Diagnostic method
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.
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.