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.

Description

RELATED APPLICATIONS[0001]This application is a division of U.S. patent application Ser. No. 15 / 713,722 filed on Sep. 25, 2017, which is a continuation of U.S. patent application Ser. No. 15 / 015,309 filed on Feb. 4, 2016, now U.S. Pat. No. 9,791,446, which is a division of U.S. patent application Ser. No. 13 / 090,893 filed on Apr. 20, 2011, now U.S. Pat. No. 9,709,565, which claims the benefit of priority of Provisional Patent Application No. 61 / 326,244 filed on Apr. 21, 2010. The contents of the above applications are all incorporated by reference as if fully set forth herein in their entirety.FIELD OF THE INVENTION[0002]The present invention relates generally to the identification of biological signatures and determinants associated with bacterial and viral infections and methods of using such biological signatures in the screening diagnosis, therapy, and monitoring of infection.BACKGROUND OF THE INVENTION[0003]Antibiotics (Abx) are the world's most prescribed class of drugs with a...

AI Technical Summary

Benefits of technology

[0007]The present invention is based on the identification of signatures and determinants associated with bacterial, viral and mixed (i.e., bacterial and viral co-infections) infections. The methods of the invention allow for the identification of type of infection a subject is suffering from, which in turn allows for the selection of an appropriate treatment regimen. Importantly, not only do the signatures and determinants of the present invention discriminate between viral and bacterial infections, the signatures and determinant also discriminate between mixed and viral infections. Thus, the methods of the invention allow for the selection of subjects whom antibiotic treatment is desired and prevent unnecessary antibiotic treatment of subject having only a viral infection or a non-infectious disease.

Problems solved by technology

For example, according to the USA center for disease control and prevention over 60 Million wrong Abx prescriptions are given annually to treat flu in the US, for which they are ineffective and inappropriate.

The major factors that limit the effectiveness of current diagnostic solutions for reducing erroneous prescription include: (i) time to diagnosis; (ii) inaccessible infection site; (iii) false positives due to non-pathogenic bacteria and (iv) the challenge of diagnosing mixed infection (i.e., bacterial and viral co-infection).

Current solutions (such as culture, PCR and immunoassays) do not fulfill all these requirements: (i) most assays (with the exception of multiplex PCRs) are often constrained to a limited set of bacterial or viral strains; (ii) they usually require hours to days (e.g. culture and nucleic acid based assays); (iii) they often do not distinguish between pathogenic and non-pathogenic bacteria (Del March 1992); (iv) they are often incapable of distinguishing between a mixed and a pure viral infection and (v) they require direct sampling of the infection site in which traces of the disease causing agent are searched for.

The latter prohibits diagnosis in cases where the pathogen resides in an inaccessible tissue, which is often the case.

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