US 12,422,343 B2
Apparatus, systems, and methods for preparing an output sample comprising a defined concentration of an infectious agent for downstream testing
Nitin K. Rajan, Palo Alto, CA (US); Andrew H. Theiss, Mountain View, CA (US); Oren S. Knopfmacher, San Francisco, CA (US); Meike Herget, Woodside, CA (US); and Mathias Wipf, Basel (CH)
Assigned to Avails Medical, Inc., Menlo Park, CA (US)
Filed by Avails Medical, Inc., Menlo Park, CA (US)
Filed on Jun. 3, 2019, as Appl. No. 16/430,266.
Application 16/430,266 is a continuation in part of application No. PCT/US2018/064093, filed on Dec. 5, 2018.
Claims priority of provisional application 62/597,657, filed on Dec. 12, 2017.
Claims priority of provisional application 62/594,838, filed on Dec. 5, 2017.
Prior Publication US 2019/0293529 A1, Sep. 26, 2019
Int. Cl. G01N 1/38 (2006.01); C12Q 1/24 (2006.01); G01N 27/00 (2006.01); G01N 27/416 (2006.01)
CPC G01N 1/38 (2013.01) [C12Q 1/24 (2013.01); G01N 27/00 (2013.01); G01N 27/4167 (2013.01); G01N 27/4168 (2013.01)] 10 Claims
 
1. A method of preparing an output sample of a bacteria of a defined concentration, comprising:
identifying a species of the bacteria within a source sample;
diluting an aliquot of the source sample comprising the bacteria by a dilution factor to yield a diluted sample, wherein the aliquot is diluted using a dilutive solution;
selecting a look-up table based on the species of the bacteria; wherein the look-up table contains concentration data;
selecting a first threshold amount and a second threshold amount from the look-up table, wherein the first threshold amount and the second threshold amount are target amounts by which an oxidation-reduction potential (ORP) of the diluted sample is required to change in order for the concentration of the bacteria in the diluted sample to reach the defined concentration, wherein the defined concentration is between 5×105 colony-forming units (CFU)/mL to 3×108 CFU/mL, wherein the first threshold amount and the second threshold amount comprise different values;
exposing one or more ORP sensors to the diluted sample, wherein each of the one or more ORP sensors comprises an active electrode and a reference electrode, wherein at least a redox-active layer of the active electrode of each of the one or more ORP sensors is in fluid communication with the diluted sample when exposed to the diluted sample;
incubating the diluted sample at an incubation temperature, wherein the diluted sample is incubated when the one or more ORP sensors are exposed to the diluted sample;
incubating the diluted sample at an incubation temperature, wherein the diluted sample is incubated when the one or more ORP sensors are exposed to the diluted sample;
measuring, using a parameter analyzer coupled to the one or more ORP sensors, a change in an ORP of the diluted and incubated sample, wherein the change in the ORP is measured between the redox-active layer of the active electrode and the reference electrode;
obtaining, using the parameter analyzer or a computing device communicatively coupled to the parameter analyzer, a first threshold time corresponding to an amount of time elapsed for the ORP of the diluted and incubated sample to change by the first threshold amount and obtaining a second threshold time corresponding to the amount of time elapsed for the ORP of the diluted and incubated sample to change by the second threshold amount, wherein the first threshold amount and the second threshold amount represent changes in the ORP of the diluted and incubated sample;
determining, using the parameter analyzer or a computing device communicatively coupled to the parameter analyzer, 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.