Summary: Healthy.io’s FDA-cleared Minuteful Kidney Test demonstrated 96.4% sensitivity and 84.2% specificity in detecting albuminuria, showcasing its potential to improve early detection and management of chronic kidney disease (CKD) through accurate, convenient, smartphone-powered at-home testing.
Takeaways:
- Accuracy and Clinical Validation: The Minuteful Kidney Test, evaluated against the gold-standard Beckman Coulter AU 480 analyzer, showed high accuracy with 96.4% sensitivity and 84.2% specificity, exceeding guideline-recommended thresholds for CKD detection.
- Addressing Barriers in CKD Testing: This at-home uACR test overcomes access challenges, offering a cost-effective and convenient solution, especially for socially marginalized communities, to increase early detection and improve adherence to clinical guidelines.
- Public Health Impact: With CKD affecting 37 million U.S. adults—90% of whom are undiagnosed—widespread adoption of the Minuteful Kidney Test can enable earlier interventions, potentially reducing the need for dialysis or transplant and saving lives.
Healthy.io, a global provider in transforming the smartphone camera into a medical device, announced the results of a new study showcasing the success of its smartphone-powered FDA-cleared at-home urinary semi-quantitative albumin-to-creatinine ratio (uACR) test for early indication of kidney disease
The Minuteful Kidney uACR Test
The research, conducted by Birdrock Laboratories, a San Diego-based analytical laboratory in collaboration with Navdeep Tangri, MD, PhD, from University of Manitoba, set out to assess the accuracy of the smartphone-enabled uACR tests compared to the quantitative laboratory test. Healthy.io’s Minuteful Kidney Test is the first and only smartphone-powered FDA-cleared at-home uACR test, the company says. The study demonstrated 96.4% sensitivity for identifying markers for chronic kidney disease against the laboratory test.
The Minuteful Kidney Test’s accuracy was evaluated in comparison to the Beckman Coulter AU 480 analyzer, a gold-standard laboratory quantitative method, for detecting albuminuria in individuals with or at risk for chronic kidney disease (CKD). The study analyzed 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.
Detecting Albuminuria
Albuminuria, an early signifier of CKD, was detected in 24.9% of samples using the quantitative gold-standard analyzer. The Minuteful Kidney Test demonstrated very high accuracy rates with 96.4% sensitivity and 84.2% specificity. The guideline-recommended threshold for sensitivity of this type of test is 85%. Ultimately, 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,” says 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”
Further Reading
Impact of CKD
An estimated 37 million U.S. adults have CKD, a leading cause of death in the U.S., yet most remain undiagnosed and 9 out of 10 Americans don’t know they have the disease. uACR testing is crucial for diagnosing, staging, and managing CKD. Still, despite clinical guidelines, adherence rates of testing remain low, with only 20% of the population at risk routinely testing.
A uACR test detects albuminuria, which is the earliest indication of kidney disease. Getting a diagnosis early is key to preventing complications like End-Stage-Renal-Disease and cardiovascular disease.
The FDA-cleared smartphone-powered home test offers accurate, convenient, cost-effective uACR analysis that can overcome access barriers. New treatments are now available that can stop or slow down the progression of CKD, and given limitations and difficulties for many individuals in accessing laboratory facilities, these tests can accelerate the identification of individuals at risk of CKD, particularly for socially marginalized communities so that they are referred or treated before it is too late.
×´Lack of albuminuria testing is the single biggest barrier in the fight for upstream intervention in CKD”, says Tangri. “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.”
