excludes a significant source of error when carrying out colorimetric assays, since it is excluded according to the invention that test strips are evaluated with the wrong colorimetric assay. Furthermore, measurement errors due to outdated test strips are ruled out, since before each measurement the usability of the test strips is automatically checked by the measuring system according to the invention and the further measurement is released only when available. Only when the test strip has been correctly identified on the basis of the machine-readable code and has been checked that, for example, its best-before date has not been exceeded (verification of the usability), does the application subsequently carry out the further measurement by means of second recording. This is particularly relevant in medical applications and significantly reduces the risk associated with the use of the assays. The application according to the measuring system according to the invention (and also according to the corresponding method) is simple, safe and intuitive. The user / device interface to the test strip and evaluation by the application gets a completely different quality than conventional, menu-driven software, since operator errors can be excluded by the automated steps performed. In addition, due to the test strip and the mobile device to be used with the application installed, the measuring system is compact and simple and can be used everywhere, regardless of location.

The machine-readable code represents a digital data storage comprising at least data for identification of the test strip. The machine-readable code may include additional data depending on the embodiment. For example, the machine-readable code is a barcode (for example, a linear barcode or a two-dimensional barcode such as a QR code). For example, in other embodiments, the machine-readable code may be implemented as an RFID tag. The coding of the data in the machine-readable code can be a standardized coding (for example GS1 code) or a self-defined coding. The machine-readable code can contain not only the unambiguous identification of the test strip (for example, name, article number, GTIN number, etc.) but also other data such as the expiration date, LOT number or identification of the calibration data. The reading of the machine-readable code takes place on the basis of the first recording and thus correspondingly available image data of the first recording by an applicable for the respective code evaluation software on the mobile device that may be part of the application or installed on the mobile device and the application can automatically access. After the first recording has taken place, the application checks, for example, whether the test to be performed identified by the machine-readable code is part of the test menu stored in the software and, accordingly, the associated colorimetric assays and calibration data are available. The machine-readable code assigned to the respective test strips may be connected to the test strips themselves or may be arranged on the packaging of the test strips contained therein, in the latter case the machine-readable code applied there being equally applicable to all test tires in the respective packaging. The packaging of the test strips may be a box or other suitable packaging. Assuming correct filling of the package with test strips of, for example, the same production lot, the usability and identification of the test strips can be determined with certainty by means of the machine-readable code on the package. In one embodiment, each individual test strip comprises the machine-readable code. In this case, the machine-readable code is permanently connected to the test strip, for example printed on the test strip as a barcode. This has the advantage that test strips which have been sorted into the wrong packaging due to a production error can be identified as unsuitable prior to the measurement or at least can be evaluated with the individually correct colorimetric assays and calibration data. In addition, one would have in this embodiment, a better control while using multiple test strips (for different analytes) by the user. A confusion of the test strips would thus be excluded.

In the context of the present invention, the mobile device refers to any device which has a processor suitable for executing applications, a storage unit for storing the installed applications and the first and second photographic recordings, an input and output unit and a camera for recording the first and second Recordings, includes. Applications designate software programs that are installed and executable on the mobile device. Such mobile devices are, for example, smartphones, tablet PCs, digital cameras connected to a computer or small portable computers with built-in camera. The camera for taking the first and second shots may be a standard commercial resolution camera. In one embodiment, the application is designed to refuse the usability of test strips, which are incompatible with the application installed on the mobile device, on the basis of the machine-readable code.

The colorimetric assay associated with the respective test strips and associated calibration data are for example stored on the mobile device (for example in the memory unit), the application being able to access this data in the mobile device.

The term "test strip" refers to any suitable sample with which the presence, amount or concentration of a substance can be determined according to one or more criteria. Frequent applications can be found - for example in the determination of blood sugar content or a pregnancy test - in medicine and pharmacy, but also, for example, in building metrology, water analysis and food production. The measurement targets are very diverse, the application partly very different. The test strips may have different shapes depending on the application, wherein the test fields may be arranged on one part of the test strip and the other part of the test strip may be used to guide and hold and / or attach the machine-readable code. The test fields include chemical substance (s) on at least one of the surfaces of the test strip, which react with color change to the presence of an analyte. Depending on the analyte and test strips, the test fields can be designed differently. One or more test fields may be present on a test strip, which are suitable for qualitatively or quantitatively detecting the presence of one or more analytes by means of color change. The test solution refers to any form of solution that is suitable for the test strip or to cover the test fields or at least to wet. For example, for contacting test strips and test solution, the test strip may be dipped in the test solution or the test solution may be suitably applied to the test strip.

