METHODS AND MATERIALS FOR CALIBRATION OF A READER

• US 20100175455A1
• Filed: 01/14/2009
• Published: 07/15/2010
• Est. Priority Date: 01/14/2009
• Status: Active Grant

• Current Assignee: Alverix, Inc. (Becton Dickinson & Co)
• Original Assignee: Alverix, Inc. (Becton Dickinson & Co)
• Inventors: Dylewski, Scott, Bilobran, William, Xie, Tong
• Granted Patent: US 8,643,837 B2
• Time in Patent Office: Days
• US Class Current: 73/1.20
• CPC Class Codes: G01N 33/48792 Data management, e.g. communication with processing unit for in vivo diagnostics A61B5/0002; transmission systems for measured values G08C

Abstract

The present disclosure relates generally to devices that may be used to calibrate a reader. Such devices may comprise an electrical memory chip, a calibration device comprising an optical check, and an interface that allows interaction with the reader.

Claims

1. A cartridge for calibration of a reader, said cartridge comprising:

an electrical memory chip;

a calibration device comprising an optical check; and

an interface that allows interaction with the reader.

2. The cartridge of claim 1, wherein the cartridge further comprises a power source.

3. The cartridge of claim 2, wherein the power source is a battery.

4. The cartridge of claim 1, wherein the reader is an electronic reader.

5. The cartridge of claim 1, wherein the optical check comprises a printed assay with no signal lines for optical or illumination checking.

6. The cartridge of claim 1, wherein the optical check comprises a printed assay with signal lines for optical or illumination checking.

7. The cartridge of claim 1, wherein the optical check comprises a printed assay with signal lines printed of known intensity for optical, illumination or algorithm checking.

8. The cartridge of claim 1, wherein the optical check is a calibrated light source that verifies the optical properties of the detector in the reader.

9. The cartridge of claim 8, wherein the calibrated light source is a laser.

10. The cartridge of claim 8, wherein the calibrated light source is a LED.

11. The cartridge of claim 1, wherein the optical check comprises wavelength specific detectors that measure the relative intensities of light from the reader.

12. The cartridge of claim 1, wherein the electrical memory chip obtains information from the reader.

13. The cartridge of claim 1, wherein the electrical memory chip provides information to the reader.

14. The cartridge of claim 13, wherein the information is calibration or lot specific data.

15. The cartridge of claim 13, wherein the electrical memory chip loads new software into the reader.

16. The cartridge of claim 1, wherein the cartridge interacts with the reader via a direct electrical contact or wireless transmission.

17. The cartridge of claim 16, wherein the wireless transmission is RFID, WIFI, bluetooth or any combination thereof.

18. The cartridge of claim 1, wherein the cartridge interacts with the reader via optical transmission.

19. The cartridge of claim 18, wherein the optical transmission is IR.

20. The cartridge of claim 1, wherein the electrical memory chip saves results obtained from the reader.

21. The cartridge of claim 1, wherein the cartridge enables the reader if the optical check determines that the reader is calibrated

22. The cartridge of claim 1, wherein the cartridge disables the reader if the optical check determines that the reader is not calibrated.

23. The cartridge of claim 1, wherein the cartridge disables the reader after a predetermined number of tests.

24. A cartridge for detecting information concerning storage or shipment of an assay, said cartridge comprising:

a sensor that detects one or more environmental conditions that effect the assay; and

a microcontroller for recording the one or more detected environmental conditions.

25. The cartridge of claim 24, wherein the sensor is a temperature sensor.

26. The cartridge of claim 24, wherein the sensor is a humidity sensor.

27. The cartridge of claim 24, wherein the sensor intermittently records the environmental condition.

28. The cartridge of claim 24, wherein the sensor continuously records the environmental condition.

29. The cartridge of claim 24 further comprising an indicator.

30. The cartridge of claim 24, wherein the indicator comprises a light.

31. The cartridge of claim 24, wherein the light illuminates when one or more detected environmental conditions exceeds a threshold.

32. The cartridge of claim 24 further comprising an interface for providing the recorded environmental conditions to a reader.

33. The cartridge of claim 32, wherein the reader is disabled when the recorded environmental conditions exceed a threshold.

34. The cartridge of claim 24 further comprising a power source.

35. The cartridge of claim 34, wherein the power source is a battery.

36. A method for providing calibration information to a reader used for measuring an analyte concentration from an assay, said method comprising:

providing the reader with a cartridge comprising

an electrical memory chip;

a calibration device comprising an optical check; and

an interface that allows interaction with the reader; and

allowing the calibration device to interact with the reader.

37. The method of claim 36, wherein the optical check obtains information from the reader.

38. The method of claim 36, wherein the optical check provides information to the reader.

39. The method of claim 36, wherein the cartridge further comprises a power source.

40. The method of claim 39, wherein the power source is a battery.

41. The method of claim 36, wherein the reader is an electronic reader.

42. The method of claim 36, wherein the assay is a lateral flow assay.

43. The method of claim 36, wherein the optical check is a calibrated light source that verifies the optical properties of the detector in the reader.

44. The method of claim 43, wherein the calibrated light source is a laser.

45. The method of claim 43, wherein the calibrated light source is a LED.

46. The method of claim 36, wherein the optical check comprises a printed assay with no signal lines for optical or illumination checking.

47. The method of claim 36, wherein the optical check comprises a printed assay with signal lines for optical or illumination checking.

48. The method of claim 36, wherein the optical check comprises a printed assay with signal lines printed of known intensity for optical, illumination or algorithm checking.

49. The method of claim 36, wherein the optical check comprises wavelength specific detectors that measure the relative intensities of light from the reader.

50. The method of claim 36, wherein the electrical memory chip obtains information from the reader.

51. The method of claim 36, wherein the electrical memory chip provides information to the reader.

52. The method of claim 36, wherein the calibration device interacts with the reader via a direct electrical contact or wireless transmission.

53. The method of claim 52, wherein the wireless transmission is RFID, WIFI, bluetooth or any combination thereof.

54. The method of claim 52, wherein the calibration device interacts with the reader via optical transmission.

55. The method of claim 54, wherein the optical transmission is IR.

56. The method of claim 36, wherein the electrical memory chip saves results obtained from the reader.

57. The cartridge of claim 36, wherein the electrical memory chip provides information to the reader.

58. The cartridge of claim 57, wherein the information is calibration or lot specific data.

59. The cartridge of claim 36, wherein the electrical memory chip loads new software into the reader.