Among the world, about 11% population has chronic kidney disease (CKD). In Taiwan, the increase rate of dialysis patients (end-stage of CKD) is the highest in the world. For dialysis patients, blood urea nitrogen (BUN) is the key parameter for doctor to determine the dialysis efficacy and the nutritional intake condition. However, through blood examination, BUN can not be obtained very frequently.

Here in this project, we like to develop a non-invasive breath ammonia detection to correlate with BUN and hence to serve as an assisting tool for doctor to frequently (i.e. 3 times per week) check the dialysis efficacy and hence to improve the treatment quality. Non-invasive breath testing has been an emerging technology. For breath ammonia, there have been several reports confirming the strong correlation between breath ammonia and BUN.
Our group members have been devoted on developing breath ammonia detecting system in the past 5 years. In 2016, we used the proposed system to do clinical trial on hemodialysis patients and obtained successful results. During the past three years, we have conducted more than 300-persons clinical trials and developed the prototype to try follow the regulation of noninvasive medical equipment. Through the multiple clinical centers’ clinical study,our team confirms that the breath ammonia detection can be used to serve as a screening tool for CKD high risky groups. Also, for hemodialysis patients, high correlation between breath ammonia and BUN can be obtained particularly through personal tracking mode. In the 4th year, we like to prepare for the next step “medical instrument clinical trials”. We will start using commercial silicon wafer process to fabricate the gas sensor. The prototype will be improved further to allow the critical parts to meet the requirement of medical instrument. With a confirmed and prioritized intended use as “CKD screening tool”, more clinical data will be collected and analyzed with bio-statistical methods to try providing a model and to clearly define the following requested sample number in the future“medical instrument clinical trials”.