Miniature Optical Readhead and Colorimeter for Analysis Media

• US 20090128816A1
• Filed: 11/20/2007
• Published: 05/21/2009
• Est. Priority Date: 11/20/2007
• Status: Active Grant

• Current Assignee: Siemens Healthcare Diagnostics Incorporated (Siemens AG)
• Original Assignee: Siemens Medical Solutions Diagnostics (Siemens AG)
• Inventors: Roman, Juan F.
• Granted Patent: US 7,768,645 B2
• Time in Patent Office: Days
• US Class Current: 356/409
• 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

Abstract

A miniature readhead is provided for photometric color detection using ambient light. The readhead is hand-held, including a superposed plate and tray. The tray receives sample media configured to react and to change color according to an amount of analyte in a sample. The plate is optically transmissive, so that ambient light is transmissible therethrough to the sample media indexed within the tray. An array of light detectors is disposed along the plate, including sets of detectors configured to detect light of at least three mutually distinct wavelengths reflected from the test areas. Light shields superposed with each of the light detectors selectively permit ambient light to pass to the tray, while substantially preventing ambient light from reaching the light detectors prior to reflecting from the test areas. The readhead may be incorporated into a photometric diagnostic instrument configured to analyze the reflections and derive a diagnosis value.

Claims

1. A miniature readhead for a photometric diagnostic instrument for detecting color information from a target area using ambient light, the readhead comprising:

a housing having a hand-held form factor, including a plate and a tray configured for being superposed with one another, said tray configured for receiving reagent sample media therein, the sample media having a plurality of test areas disposed in spaced relation thereon, each of the test areas configured to react with a sample when disposed in contact with the sample and to change color according to an amount of an analyte in the sample;

the tray sized and shaped for forming an indexed fit with the sample media;

said plate being optically transmissive, wherein ambient light is transmissible therethrough to the sample media indexed within the tray;

an array of light detectors disposed in spaced relation along said plate;

said array including sets of light detectors configured to respectively detect light of at least three mutually distinct wavelengths;

each set configured to receive diffuse, non-specular reflections of light from a respective one of the test areas when the sample media is indexed within said tray;

a plurality of light shields superposed with each of said light detectors to selectively permit ambient light to pass to the tray, while substantially preventing ambient light from reaching the light detectors prior to reflecting from the test areas; and

said readhead being operable free of any non-ambient light sources.

2. The readhead of claim 1, wherein said plate and said tray are substantially planar and hingedly coupled to one another.

3. The readhead of claim 1, wherein the ambient light is selected from the group consisting of sunlight or artificial light.

4. The readhead of claim 1, having a length equal to or less than about 100 mm, a width equal to or less than about 10 mm, and a thickness equal to or less than about 10 mm.

5. The readhead of claim 4, having a length equal to or less than about 85 mm, a width equal to or less than about 5 mm, and a thickness equal to or less than about 5 mm.

6. The readhead of claim 1, wherein said light detectors are embedded within said plate.

7. The readhead of claim 1, wherein said plate is configured for being superimposed with the sample media.

8. The readhead of claim 1, wherein said plate is optically transparent to visible light.

9. The readhead of claim 1, wherein said plate is optically translucent to visible light.

10. The readhead of claim 1, wherein said sets of light detectors comprise light detectors respectively coupled with filters configured to transmit light of the at least three mutually distinct wavelengths.

11. The readhead of claim 10, wherein the at least three mutually distinct wavelengths comprise red, green, and blue wavelengths.

12. The readhead of claim 1, wherein said housing is adapted for incorporation within a photometric diagnostic instrument.

13. The readhead of claim 1, wherein said light detectors are configured to receive diffuse, non-specular reflections of the light associated with a range of distinct analytes.

14. The readhead of claim 1, wherein said array of light detectors comprises an array of photodiodes.

15. The readhead of claim 1, wherein said array of light detectors comprises an array of CMOS devices.

16. The readhead of claim 1, comprising a memory device operatively engaged with said light detectors.

39. The readhead of claim 1, wherein said array includes sets of light detectors configured to respectively detect light of at least four mutually distinct wavelengths.

17. A photometric diagnostic instrument for detecting color information from a target area using ambient light, the instrument comprising:

a miniature readhead including;

a housing having a hand-held form factor, including a plate and a tray configured for being superposed with one another, said tray configured for receiving reagent sample media therein, the sample media having a plurality of test areas disposed in spaced relation thereon, each of the test areas configured to react with a sample when disposed in contact with the sample and to change color according to an amount of an analyte in the sample;

the tray sized and shaped for forming an indexed fit with the sample media;

said plate being optically transmissive, wherein ambient light is transmissible therethrough to the sample media indexed within the tray;

an array of light detectors disposed in spaced relation along said plate;

said array including sets of light detectors configured to respectively detect light of at least three mutually distinct wavelengths;

each set configured to receive diffuse, non-specular reflections of light from a respective one of the test areas when the sample media is indexed within said tray;

a plurality of light shields superposed with each of said light detectors to selectively permit ambient light to pass to the tray, while substantially preventing ambient light from reaching the light detectors prior to reflecting from the test areas; and

said readhead being operable free of any non-ambient light sources;

a processor operatively coupled to said light detectors;

said processor configured to analyze the reflections received by said light detectors; and

said processor configured to derive a diagnosis value from said analysis, and to generate an output corresponding thereto.

18. The instrument of claim 17, wherein said processor is disposed integrally with said housing.

19. The instrument of claim 18, comprising an integral display.

20. The instrument of claim 19, comprising an integral power supply, wherein said instrument is a hand-held, unitary device.

