Body fluid testing component for simultaneous analyte detection

• US 8,935,007 B2
• Filed: 03/26/2012
• Issued: 01/13/2015
• Est. Priority Date: 04/01/2005
• Status: Active Grant

• Current Assignee: PTS Diagnostics
• Original Assignee: 4a Medicom GmbH
• Inventors: Kloepfer, Hans G., Kloepfer, Thomas, Heim, Jason, Hafellner, Reinhard
• Primary Examiner(s): Sasaki, Shogo
• Application Number:
  US13/506,088
• Publication Number:
  US 20120183442A1
• Time in Patent Office: 1,023 Days
• Field of Search: 702/19, 702/22, 702/23, 702/25, 340/573.1, 340/539.12, 340/539.13, 422 681- 80, 422/82.05, 436164-172, 600/300
• US Class Current: 700/266
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: G01N 21/78 producing a change of colour
• CPC Class Codes: G01N 21/8483 Investigating reagent band test-element handling not specific to a test method G01N33/4875; analytical elements specific to chemical analysis of biological material G01N33/52; autometer with reagent band G01N35/04
• CPC Class Codes: G01N 33/48785 Electrical and electronic details of measuring devices for physical analysis of liquid biological material not specific to a particular test method, e.g. user interface or power supply
• CPC Class Codes: G01N 33/558 using diffusion or migration of antigen or antibody immunochromatographic test strips G01N33/54387
• CPC Class Codes: G01N 33/66 involving blood sugars, e.g. galactose
• CPC Class Codes: G01N 33/92 involving lipids, e.g. cholesterol , lipoproteins, or their receptors steroid hormones G01N33/743

Abstract

An analyte testing device is provided for use with a mobile processing device having a camera with a lens, a processor for processing an image captured by the lens. The analyte testing device comprises a casing and a test strip positioner. The test strip positioner positions an analyte containing test strip adjacent to the camera lens to permit the camera to capture an image of the analyte containing test strip. A light source is disposed within the casing. The light source is positioned within the casing to illuminate the analyte containing test strip to facilitate the capture of the image of the test strip. Software is contained within the mobile processing device for performing a quantitative analysis of at least one analyte from the captured image, and providing an output of the results of the quantitative analysis.

Claims

1. An analyte testing apparatus for providing a quantitative analysis of an analyte of a body fluid comprising:

a mobile telephone containing a mobile processing device including a digital camera having a lens for capturing a digital photographic image on an item in an optical path of the lens, the mobile processing device including software for performing a quantitative analysis on an analyte of a body fluid and providing an output of a result of the quantitative analysis;

a test wand including a housing, a test strip for receiving an analyte of a body fluid, and a test strip holder for holding the test strip on to the housing;

a positioner for coupling the test wand to the mobile telephone wherein the analyte of the body fluid on the test strip is positioned in the optical path of the lens of the digital camera so that the digital camera is positioned for capturing a digital photographic image of the analyte, so that the image so captured may then be processed by the software to perform the quantitative analysis; and

further comprising a light source configured and positioned for illuminating the analyte containing test strip.

2. The analyte testing apparatus of claim 1, wherein the light source is configured and positioned for illuminating the analyte containing test strip to illuminate the test strip to facilitate the capture of the photographic image of the an analyte containing test strip taken by a digital camera of the mobile telephone, further comprising a casing configured for enclosing the lens and the light source to provide a controlled light environment.

3. The analyte testing apparatus of claim 1, further comprising an analyte containing test strip, wherein the analyte containing test strip includes at least one of a first and a second reagent, a first analyte receiving portion containing a first analyte comprising a first body fluid fraction that has undergone a first reaction, and a second analyte receiving portion containing a second analyte comprising a second body fluid fraction that has undergone a second reaction with the second reagent.

4. The analyte testing apparatus of claim 3, wherein the light source, test strip and camera lens are configured to be positioned to define a linear light path wherein the light source shines its light through the test strips and into the camera lens.

5. The analyte testing apparatus of claim 1, further comprising a casing having an interior, the casing being configured for enclosing the lens and the light source to provide a controlled light environment within the casing interior.

6. The analyte testing apparatus of claim 5, wherein the light source, test strip and camera lens are configured to be positioned to define a linear light path wherein the light source shines its light through the test strips and into the camera lens.

7. The analyte testing apparatus of claim 5, wherein the light source, test strip and camera lens are configured to be positioned to define an angled light path wherein the lens captures an image of light emitted from the light source that is reflected off of a surface of the test strip.

