Method and device for discriminating between viral and bacterial infections

Abstract

The present invention relates to a point-of-care assay for detecting and differentiating between viral and bacterial infections, which effectively assist in the rapid differentiation of viral and bacterial infections. More particularly, the invention pertains to an immunoassay that rapidly distinguishes between viral and/or bacterial infections, wherein the viral marker is the interferon induced Mx-B protein and the bacterial markers are CRP/PCT/BPI.

1 . A point-of-care (POC) assay device comprising
 a. a sample application zone, and   b. a detection zone with a first detection reagent with binding affinity to Mx-B-protein (Mx-B), and a second detection reagent with binding affinity to C-reactive Protein (CRP) and/or procalcitonin (PCT), and   wherein the device is configured to detect Mx-B and/or CRP/PCT in a sample from a subject to discriminate between bacterial and viral infection.   
     
     
         2 . The device of  claim 1 , further comprising a third detection reagent with binding affinity to BPI. 
     
     
         3 . The device of  claim 1 , wherein said detection reagents are selected from synthetic molecules, nucleotides, nucleic acids, aptamers, peptides, proteins, enzymes, and antibodies. 
     
     
         4 . The device of  claim 3 , wherein said detection reagents are labelled with a detectable marker. 
     
     
         5 . The device of  claim 4 , wherein the detectable marker is selected from an enzyme label, fluorescent label, radiolabel, particulate label, colored latex particle, colored plastic particle, a colored phosphor particle, and a fluorescent particle. 
     
     
         6 . The device of  claim 1 , further comprising a test window configured to allow observation of the test results. 
     
     
         7 . The device of  claim 1 , wherein the detection reagents are chemically conjugated to the detectable marker to form a permanent, irreversible reagent-marker complex. 
     
     
         8 . The device of  claim 1 , wherein the detectable marker conjugated to the detection reagent is configured to be visible to a user when the sample is positive for Mx-B and/or CRP and/or PCT and/or BPI. 
     
     
         9 . The device of  claim 1 , wherein the device is configured to qualitatively and/or quantitatively measure the presence of Mx-B and/or CRP and/or PCT and/or BPI in human blood samples. 
     
     
         10 . A method for discriminating between bacterial and viral infection in a subject, comprising the steps of
 a. providing a sample from said subject,   b. providing the device of  claim 1 ,   c. applying the sample to the device,   d. observing the absence or presence of the detectable reagent-marker complex to determine whether the sample contains Mx-B and/or CRP and/or PCT and/or BPI, and   e. determining the infection status of the patient.   
     
     
         11 . The method of  claim 10 , wherein
 a. the presence of Mx-B and the absence and/or low detection of CRP/PCT/BPI is indicative for a viral infection,   b. the absence of Mx-B and the presence of CRP/PCT/BPI is indicative for a bacterial infection; and   c. the presence of Mx-B and the presence of CRP/PCT/BPI is indicative for a mixed infection.   
     
     
         12 . The method of  claim 10 , further observing the absence or presence of the detectable reagent-marker complex to determine whether the sample contains BPI. 
     
     
         13 . The method of  claim 10 , wherein
 a. the presence of Mx-B and the absence of CRP/PCT and BPI is indicative for a viral infection,   b. the absence of Mx-B and the presence of CRP/PCT and BPI is indicative for a bacterial infection; and   c. the presence of Mx-B and the presence of CRP/PCT and BPI is indicative for a mixed infection.   
     
     
         14 . The method of  claim 10 , wherein the sample is a blood sample. 
     
     
         15 . The method of  claim 10 , wherein the presence of Mx-B, CRP/PCT and/or BPI is visible to the naked eye.