Self-venting immunodiagnositic devices and methods of performing assays

• US 5,478,751 A
• Filed: 04/18/1994
• Issued: 12/26/1995
• Est. Priority Date: 12/29/1993
• Status: Expired due to Fees

• Current Assignee: Abbott Laboratories Incorporated
• Original Assignee: Abbott Laboratories Incorporated
• Inventors: Oosta, Gary M., Schapira, Thomas G.
• Primary Examiner(s): Warden, Robert J.
• Assistant Examiner(s): BHAT, NINA NMN
• Application Number:
  US08/229,256
• Time in Patent Office: 617 Days
• Field of Search: 435/4, 435/435.71, 435/14, 435/25, 435/28, 435/810, 435/970, 436/535, 436/63, 436/166, 436/178, 436/165, 436/809, 422/58, 422/61, 422/81
• US Class Current: 436/165
• CPC Class Codes: B01L 2200/0684 Venting, avoiding backpressure, avoid gas bubbles
• CPC Class Codes: B01L 2300/0825 Test strips
• CPC Class Codes: B01L 2300/0887 Laminated structure
• CPC Class Codes: B01L 2400/0406 capillary forces
• CPC Class Codes: B01L 3/502723 characterised by venting arrangements
• CPC Class Codes: G01N 33/54386 Analytical elements
• CPC Class Codes: Y10T 436/255 including use of a solid sorbent, semipermeable membrane, or liquid extraction

Abstract

Methods and devices are provided involving an inlet port, at least one chamber, a channel providing access for fluids to flow through via capillary action or differential pressure, reagents, detection means and self-venting materials. The devices allow for the appropriate mixing, reacting, incubating needed to give a detectable signal which can be read. The self-venting materials allow for the 1) displacement of gases inside a track to the outside of the device and 2) oxygen movement into the track from the outside.

Claims

1. A method for detecting the presence or an amount of an analyte in a test sample, comprising providing:

(a) an analytical device comprising;

a housing made of a hydrophobic material, said hydrophobic material consisting of;

acrylics, polycarbonates, polystyrenes, silicones, polyurethanes, polyolefins, polytetrafluoroethylenes, polypropylenes, polyethylenes, thermoplastic elastomers, copolymers, acrylnitrylbutadienestyrene, and styreneacrylonitrile;

said housing containing an inlet port, said inlet port accessing a track of predetermined width and length within said housing and having at least one reagent therein;

said track having at least one hydrophobic surface modified to create a hydrophilic surface by introducing at least one hydrophilic group onto said hydrophobic surface, said hydrophilic group consisting of;

hydroxyls, carbonyls, carboxylics, aminos, sulfonics, sulfonates, sulfates, pyrroles, acetates, acrylics, carbonates, amidos, and phosphates;

said hydrophobic material being impermeable to said test sample and allowing gaseous exchange in and out of a portion of said track;

(b) adding said test sample to said housing through said inlet port;

said test sample and said reagent producing a detectable signal upon mixing; and

(c) determining the presence or an amount of an analyte in said test sample from said detectable signal.

2. The method of claim 1 wherein said analyte is a member of a group consisting of:

proteins, peptides, amino acids, carbohydrates, hormones, steroids, vitamins, lipids, nucleic acids, trace elements, drugs including those administered for therapeutic purposes as well as those administered for illicit purposes, bacteria, viruses, metabolites, viroids, mammalian cells such as lymphocytes, epithelial cells, and neoplastic cells.

3. The method of claim 1 wherein said detectable signal is read directly from said analytical device.

4. The method of claim 1 wherein said detectable signal is read directly from said analytical device by an instrument.

5. The method of claim 4 wherein said instrument is a member of a group consisting of:

spectrophotometers, colorimeters, fluorimeters, spectroscopies, calorimeters, reflectance meters, and conductimeters.

6. The method of claim 1 wherein said modification of said hydrophobic surface is by wet chemical modification, surface coatings, gas modification, plasma deposition, plasma modification treatments and sufactants.

