Diagnosis of sepsis or SIRS using biomarker profiles
First Claim
1. A method of predicting an increased likelihood of developing sepsis in a human SIRS patient comprising:
- determining abundances of Fc fragment of IgG, high affinity 1A receptor (FCGR1A) mRNA and extra-hepatic arginase (ARG2) mRNA in a first blood sample taken from the human SIRS patient; and
comparing the abundances of FCGR1A and ARG2 mRNAs in the first blood sample to abundances of FCGR1A and ARG2 mRNAs in blood samples taken 0-48 hours prior to sepsis in a SIRS-positive human patient population that progresses to sepsis,wherein the abundances of FCGR1A and ARG2 mRNAs in the blood samples taken from the SIRS-positive human patient population that progresses to sepsis are statistically significantly greater than abundances of FCGR1A and ARG2 mRNAs in blood samples taken from a SIRS-positive human patient population that does not progress to sepsis, andwherein an increased likelihood of developing sepsis is predicted in the SIRS patient when it is determined that the FCGR1A and ARG2 mRNA abundances in the first blood sample are statistically significantly similar to the abundances of FCGR1A and ARG2 mRNAs in the blood samples taken from the SIRS-positive human patient population that progresses to sepsis, andwherein the SIRS-positive patient population that progresses to sepsis and the SIRS-positive human patient population that does not progress to sepsis each comprise at least 20 individuals.
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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 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.
110 Citations
27 Claims
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1. A method of predicting an increased likelihood of developing sepsis in a human SIRS patient comprising:
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determining abundances of Fc fragment of IgG, high affinity 1A receptor (FCGR1A) mRNA and extra-hepatic arginase (ARG2) mRNA in a first blood sample taken from the human SIRS patient; and comparing the abundances of FCGR1A and ARG2 mRNAs in the first blood sample to abundances of FCGR1A and ARG2 mRNAs in blood samples taken 0-48 hours prior to sepsis in a SIRS-positive human patient population that progresses to sepsis, wherein the abundances of FCGR1A and ARG2 mRNAs in the blood samples taken from the SIRS-positive human patient population that progresses to sepsis are statistically significantly greater than abundances of FCGR1A and ARG2 mRNAs in blood samples taken from a SIRS-positive human patient population that does not progress to sepsis, and wherein an increased likelihood of developing sepsis is predicted in the SIRS patient when it is determined that the FCGR1A and ARG2 mRNA abundances in the first blood sample are statistically significantly similar to the abundances of FCGR1A and ARG2 mRNAs in the blood samples taken from the SIRS-positive human patient population that progresses to sepsis, and wherein the SIRS-positive patient population that progresses to sepsis and the SIRS-positive human patient population that does not progress to sepsis each comprise at least 20 individuals. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27)
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Specification