NCT06820060

Clinical Performance of QIAstat-Dx® Meningitis/Encephalitis (ME) Panel Plus

An Observational, Prospective and Retrospective Clinical Study to Evaluate the Performance of QIAstat-Dx® Meningitis/Encephalitis (ME) Panel Plus During Normal Conditions of Use

• 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® ME Panel Plus using the QIAstat-Dx® Analyzer to demonstrate that the QIAstat-Dx® ME Panel Plus 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® ME Panel Plus 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® ME Panel Plus in comparison with the results obtained from the reference method. The secondary objective of the study is to evaluate the safety of QIAstat-Dx® ME Panel Plus with respect to users/operators. The primary study endpoint will be the results for each analyte obtained from testing prospective and retrospective specimens with QIAstat-Dx® ME Panel Plus and Reference Method. Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) will be determined

Conditions

• Meningitis
• Encephalitis Infection

Timeline

• Start date: 2025-04-03
• Primary completion: 2026-01-15
• Completion: 2026-05-01
• First posted: 2025-02-11
• Last updated: 2026-03-10

Locations

1 site across 1 country: United Kingdom