Urine tests can screen for opioid and other controlled substance use, test for HIV, STDs, kidney function, metabolic disorders such as diabetes and hypertension, urinary tract infections, and general health. When we wrote about a home urine test scanner developed by Stanford engineers in 2016, the physical design was a complex cardboard contraption used with test pads and smartphone video capability. In the end, you had to send the smartphone video file to a medical facility for analysis.
Inui Health recently announced FDA 510(k) clearance and a Clinical Laboratory Improvements Amendments (CLIA) waiver plus CE Mark certification for its in-home urine diagnostics and analysis platform. Clinically validated in tests in Europe, Africa, the Middle East, and the U.S., the disposable test and smartphone app are presented as a cost-effective healthcare diagnostics tool. The Inui system measures protein, glucose, leukocytes, nitrites, and ketones in urine, with test results and interpretation within one minute. The system consists of a shallow collection reservoir, a dip paddle with 12 test pads, and a smartphone app. After the paddle is immersed in a urine sample, the smartphone app uses the device’s camera to read the image and provides the analysis within one minute. The app also allows users to share results remotely with healthcare providers via a HIPAA-compliant system.
Inui In-home Urine Analysis is available for purchase by consumers directly from the manufacturer in multiple quantities, ranging from a 3-pack for $34.99 to a 20-pack for $174.99. The convenience, privacy, and potential peace of mind of clinically-validated home urine testing represent a significant step toward collaborative health and raise the potential for telemedicine.