Flow-through optical assay devices providing laminar flow of fluid samples, and methods of construction thereof

• US 7,153,651 B1
• Filed: 10/15/1997
• Issued: 12/26/2006
• Est. Priority Date: 10/31/1996
• Status: Expired due to Fees

• Current Assignee: Inverness Medical - Biostar Incorporated
• Original Assignee: Inverness Medical - Biostar Incorporated
• Inventors: Drewes, Joel A., Bogart, Gregory R., Ostroff, Rachel M., Crosby, Mark, Steaffens, Jeffrey W., Etter, Jeffrey B.
• Primary Examiner(s): FORMAN, BETTY J
• Application Number:
  US08/950,963
• Time in Patent Office: 3,359 Days
• Field of Search: 435/6, 436/518, 427/162, 427/164, 427/163.4, 427/167, 310/313
• US Class Current: 435/6.11
• CPC Class Codes: G01N 21/7703 using reagent-clad optical fibres or optical waveguides using measurement of total internal reflection or attenuated total reflection G01N21/552; optical fibres or waveguides per se G02B
• CPC Class Codes: G01N 33/54373 involving physiochemical end-point determination, e.g. wave-guides, FETS, gratings

Abstract

An optical assay device for the detection of an analyte of interest in a sample comprising a support containing channels, an optically functional layer positioned on the support such that the optically functional layer and the support allow for laminar flow of the sample through layers of the device, an attachment layer positioned on the optically functional layer, and an analyte specific receptive layer positioned on the attachment layer.

Claims

1. An optical assay device for the detection of an analyte of interest in a fluid sample comprising:

a support containing channels;

an optically functional layer containing channels, said optically functional layer having an optical property of which is detectably altered upon a change in mass on said optically functional layer related to analyte binding, positioned on said support;

an attachment layer containing channels positioned on said optically functional layer; and

an analyte specific receptive layer containing channels positioned on said attachment layer,

wherein said channels in said support, said optically functional layer, said attachment layer and said analyte specific receptive layer are positioned to allow fluid flow from the analyte specific receptive layer to the support.

7. The device of any of claims 1, 2, 3, 4, 5 or 6 wherein said optically functional layer further comprises an antireflective layer.

8. The device of any of claim 1, 2, 3, 4, 5 or 6, wherein said attachment layer is nickel.

9. The device of any of claim 1, 2, 3, 4, 5 or 6, wherein said device further comprises a liquid absorbent material surrounding said optically functional layer or beneath said support.

10. The device of any of claims 1, 2, 3, 4, 5 or 6, wherein

said support comprises polyester or polycarbonate,

said optically functional layer comprises a layer of silicon nitride positioned on a layer of amorphous silicon, and

said attachment layer comprises nickel.

11. The device of any of claims 1, 2, 3, 4, 5 or 6 wherein said support comprises polycarbonate or polyester, and

said optically functional layer comprises a layer of germanium on which is positioned a layer of diamond-like carbon.

12. The device of any of claims 1, 2, 3, 4, 5 or 6 wherein said optically functional layer comprises a layer of germanium on which is positioned a layer of diamond-like carbon, and said attachment layer comprises nickel.

30. The device of any of claims 1, 2, 3, 4, 5 6, 13, 14, 15 or 21–

29 wherein said analyte is selected from the group consisting of antigens, antibodies, receptors, ligands, chelates, proteins, enzymes, nucleic acids, DNA, RNA, pesticides, and herbicides.

31. The device of any of claims 1, 2, 3, 4, 5 6, 13, 14, 15 or 21–

29 wherein said optically functional layer comprises a layer of silicon nitride positioned on a layer of amorphous silicon.

32. The device of any of claims 1, 2, 3, 4, 5 or 6, 13, 14, 15 or 21–

29 wherein said attachment layer comprises diamond-like carbon.

35. The device of any of claims 1, 3, 5, 13, 26 or 28 wherein said channels in said analyte specific receptive layer do not exceed 15% of the surface area of the layer.

36. The device of any of claims 1, 3, 5, 13, 26 or 28 wherein said channels in said device are not interconnected.

39. The device of any of claims 1-3, 5, and 6, wherein said channels are configured to provide laminar flow of sample across the layer which binds analyte of said support, said flow achieved by the movement of sample into channels that connect the layer which binds analyte to the support.