8. The analyte testing apparatus of claim 1, further comprising a first reagent and a second reagent and wherein the analyte receiving portion of the test strip includes a first analyte receiving portion containing a first analyte comprising a first body fluid fraction that has undergone a first reaction, and a second analyte receiving portion containing a second analyte comprising a second body fluid fraction that has undergone a second reaction with a second reagent.

9. The analyte testing apparatus of claim 8, further comprising a third reagent, wherein the analyte receiving portion further includes a third analyte receiving portion and a third analyte resident on the third analyte receiving portion, the third analyte comprising a third body fluid fraction that has undergone a third reaction with the third reagent.

10. The analyte testing apparatus of claim 9, wherein the first analyte comprises a body fluid and the reagent comprises a reagent useful for determining blood glucose levels, the second analyte comprises a body fluid and second reagent, the second, reagent being useful for determining blood cholesterol levels, and the third analyte comprises a body fluid and third reagent, the third reagent being useful for determining blood lactate levels.

14. The analyte testing apparatus of claim 1, further comprising a casing that is hingedly coupled to the mobile processing device and is configured for being movable between a testing position wherein the camera lens is aligned with the test strip positioner to permit the camera to capture an image of the test strip, and a non-testing position wherein the camera lens is positioned for capturing an image of an object other than that of the test strip without interference from the casing, but wherein the casing remains coupled to the mobile processing device between the testing position and the non-testing position.

15. The analyte testing apparatus of claim 1, further comprising a casing that includes a cavity configured for storing a plurality of test strips therein, and wherein the test strip includes a reagent, an analyte receiving portion, and an analyte resident upon the analyte receiving portion, the analyte including a body fluid that has undergone a separation and a reaction with the reagent, wherein the reagent comprises a first reagent and a second reagent, wherein the analyte receiving portion includes a first analyte receiving portion containing a first body fluid fraction that has undergone a separation and a reaction with the first reagent, and a second analyte receiving portion containing a second body fluid fraction that has undergone a separation and a reaction with the second reagent, wherein the camera is configured to captures an image of the first and second analyte receiving portions;

and wherein the software contained within the mobile processing device is configured for performing a quantitative analysis of each of the first and second separated and reacted body fluid fractions.

16. The analyte testing apparatus of claim 1, wherein the mobile processing device includes an integral casing.

11. An analyte testing apparatus for providing a quantitative analysis of an analyte of a body fluid comprising:

a mobile telephone containing a mobile processing device including a digital camera having a lens for capturing a digital photographic image on an item in an optical path of the lens, the mobile processing device including software for performing a quantitative analysis on an analyte of a body fluid and providing an output of a result of the quantitative analysis;

a test wand including a housing, a test strip for receiving an analyte of a body fluid, and a test strip holder for holding the test strip on to the housing;

a positioner for coupling the test wand to the mobile telephone wherein the analyte of the body fluid on the test strip is positioned in the optical path of the lens of the digital camera so that the digital camera is positioned for capturing a digital photographic image of the analyte, so that the image so captured may then be processed by the software to perform the quantitative analysis; and

further comprising a casing configured to be coupled to the mobile processing device that includes a cavity configured for storing a plurality of test strips therein.

12. An analyte testing apparatus for providing a quantitative analysis of an analyte of a body fluid comprising:

a mobile telephone containing a mobile processing device including a digital camera having a lens for capturing a digital photographic image on an item in an optical path of the lens, the mobile processing device including software for performing a quantitative analysis on an analyte of a body fluid and providing an output of a result of the quantitative analysis;

a test wand including a housing, a test strip for receiving an analyte of a body fluid, and a test strip holder for holding the test strip on to the housing;

a positioner for coupling the test wand to the mobile telephone wherein the analyte of the body fluid on the test strip is positioned in the optical path of the lens of the digital camera so that the digital camera is positioned for capturing a digital photographic image of the analyte, so that the image so captured may then be processed by the software to perform the quantitative analysis; and

further comprising a casing configured to be coupled to the mobile processing device wherein at least one of the lens and casing are movable into a position wherein the lens of the camera is positioned for capturing images of objects other than of the test strip without interference from the casing.

13. The analyte testing apparatus of claim 12, wherein the casing is configured to be movable between a testing position wherein the camera lens is aligned with the positioner to permit the camera to capture an image of the analyte on the test strip;

and a non-testing position wherein the lens of the camera is positioned to capture an image of objects other than that of the test strip without interference from the casing, but between the two positions the casing remains coupled to the mobile processing device and wherein the casing includes a cavity for storing a plurality of test strips therein.