US-20260126396-A1 - METHOD OF PERFORMING AN ANALYTICAL MEASUREMENT USING A MOBILE DEVICE

US20260126396A1US 20260126396 A1US20260126396 A1US 20260126396A1US-20260126396-A1

Abstract

A method of performing an analytical measurement includes using a camera of a mobile device to capture a time series of images of at least a part of a medical article. From this, image-derived position information on a relative position of the mobile device and the medical article is derived, thereby generating a first time series of position information. A sensor captures measurement information on the relative position of the mobile device and the medical article. Measurement-derived position information is used to generate a second time series of position information, and the first and second time series of position information are combined to generate an augmented time series of position information. From this, guidance is provided to a user to move the mobile device and the medical article into a relative target position. A mobile device, a kit and a computer program are also disclosed.

Inventors

Lukas Alperowitz
Max Berg
Fredrik Hailer
Bernhard Limburg

Assignees

ROCHE DIABETES CARE, INC.

Dates

Publication Date: 20260507
Application Date: 20251231
Priority Date: 20200706

Claims (14)

1 . A method of performing an analytical measurement using a mobile device having a camera, the method comprising: i) deriving, from a time series of images obtained with the camera and including at least part of a medical article, image-derived position information on a relative position of the mobile device and the medical article, thereby generating a first time series of position information; ii) deriving, from measurement information on the relative position of the mobile device and the medical article obtained with a sensor of the mobile device, alone or in combination with the image-derived position information, measurement-derived position information on the relative position of the mobile device and/or the medical article, thereby generating a second time series of position information; and iii) generating an augmented time series of position information by combining the first time series of position information and the second time series of position information; whereby the augmented time series of position information can be used to provide guidance to bring the mobile device into a relative target position of the mobile device and the medical article.
2 . The method according to claim 1 , further comprising deriving an item of current position information from the augmented time series of position information and comparing the item of current position information with the relative target position.
3 . The method according to claim 2 , further comprising determining a current point in time and determining whether the current point in time corresponds to a capturing time at which an image of the time series of images is captured, and, if so, using the first time series of position information for deriving the item of current position information, and, if not, using the second time series of position information.
4 . The method according to claim 1 , wherein the relative target position of the mobile device and the medical article comprises a non-parallel relative orientation of the mobile device and the medical article.
5 . The method according to claim 1 , wherein the analytical measurement comprises determining the concentration of an analyte in a sample of a body fluid, wherein the medical article comprises an optical test strip having a reagent test field.
6 . The method according to claim 5 , wherein the medical article further comprises a color reference card comprising at least one of (i) a plurality of different color reference fields having known reference color values and (ii) a plurality of different gray reference fields.
7 . The method according to claim 1 , wherein the first time series comprises image-derived position information as a function of capturing times of the images, wherein the second time series comprises measurement-derived position information as a function of time, wherein the measurement-derived position information of the second time series is given for points in time differing from the capturing times of the images.
8 . The method according to claim 1 , further comprising using an item of position information from the first time series of position information and estimating an item of measurement-derived position information on the basis of the item of position information from the first time series of position information and the measurement information
9 . The method according to claim 8 , wherein the estimating comprises at least one of: interpolating position information based on image-derived position information derived in step i) and the measurement information; extrapolating position information based on image-derived position information derived in step i) and the measurement information; determining a prospective trajectory of the relative position of the mobile device and the medical article based on the item of position information from the first time series of position information and at least one item of measurement information captured in step iii).
10 . The method according to claim 1 , wherein the guidance provided may include information for the user indicating at least one of (i) a direction into which the mobile device is to be moved in order to achieve the target position, and (ii) an orientation into which the mobile device is to be oriented in order to achieve the target position.
11 . A mobile device, comprising: a camera; and a sensor configured for capturing position information; wherein the mobile device is configured for performing the method according to claim 1 .
12 . A kit for determining the concentration of an analyte in a body fluid sample, the kit comprising: the mobile device according to claim 11 ; and the medical article comprising an optical test strip having a reagent test field.
13 . The kit according to claim 12 , further comprising a color reference card that comprises a plurality of different gray reference fields locally assigned to the test field, wherein the color reference card further comprises a plurality of different color reference fields having known reference color values and a plurality of different gray reference fields locally assigned to the color reference fields.
14 . A non-transitory computer readable medium having stored thereon computer-executable instructions for performing the method of claim 1 .

