Method for diagnosis sepsis by determining soluble cytokeratin fragments

• US 20050106645A1
• Filed: 11/29/2002
• Published: 05/19/2005
• Est. Priority Date: 12/04/2001
• Status: Active Grant

• Current Assignee: Sphingotec GMBH
• Original Assignee: B·R·A·H·M·S GmbH (Thermo Fisher Scientific Incorporated)
• Inventors: Bergmann, Andreas
• Granted Patent: US 7,659,075 B2
• Time in Patent Office: Days
• US Class Current: 435/7.320
• 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. Method for early differential diagnosis and detection, for prognosis and for assessing the severity or for therapy-accompanying assessment of the course of sepsis or sepsis-like systemic infections, comprising testing a biological fluid of a patient in whom sepsis is present or sepsis is suspected for the presence and/or amount of one or more soluble cytokeratin fragments, wherein the presence and/or amount of one or more soluble cytokeratin fragments in said sample is indicative of the presence, the expected course, the severity and/or the success of initiated measures for the therapy of the sepsis.

2. Method according to claim 1, wherein said biological fluid is tested for the presence and/or amount of one or more soluble fragments of cytokeratins 1, 8, 18 or 19.

3. Method according to claim 2, wherein said biological fluid is tested for the presence and/or amount of TPA or TPS.

4. Method according to claim 2, wherein said biological fluid is tested for the presence and/or amount of CYFRA 21-1.

5. Method according to claim 2, wherein said biological fluid is tested for the presence and/or amount of sCY1F.

6. Method according to claim 1, wherein the presence and/or amount of one or more soluble cytokeratin fragments is determined by an immunodiagnostic assay method.

7. Method according to claim 1, wherein said method is carried out in the course of a multiparameter determination in which at least one further sepsis parameter is simultaneously determined and a measured result in the form of a set of at least two measured variables is obtained and is evaluated for fine sepsis diagnosis.

8. Method according to claim 7, wherein said at least one further sepsis parameter determined in the course of the multiparameter determination is selected from the group consisting of procalcinonin, CA 125, CA 19-9, S100B, S100A proteins, inflammin, CHP, peptide prohormones and the C-reactive protein (CRP).

9. Method according to claim 7, wherein said multiparameter determination is carried out as a simultaneous determination using a chip technology measuring apparatus or an immunochromatographic measuring apparatus.

10. Method according to claim 9, wherein said measuring apparatus provides a complex measured result and wherein the evaluation of said complex measured result is carried out using a computer program.

11. Method according to claim 1, wherein said biological fluid is patient'"'"'s serum.

12. Method according to claim 1, wherein said sepsis is a bacterial sepsis.

13. Method according to claim 7, wherein said method is carried out in the course of a multiparameter determination in which further sepsis parameters are simultaneously determined and a measured result in the form of a set of measured variables is obtained and is evaluated for fine sepsis diagnosis.