An FDA-cleared smartphone-enabled test for chronic kidney disease has demonstrated accuracy of 96.4% in a study conducted by independent laboratory Birdrock and the University of Manitoba. Healthy.io’s Minuteful Kidney Test is the only smartphone-powered FDA-cleared at-home test for urinary semi-quantitative albumin-to-creatinine, a marker for chronic kidney disease (CKD). Birdrock Laboratories and Dr Navdeep Tangri for the University of Manitoba assessed the accuracy of the Minuteful test, which uses a smartphone’s camera, compared to a quantitative laboratory test.

The Minuteful Kidney Test’s accuracy was evaluated in comparison to the Beckman Coulter AU 480 analyser, a gold-standard laboratory quantitative method, for detecting albuminuria in individuals with or at risk for CKD. The study analysed 615 urine samples from outpatient settings in economically diverse areas, all of whom showed one of the risk factors for kidney damage, including diabetes, hypertension, cardiovascular disease, a personal history of AKI, a family history of CKD, inherited kidney diseases, early-stage CKD, dyslipidemia, obesity, and other relevant conditions.

Albuminuria, an early signifier of CKD, was detected in 24.9% of samples using the quantitative gold-standard analyser. The Minuteful Kidney Test demonstrated accuracy rates of 96.4% sensitivity and 84.2% specificity. The guideline-recommended threshold for sensitivity of this type of test is 85%.

In a statement, Healthy.io said that the study demonstrates that the Minuteful Kidney Test is an accurate tool for albuminuria testing that can address key barriers and significantly improve CKD testing and management, bridging the gap in current healthcare practice guidelines.

“When trying to solve the CKD crisis, it’s important that we start upstream and identify individuals early who may be at risk before complications arise,” said Geoff Martin, CEO of Healthy.io. “Widespread use of the Minuteful Kidney home test for albuminuria can significantly mitigate the problem of under-detection, ultimately saving millions of lives and getting people to care earlier to delay or ideally reduce the need for transplant or dialysis”

״Lack of albuminuria testing is the single biggest barrier in the fight for upstream intervention in CKD”, said Dr. Navdeep Tangri from University of Manitoba. “Having an accurate at-home test like Minuteful Kidney helps patients and physicians move the needle on this challenge and be more proactive in CKD care.”