Point-of-care fluidic systems and uses thereof

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.

What is claimed is: 
     
         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.