Signatures and determinants for distinguishing between a bacterial and viral infection and methods of use thereof

Abstract

The present invention provides methods of detecting infection using biomarkers. The methods disclosed herein include measuring the expression level of one or more polypeptide determinants in which the alteration of the expression level indicates infection of the patient. The methods provided herein are for distinguishing between bacterial infection, mixed infection, and/or viral infection. The methods disclosed herein may also further comprise measuring one or more non-polypeptide determinants. The present disclosure also provides methods for selection of a treatment regimen for the subject based on whether the subject is identified as having a bacterial or mixed infection, or a viral infection.

What is claimed is: 
     
         1 . A kit for a detection assay for distinguishing between bacterial and viral infections, the kit comprising a first monoclonal antibody that specifically binds to a first polypeptide and a second monoclonal antibody that specifically binds to a second polypeptide, wherein said first polypeptide is RSAD2 and said second polypeptide is selected from the group consisting of ABTB1, ADIPOR1, ARHGDIB, ARPC2, CD15, CORO1A, CRP, CSDA, EIF4B, EPSTI1, GAS7, HERC5, IFI6, IFIT1, IFIT3, IFITM1, IFITM3, IL7R, LOC26010, LY6E, MAN1C1, MBOAT2, MX1, NPM1, OAS2, PARP12, PARP9, PDIA6, PTEN, SDCBP, and TRIM 22, wherein the kit comprises no more than two additional monoclonal antibodies which specifically bind to additional polypeptides other than said first polypeptide and said second polypeptide, wherein said additional polypeptides are differentially expressed in a statistically significant manner in subjects with a bacterial infection compared to subjects with a viral infection. 
     
     
         2 . A kit for a detection assay for distinguishing between bacterial and viral infections, the kit comprising a first monoclonal antibody that specifically binds to a first polypeptide and a second monoclonal antibody that specifically binds to a second polypeptide, wherein said first polypeptide is RSAD2 and said second polypeptide is selected from the group consisting of ABTB1, ADIPOR1, ARHGDIB, ARPC2, CD15, CORO1A, CRP, CSDA, EIF4B, EPSTI1, GAS7, HERC5, IFI6, IFIT1, IFIT3, IFITM1, IFITM3, IL7R, LOC26010, LY6E, MAN1C1, MBOAT2, MX1, NPM1, OAS2, PARP12, PARP9, PDIA6, PTEN, SDCBP and TRIM 22, wherein the kit contains two, three or four monoclonal antibodies. 
     
     
         3 . The kit of  claim 1 , wherein said second monoclonal antibody specifically binds CRP or MX1. 
     
     
         4 . The kit of  claim 2 , wherein said second monoclonal antibody specifically binds CRP or MX1. 
     
     
         5 . The kit of  claim 1 , wherein the kit comprises a second monoclonal antibody that binds CRP and a third monoclonal antibody that binds MX1. 
     
     
         6 . The kit of  claim 2 , wherein the kit comprises a second monoclonal antibody that binds CRP and a third monoclonal antibody that binds MX1. 
     
     
         7 . The kit of  claim 1 , further comprising: (i) an antibody that specifically binds to said first polypeptide at an additional site as to the site to which said first monoclonal antibody binds; and (ii) an antibody that specifically binds to said second polypeptide at an additional site as to the site to which said second monoclonal antibody binds, wherein each of said antibodies of (i) and (ii) comprise a detectable label selected from the group consisting of a radioactive label, a fluorescent label, a chemiluminescent label, a colorimetric label and an enzyme. 
     
     
         8 . The kit of  claim 2 , further comprising: (i) an antibody that specifically binds to said first polypeptide at an additional site as to the site to which said first monoclonal antibody binds; and (ii) an antibody that specifically binds to said second polypeptide at an additional site as to the site to which said second monoclonal antibody binds, wherein each of said antibodies of (i) and (ii) comprise a detectable label selected from the group consisting of a radioactive label, a fluorescent label, a chemiluminescent label, a colorimetric label and an enzyme. 
     
     
         9 . The kit of  claim 1 , wherein said first monoclonal antibody and said second monoclonal antibody are immobilized to a solid support. 
     
     
         10 . The kit of  claim 2 , wherein said first monoclonal antibody and said second monoclonal antibody are immobilized to a solid support. 
     
     
         11 . The kit of  claim 9 , wherein said first monoclonal antibody and said second monoclonal antibody are immobilized to a single solid support. 
     
     
         12 . The kit of  claim 10 , wherein said first monoclonal antibody and said second monoclonal antibody are immobilized to a single solid support. 
     
     
         13 . The kit of  claim 7 , wherein said enzyme is horseradish peroxidase or alkaline phosphatase. 
     
     
         14 . The kit of  claim 1 , wherein the kit contains antibodies that detect no more than three polypeptides. 
     
     
         15 . The kit of  claim 1 , wherein the kit comprises no more than one additional monoclonal antibody which specifically bind to an additional polypeptide other than said first polypeptide and said second polypeptide, wherein said additional polypeptide is differentially expressed in a statistically significant manner in subjects with a bacterial infection compared to subjects with a viral infection.