Lateral flow assay device and absorbent article containing same

• US 7,846,383 B2
• Filed: 12/15/2006
• Issued: 12/07/2010
• Est. Priority Date: 12/15/2006
• Status: Active Grant

• Current Assignee: Kimberly-Clark Worldwide Incorporated (Kimberly-Clark Corporation)
• Original Assignee: Kimberly-Clark Worldwide Incorporated (Kimberly-Clark Corporation)
• Inventors: Song, Xuedong
• Primary Examiner(s): SIEFKE, SAMUEL P
• Application Number:
  US11/640,116
• Publication Number:
  US 20080145945A1
• Time in Patent Office: 1,453 Days
• Field of Search: 422/58, 422/68.1, 422/99, 422/102, 436/97
• US Class Current: 422/423
• CPC Class Codes: A61F 13/42 with wetness indicator or alarm
• CPC Class Codes: A61F 13/44 with radio-opaque material or signalling means for residual material
• CPC Class Codes: G01N 33/528 Atypical element structures, e.g. gloves, rods, tampons, toilet paper
• CPC Class Codes: G01N 33/54313 the carrier being characterised by its particulate form
• CPC Class Codes: G01N 33/558 using diffusion or migration of antigen or antibody immunochromatographic test strips G01N33/54387
• CPC Class Codes: G01N 33/72 involving blood pigments, e.g. haemoglobin, bilirubin or other porphyrins; involving occult blood
• CPC Class Codes: Y10T 436/146666 Bile pigment

Abstract

A lateral flow assay device for testing a bodily fluid, such as urine, blood, mucous, saliva, etc., is provided. The lateral flow assay device includes a chromatographic medium (e.g., porous membrane) that defines a detection zone that provides a signal indicative of the presence or amount of bilirubin or urobilinogen. The device may also include a control zone that provides a signal indicative of whether a sufficient amount of bodily fluid has been provided and tested. In one embodiment, the device is integrated into an absorbent article to provide a user or caregiver with rapid information about a health condition. For example, the device may be integrated into a diaper to provide information about the presence of bilirubin and/or urobilinogen. This information may provide an early warning system to allow the user or caregiver to seek additional testing and/or treatment. Alternatively, semi-quantitative or quantitative results may be derived from the test.

Claims

1. A diagnostic test kit for detecting the presence or amount of at least one of bilirubin and urobilinogen within a test sample, the diagnostic test kit comprising:

a lateral flow assay device, the lateral flow assay device including;

a chromatographic medium defining a detection zone within which an indicator reagent is non-diffusively immobilized, wherein the indicator reagent is capable of reacting with bilirubin or urobilinogen to generate a detection signal, wherein a reagent zone is positioned upstream from the detection zone within which is diffusively immobilized a component that facilitates the reaction of the indicator reagent with bilirubin or urobilinogen; and

an absorbent material that receives the test sample after flowing through the chromatographic medium.

2. The diagnostic test kit of claim 1, wherein the indicator reagent is a diazonium salt or a derivative thereof.

3. The diagnostic test kit of claim 2, wherein the diazonium salt is p-aminobenzenesulfonic acid, 2,6-dichlorobenzene diazonium tetrafluoroborate, or 2-trifluoromethylbenzene diazonium.

4. The diagnostic test kit of claim 2, wherein the diazonium salt is 4-fluoro-3-nitrobenzenediazonium salt, 4-methoxybenzene-diazonium-tetrafluoroborate, or 3,3′

-dimethoxybiphenyl-4,4′

-diazonium salt.

5. The diagnostic test kit of claim 1, wherein the indicator reagent is an Erhlich reagent or a derivative thereof.

6. The diagnostic test kit of claim 1, wherein the indicator reagent comprises a macromolecular moiety and a reactive moiety.

7. The diagnostic test kit of claim 6, wherein the macromolecular moiety is formed from a polymer.

8. The diagnostic test kit of claim 7, wherein the polymer is a polysaccharide.

9. The diagnostic test kit of claim 6, wherein the macromolecular moiety is formed from a particle.

10. The diagnostic test kit of claim 9, wherein the particle is a carboxylated latex particle.

11. The diagnostic test kit of claim 1, wherein the chromatographic medium is a porous membrane.

12. The diagnostic test kit of claim 1, further comprising a sample application zone that is located upstream from the reagent zone.

13. The diagnostic test kit of claim 1, further comprising a quenching zone located upstream from the detection zone.

14. The diagnostic test kit of claim 1, further comprising a control zone that is capable of signaling the presence of the test sample.

15. The diagnostic test kit of claim 14, further comprising a control reagent that is capable being detected within the control zone.

16. The diagnostic test kit of claim 1, wherein the test sample is urine.

17. The diagnostic test kit of claim 1, wherein the indicator reagent preferentially reacts with bilirubin to generate the detection signal.

18. The diagnostic test kit of claim 1, the lateral flow assay device further comprising a second detection zone within which a second indicator reagent is immobilized, wherein the second indicator reagent preferentially reacts with urobilinogen to generate a second detection signal.

19. The diagnostic test kit of claim 18, the lateral flow assay device further comprising a second reagent zone which is located down stream of the first detection zone and upstream of the second detection zone.

41. The diagnostic test kit of claim 1, wherein the reagent zone is defined by a reagent pad in fluid communication with the chromatographic medium.

42. The diagnostic test kit of claim 1, wherein the component is a buffer, surfactant, or a mixture thereof.

43. The diagnostic test kit of claim 42, whereon the component includes an acidic buffer.

44. The absorbent article of claim 43, whereon the component includes an acidic buffer.

20. An absorbent article for receiving a bodily fluid suspected of containing bilirubin or urobilinogen, comprising:

a substantially liquid impermeable layer;

a liquid permeable layer;

an absorbent core positioned between the substantially liquid impermeable layer and the liquid permeable layer; and

a lateral flow assay device integrated into the article and positioned such that the device is in fluid communication with the bodily fluid when provided by a wearer of the article, the lateral flow assay device comprising a chromatographic medium that defines a first detection zone in which a first indicator reagent is non-diffusively immobilized, the first detection zone being configured for exhibiting a signal indicative of the presence or amount of at least one of bilirubin and urobilinogen in the bodily fluid, wherein a reagent zone is positioned upstream from the detection zone within which is diffusively immobilized a component that facilitates the reaction of the indicator reagent with bilirubin or urobilinogen.

21. The absorbent article of claim 20, wherein the lateral flow assay device includes a control zone for indicating that a sufficient volume of the bodily fluid has been received by the lateral flow assay device.

22. The absorbent article of claim 20, further comprising a control reagent that is capable of being detected within the control zone.

23. The absorbent article of claim 20, wherein the absorbent article defines a window through which the detection zone, the control zone, or both is observable.

24. The absorbent article of claim 20, wherein the lateral flow assay device further comprises a sample application zone.

25. The absorbent article of claim 24, wherein the sample application zone is comprised of at least part of the absorbent core.

26. The absorbent article of claim 20, wherein the lateral flow assay device is positioned between the substantially liquid impermeable layer and the absorbent core.

27. The absorbent article of claim 20, wherein the lateral flow assay device is positioned between the liquid permeable layer and the absorbent core.

28. The absorbent article of claim 20, wherein the first indicator reagent is a diazonium ion or a derivative thereof.

29. The absorbent article of claim 20, wherein the first indicator reagent is an Erhlich reagent or a derivative thereof.

30. The absorbent article of claim 20, wherein the first indicator reagent comprises a macromolecular moiety and a reactive moiety.

31. The absorbent article of claim 20, wherein the detection zone is configured to exhibit a signal indicative of the presence or amount of bilirubin in the bodily fluid.

32. The absorbent article of claim 31, wherein the lateral flow device further comprises a second detection zone, the second detection zone comprising a second indicator reagent, wherein the second detection zone is configured to exhibit a signal indicative of the presence or amount of urobilinogen in the bodily fluid.

33. The absorbent article of claim 20, wherein the absorbent article is a diaper.

34. The absorbent article of claim 33, wherein the diaper further comprises a second lateral flow assay device integrated into the article and positioned such that the second lateral flow assay device is in fluid communication with the bodily fluid when provided by a wearer of the article, the second lateral flow assay device comprising a porous membrane that defines a second detection zone, the second detection zone comprising a second indicator reagent, the second lateral flow assay device being configured for exhibiting a signal indicative of the presence or amount of at least one of bilirubin and urobilinogen in urine.

47. The absorbent article of claim 20, wherein the component is a buffer, surfactant, or a mixture thereof.

35. A method of detecting the presence or amount of at least one of bilirubin and urobilinogen within a bodily fluid, the method comprising:

providing a lateral flow assay device, the lateral flow assay device comprising a chromatographic medium that defines a first detection zone in which a first indicator reagent is non-diffusively immobilized, the first detection zone being configured for exhibiting a signal indicative of the presence or amount of at least one of bilirubin and urobilinogen in the bodily fluid, wherein a reagent zone is positioned upstream from the detection zone within which is diffusively immobilized a component that facilitates the reaction of the indicator reagent with bilirubin or urobilinogen;

contacting the lateral flow assay device with the bodily fluid; and

observing the detection zone for the visual detection signal.

36. The method of claim 35, further comprising quantitatively or semi-quantitatively testing for the bilirubin or urobilinogen after the visual detection signal is observed.

37. The method of claim 35, wherein the bodily fluid is urine.

38. The method of claim 35, wherein the lateral flow assay device is disposed within an absorbent article.

39. The method of claim 38, wherein the absorbent article is a diaper.

40. The method of claim 35, wherein the detection zone is configured to provide a visual detection signal indicative of the presence or absence of bilirubin within the bodily fluid.

45. The method of claim 35, wherein the component is a buffer, surfactant, or a mixture thereof.

46. The method of claim 45, whereon the component includes an acidic buffer.