Highly specific protein encapsulated in a porous matrix binds with exhaled nitric oxide (eNO) to accurately measure airway inflammation
The Insight™ eNO System measures exhaled nitric oxide based on a unique and advanced biosensor technology. The sensor utilizes a tiny, porous, glass matrix permeable to nitric oxide. Inside the glass matrix, nitric oxide attaches with highly specific protein molecules. This process of attachment results in a measurable optical signal when light is passed through the matrix. This signal is proportional to the concentration of nitric oxide. By measuring the signal resulting from the attachment process, the Insight system can accurately detect trace amounts of nitric oxide molecules in a single breath sample.
Apieron is the first company to successfully implement a technique utilizing Sol-Gel technology to make a commercial biosensor for the detection of nitric oxide.
The Insight system’s product design and biosensor technology are very unique in many ways:
- The Insight system is highly sensitive to nitric oxide – The Insight eNO System produces a measurable signal that very accurately indicates the amount of nitric oxide in even trace quantities. Nitric oxide measurement results are reported in parts per billion (ppb).
- The Insight system is very specific to nitric oxide – The optical signal from the Insight eNO System is generated only in response to nitric oxide molecules in the breath sample. The system is therefore able to provide reliable nitric oxide measurements over a wide range of concentrations.
- The Insight system is proven up to 18,000 test cycles without servicing. This makes it reliable and appropriate for routine application in busy clinics.
- The Insight system uses individual breath tubes for each patient and does not require the patient to handle the monitor – the system is very hygienic for use in a multi-patient environment.
In addition, the Insight eNO System offers a user-friendly interface to measure eNO and analyze patient data. This allows physicians to tailor therapy precisely and accurately. It also provides a convenient means to print patient data reports and send physician interpretations to health insurance organizations for reimbursement purposes.
The intended use of the Apieron Insight™ eNO System is to quantitatively measure exhaled nitric oxide (eNO) in expired human breath as a marker of inflammation in persons with asthma. Measurement of eNO in expired human breath by the Apieron Insight eNO System is a non-invasive, simple and safe method to measure a decrease in eNO in asthma patients that often occurs after treatment with anti-inflammatory pharmacological therapy as an indication of the therapeutic effects in patients with elevated eNO levels.The Apieron Insight eNO System is suitable for use in children 8 to 17 years of age, and in adults 18 years of age and older. As an adjunct to established clinical assessments, such as spirometry and physical examination, eNO measurements give the physician an objective marker to evaluate the patient's response to anti-inflammatory therapy. The Apieron Insight eNO System can be used by trained operators in a physician's office or laboratory setting. The Apieron Insight eNO System should not be used in critical care, emergency care or in anesthesiology.
Federal law restricts this device to sale by or on the order of a physician.