Diagnostic method for urinary tract infection

• US 10,126,312 B2
• Filed: 05/12/2016
• Issued: 11/13/2018
• Est. Priority Date: 02/07/2011
• Status: Active Grant

• Current Assignee: Hansa Biopharma AB
• Original Assignee: Hansa Medical AB
• Inventors: Bjorck, Lars, Christensson, Bertil, Herwald, Heiko, Linder, Adam, Åkesson, Per
• Primary Examiner(s): Vivlemore, Tracy
• Assistant Examiner(s): Belei, Carmencita M
• Application Number:
  US15/153,570
• Publication Number:
  US 20160252529A1
• Time in Patent Office: 915 Days
• Field of Search: None
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61P 13/02 of urine or of the urinary tract, e.g. urine acidifiers
• CPC Class Codes: C07K 16/18 against material from animals or humans
• CPC Class Codes: C07K 2317/33 Crossreactivity, e.g. for species or epitope, or lack of said crossreactivity
• CPC Class Codes: G01N 2400/40 Glycosaminoglycans, i.e. GAG or mucopolysaccharides, e.g. chondroitin sulfate, dermatan sulfate, hyaluronic acid, heparin, heparan sulfate, and related sulfated polysaccharides
• CPC Class Codes: G01N 2800/348 Urinary tract infections
• 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 urinary level of HBP increases in individuals that have a urinary tract infection. Accordingly, the urinary level of HBP in an individual can be used to determine whether or not an individual has a urinary tract infection.

Claims

1. A method of treating an individual having a urinary tract infection (UTI), comprising:

measuring the level of Heparin Binding Protein (HBP, CAP37, Azuricidin) in a urine sample obtained from an individual by;

(i) contacting the sample with an antibody which binds specifically to HBP; and

(ii) quantitating the amount of antibody-HBP complex to measure the HBP level in the urine sample;

detecting the presence of UTI in the individual at about 93% Sensitivity or greater and at about 90% Specificity or greater based on the measured HBP level in the urine sample; and

administering to the individual detected as having UTI an effective amount a therapeutic agent suitable for treating UTI.

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

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

4. The method of claim 3, wherein the detecting of UTI at about 93% Sensitivity or greater and at about 90% Specificity or greater is determined by a Receiver Operating Characteristic (ROC).

5. The method of claim 3, wherein the 93% Sensitivity and the 90% Specificity for detecting UTI is a threshold value of about 32 ng/ml in the urine sample.

6. The method of claim 1, wherein the binding of the antibody to HBP is measured by enzyme linked immunosorbent assay (ELISA).

7. The method of claim 1, wherein the binding of the antibody to HBP is measured using a dipstick assay.

8. The method of claim 1, wherein the urinary tract infection is lower urinary tract infection or pyelonephritis.

9. The method of claim 1, further comprising determining white blood cell count or level of IL6 in a urine sample from the individual, or conducting a nitrite test on a urine sample from the individual.