21. The instrument of claim 17, wherein said processor is configured to capture signals from the light detectors, and to calculate a ratio of the signals within each of said sets, to determine color reflectances from each of test areas.

22. The instrument of claim 21, wherein said plate is provided with a tint, and said processor is configured to adjust the color reflectances to compensate for said tint.

23. The instrument of claim 21, wherein said determination of color reflectances is automated.

24. The instrument of claim 21, wherein said array comprises an other set of light detectors configured to directly receive the ambient light, and said processor is configured to capture signals generated by said other set to determine a color of the ambient light.

25. The instrument of claim 24, wherein said other set comprises light detectors configured to respectively detect light of at least three mutually distinct wavelengths, said processor is configured to capture signals from the light detectors and calculate a ratio of the signals to determine the color of the ambient light.

26. The instrument of claim 24, wherein said processor is configured to adjust the color reflectances to compensate for the color of the ambient light.

27. The instrument of claim 17, wherein said light detectors are configured to receive diffuse, non-specular reflections of the light, said reflections being associated with a range of distinct analytes.

28. The instrument of claim 17, comprising a memory device coupled to said light detectors.

29. The instrument of claim 28, wherein said memory device is configured for storing diagnostic data.

30. The instrument of claim 29, wherein said memory device is configured for storing calibration data.

31. The instrument of claim 28, wherein said memory device is configured to store the reflections received by said light detectors.

32. The instrument of claim 17, wherein said diagnosis value comprises a quantitative measurement of said analyte.

33. The instrument of claim 17, wherein said diagnosis value comprises a diagnosis of a condition.

34. The instrument of claim 17, wherein said sample media includes a test strip, and said test areas include test pads.

35. The instrument of claim 17, wherein said sample media comprises an immuno-assay cassette.

36. The instrument of claim 17, wherein said sample media comprises a microfluidic device.

37. The instrument of claim 17, being free of an integral light source.

38. The instrument of claim 17, comprising a light source disposed to ambiently illuminate said readhead.

40. A method for reading reagent sample media, the sample media having a plurality of test areas disposed in spaced relation thereon, each of the test areas configured to react with a sample when disposed in contact with the sample and to change color according to an amount of an analyte in the sample, the method comprising:

(a) receiving the sample media into a sample tray of a readhead of a photometric diagnostic device, the readhead having a hand-held form factor, including a plate and a tray configured for being superposed with one another, said tray configured for receiving reagent sample media in an indexed fit therewith, said plate being optically transmissive, wherein ambient light is transmissible therethrough to the sample media indexed within the tray;

(b) exposing the readhead to ambient light wherein the sample media is illuminated by ambient light transmitted through the plate;

(c) capturing diffuse, non-specular reflectances of the test areas with respective sets of light detectors within an array of ambient light detectors disposed in spaced relation along said plate, said sets configured to respectively detect light of at least three mutually distinct ambient light wavelengths;

(d) preventing ambient light from reaching the array of light detectors prior to reflecting from the test areas during said capturing (c);

(e) determining the color of the non-specular reflectances;

(f) deriving the amount of an analyte in the sample from said determining (e); and

(g) generating an output signal corresponding to the amount.

41. The method of claim 40, wherein the sample media is selected from the group consisting of test strips, immuno-assay cassettes, and microfluidic devices.

42. The method of claim 40, further comprising the step of calibrating the array of light detectors.

43. The method of claim 42, wherein said calibrating comprises effecting steps (b)-(e) for a calibration material of known color reflectance.

44. The method of claim 43, wherein said determining (e) comprises:

dividing the reflectances in each of the wavelengths of the test pad by the reflectances of the calibration material at the respective wavelengths;

multiplying the results of said dividing by known percent reflectances of the calibration material to generate a calibrated percent reflectance of the test pad at each of the wavelengths; and

calculating a ratio of the calibrated percent reflectances to one another, to determine the color of the test areas.

45. The method of claim 44, wherein said deriving (f) comprises comparing the calibrated percent reflectance with known values of amounts of said analyte at various predetermined percent reflectances, to determine the amount of said analyte at said calibrated percent reflectance.

46. A miniature readhead for a photometric diagnostic instrument for detecting color information from a target area using ambient light, the readhead comprising:

housing means having a hand-held form factor;

said housing means including plate means and tray means configured for being superposed with one another, said tray means configured for receiving reagent sample media therein, the sample media having a plurality of test areas disposed in spaced relation thereon, each of the test areas configured to react with a sample when disposed in contact with the sample and to change color according to an amount of an analyte in the sample;

the tray sized and shaped for forming an indexed fit with the sample media;

said plate means being optically transmissive, wherein ambient light is transmissible therethrough to the sample media indexed within the tray;

light detection means disposed in spaced relation along said plate means;

said light detection means including sets of light detectors configured to respectively detect light of at least three mutually distinct wavelengths;

each set configured to receive diffuse, non-specular reflections of light from a respective one of the test areas when the sample media is indexed within said tray;

light shield means superposed with each of said light detectors to selectively permit ambient light to pass to the tray, while substantially preventing ambient light from reaching the light detectors prior to reflecting from the test areas; and

said readhead being operable free of any non-ambient light sources.

47. A miniature photometric diagnostic instrument comprising:

the miniature readhead of claim 46;

processing means operatively coupled to said light detection means;

said processing means configured to analyze the reflections received by said light detection means;

said processing means configured to derive a diagnosis value from said analysis, and to generate an output corresponding thereto; and

said instrument being operable free of any non-ambient sample illumination.