Reducing optical interference in a fluidic device

• US 8,470,524 B2
• Filed: 07/21/2011
• Issued: 06/25/2013
• Est. Priority Date: 10/13/2006
• Status: Active Grant

• Current Assignee: Labrador Diagnostics LLC (SoftBank Group Corp.)
• Original Assignee: Theranos Incorporated
• Inventors: Gibbons, Ian, O'Connell, Michael
• Primary Examiner(s): Yang, N.C.
• Application Number:
  US13/188,288
• Publication Number:
  US 20120021433A1
• Time in Patent Office: 705 Days
• Field of Search: None
• US Class Current: 435/4
• CPC Class Codes: B01L 2200/16 Reagents, handling or storing thereof
• CPC Class Codes: B01L 2300/069 Absorbents; Gels to retain a fluid
• CPC Class Codes: B01L 2300/0816 Cards, e.g. flat sample carriers usually with flow in two horizontal directions
• CPC Class Codes: B01L 2300/0887 Laminated structure
• CPC Class Codes: B01L 2400/0406 capillary forces
• CPC Class Codes: B01L 2400/0487 fluid pressure, pneumatics
• CPC Class Codes: B01L 3/5027 by integrated microfluidic structures, i.e. dimensions of channels and chambers are such that surface tension forces are important, e.g. lab-on-a-chip B01L3/5023 takes precedence; micromixers B01F33/30; microreactors for synthesis B01J19/0093; microcapillary devices in general B81B1/00
• CPC Class Codes: B01L 3/502715 characterised by interfacing components, e.g. fluidic, electrical, optical or mechanical interfaces
• CPC Class Codes: G01N 33/5304 Reaction vessels, e.g. agglutination plates for solid-phase systems G01N33/543
• CPC Class Codes: G01N 33/536 with immune complex formed in liquid phase
• CPC Class Codes: Y10T 156/10 Methods of surface bonding and/or assembly therefor

Abstract

This invention is in the field of medical devices. Specifically, the present invention provides portable medical devices that allow real-time detection of analytes from a biological fluid. The methods and devices are particularly useful for providing point-of-care testing for a variety of medical applications. In particular, the medical device reduces interference with an optical signal which is indicative of the presence of an analyte in a bodily sample.

Claims

1. A method of detecting an analyte in a sample, comprising:

a) allowing the sample to react with at least one reactant contained in a fluidic device that comprises;

an assay assembly configured to yield an optical signal that is indicative of the presence of the analyte;

b) moving unreacted reactant from the assay assembly to a quencher assembly operable to be in fluidic communication with, but spaced apart from said assay assembly, wherein said movement is effected via one or more actuating elements controlled by a controller, wherein said quencher assembly is adapted to reduce interference of said optical signal; and

c) detecting said optical signal thereby detecting the analyte in the sample.

2. The method of claim 1, wherein said assay assembly comprises reagent chambers comprising at least one reagent used in said assay and at least one reaction site comprising a reactant that binds said analyte.

3. The method of claim 2, wherein said at least one reagent comprises an enzyme conjugate or an enzyme substrate.

4. The method of claim 2, wherein said quencher assembly comprises a quenching site in fluidic communication with said reaction site and a quenching agent at said quenching site.

5. The method of claim 4, wherein said quencher assembly further comprises an absorbent material.

6. The method of claim 5, wherein said absorbent material is impregnated with said quenching agent.

7. The method of claim 5, wherein said absorbent material is selected from the group consisting of glass fiber, silica, paper, polyacylamide gel, agarose, and agar.

8. The method of claim 5, wherein said quenching agent is adapted to inactivate at least one reagent from said assay, thereby reducing said interference of said optical signal.

9. The method of claim 1, wherein said unreacted reactant is reactant not bound to the assay assembly.

25. The method of claim 1 further comprising inserting the fluidic device into a reader assembly that houses a detector that performs the detecting of said optical signal.

26. The method of claim 25 further comprising housing the controller within the reader assembly.

27. The method of claim 1 further comprising controlling, via the controller, the actuating elements including at least one pump and one valve to control and direct said movement.

28. The method of claim 1 wherein unbound sample and reagents remain on-board in chambers of the fluidic device after the assay.

29. The method of claim 1 wherein reagents are housed within the fluidic device before, during, and after the assay.

30. The method of claim 1 wherein there is no liquid outlet on the fluidic device.

31. The method of claim 1 wherein unreacted reagent is transported through the fluidic device flow through channels.

10. A method of detecting an analyte in a sample, the method comprising:

allowing the sample to react with at least one reactant at a first location in the fluidic device to yield a detectable signal indicative of the presence of the analyte in the sample;

after the sample has begun to react, reducing background signal by moving unreacted reactant from the first location to a second location and quenching said unreacted reactant at the second location that is separate from the first location, wherein said movement is effected via one or more actuating elements controlled by a controller; and

detecting the detectable signal, thereby detecting the analyte in the sample.

11. The method of claim 10 further comprising an enzyme conjugate or an enzyme substrate at the first location.

12. The method of claim 10 further comprising a quenching agent at a quenching site at the second location.

13. The method of claim 12, wherein said quencher site further comprises an absorbent material.

14. The method of claim 13, wherein said absorbent material is impregnated with said quenching agent.

15. The method of claim 13, wherein said absorbent material is selected from the group consisting of glass fiber, silica, paper, polyacylamide gel, agarose, and agar.

16. The method of claim 12, wherein said quenching agent is a denaturing agent.

17. The method of claim 12, wherein said quenching agent is 4-amino-1,11-azobenzene-3,41-disulfonic acid.

18. The method of claim 10, wherein said sample of bodily fluid is blood.

19. The method of claim 10, wherein the detectable signal is a luminescent signal.

20. The method of claim 19, wherein the luminescent signal is a chemiluminescent signal.

21. The method of claim 10 wherein said first location comprises a reagent chamber comprising said reagent and at least one reaction site comprising a reactant that binds said analyte.

22. The method of claim 21, wherein said at least one reagent comprises an enzyme conjugate or an enzyme substrate.

23. The method of claim 22 further comprising a quenching agent adapted to inactivate at least one reagent from said assay, thereby reducing said interference of said optical signal.

24. The method of claim 10, wherein said unreacted reactant is reactant not bound to the assay assembly.