The calibration data refers to data that associates the color of one or more test fields with a concentration of one or more analytes. Thus, the concentration of one or more analytes derived from the color change of the test fields of the test strip and thus the concentration can be determined.

In one embodiment, the application is intended to explicitly request the user to execute a first recording after it has started. In a further embodiment, the application is provided to explicitly request the user to execute the second recording. Thus, a single keystroke is sufficient to start the course of the measurement, which then runs automatically and without user intervention at least until the verification of the usability of the test strip and the determination of the colorimetric assay associated with this test strip and the associated calibration data. Furthermore, further information in the machine-readable code can also be read out with the first recording, for example a best-before date for the test strip. If the expiration date has already passed at the time of the first exposure, the application may reject the use of the test strip and the measurement will be aborted at this point. In one embodiment, therefore, the machine-readable code comprises a expiration date, wherein the application is intended to reject the usability of the test strip after it has been exceeded. In a further embodiment, the application requests the user to exchange the test strip or the test strip lot and to re-record a new test strip. If the application also requests to perform the second recording, the measurement is performed automatically and without user intervention until the completion of the analyte concentration calculations. In a further embodiment, the application is further designed to output the concentrations of the analyte in the test solution by means of an output unit of the mobile device. With the output of the measurement result, the measurement is completed automatically and without user intervention. The term "user intervention" does not designate the execution of the first and second recordings, but rather the input for determining, for example, measurement sequences or the input of colorimetric assays and calibration data to be used by the user / user himself. This avoids user-related errors in the selection and use of test strips and misinterpretations due to incorrect colorimetric assays and calibration data. This further enhances the user-friendly and reliable determination of analyte concentrations in test solutions and also allows flexible and error-free use of the measurement system for different analysis purposes in any order.

In a further embodiment, the application is provided after verification of the usability of the test strip to prompt the user to bring the test strip in contact with the test solution and this request is provided as evidence of usability for the user. This increases the user-friendliness of the measuring system and further reduces the source of error "users".

In a further embodiment, the application is designed to guide the user by means of a timer started by the application through the individual measurement steps starting with the contacting of the test strip with the test solution until the determination of the concentration (KA) of the analyte. Thus, time-critical measurements can be reliably and error-free carried out with the measuring system or user error when exceeding or falling below necessary periods reliably detected and evaluated the measurement results accordingly and possibly rejected as incorrect.

In a further embodiment, the machine-readable code comprises a designation of the calibration data to be used or the calibration data itself to be used. Thus, test strips which are suitable for the same test can be used, for example, from different production batches, manufacturers and test substances. For example, for test strips of different production batches, manufacturers and test substances, the same color changes may correspond to different concentrations of the analyte. For the test strips actually used, the correspondingly correct conversion of the color change to the concentration of the analyte is then reliably carried out by means of the calibration data to be used individually for this test strip. For this purpose, either the calibration data to be used in the machine-readable code must be designated, which are then read and used by the application from the data memory of the mobile device or the machine-readable code provides the calibration data itself, which guarantees that the test strip is independent of the mobile Device stored calibration data can be reliably evaluated. Similarly, test strips may be excluded which do not have correct colorimetric assays and / or or calibration data for the application are available, so-called non-associated test strips.

In a further embodiment, the application is configured to automatically request at least for updating the available calibration data in the event of non-availability of the designated calibration data on the mobile device or to automatically carry out corresponding steps for updating. Thus, measurements for associated test strips can also be carried out if the calibration data to be used is present in an unavailable manner, in that they are made available to the application by the user or the application itself obtains this calibration data. For example, this allows new application updates and updates of calibration data to be matched to one another by carrying out corresponding updates for or by the application. In a preferred embodiment, the application is configured to automatically establish a data connection to at least one server in order to download at least the designated calibration data to the mobile device for use in the measurement. This data connection can be made for example via the Internet. The data connection can be wired or wireless. The mobile device can establish the Internet connection for example by means of WLAN or by means of a mobile radio connection.

In a further embodiment, the application is configured to optionally reject or reject the usability of test strips on the basis of the machine-readable code. This can be done, for example, if the test strip is incompatible with the installed application, inter alia, if the colorimetric assays and / or the calibration data are not available.

