Device and methods for detecting an analyte in a sample

• US 20070054414A1
• Filed: 04/07/2006
• Published: 03/08/2007
• Est. Priority Date: 04/07/2005
• Status: Active Grant

• Current Assignee: Rapid Medical Diagnostics Corporation (Generex Biotechnology Corp.)
• Original Assignee: Rapid Medical Diagnostics Corporation (Generex Biotechnology Corp.)
• Inventors: Burgess-Cassler, Anthony, Agudelo, Luis, Salvo, Lawrence
• Granted Patent: US 7,749,771 B2
• Time in Patent Office: Days
• US Class Current: 436/514
• CPC Class Codes: B01L 2300/0825 Test strips
• CPC Class Codes: B01L 2300/0861 Configuration of multiple channels and/or chambers in a single devices
• CPC Class Codes: B01L 2400/0406 capillary forces
• CPC Class Codes: B01L 3/5023 with a sample being transported to, and subsequently stored in an absorbent for analysis
• CPC Class Codes: G01N 33/521 Single-layer analytical elements
• CPC Class Codes: G01N 33/54366 Apparatus specially adapted for solid-phase testing
• CPC Class Codes: G01N 33/54386 Analytical elements
• 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
• CPC Class Codes: Y10S 435/97 Test strip or test slide
• CPC Class Codes: Y10S 436/805 Optical property
• CPC Class Codes: Y10S 436/807 Apparatus included in process claim, e.g. physical support structures
• CPC Class Codes: Y10S 436/808 Automated or kit
• CPC Class Codes: Y10S 436/809 Multifield plates or multicontainer arrays
• CPC Class Codes: Y10S 436/81 Tube, bottle, or dipstick

Abstract

Disclosed is a device, for detecting an analyte in a sample, comprising a sample pad for collecting the sample, a test strip coupled to the sample pad, and a housing enclosing and allowing visualization of the test strip. The sample pad can include one or more markings for determining the amount of sample collected. The device can also include a run fluid container that fits over the sample pad and forms an air-tight seal around the housing. Further, the device can include a second sample pad/test strip combination for detection of a second analyte. Also disclosed are methods for detecting an analyte in a sample using the device.

Claims

1. A device for performing a test reaction on a sample to detect an analyte, comprising:

a sample pad for collecting the sample;

a test strip coupled to the sample pad, the test strip comprising an indicator region configured to provide a visual indication of the presence or absence of the analyte in the sample;

a housing comprising a first end and a second end, wherein the test strip is disposed within the housing, the housing allowing visualization of the test strip, and wherein at least a portion of the sample pad extends beyond the first end of the housing; and

a run fluid container configured to be positioned over the portion of the sample pad that extends beyond the first end of the housing, the run fluid container configured to form an air-tight seal around the first end of the housing.

2. The device of claim 1, wherein the sample is a fluid sample.

3. The device of claim 1, wherein the sample pad comprises at least one marking providing a visual indication of the amount of sample collected.

4. The device of claim 1, wherein the run fluid container contains a diluent.

5. The device of claim 1, further comprising a flexible collar at the first end of the housing, wherein the flexible collar allows insertion of the sample pad and the test strip into the housing and is configured to maintain coupling of the test strip to the sample pad.

6. The method of claim 5, wherein the flexible collar comprises a color providing a visual indication of the test reaction to be performed.

7. The method of claim 1, wherein at least one of the run fluid container and the test strip comprises a color providing a visual indication of the test reaction to be performed.

8. The device of claim 1, further comprising:

a second sample pad for collecting a second sample; and

a second test strip coupled to the second sample pad, the second test strip comprising a second indicator region configured to provide a visual indication of the presence or absence of a second analyte in the second sample;

wherein the second test strip is disposed within the housing, the housing allowing visualization of the second test strip, and wherein at least a portion of the second sample pad extends beyond the second end of the housing.

9. The device of claim 8, further comprising a second run fluid container configured to be positioned over the portion of the second sample pad that extends beyond the second end of the housing, the second run fluid container configured to form an air-tight seal around the second end of the housing.

10. The device of claim 8, further comprising a fluid-impermeable element that separates the first and second sample pad.

