# US 2014/0151224 A1 · Assay cartridges and methods of using the same

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- Number: US 2014/0151224 A1
- Document ID: US20140151224A1
- Status: Published application
- Kind: A1
- Application number: 14/170,721
- Filed: 2014-02-03
- Published: 2014-06-05
- Earliest claimed: 2002-12-26
- Assignees: Meso Scale Technologies, LLC.
- Applicants: Meso Scale Technologies, LLC
- Inventors: Eli N. Glezer; Jonathan K. Leland; Mark A. Billadeau; Joseph M. Leginus; Bandele Jeffrey-Coker; Jeff D. Debad; Koustubh A. Phalnikar; Sriram Jambunathan
- Web page: https://patentgrep.com/patent/US20140151224A1

## CPC

- G01N 33/5438: {Electrodes}
- B01J 19/0046: {Sequential or parallel reactions, e.g. for the synthesis of polypeptides or polynucleotides; Apparatus and devices for combinatorial chemistry or for making molecular arrays (synthesis methods per se C40B50/00)}
- 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}
- B01L 9/527: {for microfluidic devices, e.g. used for lab-on-a-chip}
- C12Q 1/001: {Enzyme electrodes}
- G01N 21/76: Chemiluminescence; Bioluminescence
- G01N 27/30: Electrodes, e.g. test electrodes; Half-cells (G01N27/414 takes precedence)
- A61M 25/0017: {specially adapted for long-term hygiene care, e.g. urethral or indwelling catheters to prevent infections}
- B01J 2219/00653: the compounds being bound to electrodes embedded in or on the solid supports
- B01J 2219/00725: Peptides
- B01J 2219/0074: Biological products
- B01L 3/5029: {using swabs}
- B01L 2200/0684: Venting, avoiding backpressure, avoid gas bubbles
- B01L 2200/10: Integrating sample preparation and analysis in single entity, e.g. lab-on-a-chip concept
- B01L 2300/0645: Electrodes
- B01L 2300/0681: Filter
- B01L 2300/0816: Cards, e.g. flat sample carriers usually with flow in two horizontal directions
- B01L 2300/0867: Multiple inlets and one sample wells, e.g. mixing, dilution
- B01L 2300/0887: Laminated structure
- B01L 2400/049: vacuum
- B01L 2400/0688: surface tension valves, capillary stop, capillary break
- B33Y 80/00: Products made by additive manufacturing
- C40B 40/10: Libraries containing peptides or polypeptides, or derivatives thereof
- G01N 33/48707: {by electrical means (G01N33/49, G01N33/493 take precedence)}
- G01N 2458/30: Electrochemically active labels
- Y10T 436/25: including sample preparation
- Y10T 436/25375: Liberation or purification of sample or separation of material from a sample [e.g., filtering, centrifuging, etc.]
- Y10T 436/255: including use of a solid sorbent, semipermeable membrane, or liquid extraction
- 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)
- B01J: CHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
- B01L: CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- C12Q: MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS (immunoassay G01N33/53); COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- B33Y: ADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING
- C40B: COMBINATORIAL CHEMISTRY; LIBRARIES, e.g. CHEMICAL LIBRARIES (in silico combinatorial libraries of nucleic acids, proteins or peptides G16B35/00; in silico combinatorial chemistry G16C20/60)
- Y10T: TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION

## Abstract

Assay modules, preferably assay cartridges, are described as are reader apparatuses which may be used to control aspects of module operation. The modules preferably comprise a detection chamber with integrated electrodes that may be used for carrying out electrode induced luminescence measurements. Methods are described for immobilizing assay reagents in a controlled fashion on these electrodes and other surfaces. Assay modules and cartridges are also described that have a detection chamber, preferably having integrated electrodes, and other fluidic components which may include sample chambers, waste chambers, conduits, vents, bubble traps, reagent chambers, dry reagent pill zones and the like. In certain preferred embodiments, these modules are adapted to receive and analyze a sample collected on an applicator stick.

## Claims

### Claim 1

An apparatus for performing a plurality of biochemical assays comprising:
a plurality of electrodes comprising at least one dedicated working electrode, at least one dual-role electrode and at least one dedicated counter electrode, said dedicated working and dual-role electrodes having deposited thereon an assay reagent, wherein said dual-role electrode is configured to operate first as the working electrode and then as the counter electrode.

