Diagnostic device and system

• US 7,244,393 B2
• Filed: 12/21/2001
• Issued: 07/17/2007
• Est. Priority Date: 12/21/2001
• Status: Expired due to Term

• Current Assignee: Kimberly-Clark Worldwide Incorporated (Kimberly-Clark Corporation)
• Original Assignee: Kimberly-Clark Worldwide Incorporated (Kimberly-Clark Corporation)
• Inventors: Lyng, Robert John, Kaylor, Rosann Marie, Chidebelu-Eze, Chibueze O., Quirk, Stephen
• Primary Examiner(s): ALEXANDER, LYLE
• Application Number:
  US10/026,415
• Publication Number:
  US 20030118480A1
• Time in Patent Office: 2,034 Days
• Field of Search: 422/58, 422/61, 436/164, 436/166, 436/165
• US Class Current: 422/412
• CPC Class Codes: B01L 2200/0642 Filling fluids into wells by specific techniques
• CPC Class Codes: B01L 2200/16 Reagents, handling or storing thereof
• CPC Class Codes: B01L 2300/048 enabling gas exchange, e.g. vents
• CPC Class Codes: B01L 2300/0654 Lenses; Optical fibres
• CPC Class Codes: B01L 2300/069 Absorbents; Gels to retain a fluid
• CPC Class Codes: B01L 2300/0803 Disc shape
• CPC Class Codes: B01L 2300/0809 rectangular shaped
• CPC Class Codes: B01L 2300/0825 Test strips
• CPC Class Codes: B01L 2300/0861 Configuration of multiple channels and/or chambers in a single devices
• CPC Class Codes: B01L 2300/0864 comprising only one inlet and multiple receiving wells, e.g. for separation, splitting
• CPC Class Codes: B01L 2400/0406 capillary forces
• CPC Class Codes: B01L 2400/0688 surface tension valves, capillary stop, capillary break
• CPC Class Codes: B01L 3/5023 with a sample being transported to, and subsequently stored in an absorbent for analysis
• CPC Class Codes: B01L 3/502723 characterised by venting arrangements
• CPC Class Codes: G01N 21/4788 Diffraction for sizing particles G01N15/0205

Abstract

Diagnostic devices, systems and methods for detecting the presence of an analyte in a sample are provided. In one embodiment, the device comprises a substrate, a binder printed in a pattern onto a surface of the substrate, and a means for directing a sample towards the surface of the substrate that is printed with the binder. Systems of the present invention further include a light source that can be directed through the aforementioned means or another opening to the binder-printed surface to test for diffraction.

Claims

1. A diffraction-based assay device for detecting the presence of an analyte, the device comprising:

a substrate that comprises a polymer film, wherein a first binder is present on the substrate in a pattern;

a fluidic guide with a first end and a second end in direct communication with a wicking agent, wherein the first end of the fluidic guide defines an opening therein for sample application and includes at least one channel through which a fluid test sample is capable of flowing via capillary action to the second end,

wherein the wicking agent is capable of receiving the fluid test sample from the second end of the fluidic guide and thereafter facilitating contact of the fluid sample with the binder on the substrate; and

an electromagnetic radiation source that is configured to direct electromagnetic radiation to the substrate through the first end of the fluidic guide to the opening to generate a diffraction pattern proximate an area of the substrate defined by the second end of the guide.

2. The diffraction-based device of claim 1, wherein the wicking agent defines an opening through which the electromagnetic radiation is capable of passing.

3. The diffraction-based device of claim 1, wherein a second binder is also present on the substrate.

4. The diffraction-based device of claim 1, wherein the first opening is beveled.

5. The diffraction-based device of claim 1, wherein the fluidic guide is generally linear.

6. The diffraction-based device of claim 1, wherein the fluidic guide has one or more turns or branches.

7. The diffraction-based device of claim 1, wherein the fluidic guide is positioned generally perpendicular to the substrate.

8. The diffraction-based device of claim 1, wherein the fluidic guide is in communication with a well, the well initially receiving the fluid sample.

9. The diffraction-based device of claim 1, wherein the fluidic guide is positioned directly adjacent to and in fluid communication with the wicking agent.

10. The diffraction-based device of claim 1, wherein the substrate comprises the metal coating.

11. The diffraction-based device of claim 1, further comprising a detector for detecting the diffraction pattern.

12. The diffraction-based device of claim 1, wherein the diffraction pattern is generated only upon exposure of the substrate to the analyte.

13. The diffraction-based device of claim 1, wherein the polymer film is generally transparent to the electromagnetic radiation.

17. The diffraction-based device of claim 1, wherein the substrate further comprises a metal coating.

14. A diffraction-based assay device for detecting the presence of an analyte, the device comprising:

a substrate that comprises a polymer film, wherein a first binder is present on the substrate in a pattern;

a fluidic guide with a first end and a second end in direct communication with a wicking agent, wherein the first end of the fluidic guide defines an opening therein for sample application and includes at least one channel through which a fluid test sample is capable of flowing via capillary action to the second end;

means for venting pressure to facilitate movement of the fluid test sample in a direction of the substrate;

wherein the wicking agent is capable of receiving the fluid test sample from the second end of the fluidic guide and thereafter facilitating contact of the fluid sample with the binder on the substrate; and

an electromagnetic radiation source that is configured to direct electromagnetic radiation to the substrate through the first end of the fluidic guide to generate a diffraction pattern proximate an area of the substrate defined by the second end of the guide.

15. The diffraction based device of claim 14, wherein the means for venting pressure is a pressure vent disposed proximate the wicking agent in communication with the wicking agent and external atmosphere.

16. The diffraction-based device of claim 14, wherein the substrate further comprises a metal coating.

18. A diffraction-based assay device for detecting the presence of an analyte, the device comprising:

a substrate that comprises a polymer film, wherein a binder is present on the substrate in a pattern;

a fluidic guide with a first and second end in direct communication with the wicking agent, wherein the first end of the fluidic guide receives a fluid test sample and includes at least one channel through which the fluid test sample is capable of flowing via capillary action to the second end,

the wicking agent defining a hole therethrough and capable of receiving the fluid test sample from the second end of the fluidic guide and thereafter facilitating contact of the fluid sample with the binder on the substrate; and

an electromagnetic radiation source that is configured to direct electromagnetic radiation to the substrate through the first end of the fluidic guide to generate a diffraction pattern proximate an area of the substrate defined by the second end of the guide.