Real-time detection of influenza virus

Abstract

The present invention provides system and methods for detecting an analyte indicative of an influenza viral infection in a sample of bodily fluid. The present invention also provides for systems and method for detection a plurality of analytes, at least two of which are indicative of an influenza viral infection in a sample of bodily fluid.

1 . A method of detecting an influenza viral particle in a sample of bodily fluid using a fluidic device comprising a sample collection unit, an assay assembly, and a waste chamber, the method comprising:
 receiving the sample of bodily fluid from a subject suspected to contain the influenza viral particle at the sample collection unit of the fluidic device;   providing the sample to the assay assembly of the fluidic device through the sample collection unit, wherein the assay assembly comprises a first reagent chamber, a second reagent chamber, a reaction site, and a fluidic channel that connects the first and second reagent chambers with the reaction site, and wherein the first reagent chamber comprises a first immunoassay reagent and the second reagent chamber comprises a second immunoassay reagent;   releasing the first and second immunoassay reagents from the first and second reagent chambers to the reaction site of the assay assembly through the fluidic channel by one or more actuating elements;   allowing the sample to react with the first and second immunoassay reagents at the reaction site of the assay assembly, wherein the first immunoassay reagent binds to a hemagglutinin molecule to form a first immune complex on the influenza viral particle, wherein the second immunoassay reagent binds to a neuraminidase molecule to form a second immune complex on the influenza viral particle, and wherein the first and second immune complexes yield one or more signals indicative of the simultaneous presence of hemagglutinin and neuraminidase on the influenza viral particle; and   detecting the influenza viral particle in the sample based on detection of the one or more signals indicative of the simultaneous presence of hemagglutinin and neuraminidase.   
     
     
         2 . The method of  claim 1 , wherein the one or more actuating elements comprise at least one pump and one valve to control and direct movement of fluids in the fluidic device. 
     
     
         3 . The method of  claim 1 , wherein detection of the one or more signals indicative of the simultaneous presence of hemagglutinin and neuraminidase is indicative of an influenza type A viral infection. 
     
     
         4 . The method of  claim 1 , wherein detection of the one or more signals indicative of the simultaneous presence of hemagglutinin and neuraminidase is indicative of an influenza type B viral infection. 
     
     
         5 . The method of  claim 1 , wherein the hemagglutinin is selected from the group consisting of H1, H2, H3, H4, H5, H6, H7, H8, H9, H10, H11, H12, H13, H14, H15, and H16, and the neuraminidase is selected from the group consisting of N1, N2, N3, N4, and N5. 
     
     
         6 . The method of  claim 1 , wherein the hemagglutinin is H5 and the neuraminidase is N1. 
     
     
         7 . A system for detecting at least one analyte indicative of influenza in a sample of bodily fluid, the system comprising:
 a fluidic device comprising:
 a sample collection unit configured to receive the sample of bodily fluid; and
 an assay assembly configured to yield one or more signals indicative of the presence of the at least one analyte in the sample of bodily fluid; 
 
 an identification detector; 
 a communication assembly; and 
 a detection assembly, 
 wherein the identification detector is configured to:
 detect an identifier of the fluidic device; and 
 transmit the identifier to the communication assembly, 
 
 wherein the communication assembly is configured to:
 receive, from an external device, a protocol to execute on the fluidic device selected in response to detection of the identifier, wherein the protocol comprises instructions to run an assay on the fluidic device; and 
 
 wherein the detection assembly is configured to:
 detect the at least one analyte in the sample during the assay by detecting the one or more signals based on the instructions in the protocol received from the external device; and 
 transmit information regarding the detected one or more signals to the external device via the communication assembly, where a comparison of the detected one or more signals with a known profile associated with the at least one analyte is performed. 
 
   
     
     
         8 . The system of  claim 7 , wherein the at least one analyte comprises at least one of a hemagglutinin molecule and a neuraminidase molecule. 
     
     
         9 . The system of  claim 8 , wherein detection of the one or more signals indicative of the presence of the at least one analyte in the sample of bodily fluid comprises detection of a simultaneous presence of hemagglutinin and neuraminidase in the sample of bodily fluid, and wherein detection of the one or more signals is indicative of an influenza type A viral infection or an influenza type B viral infection. 
     
     
         10 . The system of  claim 7 , wherein the communication assembly is further configured to:
 receive the protocol from the external device in response to transmitting the identifier to the external device.   
     
     
         11 . A method of detecting at least one analyte indicative of influenza in a sample of bodily fluid, the method comprising:
 receiving the sample of bodily fluid at a sample collection unit of a fluidic device, wherein the fluidic device further comprises an assay assembly;   detecting an identifier of the fluidic device by an identification detector;   transmitting, by the identification detector, the identifier to a communication assembly;   transmitting, by the communication assembly, the identifier to an external device;   receiving, from the external device, a protocol to execute on the fluidic device selected in response to detection of the identifier, wherein the protocol comprises instructions to run an assay on the fluidic device;   allowing the sample of bodily fluid to react with at least one reactant immobilized in the assay assembly of the fluidic device during the assay, wherein the assay assembly is configured to yield one or more signals indicative of the presence of the at least one analyte indicative of influenza in the sample of bodily fluid;   detecting, by a detection assembly, the at least one analyte indicative of influenza in the sample by detecting the one or more signals based on the instructions in the protocol received from the external device; and   transmitting, by the detection assembly, information regarding the detected one or more signals to the external device via the communication assembly, where a comparison of the detected one or more signals with a known profile associated with the at least one analyte is performed.   
     
     
         12 . The method of  claim 11 , wherein the at least one analyte comprises at least one of a hemagglutinin molecule and a neuraminidase molecule. 
     
     
         13 . The method of  claim 12 , wherein detecting the one or more signals indicative of the presence of the at least one analyte in the sample of bodily fluid comprises detecting a simultaneous presence of hemagglutinin and neuraminidase in the sample of bodily fluid. 
     
     
         14 . The method of  claim 13 , wherein detecting the one or more signals is indicative of an influenza type A viral infection or an influenza type B viral infection. 
     
     
         15 . The method of  claim 13 , wherein the hemagglutinin is selected from the group consisting of H1, H2, H3, H4, H5, H6, H7, H8, H9, H10, H11, H12, H13, H14, H15, and H16, and the neuraminidase is selected from the group consisting of N1, N2, N3, N4, and N5. 
     
     
         16 . The method of  claim 13 , wherein the hemagglutinin is H5 and the neuraminidase is N1. 
     
     
         17 . The method of  claim 11 , further comprising: selecting the protocol from a plurality of protocols stored on the external device based on the identifier. 
     
     
         18 . The method of  claim 11 , further comprising: moving the sample of bodily fluid from the sample collection unit to the assay assembly in the fluidic device. 
     
     
         19 . The method of  claim 11 , further comprising: moving the sample of bodily fluid from the assay assembly to a waste chamber in the fluidic device. 
     
     
         20 . The method of  claim 11 , further comprising: processing the sample of bodily fluid prior to receiving the sample at the sample collection unit of the fluidic device by dilution.