Systems and Methods of Sample Processing and Fluid Control in a Fluidic System
First Claim
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1. A fluidic device for detecting the presence or absence of an analyte in a bodily fluid from a subject, comprising a cartridge, said cartridge comprising a sample collection unit and an assay assembly, wherein:
- (a) said sample collection unit is configured to;
(i) collect a sample of bodily fluid from said subject, and(ii) deliver a predetermined portion of said sample to said assay assembly; and
(b) said assay assembly comprises at least one reaction site containing a reactant that reacts with said analyte to yield a detectable signal indicative of the presence of said analyte.
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Abstract
This invention is in the field of medical devices. Specifically, the present invention provides portable medical devices that allow real-time detection of analytes from a biological fluid. The methods and devices are particularly useful for providing point-of-care testing for a variety of medical applications.
281 Citations
51 Claims
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1. A fluidic device for detecting the presence or absence of an analyte in a bodily fluid from a subject, comprising a cartridge, said cartridge comprising a sample collection unit and an assay assembly, wherein:
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(a) said sample collection unit is configured to; (i) collect a sample of bodily fluid from said subject, and (ii) deliver a predetermined portion of said sample to said assay assembly; and (b) said assay assembly comprises at least one reaction site containing a reactant that reacts with said analyte to yield a detectable signal indicative of the presence of said analyte. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 18, 19, 20, 21, 22, 23, 28, 29, 30, 31, 32, 33, 34, 35, 39)
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16. A fluidic device for detecting an analyte in a bodily fluid from a subject, comprising:
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a cartridge, said cartridge comprising a sample collection unit, wherein said sample collection unit is configured to collect a sample of bodily fluid from said subject; and an assay assembly, wherein said assay assembly comprises; at least one reaction site in fluidic communication with said sample collection unit, said reaction site containing a reactant that reacts with said analyte to yield a signal indicative of the presence of said analyte; at least one reagent chamber in fluidic communication with said at least one reaction site, wherein said reagent chamber is configured to store an assay reagent; a fluidic channel connecting the reagent chamber with the reaction site; and an actuatable valve assembly configured to control the flow of reagent through said fluidic channel, wherein the valve assembly comprises a sealing element and actuator element, wherein; said channel comprises first and second locations, wherein the sealing element positioned in the first location obstructs the flow of fluid through the channel and the sealing element positioned in the second location allows the flow of fluid through the channel; and
wherein the actuator element is adapted to move the sealing element from the first location to the second location. - View Dependent Claims (17, 24, 25, 26, 27, 36, 37, 38)
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40. A method of detecting an analyte in a bodily fluid from a subject, comprising:
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a) providing a fluidic device comprising a cartridge, said cartridge comprising a sample collection unit and an assay assembly, wherein said sample collection unit is configured to collect a sample of bodily fluid from said subject, and wherein said assay assembly comprises at least one reaction site containing a reactant adapted to reacts with said analyte; b) metering a predetermined portion of said sample to be assayed in said sample collection unit; c) allowing said predetermined portion of sample to react with assay reagents contained within said assay assembly to yield a signal indicative of the presence of said analyte in said sample; and d) detecting said signal generated from said analyte collected in said sample of bodily fluid. - View Dependent Claims (41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51)
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Specification