Non-invasive assay for differentiating between bacterial and viral infections
The invention provides assays and methods for diagnosing and treating infectious diseases. The invention relates in some embodiments to urinary biomarkers and their use in the differential diagnosis of bacterial and viral infections. The invention further relates to means for determining and providing correct treatment to infection in a non-invasive manner, while minimizing antibiotic misuse.
1 . A method for treating a subject suffering from an infection, the method comprising:
determining whether the subject has a bacterial infection by performing an immunoassay on a urine sample obtained from the subject to determine if the urine sample has detect a presence of at least two peptide fragments comprising a peptide fragment of C-reactive protein (CRP) and a peptide fragment of SAA2 and not comprising a peptide fragment of tumor necrosis factor-related apoptosis-inducing ligand (TRAIL),
wherein the immunoassay comprises subjecting the urine sample to antibodies specific to the at least two peptide fragments, to thereby construe a urinary proteomic signature of the subject;
wherein the subject is administered with an antibiotic drug if the urinary proteomic signature of the subject corresponds to a bacterial control urinary proteomic signature of a subject suffering from the bacterial infection; and
wherein the subject is not administered with an antibiotic drug if the urinary proteomic signature of the subject corresponds to a viral control urinary proteomic signature of a subject suffering from a viral infection.
2 . The method of claim 1 , wherein the bacterial control proteomic signature and the viral control proteomic signature are obtained from mass-spec analysis of urine samples obtained from a plurality of subjects suffering from a bacterial and viral infections respectively.
3 . The method of claim 1 , wherein, the immunoassay is a lateral flow test.
4 . The method of claim 1 , wherein performing the immunoassay comprises determining a level of each of the at least two peptide fragments in the urine sample.
5 . The method of claim 4 , further comprising comparing the determined level of each of the at least two peptide fragments to a predetermined cutoff value.
6 . The method of claim 1 , wherein the at least two peptide fragments further comprise at least one fragment of the gene products selected from the group consisting of ENG, CD302, STC1, DSC3, OPCML, CRB2, EPHB3, CDHR5, DEFA3, DEFA1, IGFALS, F10, EPHB2, OGFOD3, CD163, RGAG1, GPR116, LYPD6B, VPS4B, and PDGFRA.
7 . The method of claim 1 , wherein the at least two peptide fragments are fragments of the gene products selected from the group consisting of LILRB4, PTMA, SEMG1, DPH3, HNRNPM, fflSTIHIE, PSMD2, SELL, and TRIM28 peptide fragments.
8 . The method of claim 1 , wherein the subject is presenting at least two systemic inflammatory response syndrome (SIRS) criteria.
9 . The method of claim 1 , wherein the infection is associated with a condition selected from the group consisting of: Epstein-Barr virus (EBV) infection, cytomegalovirus (CMV) infection, measles, parainfluenza bronchitis, upper respiratory tract infection, lower respiratory tract infection, rash, varicella-zoster virus (VZV) infection, stemitis, peritonitis, pneumonia, rickettsia infection, insect bite, cellulitis, folliculitis, diverticulitis, colitis, dental infection, bacterial endocarditis, myositis, bacteremia, ascending cholangitis, abscess, bacterial pharyngitis, cholecystitis, empyema, osteomyelitis, parotitis, bronchitis, dengue infection, herpes zoster infection, infectious mononucleosis, influenza, meningitis, and combinations thereof.
10 . The method of claim 1 , wherein the antibiotic drug is selected from the group consisting of broad-spectrum gram-positive antibiotics, broad-spectrum gram-negative antibiotics, and combinations thereof.