# US 11,442,061 B2 · Reducing optical interference in a fluidic device

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- Number: US 11,442,061 B2
- Document ID: US11442061B2
- Status: Granted
- Kind: B2
- Application number: 15/951,769
- Filed: 2018-04-12
- Published: 2018-08-16
- Granted: 2022-09-13
- Earliest claimed: 2006-10-13
- Assignees: Labrador Diagnostics LLC
- Applicants: Labrador Diagnostics LLC
- Inventors: Ian Gibbons; Michael O'Connell
- Web page: https://patentgrep.com/patent/US11442061B2

## 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 system for detecting an analyte in a sample of bodily fluid, the system comprising:
a sample collection unit configured to receive the sample of bodily fluid;
an assay assembly in fluidic communication with the sample collection unit, the assay assembly comprising a reagent chamber, a reaction site, and a fluidic channel that connects the reagent chamber with the reaction site, wherein a reactant is immobilized in the reaction site, and wherein the reagent chamber comprises a reagent;
a waste chamber in fluidic communication with, but spaced apart from, the assay assembly, wherein the waste chamber comprises absorbent material configured to absorb waste liquids from the assay assembly such that optical interference of a fluorescent signal from the waste liquids is reduced, wherein the absorbent material is impregnated with a quenching agent, wherein the quenching agent inhibits an enzymatic reaction between the reagent and a second reagent, thereby reducing the optical interference; and
a reader assembly comprising a controller, a detection assembly, and an actuating element configured to effect movements between the sample collection unit, the assay assembly, and the waste chamber, wherein the movements include:
moving the sample through the sample collection unit to the assay assembly, such that the sample is allowed to react with the reactant immobilized in the reaction site;
moving unreacted reactant from the assay assembly to the waste chamber; and
moving the reagent from the reagent chamber to the reaction site through the fluidic channel,
wherein the assay assembly is configured to yield a fluorescent signal indicative of the presence of the analyte in the sample, wherein the fluorescent signal results from a reaction between the sample and at least one of the reactant or the reagent; and
wherein the detection assembly is configured to detect the analyte in the sample by detecting the fluorescent signal.

### Claim 2 (depends on 1)

The system of claim 1, wherein the actuating element comprises one of a pump and a valve.

### Claim 3 (depends on 1)

The system of claim 1, wherein the detection assembly comprises one of a digital camera, a charge coupled device (CCD), a photomultiplier, or a phototube.

### Claim 4 (depends on 1)

The system of claim 1, wherein the reactant comprises an antibody that reacts with the analyte.

### Claim 5 (depends on 1)

The system of claim 1, wherein the sample of bodily fluid comprises blood.

### Claim 6 (depends on 1)

The system of claim 1, wherein the reagent comprises one of an enzyme conjugate and an enzyme substrate.

### Claim 7

A fluidic device having a housing and being configured to run an assay for detecting an analyte in a sample of bodily fluid within the housing, the fluidic device comprising:
a sample collection unit configured to receive the sample of bodily fluid;
an assay assembly in fluidic communication with the sample collection unit, the assay assembly comprising a reagent chamber, a reaction site, a first fluidic channel that connects the sample collection unit to the assay assembly, a second fluidic channel that connects the assay assembly to the waste chamber, and a third fluidic channel that connects the reagent chamber with the reaction site, wherein a reactant is immobilized in the reaction site, and wherein the reagent chamber comprises a reagent; and
a waste chamber in fluidic communication with, but spaced apart from, the assay assembly, wherein the waste chamber comprises absorbent material configured to absorb waste liquids from the assay assembly such that optical interference of a fluorescent signal from the waste liquids is reduced, wherein the absorbent material is impregnated with a quenching agent, wherein the quenching agent inhibits an enzymatic reaction between the reagent and a second reagent, thereby reducing the optical interference,
wherein the assay assembly is configured to:
receive the sample from the sample collection unit, wherein the sample is moved from the sample collection unit to the assay assembly through the first fluidic channel;
allow the sample to react with the reactant immobilized in the reaction site, wherein unreacted reactant is moved to the waste chamber through the second fluidic channel;
allow the reagent from the reagent chamber to react at the reaction site, wherein the reagent is moved from the reagent chamber to the reaction site through the third fluidic channel; and
yield a fluorescent signal indicative of the presence of the analyte in the sample, wherein the fluorescent signal results from a reaction between the sample and at least one of the reactant or the reagent.

### Claim 8 (depends on 7)

The fluidic device of claim 7, wherein movements between the sample collection unit, the assay assembly, and the waste chamber are effected by at least one of a pump or a valve of an actuating element.

### Claim 9 (depends on 7)

The fluidic device of claim 7, wherein the reactant comprises an antibody that reacts with the analyte.

### Claim 10 (depends on 7)

The fluidic device of claim 7, wherein the sample of bodily fluid is selected from the group consisting of blood, plasma, serum, saliva, urine, gastric and digestive fluid, tears, stool, semen, vaginal fluid, interstitial fluids derived from tumorous tissue, and cerebrospinal fluid.

### Claim 11 (depends on 7)

The fluidic device of claim 7, wherein the reagent comprises one of an enzyme conjugate and an enzyme substrate.

### Claim 12 (depends on 7)

The fluidic device of claim 7, wherein the analyte in the sample is detected via the fluorescent signal by one of a digital camera, a charge coupled device (CCD), a photomultiplier, or a phototube.