Biomarkers for sepsis

Abstract

Biomarkers for sepsis and resulting mortality can be detected by assaying blood samples. Changes in the concentration of the biomarkers can be used to indicate sepsis, risk of sepsis, progression of sepsis, remission from sepsis, and risk of mortality. Changes can be evaluated relative to data sets, natural or synthetic or semisynthetic control samples, or patient samples collected at different time points. Some biomarkers' concentrations are elevated during disease and some are depressed. These are termed informative biomarkers. Some biomarkers are diagnostic in combination with others. Individual biomarkers may be weighted when used in combinations. Biomarkers can be assessed in individual, isolated or assays, in parallel assays, or in single-pot assays.

Description

TECHNICAL FIELD OF THE INVENTION [0001] This invention is related to the area of diagnosis. In particular, it relates to diagnosis, risk assessment, and monitoring of sepsis. BACKGROUND OF THE INVENTION [0002] Sepsis is the name given to infection when symptoms of inflammatory response are present. Of patients hospitalized in an intensive care unit (ICU) who have an infection, 82% have sepsis. Sepsis is defined as an infection-induced syndrome involving two or more of the following features of systemic inflammation: fever or hypothermia, leukocytosis or leukopenia, tachycardia, and tachypnea or a supranormal minute ventilation. Sepsis may be defined by the presence of any of the following ICD-9-CM codes: 038 (septicemia), 020.0 (septicemic), 790.7 (bacteremia), 117.9 (disseminated fungal infection), 112.5 (disseminated Candida infection), and 112.81 (disseminated fungal endocarditis). [0003] Sepsis is diagnosed either by clinical criteria or by culture of microorganisms from the blo...

AI Technical Summary

Benefits of technology

[0011] In one embodiment of the invention a method of diagnosing sepsis in a human subject is provide. Concentration of at least one analyte in a test sample from a human subject is compared to concentration of the at least one analyte in a reference range that was determined for one or more control samples obtained from one or more human subjects not suf...

Problems solved by technology

Culturing some microorganisms can be tedious and time-consuming, and may provide a high rate of false negatives.

Infection at many different sites can result in sepsis.

The heterogeneity of sepsis increases the difficulty in devising a diagnostic test.

Care of patients with sepsis is expensive and accounts for $17 billion annually in the United States alone.

Sepsis is often lethal, killing 20 to 50 percent of severely affected patients.

Furthermore, sepsis substantially reduces the quality of life of those who survive: only 56% of patients surviving sepsis are discharged home; 32% are discharged to other health care facilities (i.e., rehabilitation centers or other long-term care facilities), accruing additional costs of care.

Early diagnosis of sepsis is expected to result in decreased morbidity, mortality and cost of care.

Risk of death from sepsis increases with increasing severity of sepsis.

Sepsis is a major cause of admission to a hospital intensive care unit.

Sepsis is a common complication of prolonged stay in an ICU.

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