• - Bereitstellen mindestens eines Teststreifens aus einer Vielzahl an Teststreifen mit mindestens einem Testfeld zur Bestimmung einer Konzentration mindestens eines Analyten in einer Testlösung mittels einer Farbveränderung des Testfeldes, wobei jedem Teststreifen ein maschinenlesbarer Code mit Daten zur Identifikation des Teststreifens und zur Auswertung durch eine Applikation zugeordnet ist;
• - Verwendung lediglich eines mobilen Geräts zur Durchführung der nachfolgenden Schritte mit Starten der auf dem mobilen Gerät installierten Applikation, wobei das mobile Gerät eine Kamera umfasst;
• - Aufnehmen zumindest des maschinenlesbaren Codes als eine erste Aufnahme vor einem Kontakt mit der Testlösung mit der Kamera des mobilen Geräts;
• - Verifizieren der Verwendbarkeit des Teststreifens für die jeweilige Messung auf Basis des über die erste Aufnahme ausgelesenen maschinenlesbaren Codes automatisch durch die Applikation;
• - Zugreifen auf die im mobilen Gerät gespeicherten colorimetrischen Assays und Kalibrierdaten und Festlegen des zu diesem Teststreifen zugehörigen colorimetrischen Assays und dazugehörenden Kalibrierdaten im Falle der Verwendbarkeit des Teststreifens automatisch durch die Applikation;
• - In Kontakt Bringen des Teststreifens mit der Testlösung;
• - Aufnehmen zumindest eines der Testfelder des Teststreifens, die vorher mit der Testlösung in Kontakt gebracht wurden, als eine zweite Aufnahme mit der Kamera des mobilen Geräts;
• - Bestimmen der Farbveränderung des oder der Testfelder des Teststreifens anhand der zweiten Aufnahme und des festgelegten colorimetrischen Assays; und
• - Berechnen der Konzentration des Analyten aus der bestimmten Farbveränderung auf Basis der Kalibrierdaten automatisch durch die Applikation.

The invention further relates to a method for carrying out colorimetric assays with the measuring system according to the invention comprising the steps

• - Providing at least one test strip from a plurality of test strips with at least one test field for determining a concentration of at least one analyte in a test solution by means of a color change of the test field, each test strip is associated with a machine-readable code with data for identification of the test strip and for evaluation by an application ;
• Using only a mobile device to perform the subsequent steps of starting the application installed on the mobile device, the mobile device comprising a camera;
• - receiving at least the machine-readable code as a first shot before contact with the test solution with the camera of the mobile device;
• - Verifying the usability of the test strip for each measurement on the basis of the read on the first recording machine-readable code automatically by the application;
• - accessing the colorimetric assays and calibration data stored in the mobile device and automatically determining the colorimetric assay associated with that test strip and associated calibration data in the case of the usability of the test strip by the application;
• - bringing the test strip into contact with the test solution;
• - taking at least one of the test fields of the test strip, which were previously brought into contact with the test solution, as a second recording with the camera of the mobile device;
• Determining the color change of the test field (s) of the test strip based on the second image and the determined colorimetric assay; and
• - Calculating the concentration of the analyte from the particular color change based on the calibration data automatically by the application.

This provides a measurement system compliant method for determining analyte concentrations in test solutions which allows for user-friendly and reliable determination of analyte concentrations in test solutions and which can also be used flexibly for various analytical purposes in any order.

In one embodiment of the method, each individual test strip comprises the machine-readable code and the first take is performed so that the test strip is picked up together with the machine-readable code.

In a further embodiment of the method, in the case of a negative result of the step of verifying, the test strip is rejected for carrying out the further method steps. In a preferred embodiment of the method, the step of verifying is assigned as a two-step test with a first step of verifying that one of the colorimetric assays and associated calibration data can be associated with the test strip and a second step of checking for a shelf life expiration date This test strip is not exceeded at the time of first recording. This ensures that both the data necessary for determining the concentration of the analyte are present and also that the test strip is able to show a correct color change and thus can measure correct concentrations.

In a further embodiment of the method, the application explicitly prompts the user to execute a first recording after it has been started, preferably the application also explicitly requests the user to execute the second recording.

