Early detection of sepsis

• US 7,465,555 B2
• Filed: 03/26/2003
• Issued: 12/16/2008
• Est. Priority Date: 04/02/2002
• Status: Active Grant

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Anderson, Stephen J., Haney, Douglas J., Waters, Cory A.
• Primary Examiner(s): Jung; Unsu
• Application Number:
  US10/400,275
• Publication Number:
  US 20030194752A1
• Time in Patent Office: 2,092 Days
• Field of Search: 435/7.1, 435/7.21, 435/7.24, 435/7.92
• US Class Current: 435/7.24
• CPC Class Codes: G01N 2333/70535 Fc-receptors, e.g. CD16, CD32, CD64 (CD2314/705F)
• CPC Class Codes: G01N 2333/70553 Integrin beta2-subunit-containing molecules, e.g. CD11, CD18
• CPC Class Codes: G01N 2333/70596 Molecules with a "CD"-designation not provided for elsewhere in G01N2333/705
• CPC Class Codes: G01N 2800/26 Infectious diseases, e.g. generalised sepsis
• CPC Class Codes: G01N 33/6893 related to diseases not provided for elsewhere

Abstract

Diagnostic methods, systems, and kits for identifying patients with systemic inflammatory response syndrome who are likely to progress to sepsis.

Claims

1. A method of detecting early sepsis in a patient, wherein said method comprising the steps of:

a) monitoring expression of markers comprising neutrophil-associated CD11b, neutrophil-associated CD64, and monocyte-associated HLA-DR over a period of time;

b) independently deriving marker statistics comprising a maximum of said neutrophil-associated CD11b expression, a maximum of said neutrophil-associated CD64 expression, and minimum of said monocyte-associated HLA-DR expression; and

c) applying a decision rule to the marker statistics from step (b) to detect early sepsis in said patient;

wherein said decision rule is a classification tree that detects early sepsis if

a sum of said maximum of said neutrophil-associated CD11b expression and said maximum of said neutrophil-associated CD64 expression is greater than a first threshold value, and said minimum of said monocyte-associated HLA-DR expression is less than a second threshold value;

or said decision rule is a classification tree that detects early sepsis if

a sum of said maximum of said neutrophil-associated CD11b expression and said maximum of said neutrophil-associated CD64 expression is greater than a third threshold value, and said maximum of said neutrophil-associated CD64 expression is greater than a fourth threshold value;

or

a sum of said maximum of said neutrophil-associated CD11b expression and said maximum of said neutrophil-associated CD64 expression is less than said third threshold value, and said minimum of said monocyte-associated HLA-DR expression is less than a fifth threshold value.

2. The method of claim 1, wherein said classification tree detects early sepsis if the sum of said maximum of said neutrophil-associated CD11b expression and said maximum of said neutrophil-associated CD64 expression is greater than the first threshold value, and said minimum of said monocyte-associated HLA-DR expression is less than the second threshold value.

3. The method of claim 1, wherein said classification tree detects early sepsis if

the sum of said maximum of said neutrophil-associated CD11b expression and said maximum of said neutrophil-associated CD64 expression is greater than the third threshold value, and said maximum of said neutrophil-associated CD64 expression is greater than the fourth threshold value;

or

the sum of said maximum of said neutrophil-associated CD11b expression and said maximum of said neutrophil-associated CD64 expression is less than the third threshold value, and said minimum of said monocyte-associated HLA-DR expression is less than the fifth threshold value.