Assay test system for regulating temperature

• US 20040115832A1
• Filed: 10/22/2003
• Published: 06/17/2004
• Est. Priority Date: 05/14/2002
• Status: Active Grant

• Current Assignee: Siemens Healthcare Diagnostics Incorporated (Siemens AG)
• Original Assignee: Siemens Healthcare Diagnostics Incorporated (Siemens AG)
• Inventors: Smous, James E., Albarella, James P., Shareef, Nazeer H.
• Granted Patent: US 7,285,425 B2
• Time in Patent Office: Days
• US Class Current: 436/514
• CPC Class Codes: B01L 2300/0825 Test strips
• CPC Class Codes: B01L 2300/1805 Conductive heating, heat from thermostatted solids is conducted to receptacles, e.g. heating plates, blocks
• CPC Class Codes: B01L 2300/1844 using fans
• CPC Class Codes: B01L 3/5023 with a sample being transported to, and subsequently stored in an absorbent for analysis
• CPC Class Codes: G01N 2035/00346 Heating or cooling arrangements
• CPC Class Codes: G01N 33/558 using diffusion or migration of antigen or antibody immunochromatographic test strips G01N33/54387
• CPC Class Codes: Y10S 435/805 Test papers
• CPC Class Codes: Y10S 435/81 Packaged device or kit
• CPC Class Codes: Y10S 435/97 Test strip or test slide
• CPC Class Codes: Y10S 436/81 Tube, bottle, or dipstick

Abstract

A device for evaluating at least one analyte in a test sample. The device comprises a cassette having a hollow test chamber, a test strip disposed within the test chamber for receiving the test sample, and a temperature control member. The cassette has at least one aperture extending from an exterior of the cassette to the hollow test chamber. The test strip includes a reagent adapted to react with the at least one analyte to produce a reaction indicative of the presence of the analyte. The temperature control member is adapted to extend through the at least one aperture in the cassette and into the test chamber for controlling the temperature of the test chamber.

Claims

1. A test cassette for use in an assay for evaluating at least one analyte in a test sample, the cassette comprising a hollow body having at least one aperture, the at least one aperture being adapted to receive at least one temperature control member.

2. The test cassette of claim 1 further comprising an immunochromatographic test strip disposed within the hollow body, wherein the test strip is made out of a bibulous material.

3. The test cassette of claim 1 wherein the at least one aperture comprises a plurality of apertures, each of the plurality of apertures being adapted to receive one or more temperature control members.

4. The test cassette of claim 1 wherein the body comprises a cassette top and a cassette bottom, the cassette bottom including the at least one aperture.

5. The test cassette of claim 1 wherein the cassette top and the cassette bottom are made of plastic.

6. The test cassette of claim 5 wherein the plastic is high impact polystyrene, ABS, or styrene.

7. A device for evaluating at least one analyte in a test sample, the device comprising:

a cassette having a hollow test chamber and at least one aperture extending from an exterior of the cassette to the hollow test chamber;

a test strip disposed within the test chamber for receiving the test sample, the test strip including a reagent adapted to react with the at least one analyte to produce a reaction indicative of the presence of the analyte; and

a temperature control member adapted to extend through the at least one aperture in the cassette and into the test chamber for controlling the temperature of the test chamber.

8. The device of claim 7 wherein the test strip comprises an immunochromatographic test strip.

9. The device of claim 7 wherein the test strip is made out of a bibulous material.

10. The device of claim 7 wherein the cassette top and the cassette bottom are made of plastic.

11. The device of claim 7 wherein the temperature control member comprises at least one fin.

12. The device of claim 11 further comprising a thermoelectric temperature control unit in thermal communication with the at least one fin.

13. The device of claim 12 wherein the at least one fin comprises a plurality of fins, and wherein the at least one aperture of the cassette comprises a plurality of apertures, each of the plurality of apertures adapted to receive one or more of the plurality of fins, one or more of the plurality of fins being adapted to extend through each of the plurality of apertures into the test chamber.

14. The device of claim 12 wherein the temperature control member further comprises a fixture plate attached to the plurality of fins, and wherein the fixture plate and the plurality of fins are integrally formed.

15. The device of claim 14 wherein the fixture plate and the plurality of fins are made out of a thermally conductive material.

16. The device of claim 15 wherein the thermally conductive material is aluminum.

17. The device of claim 7 in combination with a spectrometer adapted to read the reaction indicative of the presence of the analyte.

18. The device of claim 7 wherein the temperature control member comprises at least one resistive heating element.

19. The device of claim 18 wherein the at least one resistive heating element 6 comprises a plurality of resistive heating elements, and wherein the at least one aperture of the cassette comprises a plurality of apertures, each of the plurality of apertures 8 adapted to receive one or more of the plurality of resistive heating elements, one or more of the plurality of resistive heating elements being adapted to extend through each of the plurality of apertures into the test chamber.

20. The device of claim 18 further comprising a circuit adapted to control the amount of current supplied to the at least one resistive heating element.

21. An apparatus for controlling the temperature of an assay, the apparatus comprising:

a cassette carrier adapted to receive a test cassette having at least one aperture;

a thermally conductive member adapted extend through the at least one aperture of a test cassette received by the cassette carrier; and

a temperature control unit in thermal communication with the thermally conductive member.