2. An optical assay device for the detection of an analyte of interest in a fluid sample comprising:

a support containing channels;

an optically functional layer containing channels, said optically functional layer having an optical property of which is detectably altered upon a change in mass on said optically functional layer related to analyte binding, positioned on said support; and

an attachment layer containing channels positioned on said optically functional layer to provide nonspecific capture of said analyte,

wherein said channels in said support, said optically functional layer and said attachment layer are positioned to allow fluid flow from the attachment layer to the support.

3. An optical assay device for the detection of an analyte of interest in a fluid sample comprising:

a porous support;

an optically functional layer, an optical property of which is detectably altered upon a change in mass on said optically functional layer related to analyte binding, comprising discrete, optically functional particles embedded in said support configured and arranged to provide channels through said optically functional layer;

an attachment layer containing channels positioned on said particles; and

an analyte specific receptive layer containing channels positioned on said attachment layer,

wherein said channels in said optically functional layer, said attachment layer and said analyte specific receptive layer are positioned to allow fluid flow from said analyte specific receptive layer to said attachment layer and to said optically functional layer wherein fluid enters pores of said porous support.

4. An optical assay device for the detection of an analyte of interest in a sample comprising:

a porous support;

an optically functional layer, an optical property of which is detectably altered upon a change in mass on said optically functional layer related to analyte binding, comprising discrete, optically functional particles embedded in said support configured and arranged to provide channels through said optically functional layer; and

an attachment layer containing channels positioned on said particles to provide nonspecific capture of said analyte,

wherein said channels in said optically functional layer and said attachment layer are positioned to allow fluid flow from the attachment layer to said optically functional layer wherein fluid enters pores of said porous support.

5. An optical assay device for the detection of an analyte of interest in a sample comprising:

a porous support;

an optically functional layer, an optical property of which is detectably altered upon a change in mass on said optically functional layer related to analyte binding, containing channels positioned on said support;

an attachment layer containing channels positioned on said optically functional layer; and

an analyte specific receptive layer containing channels positioned on said attachment layer,

wherein said channels in said optically functional layer, said attachment layer and said analyte specific receptive layer are positioned to allow fluid flow from said analyte specific receptive layer to said attachment layer and to said optically functional layer wherein fluid enters pores of said porous support.

6. An optical assay device for the detection of an analyte of interest in a sample comprising:

a porous support;

an optically functional layer, an optical property of which is detectably altered upon a change in mass on said optically functional layer related to analyte binding, containing channels positioned on said support; and

an attachment layer containing channels positioned on said optically functional layer to provide nonspecific capture of said analyte,

wherein said channels in said optically functional layer and said attachment layer are positioned to allow fluid flow from said attachment layer to said optically functional layer wherein fluid enters pores of said porous support.

13. Method for constructing an optical assay device with laminar flow properties, comprising the steps of:

providing a support comprising channels;

providing an optically functional layer containing channels, said optically functional layer having an optical property of which is detectably altered upon a change in mass on said optically functional layer related to analyte binding, on said support;

providing an attachment layer containing channels on said optically functional layer, and

providing an analyte specific receptive layer containing channels on said attachment layer,

wherein said channels in said support, said optically functional layer, said attachment layer and said an analyte specific receptive layer are positioned to allow fluid flow from the analyte specific receptive layer to the support.

14. Method for constructing an optical assay device with laminar flow properties, comprising the steps of:

providing a support comprising channels;

providing an optically functional layer containing channels, said optically functional layer having an optical property of which is detectably altered upon a change in mass on said optically functional layer related to analyte binding, on said support; and

providing an attachment layer containing channels on said optically functional layer to provide nonspecific capture of said analyte,

wherein said channels in said support, said optically functional layer and said attachment layer are positioned to allow fluid flow from the attachment layer to the support.

33. The device of any of claims 2, 4, 6, 14, 27 or 29 wherein said channels in said attachment layer do not exceed 15% of the surface area of the layer.

