Diabetes
+1
ACR | LAB Urine Analysis Test System Evaluation of Performance
Sponsored by Healthy.io Ltd.
About this trial
Last updated 5 years ago
Study ID
CTP-ACR | LAB-MC-02
Status
Completed
Type
Interventional
Phase
N/A
Placebo
No
Accepting
18 to 80 Years
All
Trial Timing
Ended 6 years ago
What is this trial about?
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.
What are the participation requirements?
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.