Evaluation of the Analytical Performance of ALLEGRO™ Instrument

Completed

Conditions studied: Diabetes Mellitus, Kidney Diseases, Metabolic Disease

In brief

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.

Key facts

Study ID

NCT04096313

Run by

Nova Biomedical

People needed

628

Starts

2020-03-25

Expected to finish

2021-12-15

Last updated by the study team

2021-12-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• patients with ordered HbA1c, lipid profile, and UACr

You may not qualify if…

• pediatric

Where it is running

• Health Awareness, Inc — Jupiter, Florida, United States
• South Florida Research Organization — Medley, Florida, United States
• Health Awareness, Inc PSL — Port Saint Lucie, Florida, United States

Full record on ClinicalTrials.gov

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