# US 2014/0154708 A1 · Reducing optical interference in a fluidic device

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- Number: US 2014/0154708 A1
- Document ID: US20140154708A1
- Status: Published application
- Kind: A1
- Application number: 13/915,362
- Filed: 2013-06-11
- Published: 2014-06-05
- Earliest claimed: 2006-10-13
- Assignees: Theranos, Inc.
- Applicants: Theranos, Inc.
- Inventors: Ian Gibbons; Michael O'Connell
- Web page: https://patentgrep.com/patent/US20140154708A1

## CPC

- G01N 33/5304: {Reaction vessels, e.g. agglutination plates (for solid-phase systems G01N33/543)}
- 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}
- B01L 3/502715: {characterised by interfacing components, e.g. fluidic, electrical, optical or mechanical interfaces}
- G01N 33/536: with immune complex formed in liquid phase
- B01L 2200/16: Reagents, handling or storing thereof
- B01L 2300/069: Absorbents; Gels to retain a fluid
- B01L 2300/0816: Cards, e.g. flat sample carriers usually with flow in two horizontal directions
- B01L 2300/0887: Laminated structure
- B01L 2400/0406: capillary forces
- B01L 2400/0487: fluid pressure, pneumatics
- Y10T 156/10: Methods of surface bonding and/or assembly therefor
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)
- B01L: CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- Y10T: TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION

## 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

### Claim 1

A fluidic device for detecting an analyte in a sample of bodily fluid, comprising:
a sample collection unit adapted to provide a sample of bodily fluid into said fluidic device;
an assay assembly in fluidic communication with said sample collection unit, wherein said assay assembly is adapted to yield an optical signal indicative of the presence of the analyte in the sample of bodily fluid; and
a quencher assembly in fluidic communication with said assay assembly, wherein said quencher assembly is adapted to reduce interference of said optical signal.

### Claim 2 (depends on 1)

The fluidic device 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.

### Claim 3 (depends on 2)

The fluidic device of claim 2, wherein said at least one reagent comprises an enzyme conjugate and an enzyme substrate.

### Claim 4 (depends on 2)

The fluidic device 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.

### Claim 5 (depends on 4)

The fluidic device of claim 4, wherein said quencher assembly further comprises an absorbent material.

### Claim 6 (depends on 5)

The fluidic device of claim 5, wherein said absorbent material is impregnated with said quenching agent.

### Claim 7 (depends on 5)

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

### Claim 8 (depends on 5)

The fluidic device 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.

### Claim 9 (depends on 8)

The fluidic device of claim 8, wherein said quenching agent is 4-amino-1,11-azobenzene-3,41-disulfonic acid.

### Claim 10 (depends on 1)

The fluidic device of claim 1, wherein said assay assembly is adapted to run a chemiluminescent assay.

### Claim 11 (depends on 1)

The fluidic device of claim 1, wherein said quencher assembly is adapted to substantially eliminate said interference.

### Claim 12 (depends on 1)

The fluidic device of claim 1, wherein said fluidic device is adapted to run an immunoassay.

### Claim 13 (depends on 4)

The fluidic device of claim 4, further comprising a waste chamber, wherein said waste chamber comprises said quenching site.

### Claim 14 (depends on 1)

The fluidic device of claim 1, wherein said sample of bodily fluid is blood.

### Claim 15

A system for detecting an analyte in a sample, comprising:
a fluidic device comprising
an assay assembly configured to yield an optical signal that is indicative of the presence of the analyte; and
a quencher assembly in fluidic communication with said assay assembly, wherein said quencher assembly is adapted to reduce interference of said optical signal; and
a detection assembly for detecting said optical signal.

### Claim 16 (depends on 15)

The system of claim 15, further comprising a communication assembly adapted to transmit said optical signal to an external device.

### Claim 17 (depends on 15)

The system of claim 15, 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.

### Claim 18 (depends on 17)

The system of claim 17, wherein said at least one reagent comprises an enzyme conjugate and an enzyme substrate.

### Claim 19 (depends on 17)

The system of claim 17, wherein said quencher assembly comprises a quenching site in fluidic communication with said reaction site and a quenching agent at said quenching site.

### Claim 20 (depends on 19)

The system of claim 19, wherein said quencher assembly further comprises an absorbent material.

### Claim 21 (depends on 20)

The system of claim 20, wherein said absorbent material is impregnated with said quenching agent.

### Claim 22 (depends on 20)

The system of claim 20, wherein said absorbent material is selected from the group consisting of glass fiber, silica, paper, polyacylamide gel, agarose, and agar.

### Claim 23 (depends on 20)

The system of claim 20, wherein said quenching agent is adapted to inactivate at least one reagent from said assay, thereby reducing said interference of said optical signal.

