Urinary tract infection diagnostic

A method for detecting and/or monitoring a urinary tract infection in a subject comprising:

• i) determining levels of one or more biomarkers selected from MMP8, HNE, Cystatin C, MMP9, HSA, IL-8, interleukin-6 (IL-6), interleukin-1 beta (IL-1b), fibrinogen, RBP4, active MMP9 and MMP2, NGAL, Desmosine, MPO and CRP in a urine sample obtained from the subject;
• and
• ii) comparing each determined level with a threshold level;
• wherein increased levels of at least one of the biomarkers in the urine sample relative to the threshold level is indicative of the presence of a urinary tract infection;
• and/or
• wherein the continued presence of non-decreased or increased levels of at least one of the biomarkers relative to the threshold level or relative to the levels measured in a sample taken from an earlier time point is indicative that the urinary tract infection persists and/or that treatment has not been effective and/or decreased levels of at least one of the biomarkers relative to the threshold level or relative to the levels measured in a sample taken from an earlier time point is indicative of recovery from, or successful treatment of, a urinary tract infection.

A system or test kit for detecting a urinary tract infection in a subject, comprising:

• a. One or more testing devices for determining levels of one, two, three or more biomarkers selected from MMP8, HNE, Cystatin C, MMP9, HSA, IL-8, interleukin-6 (IL-6), interleukin-1 beta (IL-1b), fibrinogen, RBP4, active MMP9 and MMP2, NGAL, Desmosine, MPO and CRP in a urine sample obtained from the subject;
• b. A processor;
• and
• c. A storage medium comprising a computer application that, when executed by the processor, is configured to:
• i. Access and/or calculate the determined levels of each biomarker in the sample on the one or more testing devices;
• ii. Calculate a test score from the levels of the biomarkers in the sample that detects a urinary tract infection;
• and
• iii. Output from the processor the detected result for the subject.

A system or test kit for monitoring a urinary tract infection in a subject, comprising:

• a. One or more testing devices for determining levels of one, two, three or more biomarkers selected from MMP8, HNE, Cystatin C, MMP9, HSA, IL-8, interleukin-6 (IL-6), interleukin-1 beta (IL-1b), fibrinogen, RBP4, active MMP9 and MMP2, NGAL, Desmosine, MPO and CRP in a urine sample obtained from the subject at multiple time points;
• b. A processor;
• and
• c. A storage medium comprising a computer application that, when executed by the processor, is configured to:
• i. Access and/or calculate the determined levels of each biomarker in the sample on the one or more testing devices;
• ii. Calculate a test score from the levels of the biomarkers in the sample, optionally including a comparison of the levels with those taken at one or more earlier time points, that detects a urinary tract infection;
• and
• iii. Output from the processor the detected result for the subject.

A testing device, testing kit or testing composition of matter comprising:

• a. A sample receiving zone to which a urine sample from a subject is added;
• b. A conjugate zone comprising at least one, two or three labelled binding reagents, each of which specifically binds to one of the biomarkers selected from MMP8, HNE, Cystatin C, MMP9, HSA, IL-8, interleukin-6 (IL-6), interleukin-1 beta (IL-1b), fibrinogen, RBP4, active MMP9 and MMP2, NGAL, Desmosine, MPO and CRP;
• c. A solid support defining a liquid flow path for the sample and comprising corresponding test lines for each of the at least one, two or three biomarkers, each test line comprising:
• i. an immobilised further binding reagent that also specifically binds to one of the at least one, two or three biomarkers thereby immobilising the biomarker at the test line to produce a signal via the labelled binding reagent also specifically bound to the biomarker;
• or
• ii. an immobilised version of one of the at least one, two or three biomarkers or an analogue thereof able to compete with the biomarker in the sample for specific binding to the labelled binding reagent.

The system or test kit of claim 19 wherein the testing device comprises:

• a. A sample receiving zone to which a urine sample from a subject is added;
• b. A conjugate zone comprising at least one, two or three labelled binding reagents, each of which specifically binds to one of the biomarkers selected from MMP8, HNE, Cystatin C, MMP9, HSA, IL-8, interleukin-6 (IL-6), interleukin-1 beta (IL-1b), fibrinogen, RBP4, active MMP9 and MMP2, NGAL, Desmosine, MPO and CRP;
• c. A solid support defining a liquid flow path for the sample and comprising corresponding test lines for each of the at least one, two or three biomarkers, each test line comprising:
• i. an immobilised further binding reagent that also specifically binds to one of the at least one, two or three biomarkers thereby immobilising the biomarker at the test line to produce a signal via the labelled binding reagent also specifically bound to the biomarker;
• or
• ii. an immobilised version of one of the at least one, two or three biomarkers or an analogue thereof able to compete with the biomarker in the sample for specific binding to the labelled binding reagent.