ADJUSTMENT METHOD FOR ADJUSTING A SETUP FOR AN ANALYTICAL METHOD

Abstract

This disclosure refers to an adjustment method for adjusting a setup for an analytical method of determining a concentration of an analyte in a bodily fluid based on a color formation reaction in an optical test strip mobile device for performing analytical measurements. This disclosure further relates to a mobile device configured for performing the adjustment method, a computer program and a computer-readable storage medium for performing the adjustment method and a kit comprising a test strip or a dummy test strip and at least one of the mobile device, the computer program and the computer-readable storage medium. The method, device, computer program, storage media and kit specifically may be used in medical diagnostics, for example, qualitatively or quantitatively detect analytes in body fluids, such as for detecting glucose in blood and/or interstitial fluid. Other fields of application of this disclosure, however, are feasible.

Claims

1. A method of adjusting a setup used in an analytical method of determining a concentration of an analyte in a body fluid based on a color formation reaction in an optical test strip, the analytical method comprising using a mobile device having a camera, a processor and a memory, wherein the adjustment method comprises: a) carrying out a plurality of analyte measurement attempts with the mobile device set in a standard measuring mode, wherein each of the plurality of analyte measurement attempts comprises: capturing, by using the camera, one or more images of at least a part of an optical test strip having a test field before and/or after sample application, checking, by the processor, for the fulfillment of one or more measurement rejection criteria stored in the memory, and when one or more measurement rejection criteria are fulfilled, rejecting, by the processor, the measurement attempt and logging the one or more rejection events in the memory, and b) analyzing, by the processor, one or more of the logged rejection events in an error analysis and based on the result of the error analysis, adjusting the setup by placing the device (i) in a reduced measuring mode wherein one or more of the measurement rejection criteria are deactivated, and/or (ii) in an enhanced measuring mode wherein during a measurement attempt corrective feedback is provided to the user.

2. The adjustment method according to claim 1, wherein step a) comprises checking by the processor for the fulfillment of one or more measurement rejection criteria stored in the memory based on an analysis of the one or more images captured.

3. The adjustment method according to claim 1, further comprising, in step a), obtaining sensor data by using at least one sensor of the mobile device and checking for the fulfillment of one or more measurement rejection criteria stored in the memory based on one or more of the obtained sensor data.

4. The adjustment method according to claim 1, wherein the one or more measurement rejection criteria comprise at least one of insufficient image sharpness, insufficient ROI saturation, insufficient ROI size, insufficient ROI homogeneity, insufficient steadiness, and insufficient orientation.

5. The adjustment method according to claim 1, further comprising determining and providing, by the processor, an analytical measurement result value by using the one or more images captured in step a) when the measurement attempt was not rejected.

6. The adjustment method according to claim 1, wherein step a) comprises capturing, by using the camera, at least one image of at least a part of an optical test strip having a test field before and at least one image of at least a part of an optical test strip after sample application, and step a) further comprises checking, by the processor, for the fulfillment of one or more measurement rejection criteria stored in the memory based on an analysis of the at least two captured images, and when one or more measurement rejection criteria are fulfilled, rejecting, by the processor, the measurement attempt and logging the one or more rejection events in the memory, and step a) further comprises determining, by the processor, an analytical measurement result value by using at least one of the at least two images and providing the analytical measurement result value to the user when the measurement attempt was not rejected based on the analysis of the at least two images.

7. The adjustment method according to claim 1, wherein step b) comprises analyzing only the one or more rejection events logged from measurement attempts conducted when the mobile device was set in the standard measuring mode.

8. The adjustment method according to claim 1, wherein the analyzed one or more logged rejection events are the one or more logged rejection events from one or more of: N.sub.A most recent measurement attempts; N.sub.R most recent logged rejection events; and a timespan T.

9. The adjustment method according to claim 1, wherein the error analysis comprises determining the rejection event logged most often or logged most recently.

10. The adjustment method according to claim 1, wherein the one or more deactivated measurement rejection criteria are different from the measurement rejection event logged most often or most recently as determined in the error analysis.

11. The adjustment method according to claim 1, further comprising: c) carrying out at least one analyte measurement attempt with the mobile device set in the reduced measuring mode, the analyte measurement attempt in the reduced measuring mode comprising: capturing, by using the camera, one or more images of at least a part of an optical test strip having a test field before and/or after sample application or of a dummy test strip, checking, by the processor, for the fulfillment of one or more measurement rejection criteria stored in the memory that are not deactivated, and optionally when one or more measurement rejection criteria which are not deactivated are fulfilled rejecting, by the processor, the measurement attempt.

12. The adjustment method according to claim 1, further comprising: c) carrying out at least one analyte measurement attempt with the mobile device set in the enhanced measuring mode, wherein the corrective feedback is provided to the user before capturing, by using the camera, one or more images of at least a part of an optical test strip having a test field before and/or after sample application or of a dummy test strip.

13. A mobile device having at least at least a camera, a processor and a memory, the mobile device configured for performing the method according to claim 1.

14. A kit, comprising the mobile device of claim 13 and at least one of a test strip and a dummy test strip.

15. A non-transitory computer readable medium having stored thereon computer-executable instructions for performing the method according to claim 1.

16. A kit, comprising the computer readable medium of claim 15, and at least one of a test strip and a dummy test strip.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0215] The above-mentioned aspects of exemplary embodiments will become more apparent and will be better understood by reference to the following description of the embodiments taken in conjunction with the accompanying drawings, wherein:

[0216] FIG. 1 shows an embodiment of a kit and of a mobile device;

[0217] FIGS. 2 and 3 show flow charts of embodiments of the adjustment method; and

[0218] FIG. 4 shows a flow chart of an embodiment of a measurement attempt.

