Last reviewed · How we verify
Evaluation of the Analytical Performance of ALLEGRO™ Instrument
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.
Details
| Lead sponsor | Nova Biomedical |
|---|---|
| Status | COMPLETED |
| Enrolment | 628 |
| Start date | Wed Mar 25 2020 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Wed Dec 15 2021 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Diabetes Mellitus
- Kidney Diseases
- Metabolic Disease
Interventions
- HbA1c, Lipids, UACR
Countries
United States