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

NCT06824129 | Active Not Recruiting

• 1 other identifier: DHF-19-0598-0-CSP-001
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Complicated Urinary Tract Infection

Keywords

QIAstat-Dx; Clinical Performance Study; complicated Urinary infection

Outcome Measures

Primary Outcomes (2)

• PPA

  Positive percent agreement

  8 months

• NPA

  Negative percent agreement

  8 months

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with signs and symptoms of complicated urine infection

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• QIAGEN Gaithersburg, Inc: lead

Study Sites (1)

QIAGEN

Manchester, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Urine specimens

Study Officials

• Sarah Johnson

  Qiagen Manchester Limited

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2025
• First Posted: February 13, 2025
• Study Start: December 23, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: February 10, 2026

Record last verified: 2026-02

Locations

GB (1)