Apparatus, systems, and methods for determining the concentration of microorganisms and the susceptibility of microorganisms to anti-infectives based on redox reactions

Inventors

KNOPFMACHER, Oren S. • Herget, Meike • RAJAN, Nitin K. • Laufer, Michael D.

Assignees

Avails Medical Inc

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Publication Number

US-11655494-B2

Patent

Publication Date

2023-05-23

Expiration Date


Abstract

Various methods, devices, and systems for determining the concentration of microorganisms in a sample and determining the susceptibility of such microorganisms to one or more antibiotics or other types of anti-infectives are disclosed herein. More specifically, methods for quantifying microorganisms based on redox reactions are disclosed along with systems and devices for quantifying such microorganisms using certain oxidation reduction potential (ORP) sensors. Moreover, methods for determining the susceptibility and the degree of susceptibility of microorganisms to one or more anti-infectives are disclosed along with multiplex systems for such assays.

Core Innovation

The method determines a concentration of an infectious agent by diluting a sample comprising the infectious agent with a dilutive solution to yield a diluted sample. The diluted sample is introduced to a sensor so that the diluted sample is in fluid communication with a redox-active material of the sensor. The sensor includes an active electrode and a reference electrode, and the redox-active material comprises a gold layer, a platinum layer, a metal oxide layer, or a combination thereof.

The method monitors a decrease in an oxidation reduction potential (ORP) of the diluted sample over a period of time to determine the concentration of the infectious agent in the sample. The ORP is monitored using at least one parameter analyzer coupled to the sensor. The monitoring is performed in the absence of any added reporter molecules in the diluted sample.

The documented systems include ORP sensing for multiplex configurations using multiple ORP sensors and cartridge, test strip, lab-on-a-chip, and microfluidic architectures. The sensor arrangements can include redox-active electrode material selections, including gold, platinum, metal oxide, and carbon layer examples, and can incorporate external reference electrodes or on-chip reference electrodes with specific reference electrode types.

Claims Coverage

The provided material identifies one independent claim directed to determining an infectious agent concentration. The independent claim includes three main inventive areas: dilution-based preparation, ORP sensing using specified redox-active electrode materials with active and reference electrodes, and ORP monitoring without added reporter molecules to determine concentration over time.

Diluting the infectious agent sample for ORP-based quantification

diluting a sample comprising the infectious agent with a dilutive solution to yield a diluted sample; and introducing the diluted sample to a sensor such that the diluted sample is in fluid communication with a redox-active material of the sensor

Orp sensor architecture with specified redox-active electrodes and reference electrode

the sensor comprises an active electrode and a reference electrode, wherein the redox-active material comprises a gold layer, a platinum layer, a metal oxide layer, or a combination thereof, and wherein the active electrode comprising a redox-active layer positioned on top of at least one conductive metallic layer

Monitoring a decrease in ORP over time without added reporter molecules

monitoring a decrease in an oxidation reduction potential (ORP) of the diluted sample over a period of time using at least one parameter analyzer coupled to the sensor to determine the concentration of the infectious agent in the sample, wherein the ORP is monitored in the absence of any added reporter molecules in the diluted sample

Overall, the independent claim covers quantifying infectious agent concentration from a diluted sample by time-based monitoring of a decreasing ORP signal produced at specified redox-active electrode materials using an active/reference electrode sensor, with the ORP measurement performed without added reporter molecules.

Stated Advantages

Not explicitly described in patent.

Documented Applications

ORP sensing for multiplex configurations using multiple ORP sensors and cartridge, test strip, lab-on-a-chip, and microfluidic architectures.

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