Description

RELATED APPLICATIONS This application is a continuation of U.S. patent application Ser. No. 18/150,551, filed Jan. 5, 2023, which is a continuation of PCT/EP 2021/06843l, filed Jul. 5, 2021, which claims priority to EP 20 184 181.4, filed Jul. 6, 2020, all of which are hereby incorporated herein by reference. BACKGROUND This disclosure refers to a method of performing at least one analytical measurement by using a mobile device. This disclosure further refers to a mobile device, to a kit for performing the at least one analytical measurement and to a computer program and a computer-readable storage medium. The method and devices specifically may be used in medical diagnostics, in order to, for example, quantitatively and/or qualitatively detect one or more analytes in a sample of a body fluid, such as for detecting glucose in blood and/or in interstitial fluid. Other fields of application of this disclosure, however, are also feasible. In the field of medical diagnostics, in many cases, one or more analytes have to be detected in samples of a body fluid, such as blood, interstitial fluid, urine, saliva or other types of body fluids. Examples of analytes to be detected are glucose, triglycerides, lactate, cholesterol or other types of analytes typically present in these body fluids. According to the concentration and/or the presence of the analyte, an appropriate treatment may be chosen, if necessary. Without narrowing the scope, this disclosure specifically may be described with respect to blood glucose measurements. It shall be noted, however, that this disclosure may also be used for other types of analytical measurements, specifically analytical measurements using one or more test elements. Generally, devices and methods known to the skilled person make use of test elements comprising one or more test chemicals, which, in presence of the analyte to be detected, are capable of performing one or more detectable detection reactions, such as optically detectable detection reactions. With regard to the test chemicals comprised in test elements, reference may be made, e.g., to J. Hoenes et al.: The Technology Behind Glucose Meters: Test Strips, Diabetes Technology & Therapeutics, Volume 10, Supplement 1, 2008, S-10 to S-26. Other types of test chemistry are possible and may be used for performing this disclosure. In analytical measurements, specifically analytical measurements based on color formation reactions, one technical challenge resides in the evaluation of the color change which is due to the detection reaction. Besides using dedicated analytical devices, such as handheld blood glucose meters, 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. As an example, WO 2012/131386 A1 discloses a testing apparatus for per-forming an assay, the testing apparatus comprising: a receptacle containing a reagent, the reagent being reactive to an applied test sample by developing a color or pattern variation; a portable device, e.g., a mobile phone or a laptop, comprising a processor and an image capture device, wherein the processor is configured to process data captured by the image capture device and output a test result for the applied test sample. Another method of performing at least one analytical measurement by using a mobile device having at least one camera is disclosed in EP 1 963 828 B1. WO 2019/238500 A1 discloses a calibration method for calibrating a camera of a mobile device. As opposed to laboratory measurements and measurements performed by using dedicated analytical measurement devices, when using mobile computing devices such as smart phones, various influences need to be taken into account. Specifically, a camera-based evaluation of optical test strips by using mobile devices may require capturing images having defined intensity criteria. For example, captured images may be devoid of glare and/or specular reflection, specifically on relevant elements in the images, such as the test field, the reference fields and/or other elements. In order to enable the mobile computing device to capture images obeying the defined intensity criteria, the mobile device and the object to be imaged may be aligned in a predetermined position to each other. For example, the spatial and/or the angular orientation may be derived from elements of the captured image having known geometry. Generally, in several fields of technology, methods for deriving spatial information from digital images are known. For example, U.S. Pat. No. 10,357,092 B2 describes a shaving guidance system for guiding a user during a shaving procedure, the system comprising an image sensor configured to register an image of a part of the body of the user, an image data analyzer configured to determine a local hair-growth direction based on data in the image, a controller configured to generate instructions about a direction in which a h