Early diagnosis of infections
Inventors
Eden, Eran • Oved, Kfir • COHEN-DOTAN, Assaf • NAVON, Roy • BOICO, Olga • Paz, Meital
Assignees
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Publication Number
US-12055545-B2
Publication Date
2024-08-06
Expiration Date
Abstract
Methods of determining infection type are disclosed. In one embodiment, the method comprises measuring the amount of TRAIL and/or IP10 no more than two days from symptom onset.
Core Innovation
The disclosed invention relates to early infection diagnosis and treatment of a human subject showing symptoms of a pathogenic infection. It uses interferon γ-induced protein (IP-10) measured in a blood sample collected no more than two days following symptom onset, with an IP-10 level threshold above 160 pg/ml, and links the IP-10 level to administering a therapeutically effective amount of an antibiotic or antiviral agent to treat the subject.
The document further describes that TRAIL has distinctive dynamics across bacterial versus viral infection, with lower levels in bacterial infection and higher levels in viral infection. By measuring TRAIL in addition to IP-10, and in some embodiments other biomarkers, the system supports differentiating infection types, including mixed infections, and guiding treatment decisions by using the measured biomarker levels to select antibiotic or antiviral agents.
The disclosure also describes diagnostic performance across cutoff levels and early time windows including within ≤2 days from symptom onset and supports forming multi-biomarker panels or scores. Biomarker measurement approaches described include ELISA and lateral flow immunoassays, and the detection may use an IP-10-specific antibody including a monoclonal form.
Claims Coverage
The document contains two independent claims. Across them, the core inventive coverage centers on early IP-10-based analysis within a defined post-symptom-onset window and triggering antibiotic or antiviral treatment when IP-10 is above 160 pg/ml, with additional inventive features adding optional TRAIL and other biomarker measurements and specifying measurement modalities and antibody forms.
Early IP-10 threshold-guided antibiotic or antiviral treatment
Analyzing an amount of interferon γ-induced protein (IP-10) in a blood sample no more than two days following symptom onset, and treating the subject with a therapeutically effective amount of an antibiotic or antiviral agent when the level of IP-10 is above 160 pg/ml.
IP-10 above 160 pg/ml within two days as a treatment trigger
Treating a human subject showing symptoms of a pathogenic infection and exhibiting a level of interferon γ-induced protein (IP-10) above 160 pg/ml in a blood sample no more than two days following symptom onset by administering a therapeutically effective amount of an antibiotic or antiviral agent.
Overall, the claim set primarily covers diagnosing and treating a symptomatic human subject using early blood IP-10 measurement with an explicit threshold above 160 pg/ml to select a therapeutically effective antibiotic or antiviral agent, with dependent claim coverage expanding the analysis to additional biomarkers including TRAIL, IL-6, IL1RA, CRP, and procalcitonin and specifying measurement modality and IP-10-specific antibody embodiments.
Stated Advantages
Improved early diagnostic accuracy within early time windows, including ≤2 days from symptom onset.
Differentiation between bacterial infection and viral infection based on distinctive biomarker dynamics of TRAIL and related diagnostic analysis.
Support for diagnosing and treating, including guiding treatment decisions for antibiotic/anti-bacterial versus antiviral/anti-viral selection.
Ability to distinguish infection types including mixed infections.
Documented Applications
Early diagnosis and treatment decision support for a human subject showing symptoms of a pathogenic infection using IP-10 and optionally additional biomarkers including TRAIL.
Differentiation of infection types, including mixed infections, to guide antibiotic or antiviral recommendation and treatment regimen selection.
Potential discrimination related to COPD exacerbation and asthma exacerbation infectivity.
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