For years, people have been able to monitor their blood pressure and blood sugar at home, using a stand-alone device or a device connected to a smartphone.
This has made it easier for them to cope with a chronic health condition while making fewer trips to the doctor or medical laboratory. Overall, these tools have meant a long, healthy life for many people.
A new smartphone-enabled test that received 510(k) clearance from the Food and Drug Administration (FDA) in July will give Americans at risk of developing chronic kidney disease (CKD) the ability the same to monitor their kidney health from their comfort. home.
The Minuteful Kidney test, developed by Boston company Healthy.io, uses a smartphone camera to look for the presence of a specific protein in the urine called albumin.
Andrea Somerville, of Boston, whose doctor monitors her kidney function, received a Minuteful Kidney test in the mail after her health insurance purchased one for her.
“It was easy to do and very easy to put everything on my phone so that the results would be available to me and my doctor,” he said.
“One good thing is that you get immediate results, and it’s done in the privacy of your own home,” he added.
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 bathroom and on their own time, and get the results immediately on their cell phone,” said Paula LeClair, US general manager for of Healthy.io.
And because this test can be done at home with a smartphone, he said people living in underserved communities who may have limited access to health care can easily check their kidney health.
Some research has found that people of lower socioeconomic status are more likely to develop CKD, as well as have less access to treatment and worse outcomes.
This is the first time the FDA has approved this type of smartphone test, also known as albumin to creatinine ratio (ACR).
An estimated 37 million Americans have CKD, according to the Centers for Disease Control and Prevention. About 9 out of 10 people with this problem do not know they have it.
Dr. Kamyar Kalantar-Zadeh, director of the Division of Nephrology, Hypertension and Kidney Transplantation at UCI Health, Orange, California, says home testing can fill an unmet need by enabling people at risk of CKD to monitor their health. kidney. home.
“Knowing where [high urinary albumin] is present—and how mild or severe it is, or how it changes over time—can help people manage their disease.” Chronic diseases, such as diabetes and high blood pressure, are the most prominent. causes of kidney disease in the US and in many countries,” he said.
Other risk factors for CKD include heart disease, obesity, a family history of CKD, inherited kidney disease, previous kidney damage, and aging.
Kalantar-Zadeh said a high level of albumin, also known as albuminuria, is a common symptom of diabetic kidney disease. He added that if this is detected quickly, the situation can be well managed.
Research suggests that this type of home testing can improve test compliance.
A study conducted by Healthy.io, along with a Pennsylvania health system, found that people who were given the option to use home devices were more likely to complete the ACR test, compared to those who were not. must go. medical laboratory.
LeClair said that once the company has its own supply chain in the US, insurers or doctors will be able to order diagnostic equipment for patients.
In either case, the results will be sent to the doctors, either directly in the electronic medical record or by fax. This can inform doctors about the health of the patients’ kidneys.
“ACR home care will help physicians empower patients to be more involved and compliant in disease management in a patient-centered way,” said Kalantar-Zadeh.
While welcoming this new testing option for patients, Kalantar-Zadeh thinks more home tests for patients with kidney disease, or at risk of kidney disease, are needed. This includes checking kidney function and measuring blood levels of medications used by these patients.
“Home-based measures and care for the management of kidney disease are just beginning, and there is much more to be done,” he said.
As for Somerville, he said he would definitely use the home kidney test again because it’s easier than going to the doctor.
He said: “Often when you go to the doctor, you pick up [a virus or other illness] that you didn’t have the day you came.