In a further embodiment of the method, after the verification of the usability of the test strip, the application prompts the user to bring the test strip into contact with the test solution and then starts a timer in order to guide the user through the individual measuring steps starting with the contacting of the test strip the test solution to determine the concentration of the analyte.

In a further embodiment of the method, the machine-readable code of the test strip comprises a designation of the calibration data to be used or the calibration data itself and the application automatically requests at least updating of the available calibration data if the designated calibration data on the mobile device is not available or automatically takes corresponding steps to update the calibration data.

In a further embodiment of the method, the application automatically establishes a data connection to at least one server and downloads at least the designated calibration data to the mobile device for use in the measurement.

In a further embodiment of the method, the application automatically outputs the concentrations of the analyte in the test solution by means of an output unit of the mobile device. This output unit is for example a screen or monitor of the mobile device.

list of figures

• 1: eine Ausführungsform des erfindungsgemäßen Messsystems;
• 2: eine Ausführungsform des ersten Teils des erfindungsgemäßen Verfahrens;
• 3: eine Ausführungsform des zweiten Teils des erfindungsgemäßen Verfahrens;
• 4: eine Ausführungsform der Führung des Nutzers durch das Messverfahren mittels der Applikation.

These and other aspects of the invention are shown in detail in the figures as follows.

• 1 : an embodiment of the measuring system according to the invention;
• 2 an embodiment of the first part of the method according to the invention;
• 3 an embodiment of the second part of the method according to the invention;
• 4 an embodiment of the guidance of the user by the measuring method by means of the application.

Detailed description of the embodiments

1 shows an embodiment of the measuring system according to the invention 1 for carrying out colorimetric assays comprising at least one test strip 2 with at least one test field 21 for determining a concentration of at least one analyte in a test solution 3 by means of a color change of the test field 21. Here, each test strip 2 a machine-readable code 22 with data for identification of the test strip 2 and for evaluation by an application 4 assigned. This association between test strips 2 and machine-reading code 22 can be made by making the test strip 2 a packaging 7 on which the machine-readable code 22 is arranged, is taken, wherein the machine-readable code 22 on the packaging 7 for everyone in the packaging 7 located test strips 2 apply, in this embodiment, the test strips 2 no machine-readable code 22 have to wear themselves. In another embodiment, the machine-readable code 22 but also directly on each of the test strips 2 be arranged as in 1 through the dashed box 22 on the test strip 2 is indicated. In the latter case, the machine-readable code needs 22 then no longer on the packaging 7 be arranged. The measuring system 1 further includes a mobile device 5 , In this embodiment, the mobile device is 5 for example as a smartphone with a camera 51 on the back of the smartphone 5 facing the machine-readable code 22 is arranged and therefore in 1 is shown in dashed lines. The mobile device 5 includes next to the camera 51 an output unit 52 , here the screen of the smartphone as a user interface, a storage unit 53 on which among other things the application 4 is stored for performing the colorimetric assay and determining the concentrations of at least one analyte and a processor 54 to execute the application. With the camera 51 will be a first shot A1 at least the machine-readable code 22 before a contact of the test strip 2 with the test solution 3 and a second shot A2 of the test strip 2 and the test field (s) 21 after a contact ET (For example, by immersing the test strip 2 in the test solution) with the test solution 3 made. This is depending on the embodiment of the measuring system 1 the machine-readable code 22 at the first shot A1 either on the packaging 7 or on the test strip 2 photographed (both variants are in 1 shown). The application 4 is doing it on the mobile device 5 to carry out the measuring process and to evaluate the first and second images A1 . A2 installed, the application 4 is provided on the basis of the first recording A1 the machine-readable code 22 to evaluate this and thus the availability of the test strip 2 to verify automatically for the respective measurement V. The machine-readable code 22 next to data for identification of the test strip 2 additionally includes a designation of the calibration data to be used or the calibration data itself required later for calculating the concentration of the analyte. In the case of availability this becomes that test strip 2 associated colorimetric assay and associated calibration data automatically for the evaluation of the color change of this test strip 2 established. In the embodiment shown here is the application 4 also configured for non-availability of the designated calibration data on the mobile device 5 automatically take appropriate steps to update. This builds the application 4 via a suitable communication interface, not explicitly shown here, of the mobile device 5 automatically a data connection DV to at least one server 6 to at least the designated calibration data on the mobile device 5 for use in measuring and calculating the concentration of the analyte HL , Only then is the second shot taken A2 automatically determines the color change of the test field (s) based on the colorimetric assay and calculates the concentration of the analyte on the basis of the calibration data. In the embodiment shown here, the application 4 the calculated concentrations KA of the analyte in the test solution 3 by means of the output unit 52 , here the screen of the smartphone as a mobile device 5 , show what is symbolically represented here as "KA".

