Self-contained swab-based diagnostic systems

• US 20050136553A1
• Filed: 12/23/2003
• Published: 06/23/2005
• Est. Priority Date: 12/23/2003
• Status: Active Grant

• Current Assignee: Kimberly-Clark Worldwide Incorporated (Kimberly-Clark Corporation)
• Original Assignee: Kimberly-Clark Worldwide Incorporated (Kimberly-Clark Corporation)
• Inventors: Yang, Kaiyuan, Kaylor, Rosann Marie Matthews, Boga, RameshBabu, Velazquez, Herb, Cohen, David Samuel, O'Connor, Amanda Lee
• Granted Patent: US 7,098,040 B2
• Time in Patent Office: Days
• US Class Current: 436/518
• CPC Class Codes: C12M 33/02 by impregnation, e.g. using swabs or loops fluid transport using swabs B01L3/5029
• CPC Class Codes: G01N 1/02 Devices for withdrawing samples sampling of foundation soil E02D1/04; collecting or conveying radioactive samples G01T7/00, e.g. G01T7/02, G01T7/08
• CPC Class Codes: G01N 2001/028 Sampling from a surface, swabbing, vaporising
• 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 436/805 Optical property
• CPC Class Codes: Y10S 436/81 Tube, bottle, or dipstick

Abstract

A diagnostic test unit is provided. The test unit comprises a stem having a first end and a second end, the stem defining at least one flow channel extending between the first end and the second end. A swab is disposed at the first end of the stem, the swab being configured to collect a test sample derived from a biological source that is suspected of containing an analyte. The test unit also comprises a fluid chamber configured to contain a fluid, wherein the fluid chamber is in fluid communication with the swab via the flow channel. The test unit also comprises a rupturable seal that inhibits leakage of the fluid from the fluid chamber prior to use, and an assay for detecting the presence or absence of the analyte. The assay is in fluid communication with the swab, the flow channel, and the fluid chamber.

Claims

1. A diagnostic test unit comprising:

a stem having a first end and a second end, said stem defining at least one flow channel extending between said first end and said second end;

a swab disposed at said first end of said stem, said swab being configured to collect a test sample derived from a biological source that is suspected of containing an analyte;

a fluid chamber configured to contain a fluid, wherein said fluid chamber is in fluid communication with said swab via said flow channel;

a rupturable seal that inhibits leakage of the fluid from said fluid chamber prior to use; and

an assay for detecting the presence or absence of the analyte in the test sample, said assay being in fluid communication with said swab, said flow channel, and said fluid chamber.

2. A diagnostic test unit as defined in claim 1, wherein said flow channel has a length of greater than about 1 centimeter.

3. A diagnostic test unit as defined in claim 1, wherein said flow channel has a length of from about 5 to about 10 centimeters.

4. A diagnostic test unit as defined in claim 1, wherein at least a portion of said flow channel has a width of less than about 3 millimeters.

5. A diagnostic test unit as defined in claim 1, wherein at least a portion of said flow channel has a width of from about 0.05 to about 1 millimeter.

6. A diagnostic test unit as defined in claim 1, further comprising a base portion disposed at said second end of said stem.

7. A diagnostic test unit as defined in claim 6, wherein said base portion defines said fluid chamber.

8. A diagnostic test unit as defined in claim 6, wherein said base portion includes an absorbent pad to facilitate wicking.

9. A diagnostic test unit as defined in claim 1, further comprising a syringe disposed at said second end of said stem.

10. A diagnostic test unit as defined in claim 9, wherein said syringe defines said fluid chamber.

11. A diagnostic test unit as defined in claim 1, wherein said fluid chamber is defined by a component configured to selectively receive said swab.

12. A diagnostic test unit as defined in claim 11, wherein said seal is configured to be ruptured by said swab when received by said component.

13. A diagnostic test unit as defined in claim 1, wherein said stem defines at least one additional flow channel.

14. A diagnostic test unit as defined in claim 13, wherein the fluid is capable of flowing from said fluid chamber through one of said flow channels to contact said swab, and the fluid is capable of flowing from said swab through another of said flow channels to contact said assay.

15. A diagnostic test unit as defined in claim 1, wherein said assay is positioned within said flow channel.

16. A diagnostic test unit as defined in claim 1, wherein said seal is formed from film, metallic foil, or combinations thereof.

17. A diagnostic test unit as defined in claim 1, wherein said seal has a thickness of less than about 0.05 inches.

18. A diagnostic test unit as defined in claim 1, wherein said seal has a thickness of from about 0.0007 inches to about 0.02 inches.

19. A diagnostic test unit as defined in claim 1, wherein the fluid is configured to flow from said fluid chamber, into said flow channel, and then contact said swab.