### Claim 24 (depends on 23)

The system of claim 23, wherein said quenching agent is 4-amino-1,11-azobenzene-3,41-disulfonic acid.

### Claim 25 (depends on 17)

The system of claim 17, wherein said assay assembly is adapted to run a chemiluminescent assay.

### Claim 26 (depends on 17)

The system of claim 17, wherein said quencher assembly is adapted to substantially eliminate said interference.

### Claim 27 (depends on 17)

The system of claim 17, wherein said fluidic device is adapted to run an immunoassay.

### Claim 28 (depends on 19)

The system of claim 19, further comprising a waste chamber, wherein said waste chamber comprises said quenching site.

### Claim 29 (depends on 15)

The system of claim 15, wherein said sample of bodily fluid is blood.

### Claim 30

A method of detecting an analyte in a sample, comprising:
allowing a sample suspected to contain the analyte 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; and
an quencher assembly in fluidic communication with said assay assembly, wherein said quencher assembly is adapted to reduce interference of said optical signal; and
detecting said optical signal thereby detecting the analyte in the sample.

### Claim 31 (depends on 30)

The method of claim 30, 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.

### Claim 32 (depends on 31)

The method of claim 31, wherein said at least one reagent comprises an enzyme conjugate and an enzyme substrate.

### Claim 33 (depends on 31)

The method of claim 31, wherein said quencher assembly comprises a quenching site in fluidic communication with said reaction site and a quenching agent at said quenching site.

### Claim 34 (depends on 33)

The method of claim 33, wherein said quencher assembly further comprises an absorbent material.

### Claim 35 (depends on 34)

The method of claim 34, wherein said absorbent material is impregnated with said quenching agent.

### Claim 36 (depends on 34)

The method of claim 34, wherein said absorbent material is selected from the group consisting of glass fiber, silica, paper, polyacylamide gel, agarose, and agar.

### Claim 37 (depends on 34)

The method of claim 34, wherein said quenching agent is adapted to inactivate at least one reagent from said assay, thereby reducing said interference of said optical signal.

### Claim 38

A method of manufacturing a fluidic device having a quencher assembly, comprising:
providing a plurality of layers of the fluidic device;
affixing said layers together to provide for a fluidic network between a sample collection unit, at least one reagent chamber, at least one reaction site, and at least one quencher assembly.

### Claim 39 (depends on 38)

The method of claim 38, wherein said affixing comprising ultrasonically welding said layers together.

### Claim 40 (depends on 38)

The method of claim 38, wherein said quencher assembly comprises a quenching site in fluidic communication with said at least one reaction site and a quenching agent at said quenching site.

### Claim 41 (depends on 40)

The method of claim 40, wherein said quencher assembly further comprises an absorbent material.

### Claim 42 (depends on 41)

The method of claim 41, wherein said absorbent material is impregnated with said quenching agent.

### Claim 43 (depends on 41)

The method of claim 41, wherein said absorbent material is selected from the group consisting of glass fiber, silica, paper, polyacylamide gel, agarose, and agar.

### Claim 44 (depends on 42)

The method of claim 42, wherein said quenching agent is 4-amino-1,11-azobenzene-3,41-disulfonic acid.

### Claim 45

A fluidic device for detecting an analyte in a sample, comprising:
a sample collection unit;
an assay assembly comprising
at least one reaction site, said reaction site comprising a surface and a reactant that binds an analyte immobilized thereto;
a first reagent chamber comprising an enzyme conjugate;
a second reagent chamber comprising an enzyme substrate, wherein the enzyme substrate reacts with the enzyme conjugate to produce a luminescent signal; and
fluidic channels that connect the reagent chambers with the at least one reaction site;
a quencher assembly comprising an absorbent material and a quenching agent, wherein the quenching agent diminishes the reaction between the enzyme conjugate and the enzyme substrate; and
a plurality of fluidic channels that connect the sample collection unit and the quencher assembly with the assay assembly.

### Claim 46 (depends on 45)

The fluidic device of claim 45, wherein said quencher assembly further comprises a waste chamber connected through a fluid channel with the assay assembly, wherein the waste chamber comprises the absorbent material.

### Claim 47 (depends on 45)

The fluidic device of claim 45, wherein said absorbent material is selected from the group consisting of glass fiber, silica, paper, polyacylamide gel, agarose, or agar.

### Claim 48 (depends on 47)

The fluidic device of claim 47, wherein said quenching agent is 4-amino-1,11-azobenzene-3,41-disulfonic acid and said enzyme conjugate is an alkaline phosphotase-labeled reagent.

### Claim 49 (depends on 45)

The fluidic device of claim 45, wherein said assay assembly is adapted to run an immunoassay.