11. A device for performing a test reaction on a sample to detect an analyte, comprising:

a sample pad for collecting the sample, the sample pad comprising at least one marking providing a visual indication of the amount of sample collected;

a test strip coupled to the sample pad, the test strip comprising an indicator region configured to provide a visual indication of the presence or absence of the analyte in the sample; and

a housing comprising a first end and a second end, wherein the test strip is disposed within the housing, the housing allowing visualization of the test strip, and wherein at least a portion of the sample pad extends beyond the first end of the housing.

12. The device of claim 11, wherein the sample is a fluid sample.

13. The device of claim 11, comprising at least two markings providing a visual indication of the amount of sample collected.

14. The device of claim 13, wherein the at least two markings providing a visual indication of the amount of sample collected comprise

a first marking indicating a minimum amount of sample sufficient for performing the test reaction;

and

a second marking indicating a maximum amount of sample for performing the test reaction.

15. The device of claim 11, further comprising a run fluid container configured to be positioned over the portion of the sample pad that extends beyond the first end of the housing.

16. The device of claim 11, wherein the run fluid container contains a diluent.

17. The device of claim 11, further comprising a flexible collar at the first end of the housing, wherein the flexible collar allows insertion of the sample pad and the test strip into the housing and is configured to maintain coupling of the test strip to the sample pad.

18. The method of claim 17, wherein the flexible collar comprises a color providing a visual indication of the test reaction to be performed.

19. The device of claim 11, wherein at least one of the run fluid container and the test strip comprises a color providing a visual indication of the test reaction to be performed.

20. The device of claim 11, further comprising:

a second sample pad for collecting a second sample; and

a second test strip coupled to the second sample pad, the second test strip comprising a second indicator region configured to provide a visual indication of a second test reaction with the second sample;

wherein the second test strip is disposed within the housing, the housing allowing visualization of the second test strip, and wherein at least a portion of the second sample pad extends beyond the second end of the housing.

21. The device of claim 20, further comprising a second run fluid container configured to be positioned over the portion of the second sample pad that extends beyond the second end of the housing.

22. The device of claim 20, further comprising a fluid-impermeable element that separates the first and second sample pads.

23. A device for performing first and second test reactions to detect, respectively, first and second analytes in first and second samples, comprising:

a first sample pad for collecting the first sample;

a first test strip coupled to the first sample pad, the first test strip comprising an first indicator region configured to provide a visual indication of the presence or absence of the first analyte in the first sample;

a second sample pad for collecting the second sample;

a second test strip coupled to the second sample pad, the second test strip comprising a second indicator region configured to provide a visual indication of the presence or absence of the second analyte in the second sample; and

a housing comprising a first end and a second end, wherein the first and second test strips are disposed within the housing, the housing allowing visualization of the first and second test strips, and wherein at least a portion of the first sample pad extends beyond the first end of the housing and at least a portion of the second sample pad extends beyond the second end of the housing.

24. The device of claim 23, wherein at least one of the first and second samples is a fluid sample.

25. The device of claim 24, wherein both the first and second samples are fluid samples.

26. The device of claim 23, further comprising a fluid-impermeable element that separates the first and second sample pad.

27. The device of claim 23, wherein the first and second test strips are disposed within the housing in a back-to-back configuration.

28. The device of claim 23, wherein the first analyte to be detected is different in type from the second analyte.

29. The device of claim 23, wherein the samples corresponding to the first and second test reactions to be performed are different in type.

30. The device of claim 23, further comprising:

a first run fluid container configured to be positioned over the portion of the first sample pad that extends beyond the first end of the housing; and

a second run fluid container configured to be positioned over the portion of the second sample pad that extends beyond the second end of the housing.

31. The device of claim 30, wherein at least one of the first and second run fluid containers contains a diluent.

32. The device of claim 30, wherein at least one of the first and second run fluid containers comprises a color providing a visual indication of the test reaction to be performed.

33. The device of claim 23, wherein at least one of the first and second sample pads comprises at least one marking providing a visual indication of the amount of sample collected.

34. The device of claim 23, wherein at least one of the first and second sample pads comprises at least two markings providing a visual indication of the amount of sample collected.

