An electrochemical sensor device for measuring blood ammonia at the point of care.

The level of ammonia in blood is relevant in a number of medical conditions. While ammonia is a marker of dysfunction, elevated ammonia is itself a serious medical emergency and can lead to significant and permanent neurological impairment if not addressed quickly. Blood ammonia testing is typically performed in the central laboratory. While a number of point of care devices have been developed, these are based on classical enzymatic or colorimetric principles and have not been widely adopted. In this work, an electrochemical sensor device was developed for measuring blood ammonia. The device was based on the deposition of polyaniline nanoparticle films onto screen printed interdigitated electrodes using inkjet printing and their integration into a polymer microfabricated device with a polytetrafluoroethylene membrane. The device required a 52µL serum sample and measured the change in impedance of the sensor with respect to air at 1kHz, 5mV rms. The device was capable of the measurement of ammonia in serum across the physiologically relevant range of 25-200µM (r2 =0.9984) and had a limit of detection of 12µM (n =3). The device showed no significant issues with common electrochemical interferences in blood. The device was also validated against a commercial spectrophotometric assay which resulted in excellent correlation (r =0.9699, p<0.0001) between both methods (n =3). When stored under desiccation, devices displayed minimal variation over time (0.64%) with respect to their impedance in air (n =12) and could be stored in desiccant for at least five months.