Becton Dickinson and Company Limited

James A Garrett

Richard L Moore

Song Shi

Robert W Rosenstein

Nicholas Robert Bachur, Jr

Keith Edward Thornton

Sha-Sha Wang

Gregory Tice

Donald W Copertino

William E Keating

William A Nussbaumer

Thomas M Gentle, Jr

Craig C Whiteford

Paul Ernest Goldenbaum

Richard Ivey

Michael L Towns

James G Nadeau

Gary Siuzdak

Elizabeth J Want

Zhouxin Shen

Methods for predicting the development of sepsis in a subject at risk for developing sepsis are provided. In one method, features in a biomarker profile of the subject are evaluated. The subject is likely to develop sepsis if these features satisfy a particular value set. Methods for predicting the development of a stage of sepsis in a subject at risk for developing a stage of sepsis are provided. In one method, a plurality of features in a biomarker profile of the subject is evaluated. The subject is likely to have the stage of sepsis if these feature values satisfy a particular value set. Methods of diagnosing sepsis in a subject are provided. In one such method, a plurality of features in a biomarker profile of the subject is evaluated. The subject is likely to develop sepsis when the plurality of features satisfies a particular value set.

Diagnosis of sepsis

The present invention relates to methods, monitors and systems, useful, for example, for advanced detection of sepsis in a subject.

Advanced detection of sepsis

The present invention relates to methods, monitors and systems measuring lysophosphatidylcholine, its derivatives and/or procalcitonin as well as at least one clinical marker (e.g. temperature or respiration rate) and/or at least one biomarker for the early detection of sepsis in a subject.

The early prediction or diagnosis of sepsis advantageously allows for clinical intervention before the disease rapidly progresses beyond initial stages to the more severe stages, such as severe sepsis or septic shock, which are associated with high mortality. Early prediction or diagnosis is accomplished using a molecular diagnostics approach, involving comparing an individual's profile of biomarker expression to profiles obtained from one or more control, or reference, populations, which may include a population who develops sepsis. Recognition of features in the individual's biomarker profile that are characteristic of the onset of sepsis allows a clinician to diagnose the onset of sepsis from a bodily fluid isolated at the individual at a single point in time. The necessity of monitoring the patient over a period of time is, therefore, avoided, advantageously allowing clinical intervention before the onset of serious symptoms. Further, because the biomarker expression is assayed for its profile, identification of the particular biomarkers is unnecessary. The comparison of an individual's biomarker profile to biomarker profiles of appropriate reference populations likewise can be used to diagnose SIRS in the individual.

Diagnosis of sepsis or SIRS using biomarker profiles

Mass spectrometry techniques for determining the status of sepsis in an individual are provided. A biomarker profile resolved from a biological sample, taken from the individual, using a mass spectrometry technique is compared to a reference biomarker profile. A single such comparison classifies the individual as belonging to or not belonging to a reference population. The individual's biomarker profile and the reference biomarker profile comprise a plurality of ions each having a mass-to-charge ratio of about 100 Daltons to about 1000 Daltons. The plurality of ions can be detected by electrospray ionization mass spectrometry in positive mode. The comparison uses a decision rule, such as a classification tree, that determines the status of sepsis in the individual without requiring knowledge of the identity of the biomarkers in the biomarker profile from the individual and without requiring knowledge of the identity of the biomarkers in the reference biomarker profile.

Mass spectrometry techniques for determining the status of sepsis in an individual

Method of predicting the onset of sepsis in SIRS-positive individuals using mass spectrometry

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Baltimore, MD, United States of America

James A Garrett