System and device for analyzing a fluidic sample

• US 10,114,020 B2
• Filed: 03/15/2013
• Issued: 10/30/2018
• Est. Priority Date: 10/11/2010
• Status: Active Grant

• Current Assignee: MBio Diagnostics, Inc. (Mars Incorporated)
• Original Assignee: MBio Diagnostics, Inc. (Mars Incorporated)
• Inventors: Dunn, John S., Ives, Jeffrey T., Lochhead, Michael J., Vogel, Kurt R., Rowley, Keagan B.
• Primary Examiner(s): Hobbs, Michael L
• Assistant Examiner(s): Hassan, Liban M
• Application Number:
  US13/831,809
• Publication Number:
  US 20130244313A1
• Time in Patent Office: 2,055 Days
• Field of Search: 4352872, 4352887
• CPC Class Codes: B01L 2200/16 Reagents, handling or storing thereof
• CPC Class Codes: B01L 2300/0636 Integrated biosensor, microarrays
• 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 3/50273 characterised by the means or forces applied to move the fluids micropumps F04B19/006, of the membrane type F04B43/043
• CPC Class Codes: G01N 15/1456 without spatial resolution of the texture or inner structure of the particle, e.g. processing of pulse signals
• CPC Class Codes: G01N 15/1484 microstructural devices
• CPC Class Codes: G01N 2015/1006 for cytology
• CPC Class Codes: G01N 2035/00158 Elements containing microarrays, i.e. "biochip"
• CPC Class Codes: G01N 33/56972 White blood cells

Abstract

A device for analyzing an analyte in a sample includes a first substrate, a second substrate, a fluidic channel, an inlet port and an outlet port. Each of the first substrate and the second substrate has an inner surface and an outer surface, the inner surface of the first substrate forming, at least in part, the lower wall of the fluidic channel, and the inner surface of the second substrate forming, at least in part, the upper wall of the fluidic channel. The fluidic channel is connected to the inlet port and the outlet port. The fluidic channel includes a reagent region and a detection region, at least a portion of the reagent region being coated with one or more dried reagents. The device further includes a wicking pad located on the outer surface of the second substrate, the wicking pad being positioned at a pre-determined distance from the outlet port.

Claims

1. A device for analyzing an analyte in a liquid sample, said device comprising,

a first substrate,

a second substrate,

a fluidic channel,

an inlet port through the second substrate, and

an outlet port through the second substrate,

wherein said first substrate and said second substrate each has an inner surface and an outer surface, the inner surface of the first substrate forming, at least in part, a lower wall of said fluidic channel, the inner surface of said second substrate forming, at least in part, an upper wall of said fluidic channel, said fluidic channel being connected to said inlet port and said outlet port,

wherein said fluidic channel comprises a reagent region and a detection region, at least a portion of the reagent region having a coating with one or more dried reagents,

wherein the outlet port forms a capillary valve having burst pressure exceeded when the device is oriented at a tilt relative to a level orientation, to break the capillary valve and drive flow of said liquid sample from the inlet port to the outlet port, and

wherein said device further comprises a wicking pad configured to absorb excess liquid sample emerging from the outlet port, the wicking pad being characterized by an absorbance rate and being located on the outer surface of said second substrate at a distance from said outlet port, the absorbance rate and the distance cooperating to prevent draining the fluidic channel into the wicking pad, the outlet port and the outer surface of said second substrate between the outlet port and the wicking pad being characterized by surface tension forces that cooperate with the distance to break fluidic connection between the wicking pad and the outlet port when rate at which the liquid sample emerges from the outlet port is less than the absorbance rate, thereby preventing further fluidic flow from the outlet port to the wicking pad.

2. The device of claim 1, wherein the reagent region is located between the inlet port and the detection region, such that the liquid sample, when added to the inlet port, passes through the reagent region before entering the detection region.

3. The device of claim 1, wherein the one or more dried reagents comprise a detection molecule that binds to the analyte in the liquid sample.

4. The device of claim 3, wherein the coating is formulated to release the detection molecule into the liquid sample for detection of the analyte bound with the detection molecule in the detection region.

5. The device of claim 1, wherein the one or more dried reagents form a single spatially uniform, continuous layer at the reagent region.

6. The device of claim 1, wherein the coating with one or more dried reagents is distributed evenly along the width of the fluidic channel that is perpendicular to a sample flow path from the inlet port to the outlet port.

7. The device of claim 5, wherein the single spatially uniform, continuous layer is formed by depositing liquid reagents onto the reagent region forming a plurality of single spots, wherein the plurality of single spots merge before the liquid in each single spot evaporates thereby forming the single spatially uniform, continuous layer of dried reagents.

8. The device of claim 7, wherein each of the single spots receives 1-50 nanoliters of liquid reagents in volume, wherein the center-to-center spacing of the single spots and the volume deposited to each spot collectively ensure droplet-to-droplet contact following deposition.

9. The device of claim 1, wherein the coating with one or more dried reagents has a rehydration rate and physical dimension that collectively yield spatially uniform reagent-sample interaction within the detection region.

10. The device of claim 1, wherein rehydration rate of the one or more dried reagents is determined by reagent formulation of the coating and composition of the liquid sample.

11. The device of claim 10, wherein the one or more dried reagents comprise an additive that slows the rehydration rate of the coating with one or more dried reagents.

12. The device of claim 11, wherein the additive is sucrose.

13. The device of claim 1, wherein the coating with one or more dried reagents comprises sucrose, polyethylene glycol, and a dye-labeled antibody.

14. The device of claim 1, wherein the inlet port has a volume greater than the volume of the fluidic channel.

15. The device of claim 1, wherein walls of the inlet port and walls of the fluidic channel are coated, at least in part, with a hydrophilic layer.

16. The device of claim 15, wherein the walls of the inlet port and the walls of the fluidic channel are hydrophilic having a water contact angle of less than 50 degrees.

17. The device of claim 1, further comprising a lid that irreversibly closes over the inlet port.

18. The device of claim 1, wherein said tilt is at an angle between 2 and 45 degrees relative to a level orientation.

19. The device of claim 1, the absorbance rate being between 10 and 200 seconds per 4 centimeters (cm).

20. The device of claim 1, wherein said distance between the wicking pad and the outlet port is between 1 and 5 mm.

21. The device of claim 1, wherein the detection region comprises a plurality of capture molecules bound to the inner surface of the first substrate.

22. The device of claim 1, wherein a plurality of capture molecules are arranged as an array including at least two reaction sites, each of the at least two reaction sites being formed by depositing a composition onto the inner surface of the first substrate, said composition comprising at least one of the capture molecules.

23. The device of claim 1, the outer surface of the second substrate comprising rails for creating capillary forces to steer, from the outlet port to the wicking pad, a portion of the liquid sample located on the outer surface of the second substrate.