Dip.io test kit (Healthy.io)
10 April 2018. A clinical trial will soon get under way that tests whether a smartphone app can easily and accurately screen for chronic kidney disease among people with high blood pressure. The trial is a joint project of the National Kidney Foundation, in Austin, Texas, with Israeli health technology company Healthy.io, and Geisinger, a Pennsylvania health care provider network.
Chronic kidney disease occurs when the kidneys become damaged and stop fully functioning. When this happens, waste products usually filtered out by the kidneys begin to build up in the blood, which can affect other parts of the body. National Kidney Foundation says some 30 million people in the U.S. have chronic kidney disease, with about 90 percent of those affected by the disease unaware of their condition. Without interventions, kidney functions can deteriorate until the kidneys fail, which requires either dialysis or a kidney transplant.
The two main causes of chronic kidney disease are diabetes and high blood pressure. The clinical trial is testing the concept of an easy-to-use method that allows people at risk of chronic kidney disease to test their urine at home for indicators of the disorder. That method uses a smartphone-based testing system developed by Healthy.io, a medical technology company in Tel Aviv, Israel. Like a urine test at a doctor’s office, the system called Dip.io, asks the user to collect a urine sample, but instead of leaving for a lab to analyze, the user performs the analysis.
The Dip.io system employs a dipstick with reagents printed on the stick that test for 10 factors, such as infections, pregnancy conditions, and chronic disease. The user then takes a picture of the stick with smartphone’s camera after dipping into the urine sample. The company says computer vision algorithms in the app calibrate and interpret the images, then send the results to a designated clinician. Healthy.io says the system already received CE regulatory approval in Europe, and is awaiting clearance from FDA to market the system in the U.S.
The company is also expanding the Dip.io system to include tests for albuminuria, a key indicator of chronic kidney disease. Albuminuria is elevated levels of the protein albumin in the blood, calculated as a ratio to creatinine, a metabolite and waste product in the blood.
The clinical trial is testing the feasibility of a home-based smartphone system to test for albuminuria, and follow-up with pharmacists. Some 1,000 Geisinger patients diagnosed with high blood pressure, a risk factor for chronic kidney disease, or CKD, will be asked to take part in the trial. Half of the participants will be randomly offered to use the Dip.io system for albuminuria screening at home, while the other 500 participants receive the usual care. For participants using the Dip.io kit, pharmacists will be enlisted to confirm the test results.
“Our hope,” says Kerry Willis, chief scientist at National Kidney Foundation in an organizational statement, “is that a home-based test makes it easier for patients at risk for CKD to comply with regular albuminuria screening, and that this will lead to earlier diagnosis and treatment of CKD, reducing cardiovascular risk, and preserving kidney function.”
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