At-Home/Point-of-Care Breath-Based Ammonia In-vitro Diagnostic Platform for CKD Patients

Chronic kidney disease (CKD), a condition in which a patient’s kidneys fail to effectively filter blood, is estimated to affect more than one-in-seven Americans placing a significant burden on the US healthcare system costing Medicare over $120 billion in 2017. Commonly called the "silent disease," CKD presents with no symptoms in its early stages; therefore, most patients are diagnosed at an advanced stage leading to poor prognosis. Hemodialysis or kidney transplantation are the treatment options for the most advanced stage of kidney disease known as end-stage renal disease (ESRD). However, due to hemodialysis's deleterious effects on cardiac health,and a lack of available kidneys for transplant, ESRD mortality rates remain high. The ability to frequently monitor kidney function, especially in the later stages of CKD, is the key to providing improved management of this chronic condition.
Blood and urine tests are necessary to obtain the measurements needed to monitor and manage kidney disease progression. Glomerular filtration rates (GFR) and albuminuria are used as the criteria for diagnosing and staging CKD. Blood urea nitrogen (BUN) levels help decide when to start dialysis and/or make dietary adjustments. These tests require significant patient compliance as the patient must travel to the clinic for blood drawing for laboratory analysis, with results often taking several days to be returned. Current research has shifted to exploiting biomarkers other than blood and urine as a diagnostic aid to resolve existing clinical diagnostic issues. Measurement of clinically relevant volatile organic compounds (VOCs) in exhaled breath, such as ammonia, has emerged as an ideal solution to this problem due to its non-invasive nature and ease of use, thus leading to increased patient compliance.