MODULAR POINT-OF-CARE DEVICES, SYSTEMS, AND USES THEREOF
First Claim
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1. A cartridge for automated detection of an analyte in a bodily fluid sample comprising:
- an array of addressable assay units configured to run a chemical reaction that yields a detectable signal indicative of the presence or absence of the analyte; and
an array of addressable reagent units, wherein an individual addressable reagent unit of the array is addressed to correspond to an individual addressable assay unit of the array of assay units, and wherein the individual reagent unit is configured to be calibrated in reference to the corresponding individual assay unit before the arrays are assembled on the cartridge.
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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.
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Citations
78 Claims
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1. A cartridge for automated detection of an analyte in a bodily fluid sample comprising:
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an array of addressable assay units configured to run a chemical reaction that yields a detectable signal indicative of the presence or absence of the analyte; and an array of addressable reagent units, wherein an individual addressable reagent unit of the array is addressed to correspond to an individual addressable assay unit of the array of assay units, and wherein the individual reagent unit is configured to be calibrated in reference to the corresponding individual assay unit before the arrays are assembled on the cartridge. - View Dependent Claims (3, 4, 5, 6, 7, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 38, 39, 67, 75)
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2. A cartridge for automated detection of an analyte in a bodily fluid sample comprising:
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a sample collection unit configured to receive the bodily fluid sample; an array of assay units configured to receive a portion of the sample from the sample collection unit and run a chemical reaction that yields a detectable signal indicative of the presence of the analyte in the sample; and an array of reagent units containing reagents for running the chemical reaction; wherein an individual assay unit of the array of assay units and an individual reagent unit of the array of reagent units are configured to be movable into fluid communication such that reagents for running the chemical reaction are brought to contact with the portion of the sample in the assay unit. - View Dependent Claims (8, 9)
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20. A system for automated detection of a plurality of analytes in a bodily fluid sample, comprising:
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a fluidic device comprising; a sample collection unit configured to contain the bodily fluid sample; an array of assay units, wherein an individual assay unit of said array of assay units is configured to run a chemical reaction that yields a signal indicative of an individual analyte of said plurality of analytes being detected; and an array of reagent units, wherein an individual reagent unit of said array of reagent units contains a reagent; and a fluid transfer device comprising a plurality of heads, wherein an individual head of the plurality of heads is configured to engage the individual assay unit, and wherein said fluid transfer device comprises a programmable processor configured to direct fluid transfer of the bodily fluid sample from the sample collection unit and the reagent from the individual reagent unit into the individual assay unit. - View Dependent Claims (21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36)
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37. A system for automated detection of an analyte in a plasma portion of a whole blood sample, comprising:
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a. a device configured to automatically receive and process the whole blood sample to yield the plasma portion, from which a detectable signal indicative of the presence or absence of the analyte of interest is generated onboard the device; and b. a detection assembly for detecting the detectable signal indicative of the presence or absence of the analyte.
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40. A method of on-demand assembly of a cartridge for automated detection of an analyte in a bodily fluid sample, wherein the device comprises a housing, said housing comprising:
- an array of addressable assay units, wherein an individual assay unit of the array is configured to run a chemical reaction that yields a detectable signal indicative of the presence or absence of the analyte; and
an array of addressable reagent units, wherein an individual reagent unit of the array is addressed to correspond to the individual assay unit, said method comprising;(i) placing according to the analyte to be detected an array of addressable assay units, wherein an individual assay unit of the array is configured to run a chemical reaction that detects an analyte of interest ordered by said end user, into the housing; (ii) placing according to the analyte to be detected an array of reagent units, wherein an individual reagent unit of the array corresponds to the individual assay unit, into the housing; and (iii) securing the arrays of (i) and (ii) within the housing of the device. - View Dependent Claims (41, 42, 43, 44)
- an array of addressable assay units, wherein an individual assay unit of the array is configured to run a chemical reaction that yields a detectable signal indicative of the presence or absence of the analyte; and
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45. A method for automated detection of a plurality of analytes in a bodily fluid sample, comprising:
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a. providing the bodily fluid sample to a fluidic device, wherein the fluidic device comprises;
a sample collection unit configured to contain the bodily fluid sample;
an array of assay units, wherein an individual assay unit of said array of assay units is configured to run a chemical reaction that yields a signal indicative of an individual analyte of said plurality of analytes being detected; and
an array of reagent units, wherein an individual reagent unit of said array of reagent units contains a reagent;b. engaging the individual assay unit using a fluid transfer device; c. transferring the bodily fluid sample from the sample collection unit to the individual assay unit using the fluid transfer device; and d. transferring the reagent from the individual reagent unit to the individual assay unit, thereby reacting the reagent with the bodily fluid sample to yield the signal indicative of the individual analyte of the plurality of analytes being detected. - View Dependent Claims (46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58)
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59. A method of measuring a volume of a sample of a biological fluid, comprising:
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a. reacting a known quantity of a control analyte in said sample with a reagent to yield a detectable signal indicative of the quantity of the control analyte; and b. comparing said detectable signal with an expected detectable signal, wherein the expected signal is indicative of an expected volume of the sample, and wherein said comparison provides a measurement of said volume of said sample being measured. - View Dependent Claims (60, 61, 62, 63, 64, 65, 66)
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68. A method of retrieving plasma from a blood sample comprising:
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a. mixing a blood sample in the presence of magnetizable particles in a sample collection unit, wherein the magnetizable particles comprise an antibody capture surface for binding to non-plasma portions of the blood sample; and b. applying a magnetic field above a plasma collection area to the mixed blood sample to effect suspension of the non-plasma portions of the blood sample on top of the plasma collection area. - View Dependent Claims (69, 70, 71, 72, 73, 74)
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76. A method of using automated immunoassay for detecting an analyte present in plasma portion of a whole blood sample, comprising:
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a. providing a whole blood sample to a device that is configured to automatically receive and process on board the whole blood sample to yield the plasma portion, from which a detectable signal indicative of the presence or absence of the analyte of interest is generated on board; b. detecting said signal that is indicative of the presence or absence of the analyte in said bodily fluid sample; and c. transmitting result of (b) to an end user. - View Dependent Claims (77, 78)
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Specification