Avails Medical, Inc.

E-Sense, Inc.

Oren S Knopfmacher

Meike Herget

Nitin K Rajan

Michael D Laufer

August Estabrook

Creighton T Buie

Eszter Deak

Suzanne Putney

Ashraf M Wahba

Andrew H Theiss

Elizabeth Botbol Ponte

Hima Shah

Mathias Wipf

Various methods, devices, and systems for preparing an output sample of a defined concentration are disclosed. The output sample can be used for downstream tests such as downstream anti-infective or antibiotic susceptibility testing (AST). The method can comprise diluting an aliquot of a source sample comprising an infectious agent to yield a diluted sample; exposing one or more sensors to the diluted sample, wherein at least a part of each of the one or more sensors is in fluid communication with the diluted sample; incubating the diluted sample at an incubation temperature; monitoring a change in a solution characteristic of the diluted sample using a parameter analyzer or a computing device coupled to the one or more sensors; and cooling the diluted sample to a cooling temperature when the concentration of infectious agents within the diluted sample reaches the defined concentration to yield the output sample.

Apparatus, systems, and methods for preparing an output sample comprising a defined concentration of an infectious agent for downstream testing

Sensor array

Various methods, devices, and systems for determining the concentration of infectious agent in a target sample are disclosed herein. In one embodiment, a method for determining the concentration of an infectious agent of an unknown strain can include diluting aliquots of a target sample comprising the infectious agent by different dilution factors to yield diluted samples. The method can also include determining the time it takes a solution characteristic of each of the diluted samples to undertake a predetermined threshold change. The method can also include determining the concentration of the infectious agent of the unknown strain by taking into account the different dilution factors, the monitored times, and certain curve fitting parameters calculated from predetermined calibration curves generated for infectious agents of different known strains.

Apparatus, systems, and methods for quantifying infectious agents

Various devices, systems and methods for detecting the presence of β-lactam antibiotic hydrolyzing bacteria in a sample are disclosed. In one embodiment, a method of detecting the presence of β-lactam antibiotic hydrolyzing bacteria includes introducing the sample to a filter configured to capture bacteria in the sample; introducing a buffer solution to the bacteria captured on the filter surface, wherein the buffer solution comprises a β-lactamase substrate, a β-lactamase activator, and a lysing agent to lyse cells of the bacteria to release β-lactam antibiotic hydrolyzing enzymes; exposing a sensor having an electrical characteristic to a reaction mixture comprising the buffer solution and the β-lactam antibiotic hydrolyzing enzymes; and monitoring a change in the electrical characteristic of the sensor to detect the presence of the β-lactam antibiotic hydrolyzing bacteria in the sample originally introduced.

Devices, systems and methods to detect the presence of ß-lactam antibiotic hydrolyzing bacteria in a sample

Laboratory or medical reader

Various devices, systems and methods of detecting a susceptibility of one or more infectious agents to one or more anti-infectives are described herein. In one embodiment, a method of detecting the susceptibility of the infectious agents to the anti-infectives involves introducing a sample comprising the infectious agents to a filter comprising a filter surface. The filter surface can be configured to capture the infectious agents in the sample. The method can also involve introducing a solution to the filter surface such that the solution is in fluid communication with the infectious agents captured on the filter surface. The solution can comprise nutrients and one or more anti-infectives. The method can further involve monitoring an oxidation reduction potential (ORP) of the solution using one or more parameter analyzers coupled to a sensor currently in fluid communication with the solution to assess the susceptibility of the infectious agents to the anti-infectives.

Apparatus, systems, and methods for determining susceptibility of microorganisms to anti-infectives

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.

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

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.

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

Various apparatus, systems, and methods for measuring a solution characteristic of a sample comprising microorganisms are disclosed. The measured solution characteristic can be used to generate a standardized inoculum. In one embodiment, a sensor apparatus is disclosed comprising a sample container having a chamber lateral wall surrounding a chamber cavity configured receive the sample, a reference sensor fabricated as a container cap and comprising a reference electrode material and, and an active sensor made of a substrate covered in part by an active electrode layer. The active sensor can be coupled to at least part of the chamber lateral wall at a window opening defined along the chamber lateral wall. The solution characteristic can be measured using a reader configured to electrically couple to the sensor apparatus and measure the solution characteristic based on a potential difference between the active sensor and the active sensor.

Devices, systems, and methods for preparing a standardized inoculum for antimicrobial susceptibility testing

Various methods, devices, and systems for determining the susceptibility of infectious agents to anti-infectives are disclosed herein. A method comprises introducing an inoculum solution comprising the infectious agent into a sample receiving space of a diagnostic device. The sample receiving space comprises a plurality of growth control wells devoid of the anti-infective and a plurality of active electrode wells comprising the anti-infective at differing concentrations. A water immiscible liquid can be introduced into the sample receiving space to seal the plurality of wells and the diagnostic device can be incubated for a period of time. The minimum inhibitory concentration (MIC) of the anti-infective on the infectious agent can be determined by monitoring and comparing one or more solution characteristics of the inoculum solution within the active electrode wells with the one or more solution characteristics of the inoculum solution with the growth control wells.

Apparatus, systems, and methods for determining the susceptibility of infectious agents to anti-infectives

Various apparatus, systems, and methods for measuring a solution characteristic of a sample comprising microorganisms are disclosed. In one embodiment, a sensor apparatus is disclosed comprising a sample container comprising a sample chamber configured to receive the sample and a reference sensor component comprising a reference conduit having a reference conduit cavity defined therein. The reference conduit cavity can be at least partially filled with a reference buffer gel, buffer solution, or wicking component. A segment of the reference conduit can extend into the sample chamber. A reference electrode material can be positioned at a proximal end of the wicking component or extend partially into the reference conduit cavity. The sensor apparatus can also comprise an active sensor component having an active electrode in fluid contact with the sample. The sample in the sample chamber can be aerated through an aeration port defined along a surface of the sample container.

Growing community of inventors

San Francisco, CA, United States of America

Oren S Knopfmacher