Cartridge for diagnostic testing

• US 10,036,726 B2
• Filed: 03/24/2017
• Issued: 07/31/2018
• Est. Priority Date: 07/25/2011
• Status: Active Grant

• Current Assignee: Proxim Diagnostics Corporation
• Original Assignee: Proxim Diagnostics Corporation
• Inventors: Briman, Mikhail
• Primary Examiner(s): Gordon, Brian R
• Application Number:
  US15/469,275
• Publication Number:
  US 20170199152A1
• Time in Patent Office: 494 Days
• CPC Class Codes: B01L 2200/16 Reagents, handling or storing thereof
• CPC Class Codes: B01L 2300/0645 Electrodes
• CPC Class Codes: B01L 2300/0672 Integrated piercing tool
• CPC Class Codes: B01L 2300/0681 Filter
• CPC Class Codes: B01L 2300/0816 Cards, e.g. flat sample carriers usually with flow in two horizontal directions
• CPC Class Codes: B01L 2300/0867 Multiple inlets and one sample wells, e.g. mixing, dilution
• CPC Class Codes: B01L 2300/0883 Serpentine channels
• CPC Class Codes: B01L 2300/161 Control and use of surface tension forces, e.g. hydrophobic, hydrophilic
• CPC Class Codes: B01L 2400/0478 pistons
• CPC Class Codes: B01L 2400/0487 fluid pressure, pneumatics
• CPC Class Codes: B01L 2400/0638 membrane valves, flap valves
• CPC Class Codes: B01L 2400/0655 pinch valves
• CPC Class Codes: B01L 2400/0683 mechanically breaking a wall or membrane within a channel or chamber
• CPC Class Codes: B01L 2400/0694 vents used to stop and induce flow, backpressure valves
• 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 3/502707 characterised by the manufacture of the container or its components by shaping or joining plastic parts B29C59/00, B29C65/00; by laminating B32B37/00; manufacture of microstructural devices in general B81C
• CPC Class Codes: G01N 2333/4712 Muscle proteins, e.g. myosin, actin, protein
• CPC Class Codes: G01N 27/3272 Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels optical biosensors G01N33/52
• CPC Class Codes: G01N 27/48 using polarography, i.e. measuring changes in current under a slowly-varying voltage
• CPC Class Codes: G01N 27/49 Systems involving the determination of the current at a single specific value, or small range of values, of applied voltage for producing selective measurement of one or more particular ionic species
• CPC Class Codes: G01N 2800/324 : Coronary artery diseases, e.g. angina pectoris, myocardial infarction
• CPC Class Codes: G01N 33/5438 : Electrodes
• CPC Class Codes: G01N 33/6893 : related to diseases not provided for elsewhere

Abstract

The present invention relates to a cartridge for conducting diagnostic assays. The cartridge consists of an assembly of components that are easily assembled. The cartridge provides means for receiving a patient sample, precisely controlling fluid introduction, onboard storage of assay fluid and conducting different assay protocols and detection of a plurality of analytes. Methods of use for the cartridge are described. The disclosed invention is suitable for point of care environments or any place where rapid, ultrasensitive testing is required.

Claims

1. A method for performing a diagnostic assay on a cartridge;

providing a cartridge comprising

a sample chamber comprising an aperture;

a first inlet fluidly connected to the sample chamber;

a detection channel having a first end, a second end, and an analyte sensor positioned along the detection channel between the first end and the second end, the analyte sensor having a first side and a second side, the second side opposite the first side, the sample chamber connected to the detection channel;

a second inlet fluidly connected to the first end of the detection channel;

a reagent channel connected to the detection channel between the analyte sensor and the second end of the detection channel;

a third inlet fluidly connected to the reagent channel; and

a waste compartment connected to the detection channel at the first end of the detection channel;

depositing a sample into the sample chamber;

applying pressure to the first inlet to move the sample from the sample chamber to the detection channel;

applying pressure to the second inlet to transfer the sample from the detection channel to the waste compartment; and

applying pressure to the third inlet to transfer a reagent from the reagent channel to the detection channel.

2. The method of claim 1, further comprising

applying pressure to a blister pack positioned on the cartridge, connected to the reagent channel and comprising the reagent to transfer the reagent to the reagent channel;

and

trapping air bubbles from the reagent in a bubble trap connecting the blister pack to the reagent channel.

3. The method of claim 2, further comprising oscillating the sample in the detection channel by applying pressure to at least one of the first inlet, the second inlet and the third inlet.

4. The method of claim 1, wherein the sample transferred to the waste compartment is substantially prevented from leaking back into the detection channel.

5. The method of claim 1, wherein the analyte sensor comprises at least two of a reference electrode, a working sensor electrode and a conductimetric electrode;

positioned in the detection channel,

the method further comprising exposing the sample to the at least two of a reference electrode, a working sensor electrode and a conductimetric electrode in the detection channel.