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 removable cartridge comprising:
- a plurality of addressable reagent units configured to contain cartridge reagents for running chemical reactions for detecting the analyte;
- and
- a sample collection unit configured to receive the bodily fluid sample;
- an addressable assay unit configured to receive the bodily fluid sample from the sample collection unit and the cartridge reagents from the plurality of addressable reagent units, 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;
- a fluid transfer device comprising a programmable processor configured to direct fluid transfer of the sample and the cartridge reagents to the addressable assay unit according to a protocol corresponding to the analyte;
- 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 removable cartridge, an addressable assay unit, a fluid transfer device, and a detection assembly, the method comprising
- determining a protocol comprising instructions for detecting the analyte in the bodily fluid sample;
- placing the bodily fluid sample in an addressable reagent unit of the removable cartridge according to the analyte to be detected, the addressable reagent unit including a first reagent for running a primary chemical reaction for detecting the analyte;
- transferring, by the fluid transfer device, the bodily fluid sample and the first reagent to the addressable assay unit in accordance with the protocol, the addressable assay unit corresponding to the addressable reagent unit and including a reaction site having thereon an immobilized second reagent that yields a detectable signal indicative of the presence of the analyte in the bodily fluid sample;
- and
- detecting, by the detection assembly, the detectable signal indicative of the presence of the analyte.
A point-of-care device for detecting an analyte in a bodily fluid sample, the device comprising:
- a removable cartridge comprising:
- a plurality of addressable reagent units configured to contain cartridge reagents for running chemical reactions for detecting the analyte;
- and
- a sample collection unit configured to receive the bodily fluid sample;
- an addressable assay unit configured to receive the bodily fluid sample from the sample collection unit and the cartridge reagents from the plurality of addressable reagent units, 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 bodily fluid sample;
- a fluid transfer unit comprising a programmable processor configured to direct fluid transfer of the bodily fluid sample and the cartridge reagents to the addressable assay unit according to a protocol corresponding to the analyte;
- and
- a detection assembly configured to detect the detectable optical signal indicative of the presence or absence of the analyte.
Dependencies are inferred from the claim text.