Protein signatures for distinguishing between bacterial and viral infections
Inventors
Eden, Eran • Oved, Kfir • COHEN-DOTAN, Assaf • NAVON, Roy • BOICO, Olga • KRONENFELD, Gali • Paz, Meital • Bamberger, Ellen
Assignees
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Publication Number
US-12044681-B2
Publication Date
2024-07-23
Expiration Date
Abstract
Methods of diagnosing infections are disclosed. In one embodiment, the method comprises measuring the amount of each of the polypeptides TRAIL, CRP, IP10 and at least one additional polypeptide selected from the group consisting of IL-6 and PCT.
Core Innovation
The disclosed subject matter is directed to distinguishing between a viral and a bacterial infection using a blood sample from a subject. The protein signature is centered on TRAIL, CRP, and IP10 as part of a TCP signature, with antibody-based detection of specified proteins used to distinguish infection types and related conditions.
The disclosure addresses early sensitivity by adding IL-6 and/or procalcitonin (PCT) to the TCP signature. It describes algorithmic combinations, logistic regression, fuzzy OR modeling, and cutoff-based ruling-in and ruling-out using biomarker thresholds or cutoffs, including sample timing relative to symptom onset.
The disclosure further describes differentiation of infectious versus non-infectious patients using single and multi-protein logistic regression combinations. It also includes kit-based implementation using antibodies and assay formats in which at least one antibody is attached to a detectable label or a solid support.
Claims Coverage
The independent claim defines a kit-based diagnostic for distinguishing viral versus bacterial infection from a blood sample, with antibodies specific for TRAIL, IL-6, CRP, and IP10, limited to no more than 5 proteins, and with at least one antibody attached to a detectable label or a solid support.
Antibody set for TRAIL, IL-6, CRP, and IP10 to distinguish viral vs bacterial infection
A kit for distinguishing between a viral and a bacterial infection using a blood sample comprising an antibody that specifically detects TRAIL, an antibody that specifically detects IL-6, an antibody that specifically detects CRP, and an antibody that specifically detects IP10.
Limited protein targets
The kit comprises antibodies that specifically detect no more than 5 proteins.
Detectable label or solid support attachment
At least one of the antibodies is attached to a detectable label or a solid support.
Overall claim coverage is directed to a viral-versus-bacterial infection diagnostic kit based on antibodies against TRAIL, IL-6, CRP, and IP10, constrained to no more than 5 proteins and with at least one antibody configured with a detectable label or solid support.
Stated Advantages
Improved sensitivity when IL-6 and PCT are mathematically combined using the described model.
Reduced equivocal rates when IL-6 and PCT are mathematically combined using the described model.
Improved early sensitivity by adding IL-6 and/or PCT to the TCP signature.
Diagnostic performance improvement reported using heterogeneous cohort results, including reported AUC, sensitivity, and specificity improvements from adding IL-6 and PCT.
Documented Applications
Distinguishing between viral and bacterial infection using a blood sample.
Classifying early infections (days 0–1) or within 0–2 days of symptom onset.
Differentiating infectious versus non-infectious patients.
Distinguishing sepsis versus non-infectious SIRS.
Distinguishing COPD infective versus non-infective exacerbation.
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