### Claim 2 (depends on 1)

The apparatus according to claim 1 wherein said assay reagent is a binding reagent specific for an analyte of interest.

### Claim 3 (depends on 2)

The apparatus according to claim 2 wherein said binding reagent is different for each of said dedicated working and dual-role electrodes.

### Claim 4 (depends on 1)

The apparatus according to claim 1 wherein said plurality of electrodes are arranged within a flow cell, said flow cell having a flow cell path.

### Claim 5 (depends on 4)

The apparatus according to claim 4 wherein said plurality of electrodes are arranged along said flow cell path.

### Claim 6 (depends on 1)

The apparatus according to claim 1 wherein said dedicated counter electrode is adjacent said dual-role electrode and said dual-role electrode is adjacent said dedicated working electrode.

### Claim 7 (depends on 1)

The apparatus according to claim 1 wherein said plurality of electrodes are arranged within a single detection chamber.

### Claim 8 (depends on 1)

The apparatus according to claim 1 wherein said plurality of electrodes are printed carbon ink.

### Claim 9 (depends on 2)

The apparatus according to claim 2 wherein said assay reagents are present within an assay domain defined by a dielectric layer on said dedicated working and dual-role electrodes.

### Claim 10 (depends on 4)

The apparatus according to claim 4 further comprising:
dedicated working, dual-role and dedicated counter electrical leads for supplying electrical energy to said plurality of electrodes, wherein at least two non-adjacent electrical leads have an exposed surface located thereon;
an inlet conduit in fluid communication with said flow cell and at least partially defined by said exposed surfaces of said electrical leads, wherein fluid in said inlet conduit is in electrical contact with said exposed surfaces,
wherein the exposed surfaces are configured to apply an inlet conduit interrogation potential between said exposed surfaces to determine the presence or composition of fluid in said inlet conduit.

### Claim 11 (depends on 10)

The apparatus according to claim 10 wherein said exposed surfaces are further configured such that the applied interrogation potential is of insufficient magnitude to induce electrochemiluminescence at the corresponding electrodes.

### Claim 12 (depends on 1)

The apparatus according to claim 1 further comprising an optical detector for detecting luminescence generated at said dedicated working and dual-role electrodes.

### Claim 13 (depends on 1)

The apparatus according to claim 1 further comprising a voltmeter for measuring potentials at said dedicated working and dual-role electrodes.

### Claim 14 (depends on 1)

The apparatus according to claim 1 further comprising an ammeter for measuring electrical current at said dedicated working and dual-role electrodes.

### Claim 15

A cartridge for conducting a plurality of assays, comprising:
a flow cell having an inlet, an outlet and a detection chamber, the inlet, detection chamber and outlet defining a flow path through the flow cell, said detection chamber comprising:
a plurality of electrodes wherein at least a first electrode has a first assay reagent immobilized thereon, said electrodes being arranged in a one-dimensional array along the flow path; and
a plurality of electrical leads for supplying electrical energy to said plurality of electrodes.

### Claim 16 (depends on 15)

The cartridge of claim 15 further comprising a second electrode having a second assay reagent immobilized thereon, said second electrode being arranged adjacent to said first electrode.

### Claim 17 (depends on 15)

The cartridge of claim 15 wherein said plurality of electrodes comprise carbon ink.

### Claim 18 (depends on 15)

The cartridge of claim 15 wherein said detection chamber further comprises at least one detection chamber surface, wherein at least a portion of said detection chamber surface is transparent.

### Claim 19 (depends on 15)

The cartridge of claim 15 further comprising an optical detector adapted and arranged to detect luminescence from said detection chamber.

### Claim 20

A cartridge for conducting a plurality of assays, comprising:
a flow cell having an inlet, an outlet and a detection chamber, said inlet, detection chamber and outlet defining a flow path through the flow cell, said detection chamber comprising:
a plurality of working electrodes having assay reagents immobilized thereon, said electrodes being arranged in a one-dimensional array along the flow path; and
a common counter electrode.