Modular point-of-care devices, systems, and uses thereof
AssigneeTheranos IP Company, LLC
InventorsTammy BURD, Ian GIBBONS, Elizabeth A. HOLMES, Gary FRENZEL, Anthony Joseph NUGENT
Life of this patent
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Abstract
The present invention provides devices and systems for use at the point of care. The methods devices of the invention are directed toward automatic detection of analytes in a bodily fluid. The components of the device are modular to allow for flexibility and robustness of use with the disclosed methods for a variety of medical applications.
Claims20
A bench-top, point-of-care system for detecting an analyte in a bodily fluid sample, the system comprising:
- a cartridge comprising:
- an addressable reagent unit configured to contain a cartridge reagent for running a chemical reaction for detecting the analyte;
- and
- a sample collection unit configured to receive the bodily fluid sample;
- an assay assembly comprising:
- an addressable assay unit configured to receive the bodily fluid sample from the sample collection unit and the cartridge reagent from the addressable reagent unit, wherein the addressable assay unit comprises a reaction site having thereon an immobilized binding reagent that is configured to yield a detectable optical signal indicative of the presence of the analyte in the sample;
- and
- an assembly tip comprising an opening configured to allow the transfer of fluids into the addressable assay unit;
- a fluid transfer device comprising a programmable processor configured to direct movement of the cartridge to a location that places one of the addressable reagent unit and the sample collection unit into fluid communication with the addressable assay unit via the assembly tip;
- and
- a detection assembly configured to detect the detectable optical signal indicative of the presence of the analyte.
A method for detecting an analyte in a bodily fluid sample using a bench-top, point-of-care system including a cartridge, an assay assembly, a fluid transfer device, and a detection assembly, the method comprising:
- positioning, via the fluid transfer device, the cartridge at a first location that places a sample collection unit of the cartridge into fluid communication with an addressable assay unit of the assay assembly, the addressable assay unit comprising a reaction site having thereon an immobilized binding reagent that yields a detectable optical signal indicative of the presence of the analyte in the bodily fluid sample;
- transferring the bodily fluid sample from the sample collection unit to the addressable assay unit via an assembly tip of the assay assembly;
- positioning, via the fluid transfer device, the cartridge at a second location that places an addressable reagent unit of the cartridge into fluid communication with the addressable assay unit, the addressable reagent unit comprising a cartridge reagent for running a chemical reaction for detecting the analyte;
- transferring the cartridge reagent from the addressable reagent unit to the addressable assay unit via the assembly tip of the assay assembly;
- and
- detecting, by the detection assembly, the detectable signal indicative of the presence of the analyte.
A bench-top, point-of-care device for detecting an analyte in a bodily fluid sample, the device comprising:
- a cartridge comprising:
- an addressable reagent unit configured to contain a cartridge reagent for running a chemical reaction for detecting the analyte;
- and
- a sample collection unit configured to receive the bodily fluid sample;
- an assay assembly comprising:
- an addressable assay unit configured to receive the bodily fluid sample from the sample collection unit and the cartridge reagent from the addressable reagent unit, wherein the addressable assay unit comprises a reaction site having thereon an immobilized binding reagent configured to yield a detectable optical signal indicative of the presence of the analyte in the bodily fluid sample;
- an assembly tip comprising an opening configured to allow the transfer of fluids into the addressable assay unit;
- a fluid transfer device comprising a programmable processor configured to direct movement of the cartridge to a location that places one of the addressable reagent unit and the sample collection unit into fluid communication with the addressable assay unit via the assembly tip;
- and
- a detection assembly configured to detect the detectable optical signal indicative of the presence of the analyte.
Dependencies are inferred from the claim text.