Systems and methods for conducting animal studies

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.

1 . A method for detecting a biological analyte, comprising:
 determining an identity of a fluidic device, the fluidic device configured for performing an assay to yield a signal indicative of the presence or concentration of the biological analyte in a sample;   receiving a protocol from an external device, the protocol associated with the identity of the fluidic device and for controlling fluid movement caused by actuating elements interacting with the fluidic device to perform the assay;   controlling the actuating elements in accordance with the protocol to perform the assay; and   detecting:
 the signal indicative of the presence or concentration of the biological analyte in the sample; or 
 an absence of the biological analyte in the sample. 
   
     
     
         2 . The method of  claim 1 , wherein the protocol is a first protocol, the assay is a first assay, the signal is a first signal, and the biological analyte is a first biological analyte, the method further comprising:
 receiving a second protocol from the external device, the second protocol associated with the identity of the fluidic device and for controlling fluid movement caused by the actuating elements interacting with the fluidic device to perform a second assay to yield a second signal indicative of the presence or concentration of a second biological analyte, different from the first biological analyte, in the sample;   controlling the actuating elements in accordance with the second protocol to perform the second assay; and   detecting the second signal indicative of the presence or concentration of the second biological analyte in the sample.   
     
     
         3 . The method of  claim 1 , wherein the protocol is a first protocol, the assay is a first assay, and the signal is a first signal, the method further comprising:
 receiving a second protocol from the external device, the second protocol associated with the identity of the fluidic device and for controlling fluid movement caused by the actuating elements interacting with the fluidic device to perform a second assay to yield a second signal indicative of the presence or concentration of the biological analyte in the sample;   controlling the actuating elements in accordance with the second protocol to perform the second assay; and   detecting the second signal indicative of the presence or 5 concentration of the biological analyte in the sample.   
     
     
         4 . The method of  claim 1 , wherein the fluidic device is a first fluidic device, the protocol is a first protocol, the assay is a first assay, the signal is a first signal, the sample is a first sample, and the biological analyte is a first biological analyte, the method further comprising:
 determining an identity of a second fluidic device, the second fluidic device configured for performing a second assay to yield a second signal indicative of the presence or concentration of a second biological analyte, different from the first biological analyte, in a second sample;   receiving a second protocol from the external device, the second protocol associated with the identity of the second fluidic device and for controlling fluid movement caused by the actuating elements interacting with the second fluidic device to perform the second assay;   controlling the actuating elements in accordance with the second protocol to perform the second assay; and   detecting the second signal indicative of the presence or concentration of the second biological analyte in the second sample.   
     
     
         5 . The method of  claim 2 , wherein the external device stores a plurality of protocols from which at least one of:
 the second protocol is selected on the basis of the identity of the second fluidic device; or   the protocol is selected on the basis of the identity of the fluidic device.   
     
     
         6 . The method of  claim 1 , further comprising:
 transmitting the signal indicative of the presence or concentration of the biological analyte in the sample to the external device.   
     
     
         7 . The method of  claim 1 , further comprising:
 controlling the actuating elements to pump and/or valve fluid in accordance with the protocol.   
     
     
         8 . The method of  claim 1 , further comprising:
 controlling the actuating elements to dilute a sample in accordance with the protocol.   
     
     
         9 . The method of  claim 1 , further comprising:
 reading an identifier of the fluidic device for determining the identity of the fluidic device; and   transmitting the identifier to the external device, wherein the identifier is a bar code identifier read by a bar code reader.   
     
     
         10 . A system comprising:
 a fluidic device configured for performing an assay to yield a signal indicative of the presence or concentration of a biological analyte in a sample;   an external device storing a protocol associated with an identity of the fluidic device and for controlling fluid movement caused by actuating elements interacting with the fluidic device to perform the assay;   an assembly comprising:
 a mechanism for receiving the fluidic device, the actuating elements for interacting with the fluidic device in accordance with the protocol, and a detection assembly for detecting the signal; and 
   a communication assembly for receiving the protocol from the external device.   
     
     
         11 . The system of  claim 10 , the actuating elements controllable to pump and/or valve fluid in accordance with the protocol. 
     
     
         12 . The system of  claim 10  wherein the actuating elements comprise a pump and/or a valve for the fluid movement. 
     
     
         13 . The system of  claim 10 , wherein the fluidic device does not include a pump. 
     
     
         14 . The system of  claim 10 , wherein the fluidic device comprises multiple reaction sites, each for performing a different assay. 
     
     
         15 . The system of  claim 10 , wherein the actuating elements are controllable to dilute a sample in accordance with the protocol. 
     
     
         16 . The system of  claim 10 , wherein the fluidic device comprises a burstable seal, a reagent chamber, and a fluidic channel, wherein the actuating elements are controllable to burst the burstable seal to move reagent from the reagent chamber into the fluidic channel for fluid communication with a reaction site to perform the assay. 
     
     
         17 . The system of  claim 10 , wherein the fluidic device comprises a cover comprising at least one of an elastomeric, flexible, silicone, or moisture impermeable material. 
     
     
         18 . The system of  claim 10 , wherein the external device comprises at least one of: a computer system, server, or an electronic device capable of storing information or processing information. 
     
     
         19 . The system of  claim 10 , wherein the protocol comprises instructions to a controller to control the actuating elements to perform the assay. 
     
     
         20 . The system of  claim 10 , wherein the sample is a plasma sample. 
     
     
         21 . The system of  claim 10 , wherein the fluidic device comprises an assay assembly for the sample to react with reactants contained within the assay assembly for performing the assay, the actuating elements controllable to move fluid through the fluidic device.