Rapid Point-of-care Bacteriuria and Microbial Susceptibility for Women With Suspected Uncomplicated Urinary Tract Infections: Diagnostic Accuracy in General Practice.

Condition(s) studied

Study summary

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.

Eligibility

Primary outcome measure(s)

• Sensitivity — On the 1 day of inclusion
  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 — On the 1 day of inclusion
  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 — On the 1 day of inclusion
  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 — On the 1 day of inclusion
  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)
• Positive likelihood ratio — On the 1 day of inclusion
  Positive likelihood ratio 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 likelihood ratio — On the 1 day of inclusion
  Negative likelihood ratio 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)

Trial sites (2)

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