For years, people have been able to monitor their blood pressure and blood sugar at home, using either a stand-alone device or a tool connected to a smartphone.
This has enabled them to successfully manage a chronic health condition while taking fewer trips to the doctor’s office or clinical laboratory. Overall, these tools have meant a longer, healthier life for many people.
A new smartphone-enabled test that received 510(k) clearance from the Food and Drug Administration (FDA) in July will provide Americans at risk of chronic kidney disease (CKD) the same ability to monitor their kidney health from the comfort of their own home.
The Minuteful Kidney test, developed by Boston-based company Healthy.io, uses a smartphone camera to look for the presence of a specific protein in the urine called albumin.
Andrea Somerville, from Boston, whose doctor is monitoring her kidney function, received a Minuteful Kidney test kit in the mail after her health insurer ordered one for her.
“It was easy to do and really easy to upload everything to my phone so that the results could go to me and to my doctor,” she said.
“The other piece that’s nice,” she added, “is that you find out the results right then and there, and it’s done in the privacy of your own home.”
Many people are unaware they have kidney disease
For the Minuteful Kidney test, urine samples do not need to be sent to a lab. The test also works on a wide range of smartphones, including iOS and Android.
“With a cell phone and an app, a person can complete this test in their own bathroom and on their own time, and actually get the result immediately on their cell phone,” said Paula LeClair, US general manager for Healthy.io.
And because this test can be done at home with a smartphone, she said people living in underserved communities that may have less access to healthcare can more easily monitor their kidney health.
Some research has found that people of lower socioeconomic status are more likely to have CKD, as well as limited access to treatment and worse outcomes.
This is the first time the FDA has granted clearance for this kind of smartphone-enabled test, also known as the albumin to creatinine ratio (ACR)Trusted Source.
An estimated 37 million AmericansTrusted Source have CKD, according to the Centers for Disease Control and Prevention. As many as 9 in 10 people with this condition do not know they have it.
Dr. Kamyar Kalantar-Zadeh, chief of the Division of Nephrology, Hypertension and Kidney Transplantation at UCI Health, in Orange, California, said home-based testing can fulfill an unmet need by enabling people at risk of CKD to monitor their kidney health at home.
“Knowing whether [a high level of albumin in the urine] exists — and how mild or severe, or how it changes over time — conveniently can help persons be in control of their chronic diseases, such as diabetes and hypertension, which are the leading causes of kidney disease in the US and most nations,” he said.
Other risk factors for CKDTrusted Source include heart disease, obesity, a family history of CKD, inherited kidney disorders, past damage to the kidneys and older age.
Kalantar-Zadeh said an elevated level of albumin, also known as albuminuria, is a common sign of diabetic kidney disease. If this is detected early, he added, the condition can be well-controlled.
