Diagnostic devices for use in the assaying of biological fluids

• US 20040115831A1
• Filed: 10/16/2003
• Published: 06/17/2004
• Est. Priority Date: 04/19/2002
• Status: Active Grant

• Current Assignee: Adhesives Research Inc.
• Original Assignee: Adhesives Research Inc.
• Inventors: Hand, Herbert M. Sr., Su, Li-Hung, Meathrel, William G.
• Granted Patent: US 7,476,533 B2
• Time in Patent Office: Days
• US Class Current: 436/514
• CPC Class Codes: G01N 33/54366 Apparatus specially adapted for solid-phase testing
• CPC Class Codes: G01N 33/558 using diffusion or migration of antigen or antibody immunochromatographic test strips G01N33/54387
• CPC Class Codes: Y10S 435/81 Packaged device or kit
• CPC Class Codes: Y10S 436/81 Tube, bottle, or dipstick

Abstract

Diagnostic in-vitro devices for use in the assaying of biological fluids are provided which include cover plates or backing strips which exhibit hydrophilic properties to assist in transport of the biological fluid or retention of same within the device. Exemplary diagnostic devices include lateral flow devices, microfluidic devices and microtiter plates. The devices may also be comprised of low fluorescent material in order to facilitate any diagnostic determination by use of fluorescent emissions. Hydrophilic properties may be imparted to the cover plates or backing strips by physical or chemical treatment thereof. The cover plates or backing strips may exhibit heat sealable or pressure sensitive properties.

Claims

1. In a lateral flow in-vitro diagnostic device comprising a housing, means in the housing to introduce a sample to be assayed in said device, means in said housing for fluid collection, and a backing strip having spaced apart first and second ends, the improvement wherein the surface of said backing strip is hydrophilic in character.

2. The lateral flow device of claim 1, further comprising a microporous or porous membrane attached to said backing strip between said first and second ends.

3. The lateral flow device of any one of claims 1 or 2, wherein said hydrophilic surface of said backing strip is heat-sealable.

4. The lateral flow device of any one of claims 1 or 2, wherein said hydrophilic surface of said backing strip exhibits pressure sensitive adhesive properties.

5. The lateral flow device of claim 1 or 2, further comprising a reagent with which said sample must contact or react with applied directly to the surface of said backing strip.

6. The lateral flow device of claim 1 or 2, further comprising a reagent with which said sample must contact or react with contained in a reservoir attached to said backing strip.

7. The lateral flow device of claim 1 or 2, wherein said means for fluid collection comprises an absorbent pad.

8. The lateral flow device of claim 1 or 2, wherein said backing strip includes spaced apart hydrophilic and hydrophobic areas.

9. The lateral flow device of claim 8, wherein a reagent with which said sample must contact or react with is applied to at least a portion of said hydrophobic areas.

10. The lateral flow device of claim 1, wherein said backing strip includes spaced apart first surface portions exhibiting hydrophilic character and second surface portions exhibiting lesser hydrophilic character than said first portions.

11. The lateral flow device of claim 10, wherein a reagent with which said sample must contact or react with is applied to at least a portion of said second portions exhibiting lesser hydrophilic character than said first portions.

12. The lateral flow device of claim 2;

wherein a microporous or porous membrane is heat-sealed to said backing strip.

13. The lateral flow device of claim 2, wherein a microporous or porous membrane is attached to said backing strip having hydrophilic pressure sensitive adhesive properties.

14. The lateral flow device of claim 1, wherein said backing strip is provided with hydrophilic surface properties by use of at least one surfactant.

15. The lateral flow device of claim 14, wherein said backing strip is comprised of a polymeric material and said surfactant is blended with said polymeric material.

16. The lateral flow device of claim 2, wherein said membrane is comprised of nitrocellulose.

17. The lateral flow device of claim 10, wherein said second areas which are less hydrophilic are formed by cross-linking of said polymer in said second areas.

18. The lateral flow device of claim 10, wherein said second areas which are less hydrophilic are formed by exposure of said polymer in said second areas to thermal radiant energy.

19. The lateral flow device of claim 18, wherein said backing strip comprises a polymer containing an ammonium salt of nonyl phenol ethoxyl sulfonic acid.

20. The lateral flow device of claim 1, wherein said device is comprised of low fluorescent materials.

21. The lateral flow device of claim 14 or 15, wherein said surfactant is a non-ionic or anionic surfactant.

22. The lateral flow device of claim 21, wherein said surfactant is selected from the group consisting of polyethylene oxide, polypropylene oxide, nonylphenol ethyoxylate and polyalkylenyeneoxide modified heptamethyltrisiloxane.

23. The lateral flow device of claim 21, wherein said surfactant is selected from the group consisting of sodium or ammonium salts of nonyl phenol ethoxyl sulfonic acid, sodium lauryl sulfate, sodium 2-ethylhexyl sulfate and sodium dioctylsulfo succinate.

