Devices, systems and methods to detect viable infectious agents in a fluid sample and susceptibility of infectious agents to anti-infectives

Inventors

KNOPFMACHER, Oren S. • Herget, Meike • Laufer, Michael D. • Estabrook, August

Assignees

Avails Medical Inc

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Publication Number

US-10174356-B2

Patent

Publication Date

2019-01-08

Expiration Date


Abstract

Various devices, systems and methods for detecting infectious agents or determining a susceptibility of an infectious agent to an anti-infective are described herein. One example method comprises introducing a fluid sample to a surface; exposing the surface to a solution; sampling the solution after exposing the solution to the surface; and detecting a change in an electrical characteristic of a sensing device exposed to the solution sampled corresponding to a presence of the infectious agent in the fluid sample.

Core Innovation

A method assesses the susceptibility of an infectious agent to an anti-infective by introducing a fluid sample to a first surface and a second surface, exposing the first surface to a first solution and the second surface to a second solution, where at least one of the second surface and the second solution comprises an anti-infective. After exposing each surface, the method samples the first solution and samples the second solution, thereby generating two sampled solutions that reflect the different exposures of the infectious agent.

The method monitors a first electrical characteristic of a first sensing device exposed to the sampled first solution and monitors a second electrical characteristic of a second sensing device exposed to the sampled second solution. The comparing includes a change in the first electrical characteristic and changes in the second electrical characteristic, and uses differences between the electrical characteristics, or lack thereof, to assess the susceptibility of the infectious agent to the anti-infective.

The disclosure further specifies that the electrical characteristics are monitored using sensing devices such as electrochemical cells and light-addressable potentiometric (LAP) sensors, with reference and working electrodes and functionalization layers. It also refines the susceptibility comparison by defining differences between the first and second electrical outcomes in terms of solution-characteristic differences and by enabling sensor architectures that can include external or on-chip reference electrode configurations and functionalization-layer voltage change.

Claims Coverage

The independent claim focuses on susceptibility assessment by comparing electrical characteristics from sensing devices exposed to sampled solutions from two separate exposures. The main inventive features refine how the infectious agent is exposed on two surfaces, how the solutions are sampled, and how electrical characteristics are monitored and compared using specified sensing-device types and architectures.

Two-surface exposure with anti-infective-containing second solution

A method assessing susceptibility by exposing an infectious agent on a first surface to a first solution and on a second surface to a second solution, wherein at least one of the second surface and the second solution comprises an anti-infective.

Sampling each exposed solution after exposure

Sampling the first solution after exposing the first surface to the first solution and sampling the second solution after exposing the second surface to the second solution.

Monitoring and comparing electrical characteristics from two sensing devices

Monitoring a first electrical characteristic with a first sensing device exposed to the sampled first solution and monitoring a second electrical characteristic with a second sensing device exposed to the sampled second solution, then comparing the electrical characteristics including changes to assess susceptibility.

Electrochemical-cell measurement relative to reference and functionalization layers

Using first and second electrochemical cells such that each monitored electrical characteristic is determined by measuring a voltage change at a corresponding functionalization layer relative to a corresponding reference electrode, with each functionalization layer covering the respective working electrode and being exposed to a respective sampled solution.

Glucose added to both solutions prior to sampling

Adding a known concentration of glucose to both the first and second solutions prior to sampling each one, using the same glucose concentration for both.

LAP sensor electrical readout using bias voltage, modulated light, and photocurrent

Monitoring an electrical characteristic using a light-addressable potentiometric (LAP) sensor by applying a bias voltage with a reference electrode, illuminating a semiconductor layer with modulated light, detecting resulting photocurrent, and determining a voltage change at a functionalization layer while exposed to the sampled solution.

Solution-characteristic difference constraints for defining comparison

Defining the difference between the first and second solutions by at least one of molecular count, ion concentration, or solution temperature.

Physically separated second surface forming another filter or well surface

Specifying that the second surface is physically separated from the first surface and constitutes another instance of the filter surface or the well surface.

Across the independent claim and its refinements, susceptibility is assessed by comparing electrical characteristics from two sensing-device exposures to sampled solutions generated from two distinct surface-and-solution interactions, with additional claim refinements specifying electrochemical-cell voltage-change measurements, glucose addition, LAP sensor photocurrent-based readout, defined solution-characteristic differences, and physically separated filter or well surfaces.

Stated Advantages

Enables assessing susceptibility of an infectious agent to an anti-infective by comparing electrical characteristics from sensing devices exposed to sampled solutions.

Documented Applications

Assessing susceptibility of an infectious agent to an anti-infective.

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