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1. WO2020109525 - METHOD OF DETERMINING A CONCENTRATION OF AN ANALYTE IN A BODILY FLUID

Note: Text based on automatic Optical Character Recognition processes. Please use the PDF version for legal matters

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Claims

1. A method of determining a concentration of an analyte in a bodily fluid by using a mobile device (110) having a camera (112), the method comprising:

a) prompting a user to one or more of

apply a drop of bodily fluid to at least one test field (114) of an optical test strip (116), or

confirm an application of a drop of bodily fluid to at least one test field (114) of an optical test strip (116);

b) waiting for a predetermined minimum amount of waiting time;

c) capturing at least one image of at least one part of the test field (114), with the test field (114) having the drop of bodily fluid applied thereto, by using the camera (112); and

d) determining the concentration of the analyte in the bodily fluid based on the image captured in step c), comprising:

i) estimating a point in time of sample application to the test field (114), by taking into account at least one first item of information derived from the image captured in step c) by using at least one first color channel of a color space, wherein the first item of information is time-dependent; and ii) estimating the concentration of the analyte in the bodily fluid, by taking into account at least one second item of information derived from the im age by using at least one second color channel of the color space, where in the second item of information is concentration-dependent, wherein the estimating of the concentration of the analyte in the bodily fluid fur ther takes into account the point in time of sample application estimated in step i).

2. The method according to the preceding claim, wherein the minimum amount of wait- ing time is determined by using a method selected from the group consisting of: a time span is chosen for the minimum amount of waiting time, wherein the time span is known to be sufficient for a detection reaction in the test field (114) for samples having a concentration of the analyte within a predetermined concentration range to have reached a steady state;

- a predetermined time span is chosen for the minimum amount of waiting time; a time span confirmed by the user in step a) is chosen for the minimum amount of waiting time.

3. The method according to any one of the preceding claims, wherein the estimated analyte concentration in step ii) is determined by determining the concentration of the analyte corresponding to the second item of information by means of a correla- tion between the analyte concentration and the second item of information and by us ing an assumed time span elapsed since the application of the bodily fluid to the test field.

4. The method according to the preceding claim, the method further comprising step e): e) a refining step, comprising one or both of assessing a plausibility of the esti mated analyte concentration determined in step ii) by means of the first item of information, or improving an accuracy of the estimated analyte concentration determined in step ii) by means of the first item of information.

5. The method according to the preceding claim, wherein the refining step is performed in an iterative manner.

6. The method according to any one of the two preceding claims, wherein the second item of information is time-dependent, wherein, in step ii), the concentration of the analyte in the bodily fluid is estimated by using an assumed time span elapsed since the application of the bodily fluid to the test field (114), wherein the first item of in formation, in addition to being time-dependent, additionally is dependent on the ana lyte concentration, wherein, in step e), the dependency of the first item of infor mation on the concentration is eliminated by assuming the concentration of the ana- lyte in the bodily fluid estimated in step ii), thereby deriving a probable time span elapsed since the application of the bodily fluid to the test field (114) from the first item of information, wherein the probable time span elapsed since the application of the bodily fluid to the test field is compared with the assumed time span elapsed since the application of the bodily fluid to the test field, and wherein the concentra- tion of the analyte in the bodily fluid is re-estimated by performing step ii) and by us ing the probable time span as the assumed time span in step ii).

7. The method according to any one of the three preceding claims, wherein step e) comprises applying a correction to the estimated analyte concentration.

8. The method according to any one of the four preceding claims, wherein step e) com prises at least one of the following options:

a) selecting at least one correlation from a predetermined set of correlations, wherein each correlation describes a relationship between the first item of in formation and the analyte concentration for a specific time span elapsed since the application of the bodily fluid to the test field;

b) selecting at least one correlation from a predetermined set of correlations, wherein each correlation describes a relationship between the first item of in formation and the time elapsed since the application of the bodily fluid to the test field for a specific analyte concentration,

wherein step e) further comprises determining an expected first item of information corresponding to the estimated analyte concentration determined in step ii) by means of the correlation selected in step e), wherein step e) further comprises comparing the determined expected first item of information with the first item of information de rived from the image captured in step c), wherein the estimated analyte concentration determined in step d) is classified as plausible if a difference between the expected first item of information and the first item of information derived in step i) from the image captured in step c) is equal to or smaller than a predetermined threshold value, wherein the estimated analyte concentration determined in step d) is classified as im plausible if the difference between the expected first item of information and the first item of information derived in step i) is greater than the predetermined threshold val ue.

9. The method according to any one of the preceding claims, wherein the first color channel comprises a blue color channel, and wherein the second color channel com prises at least one element selected from the group consisting of: a red color channel; a green color channel.

10. The method according to any one of the preceding claims, wherein the method fur ther comprises capturing at least one dry image of the at least one part of the test field (114), with the test field (114) not having the drop of bodily fluid applied there- to, by using the camera (112).

11. The method according to any one of the preceding claims, wherein step d) further comprises deriving at least one reference information from at least one reference part of the optical test strip outside the test field.

12. The method according to any one of the preceding claims, wherein in step c) at least two images are captured, wherein the method further comprises step f), wherein step f) is carried out between step c) and step d):

f) comparing the second items of information of the at least two images.

13. A computer program including computer-executable instructions for performing the method according to any one of the preceding claims when the program is executed on a computer or computer network.

14. A mobile device (110) having a camera (112), the mobile device (110) being config ured for determining a concentration of an analyte in a bodily fluid by using the fol lowing steps:

A) prompting a user to one or more of:

- apply a drop of bodily fluid to at least one test field (114) of an optical test strip (116), or

- confirm an application of a drop of bodily fluid to at least one test field (114) of an optical test strip;

B) prompting the user to wait for a predetermined minimum amount of waiting time; and

C) capturing at least one image of at least one part of the test field (114), with the test field (114) having the drop of bodily fluid applied thereto, by using the camera (112); and

D) determining the concentration of the analyte in the bodily fluid based on the image captured in step c), comprising:

I. estimating a point in time of sample application to the test field (114) by taking into account at least one first item of information derived from the image captured in step c) by using at least one first color channel of a color space, wherein the first item of information is time-dependent; and

II. estimating the concentration of the analyte in the bodily fluid, by taking into account at least one second item of information derived from the im age by using at least one second color channel of the color space, where in the second item of information is concentration-dependent, wherein the estimating of the concentration of the analyte in the bodily fluid fur ther takes into account the point in time of sample application estimated in step I).

15. A kit (172) for determining a concentration of an analyte in a bodily fluid, the kit (172) comprising:

at least one mobile device (110) according to any one of the preceding claims referring to a mobile device (110); and

- at least one optical test strip (116) having at least one test field (114).