2 1 shows an embodiment of the first part of the method according to the invention for carrying out colorimetric assays ( CA ) with the measuring system according to the invention, such as in 1 shown. In the process, at least one test strip is first 2 from a variety of test strips 2 with at least one test field 21 to determine a concentration KA at least one analyte in a test solution 3 by means of a color change FV of the test field 21 provided, with each test strip 2 a machine-readable code 22 with data for identification of the test strip 2 and for evaluation by an application 4 as already in 1 is assigned described. By starting S on a mobile device 5 installed application 4 the measurement process will go through, for example, the application will 4 click to start and then with the camera 51 of the mobile device 5 the inclusion of at least the machine-readable code 22 as a first shot A1 before contact with the test solution 3 carried out. Based on the first shot A1 read machine-readable codes 22 automatically becomes the availability of the test strip 2 for the respective measurement by the application 4 verifies V. Here, in this embodiment, the step of verifying V designed as a two-stage test, in a first step P1 Checking is checked if the test strip 2 a colorimetric assay CA and associated calibration data KD can be assigned. If the test result is positive ("J"), the test strip becomes 2 a colorimetric assay CA and associated calibration data KD assigned and executed the second step P2. Is the test result of the first step P1 negative ("N"), becomes the test strip 2 rejected for the execution of further steps RW , In the second step P2 of the checking, it is checked whether a use-by date for this test strip has not been exceeded at the time of the first pick-up. This includes the machine-readable code 22 a shelf life, beyond which the usability of the test strip 2 rejected RW is. In this case, the second step would end with a negative test result ("N"). With the rejection of the test strip RW ends for this test strip the measuring method according to the invention. On the other hand, if the second step ends with a positive test result ("J"), this is added to this test strip ( 2 ) associated colorimetric assay CA and the associated calibration data KD automatically through the application 4 determined F. If the calibration data KD for the test strip 2 on the mobile device 5 or for the application 4 are not available, the application can 4 automatically a data connection DV to at least one server 6 build up and at least those through the test strip 2 or by the read-out machine-readable code 22 designated calibration data BKD on the mobile device 5 for use in the measurement download HL , After verification V the availability of the test strip and fixing F the colorimetric assay and the associated calibration data KD can the application 4 for example, the user of the measuring system 1 and the corresponding measuring method for bringing into contact ET of the test strip 2 with the test solution 3 ask AF3 , The further following steps are in 3 described.

3 shows an embodiment of the second part of the method according to the invention beginning with the step AF3 who is already in 2 has been described. Then the test strip 2 with the test solution 3 brought into contact ET , picking up at least one of the test fields 21 of the test strip 2 previously with the test solution 3 were contacted as a second shot A2 with the camera 51 of the mobile device 5 subsequently, the color change FV of the or test fields 21 of the test strip 2 based on the second shot A2 and the specified colorimetric assay CA determines and from it the concentration KA of the analyte based on the calibration data KD automatically through the application 4 calculated. Subsequently, the application 4 automatically the concentrations KA of the analyte in the test solution 3 by means of an output unit 52 of the mobile device 5 output AG ,

4 shows an embodiment of the guidance of the user by the measuring method 1 by means of the application 4 , Hereby the application demands 4 after her start S the user to take a first shot A1 explicitly on AF1 ,

After verification V the availability of the test strip 2 calls the application 4 the user AF3 , the test strip 2 in contact with the test solution 3 and in one embodiment can additionally provide a timer T Start as a timer to prompt the user through the individual measuring steps starting with the ET of the test strip 2 with the test solution 3 to time to determine the concentration KA of the analyte. In one embodiment, the application 4 , provided the test strip 2 a name BKD the calibration data to be used KD includes and these designated calibration data BKD on the mobile device 5 are not available, automatically at least to update the available calibration data KD asks AF4 , In another embodiment, the application automatically takes appropriate steps to update the calibration data KD before, see 1 and 2 , After contacting ET of the test strip 2 with his test fields 21 with the test solution 3 the application 4 also asks the user to execute the second recording A2 explicitly on AF2 , Through this guidance of the user through the application 4 The measuring procedure can cause incorrect operation of the test strip 2 avoided and an accurate and reliable measurement result for the concentration KA of the analyte can be achieved. Subsequently, the concentration KA of the analyte on an output unit of the mobile device 5 be issued AG ,

The embodiments shown herein are only examples of the present invention and therefore should not be considered as limiting. Alternative embodiments contemplated by one skilled in the art are equally within the scope of the present invention.

