Microfluidic devices, and methods of making and using the same

• US 9,797,899 B2
• Filed: 11/05/2014
• Issued: 10/24/2017
• Est. Priority Date: 11/06/2013
• Status: Active Grant

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Bornheimer, Scott Joseph, Sugarman, Jeffrey, Huang, Wei, Goldberg, Edward Michael, Tan, Ming
• Primary Examiner(s): Gabel, Gail R
• Application Number:
  US14/533,949
• Publication Number:
  US 20150125882A1
• Time in Patent Office: 1,084 Days
• CPC Class Codes: B01F 2215/0431 Numerical size values, e.g. diameter of a hole or conduit, area, volume, length, width, or ratios thereof
• CPC Class Codes: B01F 25/4522 the components being pressed through porous bodies, e.g. flat plates, blocks or cylinders, which obstruct the whole diameter of the tube B01F25/45243 takes precedence
• CPC Class Codes: B01F 33/30 Micromixers
• CPC Class Codes: B01F 33/301 using specific means for arranging the streams to be mixed, e.g. channel geometries or dispositions
• CPC Class Codes: B01L 2200/16 Reagents, handling or storing thereof
• CPC Class Codes: B01L 2300/0816 Cards, e.g. flat sample carriers usually with flow in two horizontal directions
• CPC Class Codes: B01L 2400/0406 capillary forces
• CPC Class Codes: B01L 2400/086 using baffles or other fixed flow obstructions
• CPC Class Codes: B01L 3/5023 with a sample being transported to, and subsequently stored in an absorbent for analysis
• CPC Class Codes: B01L 3/502746 characterised by the means for controlling flow resistance, e.g. flow controllers, baffles B01L3/502738 takes precedence
• CPC Class Codes: G01N 33/558 using diffusion or migration of antigen or antibody immunochromatographic test strips G01N33/54387

Abstract

The present disclosure provides methods and systems for assaying a sample. A microfluidic device to perform an assay of a sample (e.g., biological sample) is described having a sample application site, a porous component and a flow channel. The porous component provides for uniform dissolution of a reagent and mixing of the sample and reagent without filtering the sample.

Claims

1. A microfluidic device comprising:

a sample application site;

a flow channel in fluid communication with the sample application site; and

a porous component positioned between the sample application site and flow channel, wherein the porous component comprises;

a porous matrix comprising pores; and

unbound dry assay reagent positioned within the pores of the porous matrix,

wherein the porous matrix has a length sufficient for the unbound dry assay reagent and a sample to substantially mix, and

wherein the porous matrix is configured to uniformly mix the assay reagent into a sample mixture flowing therethrough upon exit from the porous component and into the flow channel.

2. The microfluidic device according to claim 1, wherein the porous matrix is configured to be non-filtering with respect to the sample for which the device is configured to assay.

3. The microfluidic device according to claim 1, wherein the porous matrix comprises pores having diameters between 1 μ

m and 200 μ

m.

4. The microfluidic device according to claim 1, wherein the porous matrix comprises a pore volume between 1 μ

L and 25 μ

L.

5. The microfluidic device according to claim 1, wherein the porous matrix is a frit.

6. The microfluidic device according to claim 1, wherein the porous component further comprises a buffer.

7. The microfluidic device according to claim 6, wherein the buffer comprises bovine serum albumin (BSA), trehalose, polyvinylpyrrolidone (PVP) or 2-(N-morpholino) ethanesulfonic acid or a combination thereof.

8. The microfluidic device according to claim 7, wherein the buffer comprises BSA, trehalose and PVP.

9. The microfluidic device according to claim 1, wherein the assay reagent comprises an analyte-specific binding member.

10. The microfluidic device according to claim 9, wherein the analyte-specific binding member comprises an antibody or analyte binding fragment thereof.

11. The microfluidic device according to claim 9, wherein the analyte specific binding member is coupled to a detectable label.

12. The microfluidic device according to claim 11, wherein the detectable label comprises a fluorescent dye.

13. The microfluidic device according to claim 1, wherein the assay reagent comprises a chelating agent.

14. The microfluidic device according to claim 1, wherein the flow channel comprises an optically transmissive wall.

15. The microfluidic device according to claim 14, wherein the walls of the flow channel are optically transmissive to one or more of ultraviolet light, visible light and near-infrared light.

16. The microfluidic device according to claim 1, where the sample application site is configured to receive a sample having a volume ranging from 5 μ

L to 2000 μ

L.

17. The microfluidic device according to claim 1, wherein the device is configured to be hand held.

18. The microfluidic device according to claim 1, wherein the porous matrix comprises a porous organic polymer.

19. A kit comprising:

a microfluidic device comprising;

a sample application site;

a flow channel in fluid communication with the sample application site; and

a porous component positioned between the sample application site and flow channel, wherein the porous component comprises a porous matrix comprising pores and unbound dry assay reagent positioned within the pores of the porous matrix, wherein the porous matrix has a length sufficient for the unbound dry assay reagent and a sample to substantially mix, and wherein the porous matrix is configured to uniformly mix the assay reagent into a sample mixture flowing therethrough upon exit from the porous component and into the flow channel; and

a container housing the device.