7. A method for detecting the presence or an amount of an analyte in a test sample comprising providing:

(a) an analytical device comprising a first hydrophobic material and a second hydrophilic material,

said first hydrophobic material consisting of;

acrylics, polycarbonates, polystyrenes, silicones, polyurethanes, polyolefins, polytetrafluoroethylenes, polypropylenes, polyethylenes thermoplastic elastomers, copolymers, acrylnitrylbutadienestyrene, and styreneacrylonitrile;

said housing containing an inlet port, said inlet port accessing a track of predetermined width and length within said housing and containing a reagent therein;

said first hydrophobic material allowing gaseous exchange in and out of a portion of said track; and

said track having at least one surface of said first hydrphobic material modified to create said second hydrophilic material by introducing at least one hydrophilic group onto said first hydrophobic surface, said hydrophilic group consisting of;

hydroxyls, carbonyls, carboxylics, aminos, sulfonics, sulfonates, sulfates, pyrroles, acetates, acrylics, carbonates, amidos, and phosphates; and

(b) adding said test sample to said housing through said inlet port;

said test sample and said reagent producing a detectable signal upon mixing; and

(c) determining the presence or an amount of an analyte in said test sample from said detectable signal.

8. The method of claim 7 wherein said analyte is a member of a group consisting of:

proteins, peptides, amino acids, carbohydrates, hormones, steroids, vitamins, lipids, nucleic acids, trace elements, drugs including those administered for therapeutic purposes as well as those administered for illicit purposes, bacteria, viruses, metabolites, viroids, mammalian cells such as lymphocytes, epithelial cells, and neoplastic cells.

9. The method of claim 7 wherein said detectable signal is read directly from said analytical device.

10. The method of claim 7 wherein said detectable signal is read directly from said analytical device by an instrument.

11. The method of claim 10 wherein said instrument is a member of a group consisting of:

spectrophotometers, colorimeters, fluorimeters, spectroscopies, calorimeters, reflectance meters, and conductimeters.

12. A method for detecting the presence or an amount of an analyte in a test sample comprising providing:

(a) a housing having a first layer, a core layer, and a second layer, said core layer made of a hydrophobic material containing a track of predetermined width and length and having at least one reagent therein, said track having a sidewall defining the boundaries for flow of said test sample, said first and second layers being impermeable to said test sample;

at least one of said first or second layers having a hydrophilic surface;

said housing containing an inlet port, said inlet port accessing said track, at least one of said first layer, second layer, or core layer made of a porous material that will vent gases in and out of a portion of said track;

(b) adding said test sample to said housing through said inlet port;

said test sample and said reagent producing a detectable signal upon mixing; and

(c) determining the presence or an amount of an analyte in said test sample from said detectable signal.

13. The method of claim 12 wherein said analyte is a member of a group consisting of:

proteins, peptides, amino acids, carbohydrates, hormones, steroids, vitamins, lipids, nucleic acids, trace elements, drugs including those administered for therapeutic purposes as well as those administered for illicit purposes, bacteria, viruses, metabolites, viroids, mammalian cells such as lymphocytes, epithelial cells, and neoplastic cells.

14. The method of claim 12 wherein said detectable signal is read directly from said analytical device.

15. The method of claim 12 wherein said detectable signal is read directly from said analytical device by an instrument.

16. The method of claim 15 wherein said instrument is a member of a group consisting of:

spectrophotometers, colorimeters, fluorimeters, spectroscopies, calorimeters, reflectance meters, and conductimeters.

17. An analytical device for detecting the presence or an amount of an analyte in a test sample, comprising:

a housing made of a hydrophobic material, said hydrophobic material consisting of;

acrylics, polycarbonates, polystyrenes, silicones, polyurethanes, polyolefins, polytetrafluoroethylenes, polypropylenes, polyethylenes, thermoplastic elastomers, copolymers, acrylnitrylbutadienestyrene, and styreneacrylonitrile;

said housing containing an inlet port, said inlet port accessing a track of predetermined width and length within housing;

said track having at least one hydrophobic surface modified to create a hydrophilic surface by introducing at least one hydrophilic group onto said hydrophobic surface, said hydrophilic group consisting of;

hydroxyls, carbonyls, carboxylics, aminos, sulfonics, sulfonates, sulfates, pyrroles, acetates, acrylics, carbonates, amidos, and phosphates; and

said hydrophobic material being impermeable to said test sample and allowing gaseous exchange in and out of a portion of said track.

