NCT06824129

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,500 (estimated)
• Sponsor: QIAGEN Gaithersburg, Inc · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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

Conditions

• Complicated Urinary Tract Infection

Timeline

• Start date: 2025-12-23
• Primary completion: 2026-05-01
• Completion: 2026-09-01
• First posted: 2025-02-13
• Last updated: 2026-02-10

Locations

1 site across 1 country: United Kingdom