PA-100 Workflow Assessment

Uncomplicated cystitis in females is among the most frequent community-acquired infections. Urinary tract infection (UTI) is classified as uncomplicated if it occurs in patients with a structurally and functionally normal urinary tract in otherwise healthy, non-pregnant women. Such acute uncomplicated UTIs occur frequently and are associated with high morbidity. Approximately one third of women up to 24 years of age have experienced uncomplicated UTI.

The current gold standard for UTI diagnosis is urine culture of a midstream, clean-catch urine specimen, followed by antibiotic susceptibility testing (AST). UTI patients are often treated empirically with antibiotics, and most guidelines recommend starting antibiotic treatment without or before urine culture and AST results become available. This results in patient treatment without laboratory evidence or at least in a delay of targeted antibacterial therapy by approximately 48 h, when applicable. Due to the continually changing local rates of antimicrobial resistance, empiric treatments do not ensure appropriate stewardship and can result in therapeutic failure.

Therefore, rapid and accurate diagnosis, leading to evidence-based treatment, is essential to achieve a timely and effective therapy.

With antibiotic resistance rates for common antibiotics reaching values as high as 20% of bacteria, the current empiric treatment at GP level carries the risk of clinical failure and the possibility to further increase the prevalence of antibiotic resistant strains.

A point-of-care test (POCT) is defined as a diagnostic tool applicable near the site of patient care that has the potential to provide an accurate and fast diagnostic result. Several POCTs for UTI have been developed and are currently commercially available to detect the presence of bacteria or their activity in urine samples, including both culture-based and enzymatic assays, also in automated format. Existing POC tests, however, cannot provide rapid AST results during the patients first doctor visit, resulting in a delay of personalized treatment. It is the goal of the PA-100 AST System to perform a fast, automated and objective results for bacteriuria detection and AST results in less than 45 minutes and independent from the operator determination of bacteriuria and AST test.