LIST OF REFERENCE NUMBERS

1

Measuring system according to the invention

2

test strips

21

(S) test field

22

machine-readable code

3

test solution

4

application

5

mobile device

51

Camera of the mobile device (s)

52

output unit

53

Storage unit for storing the application

54

Processor for executing the application

6

server

7

Packaging of the test strips

A1

first recording (recording of the first recording)

A2

second recording (recording of the second recording)

AG

Outputting the concentration of the analyte in an output unit

AF1

Request to record the first recording

AF2

Request to record the second recording

AF3

Prompt to contact the test strip with the test solution

AF4

Request to update the calibration data

B

Providing the test strip

BKD

Name of the calibration data

CA

colorimetric assays

DV

Data Connection

ET

Contacting the test strip with the test solution

F

Determine the colorimetric assay associated with the test strip and the associated calibration data

FV

(Determining the) color change of the test field (s)

HL

Download the calibration data

KA

(Calculate the) concentration of the analyte

KD

calibration

P1

first step of the review as part of the verification step

P1

second step of the review as part of the verification step

RW

Rejection of the test strip as unusable

S

Start of the application

T

(Start) timer

V

Verifying the usability of the test strip

Claims (21)

A measuring system (1) for carrying out colorimetric assays (CA) comprising at least one test strip (2) with at least one test field (21) for determining a concentration (KA) of at least one analyte in a test solution (3) by means of a color change of the test field (21) , wherein each test strip (2) is assigned a machine-readable code (22) with data for identification of the test strip (2) and for evaluation by an application (4), only a mobile device (5) with a camera (51) for executing a first receptacle (A1) of at least the machine-readable code (22) before contact of the test strip (2) with the test solution (3) and a second receptacle (A2) of the test strip (2) after contact with the test solution (3) and with the Application (4) for evaluating the first and second recordings (A1, A2) installed on the mobile device (5), the application (4) being provided at least on the basis of the readout via the first record (A1) Machine readable codes (22) automatically verify the usability of the test strip (2) for the respective measurement (V) and, in the case of usability, access the colorimetric assays (CA) and calibration data (KD) stored in the mobile device (5) to determine for this test strip (2) associated colorimetric assay (CA) and associated calibration data (KD) automatically for the evaluation of the color change of the test strip (2) (F), and only then by means of the second image (A2) using the colorimetric assay (CA ) to automatically determine the color change of the test field (s) (21) and to calculate thereon the concentration (KA) of the analyte based on the calibration data (KD). The measuring system (1) after Claim 1 , characterized in that each individual test strip (2) comprises the machine-readable code (22). The measuring system (1) after Claim 1 or 2 , characterized in that the application (4) is provided to explicitly prompt the user to execute the first recording (A1) after their start (AF1), preferably the application (4) is provided to the user also to execute the second To request recording (A2) explicitly. The measuring system (1) after Claim 3 , characterized in that the application (4) is provided after verification (V) of the usability of the test strip (2) to prompt the user (AF3) to bring the test strip (2) in contact with the test solution (3), and this request (AF3) is intended as proof of usability for the user. The measuring system (1) after Claim 4 , characterized in that the application (4) is adapted to the user by means of a timer started by the application (T) by the individual measuring steps starting with the bringing into contact (ET) of the test strip (2) with the test solution (3) until the determination of the concentration (KA) of the analyte. The measuring system (1) according to one of the preceding claims, characterized in that the machine-readable code (22) comprises a designation (BKD) of the calibration data (KD) to be used or the calibration data (KD) to be used itself. The measuring system (1) after Claim 6 , characterized in that the application (4) is configured to automatically request at least for updating the available calibration data (KD) in the event of non-availability of the designated calibration data (KD) on the mobile device (5) or automatically corresponding steps for Update. The measuring system (1) after Claim 7 characterized in that the application (4) is adapted to automatically establish a data connection (DV) to at least one server (6) for downloading at least the designated calibration data (KD) to the mobile device (5) for use in the measurement to load (HL). The measuring system (1) according to any one of the preceding claims, characterized in that the application (4) is designed to optionally refuse the usability of test strips (2) based on the machine-readable code (22) (RW). The measuring system (1) according to any one of the preceding claims, characterized in that the machine-readable code (22) comprises a expiration date, wherein the application (4) is provided to refuse the usability of the test strip (2) after exceeding it (RW). The measuring system (1) according to one of the preceding claims, characterized in that the application (4) for outputting the concentrations (KA) of the analyte in the test solution (3) is designed by means of an output unit (52) of the mobile device (5). The measuring system (1) according to any one of the preceding claims, characterized in that the mobile device is a smartphone or a tablet PC. A method for performing colorimetric assays (CA) with a measuring system (1) according to Claim 1 comprising the steps of providing (B) at least one test strip (2) from a multiplicity of test strips (2) with at least one test field (21) for determining a concentration (KA) of at least one analyte in a test solution (3) by means of a color change ( FV) of the test field (21), wherein each test strip (2) is assigned a machine-readable code (22) with data for identification of the test strip (2) and for evaluation by an application (4); Using only a mobile device to perform the subsequent steps of starting (S) the application (4) installed on the mobile device (5), the mobile device (5) comprising a camera (51); - receiving at least the machine-readable code (22) as a first image (A1) prior to contact with the test solution (3) with the camera (51) of the mobile device (5); - Verifying (V) the usability of the test strip (2) for the respective measurement on the basis of the first recording (A1) read machine-readable code (22) automatically by the application (4) - accessing the stored in the mobile device (5) colorimetric assay (CA) and calibration data (KD) and determination (F) of the colorimetric assay (CA) associated with this test strip (2) and the associated calibration data (KD) in the case of the usability of the test strip (2) automatically by the application (4 ); - bringing into contact (ET) the test strip (2) with the test solution (3); - receiving at least one of the test fields (21) of the test strip (2) previously brought into contact with the test solution (3) as a second image (A2) with the camera (51) of the mobile device (5); - determining the color change (FV) of the test field (s) (21) of the test strip (2) on the basis of the second image (A2) and the specified colorimetric assay (CA); and - calculating the concentration (KA) of the analyte from the determined color change (FV) on the basis of the calibration data (KD) automatically by the application (4). The procedure according to Claim 13 wherein each individual test strip (2) comprises the machine-readable code (22) and the first receptacle (A1) is carried out to receive the test strip (2) together with the machine-readable code (22). The procedure according to Claim 13 or 14 In the case of a negative result of the step of verifying (V), the test strips (2) reject the execution of the further method steps (RW). The procedure according to Claim 15 wherein the step of verifying (V) as a two-step test with a first step (P1) of verifying whether the test strip (2) of one of the colorimetric assay (CA) and associated calibration data (KD) can be assigned, and with a second step (P2) of verifying that a use-by date for this test strip has not been exceeded at the time of the first exposure. The method according to one of Claims 13 to 16 , wherein the application after its start (S) explicitly prompts the user to execute a first recording (A1) (AF1), preferably the application (4) explicitly requests the user to execute the second recording (A2) (AF2). The method according to one of Claims 13 to 17 wherein the application (4) after verification (V) of the usability of the test strip (2) prompts the user (AF3) to bring the test strip (2) into contact with the test solution (3) and then starts a timer (T), to guide the user through the individual measurement steps beginning with contacting (ET) of the test strip (2) with the test solution (3) until the determination of the concentration (KA) of the analyte. The method according to one of Claims 13 to 18 wherein the machine-readable code (22) of the test strip (2) comprises a designation (BKD) of the calibration data (KD) to be used or the calibration data (KD) itself and the application (4) if the designated calibration data (BKD) is not available the mobile device (5) automatically at least to update the available calibration data (KD) prompts (AF4) or automatically performs appropriate steps to update the calibration data (KD). The procedure according to Claim 19 wherein the application (4) automatically establishes a data connection (DV) to at least one server (6) and at least downloads the designated calibration data (BKD) to the mobile device (5) for use in the measurement (HL). The method according to one of Claims 13 to 20 , wherein the application (4) automatically the Concentrations (KA) of the analyte in the test solution (3) by means of an output unit (52) of the mobile device (5) outputs (AG).

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