The present invention relates to methods and compositions for monitoring, diagnosis, prognosis, and determination of treatment regimens in subjects suffering from or suspected of having a renal injury. In particular, the invention relates to using assays that detect one or more of Follistatin-related protein 3, Basigin, Cathepsin B, and Tenascin as diagnostic and prognostic biomarker assays in renal injuries.

Method for detecting a urinary tract infection (UTI) in a subject comprising 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. The determined levels may then be compared 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. Methods for monitoring a UTI and monitoring treatment of a UTI are also provided as are companion systems or test kits.

The present invention relates to methods for detecting, diagnosing and/or treating ulcerative interstitial cystitis (UIC) by detecting in a urine sample from a patient the levels of each of the proteins IL-6, IL-8 and GRO [also known as CXCL 1 (chemokine C-X-C motif ligand 1]. In some embodiments, the method also includes diagnosing the patient with UIC when each of the proteins IL-6, IL-8 and GRO in the urine sample is at a different level than a statistically validated threshold for the respective proteins. In some embodiments a companion diagnostic, e.g., a cystoscopy, is used in conjunction with the protein biomarker diagnostic. In some embodiments, once UIC is diagnosed, the patient is treated for the UIC.

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.

The present disclosure relates to compositions, methods and test devices for determining the presence of active leukocyte cells, for example, by using novel LE and/or FINE substrates in an electrochemical assay.

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.

The present invention relates to methods and compositions for monitoring, diagnosis, prognosis, and determination of treatment regimens in subjects suffering from or suspected of having a renal injury. In particular, the invention relates to using assays that detect one or more of Follistatin-related protein 3, Basigin, Cathepsin B, and Tenascin as diagnostic and prognostic bio-marker assays in renal injuries.

A method for treating cystitis, in particular acute cystitis, comprising administering to a patient in need thereof, an effective amount of a reagent selected from the group consisting of IL-1 inhibitors and MMP inhibitors, or proteins selected from ASC or NLRP-3. Diagnostic methods are also described and claimed.

Current UTI diagnostics face sensitivity challenges, especially with fastidious organisms and polymicrobial infections. Diagnosing UTIs in geriatric and pediatric patients, including those with communication difficulties like dementia, adds complexity due to atypical symptoms. Thus, systems, devices, and methods for UTI diagnosis across diverse patient groups are described herein. These methods utilize urinary biomarkers (NGAL, IL-8, IL-1?) to differentiate UTIs from asymptomatic bacteriuria. A consensus criterion, requiring?2 biomarkers, achieves high sensitivity (84.0%), specificity (91.2%), and accuracy (86.9%). This biomarker consensus enhances UTI diagnosis in compact diagnostic systems, especially when standard urine culture and multiplex PCR results diverge.

A lateral flow device for testing a bodily fluid, such as urine, blood, mucous, saliva, etc., is provided. The lateral flow device is configured to be attached to an absorbent article via an attachment mechanism located on the lateral flow device or the absorbent article. The lateral flow device includes a chromatographic medium (e.g., porous membrane) that defines a detection zone that provides a signal indicative of the presence or absence of the analyte. The device may also include a control zone that provides a signal indicative of whether a sufficient amount of bodily fluid has been provided and tested. Regardless of its specific configuration, the lateral flow device is configured to be attached onto the absorbent article to provide a user or caregiver with rapid information about a health condition. For example, the device may be attached onto a diaper to provide information about the presence of enzymes or other compounds often encountered with a patient having a urinary tract infection. This information may provide an early warning system to allow the user or caregiver to seek additional testing and/or treatment. Alternatively, semi-quantitative or quantitative results may be derived from the test.