To assess the performance of the Allegro in the hands of CLIA-Waived Point-of-Care users in at least three distinct Point-of-Care clinical settings and compare the performance characteristics to other accepted Point-of-Care methods and central laboratory reference methods. To assess the Ease of Use of the Allegro in the hands of the intended CLIA-Waived Point-of-Care users. CLIA-Waived operators will be provided with all package insert sheets, a Quick Reference Guide poster and Instructions for Use. No training, coaching, or prompting will be provided other than clarifying the protocol.
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Analytical verification of Allegro - HbA1c comparison
Timeframe: 10 minutes
Analytical verification of Allegro - Cholesterol comparison
Timeframe: 10 minutes
Analytical verification of Allegro - HDL comparison
Timeframe: 10 minutes
Analytical verification of Allegro - Triglycerides comparison
Timeframe: 10 minutes
Analytical verification of Allegro - Urine creatinine comparison
Timeframe: 10 minutes
Analytical verification of Allegro - Urine Albumin comparison
Timeframe: 10 minutes