Assay Reader Insert and Method of Maintaining a Reader

• US 20100311181A1
• Filed: 09/22/2008
• Published: 12/09/2010
• Est. Priority Date: 09/21/2007
• Status: Active Grant

• Current Assignee: Charm Sciences, Inc.
• Original Assignee: Charm Sciences, Inc.
• Inventors: Abraham, Rami H., Charm, Stanley E.
• Granted Patent: US 8,475,731 B2
• Time in Patent Office: Days
• US Class Current: 436/164
• CPC Class Codes: G01N 2021/7759 Dipstick; Test strip
• CPC Class Codes: G01N 2021/7773 Reflection
• CPC Class Codes: G01N 2021/7776 Index
• CPC Class Codes: G01N 2021/7786 Fluorescence
• CPC Class Codes: G01N 21/77 by observing the effect on a chemical indicator
• CPC Class Codes: G01N 21/78 producing a change of colour
• CPC Class Codes: G01N 33/54388 based on lateral flow
• CPC Class Codes: G01N 33/558 using diffusion or migration of antigen or antibody immunochromatographic test strips G01N33/54387

Abstract

An assay reader system incorporating a conventional assay reader, for example a lateral flow reader, and an insert aligned with the reader'"'"'s sensor to detect an assay result. The insert may include a housing which defines a cavity to receive a removable barrier, wherein the removable barrier can be aligned between the sensor and the test strip. The barrier may include an optical window, and may be cleanable and/or disposable to maintain the accuracy of the reader. Test strips are introduced into the reader through a receiving port within the insert'"'"'s housing. An air inlet on the insert further maintains the reader'"'"'s accuracy by allowing air to be tunneled over the housing to remove excess dust, debris, or the like.

Claims

1. An insert for an assay reader, the reader being configured to align a test strip, positioned within the insert, with a sensor to detect an assay result, the insert comprising:

a housing having an exterior and an interior, wherein said exterior and said interior define a cavity to receive a removable barrier and has a depth to allow the barrier to align between the test strip and the sensor; and

a receiving port within the housing, the receiving port being configured to accept the test strip from the exterior of the housing to the interior of the housing, whereby the test strip is exposed to the sensor.

2. The device of claim 1, wherein the reader is a lateral flow assay reader.

3. The device of claim 1, wherein the barrier further comprises an optical window.

4. The device of claim 1, wherein the barrier is positioned on the exterior housing.

5. The device of claim 1, wherein the barrier further comprises a handle to engage and remove the barrier from the insert.

6. The device of claim 1, wherein the barrier is cleanable.

7. The device of claim 1, wherein the barrier is disposable.

8. The device of claim 1, wherein the barrier comprises clear polyvinyl chloride plastic.

9. The device of claim 1, wherein the barrier comprises glass.

10. The device of claim 1, wherein the barrier comprises a clear optical slide.

11. The device of claim 1, further comprising a debris cap removable affixed to the sensor and the optical sensor.

12. The device of claim 1, wherein the housing further comprises an aperture positioned relative to the receiving port, whereby the test strip is exposed to the sensor through the aperture.

13. The device of claim 1, further comprising an air inlet within the housing and being configured to allow air to be blown in the device.

14. The device of claim 13, further comprising a removable cap secured to the inlet.

15. The device of claim 13, further comprising a ridge positioned between the inlet and the receiving port, whereby the ridge is configured to reduce moisture from entering the interior when air is blown in the device.

16. The device of claim 1, wherein the test strip is a film.

17. The device of claim 1, wherein the test strip comprises nitrocellulose.

18. The device of claim 1, wherein the sensor is an optical sensor.

19. The device of claim 18, wherein the sensor detects light refraction on the test strip.

20. The device of claim 18, further comprising a light source aligned with the sensor, wherein the insert is positioned between the light source and the sensor.

21. The device of claim 20, wherein the light source comprises a light emitting diode.

22. The device of claim 21, wherein the light emitting diode is positioned on a printed circuit board.

23. The device of claim 22, wherein the printed circuit board is positioned above the test strip.

24. The device of claim 22, wherein the printed circuit board is positioned below the test strip.

25. The device of claim 18, wherein the optical sensor is material selected from the group consisting of:

a single photodiode, multiple photodiodes, a linear photodiode array, a charged couple device and a complimentary metal oxide semiconductor image sensor.

26. The device of claim 18, further comprising a debris cap removable affixed to the sensor and the optical sensor.

27. An insert for an assay reader, the reader being configured to align a test strip, positioned within the insert, with a sensor to detect an assay result, the insert comprising:

a housing having an exterior and an interior;

a receiving port within the housing, the receiving port being configured to accept the test strip from the exterior of the housing to the interior of the housing, whereby the test strip is exposed to the sensor; and

a removable barrier positioned within a cavity of the housing, whereby the barrier is aligned between the test strip and the sensor.

