Low-cost point-of-care assay device

• US 9,678,065 B2
• Filed: 01/10/2014
• Issued: 06/13/2017
• Est. Priority Date: 01/11/2013
• Status: Active Grant

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Sugarman, Jeffrey, Morton, Justin, Huang, Wei
• Primary Examiner(s): Wecker, Jennifer
• Application Number:
  US14/152,954
• Publication Number:
  US 20140200154A1
• Time in Patent Office: 1,250 Days
• CPC Class Codes: B01L 2200/0684 Venting, avoiding backpressure, avoid gas bubbles
• CPC Class Codes: B01L 2200/0689 Sealing
• CPC Class Codes: B01L 2200/141 Preventing contamination, tampering
• CPC Class Codes: B01L 2300/042 Caps; Plugs
• CPC Class Codes: B01L 2300/048 enabling gas exchange, e.g. vents
• CPC Class Codes: B01L 2300/0663 Whole sensors
• CPC Class Codes: B01L 2300/0825 Test strips
• CPC Class Codes: B01L 2400/0406 capillary forces
• CPC Class Codes: B01L 3/502715 characterised by interfacing components, e.g. fluidic, electrical, optical or mechanical interfaces
• CPC Class Codes: B01L 3/502723 characterised by venting arrangements
• CPC Class Codes: G01N 33/5302 Apparatus specially adapted for immunological test procedures
• CPC Class Codes: G01N 33/56972 White blood cells
• CPC Class Codes: G01N 33/56988 HIV or HTLV

Abstract

The present disclosure provides methods and systems for analyzing a liquid sample. A micro-fluidic device to perform an assay of a liquid sample is described that includes a sample application site and a vent outlet in fluid communication with the capillary channel. A cap is provided that is configured to seal both the vent outlet and the sample application site in a shared volume and separate from an outside environment.

Claims

1. A micro-fluidic device configured to perform an assay of a liquid sample, the device comprising:

a sample application site in communication with a capillary channel;

a vent outlet in communication with the capillary channel; and

a capping element configured to seal both the vent outlet and the sample application site from an outside environment, wherein the capping element is configured to provide a sealed volume over the sample application site and the vent outlet separate from the outside environment and is configured to provide a sealed volume of a gas shared between the sample application site and the vent outlet.

2. The device according to claim 1, further comprising a venting channel between the vent outlet and the capillary channel.

3. The device according to claim 1, further comprising a liquid barrier surrounding the application site, wherein the liquid barrier is disposed between the application site and the vent outlet.

4. The device according to claim 3, wherein the liquid barrier comprises a raised edge surrounding the application site.

5. The device according to claim 3, wherein the liquid barrier comprises a depression surrounding the application site.

6. The device according to claim 1, wherein the capping element comprises a gasket.

7. The device according to claim 1, wherein the capillary channel is between 20 and 70 microns deep.

18. The micro-fluidic device of claim 1, wherein the capping element is dimensioned to cover a surface area on a surface of the device that ranges from 10 to 1000 mm².

19. The micro-fluidic device of claim 18, wherein the capping contacts only a single surface of the device.

20. The micro-fluidic device of claim 1, wherein the capping element seals two openings.

21. The micro-fluidic device of claim 1, wherein the device further comprises a mixing chamber comprising a higher surface area component upon which a reagent is positioned.

22. The micro-fluidic device of claim 2, wherein the capillary channel is separated from the venting channel by a hydrophobic junction.

8. A method for performing an assay of a liquid sample, the method comprising:

applying a liquid sample to a sample application site in fluid communication with a capillary channel wherein the liquid sample flows via a capillary action force through the capillary channel;

providing venting for the capillary action force through a vent outlet; and

sealing the liquid sample from the outside environment with a capping element, wherein the capping element provides a shared sealed volume around both the sample application site and the vent outlet.

9. The method according to claim 8, wherein the device further comprises a liquid barrier surrounding the application site and the liquid barrier is disposed between the application site and the vent outlet.

10. The method according to claim 9, wherein the liquid barrier comprises a raised edge surrounding the application site.

11. The method according to claim 9, wherein the liquid barrier comprises a depression surrounding the application site.

12. The method according to claim 8, wherein the capping element comprises a gasket.

13. The method according to claim 8, wherein the depth of the capillary channel is between 20 and 70 microns deep.

14. The method according to claim 8, wherein the method further comprises reading at least a portion of the capillary channel to obtain a result.

15. The method according to claim 14, wherein the method further comprises making a diagnosis based on the obtained result.

16. A system comprising:

(a) a reader; and

(b) a micro-fluidic device configured to perform an assay of a liquid sample and loaded into the reader, the device comprising;

a sample application site in communication with a capillary channel;

a vent outlet in communication with the capillary channel; and

a capping element configured to seal both the vent outlet and the sample application site from an outside environment, wherein the capping element is configured to provide a sealed volume over the sample application site and the vent outlet separate from the outside environment and is configured to provide a sealed volume of a gas shared between the sample application site and the vent outlet.

17. The system according to claim 16, wherein the reader comprises an illuminator and a detector.