POINT-OF-CARE FLUIDIC SYSTEMS AND USES THEREOF
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.
1 . A system for detecting an analyte in a bodily fluid from a subject, the system comprising:
a reader assembly comprising at least one communication interface operable to receive an assay protocol from an external device; and
an assay device configured to be coupled to the reader assembly, said assay device comprising:
i) at least one structure for receiving at least a portion of the bodily fluid;
ii) at least one reactant that reacts with the bodily fluid based on the assay protocol transmitted from said external device to yield a detectable signal indicative of said analyte; and
iii) an information storage unit;
wherein the reader assembly comprises a detection assembly for detecting the detectable signal;
wherein the assay protocol effects selection of a detection method for detecting said signal;
wherein the information storage unit has information to be used in selection of the assay protocol.
2 . A system as in claim 1 wherein the communication interface is configured to receive said protocol wirelessly from said external device.
3 . A system as in claim 1 wherein the communication interface is configured to receive said protocol via a wired connection from said external device.
4 . A system as in claim 1 wherein the assay device comprises a cartridge.
5 . A system as in claim 1 wherein said reactant comprises an immunoassay or a nucleic acid reagent immobilized within the assay device.
6 . A system as in claim 1 wherein the information storage unit comprise a bar code.
7 . A system as in claim 1 wherein the information storage unit comprise a semiconductor memory device.
8 . A system as in claim 1 wherein the information comprises an identifier for the assay unit.
9 . A system as in claim 1 wherein the reader assembly is configured to detect a plurality of analytes and said assay device comprises immunoassay or nucleic acid reagents for said plurality of analytes.
10 . A system as in claim 11 wherein the detection assembly is configured to detect a plurality of analytes that generate distinct signals, wherein the intensities of said distinct signals vary over a range of 3 orders of magnitude.
11 . A system as in claim 1 wherein the detection assembly is configured to detect luminescent signals from said plurality of reactions.
12 . A system as in claim 1 wherein the detection assembly is configured to detect chemiluminescent signals from said plurality of reactions.
13 . A system as in claim 1 wherein the detection assembly comprises sensors from one or more of the following sensor types: temperature, conductivity, potentiometric, or amperometric.
14 . A system as in claim 1 wherein the reader assembly further comprises a controller having computer-executable commands for performing the reaction at a designated point-of-care location remote from a location of the external device.
15 . A system as in claim 1 wherein the reader assembly further comprises a controller configured for executing having computer-executable commands for performing on-board calibration of said reader assembly.
16 . A system as in claim 1 wherein said reader assembly comprises an identifier detector that detects an identifier from the information storage unit on the assay device.
17 . A system as in claim 1 wherein the assay device is configured to run a plurality of types of assays.
18 . A system as in claim 1 wherein the reader assembly comprises a communication assembly for transmitting data regarding the detectable signal.
19 . A system as in claim 1 wherein the system has a programmable processor that compares the amount of said analyte determined from the detectable signal to a predetermined amount of said analyte.
20 . A system as in claim 1 wherein the protocol dictates the actuation of one or more elements of the device, thereby directing fluid movement.