IP Library › Granted Patent US 10,443,099
Granted Patent B2
US 10,443,099 · App. 14/850,933 · Granted Oct 15, 2019

Diagnosis of sepsis

Inventors: James A. Garrett (Baltimore, MD); Sha-Sha Wang (Cockeysville, MD); Keith Thornton (Owing Mills, MD); Richard L. Moore (Glenville, PA); William Keating (Reisterstown, MD); William A. Nussbaumer (Lutherville, MD); Craig C. Whiteford (York, PA)
Assignee: Becton, Dickinson and Company
C12Q1/6883C12Q1/6888G01N33/56911G01N33/6893C12Q2600/112C12Q2600/158C12Q2600/16G01N2333/5412G01N2333/5421G01N2800/26G01N2800/50
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Quick Facts
Patent No.
US 10,443,099
App. No.
14/850,933
Granted
Oct 15, 2019
Kind
B2
Abstract

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.

Claims (13)

1. A method of treating sepsis in a subject at risk for developing sepsis, the method comprising:

obtaining from at least one blood sample taken from a SIRS-positive subject an expression level of IL-6 protein, IL-8 protein, VNN-1 nucleic acid, and GADD45B nucleic acid;

determining that the subject is likely to develop sepsis based on the expression level of each of IL-6 protein, IL-8 protein, VNN-1 nucleic acid and GADD45B nucleic acid being elevated compared to a control expression level of each, wherein said control expression level of each is from SIRS patients that did not develop sepsis; and

administering to said subject that is determined to be likely to develop sepsis a therapeutically effective sepsis treatment regimen.

2. The method of claim 1 , wherein the at least one blood sample was taken from said subject at a single point in time.

3. The method of claim 1 , wherein the expression level of IL-6 protein, IL-8 protein, VNN-1 nucleic acid, and GADD45B nucleic acid is determined from a plurality of blood samples taken from said subject at different points in time.

4. The method of claim 3 , wherein at least one of the expression level of IL-6 protein, IL-8 protein, VNN-1 nucleic acid, and GADD45B nucleic acid indicates whether the expression level of said biomarker is increasing or decreasing over time.

5. The method of claim 3 , wherein a first blood sample in said plurality of blood samples is taken on a first day before the subject acquires sepsis and a second blood sample in said plurality of blood samples is taken on a second day before the subject acquires sepsis.

6. The method of claim 1 , the method further comprising constructing, prior to the determining step, a biomarker profile of said subject comprising the expression level of IL-6 protein, IL-8 protein, VNN-1 nucleic acid, and GADD45B nucleic acid.

7. The method of claim 6 , wherein the constructing step comprises applying a data analysis algorithm to the expression level of IL-6 protein, IL-8 protein, VNN-1 nucleic acid, and GADD45B nucleic acid of the subject, wherein the data analysis algorithm is derived from an expression level of IL-6 protein, IL-8 protein, VNN-1 nucleic acid, and GADD45B nucleic acid that are obtained from members of a population.

8. The method of claim 7 , wherein said population comprises subjects that develop sepsis subsequent to obtaining said expression level of IL-6 protein, IL-8 protein, VNN-1 nucleic acid, and GADD45B nucleic acid and subjects that do not develop sepsis subsequent to obtaining said expression level of IL-6 protein, IL-8 protein, VNN-1 nucleic acid, and GADD45B nucleic acid.

9. The method of claim 2 , wherein the expression level of IL-6 protein and IL-8 protein in said blood sample was determined using a method comprising detection via interaction with protein-specific antibodies.

10. The method of claim 9 , wherein one or more of the protein-specific antibodies is selected from the group consisting of a polyclonal antibody, a monoclonal antibody, an antibody fragment, a scFv fragment, a Fab fragment, a F(ab′) 2 fragment.

Continuity (6)
Continuation 13965038 · Aug 12, 2013
Continuation 12776245 · May 7, 2010
Continuation 11404744 · Apr 14, 2006
Provisional Application 60674046 · Apr 22, 2005
Provisional Application 60671620 · Apr 15, 2005
Related Publication 20160168638A1 · Jun 16, 2016