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Diagnosis of sepsis or SIRS using biomarker profiles

A technology of biomarkers and sepsis, applied in the diagnosis of systemic inflammatory response syndrome in individuals, diagnosis or prediction of sepsis in individuals or its development stage, can solve the problem of not predicting the development of sepsis, and achieve rapid and sensitive The effect of prediction and diagnosis

Inactive Publication Date: 2006-02-22
BECTON DICKINSON & CO
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

However, these systems and models do not predict the development of sepsis itself

Method used

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  • Diagnosis of sepsis or SIRS using biomarker profiles
  • Diagnosis of sepsis or SIRS using biomarker profiles
  • Diagnosis of sepsis or SIRS using biomarker profiles

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0093] Example 1: Identification of small molecule biomarkers using quantitative liquid chromatography / electrospray ionization mass spectrometry (LC / ESI-MS)

[0094] 1.1 Samples received and analyzed

[0095]Reference biomarker profiles were established for two populations of patients. The first cohort ("SIRS group") represented 20 patients with SIRS who entered the study on "Day 1" but did not develop sepsis during their hospitalization. The second population ("sepsis group") represented patients who also had SIRS and entered the study on Day 1 but developed sepsis at least several days after entering the study. Blood samples were collected approximately every 24 hours from each study group. Clinical suspicion of sepsis in the sepsis group occurred at "time 0", detected by conventional techniques. "Time - 24 hours" and "Time - 48 hours" represent samples taken about 24 hours and about 48 hours before clinical suspicion of onset of sepsis in the sepsis group, respectively. ...

Embodiment 2

[0198] Example 2: Identification of protein biomarkers using quantitative liquid chromatography-mass spectrometry / mass spectrometry (LC-MS / MS)

[0199] 2.1 Samples received and analyzed

[0200] As above, the reference biological Mark spectrum. Blood was drawn from the patient on day 1, time 0, time -48 hours. In this case, 50-75 μL plasma samples from patients were pooled into four batches: two batches consisting of 5 and 10 individuals, respectively, who were SIRS positive, and two batches consisting of 5 and 10 individuals, who were both is positive for sepsis. Six samples from each pooled batch were further analyzed.

[0201] 2.2 Sample preparation

[0202] Plasma samples were first immunodepleted to remove excess proteins, particularly albumin, transferrin, haptoglobin, anti-trypsin, IgG, and IgA, which together make up approximately 85% (wt%) of the protein in the sample . Immunodepletion was performed with Multiple Affinity Removal System columns (Agilent Technol...

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Abstract

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 that 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 of sepsis. 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.

Description

[0001] This application claims priority to U.S. Provisional Patent Application Serial No. 60 / 425,322, filed November 12, 2002, and U.S. Provisional Patent Application Serial No. 60 / 503,548, filed September 17, 2003, both U.S. Provisional Patent Applications are incorporated herein by reference in their entirety. field of invention [0002] The present invention relates to methods of diagnosing or predicting sepsis or the stages of its development in an individual. The invention also relates to methods of diagnosing systemic inflammatory response syndrome in an individual. Background of the invention [0003] Early detection of a disease state often allows for more effective therapeutic treatment and correspondingly more favorable clinical outcomes. In many cases, however, early detection of disease symptoms is problematic; therefore, the disease may become relatively advanced before diagnosis is possible. Systemic inflammatory disorders represent one class of such diseases...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C12Q1/68C12P19/34C12P21/06G01N33/68
CPCG01N33/6893C12Q1/686C12Q2600/158G01N2800/26C12Q1/6883C12Q1/6837
Inventor R·艾维T·根特尔R·穆尔M·汤斯G·休兹达克E·万特Z·沈N·巴丘尔R·罗森斯坦J·纳多P·戈登鲍姆S·施D·科珀蒂诺J·加雷特G·泰斯
Owner BECTON DICKINSON & CO
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