Apparatus, systems, and methods for preparing an output sample comprising a defined concentration of an infectious agent for downstream testing
Inventors
RAJAN, Nitin K. • THEISS, Andrew H. • KNOPFMACHER, Oren S. • Herget, Meike • WIPF, Mathias
Assignees
Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
Publication Number
US-12422343-B2
Publication Date
2025-09-23
Expiration Date
Abstract
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.
Core Innovation
The invention describes a method of preparing an output sample of a bacteria of a defined concentration by identifying a species of the bacteria within a source sample and diluting an aliquot of the source sample using a dilutive solution to yield a diluted sample. A species-based look-up table containing concentration data is selected based on the species, and first and second threshold amounts are selected from the look-up table as target amounts by which an oxidation-reduction potential (ORP) of the diluted sample is required to change for the concentration of the bacteria in the diluted sample to reach the defined concentration between 5×10^5 colony-forming units (CFU)/mL to 3×10^8 CFU/mL.
One or more ORP sensors are exposed to the diluted sample, with each ORP sensor including an active electrode and a reference electrode, where a redox-active layer of the active electrode is in fluid communication with the diluted sample when exposed. The diluted sample is incubated at an incubation temperature while the ORP sensors are exposed, and changes in ORP are measured using a parameter analyzer coupled to the ORP sensors by measuring the change between the redox-active layer of the active electrode and the reference electrode.
Using the parameter analyzer or a computing device, a first threshold time is obtained corresponding to an amount of time elapsed for the ORP to change by the first threshold amount, and a second threshold time is obtained corresponding to the amount of time elapsed for the ORP to change by the second threshold amount. A sample preparation time is then determined based on the first threshold time, the second threshold time, the concentration data from the look-up table, and the defined concentration, and the diluted and incubated sample is cooled to a cooling temperature between about 4° C. and about 25° C. when the sample preparation time is reached.
Claims Coverage
Independent claim clm-00001 provides coverage for preparing an output sample of bacteria with a defined concentration using ORP sensor measurements linked to species-based look-up tables, with determination of threshold times and sample preparation time followed by cooling. The claim includes four inventive features.
Species-based ORP thresholding for defined CFU concentration
Selecting a look-up table based on the species of the bacteria, where the look-up table contains concentration data, and selecting a first threshold amount and a second threshold amount from the look-up table as target amounts by which an oxidation-reduction potential (ORP) of the diluted sample is required to change to reach the defined concentration between 5×10^5 colony-forming units (CFU)/mL to 3×10^8 CFU/mL.
ORP sensors with active and reference electrodes exposed during incubation
Exposing one or more ORP sensors to the diluted sample, where each ORP sensor comprises an active electrode and a reference electrode, with at least a redox-active layer of the active electrode in fluid communication with the diluted sample when exposed, and incubating the diluted sample at an incubation temperature when the one or more ORP sensors are exposed.
Determining threshold times from measured ORP change using parameter analyzer or computing device
Measuring, using a parameter analyzer coupled to the one or more ORP sensors, a change in an ORP of the diluted and incubated sample, and obtaining using the parameter analyzer or a computing device a first threshold time corresponding to time elapsed for the ORP to change by the first threshold amount and a second threshold time corresponding to time elapsed for the ORP to change by the second threshold amount.
Sample preparation time determination and cooling when reached
Determining, using the parameter analyzer or a computing device, a sample preparation time corresponding to the amount of time necessary for the bacteria within the diluted and incubated sample to reach the defined concentration based on the first threshold time, the second threshold time, concentration data from the look-up table, and the defined concentration, and cooling the diluted and incubated sample to a cooling temperature between about 4° C. and about 25° C. when the sample preparation time is reached.
The claim coverage centers on using species-based concentration look-up tables with selected ORP threshold amounts, measuring ORP changes with ORP sensors having active and reference electrodes during incubation, deriving threshold times from measured ORP change, and determining a sample preparation time that is followed by cooling once the defined concentration is reached.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
Interested in licensing this patent?