20. A diagnostic test unit as defined in claim 1, wherein the fluid is configured to flow from said fluid chamber, contact said swab, and then flow into said flow channel.

21. A diagnostic test unit as defined in claim 1, wherein said assay comprises a porous membrane through which said fluid is capable of flowing.

22. A diagnostic test unit as defined in claim 1, further comprising a reader capable of detecting the presence of the analyte on said assay.

23. A diagnostic test unit as defined in claim 1, wherein said assay is an immunoassay.

24. A diagnostic test unit comprising:

a generally elongated, tubular stem having a first end and a second end, said stem defining at least one flow channel extending between said first end and said second end, said flow channel having a length of from about 1 to about 15 centimeters and at least a portion of said flow channel having a width of from about 0.01 to about 3 millimeters;

a swab disposed at said first end of said stem, said swab being configured to collect a test sample derived from a biological source that is suspected of containing an analyte;

a fluid chamber configured to contain a fluid, wherein said fluid chamber is in fluid communication with said swab via said flow channel;

a rupturable seal that inhibits leakage of the fluid from said fluid chamber prior to use, wherein said seal is formed from film, metallic foil, or combinations thereof, and has a thickness of less than about 0.05 inches; and

an immunoassay for detecting the presence or absence of the analyte in the test sample, said immunoassay comprising a porous membrane that is in fluid communication with said swab, said flow channel, and said fluid chamber.

25. A diagnostic test unit as defined in claim 24, further comprising a base portion disposed at said second end of said stem.

26. A diagnostic test unit as defined in claim 25, wherein said base portion defines said fluid chamber.

27. A diagnostic test unit as defined in claim 25, wherein said base portion includes an absorbent pad to facilitate wicking.

28. A diagnostic test unit as defined in claim 24, further comprising a syringe disposed at said second end of said stem.

29. A diagnostic test unit as defined in claim 28, wherein said syringe defines said fluid chamber.

30. A diagnostic test unit as defined in claim 24, wherein said fluid chamber is defined by a component configured to selectively receive said swab.

31. A diagnostic test unit as defined in claim 30, wherein said seal is configured to be ruptured by said swab when received by said component.

32. A diagnostic test unit as defined in claim 24, wherein said stem defines at least one additional flow channel.

33. A diagnostic test unit as defined in claim 32, wherein the fluid is capable of flowing from said fluid chamber through one of said flow channels to contact said swab, and the fluid is capable of flowing from said swab through another of said flow channels to contact said immunoassay.

34. A diagnostic test unit as defined in claim 24, wherein said immunoassay is positioned within said flow channel.

35. A method for detecting the presence or absence of an analyte within a test sample derived from a biological source, said method comprising:

i) providing a diagnostic test unit, said test unit comprising;

a) a stem having a first end and a second end, said stem defining at least one flow channel extending between said first end and said second end;

b) a swab disposed at said first end of said stem;

c) a fluid chamber configured to contain a fluid, wherein said fluid chamber is in fluid communication with said swab via said flow channel;

d) a seal that inhibits leakage of the fluid from said fluid chamber prior to use; and

e) an assay for detecting the presence or absence of the analyte in the test sample, said assay being in fluid communication with said swab, said flow channel, and said fluid chamber;

ii) collecting the test sample on said swab; and

iii) rupturing said seal to release said fluid from said fluid chamber, wherein said fluid mixes with the test sample on said swab and then contacts said assay.

36. A method as defined in claim 35, wherein said flow channel has a length of greater than about 1 centimeter.

37. A method as defined in claim 35, wherein at least a portion of said flow channel has a width of from about 0.01 to about 3 millimeters.

38. A method as defined in claim 35, wherein said seal is ruptured by physically puncturing said seal.

39. A method as defined in claim 38, wherein seal is ruptured by inserting said swab through said seal.

40. A method as defined in claim 35, wherein said seal is ruptured by fluid pressure.

41. A method as defined in claim 40, wherein said seal is ruptured by depressing a shaft of a syringe.

42. A method as defined in claim 35, wherein said assay is positioned within said flow channel.

43. A method as defined in claim 35, wherein said rupturing of said seal causes said fluid to flow from said fluid chamber, into said flow channel, and then contact said swab.

44. A method as defined in claim 35, wherein said rupturing of said seal causes said fluid to flow from said fluid chamber, contact said swab, and then flow into said flow channel.

45. A method as defined in claim 35, wherein said assay is an immunoassay.

46. A method as defined in claim 35, wherein the amount of the analyte within the test sample is determined from said detection signal.

47. A method as defined in claim 46, further comprising calibrating said detection signal with a calibration signal generated at a calibration zone of said assay, wherein the amount of the analyte within the test sample is determined from said detection signal as calibrated by said calibration signal.