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1. (WO2013106269) IMMUNOASSAY TEST SLIDE
Note: Text based on automatic Optical Character Recognition processes. Please use the PDF version for legal matters

What is claimed is:

1. An immunoassay test slide, which comprises:

a housing, the housing defining a cavity; and

a fluid flow matrix, the fluid flow matrix being disposed within the cavity of the housing for receiving a fluid sample containing an analyte, or one or more liquid reagents.

2. An immunoassay test slide as defined by Claim 1, wherein the housing includes a bottom side which is formed from a light transmissive material, a top side, the top side including a recessed portion to at least partially define the cavity for receiving the fluid flow matrix, a front side, a rear side situated opposite the front side, and opposite lateral sides, the cavity being situated between the front and rear sides and between the opposite lateral sides of the housing; and wherein the test slide further comprises:

a top film portion, the top film portion being situated on the housing opposite the bottom side and in alignment with and covering the fluid flow matrix, the top film portion having an opening formed through the thickness thereof which is in communication with the cavity of the housing and which is provided to receive the fluid sample containing an analyte or the one or more liquid reagents, the fluid flow matrix being disposed within the housing and situated in alignment with the top opening formed in the film portion to receive thereon the fluid sample or the one or more liquid reagents.

3. An immunoassay test slide as defined by Claim 2, wherein the top side of the housing includes at least one recessed ledge, the at least one recessed ledge being situated adjacent to the recessed portion which receives the fluid flow matrix, the at least one recessed ledge having a top surface on which a portion of the underside surface of the top film portion rests.

4. An immunoassay test slide as defined by Claim 2, wherein the housing has a generally trapezoidal shape, and wherein the front and rear sides of the housing are generally parallel to each other and the rear side is longer than the front side.

5. An immunoassay test slide as defined by Claim 2, wherein the top film portion is formed from a polystyrene material.

6. An immunoassay test slide as defined by Claim 2, wherein the top film portion has a thickness of about .2 millimeters.

7. An immunoassay test slide as defined by Claim 2, wherein the opening formed through the top film portion is one of circular or oblong.

8. An immunoassay test slide as defined by Claim 7, wherein the opening formed through the top film portion has a width along a minor axis thereof of between about 6 millimeters and about 12 millimeters if the opening is oblong in shape, and has a diameter of between about 6 millimeters and about 12 millimeters if the opening is circular in shape.

9. An immunoassay test slide as defined by Claim 2, wherein the fluid flow matrix is formed from a glass fiber-based material that contains a plastic binder.

10. An immunoassay test slide as defined by Claim 2, wherein the slide housing is formed from a polystyrene material.

1 1. An immunoassay test slide as defined by Claim 2, wherein the top side of the slide housing includes a bar code situated thereon.

12. An immunoassay test slide as defined by Claim 2, wherein the housing includes a side wall surrounding the cavity, at least a portion of the sidewall being spaced laterally from the fluid flow matrix to define therebetween a channel for receiving an excess volume of the fluid sample or the one or more liquid reagents.

13. An immunoassay test slide, which comprises:

a slide housing which is generally trapezoidal in overall shape, the housing including a front portion, a rear portion, first and second side portions and a bottom side, wherein the front and rear portions are generally parallel to each other and the rear portion is longer than the front portion, the housing defining a cavity;

an absorbent material disposed in the cavity of the housing; and

means defining an opening, the opening defining means being one of a top side of the housing having the opening formed through the thickness thereof and a top film portion having the opening formed through the thickness thereof, the opening being disposed in alignment with and covering the absorbent material disposed in the cavity of the housing and being in communication with the cavity and the absorbent material disposed therein, the opening being provided to receive a fluid sample containing an analyte, or one or more liquid reagents.

14. An immunoassay test slide, which comprises:

a housing, the housing having a cover portion and a bottom portion joined to the cover portion, the housing defining an interior cavity between the cover portion and the bottom portion, the cover portion having a top opening formed through the thickness thereof which is in fluid communication with the interior cavity of the housing and which is provided to receive a fluid sample containing an analyte, or one or more liquid reagents; and

a fluid flow matrix, the fluid flow matrix being disposed within the housing and situated in alignment with the top opening fomied in the cover portion to receive thereon the fluid sample or the one or more liquid reagents.

