Signatures and determinants for diagnosing infections and methods of use thereof
Inventors
Oved, Kfir • Eden, Eran • Ifergan, Ilan
Assignees
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Publication Number
US-12188934-B2
Publication Date
2025-01-07
Expiration Date
Abstract
A kit is disclosed for distinguishing between bacterial and viral infections. One of the antibodies of the kit specifically binds to TNF-related apoptosis-inducing ligand (TRAIL) protein and another of the antibodies of the kit specifically binds to Procalcitonin (PCT) protein.
Core Innovation
The invention discloses diagnostic methods and kits that distinguish between viral and bacterial infection, including mixed infections, using host determinants and polypeptide signatures. The diagnostic approach is centered on specific determinants and their corresponding polypeptide levels in a patient sample.
A key aspect is the use of determinants corresponding to TNF-related apoptosis-inducing ligand (TRAIL), and optionally Procalcitonin (PCT) and C-Reactive protein (CRP), for determining whether an infection is viral and/or bacterial. The document further supports inclusion of additional determinants associated with differential expression between viral and bacterial infection.
The document describes diagnostic logic based on threshold value and mathematical scoring/indexes that incorporate polypeptide measurements from one or more determinants. It also reports that combining determinants, including low-correlation biomarkers such as TRAIL and CRP, improves diagnostic performance.
The disclosure further provides definitions of determinants and reference profiles, and describes kit and reagent and immunoassay detection approaches that use antibodies. Immunoassay detection formats explicitly include labeled immunoassays such as ELISA, Luminex, and flow cytometry, and the kit embodiments include antibody immobilization on a solid support and exemplary monoclonal antibodies for TRAIL, PCT, and CRP.
Claims Coverage
The independent claims cover antibody-based diagnostic kits centered on TRAIL, PCT, and CRP, with one claim limiting additional determinant antibodies and another requiring immobilization on a solid support.
Antibody kit targeting TRAIL, PCT, and CRP with limited additional soluble determinant antibodies
A kit comprising antibodies including a first antibody that specifically binds to TNF-related apoptosis-inducing ligand (TRAIL) protein, a second antibody that specifically binds to Procalcitonin (PCT) protein, and a third antibody that specifically binds to C-Reactive protein (CRP), wherein the kit does not comprise more than three additional antibodies that specifically bind to additional determinants, each of the additional antibodies targeting a different soluble determinant whose level is differentially expressed in a viral and bacterial infection.
Solid-support immobilized antibody kit for TRAIL, PCT, and CRP
A kit comprising antibodies immobilized on a solid support, wherein the antibodies consist of a first antibody that specifically binds to TRAIL protein, a second antibody that specifically binds to PCT protein, and a third antibody that specifically binds to C-Reactive protein (CRP).
Overall claim coverage centers on kits that use antibody binding to TRAIL, PCT, and CRP for differential infection diagnosis, with one claim adding a restriction on the number of additional determinant-targeting antibodies and another requiring antibody immobilization on a solid support.
Stated Advantages
Improved diagnostic accuracy when combining low-correlation biomarkers, including TRAIL and CRP.
Documented Applications
Distinguishing viral and bacterial infections, including mixed infections, using host determinants and polypeptide signatures centered on TRAIL and optionally PCT and CRP.
Immunoassay detection of the biomarkers using antibody-based kit formats, including ELISA, Luminex, flow cytometry, and a lateral flow immunoassay embodiment.
Development and validation of the diagnostic approach using a prospective multi-center clinical trial with 655 patients and measurement of more than 570 polypeptides.
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