ACR | LAB Urine Analysis Test System Evaluation of Performance

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

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.

Study Overview

• Status: Completed
• Conditions: Hypertension; Diabetes
• Intervention / Treatment: Device: ACR LAB

• Study Type: Interventional
• Enrollment (Actual): 375
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30331
      • Atlanta Center for Medical Research
  • Kentucky
    • Lexington, Kentucky, United States, 40509
      • Central Kentucky Research Associates
  • New York
    • Garden City, New York, United States, 11530
      • AccuMed Research Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: ACR LAB for Professional User	Device: ACR LAB; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Evaluate the performance agreement of the ACR |LAB compared to the comparator device, tested by professional users.	11 months

Collaborators and Investigators

• Sponsor: Healthy.io Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 30, 2019
• Primary Completion (ACTUAL): September 30, 2019
• Study Completion (ACTUAL): September 30, 2019

Study Registration Dates

• First Submitted: July 1, 2020
• First Submitted That Met QC Criteria: July 7, 2020
• First Posted (ACTUAL): July 10, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 10, 2020
• Last Update Submitted That Met QC Criteria: July 7, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: CTP-ACR | LAB-MC-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No