Optical assay device and method

• US 6,287,783 B1
• Filed: 03/18/1999
• Issued: 09/11/2001
• Est. Priority Date: 03/18/1999
• Status: Expired due to Fees

• Current Assignee: Inverness Medical-Biostar, Inc. (Abbott Laboratories)
• Original Assignee: BioStar, Inc. (Thermo Fisher Scientific Incorporated)
• Inventors: Fujii, Alan J., Crosby, Mark A., Maynard, James E.
• Primary Examiner(s): Chin, Christopher L.
• Application Number:
  US09/272,641
• Time in Patent Office: 908 Days
• Field of Search: 422/55-58, 422/61, 422/82.05, 422/82.08, 435/287.1, 435/287.2, 435/287.7, 435/287.8, 435/287.9, 435/810, 435/7.1, 435/808, 436/164, 436/165, 436/172, 436/169, 436/170, 436/805, 436/518, 436/530, 436/531
• US Class Current: 435/7.1
• CPC Class Codes: B01L 2300/042 Caps; Plugs
• CPC Class Codes: B01L 2300/046 Function or devices integrated in the closure
• CPC Class Codes: B01L 2300/069 Absorbents; Gels to retain a fluid
• CPC Class Codes: B01L 2300/0832 cylindrical, tube shaped
• CPC Class Codes: B01L 2400/0406 capillary forces
• CPC Class Codes: B01L 3/5023 with a sample being transported to, and subsequently stored in an absorbent for analysis
• CPC Class Codes: Y10S 435/808 Optical sensing apparatus
• CPC Class Codes: Y10S 435/81 Packaged device or kit
• CPC Class Codes: Y10S 436/805 Optical property

Abstract

The present invention involves an optical assay device and method of use for the detection of an analyte of interest in a sample that conveniently allows control of the flow characteristics of the sample through the device without significant user intervention. The optical assay device includes a base having an absorbent material, and a member having an optically active test stack that is rotatably coupled to the base for rotation between a lowered position and a raised position. In the lowered position, the optically active test stack contacts the absorbent material for drawing the sample through the surface. In the raised position, the optically active test stack does not contact the absorbent material.

Claims

1. An optical assay device for the detection of an analyte of interest, comprising:

a base including absorbent material; and

a member including an optically active test stack, the member rotatably coupled to the base for rotation between a lowered position where the optically active test stack contacts the absorbent material for drawing a sample through the stack and a raised position where the optically active test stack does not contact the absorbent material.

2. The optical assay device of claim 1, wherein the member is rotatable coupled to the base through a cam mechanism.

3. The optical assay device of claim 2, wherein the cam mechanism includes at least one ramp, whereby the member moves up said at least one ramp when the member is moved from the lowered position to the raised position, and down said at least one ramp when the member is moved from the raised position to the lowered position.

4. The optical assay device of claim 1, further including a retaining mechanism that retains the member to the base.

5. The optical assay device of claim 1, further including a stop mechanism that restrains the rotation of the member to the lowered position, the raised position, and therebetween.

6. The optical assay device of claim 1, wherein the member includes a projection on a surface thereof.

7. The optical assay device of claim 1, wherein the base includes a pair of finger grips to assist in holding the base.

8. The optical assay device of claim 1, wherein the optically active test stack includes an optically functional layer made of an amorphous silicon having a thickness between 1000 and 5000 Å

.

9. The optical assay device of claim 1, further including a support that carries the optically active test stack, the support selected from a group consisting of nylon, track-etch polyester, nitrocellulose, polysulfone and track-etch polycarbonate.

10. The optical assay device of claim 8, wherein the optically functional layer is coated with an antfireflective layer having a thickness between 400 and 700 Å

.

11. The optical assay device of claim 10, wherein the antireflective layer is coated with an attachment layer made of a diamond-like carbon having a thickness between 50 and 1000 Å

.

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

a base including absorbent material;

a member including an optically active test stack, the member rotatably coupled to the base through a cam mechanism for rotation between a lowered position where the optically active test surface contact the absorbent material for drawing a sample through the stack and a raised position where the optically active test stack does not contact the absorbent material; and

a retaining mechanism that retains the member to the base.

13. The optical assay device of claim 12, wherein the cam mechanism includes at least one ramp, whereby the member moves up said at least one ramp when the member is moved from the lowered position to the raised position, and down said at least one ramp when the member is moved from the raised position to the lowered position.

14. The optical assay device of claim 12, further including a stop mechanism that restrains rotation of the member to the lowered position, the raised position, and therebetween.

15. The optical assay device of claim 12, wherein the member includes a projection on a surface thereof.

16. The optical assay device of claim 12, where the base includes a pair of finger grips to assist in holding the base.

17. An optical assay device for the detection of an analyte of interest, comprising:

a base including absorbent material, the base lying generally in a first plane;

a member including an optically active test stack, the member lying generally in a second plane that is parallel to the first plane, the member operatively associated with the base for movement between a lowered position where the optically active test stack contacts the absorbent material and the member lies generally in the same plane as the base for drawing a sample through the stack and a raised position where the optically active test stack does not contact the absorbent material and the member does not lie in the same plane as the base.

18. The optical assay device of claim 17, wherein the member is rotatably coupled to the base through a cam mechanism.

19. The optical assay device of claim 18, wherein the cam mechanism includes at least one ramp, whereby the member moves up said at least one ramp when the member is moved from the lowered position to the raised position, and down said at least one ramp when the member is moved from the raised position to the lowered position.

20. The optical assay device of claim 17, further including a retaining mechanism that retains the member to the base.

21. The optical assay device of claim 17, further including a stop mechanism that restrains rotation of the member to the first position, the second position, and therebetween.

22. The optical assay device of claim 17, wherein the member includes a projection on a surface thereof.

23. The optical assay device of claim 17, wherein the base includes a pair of finger grips to assist in holding the base.

24. An optical assay device for the detection of an analyte of interest, comprising:

a base including absorbent material;

a member including a central axis, the member including a central aperture and an optically active test stack covering the aperture, the member rotatably coupled to the base through a cam mechanism for rotation about the axis between a lowered position where the optically active test stack contacts the absorbent material for drawing a sample through the stack and a raised position where the optically active test stack does not contact the absorbent material;

a stop mechanism that restrains rotation of the member to the lowered position, the raised position, and therebetween; and

a retaining mechanism that retains the member to the base.

25. The optical assay device of claim 24, wherein the cam mechanism includes a plurality of ramping members extending from the base, and a plurality of respective ramping members extending from the upper member that slidably cooperate with the ramping members upon rotation of the member for raising and lowering the generally circular member.

26. The optical assay device of claim 24, wherein the base includes a well that carries the absorbent material.

27. The optical assay device of claim 24, wherein the base includes a pair of finger grips to assist in holding the base.

28. The optical assay device of claim 24, wherein the member includes a projection on a surface thereof.

29. An optical assay device for the detection of an analyte of interest, comprising:

a base including absorbent material;

a member including an optically active test stack; and

means for raising and lowering the member between a lowered position where the optically active test stack contacts the absorbent material for drawing an applied medium or the sample through the stack and a raised position where the optically active test stack does not contact the absorbent material.

30. The optical assay device of claim 29, further including means for retaining the member to the base.