Roche Diabetes Care, Inc.

Other

Roche Diagnostics Gmbh

F. Hoffmann-la Roche Ag

Bernd Limburg

Max Berg

Fredrik Hailer

Daniel Sieffert

Volker Tuerck

Herbert Wieder

Siva Chittajallu

Peter Seelig

Benhur Aysin

Daria Skuridina

Carina Horn

Wolfgang Petrich

Christian Ringemann

Markus Serr

Momme Winkelnkemper

Christian Melchinger

Ingrid Keth

Irina Ostapenko

Markus Plum

Timo Ottenstein

Simon Aigner

Frank Rueckert

Gabriele Chemnitius

Christian Hoertz

Bernhard Schmidt

Zied Guermazi

Diva Chittajallu

An optical test strip () for measuring an analyte concentration in a sample of bodily fluid is disclosed. The optical test strip () comprises:

Devices and method for measuring an analyte concentration in a sample of bodily fluid

A method of determining concentration of an analyte in a body fluid using a mobile device having a camera is disclosed. In the inventive method, the camera is used to take a series of calibration images of a region of interest of an object. The calibration images differ in their brightness. A key calibration figure is derived from each calibration image, the key calibration images being characteristic for a tone mapping function of the mobile device. A probable tone mapping function of the mobile device is determined by taking into account the key calibration figures. An analysis image is taken of at least part of a test field of an optical test strip, the test field having a body fluid applied thereto. Analyte concentration is determined from the analysis image of the test field by taking into account the probable tone mapping function of the mobile device.

Method of determining a concentration of an analyte in a bodily fluid and mobile device configured for determining a concentration of an analyte in a bodily fluid

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.

Method and system for determining concentration of an analyte in a sample of a bodily fluid, and method and system for generating a software-implemented module

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.

Method of determining a concentration of an analyte in a bodily fluid

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.

Method for evaluating suitability of lighting conditions for detecting an analyte in a sample using a camera of a mobile device

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.

Methods and systems for calibrating and using a camera for detecting an analyte in a sample

A method for evaluating the suitability of a mobile device having a camera for performing an analytical measurement based on a color formation reaction. A mobile device is provided and is used to take an image of a reference color field of an object. A color coordinate of pixels of a region of interest within the image is determined and a histogram analysis is performed on a distribution of the color coordinates of the pixels. The width of a color peak within the distribution from the histogram analysis is ascertained and compared with a threshold value to thereby determine suitability of the mobile device for performing the analytical measurement based on the color formation reaction.

Methods and devices for performing an analytical measurement based on a color formation reaction

A method for evaluating the suitability of a mobile device having a camera for performing an analytical measurement is disclosed. The method includes providing the mobile device and providing a reference object having a predefined spatial extension in a spatial dimension. An image is taken of at least part of the reference object using the camera and is used to derive spatial resolution information that includes one or more numerical values that quantify the capability of the camera to resolve two or more objects in the image. A threshold value based on a minimum number of pixels in the spatial dimension within a region of interest in the image is provided and the spatial resolution information is compared with the threshold value. It is determined from the comparison whether the mobile device is suitable for performing the analytical measurement.

Methods and devices for performing an analytical measurement

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

Methods of evaluating medical measurement curves, as well as computer programs and devices therefor

Growing community of inventors

Soergenloch, Germany

Bernd Limburg