- A new smartphone-enabled test provides people at risk of chronic kidney disease (CKD) the ability to monitor their kidney health from the comfort of their own homes.
- The Minuteful Kidney test uses a smartphone camera to look for the presence of a specific protein in the urine called albumin.
- 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).
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.”
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
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.
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.
Research suggests that this kind of at-home testing can improve testing adherence.
LeClair said once the company has its US supply chain up and running, insurers or doctors will be able to order the test kits for patients.
In either case, the results will be sent to the doctors, either directly to the electronic medical record or by fax. This can keep doctors informed of patients’ kidney health.
“ACR monitoring at home will help doctors empower patients to be more engaged and realigned with disease management in a more patient-centered format,” said Kalantar-Zadeh.
While he welcomes this new testing option for patients, Kalantar-Zadeh thinks more home-based tests for patients with kidney disease, or at risk of kidney disease, are needed. This includes testing kidney function and measuring the blood level of drugs used by these patients.
“Home-based measurements and monitoring for kidney disease management is in its infancy, and a lot more needs to be done,” he said.
As for Somerville, she said she would definitely use the at-home kidney test again because it is easier than going to a doctor’s office.
It’s also safer, she added.
“Usually when you go to the doctor’s office, you pick up some [virus or other illness] that you didn’t have the day you came in,” she said.