DESCRIPTION

[0219] The embodiments described below are not intended to be exhaustive or to limit the invention to the precise forms disclosed in the following detailed description. Rather, the embodiments are chosen and described so that others skilled in the art may appreciate and understand the principles and practices of this disclosure.

[0220] In FIG. 1, an exemplary embodiment of a kit 110 is shown in a perspective view. The kit 110 comprises a mobile device 112 such as a smart phone and, further, at least one optical test strip 114, in this setup placed in a field of view 116 of a camera 118 of the mobile device 112.

[0221] The mobile device 112 may comprise, besides the at least one camera 118, at least one processor 120, at least one memory 122, and at least one sensor 132. The mobile device 112 may further comprise at least one display 124, such as for displaying a life image taken by the camera 118 and/or for displaying information to a user. The mobile device 112 may further comprise at least one illumination source 123 such as an LED or the like.

[0222] The optical test strip 114 may comprise at least one substrate 126 such as a flexible, strip-shaped substrate. The optical test strip 114 further comprises at least one test field 128 applied to the substrate, the test field 128 comprising at least one test chemical for performing a detection reaction with at least one analyte comprised by a sample 130. The sample 130 may directly or indirectly be applied to the test field 128, such as by applying a droplet of a bodily fluid to the test field 128 and/or to a capillary element for conducting the sample 130 to the test field 128.

[0223] The mobile device 112 is configured, by appropriate programming of the processor 120, for performing and/or supporting the method according to this disclosure which will be described with reference to an exemplary embodiment shown in a flow chart in FIG. 2.

[0224] A flow chart of an exemplary embodiment of an adjustment method 134 is shown in FIG. 2. The adjustment method 134 comprises the following steps, which may specifically be performed in the given order. Still, a different order may also be possible. It may be possible to perform two or more of the method steps fully or partially simultaneously. It may further be possible to perform one, more than one or even all of the method steps once or repeatedly. The adjustment method 134 comprises: [0225] a) (denoted with reference number 136) carrying out, a plurality of analyte measurement attempts with the mobile device (114) set in a standard measuring mode, wherein each of the plurality of analyte measurement-attempts comprises [0226] i) capturing, by using the camera (118), one or more images of at least a part of an optical test strip (114) having a test field (128) before and/or after sample (130) application; and [0227] ii) checking, by the processor (120), for the fulfillment of one or more measurement rejection criteria stored in the memory (122), and if one or more measurement rejection criteria are fulfilled rejecting, by the processor (120), the measurement attempt and logging the one or more rejection events in the memory (122), [0228] b) (denoted with reference number 138) analyzing, by the processor (120), one or more of the logged rejection events in an error analysis and based on the result of the error analysis adjusting the setup by placing the device (112) in: [0229] i) a reduced measuring mode wherein one or more of the measurement rejection criteria are deactivated, and/or [0230] ii) an enhanced measuring mode wherein during a measurement attempt corrective feedback is provided to the user.

[0231] The adjustment method 134 may comprise additional method steps that are not listed in FIG. 2. As exemplarily illustrated by FIG. 3, the method 134 may comprise an additional step [0232] c) (denoted with reference number 140) carrying out at least one analyte measurement attempt with the mobile device set in the reduced measuring mode and/or set in the advanced measuring mode.

[0233] A flow chart of an exemplary embodiment of a measurement attempt 142 is shown in FIG. 4. Specifically, measurement attempt 142 may start, for example, with starting an App on the mobile device, e.g., the smartphone. An optical test strip (114) having a test field (128) may be provided (denoted with reference number 144). The measurement attempt further comprises. [0234] i) capturing (denoted with reference number 146), by using the camera (118), one or more images of at least a part of an optical test strip (114) having a test field (128) before and/or after sample (130) application; and [0235] ii) checking (denoted with reference number 148) for the fulfillment of one or more measurement rejection criteria stored in the memory (122).

[0236] The branching point 150 may indicate a condition query, such as deciding between a first branch 152 and a second branch 154. As an example, the first branch 152 may indicate fulfillment (“y”) of one or more measurement rejection criteria. Thus, the first branch 152 leads to the step (denoted with reference number 156) of rejecting the measurement attempt and logging the one or more rejection events in the memory (122). The second branch 154 may indicate non-fulfillment (“n”) of one or more measurement rejection criteria and, thus, may lead to: [0237] iii) (denoted with reference number 158) determining and providing, by the processor, an analytical measurement result value.

[0238] While exemplary embodiments have been disclosed hereinabove, the present invention is not limited to the disclosed embodiments. Instead, this application is intended to cover any variations, uses, or adaptations of this disclosure using its general principles. Further, this application is intended to cover such departures from the present disclosure as come within known or customary practice in the art to which this invention pertains and which fall within the limits of the appended claims.

LIST OF REFERENCE NUMBERS

[0239] 110 kit [0240] 112 mobile device [0241] 114 optical test strip [0242] 116 field of view [0243] 118 camera [0244] 120 processor [0245] 122 memory [0246] 123 illumination source [0247] 124 display [0248] 126 substrate [0249] 128 test field [0250] 130 sample [0251] 132 sensor [0252] 134 adjustment method [0253] 136 step a) [0254] 138 step b) [0255] 140 step c) [0256] 142 measurement attempt [0257] 144 providing an optical test strip [0258] 146 step a) i) [0259] 148 checking for the fulfillment of one or more measurement rejection criteria stored in the memory [0260] 150 branching point [0261] 152 first branch [0262] 154 second branch [0263] 156 rejecting the measurement attempt and logging the one or more rejection events in the memory [0264] 158 step a) iii)