Diabetes, Hypertension
Conditions
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.
Interventions
DEVICEACR 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.
Sponsors
Healthy.io Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate the performance agreement of the ACR |LAB compared to the comparator device, tested by professional users. | 11 months |
Countries
United States
Outcome results
None listed