Diagnostic method

• US 9,784,741 B2
• Filed: 12/02/2013
• Issued: 10/10/2017
• Est. Priority Date: 06/12/2007
• Status: Active Grant

• Current Assignee: Hansa Biopharma AB
• Original Assignee: Hansa Medical AB
• Inventors: Bjrck, Lars, Christensson, Bertil, Herwald, Heiko, Linder, Adam, kesson, Per
• Primary Examiner(s): MARTINEZ, REBECCA L
• Application Number:
  US14/094,679
• Publication Number:
  US 20140187503A1
• Time in Patent Office: 1,408 Days
• CPC Class Codes: A61P 31/04 Antibacterial agents
• CPC Class Codes: G01N 2800/26 Infectious diseases, e.g. generalised sepsis
• CPC Class Codes: G01N 33/569 for microorganisms, e.g. protozoa, bacteria, viruses
• CPC Class Codes: G01N 33/6893 related to diseases not provided for elsewhere

Abstract

It has been demonstrated that the level of HBP increases in individuals that subsequently develop severe sepsis. Accordingly, the level of HBP, HBP/WBC ratio or HBP/NC ratio in an individual can be used to determine whether or not an individual is at risk of developing severe sepsis.

Claims

1. A method of detecting onset or presence of severe sepsis in an individual, the method comprising:

providing a blood sample or fraction thereof obtained from an individual suspected of being at risk of developing severe sepsis;

contacting the sample with an antibody which is capable of binding specifically to Heparin Binding Protein (HBP;

Cationic Anti-microbial Protein 37;

Azurocidin);

quantitating the amount of antibody-HBP complex to measure the HBP level in the sample; and

detecting onset or presence of severe sepsis in the individual at about 88% Sensitivity or lower and about 95% Specificity or greater based on the measured HBP level in the sample.

2. The method according to claim 1, wherein the individual is a mammal.

3. The method according to claim 2, wherein the mammal is a human.

4. The method according to claim 3, wherein the % Sensitivity and % Specificity are based on a Receiver Operating Characteristic (ROC) of HBP levels in blood or fraction thereof for severe sepsis.

5. The method according to claim 3, wherein the detecting of onset or presence of severe sepsis at about 88% Sensitivity or lower and about 95% Specificity or greater has a threshold level of HBP in blood or fraction thereof of about 15 ng/mL or higher.

6. The method according to claim 3, wherein the blood sample or fraction thereof is serum or plasma.

7. The method according to claim 3, wherein the detecting is prior to manifestation of clinical symptoms of severe sepsis.

8. The method according to claim 3, wherein the individual suspected of being at risk for severe sepsis has a confirmed or suspected infection and/or displays one or more of Severe Inflammatory Response (SIRS) criteria.

9. The method according to claim 3, wherein the individual has a confirmed or suspected infection and/or displays two or more of Severe Inflammatory Response (SIRS) criteria.

10. The method according to claim 3, wherein the quantitating of the antibody-HBP complex is by a dipstick assay, wherein the dipstick comprises the antibody which binds specifically to HBP.

11. The method according to claim 3, wherein the quantitating of the antibody-HBP complex is by enzyme linked immunosorbent assay (ELISA).

12. The method according to claim 11, wherein the ELISA is a sandwich ELISA assay.