In this study, adult women presenting at their general practitioner with a likely bladder infection (with symptoms like a burning sensation when urinating, pain in the lower abdomen, and frequent or urgent need to urinate) will be invited. After informed consent, women provide a urine sample, which is tested using a new system called the PA-100-AST (from the manufacturer Sysmex). This point-of-care test showed first evidence to be able to quickly detect the presence of bacteria commonly responsible for bladder infections. If bacteria are found, the test also checks which antibiotics may work best to treat the infection. Additionally, a sample of the urine is sent to a lab for a traditional culture test, which is considered the most accurate method. The goal of this study is to compare the accuracy of the PA-100-AST system to the lab-based test to see how well it works in general practice.
Female sex
Age 18 or older
Clinically suspected UTI according to the general practitioner
Urinary catheter
Severe urinary tract abnormality (such as cancer or strictures)
Immunosuppression (such as chronic immunosuppressant use or AIDS)
Dementia or any other condition (including insufficient knowledge of the German language) that could affect informed consent
Consecutively enrolled adult non-pregnant women with a suspected uncomplicated UTI (uncomplicated is defined according to German guidelines/usual care as having no symptoms or signs of systemic illness, such as fever).
Cohort
Cross-sectional
Not listed
Sensitivity
Sensitivity of point-of-care urinalysis through Sysmex PA-100-AST vs. laboratory-based urine culture (gold standard) of point-of-care urinalysis through Sysmex PA-100-AST vs. laboratory-based urine culture (gold standard)
Specificity
Specificity of point-of-care urinalysis through Sysmex PA-100-AST vs. laboratory-based urine culture (gold standard) of point-of-care urinalysis through Sysmex PA-100-AST vs. laboratory-based urine culture (gold standard)
Positive predictive value
Positive predictive value of point-of-care urinalysis through Sysmex PA-100-AST vs. laboratory-based urine culture (gold standard) of point-of-care urinalysis through Sysmex PA-100-AST vs. laboratory-based urine culture (gold standard)
Negative predictive value
Negative predictive value of point-of-care urinalysis through Sysmex PA-100-AST vs. laboratory-based urine culture (gold standard) of point-of-care urinalysis through Sysmex PA-100-AST vs. laboratory-based urine culture (gold standard)
Agreement of test results for antibiotic susceptibility
Agreement of point-of-care based with laboratory-based antibiotic susceptibility test results measured through kappa coefficients
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Wuerzburg University Hospital
Lead sponsor
Jena University Hospital
Collaborator
