ACR | LAB Urine Analysis Test System Evaluation of Performance

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.

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Key information

Conditions

Diabetes Cardiovascular Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hypertension Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Atlanta Center for Medical Research, Atlanta, Georgia, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Treatment and study plan

ACR LAB

Device

The ACR | LAB is a prescription-only, nurse- or clinician-conducted in vitro diagnostic (IVD) device. The device combines a urine stick kit with an easy to use smartphone application using an image recognition algorithm.

Primary outcomes

Evaluate the performance agreement of the ACR |LAB compared to the comparator device, tested by professional users.

Time frame: 11 months

Sponsors and collaborators

Lead sponsor

Healthy.io Ltd.

Industry

Registry information

Official study title

A Comparative, Controlled Study to Evaluate the Performance of the ACR | LAB Urine Analysis Test System

Important dates

Study start: 2019
Primary completion: 2019
Study completion: 2019
First posted: Jul 10, 2020
Registry last updated: Jul 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed