Abstract: A method of determining a color expectation range for assessing the plausibility of an assumed reaction time value used in an analytical measurement based on a color formation reaction and a measurement method of performing an analytical measurement based on a color formation reaction by using a mobile device having a camera and a processor are disclosed. Further disclosed are a determination system for determining a color expectation range for assessing the plausibility of an assumed reaction time value used in an analytical measurement based on a color formation reaction, a mobile device having a camera and a processor, a kit for determining the concentration of at least one analyte in a sample of a body fluid having the mobile device as well as computer programs and computer-readable storage media having instructions which, when performed on the respective device, cause the device to perform the determination method and/or the measurement method.

Abstract: Methods and devices for determining the concentration of at least one analyte in a bodily fluid. Including a determination method of determining a color expectation range for assessing the plausibility of a color formation value obtained in an analytical measurement based on a color formation reaction and a measurement method of performing an analytical measurement based on a color formation reaction by using a mobile device having a camera and a processor. Further including a determination system for determining a color expectation range for assessing the plausibility of a color formation value obtained in an analytical measurement based on a color formation reaction. The determination system comprises a training set of optical test strips having a reagent test region. At least two of the training optical test strips are non-corrupted and at least two are corrupted.

Abstract: A determination method of determining a dynamic coefficient of variation limit (CvTR, lim) for assessing validity of an optical test strip usable for an analytical measurement based on a color formation reaction is disclosed. Training sets of optical test strips and mobile devices are provided. A color reference card is also provided. Images are captured of reagent test regions of the optical test strip and of a color reference field(s) of the reference card. A training set of pairs of reagent test region coefficients of variation (CvTR) and corresponding minimum color reference field coefficients of variation (CvRF, min) are determined. A relation for determining the dynamic coefficient of variation limit (CvTR, lim) for the respective reagent test region is derived. The dynamic coefficient of variation limit (CvTR, lim) defines a maximum coefficient of variation (CvTR, max) for reagent test regions of non-corrupted optical test strips.

Abstract: A method for detecting an analyte in a sample is disclosed. The method includes providing a mobile device having a camera and an illumination source. A test strip having a test field with at least one test chemical for performing an optical detection reaction in the presence of the analyte is provided. The sample is applied to the test field. Several images of a region of the test strip are captured. The region includes at least part of the test field to which sample is applied. The images are captured before and after the sample is applied and with the illumination source turned on and off. The images captured are compared and differences in light intensities are determined. Analyte concentration is determined using the images captured and the determined light intensities.

Abstract: A method for calibrating a camera of a mobile device for detecting an analyte in a sample. An image of an object is captured using the camera with an illumination source turned on. A first area is determined in the image which is affected by direct reflection of light originating from the illumination source and reflected by the object. A second area which does not substantially overlap with the first area is determined as a target area of a test strip. Also disclosed is a detection in which a sample is applied to a test strip and a visual indication is provided to position the test strip relative to the camera to thereby locate the test field of the strip in the target area. An image of the test field is captured using the camera while the illumination source is turned on, and analyte concentration is determined from the image.

Abstract: A method for determining analyte concentration in a body fluid using a mobile device having a camera and a lidar sensor that have an overlapping field of view. In the method, an object is selected and the user is prompted to apply a body fluid sample to a reagent test region. The user is prompted to provide the object within the overlapping field of view of the camera and the lidar sensor. The processor of the mobile device generates a lidar measurement data set representing the object, which is compared to a pre-generated data set. When there is a degree of congruence from the comparison that is above a pre-determined minimum, the camera captures an image of the reagent test region having the body fluid sample applied thereto and concentration of analyte in the sample is determined. When the congruence is below a pre-determined minimum, image capturing is not allowed.

Abstract: Systems and methods for measuring an analyte include devices configured to perform an analyte testing operation. The devices include a wearable electronic device and a remote device operatively connected to each other and each having a processor, the processors cooperating with each other in the execution of program instructions to measure an analyte. The wearable electronic device includes a camera configured to generate a video stream, which is analyzed to identify missing test components, to identify the application of a body fluid on a test strip where the sample undergoes changes in one or more optical properties, the image of which is analyzed to determine a level of the analyte. The wearable electronic device further includes a head-up display (HUD) for providing output messages to the user relating to the performance and status of the analyte testing operation.

Abstract: Systems and methods for measuring an analyte include devices configured to perform an analyte testing operation. The devices include a wearable electronic device and a remote device operatively connected to each other and each having a processor, the processors cooperating with each other in the execution of program instructions configured to direct the devices in the performance of the analyte testing operation. The wearable electronic device includes a camera configured to generate a video stream and one or more images relating to a user removing a test strip from a vial, producing a bodily fluid sample, and applying the sample to a deposit site of the test strip where the sample undergoes changes in one or more optical properties, the image of which is analyzed to determine a level of the analyte. The wearable electronic device further includes a head-up display (HUD) for providing output messages to the user relating to the performance and status of the analyte testing operation.

Abstract: A method for measuring an analyte includes identifying a test strip in a video stream generated by a camera based on at least one registration mark associated with the test strip depicted in the video stream, identifying application of a fluid dose to a deposit site formed on the test strip based on the video stream, activating a timer in response to the identification of the application of the fluid dose, generating at least one optical measurement of a reagent located at a measurement site on the test strip, and generating a measurement of an analyte in the fluid dose based on the at least one optical measurement of the reagent only in response to the at least one optical measurement being generated after a predetermined minimum time period has elapsed and prior to a predetermined maximum time period elapsing subsequent to the activating of the timer.

Abstract: A method of controlling auto white balance settings of a mobile device with a camera and preset auto white balance modes for performing a color based measurement comprising the steps of capturing an image of at least part of one or more gray fields of a color reference card, determining, for a region of interest within the image, a number of gray fields for which the color information for a first color and a second color shows overexposure as a first overexposure-number and a second overexposure-number, respectively, the first color relating to a smaller wavelength than the second color, and re-capturing the image with a warmer white balance mode if the first overexposure number is greater than the second overexposure number or re-capturing the image with a cooler white balance mode if the first overexposure number is smaller than the second overexposure number.

Abstract: A method for generating a module configured to determine concentration of an analyte in a sample of a body fluid is disclosed. The method includes providing a first set of measurement data derived from images of one or more test strips indicating a color transformation in response to a body fluid containing an analyte. The images can be recorded by multiple devices with differing cameras, software and/or hardware device configurations for image recording and image data processing. A neural network model can be generated in a machine learning process applying an artificial neural network and a module configured to determine concentration of an analyte in a second sample of a body fluid can be generated. Further, the present disclosure includes a system for generating the module as well as a method and a system for determining concentration of an analyte in a sample of a bodily fluid.

Abstract: A method of determining analyte concentration in a body fluid with a mobile device having a camera. A user is prompted to apply body fluid to an optical test strip and then waits a predetermined minimum waiting time. The camera captures an image of part of the test field having the body fluid applied thereto. Analyte concentration is determined based on the image captured. The determination includes estimating a point in time of sample application to the test field by taking into account time-dependent information derived from the image captured using a first color channel of a color space. The determination also estimates the concentration of the analyte by taking into account concentration-dependent information derived from the image using a second color channel of the color space.

Abstract: A method for generating a module configured to determine concentration of an analyte in a sample of a body fluid is disclosed. The method includes providing a first set of measurement data derived from images of one or more test strips indicating a color transformation in response to a body fluid containing an analyte. The images can be recorded by multiple devices with differing cameras, software and/or hardware device configurations for image recording and image data processing. A neural network model can be generated in a machine learning process applying an artificial neural network and a module configured to determine concentration of an analyte in a second sample of a body fluid can be generated. Further, the present disclosure includes a system for generating the module as well as a method and a system for determining concentration of an analyte in a sample of a bodily fluid.

Abstract: A method of determining analyte concentration in a body fluid with a mobile device having a camera. A user is prompted to apply body fluid to an optical test strip and then waits a predetermined minimum waiting time. The camera captures an image of part of the test field having the body fluid applied thereto. Analyte concentration is determined based on the image captured. The determination includes estimating a point in time of sample application to the test field by taking into account time-dependent information derived from the image captured using a first color channel of a color space. The determination also estimates the concentration of the analyte by taking into account concentration-dependent information derived from the image using a second color channel of the color space.

Abstract: A method of evaluating suitability of lighting conditions for detecting an analyte in a sample using a mobile device camera. A test strip is provided for detecting the analyte. A first image of the test strip is captured while an illumination source of the mobile device is turned off and a second image of the test strip is captured while the illumination source is turned on. A sample is applied to the test strip and the first and second images are compared to thereby determine the difference in lighting conditions between the first image and the second image. The comparison is used to derive information on suitability of the lighting conditions for analyte detection. The lighting conditions are indicated as suitable when a predetermined threshold amount of light intensity used for illumination of the test strip originates from the illumination source.

Abstract: A method of evaluating suitability of lighting conditions for detecting an analyte in a sample using a mobile device camera. A test strip is provided for detecting the analyte. A first image of the test strip is captured while an illumination source of the mobile device is turned off and a second image of the test strip is captured while the illumination source is turned on. A sample is applied to the test strip and the first and second images are compared to thereby determine the difference in lighting conditions between the first image and the second image. The comparison is used to derive information on suitability of the lighting conditions for analyte detection. The lighting conditions are indicated as suitable when a predetermined threshold amount of light intensity used for illumination of the test strip originates from the illumination source.

Abstract: A calibration method for calibrating a camera for detecting an analyte in a sample is disclosed. A plurality of different color coordinate systems and a set of test samples are provided. The test samples are applied to test elements that have test fields for producing an optically detectable reaction. Images of the colored test fields are acquired using the camera and color coordinates for the images are generated. The color coordinates that are generated are transformed into a set of measured concentrations by using a set of coding functions. The set of measured concentrations is compared with the known concentrations of the test samples and a best match color coordinate system of the plurality of color coordinate systems is determined. A best match coding function of the plurality of coding functions is also determined.

Abstract: A method is disclosed for controlling auto-exposure settings of a mobile device when capturing an image of a color reference card and of a test field. Provided are a color reference card and an optical test strip having the test field with a sample applied thereto. The color reference card has different color reference fields having known reference color values and one or more gray background fields having defined gray values. An exposure metering area is set and auto-exposure settings are determined based on a scene in the exposure metering area. The scene has at least part of the test field and at least part of the different color reference fields and the one or more gray background fields. The camera captures an image of the scene using the determined auto-exposure settings. A method of determining concentration of analyte in a sample by using a mobile device is also disclosed.

Abstract: A method of determining concentration of an analyte in a body fluid uses a mobile device having a camera and an ambient light detector. The ambient light detector has an ambient light sensor and/or an additional camera. An ambient light check is performed. In the ambient light check, ambient light is used to determine an item of ambient light information. If a validity criterion is determined to be met, the concentration of the analyte is determined by evaluating an image of at least a part of a reagent test region of an optical test strip having a sample of body fluid applied thereto. The image is captured by the camera. A mobile device, a kit, a computer program and a computer-readable storage medium are also disclosed.

Abstract: A test strip fixation device for use in a method of determining analyte concentration in a body fluid using a mobile device with a camera. The device has top and bottom surfaces, has an essentially planar shape, and also has a cut-out portion configured for application of a body fluid sample. The top surface has color reference fields with known reference color values, including grey and non-grey reference fields. The grey reference fields are symmetrically arranged around the cut-out portion and around at least some of the non-grey color reference fields. The top surface also has position detection code elements. The bottom surface has a connector configured for detachable connection of an optical test strip relative to the test strip fixation device, and a reagent test region of the test strip can be aligned with the cut-out portion. A method of using the device is also disclosed.