28. The device of claim 27, wherein the reader is a lateral flow assay reader.

29. The device of claim 27, wherein the barrier further comprises an optical window.

30. The device of claim 27, wherein the barrier is cleanable.

31. The device of claim 27, wherein the barrier is disposable.

32. The device of claim 27, wherein the exterior housing further comprises an aperture positioned relative to the receiving port, whereby the test strip is exposed to the sensor through the aperture.

33. The device of claim 27, further comprising an air inlet within the housing and being configured to allow air to be blown in the device.

34. A method of conducting an assay reader to detect an analyte, the reader configured to align a test strip, being secured by an insert thereto, with a sensor, the method comprising:

immobilizing a capture agent on the test strip, the capture agent being configured to generate a signal of an analyte;

providing a sample on the test strip, whereby the test strip being configured to allow capillary lateral flow of the test sample to the capture agent;

engaging the test strip in a receiving port within the insert; and

affixing a removable barrier within a cavity defined by a housing of the insert, whereby the barrier is aligned between the test strip and the sensor.

35. The method of claim 34, further comprising the step of removing the barrier from the insert for maintenance.

36. The method of claim 34, further comprising the step of blowing air in an air inlet positioned on the insert.

b) a receiving port within the housing, the receiving port being configured to accept the test strip from the exterior of the housing to the interior of the housing,

whereby the test strip is exposed to the sensor.

38. The device of claim 37, wherein the reader is a lateral flow assay reader.

39. The device of claim 37, wherein the barrier further comprises an optical window.

40. The device of claim 37, wherein the barrier is positioned on the exterior housing.

41. The device of claim 37, wherein the barrier further comprises a handle to engage and remove the barrier from the insert.

42. The device of claim 37, wherein the barrier is cleanable.

43. The device of claim 37, wherein the barrier is disposable.

44. The device of claim 37, wherein the barrier comprises clear polyvinyl chloride plastic.

45. The device of claim 37, wherein the barrier comprises glass.

46. The device of claim 37, wherein the barrier comprises a clear optical slide.

47. The device of claim 37, wherein the housing further comprises an aperture positioned relative to the receiving port, whereby the test strip is exposed to the sensor through the aperture.

48. The device of claim 37, further comprising an air inlet within the housing and being configured to allow air to be blown in the device.

49. The device of claim 48, further comprising a ridge positioned between the inlet and the receiving port, whereby the ridge is configured to reduce moisture from entering the interior when air is blown in the device.

50. The device of claim 37, wherein the test strip comprises nitrocellulose.

51. The device of claim 37, wherein the sensor is an optical sensor that detects light refraction on the test strip.

52. The device of claim 51, further comprising a light source aligned with the sensor, wherein the insert is positioned between the light source and the sensor.

53. The device of claim 52, wherein the light source comprises a light emitting diode and wherein the light emitting diode is positioned on a printed circuit board.

54. The device of claim 51, wherein the optical sensor is material selected from the group consisting of:

a single photodiode, multiple photodiodes, a linear photodiode array, a charged couple device and a complimentary metal oxide semiconductor image sensor.

55. An insert for an assay reader, the reader being configured to align a test strip, positioned within the insert, with a sensor to detect an assay result, the insert comprising:

a) a housing having an exterior and an interior;

b) a receiving port within the housing, the receiving port being configured to accept the test strip from the exterior of the housing to the interior of the housing, whereby the test strip is exposed to the sensor; and

c) a removable barrier positioned within a cavity of the housing, whereby the barrier is aligned between the test strip and the sensor.

56. The device of claim 55, wherein the reader is a lateral flow assay reader.

57. The device of claim 55, wherein the barrier further comprises an optical window.

58. The device of claim 55, wherein the barrier is cleanable.

59. The device of claim 55, wherein the barrier is disposable.

60. The device of claim 55, wherein the exterior housing further comprises an aperture positioned relative to the receiving port, whereby the test strip is exposed to the sensor through the aperture.

61. The device of claim 55, further comprising an air inlet within the housing and being configured to allow air to be blown in the device.

62. A method of maintaining an assay reader to detect an analyte, the reader configured to align a test strip, being secured by an insert thereto, with a sensor, the method comprising:

a) immobilizing a capture agent on the test strip, the capture agent being configured to generate a signal in the presence of an analyte;

b) providing a sample on the test strip, whereby the test strip is configured to allow capillary lateral flow of the test sample to the capture agent;

c) engaging the test strip in a receiving port within the insert; and

d) affixing a removable barrier within a cavity defined by a housing of the insert, whereby the barrier is aligned between the test strip and the sensor.

63. The method of claim 62, further comprising the step of removing the barrier from the insert for maintenance.

64. The method of claim 62, further comprising the step of blowing air in an air inlet positioned on the insert.