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

Launched by QIAGEN GAITHERSBURG, INC · Feb 7, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new test called the QIAstat-Dx® cUTI Plus AMR Panel, which is designed to quickly and accurately detect complicated urinary tract infections (cUTIs) and identify the bacteria causing them. The goal is to see how well the test performs when used by healthcare providers in regular clinical settings. This could help doctors make better treatment decisions for patients with cUTIs.

Anyone of any age who has symptoms of a cUTI, such as fever, pelvic pain, or frequent urination, may be eligible to participate. To join, patients need to provide a urine sample that shows signs of infection, and this sample must meet specific storage and collection guidelines. Participants can expect their leftover urine samples to be tested without needing additional procedures. It’s important to note that this trial is not yet recruiting participants, so people interested will need to wait until it officially begins.

Gender

ALL

Eligibility criteria

• 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.