Methods of prognosis and treatment
Inventors
Eden, Eran • Oved, Kfir • COHEN-DOTAN, Assaf • NAVON, Roy • BOICO, Olga • Paz, Meital
Assignees
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Publication Number
US-12228579-B2
Publication Date
2025-02-18
Expiration Date
Abstract
A method of determining a management course for treating a subject showing symptoms of a disease is disclosed. The method comprises measuring the TRAIL protein level in a blood sample of the subject, wherein when the TRAIL level is below a predetermined amount, the subject is treated as a high-risk patient.
Core Innovation
A method is provided for triaging subjects who are suspected of having a viral infection by measuring the TRAIL protein level in a blood sample of the subject. The triage is based on whether the TRAIL level is below a predetermined threshold, and when the TRAIL level is below 30 pg/ml the subject is subjected to management selected from specified care actions.
The disclosed approach links low TRAIL protein levels in blood to disease severity classification and prognosis/risk stratification, including poorer outcomes associated with very low TRAIL. The description reports study findings relating a TRAIL level below 25 pg/mL to outcomes such as longer hospitalization and higher need for intensive care interventions, including ICU admission and mechanical ventilation.
In certain embodiments, the blood sample is specified by fraction and cellular content, including serum or plasma and optionally cells selected from lymphocytes, monocytes, and granulocytes. TRAIL can be determined by electrophoretic measurement or immunochemical measurement using immunoassay formats such as ELISA and lateral flow immunoassay, with additional determinant markers optionally measured for refining the triage criteria.
Claims Coverage
The independent claim contains multiple inventive features centered on TRAIL-based triage and specified management actions triggered by a quantitative threshold. Dependent claims further define specimen type/fractions, TRAIL measurement modality and immunoassay technology, optional additional determinant markers, and an alternative (stricter) TRAIL threshold.
TRAIL protein level triage for suspected viral infection
Measuring the TRAIL protein level in a blood sample of the subject for triaging subjects who are suspected of having a viral infection.
Quantitative TRAIL threshold and management selection
When the TRAIL level is below 30 pg/ml, subjecting the subject to a management selected from the group consisting of hospitalization, mechanical ventilation, invasive monitoring, sedation, intensive care admission and surgical intervention.
Serum or plasma specimen fraction
The method where the fraction used is serum or plasma.
Specified immunochemical determination formats
Measuring the immunochemical determination using one of several specified immunoassay technologies including lateral flow immunoassay, flow cytometry, radioimmunoassay, immunofluorescence, and enzyme-linked immunosorbent assay.
Additional determinant markers for refined triage
Further triaging by measuring the level of at least one additional determinant selected from IP10, CRP, PCT, IL1RA, and IL-6.
Lower TRAIL threshold for triggering management
Managing a subject when the TRAIL level is below 25 pg/ml.
Blood sample with specified cell types
The blood sample includes cells selected from lymphocytes, monocytes, and granulocytes.
Across the independent claim and its dependents, the core coverage is TRAIL-based triage for suspected viral infection using a quantitative TRAIL threshold to trigger defined management actions, with refinements that specify specimen fractions, TRAIL determination modality and immunoassay technologies, optional additional determinant markers, and an alternative TRAIL cutoff.
Stated Advantages
Supports prognosis/risk stratification for suspected viral infection based on TRAIL protein levels.
Enables identification of high-risk subjects when TRAIL is below predetermined thresholds.
Enables linking very low TRAIL levels to poorer outcomes such as longer hospitalization and higher need for intensive care interventions.
Documented Applications
Emergency department triage and disease severity classification for subjects suspected of having a viral infection based on TRAIL protein measurement.
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