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

Clinical Performance Evaluation of the QIAstat-Dx® cUTI Plus AMR Panel on Patients Suspected of Complicated Urinary Tract Infection

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

The objective of the study is 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.

The primary objective is to evaluate the performance of QIAstat-Dx cUTI Plus AMR Panel in comparison with the results obtained from the reference method.

The secondary objective of the study is to evaluate the safety ofQIAstat-Dx cUTI Plus AMR Panel with respect to users/operators.

The primary study endpoint will be the results for each analyte obtained from testing prospective specimens with QIAstat-Dx cUTI Plus AMR Panel and Reference Method. Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) will be determined

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.