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Keywords: Disease Treatment

Market Overview

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.

Applications:

Clinical Diagnostics, Chronic Kidney Disease Monitoring, At-home Testing

Technical Summary:

The components of the prototype device include a mouthpiece, pressure gauge, colorimetric sensor assembly, and breath-collection bag (Fig. 1: Photograph of Prototype Device; Fig. 2: Schematic Showing Principle of Operation). The critical control variables for the breath test are the volume of breath passed through the device, which is simply controlled by the volume of the breath-collection bag, and the flow rate of the breath, which is simply controlled by feedback to the user provided by the pressure gauge.  Thus, unlike several other exhaled-breath-test systems, which rely on complex and expensive components such as electronic sensors, heaters, pumps, dehumidifiers, and filters, this system provides an accurate and immediate measurement of the ammonia concentration in exhaled breath without any electronic components.  Clinical studies have demonstrated high correlation between exhaled-breath ammonia concentration measured using this device and laboratory-provided BUN-level values for patients with various stages of CKD.

Advantages:

  • Non-invasive, real-time sample collection, and immediate results
  • Simple control of breath flow rate and volume providing accurate measurement of breath ammonia concentration in physiological range.
  • Reduced analytical complexity & cost
  • At-home/Point-of-care portability & operation

Download Printable PDF

Technology Overview

State of Development

Utility Application

Category

Biomedical

Serial Number

17/517,919

CURF Reference No.

2021-033

Inventors

Dr. Robert Latour Dr. George Chumanov


For More Info, Contact:

Chris Gesswein
Director of Licensing for Technology Transfer
agesswe@clemson.edu

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