Modular point-of-care devices, systems, and uses thereof

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.

What is claimed is: 
     
         1 . A system for detecting an analyte in a biological sample, comprising:
 a cartridge comprising a first well configured to receive the biological sample, and a second well that stores a cartridge reagent for conducting an assay to detect the analyte, wherein the cartridge comprises an identifier encoding information corresponding to the cartridge;   a reader assembly for conducting the assay to detect the analyte, wherein the reader assembly comprises a stage on which the cartridge is received;   an identifier reader configured to read the identifier on the cartridge; and   a computer system configured to receive the information from the identifier reader, wherein the computer system stores a plurality of protocols, and wherein the computer system is configured to transmit a protocol to the reader assembly based at least in part on the information, and wherein the reader assembly conducts the assay based on the protocol received from the computer system.   
     
     
         2 . The system of  claim 1 , wherein the information encoded by the identifier comprises an address or contents of the first well or of the second well. 
     
     
         3 . The system of  claim 1 , wherein the information encoded by the identifier comprises an identity of the analyte to be detected. 
     
     
         4 . The system of  claim 1 , wherein the first and second wells are arranged in a grid. 
     
     
         5 . The system of  claim 1 , wherein the cartridge comprises all cartridge reagents necessary for performing the assay. 
     
     
         6 . The system of  claim 1 , wherein the computer system comprises a server and a user interface. 
     
     
         7 . The system of  claim 1 , wherein the reader assembly comprises a fluid transfer device having a programmable processor configured to execute the protocol. 
     
     
         8 . The system of  claim 7 , wherein the protocol further comprises instructions for the fluid transfer device to transfer a predetermined volume of each of the biological sample and the cartridge reagent from the cartridge to an assay unit. 
     
     
         9 . The system of  claim 7 , wherein the protocol comprises instructions for moving the fluid transfer device relative to the cartridge based on addresses of the first well and the second well. 
     
     
         10 . The system of  claim 1 , wherein the protocol comprises instructions for a detection method to be performed. 
     
     
         11 . The system of  claim 1 , wherein the identifier comprises a barcode. 
     
     
         12 . The system of  claim 1 , wherein the identifier comprises a RFID tag. 
     
     
         13 . The system of  claim 1 , wherein the identifier reader is in communication with a communication assembly of the reader assembly, wherein the communication assembly is configured to transmit the information to the computer system. 
     
     
         14 . The system of  claim 1 , wherein the protocol is selected in part based on the day of the week. 
     
     
         15 . The system of  claim 1 , wherein the reader assembly is configured to transmit a result of the assay to the computer system, and wherein the computer system stores the result of the assay. 
     
     
         16 . The system of  claim 15 , wherein the computer system further stores patient information. 
     
     
         17 . The system of  claim 15 , wherein the computer system is configured to determine a trend in assay results over time. 
     
     
         18 . A method for performing an assay to detect a presence or absence of an analyte in a biological sample, the method comprising:
 receiving in a reader assembly a prefilled cartridge comprising an identifier and a plurality of wells containing the biological sample and cartridge reagents;   reading, by an identifier reader, the identifier of the cartridge, wherein the identifier encodes information corresponding to the cartridge;   transferring the information read by the identifier reader to a computer system, wherein the computer system stores a plurality of protocols;   receiving from the computer system a protocol for conducting the assay based on the information; and   conducting, by the reader assembly, an assay to detect the analyte based on the protocol received from the computer system.   
     
     
         19 . The method of  claim 18 , wherein the information encoded by the identifier comprises addresses or contents of one or more of the plurality of wells. 
     
     
         20 . The method of  claim 18 , further comprising receiving by the reader assembly an assay unit in which the assay is conducted. 
     
     
         21 . The method of  claim 18 , wherein conducting the assay comprises transferring the biological sample and the cartridge reagents stored in the cartridge to an assay unit in an order and combination based on the protocol. 
     
     
         22 . The method of  claim 18 , wherein conducting the assay comprises transferring a volume of the biological sample and of one or more of the cartridge reagents stored in the cartridge to an assay unit based on the protocol. 
     
     
         23 . The method of  claim 18 , further comprising detecting a signal produced by the assay by a detector of the reader assembly. 
     
     
         24 . The method of  claim 18 , wherein the reader assembly comprises a fluid transfer device configured to transfer the biological sample and the cartridge reagents to an assay unit, and wherein the protocol comprises instructions for operating the fluid transfer device to transfer the biological sample and the cartridge reagents to the assay unit. 
     
     
         25 . The method of  claim 18 , further comprising determining prior use of the cartridge after reading the identifier of the cartridge. 
     
     
         26 . The method of  claim 18 , further comprising modifying the protocol received from the computer system prior to conducting the assay to detect the analyte. 
     
     
         27 . The method of  claim 18 , further comprising determining a date on which the assay is performed and comparing the date the assay is performed to a predetermined schedule.