Method for the diagnosis of sepsis with determination of soluble cytokeratin fragments

• US 7,659,075 B2
• Filed: 11/29/2002
• Issued: 02/09/2010
• Est. Priority Date: 12/04/2001
• Status: Expired due to Fees

• Current Assignee: Sphingotec GMBH
• Original Assignee: B.R.A.H.M.S Aktiengesellschaft
• Inventors: Bergmann, Andreas
• Primary Examiner(s): Chin; Christopher L
• Assistant Examiner(s): FOSTER, CHRISTINE E
• Application Number:
  US10/496,096
• Publication Number:
  US 20050106645A1
• Time in Patent Office: 2,629 Days
• Field of Search: None
• US Class Current: 435/7.1
• CPC Class Codes: G01N 2800/26 Infectious diseases, e.g. generalised sepsis
• CPC Class Codes: G01N 33/56911 Bacteria
• CPC Class Codes: G01N 33/6893 related to diseases not provided for elsewhere
• CPC Class Codes: Y10S 436/811 Test for named disease, body condition or organ function

Abstract

Method for early differential diagnosis and detection, for prognosis and assessment of the severity and for therapy-accompanying assessment of the course of sepsis and sepsis-like systemic infections, in which, preferably with additional determination of at least one further parameter suitable for sepsis diagnosis, the amount of soluble cytokeratin fragments, in particular of CYFRA 21-1, TPS, TPA and/or sCY1F, in a biological fluid of a patient in whom a sepsis is present or a sepsis is suspected is determined and conclusions with regard to the presence, the expected course, the severity and/or the success of initiated measures for the therapy of the sepsis are drawn from the determined amount of soluble cytokeratin fragments.

Claims

1. A method for diagnosis and detection of sepsis, comprising providing a biological fluid of a patient in whom sepsis is suspected based on clinical findings and elevated levels of procalcitonin in said patient;

and determining the amount of cytokeratin fragment 21-1 (CYFRA 21-1) in said fluid wherein an elevated concentration of CYFRA 21-1 in said fluid as compared to healthy individuals is indicative of sepsis.

2. The method of claim 1, wherein the amount of CYFRA 21-1 is determined by an immunodiagnostic assay method.

3. The method of claim 1, wherein said biological fluid is patient'"'"'s serum.

4. The method of claim 1, wherein CYFRA 21-1 in an amount greater than 1 ng/ml is indicative of sepsis.