34. The device of any of claims 2, 4, 6, 14, 27 or 29 wherein said channels in said device are not interconnected.

15. A composition comprising:

a support comprising channels or a porous support, and an optically functional layer containing channels positioned on said support, said optically functional layer having an optical property of which is detectably altered upon a change in mass on said optically functional layer related to analyte binding;

wherein said channels in said optically functional layer are positioned to allow fluid flow to the support either through channels in the support or via pores in the porous support.

16. The composition of claim 15, wherein said support is porous and said channels in said optically functional layer are formed from optically functional particles.

17. The composition of claim 15, wherein said support is porous.

18. The composition of claim 15, wherein said support comprises polycarbonate and said optically functional layer comprises amorphous silicon.

19. The composition of claim 18, wherein said optically functional layer further comprises a layer of silicon nitride positioned on said amorphous silicon.

20. The composition of claim 15, wherein said support comprises polycarbonate and said optically functional layer comprises germanium.

21. The composition of claim 20, wherein said optically functional layer further comprises a layer of diamond-like carbon positioned on said germanium.

22. The composition of claim 15, wherein said support comprises polyester and said optically functional layer comprises amorphous silicon.

23. The composition of claim 22, wherein said optically functional layer further comprises a layer of silicon nitride positioned on said amorphous silicon.

24. The composition of claim 15, wherein said support comprises polyester and said optically functional layer comprises germanium.

25. The composition of claim 24, wherein said optically functional layer further comprises a layer of diamond-like carbon positioned on said layer of germanium.

37. The composition of claim 15 wherein said channels in said optically functional layer do not exceed 15% of the surface area of the layer.

38. The composition of claim 15 wherein said channels in said device are not interconnected.

40. The composition of any of claims 15, 16–

25, 37 and 38 wherein said channels are configured to provide laminar flow of sample across the layer which binds analyte of said support, said flow achieved by the movement of sample into channels that connect the layer which binds analyte to the support.

26. Method for constructing an optical assay device with laminar flow properties, comprising the steps of:

providing a porous support;

providing an optically functional layer, an optical property of which is detectably altered upon a change in mass on said optically functional layer related to analyte binding, comprising discrete, optically functional particles embedded in said support configured and arranged to provide channels through said optically functional layer;

providing an attachment layer containing channels positioned on said particles; and

providing an analyte specific receptive layer containing channels positioned on said attachment layer,

wherein said channels in said optically functional layer, said attachment layer and said analyte specific receptive layer are positioned to allow fluid flow from said analyte specific receptive layer to said attachment layer and to said optically functional layer wherein fluid enters pores of said porous support.

27. Method for constructing an optical assay device with laminar flow properties, comprising the steps of:

providing a porous support;

providing an optically functional layer, an optical property of which is detectably altered upon a change in mass on said optically functional layer related to analyte binding, comprising discrete, optically functional particles embedded in said support configured and arranged to provide channels through said optically functional layer; and

providing an attachment layer containing channels positioned on said particles to provide nonspecific capture of said analyte,

wherein said channels in said optically functional layer and said attachment layer are positioned to allow fluid flow from the attachment layer to said optically functional layer wherein fluid enters pores of said porous support.

28. Method for constructing an optical assay device with laminar flow properties, comprising the steps of:

providing a porous support,

providing an optically functional layer, an optical property of which is detectably altered upon a change in mass on said optically functional layer related to analyte binding, containing channels positioned on said support;

providing an attachment layer containing channels positioned on said optically functional layer; and

providing an analyte specific receptive layer containing channels positioned on said attachment layer,

wherein said channels in said optically functional layer, said attachment layer and said analyte specific receptive layer are positioned to allow fluid flow from said analyte specific receptive layer to said attachment layer and to said optically functional layer wherein fluid enters pores of said porous support.

29. Method for constructing an optical assay device with laminar flow properties, comprising the steps of:

providing a porous support;

providing an optically functional layer, an optical property of which is detectably altered upon a change in mass on said optically functional layer related to analyte binding, containing channels positioned on said support; and

providing an attachment layer containing channels positioned on said optically functional layer to provide nonspecific capture of said analyte,

wherein said channels in said optically functional layer and said attachment layer are positioned to allow fluid flow from said attachment layer to said optically functional layer wherein fluid enters pores of said porous support.