15. An immunoassay test slide as defined in Claim 14, wherein the cover portion is formed as a film affixed to the bottom portion of the housing.

16. An immunoassay test slide as defined by Claim 14, which further comprises: at least one immobilized analyte capture reagent situated on the fluid flow matrix in alignment with the top opening in the cover portion.

17. An immunoassay test slide as defined by Claim 14, wherein the housing includes a side wall surrounding the interior cavity, at least a portion of the side wall being spaced laterally from the fluid flow matrix to define therebetween a channel for receiving an excess volume of the fluid sample or the one or more liquid reagents.

1 8. An immunoassay test slide as defined by Claim 14, which further comprises: at least one support extending between the cover portion and the bottom portion within the interior cavity of the housing.

19. An immunoassay test slide as defined by Claim 18, wherein the fluid flow matrix has fonned through the thickness thereof at least one opening situated in alignment with the at least one support, the at least one support passing through the at least one opening in the fluid flow matrix.

20. An immunoassay test slide as defined by Claim 14, which further comprises: a plurality of supports extending between the cover portion and the bottom portion within the interior cavity of the housing, the plurality of supports being disposed about the peripherv' of the top opening of the cover portion.

21. An immunoassay test slide as defined by Claim 20, wherein the fluid flow matrix has fonned tlirough the thickness thereof a plurality of openings, the openings of the fluid flow-matrix being situated in alignment with and receiving corresponding supports therethrough.

22. An immunoassay test slide as defined by Claim 14, wherein the bottom portion has a bottom opening formed through the thickness thereof, the bottom opening in the bottom portion being at least partially situated in alignment with the top opening of the cover portion.

23. An immunoassay test slide as defined by Claim 22, which further comprises: a light transmissive film, the light transmissive film being situated within the interior cavity of the housing and covering the bottom opening of the bottom portion.

24. An immunoassay test slide as defined by Claim 14, wherein the bottom portion is formed of a material winch is light transmissive.

25. An immunoassay test slide as defined by Claim 14, wherein the housing is generally rectangular in shape.

26. An immunoassay test slide as defined by Claim 14, wherein the housing is generally trapezoidal in shape, and includes a front wall, a rear wall situated opposite the front wall, and two opposite lateral walls, the two lateral walls extending in a non-parallel direction with respect to each other, the front wall having a length which is less than the length of the rear wall.

27. An immunoassay test slide as defined by Claim 26, wherein the front wall of the housing has formed therein an orientation notch.

28. An immunoassay test slide as defined by Claim 26, wherein each lateral wall of the housing has formed therein a recess.

29. An immunoassay test slide as defined by Claim 14, wherein the fluid flow matrix is formed from a porous material selected from the group consisting of natural, synthetic, or naturally occurring or synthetically modified materials; fibrous materials; membranes of cellulose materials, including paper, cellulose, and cellulose derivatives, including cellulose acetate and nitrocellulose, fiberglass, glass fiber, cloth, both naturally occurring, including cotton, and synthetic, including nylon; porous gels, including silica gel, agarose, dextran and gelatin; porous fibrous matrices; starch based materials; cross-linked dextran chains; ceramic materials; olefin and thermoplastic materials, including films of polyvinyl chloride, polyethylene, polyvinyl acetate, polyamide, polycarbonate, polystyrene, copolymers of vinyl acetate and vinyl chloride and combinations of polyvinyl chloride-silica.

30. A method of performing an assay using the immunoassay test slide defined by Claim 14, which comprises the steps of:

depositing a mixture of a fluid sample and a conjugate reagent on the fluid flow matrix through the top opening of the cover portion of the slide;

depositing a wash reagent at least once on the fluid flow matrix through the top opening of the cover portion of the slide; and

depositing a substrate on the fluid flow matrix through the top opening of the cover portion of the slide.

31. A method as defined by Claim 30, which further comprises the steps of:

illuminating the bottom portion of the slide with light of a predetermined wavelength; and

detecting the light reflected or emitted by the slide.

