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

Study Overview

• Status: Active, not recruiting
• Conditions: Complicated Urinary Tract Infection

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

• Study Type: Observational
• Enrollment (Estimated): 1500

Contacts and Locations

Study Locations

• United Kingdom
  • Manchester, United Kingdom
    • QIAGEN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with signs and symptoms of complicated urine infection

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PPA	Positive percent agreement	8 months
NPA	Negative percent agreement	8 months

Collaborators and Investigators

• Sponsor: QIAGEN Gaithersburg, Inc
• Investigators: Principal Investigator: Sarah Johnson, Qiagen Manchester Limited

Study record dates

Study Major Dates

• Study Start (Actual): December 23, 2025
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: February 7, 2025
• First Submitted That Met QC Criteria: February 7, 2025
• First Posted (Actual): February 13, 2025

Study Record Updates

• Last Update Posted (Actual): February 10, 2026
• Last Update Submitted That Met QC Criteria: February 9, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Clinical Performance Study; QIAstat-Dx; complicated Urinary infection
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Infections; Urinary Tract Infections
• Other Study ID Numbers: DHF-19-0598-0-CSP-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No