35. The device of claim 34, wherein the at least two markings providing a visual indication of the amount of fluid sample collected comprise

a first marking indicating a minimum amount of sample sufficient for performing the respective test reaction;

and

a second marking indicating a maximum amount of sample for performing the respective test reaction.

36. The device of claim 23, wherein at least one of the first and second ends of the housing comprises a flexible collar that allows insertion of the respective sample pad and corresponding test strip into the housing and is configured to maintain coupling of the test strip to the sample pad.

37. The device of claim 36, wherein the flexible collar comprises a color providing a visual indication of the respective test reaction to be performed.

38. The device of claim 23, wherein at least one of the first and second test strips comprises a color providing a visual indication of the respective test reaction to be performed.

39. The device of claim 38, wherein both the first and second test strips comprise a color corresponding to the test reactions to be performed.

40. A method for detecting an analyte in a sample, the method comprising:

contacting a substance to be tested with a sample pad, wherein said sample pad is coupled to a test strip having an indicator region configured to provide a visual indication of the presence or absence of the analyte;

retaining contact of the substance with the sample pad until a sample of the substance is collected;

positioning a run fluid container over the sample pad so that the run fluid container forms an air-tight seal around a first end of a housing that contains the test strip;

allowing the sample to progress through the sample pad and onto the test strip; and

reading the presence or absence of the analyte from the indicator region on the test strip.

41. The method of claim 40, wherein the substance to be tested is a fluid.

42. The method of claim 41, wherein the fluid is a biological fluid.

43. The method of claim 42, wherein the fluid is a biological fluid selected from the group consisting of an oral fluid, blood, spinal fluid, and urine.

44. The method of claim 40, wherein the test reaction is for a chemical or environmental evaluation of the substance.

45. A method for performing a test reaction to detect an analyte in a sample, the method comprising:

contacting a substance to be tested with a sample pad, wherein said sample pad is coupled to a test strip having an indicator region configured to provide a visual indication of the presence or absence of the analyte;

retaining contact of the substance with the sample pad until a sample of the substance is collected;

determining whether the amount of the sample collected is sufficient for performing the test reaction or exceeds a maximum amount for performing the test reaction;

allowing the sample to progress through the sample pad and onto the test strip; and

reading the presence or absence of the analyte from the indicator region on the test strip.

46. The method of claim 45, wherein determining the amount of sample collected is at least partially based on at least one marking on the sample pad, said marking providing a visual indication of the amount of sample collected.

47. The method of claim 46, wherein the substance to be tested is a fluid.

48. The method of claim 45, wherein the fluid is a biological fluid.

49. The method of claim 48, wherein the fluid is a biological fluid selected from the group consisting of an oral fluid, blood, spinal fluid, and urine.

50. The method of claim 46, wherein the test reaction is for a chemical or environmental evaluation of the substance.

51. A method for performing first and second test reactions to detect first and second analytes in first and second samples, the method comprising:

contacting a first substance to be tested with a first sample pad, wherein said first sample pad is coupled to a first test strip having a first indicator region configured to provide a visual indication of the presence or absence of the first analyte;

retaining contact of the first substance with the first sample pad until a first sample is collected;

contacting a second substance to be tested with a second sample pad, wherein said second sample pad is coupled to a second test strip having a second indicator region configured to provide a visual indication of the presence or absence of the second analyte, and wherein the second test strip is coupled to the first test strip in a back-to-back configuration;

retaining contact of the second substance with the second sample pad until a second sample is collected;

allowing the first sample to progress through the first sample pad and onto the first test strip;

allowing the second sample to progress through the second sample pad and onto the second test strip;

reading the presence or absence of the first analyte from the first indicator region on the first test strip; and

reading the presence or absence of the second analyte from the second indicator region on the second test strip.

52. The method of claim 51, wherein at least one of the first and second substances is a fluid.

53. The method of claim 52, wherein the fluid is a biological fluid.

54. The method of claim 53, wherein the fluid is a biological fluid selected from the group consisting of an oral fluid, blood, spinal fluid, and urine.

55. The method of claim 51, wherein at least one of the first and second test reactions is for a chemical or environmental evaluation of the corresponding substance.