32. A method of manufacturing the immunoassay test slide defined by Claim 14, which comprises the steps of:

forming the cover portion and the bottom portion of the slide;

positioning the porous earner matrix between the cover portion and the bottom portion and

joining the cover portion and the bottom portion together, with the porous carrier matrix interposed therebetween.

33. A method as defined by Claim 32, wherein the step of joining the cover portion and the bottom portion together includes at least one of the sub-steps of a) applying adhesive to at least one of the cover portion and the bottom portion, and b) melting at least a portion of at least one of the cover portion and the bottom portion by one of heat stamping and sonic welding.

34. An immunoassay device comprising:

a generally trapezoidal cover portion having a front portion, a rear portion, first and second side portions and top and bottom sides, wherein the front and rear portions are generally parallel to each other and the rear portion is longer than the front portion, wherein at least one orifice is formed in the cover portion, the orifice passing through the top and bottom sides and wherein the bottom side of the top portion has at least one recess formed therein;

a generally trapezoidal bottom portion having a front portion, a rear portion, first and second side portions and top and bottom sides, wherein the front and rear portions are generally parallel to each other and the rear portion is longer than the front portion and wherein the top side of the bottom portion has at least one recess formed therein;

means for joining the cover portion to the base portion to form a generally trapezoidal device that has an interior space at least partially defined by the at least one cover portion recess and the at least one bottom portion recess, the interior space having a volume of from about 20 microliters to about 200 microliters; and

an absorbent material disposed in the interior space.

35. The immunoassay device of claim 34, wherein at least one notch is formed in the device.

36. The immunoassay device of claim 35, wherein the at least one notch is defined by the absence of material in the front portions of both the cover portion and the bottom portion.

37. The immunoassay device of claim 34, wherein the absorbent material is selected from the group of materials consisting of: sintered polyethylene beads; nitrocellulose; glass fibers; and paper.

38. The immunoassay device of claim 34, wherein the absorbent material is treated with a surfactant.

39. The immunoassay device of claim 34, wherein the cover and bottom portions are fabricated from the same material.

40. The immunoassay device of claim 34, wherein the cover and bottom portions are fabricated from a material comprising polystyrene.

41. The immunoassay device of claim 34, wherein the bottom portion is fabricated from a material that can be permeated by visible or infrared light.

42. The immunoassay device of claim 41 , wherein the bottom portion is fabricated from a material that can be permeated by light having a wavelength of 645 nanometers.

43. The immunoassay device of claim 34, further comprising an antibody or antigen disposed on the absorbent material.

44. The immunoassay device of claim 34, wherein the means for joining the cover portion to the bottom portion comprises material from either the cover portion, the bottom portion or both the cover portion and bottom portion that has been melted and allowed to harden.

45. The immunoassay device of claim 44, wherein the material was melted by sonic welding.

46. The immunoassay device of claim 44, wherein the material was melted by heat stamping.

47. The immunoassay device of claim 34, wherein the means for joining the cover portion to the bottom portion comprises at least one projection extending from the bottom side of the cover portion and at least one structure formed on the top side of the bottom portion that is configured and dimensioned to receive the at least one projection from the cover portion when the cover portion and the bottom portion are joined together.

48. The immunoassay device of claim 34, wherein the means for joining the cover portion to the bottom portion comprises at least one projection extending from the top side of the bottom portion and at least one structure formed on the bottom side of the cover portion that is configured and dimensioned to receive the at least one projection from the bottom portion when the cover portion and the bottom portion are joined together.

49. The immunoassay device of claim 34, wherein the absorbent material has a volume that occupies at least about 50% of the interior space.

50. The immunoassay device of claim 34. wherein the absorbent material has a volume that occupies at least about 60% of the interior space.

51. The immunoassay device of claim 34, wherein the absorbent material has a volume that occupies at least about 70% of the interior space.

52. The immunoassay device of claim 34, wherein the absorbent material has a volume that occupies at least about 80% of the interior space.

53. The immunoassay device of claim 34, wherein the absorbent material has a volume that occupies at least about 90% of the interior space.

54. An immunoassay test slide as defined by Claim 8, wherein the opening fonned through the top film portion has a width along a minor axis thereof of about 10 millimeters if the opening is oblong in shape, and has a diameter of about 10 millimeters if the opening is circular in shape.