Analytical measurement method for detecting multiple analytes in a bodily fluid

The hybrid test element with optical and electrochemical detection reactions simplifies simultaneous detection of multiple analytes using a mobile device, addressing the challenges of multiple test elements and enhancing usability for home testing.

WO2026008668A1 Publication Date: 2026-01-08ROCHE DIABETES CARE GMBH +1
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Patent Information

Application Number
PCT/EP2025/068753
Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
Priority Date
2024-07-04
Filing Date
2025-07-02
Publication Date
2026-01-08

AI Technical Summary

Technical Problem

Existing methods require multiple test elements and systems for simultaneous detection of different analytes, posing challenges for layman users in home testing scenarios, particularly when different analytes need different measurement techniques, and there is a need to simplify and enhance usability of mobile devices for such measurements.

Method used

A hybrid test element that combines optical and electrochemical detection reactions in a single sample, using a mobile device with a camera and an electrochemical reader unit to detect different analytes simultaneously, allowing for a single test element to perform multiple analyses.

Benefits of technology

Enables simultaneous and accurate detection of multiple analytes in a single sample using a single test element, enhancing usability and reliability for layman users in home testing scenarios.

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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.
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