Clinical Performance Evaluation of the QIAstat-Dx® cUTI Plus AMR

Performance evaluation of QIAstat-Dx cUTI Plus AMR Panel using the QIAstat-Dx® Analyzer to demonstrate that the QIAstat-Dx cUTI Plus AMR Panel achieves its intended performance during normal conditions of use by the intended user in the intended environment

Inclusion Criteria: * Specimens from subjects of all ages and demographic characteristics can be enrolled. * Specimen must come from patients with suspected cUTI by their healthcare provider: * Urine specimen with evidence of pyuria confirmed by positive urine analysis (Dipstick analysis positive for leukocyte esterase or at least 10 White Blood Cells percubic millimeter) And * A sign or symptom of a cUTI (for example: chills or rigors or warmth associated with fever, malaise, flank pain or pelvic pain and/or costo-vertebral angle pain or tenderness on physical examination, nausea or vomiting, dysuria, urinary frequency or urinary urgency) * Specimen must be residual leftover and de-identified * Specimen obtained preserved (containing boric acid, sodium formate or sodium borate) or unpreserved as midstream urine or fresh urine catheter * For Preserved Only: Fresh prospectively collected preserved specimens stored to up 48 hours at 15°C-25°C or 24 hours at 2°C-8°C. * For Unpreserved Only: Fresh prospectively collected unpreserved specimens stored up to 24 hours at 2°C-8°C. * Specimen must have a minimum of 3 ml of urine available. * Specimen date of collection and standard of Care testing results should be available. * Specimen must be unique (only one sample enrolled per patient). Exclusion Criteria: * Specimens enrolled in the study may be excluded for the following reasons: * Lack of clear subject identification or label on urine specimen. * Specimen has been centrifuged. * Obvious physical damage of residual specimen.