ACR | LAB Urine Analysis Test System Evaluation of Performance

Completed · Not applicable

Conditions studied: Diabetes, Hypertension

In brief

The ACR LAB is a prescription-only, nurse- or clinician-conducted in vitro diagnostic (IVD) device. The test is for the qualitative and semi- quantitative detection of Albumin, Creatinine, and the Albumin-to- Creatinine Ratio. The device is composed of a kit and a smartphone application using an image recognition algorithm. The degree of agreement of the ACR \| LAB as compared to the comparator device will be tested. Urine samples will be tested by a separate professional user on each device.

Key facts

Study ID

NCT04466501

Run by

Healthy.io Ltd.

People needed

375

Starts

2019-06-30

Expected to finish

2019-09-30

Last updated by the study team

2020-07-10

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Men and women 18-80 years of age;
• Subjects who are healthy or pregnant; or
• Subjects diagnosed with a disease that normally represents itself with an abnormal concentration of albumin:
• Diabetes Type I/Type II,
• Hypertension,
• Any kidney disease,
• Other relevant conditions.
• Subjects with any pathological findings which might be identified by the urine test (according to the physician discretion);
• Subject is capable and willing to provide informed consent;
• Subject has facility with both hands
• Subject is capable and willing to adhere to the study procedures.

Where it is running

• Atlanta Center for Medical Research — Atlanta, Georgia, United States
• Central Kentucky Research Associates — Lexington, Kentucky, United States
• AccuMed research associates — Garden City, New York, United States

Full record on ClinicalTrials.gov

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