ACR | LAB Urine Analysis Test System Evaluation of Performance

Not Applicable

Completed

• Conditions: Hypertension; Diabetes
• Interventions: Device: ACR LAB

• Registration Number: NCT04466501
• Lead Sponsor: Healthy.io Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-06-30
• Primary Completion: 2019-09-30
• Study Completion: 2019-09-30
• Status Verified: 2020-07
• Study First Submitted: 2020-07-01
• Study First Submitted QC: 2020-07-07
• Last Update Submitted: 2020-07-07
• Study First Posted: 2020-07-10
• Last Update Posted: 2020-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 375

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ACR LAB for Professional User	ACR LAB	-

Primary Outcome Measures

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

Trial Locations

Locations (3)

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