24. The lateral flow device of claim 1, comprising a fluid transport channel which is provided with a hydrophilic surface by covalent bonding a hydrophilic surfactant to the surface of said channel.

25. The lateral flow device of claim 21, wherein said surfactant is selected from the group consisting of the ionic salt of 2-acrylamido-2-methyl propanesulfonic acid, N-vinyl caprolactam, caprolactone acrylate, N-vinyl pyrrolidone, and sulfate and acrylic monomers.

26. In a microfluidic in-vitro diagnostic device comprised of a base having at least one fluid channel within which a fluid sample to be assayed passes from an inlet port to a detection zone, the improvement wherein said at least one fluid channel is enclosed by at least one enclosure surface wherein at least one surface of the fluid channel is hydrophilic in character.

27. The microfluidic device of claim 26, wherein said at least one enclosure surface is heat-sealed to said base to seal said at least one fluid channel.

28. The microfluidic device of claim 26, wherein the surface of said at least one enclosure surface facing said at least one fluid channel exhibits pressure sensitive adhesive properties.

29. The microfluidic device of claim 26, wherein the surface of said at least one enclosure surface facing said at least one fluid channel is surface-treated to be hydrophilic in character.

30. The microfluidic device of claim 26, wherein said enclosure surface is comprised of a low fluorescent material.

31. The microfluidic device of claim 26, wherein said enclosure surface is comprised of a polymeric material with which a surfactant is admixed to provide hydrophilic surface properties.

32. The microfluidic device of claim 26, wherein said enclosure surface is comprised of a polymeric material having a surfactant applied to a surface thereof.

33. The microfluidic device of claim 31 or 32, wherein said surfactant is a non-ionic or anionic surfactant.

34. The microfluidic device of claim 33, wherein said surfactant is selected from the group consisting of polyethylene oxide, polypropylene oxide, nonylphenol ethyoxylate and polyalkylenyeneoxide modified heptamethyltrisiloxane.

35. The microfluidic device of claim 33, wherein said surfactant is selected from the group consisting of sodium or ammonium salts of nonyl phenol ethoxyl sulfonic acid, sodium lauryl sulfate, sodium 2-ethylhexyl sulfate and sodium dioctylsulfo succinate.

36. The microfluidic device of claim 33, wherein said surfactant is selected from the group consisting of the ionic salt of 2-acrylamido-2-methyl propanesulfonic acid, N-vinyl caprolactam, caprolactone acrylate, N-vinyl pyrrolidone, and sulfate and acrylic monomers.

37. The microfluidic device of claim 26, wherein said base portion comprises an adhesive layer.

38. The microfluidic device of claim 37, wherein said base portion exhibits pressure sensitive adhesive properties.

39. The microfluidic device of claim 37 or 38, wherein said fluid channels are die-cut into said adhesive layer.

40. In an in-vitro diagnostic device comprised of a microplate having a base plate having formed therein a multitude of microholes or cavities and at least one cover placed in sealing relationship to said microholes or cavities, the improvement wherein a surface of at least said cover which seals said microholes or cavities is hydrophilic in character.

41. The diagnostic device of claim 40, wherein said at least one cover portion is heat-sealed to said base to seal said microholes or cavities.

42. The diagnostic device of claim 40, wherein the surface of said at least one cover facing said microholes or cavities exhibits pressure sensitive adhesive properties.

43. The diagnostic device of claim 40, wherein the surface of said at least one cover facing said microholes or cavities is surface-treated to be hydrophilic in character.

44. The diagnostic device of claim 40, wherein said cover is comprised of a low fluorescent material.

45. The diagnostic device of claim 40, wherein said cover is comprised of a polymeric material with which a surfactant is admixed to provide hydrophilic surface properties.

46. The diagnostic device of claim 40, wherein said cover is comprised of a polymeric material having a surfactant applied to a surface thereof.

47. The diagnostic device of claim 40, wherein said portion of said base portion adjacent said microholes or cavities is hydrophilic in character.

48. The diagnostic device of claim 45 or 46, wherein said surfactant is a non-ionic or anionic surfactant.

49. The diagnostic device of claim 48, wherein said surfactant is selected from the group consisting of polyethylene oxide, polypropylene oxide, nonylphenol ethyoxylate and polyalkylenyeneoxide modified heptamethyltrisiloxane.

50. The diagnostic device of claim 48, wherein said surfactant is selected from the group consisting of sodium or ammonium salts of nonyl phenol ethoxyl sulfonic acid, sodium lauryl sulfate, sodium 2-ethylhexyl sulfate and sodium dioctylsulfo succinate.

51. The diagnostic device of claim 48, wherein said surfactant is selected from the group consisting of the ionic salt of 2-acrylamido-2-methyl propanesulfonic acid, N-vinyl caprolactam, caprolactone acrylate, N-vinyl pyrrolidone, and sulfate and acrylic monomers.