Evaluation of the Accuracy and Usability of the ACR | U.S. Urine Analysis Test System in the Lay User Hands
Albuminuria
About this trial
This is an interventional diagnostic trial for Albuminuria
Eligibility Criteria
Inclusion Criteria: Males and Females 18-80 years of age. 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, or, subjects who are healthy or pregnant. Subject is familiar with the use of a smartphone. Subject is capable of comprehending and following instructions in English. Subject has facility with both hands. Subject is capable and willing to adhere to the study procedures. Subject is capable and willing to provide informed consent. Exclusion Criteria: Subject has dementia. Subject has severe mental disorders. Subject cannot collect urine in a receptacle. Subject is visually impaired (cannot read the user manual). Any additional reason the study physician believes disqualifies the subject from participating in the study.
Sites / Locations
- AccuMed research associates
- PMG Research of Charleston
Arms of the Study
Arm 1
Experimental
ACR | U.S. Urine Analysis Test System
Urine samples are collected and tested by a lay user, using the new home use device. The lay user test results are compared to the results obtained by testing the same urine sample on the comparison device.