18. The analytical device of claim 17 wherein said track has at least one chamber.

19. The analytical device of claim 17 further comprising a reagent within said device.

20. The analytical device of claim 19 wherein said reagent is on said hydrophilic surface.

21. The analytical device of claim 17 wherein said test sample flows along said hydrophilic surface by differential pressure.

22. The analytical device of claim 17 wherein said device is a cuvette.

23. The analytical device of claim 17 wherein said modification of said hydrophobic surface is by wet chemical modification, surface coatings, gas modification, plasma deposition, plasma modification treatments, and a surfactant.

24. An analytical device for detecting the presence or an amount of an analyte in a test sample comprising:

a housing made of a first hydrophobic material and a second hydrophilic material,

said first hydrophobic material consisting of;

acrylics, polycarbonates, polystyrenes, silicones, polyurethanes, polyolefins, polytetrafluoroethylenes, polypropylenes, polyethylenes, thermoplastic elastomers, copolymers, acrylnitrylbutadienestyrene, and styreneacrylonitrile;

said housing containing an inlet port, said inlet port accessing a track of predetermined width and length within said housing;

said first hydrophobic material allowing gaseous exchange in and out of a portion of said track; and

said track having at least one surface of said first hydrophobic material modified to create said second hydrophilic material by introducing at least one hydrophilic group onto said first hydrophobic surface, said hydrophilic group consisting of;

hydroxyls, carbonyls, carboxylics, aminos, sulfonics, sulfonates, sulfates, pyrroles, acetates, acrylics, carbonates, amidos, and phosphates.

25. The analytical device of claim 24 wherein said track has at least one chamber.

26. The analytical device of claim 24 wherein said reagent is on the surface of said hydrophilic surface.

27. The analytical device of claim 24 wherein said reagent is on the hydrophobic surface of said track.

28. The analytical device of claim 24 wherein said test sample is moved along said hydrophilic surface by a differential pressure.

29. The analytical device of claim 24 wherein said device is a cuvette.

30. The analytical device of claim 24 wherein said modification of said first hydrophobic surface is by wet chemical modification, surface coatings, gas modification, plasma deposition, plasma modification treatments, and surfactants.

31. The analytical device of claim 24 wherein said hydrophilic material is modified by application of an adhesive system to a polymer screen.

32. The analytical device of claim 24 wherein said hydrophilic material is modified by an adhesive systems consisting of:

hot melt adhesives, one part curables, two part curables, solvent based/emulsion adhesives, ultraviolet curables, and water induced curables.

33. The analytical device of claim 24 wherein said hydrophilic material is modified by application of an adhesive system as one or more islands.

34. The analytical device of claim 24 wherein said hydrophilic material is modified by application of an adhesive system to a bibulous material.

35. An analytical device for detecting the presence or an amount of an analyte in a test sample comprising:

a housing having a first layer, a core layer, and a second layer, said core layer made of a hydrophobic material containing a track of predetermined width and length, said track having a sidewall defining the boundaries for flow of said test sample, said first and second layers being impermeable to said test sample;

at least one of said first or second layers having a hydrophilic surface; and

said housing containing an inlet port, said inlet port accessing said track of, at least one of said first layer, second layer, or core layer made of a porous material that will vent gases in and out of a portion of said track.

36. The analytical device of claim 35 wherein said track has at least one chamber.

37. The analytical device of claim 35 further comprising a reagent on the surface of said first or second layer.

38. The analytical device of claim 35 further comprising a reagent on the hydrophobic material of said track.

39. The analytical device of claim 35 wherein said test sample flows along said hydrophilic surface by differential pressure.

40. The analytical device of claim 35 wherein said device is a cuvette.

41. The analytical device of claim 35 wherein said hydrophilic surface is modified by wet chemical modification, surface coatings, gas modification, plasma deposition, plasma modification treatments and surfactants.

42. The analytical device of claim 35 wherein said core layer is a hydrophilic material which is modified by application of an adhesive system.

43. The adhesive system of claim 42 selected from the group consisting of:

hot melt adhesives, one part curables, two part curables, solvent based/emulsion adhesives, ultraviolet curables, and water induced curables.

44. The analytical device of claim 42 wherein said adhesive system is applied as one or more islands.