22. The apparatus of claim 21 wherein the thermally conductive member is made of aluminum.

23. The apparatus of claim 21 wherein the thermally conductive member comprises at least one fin fixedly attached to a fixture plate.

24. The apparatus of claim 23 wherein the fixture plate and at least one fin arc integrally formed.

25. The apparatus of claim 23 wherein the at least one fin comprises two or more fins.

26. The apparatus of claim 23 wherein the material is a thermally conductive material.

27. The apparatus of claim 23 wherein the temperature control unit comprises a thermoelectric device.

28. The apparatus of claim 27 wherein the thermoelectric device is a Peltier Effect thermoelectric device.

29. A method for evaluating at least one analyte in a test sample, the method comprising:

providing a test cassette having at least one aperture;

disposing a test strip within a test chamber of the test cassette, the test strip including a reagent adapted to react with the at least one analyte to produce a reaction indicative of the presence of the analyte;

applying the test sample to the test strip; and

controlling the temperature of the test chamber with a temperature control member adapted to extend through the at least one aperture formed in the test cassette.

30. The method of claim 29 further comprising detecting any change in the test strip.

31. The method of claim 29 wherein the test strip comprises an immunochromatographic test strip.

32. The method of claim 29 further comprising forming the test cassette from a cassette top and a cassette bottom.

33. The method of claim 29 wherein the temperature control member element includes at least one fin.

34. The method of claim 33 wherein the temperature control member includes a fixture plate attached to the at least one fin, and wherein the fixture plate and the at least one fin are integrally formed.

35. The method of claim 34 wherein the fixture plate and the at least one fin are made out of a thermally conductive material.

36. The method of claim 29 wherein the temperature control member includes at least one resistive heating element.

37. The method of claim 36 wherein controlling further comprises controlling the amount of electrical current that passes through the at least one resistive heating element.

38. A test cassette for use in an assay for evaluating at least one analyte in a test sample, the cassette comprising a hollow body having at least one aperture, the at least one aperture being adapted to receive air from a hot air blower.

39. The test cassette of claim 38 further comprising an immunochromatographic test strip disposed within the hollow body, wherein the test strip is made out of a bibulous material.

40. The test cassette of claim 38 wherein the at least one aperture comprises a plurality of apertures, each of the plurality of apertures being adapted to receive air from one or more hot air blowers.

41. The test cassette of claim 40 wherein one or more of the plurality of apertures are disposed at one end of the test cassette and one or more of the plurality of apertures arc disposed at an opposite end of the test cassette.

42. The test cassette of claim 38 wherein the body comprises a cassette top and a cassette bottom, the cassette bottom including the at least one aperture.

43. The test cassette of claim 38 wherein the cassette top and the cassette bottom are made of plastic.

44. The test cassette of claim 43 wherein the plastic is high impact polystyrene, ABS, or styrene.

45. An apparatus for controlling the temperature of an assay, the apparatus comprising:

a cassette carrier adapted to receive a test cassette having at least one aperture;

at least one resistive heating element adapted to extend through the at least one aperture of a test cassette received by the cassette carrier; and

a temperature control unit electrically coupled to the at least one resistive heating element, the temperature control unit being adapted to control current passing through the at least one resistive heating element.

46. The apparatus of claim 45 wherein the at least one resistive heating element comprises two or more resistive heating elements, and wherein the at least one aperture of the cassette comprises a plurality of apertures, one or more of the resistive heating elements being adapted to extend through each of the plurality of apertures into the test chamber.

47. An apparatus for controlling the temperature of an assay, the apparatus comprising:

a cassette carrier adapted to receive a test cassette having at least one aperture;

at least one hot air blower adapted to blow hot air through the at least one aperture and into the test cassette; and

a temperature control unit electrically coupled to the at least one hot air blow er, the temperature control unit being adapted to control the temperature of the air produced by the hot air blower.

48. The apparatus of claim 47 wherein the temperature control unit is adapted to control the amount of hot air produced by the at least one hot air blower.

49. The apparatus of claim 47 wherein the at least one hot air blower comprises two or more hot air blowers, and wherein the at least one aperture of the cassette comprises a plurality of apertures.

50. The apparatus of claim 47 wherein one of the plurality of apertures is disposed at a first end of the test cassette and another of the plurality of apertures is disposed at an opposite end of the test cassette.

51. The apparatus of claim 47 wherein the hot air blower includes at least one resistive heating element.

52. A method for evaluating at least one analyte in a test sample, the method comprising:

providing a test cassette having at least one aperture;

disposing a test strip within a test chamber of the test cassette, the test strip including a reagent adapted to react with the at least one analyte to produce a reaction indicative of the presence of the analyte;

applying the test sample to the test strip; and

blowing hot air into the test chamber of the test cassette to control the temperature of the test chamber.

53. The method of claim 52 further comprising detecting any change in the test strip.

54. The method of claim 52 wherein the test strip comprises an immunochromatographic test strip.

55. The method of claim 52 further comprising forming the test cassette from a cassette top and a cassette bottom.

56. The method of claim 52 further comprising controlling the temperature of the hot air blown into the test chamber.

57. The method of claim 56 wherein blowing hot air further comprises blowing hot air with a hot air blower, the hot air blower includes a resistive heating element, and wherein controlling the temperature of the hot air further comprises controlling the current passing through the resistive heating element.